Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 07, 2023 | |
Document Information Line Items | ||
Entity Registrant Name | Bluejay Diagnostics, Inc. | |
Trading Symbol | BJDX | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 1,239,140 | |
Amendment Flag | false | |
Entity Central Index Key | 0001704287 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Shell Company | false | |
Entity Ex Transition Period | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-41031 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 47-3552922 | |
Entity Address, Address Line One | 360 Massachusetts Avenue | |
Entity Address, Address Line Two | Suite 203 | |
Entity Address, City or Town | Acton | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 01720 | |
City Area Code | (844) | |
Local Phone Number | 327-7078 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 5,076,937 | $ 10,114,990 |
Prepaid expenses and other current assets | 1,450,805 | 1,673,480 |
Total current assets | 6,527,742 | 11,788,470 |
Property and equipment, net | 1,321,711 | 1,232,070 |
Operating lease right-of-use assets | 367,248 | 465,514 |
Other non-current assets | 29,907 | 35,211 |
Total assets | 8,246,608 | 13,521,265 |
Current liabilities: | ||
Accounts payable | 755,949 | 635,818 |
Operating lease liability, current | 168,716 | 168,706 |
Accrued expenses and other current liabilities | 1,875,475 | 835,730 |
Total current liabilities | 2,800,140 | 1,640,254 |
Operating lease liability, non-current | 220,093 | 323,915 |
Other non-current liabilities | 13,220 | 15,823 |
Total liabilities | 3,033,453 | 1,979,992 |
Commitments and contingencies (Note 9) | ||
Stockholders’ equity: | ||
Common stock, $0.0001 par value; 7,500,000 shares authorized; 1,239,140 and 1,010,560 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 124 | 101 |
Additional paid-in capital | 29,861,279 | 28,538,274 |
Accumulated deficit | (24,648,248) | (16,997,102) |
Total stockholders’ equity | 5,213,155 | 11,541,273 |
Total liabilities and stockholders’ equity | $ 8,246,608 | $ 13,521,265 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in Dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 7,500,000 | 7,500,000 |
Common stock, shares issued | 1,239,140 | 1,010,560 |
Common stock, shares outstanding | 1,239,140 | 1,010,560 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Revenue | $ 249,040 | |||
Cost of sales | 200,129 | |||
Gross profit | 48,911 | |||
Operating expenses: | ||||
Research and development | 1,397,318 | 1,379,665 | 4,428,123 | 2,830,705 |
General and administrative | 963,534 | 1,284,411 | 3,213,614 | 3,801,226 |
Sales and marketing | (19,619) | 146,102 | 282,756 | 281,144 |
Total operating expenses | 2,341,233 | 2,810,178 | 7,924,493 | 6,913,075 |
Operating loss | (2,341,233) | (2,810,178) | (7,924,493) | (6,864,164) |
Other income (expense): | ||||
Impairment of property and equipment | (210,117) | (210,117) | ||
Other income, net | 43,235 | 60,406 | 273,347 | 163,587 |
Total other income (expense), net | 43,235 | (149,711) | 273,347 | (46,530) |
Net loss | $ (2,297,998) | $ (2,959,889) | $ (7,651,146) | $ (6,910,694) |
Net loss per share - Basic (in Dollars per share) | $ (2.08) | $ (2.94) | $ (7.3) | $ (6.86) |
Weighted average common shares outstanding Basic (in Shares) | 1,102,966 | 1,007,617 | 1,048,430 | 1,007,445 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Unaudited) (Parentheticals) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Net loss per share - Diluted | $ (2.08) | $ (2.94) | $ (7.30) | $ (6.86) |
Weighted average common shares outstanding Diluted | 1,102,966 | 1,007,617 | 1,048,430 | 1,007,445 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Unaudited) - USD ($) | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2021 | $ 101 | $ 28,076,394 | $ (7,694,786) | $ 20,381,709 |
Balance (in Shares) at Dec. 31, 2021 | 1,005,612 | |||
Impact of adoption of ASC 842 | (5,368) | (5,368) | ||
Stock-based compensation expense | 126,086 | 126,086 | ||
Exercise of common stock Series B Warrants | ||||
Exercise of common stock Series B Warrants (in Shares) | 1,950 | |||
Net loss | (2,013,403) | (2,013,403) | ||
Balance at Mar. 31, 2022 | $ 101 | 28,202,480 | (9,713,557) | 18,489,024 |
Balance (in Shares) at Mar. 31, 2022 | 1,007,562 | |||
Balance at Dec. 31, 2021 | $ 101 | 28,076,394 | (7,694,786) | 20,381,709 |
Balance (in Shares) at Dec. 31, 2021 | 1,005,612 | |||
Net loss | (6,910,694) | |||
Balance at Sep. 30, 2022 | $ 101 | 28,421,812 | (14,610,848) | 13,811,065 |
Balance (in Shares) at Sep. 30, 2022 | 1,007,617 | |||
Balance at Mar. 31, 2022 | $ 101 | 28,202,480 | (9,713,557) | 18,489,024 |
Balance (in Shares) at Mar. 31, 2022 | 1,007,562 | |||
Stock-based compensation expense | 106,114 | 106,114 | ||
Exercise of common stock Series B Warrants | ||||
Exercise of common stock Series B Warrants (in Shares) | 55 | |||
Net loss | (1,937,402) | (1,937,402) | ||
Balance at Jun. 30, 2022 | $ 101 | 28,308,594 | (11,650,959) | 16,657,736 |
Balance (in Shares) at Jun. 30, 2022 | 1,007,617 | |||
Stock-based compensation expense | 113,218 | 113,218 | ||
Net loss | (2,959,889) | (2,959,889) | ||
Balance at Sep. 30, 2022 | $ 101 | 28,421,812 | (14,610,848) | 13,811,065 |
Balance (in Shares) at Sep. 30, 2022 | 1,007,617 | |||
Balance at Dec. 31, 2022 | $ 101 | 28,538,274 | (16,997,102) | $ 11,541,273 |
Balance (in Shares) at Dec. 31, 2022 | 1,010,560 | 1,010,560 | ||
Stock-based compensation expense | 54,730 | $ 54,730 | ||
Grants of fully vested restricted stock units to settle accrued bonus, net of shares withheld | $ 1 | 107,234 | 107,235 | |
Grants of fully vested restricted stock units to settle accrued bonus, net of shares withheld (in Shares) | 12,188 | |||
Net loss | (2,539,843) | (2,539,843) | ||
Balance at Mar. 31, 2023 | $ 102 | 28,700,238 | (19,536,945) | 9,163,395 |
Balance (in Shares) at Mar. 31, 2023 | 1,022,748 | |||
Balance at Dec. 31, 2022 | $ 101 | 28,538,274 | (16,997,102) | $ 11,541,273 |
Balance (in Shares) at Dec. 31, 2022 | 1,010,560 | 1,010,560 | ||
Exercise of common stock Series B Warrants (in Shares) | ||||
Net loss | $ (7,651,146) | |||
Balance at Sep. 30, 2023 | $ 124 | 29,861,279 | (24,648,248) | $ 5,213,155 |
Balance (in Shares) at Sep. 30, 2023 | 1,239,140 | 1,239,140 | ||
Balance at Mar. 31, 2023 | $ 102 | 28,700,238 | (19,536,945) | $ 9,163,395 |
Balance (in Shares) at Mar. 31, 2023 | 1,022,748 | |||
Stock-based compensation expense | 27,702 | 27,702 | ||
Issuance of common stock | ||||
Issuance of common stock (in Shares) | 750 | |||
RSU tax withholding | (1,453) | (1,453) | ||
RSU tax withholding (in Shares) | (358) | |||
Net loss | (2,813,305) | (2,813,305) | ||
Balance at Jun. 30, 2023 | $ 102 | 28,726,487 | (22,350,250) | 6,376,339 |
Balance (in Shares) at Jun. 30, 2023 | 1,023,140 | |||
Stock-based compensation expense | (42,482) | (42,482) | ||
Issuance of common stock | $ 22 | 1,177,274 | 1,177,296 | |
Issuance of common stock (in Shares) | 216,000 | |||
Net loss | (2,297,998) | (2,297,998) | ||
Balance at Sep. 30, 2023 | $ 124 | $ 29,861,279 | $ (24,648,248) | $ 5,213,155 |
Balance (in Shares) at Sep. 30, 2023 | 1,239,140 | 1,239,140 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Unaudited) (Parentheticals) - USD ($) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Stockholders' Equity [Abstract] | |||
Net of issuance costs | $ 413,544 | $ 413,544 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (7,651,146) | $ (6,910,694) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 626,366 | 125,916 |
Stock-based compensation expense | 204,810 | 345,418 |
Amortization of right-of-use asset | 98,266 | 111,527 |
Impairment of property and equipment | 1,787 | 210,117 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 222,675 | 965,814 |
Other non-current assets | 5,304 | (12,460) |
Accounts payable | 18,609 | (81,067) |
Due to related party | (2,000) | |
Accrued expenses and other current liabilities | 936,936 | 450,079 |
Net cash used in operating activities | (5,536,393) | (4,797,350) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (616,272) | (961,063) |
Net cash used in investing activities | (616,272) | (961,063) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock, gross | 1,590,840 | |
Payment for issuance costs of common stock | (413,544) | |
Payment of tax withholding on obligations on restricted stock units | (59,079) | |
Payment of finance lease | (3,605) | |
Net cash provided by financing activities | 1,114,612 | |
Net decrease in cash and cash equivalents | (5,038,053) | (5,758,413) |
Cash and cash equivalents, beginning of period | 10,114,990 | 19,047,778 |
Cash and cash equivalents, end of period | 5,076,937 | 13,289,365 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION AND NON-CASH INVESTING ACTIVITIES | ||
Reclassification of goods previously classified as inventory to property and equipment | 615,313 | |
Liabilities incurred for the purchase of property and equipment | $ 101,522 | $ 228,324 |
Nature of Operations and Basis
Nature of Operations and Basis of Presentation | 9 Months Ended |
Sep. 30, 2023 | |
Nature of Operations and Basis of Presentation [Abstract] | |
NATURE OF OPERATIONS AND BASIS OF PRESENTATION | 1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION Business Bluejay Diagnostics, Inc. (“Bluejay” or the “Company”) is a medical diagnostics company developing rapid tests using whole blood, plasma, and serum on our Symphony technology platform (“Symphony”) to improve patient outcomes in critical care settings. The Company’s Symphony platform is a combination of Bluejay’s intellectual property (“IP”) and exclusively licensed and patented IP that consists of a mobile device and single-use test cartridges that if cleared, authorized, or approved by the U.S. Food and Drug Administration (the “FDA”), can provide a solution to a significant market need in the United States. Clinical trials indicate the Symphony device produces laboratory-quality results in less than 20 minutes in intensive care units and emergency rooms, where rapid and reliable results are required. Bluejay’s first product, the Symphony IL-6 test, is for the monitoring of disease progression in critical care settings. IL-6 is a clinically established inflammatory biomarker, considered a ‘first-responder’ for the assessment of severity of infection and inflammation across many disease indications, including sepsis. A current challenge of healthcare professionals is the excessive time and cost associated with the determination of a patient’s level of severity at triage and The Symphony IL-6 test has the ability to consistently monitor this critical care biomarker with rapid results. In the future, Bluejay plans to develop additional tests for the Symphony platform, including two cardiac biomarkers (hsTNT and NT pro-BNP), as well as others. The Company does not yet have regulatory clearance for its Symphony products, and its Symphony products will need to receive regulatory authorization from the FDA to be marketed as a diagnostic product in the United States. Bluejay’s operations to date have been funded primarily through the proceeds of the Company’s initial public offering (the “IPO”) in November 2021 (the “IPO Date”). On June 4, 2021, the Company formed Bluejay Spinco, LLC, a wholly owned subsidiary of the Company, for potential further development of the Company’s ALLEREYE diagnostic test. ALLEREYE is a point-of-care device offering healthcare providers a solution for diagnosing Allergic Conjunctivitis. August 2023 Financing On August 24, 2023, the Company entered into a securities purchase agreement with certain institutional and accredited investors (the “Purchase Agreement”) relating to the registered direct offering and sale of 216,000 shares of the Company’s common stock at a purchase price of $7.365 per share (the “Offering”). In a concurrent private placement, the Company also issued to such institutional and accredited investors unregistered warrants to purchase up to 216,000 shares of Common Stock (the “Warrants”). Pursuant to the terms of the Purchase Agreement, for each share of Common Stock issued in this offering an accompanying Warrant was issued to the purchaser thereof. Each Warrant is exercisable for one share of Common Stock (the “Warrant Shares”) at an exercise price of $7.24 per share, will be immediately exercisable upon issuance and will expire five years from the date of issuance. The Warrants were offered and sold at a purchase price of $0.125 per underlying warrant share, which purchase price is included in the offering price per share of Common Stock issued in the Offering (the “Private Placement”). Pursuant to an engagement letter, dated as of August 7, 2023 (the “Engagement Letter”), between the Company and H.C. Wainwright & Co., LLC, or the placement agent, the Company agreed to pay the placement agent a total cash fee equal to 7.0% of the gross proceeds received in the Offering and the Private Placement. The Company also agreed to pay the placement agent in connection with the Offering and the Private Placement a management fee equal to 1.0% of the gross proceeds raised in the Offering and Private Placement, $45,000 for non-accountable expenses, and $15,950 for clearing fees. In addition, the Company agreed to issue to the placement agent, or its designees, warrants to purchase up to 15,120 shares of Common Stock (the “Placement Agent Warrants”), which represents 7.0% of the aggregate number of shares of Common Stock sold in the Offering. The Placement Agent Warrants have substantially the same terms as the Warrants, except that the Placement Agent Warrants have an exercise price equal to $ 9.2063, or 125% of the offering price per share of Common Stock sold in the Offering, and a term of five years from the commencement of the sales pursuant to the Offering. The gross proceeds to the Company from the Offering and the Private Placement are $1,590,840. The Company incurred offering costs of $413,544. FDA Regulatory Strategy The Company’s current regulatory strategy is designed to support commercialization of Symphony in the United States pending marketing authorization from the FDA. Previously, the Company’s regulatory strategy involved clinical studies involving COVID-19 patients. However, the Company has shifted its focus away from COVID-19 patients due to a significant decline in the number of COVID-19 related hospitalizations. Pursuant to this revised strategy, the Company plans to conduct a clinical study to support an FDA regulatory submission with an initial indication for risk stratification of hospitalized sepsis patients. The Company submitted a pre-submission application to the FDA presenting the new study design in May 2023 and participated in a pre-submission meeting on August 11, 2023. At the meeting, the FDA provided feedback on the new study design, determined that the submission of a 510(k) is the appropriate premarket submission pathway, and requested that certain data be provided in the 510(k). Based on this feedback, the Company intends to proceed as planned while taking into account the FDA’s feedback. The Company believes that it will maintain the previously disclosed Symphony IL-6 regulatory submission timeline of the first half of 2024. The Company has targeted certain medical institutions for its study, which the Company believes will also help support initial commercialization and market penetration. The Company believes that this clinical trial expansion could also support additional indications, but that any such expansion also could delay obtaining marketing authorization for the product. Based on the pre-submission meeting with the FDA, the focus of the clinical trial will be the risk stratification of hospitalized sepsis patients. The Company maintains contracts with Sanyoseiko Co. Ltd (“Sanyoseiko”) to manufacture our device and cartridges, and with Toray Industries, Inc (“Toray”) to manufacture in the near-term (through its wholly owned subsidiary Kamakura Techno-Science, Inc.) certain product intermediary components for use in cartridges being manufactured for the Company by Sanyoseiko. Risks and Uncertainties As noted above, Bluejay is reliant upon Toray and Sanyoseiko to provide cartridges in sufficient quantity and quality to complete our clinical trials, and our clinical trials could be delayed if the Company encountered any material supply interruptions while the clinical trials are being conducted. In addition, there can be no assurance that we will be able to obtain necessary regulatory authorization for the manufacturing or marketing of the Symphony in the United States or elsewhere. There also can be no assurance that we will successfully complete any clinical evaluations necessary to receive regulatory approvals, or that the clinical trial will demonstrate sufficient safety and efficacy of the Symphony. The failure to adequately demonstrate the clinical performance of the Symphony device could delay or prevent regulatory approval of the device, which could prevent or result in delays to market launch and could materially harm our business. In addition to the FDA regulatory strategy 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. On October 25, 2022, the Company received a notification letter from the Nasdaq Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the closing bid price for its common stock had been below $1.00 for the previous 30 consecutive business days and that the Company therefore is not in compliance with the minimum bid price requirement for continued inclusion on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). On April 25, 2023, at the Company’s request, Nasdaq’s Listing Qualifications Staff notified the Company that it had extended the time for the Company to regain compliance with the Minimum Bid Requirement until October 23, 2023. To regain compliance, the closing bid price of the Company’s common stock needed to be at least $1.00 or higher for a minimum of ten consecutive business days. On July 24, 2023, the Company executed a reverse stock split of its shares of common stock at a ratio of 1-for-20 (the “Reverse Stock Split”), with a corresponding reduction in the number of authorized outstanding number of shares of common stock from 100,000,000 to 7,500,000. The Reverse Stock Split became effective on July 24, 2023, when the Company’s common stock opened for trading on The Nasdaq Capital Market on a post-split basis under the Company’s existing trading symbol, “BJDX.” At such time, the Company’s common stock also commenced trading with a new CUSIP number, 095633301. On August 8, 2023, the Company received a letter from the Listing Qualifications Department of Nasdaq notifying the Company that, based on the closing bid price of the Company’s common stock having been at least $1.00 per share for the required period, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2) and the minimum bid price deficiency matter previously disclosed by the Company on October 25, 2022 is now closed. All of the Company’s historical share and per share information related to issued and outstanding common stock and outstanding options and warrants exercisable for common stock in these financial statements have been adjusted, on a retroactive basis, to reflect this 1-for-20 reverse stock split. Going Concern The Condensed Consolidated Financial Statements for the nine month periods ended September 30, 2023 and 2022 were prepared under the assumption that the Company will continue as a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business. The Company has incurred net losses since its inception, and has negative cash flows from operations and will need additional funding to complete planned development efforts. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The Company had cash and cash equivalents of $5,076,937, as of September 30, 2023. The Company continues to develop the Symphony device and its first test for the measurement of IL-6. The Company remains committed to obtaining FDA clearance and will conduct clinical trials to obtain sufficient data to support its FDA submission, while also continuing to build its manufacturing operations with its contract manufacturing organizations. Current cash resources and expected operating expenses are considered in determining its liquidity requirement; as well as $2,800,140 of current liabilities on its balance sheet as of September 30, 2023. The Company estimates cash resources will be sufficient to fund its operations into the first quarter of 2024. The Company will need additional capital to fund its planned operations for the next 12 months. The Company expects that it will seek to raise such additional capital through public or private equity offerings, grant financing and support from governmental agencies, convertible debt, collaborations, strategic alliances and distribution arrangements. Additional funds may not be available when it needs them on terms that are acceptable to them, or at all. If adequate funds are not available, it may be required to delay its FDA regulatory strategy, and to delay or reduce the scope of its research or development programs, its commercialization efforts or its manufacturing commitments and capacity. In addition, if it raises additional funds through collaborations, strategic alliances or distribution arrangements with third parties, it may have to relinquish valuable rights to its technologies or future revenue streams. 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, 2022 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 September 30, 2023 and December 31, 2022, its results of operations and cash flows for the three and nine months ended September 30, 2023 and 2022, 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 three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2023, or any other interim period within this fiscal year. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Significant Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | 2. SIGNIFICANT ACCOUNTING POLICIES During the nine months ended September 30, 2023, there were no changes to the significant accounting policies as described in the 2022 Audited Financial Statements. Use of estimates The preparation of financial statements in conformity with U.S. 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, 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. Stock-based compensation Stock-based compensation expense for all stock-based payment awards made to employees, directors and non-employees is measured based on the grant-date fair value of the award. Stock-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 stock-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 stock-based payments when they occur. Forfeited options are recorded as a reduction to stock compensation expense. 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’s structure and how it manages the business. 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 options outstanding under the Company’s stock option plan, restricted stock units, 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): September 30, 2023 2022 Options to purchase common stock 31,361 39,389 Restricted stock units 7,875 - Warrants for common stock 271,714 40,594 Class A warrants for common stock 124,200 124,200 Class B warrants for common stock 3,770 3,770 Recently Adopted Accounting Standards In October 2021, the FASB issued ASU No. 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers (“ASU 805”) Revenue from Contracts with Customers (Topic 606) (“ Recently Issued Accounting Standards The Company does not believe that any recently issued but not yet effective accounting pronouncements will have a material effect on the accompanying condensed consolidated financial statements. |
License and Supply Agreement wi
License and Supply Agreement with Toray Industries | 9 Months Ended |
Sep. 30, 2023 | |
License and Supply Agreement with Toray Industries [Abstract] | |
LICENSE AND SUPPLY AGREEMENT WITH TORAY INDUSTRIES | 3. LICENSE AND SUPPLY AGREEMENT WITH TORAY INDUSTRIES On October 6, 2020, the Company entered into a License and Supply Agreement (“License Agreement”) with Toray Industries, Inc. (“Toray”). Under the License Agreement, the Company received the exclusive license (outside of Japan) to make and distribute protein detection cartridges that have a function of automatic stepwise feeding of reagent (the “Cartridges”). In addition, following the first sale of the Cartridges after regulatory approval, the Company will make royalty payments to Toray equal to 15% of the net sales of the Cartridges for the period that any underlying patents exist or five years after the first sale. Following the first sale after obtaining regulatory approval, the Company will make minimum annual royalty payments of $60,000 for the first year and $100,000 for each year thereafter, which shall be creditable against any royalties owed to Toray in such calendar year. There were no sales of or revenues from the Cartridges during the nine-month periods ended September 30, 2023 and 2022. As of September 30, 2023 and December 31, 2022, there were no amounts accrued related to the License Agreement. On October 23, 2023, the Company and Toray entered into an Amended and Restated License Agreement (the “New Toray License Agreement”) and a Master Supply Agreement (the “New Toray Supply Agreement”). Please refer to Note 10 for further detail. |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2023 | |
Warrants [Abstract] | |
WARRANTS | 4. WARRANTS The following table summarizes information with regard to warrants outstanding as of September 30, 2023: Shares Exercisable for Weighted Weighted Common Stock Warrants 271,714 Common Stock $ 15.94 4.5 Class A Warrants 124,200 Common Stock $ 140.00 3.1 Class B Warrants 3,770 Common Stock $ 200.00 3.1 As part of the Offering that occurred during the three- and nine- month periods ended September 30, 2023, the Company also issued 216,000 Warrants and 15,120 Placement Agent Warrants, which were accounted for as equity classified financial instruments under ASC 815, Derivatives and Hedging No warrants were issued during the three and nine months ended September 30, 2022. Class A Warrants and Class B Warrants In conjunction with the Company’s IPO in November 2021 the Company issued 108,000 Class A Warrants and 108,000 Class B Warrants. Additionally, the underwriter of the IPO exercised their overallotment option, solely with respect to the Class A Warrants and Class B Warrants, shortly after the IPO Date resulting in an additional issuance of 16,200 Class A Warrants and 16,200 Class B Warrants. Class A Warrants entitle the holder to purchase one share of common stock at an exercise price of $140.00 per share. As of September 30, 2023 all Class A Warrants were outstanding. As of September 30, 2023 and 2022, there remain 124,200 Class A Warrants outstanding. Class B Warrants entitle the holder to purchase one share of common stock at an exercise price of $200.00 per share. Holders of Class B Warrants may also exercise such warrants on a “cashless” basis after the earlier of (i) 10 trading days from closing date of the offering or (ii) the time when $10.0 million of volume is traded in the Company’s common stock, if the volume weighted average price of the Company’s common stock on any trading day on or after the closing date of the offering fails to exceed the exercise price of the Class B Warrant (subject to adjustment as described in the warrant agreement). During the nine months ended September 30, 2023, no Class B Warrants were exercised, while during the nine months ended September 30, 2022, 40,100 Class B Warrants were exercised, all on a cashless basis. As of September 30, 2023 and 2022, there were 3,770 Class B Warrants outstanding. |
Stock Compensation
Stock Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Stock Compensation [Abstract] | |
STOCK COMPENSATION | 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, 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 units. The maximum number of shares reserved for issuance under the 2018 Plan is 31,472. As of September 30, 2023, there were 13,113 shares available for grant under the 2018 Plan. 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 98,000 shares of common stock were approved to be initially reserved for issuance under the 2021 Stock Plan. As of September 30, 2023, there were 40,377 shares available for grant under the 2021 Plan. Stock Award Activity The following table summarizes the status of the Company’s non-vested restricted stock units for the nine months ended September 30, 2023: Non-vested Restricted Stock Units Number of Weighted Outstanding at December 31, 2022 3,000 $ 25.80 Granted 25,609 8.80 Vested (19,484 ) 9.45 Cancelled / forfeited (1,250 ) 25.80 Outstanding at September 30, 2023 7,875 $ 10.96 In February 2023, the Company issued 18,734 fully vested restricted stock units to certain employees as a portion of their 2022 bonuses, for which, the Company incurred expenses of $164,860. The following is a summary of stock option activity for the nine months ended September 30, 2023: Stock options Number of Weighted Weighted Aggregate Outstanding at December 31, 2022 35,992 $ 39.25 6.5 $ 20,578 Granted 1,000 10.60 Exercised - - Cancelled / forfeited (5,631 ) 50.66 Outstanding at September 30, 2023 31,361 $ 36.28 7.0 $ 5,141 Exercisable at September 30, 2023 26,405 $ 35.10 6.8 $ 5,141 The weighted average grant date fair value of options granted during the nine months ended September 30, 2023 and 2022 was $8.80 per share and $29.00 per share, respectively. The Company calculated the grant-date fair value of stock option awards granted during the nine months ended September 30, 2023 and 2022 using the Black-Scholes model with the following assumptions: Nine Months Ended 2023 2022 Risk-free interest rate 3.63% 1.58% – 3.06% Expected dividend yield 0.00% 0.00% Volatility factor 108.78% 102.03% - 140.40% Expected life of option (in years) 6.00 5.37 – 6.00 Stock-Based Compensation Expense For the three and nine months ended September 30, 2023 and 2022, the Company recorded stock-based compensation expense as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 9,393 $ 20,528 $ 54,389 $ 54,231 General and administrative (30,275 ) 92,531 157,971 290,397 Sales and marketing (21,600 ) 160 (7,550 ) 790 Total stock-based compensation $ (42,482 ) $ 113,219 $ 204,810 $ 345,418 As of September 30, 2023, there was $46,083 of unrecognized compensation expense related to non-vested stock option awards that are expected to be recognized over a weighted-average period of 8.56 years. As of September 30, 2023, there was $31,872 of unrecognized compensation expense related to non-vested restricted stock units that are expected to be recognized over a weighted-average period of 9.11 years. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | 6. RELATED PARTY TRANSACTIONS NanoHybrids Inc. In December 2021, the Company entered into an agreement with NanoHybrids, Inc. (“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 10%. Additionally, the Company may purchase certain lab supplies for NanoHybrids and rebill these costs to NanoHybrids. The Company’s Chief Technology Officer is the majority shareholder of NanoHybrids. The table below summarizes the amounts earned and due from NanoHybrids as of and for the three and nine month periods ended September 30, 2023 and 2022, and balances due as of September 30, 2023 and December 31, 2022: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Income from NanoHybrids included in Other Income $ - $ 42,649 $ 136,773 $ 118,575 Cash receipts from NanoHybrids $ - $ 35,040 $ 156,504 $ 75,926 As of September 30, December 31, Amounts receivable from NanoHybrids included in Prepaids and Other Current Assets $ - $ 19,731 |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2023 | |
Property and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | 7. PROPERTY AND EQUIPMENT, NET Property and equipment, net consisted of the following at September 30, 2023 and December 31, 2022: Depreciable September 30, December 31, Construction-in-process $ 1,067,149 $ 375,466 Furniture, fixtures, and equipment 3-5 years 141,164 136,942 Software 3-5 years 4,457 4,457 Lab equipment 3-5 years 1,287,783 1,268,380 Leasehold improvements Shorter of useful life or lease term 43,231 43,231 2,543,784 1,828,476 Less: accumulated depreciation (1,222,073 ) (596,406 ) Property and equipment, net $ 1,321,711 $ 1,232,070 The Company reviews long-lived assets for impairment when events, expectations, or changes in circumstances indicate that the asset’s carrying value may not be recoverable. As a result of this review in 2023, the Company revised the useful life of certain lab equipment in the first quarter of 2023 due to a change in expectations of the time the equipment will be used which resulted in approximately $431,740 of additional depreciation recorded in the nine months ended September 30, 2023. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
LEASES | 8. LEASES The Company primarily enters into lease arrangements for office and laboratory space. A summary of supplemental lease information is as follows: Nine Months Ended September 30, September 30, Weighted average remaining lease term - operating leases (in years) 3.1 3.9 Weighted average remaining lease term - finance leases (in years) 4.3 5.3 Weighted average discount rate 7.0 % 7.0 % Operating cash flows from operating leases $ 130,692 $ 113,083 Operating cash flows from finance leases $ 3,605 - A summary of the Company’s lease assets and liabilities are as follows: As of September 30, December 31, 2022 Operating lease right-of-use asset $ 367,248 $ 465,514 Finance leases in Property and Equipment 21,067 21,067 Total lease assets 388,315 486,581 Current portion of operating lease liability 168,716 168,706 Current portion of finance lease liability included in accrued expenses 4,807 4,807 Noncurrent operating lease liabilities 220,093 323,915 Noncurrent finance lease liabilities 13,220 15,823 Total lease liabilities $ 406,836 513,251 A summary of the Company’s estimated lease payments are as follows: Year Finance Leases Operating Leases 2023* $ 1,202 $ 42,177 2024 4,807 162,991 2025 4,807 100,000 2026 4,807 100,000 2027 5,207 25,000 Thereafter - - Total future lease payments 20,830 430,168 Less: Imputed interest 2,803 41,359 Present value of lease liability $ 18,027 $ 388,809 (*) Excludes the nine months ended September 30, 2023 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 9. COMMITMENTS AND CONTINGENCIES Separation Agreement Under the terms of a separation agreement with Mr. Kenneth Fisher, the Company’s former Chief Financial Officer, the Company has agreed to compensate Mr. Fisher $240,000 (representing six months of base salary and the pro rata amount of Mr. Fisher’s 2023 target bonus). The payment of such amounts are subject to the compliance by Mr. Fisher of certain ongoing covenants with respect to confidentiality, cooperation and other matters. Mr. Fisher departed from the Company on September 26, 2023, and the Company has recorded a severance liability of $240,000, which has been included in accrued expenses and other current liabilities on the Company’s Condensed Consolidated Balance Sheets as of September 30, 2023. Minimum Royalties As required under the License Agreement (see Note 3), following the first sale of Cartridges, the Company will also make royalty payments to Toray equal to 15% of the net sales of the Cartridges for the period that any underlying patents exist or for 5 years after the first sale. Following the first sale, the Company will pay a one-time minimum royalty of $60,000, which shall be creditable against any royalties owed to Toray in such calendar year. The Company will pay a minimum royalty of $100,000 in each year thereafter, which are creditable against any royalties owed to Toray in such calendar year. There were no sales of or revenues from the Cartridges through September 30, 2023. On October 23, 2023, the Company and Toray entered into an Amended and Restated License Agreement (the “New Toray License Agreement”) and a Master Supply Agreement (the “New Toray Supply Agreement”). Please refer to Note 10 for further detail. Indemnification The Company has certain agreements with service providers with which it does business that contain indemnification provisions pursuant to which the Company typically agrees to indemnify the party against certain types of third-party claims. The Company accrues for known indemnification issues when a loss is probable and can be reasonably estimated. The Company would also accrue for estimated incurred but unidentified indemnification issues based on historical activity. As the Company has not incurred any indemnification losses to date, there were no accruals for or expenses related to indemnification issues for any period presented. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 10. SUBSEQUENT EVENTS The Company did not identify any subsequent events that require adjustment or disclosure in the unaudited condensed consolidated financial statements other than discussed below. On October 23, 2023, the Company and Toray entered into the New Toray License Agreement and the New Toray Supply Agreement. The New Toray License Agreement and the New Toray Supply Agreement amend and supersede the prior License and Supply Agreement entered into by the parties in October 2020 and amended in July 2021. Under the New Toray License Agreement, the Company continues to license from Toray intellectual property rights needed to manufacture single-use test cartridges, and the Company has received the right to sublicense certain Toray intellectual property to Sanyoseiko in connection with Sanyoseiko’s ongoing agreement with the Company to manufacture its Symphony device and cartridges (including in connection with the Company’s clinical trials). In addition, the New Toray License Agreement provides for the transfer of certain technology related to the cartridges to Sanyoseiko. The royalty payments payable by the Company to Toray have been reduced under the New Toray License Agreement from 15% to 7.5% (or less in certain circumstances) of net sales of certain cartridges for a term of 10 years. A 50% reduction in the royalty rate applies upon expiry of applicable Toray patents on a product-by-product and country-by-country basis. The New Toray License Agreement contemplates that applicable royalty payment obligations from the Company to Toray for other products will be determined separately by the parties in the future. Under the New Toray Supply Agreement, Toray will manufacture in the near-term (through its wholly owned subsidiary Kamakura Techno- Science, Inc.) certain product intermediary components for use in cartridges being manufactured for the Company by Sanyoseiko. These cartridges made using Toray intermediates are for the purpose of obtaining FDA approval and not for commercial sale. The New Toray Supply Agreement has a term ending on the earlier of October 23, 2025 or the date that the Company obtains FDA approval for its product, and may be extended for up to six months by mutual agreements of the parties. Once FDA approval has been obtained, the intermediates and cartridges will be manufactured by SanyoSeiko under a separate supply agreement between the Company and SanyoSeiko. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Significant Accounting Policies [Abstract] | |
Use of estimates | Use of estimates The preparation of financial statements in conformity with U.S. 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, 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. |
Stock-based compensation | Stock-based compensation Stock-based compensation expense for all stock-based payment awards made to employees, directors and non-employees is measured based on the grant-date fair value of the award. Stock-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 stock-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 stock-based payments when they occur. Forfeited options are recorded as a reduction to stock compensation expense. |
Research and development expenses | 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 | Segment Reporting Management has determined that the Company has one operating segment, which is consistent with the Company’s structure and how it manages the business. |
Net Loss per Share | 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 options outstanding under the Company’s stock option plan, restricted stock units, 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): September 30, 2023 2022 Options to purchase common stock 31,361 39,389 Restricted stock units 7,875 - Warrants for common stock 271,714 40,594 Class A warrants for common stock 124,200 124,200 Class B warrants for common stock 3,770 3,770 |
Recently Issued Accounting Standards | Recently Issued Accounting Standards The Company does not believe that any recently issued but not yet effective accounting pronouncements will have a material effect on the accompanying condensed consolidated financial statements. |
Recently Adopted Accounting Standards | Recently Adopted Accounting Standards In October 2021, the FASB issued ASU No. 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers (“ASU 805”) Revenue from Contracts with Customers (Topic 606) (“ |
Significant Accounting Polici_2
Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Significant Accounting Policies [Abstract] | |
Schedule of Diluted Net Loss Per Share | 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): September 30, 2023 2022 Options to purchase common stock 31,361 39,389 Restricted stock units 7,875 - Warrants for common stock 271,714 40,594 Class A warrants for common stock 124,200 124,200 Class B warrants for common stock 3,770 3,770 |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Warrants [Abstract] | |
Schedule of Information with Regard to Warrants Outstanding | The following table summarizes information with regard to warrants outstanding as of September 30, 2023: Shares Exercisable for Weighted Weighted Common Stock Warrants 271,714 Common Stock $ 15.94 4.5 Class A Warrants 124,200 Common Stock $ 140.00 3.1 Class B Warrants 3,770 Common Stock $ 200.00 3.1 |
Stock Compensation (Tables)
Stock Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stock Compensation [Abstract] | |
Schedule of Non-vested Restricted Stock Units | The following table summarizes the status of the Company’s non-vested restricted stock units for the nine months ended September 30, 2023: Non-vested Restricted Stock Units Number of Weighted Outstanding at December 31, 2022 3,000 $ 25.80 Granted 25,609 8.80 Vested (19,484 ) 9.45 Cancelled / forfeited (1,250 ) 25.80 Outstanding at September 30, 2023 7,875 $ 10.96 |
Schedule of Stock Option Activity | The following is a summary of stock option activity for the nine months ended September 30, 2023: Stock options Number of Weighted Weighted Aggregate Outstanding at December 31, 2022 35,992 $ 39.25 6.5 $ 20,578 Granted 1,000 10.60 Exercised - - Cancelled / forfeited (5,631 ) 50.66 Outstanding at September 30, 2023 31,361 $ 36.28 7.0 $ 5,141 Exercisable at September 30, 2023 26,405 $ 35.10 6.8 $ 5,141 |
Schedule of Grant-Date Fair Value of Stock Option Awards Granted | The Company calculated the grant-date fair value of stock option awards granted during the nine months ended September 30, 2023 and 2022 using the Black-Scholes model with the following assumptions: Nine Months Ended 2023 2022 Risk-free interest rate 3.63% 1.58% – 3.06% Expected dividend yield 0.00% 0.00% Volatility factor 108.78% 102.03% - 140.40% Expected life of option (in years) 6.00 5.37 – 6.00 |
Schedule of Stock-Based Compensation Expense | For the three and nine months ended September 30, 2023 and 2022, the Company recorded stock-based compensation expense as follows: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Research and development $ 9,393 $ 20,528 $ 54,389 $ 54,231 General and administrative (30,275 ) 92,531 157,971 290,397 Sales and marketing (21,600 ) 160 (7,550 ) 790 Total stock-based compensation $ (42,482 ) $ 113,219 $ 204,810 $ 345,418 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Schedule of Due from Related Parties | The table below summarizes the amounts earned and due from NanoHybrids as of and for the three and nine month periods ended September 30, 2023 and 2022, and balances due as of September 30, 2023 and December 31, 2022: Three Months Ended Nine Months Ended 2023 2022 2023 2022 Income from NanoHybrids included in Other Income $ - $ 42,649 $ 136,773 $ 118,575 Cash receipts from NanoHybrids $ - $ 35,040 $ 156,504 $ 75,926 |
Schedule of Balance Due | As of September 30, December 31, Amounts receivable from NanoHybrids included in Prepaids and Other Current Assets $ - $ 19,731 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following at September 30, 2023 and December 31, 2022: Depreciable September 30, December 31, Construction-in-process $ 1,067,149 $ 375,466 Furniture, fixtures, and equipment 3-5 years 141,164 136,942 Software 3-5 years 4,457 4,457 Lab equipment 3-5 years 1,287,783 1,268,380 Leasehold improvements Shorter of useful life or lease term 43,231 43,231 2,543,784 1,828,476 Less: accumulated depreciation (1,222,073 ) (596,406 ) Property and equipment, net $ 1,321,711 $ 1,232,070 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Schedule of Lease Arrangements for Office and Laboratory Space | The Company primarily enters into lease arrangements for office and laboratory space. A summary of supplemental lease information is as follows: Nine Months Ended September 30, September 30, Weighted average remaining lease term - operating leases (in years) 3.1 3.9 Weighted average remaining lease term - finance leases (in years) 4.3 5.3 Weighted average discount rate 7.0 % 7.0 % Operating cash flows from operating leases $ 130,692 $ 113,083 Operating cash flows from finance leases $ 3,605 - |
Schedule of Lease Assets and Liabilities | A summary of the Company’s lease assets and liabilities are as follows: As of September 30, December 31, 2022 Operating lease right-of-use asset $ 367,248 $ 465,514 Finance leases in Property and Equipment 21,067 21,067 Total lease assets 388,315 486,581 Current portion of operating lease liability 168,716 168,706 Current portion of finance lease liability included in accrued expenses 4,807 4,807 Noncurrent operating lease liabilities 220,093 323,915 Noncurrent finance lease liabilities 13,220 15,823 Total lease liabilities $ 406,836 513,251 |
Schedule of Estimated Operating Lease Payments | A summary of the Company’s estimated lease payments are as follows: Year Finance Leases Operating Leases 2023* $ 1,202 $ 42,177 2024 4,807 162,991 2025 4,807 100,000 2026 4,807 100,000 2027 5,207 25,000 Thereafter - - Total future lease payments 20,830 430,168 Less: Imputed interest 2,803 41,359 Present value of lease liability $ 18,027 $ 388,809 (*) Excludes the nine months ended September 30, 2023 |
Nature of Operations and Basi_2
Nature of Operations and Basis of Presentation (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||||||||
Aug. 24, 2023 | Aug. 08, 2023 | Aug. 07, 2023 | Apr. 25, 2023 | Oct. 25, 2022 | Sep. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Jul. 24, 2023 | Apr. 07, 2023 | Dec. 31, 2022 | |
Nature of Operations and Basis of Presentation (Details) [Line Items] | |||||||||||
Exercisable warrant (in Shares) | 1 | 1 | |||||||||
Exercise price per share | $ 9.2063 | $ 7.24 | $ 7.24 | ||||||||
Purchase price of per underlying warrant share | $ 0.125 | $ 0.125 | |||||||||
Percentage of cash fees | 7% | ||||||||||
Percentage of management fees | 1% | ||||||||||
Non-accountable expenses (in Dollars) | $ 45,000 | ||||||||||
Clearing fees (in Dollars) | $ 15,950 | ||||||||||
Warrants to purchase (in Shares) | 15,120 | ||||||||||
Common stock percentage | 7% | ||||||||||
Offering price percentage | 125% | ||||||||||
Gross proceeds (in Dollars) | $ 1,590,840 | ||||||||||
Offering costs (in Dollars) | $ 413,544 | $ 413,544 | |||||||||
Common stock closing bid price | $ 1 | $ 1 | $ 1 | ||||||||
Reverse stock split, description | On July 24, 2023, the Company executed a reverse stock split of its shares of common stock at a ratio of 1-for-20 | ||||||||||
Common stock shares outstanding (in Shares) | 1,239,140 | 1,239,140 | 1,010,560 | ||||||||
Cash and cash equivalents (in Dollars) | $ 5,076,937 | $ 5,076,937 | $ 10,114,990 | ||||||||
Current liabilities (in Dollars) | $ 2,800,140 | $ 2,800,140 | $ 1,640,254 | ||||||||
IPO [Member] | |||||||||||
Nature of Operations and Basis of Presentation (Details) [Line Items] | |||||||||||
Sale of shares (in Shares) | 216,000 | ||||||||||
Price per share | $ 7.365 | ||||||||||
Private Placement [Member] | |||||||||||
Nature of Operations and Basis of Presentation (Details) [Line Items] | |||||||||||
Class of warrants or rights warrants issued during the period (in Shares) | 216,000 | ||||||||||
Maximum [Member] | |||||||||||
Nature of Operations and Basis of Presentation (Details) [Line Items] | |||||||||||
Common stock shares outstanding (in Shares) | 100,000,000 | ||||||||||
Minimum [Member] | |||||||||||
Nature of Operations and Basis of Presentation (Details) [Line Items] | |||||||||||
Common stock shares outstanding (in Shares) | 7,500,000 |
Significant Accounting Polici_3
Significant Accounting Policies (Details) - Schedule of Diluted Net Loss Per Share - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Class A warrants for common stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 124,200 | 124,200 |
Class B warrants for common stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 3,770 | 3,770 |
Warrants for Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 271,714 | 40,594 |
Options to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 31,361 | 39,389 |
Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities | 7,875 |
License and Supply Agreement _2
License and Supply Agreement with Toray Industries (Details) - USD ($) | Oct. 06, 2020 | Sep. 30, 2023 |
License and Supply Agreement with Toray Industries [Line Items] | ||
Percentage of net sales | 15% | |
Sale term for the period | 5 years | |
First Year [Member] | ||
License and Supply Agreement with Toray Industries [Line Items] | ||
Annual royalty payments | $ 60,000 | |
Each Year Thereafter [Member] | ||
License and Supply Agreement with Toray Industries [Line Items] | ||
Annual royalty payments | $ 100,000 |
Warrants (Details)
Warrants (Details) - $ / shares | 1 Months Ended | 9 Months Ended | ||||
Nov. 30, 2021 | Sep. 30, 2023 | Dec. 30, 2023 | Aug. 07, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | |
Warrant [Line Items] | ||||||
Purchase share of common stock issued | 1 | |||||
Issuance exercise price, per share (in Dollars per share) | $ 7.24 | $ 9.2063 | ||||
Class B warrant rights, description | Holders of Class B Warrants may also exercise such warrants on a “cashless” basis after the earlier of (i) 10 trading days from closing date of the offering or (ii) the time when $10.0 million of volume is traded in the Company’s common stock, if the volume weighted average price of the Company’s common stock on any trading day on or after the closing date of the offering fails to exceed the exercise price of the Class B Warrant (subject to adjustment as described in the warrant agreement). | |||||
Warrants [Member] | ||||||
Warrant [Line Items] | ||||||
Shares issued | 216,000 | |||||
Placement Agent Warrants [Member] | ||||||
Warrant [Line Items] | ||||||
Shares issued | 15,120 | |||||
Class B Warrants [Member] | ||||||
Warrant [Line Items] | ||||||
Warrants outstanding | 3,770 | 3,770 | ||||
Class A Warrants [Member] | ||||||
Warrant [Line Items] | ||||||
Issuance exercise price, per share (in Dollars per share) | $ 140 | $ 140 | ||||
Warrants outstanding | 124,200 | 124,200 | 124,200 | |||
Class A Warrants [Member] | IPO [Member] | ||||||
Warrant [Line Items] | ||||||
Warrant issued | 108,000 | |||||
Additional issuance shares | 16,200 | |||||
Class B Warrants [Member] | ||||||
Warrant [Line Items] | ||||||
Issuance exercise price, per share (in Dollars per share) | $ 200 | $ 200 | ||||
Warrants outstanding | 3,770 | |||||
Warrant exercised | 40,100 | |||||
Class B Warrants [Member] | IPO [Member] | ||||||
Warrant [Line Items] | ||||||
Warrant issued | 108,000 | |||||
Additional issuance shares | 16,200 |
Warrants (Details) - Schedule o
Warrants (Details) - Schedule of Information with Regard to Warrants Outstanding - $ / shares | 12 Months Ended | ||
Dec. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Common Stock Warrants [Member] | |||
Schedule of Information with Regard to Warrants Outstanding [Abstract] | |||
Warrants outstanding Shares | 271,714 | ||
Warrants outstanding Exercisable for Common Stock | Common Stock | ||
Warrants outstanding Weighted Average Exercise Price | $ 15.94 | ||
Warrants outstanding Weighted Average Remaining Life (in Years) | 4 years 6 months | ||
Class A Warrants [Member] | |||
Schedule of Information with Regard to Warrants Outstanding [Abstract] | |||
Warrants outstanding Shares | 124,200 | 124,200 | 124,200 |
Warrants outstanding Exercisable for Common Stock | Common Stock | ||
Warrants outstanding Weighted Average Exercise Price | $ 140 | $ 140 | |
Warrants outstanding Weighted Average Remaining Life (in Years) | 3 years 1 month 6 days | ||
Class B Warrants [Member] | |||
Schedule of Information with Regard to Warrants Outstanding [Abstract] | |||
Warrants outstanding Shares | 3,770 | ||
Warrants outstanding Exercisable for Common Stock | Common Stock | ||
Warrants outstanding Weighted Average Exercise Price | $ 200 | $ 200 | |
Warrants outstanding Weighted Average Remaining Life (in Years) | 3 years 1 month 6 days |
Stock Compensation (Details)
Stock Compensation (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Feb. 28, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stock Compensation (Details) [Line Items] | |||||
Number of shares vested | 19,484 | ||||
Incurred expenses (in Dollars) | $ 164,860 | $ (42,482) | $ 113,219 | $ 204,810 | $ 345,418 |
Weighted average grant date fair value of options granted (in Dollars per share) | $ 8.8 | $ 29 | |||
Unrecognized compensation expense (in Dollars) | $ 31,872 | $ 31,872 | |||
2018 Stock Incentive Plan [Member] | |||||
Stock Compensation (Details) [Line Items] | |||||
Maximum number of shares reserved | 31,472 | 31,472 | |||
Shares available for grants | 13,113 | 13,113 | |||
2021 Incentive Plan [Member] | |||||
Stock Compensation (Details) [Line Items] | |||||
Shares available for grants | 40,377 | 40,377 | |||
Number of shares issued | 98,000 | 98,000 | |||
Non-vested stock option [Member] | |||||
Stock Compensation (Details) [Line Items] | |||||
Unrecognized compensation expense (in Dollars) | $ 46,083 | $ 46,083 | |||
Restricted Stock Units (RSUs) [Member] | 2022 Incentive Plan [Member] | |||||
Stock Compensation (Details) [Line Items] | |||||
Number of shares vested | 18,734 | ||||
Non-vested stock option [Member] | |||||
Stock Compensation (Details) [Line Items] | |||||
Weighted-average period | 8 years 6 months 21 days | ||||
Non-vested Restricted Stock Units [Member] | |||||
Stock Compensation (Details) [Line Items] | |||||
Weighted-average period | 9 years 1 month 9 days |
Stock Compensation (Details) -
Stock Compensation (Details) - Schedule of Non-vested Restricted Stock Units | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Stock Compensation [Abstract] | |
Number of Shares, Outstanding at beginning balance | shares | 3,000 |
Weighted Average Grant Date Fair Value, Outstanding at beginning balance | $ / shares | $ 25.8 |
Number of Shares, Granted | shares | 25,609 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | $ 8.8 |
Number of Shares, Vested | shares | (19,484) |
Weighted Average Grant Date Fair Value, Vested | $ / shares | $ 9.45 |
Number of Shares, Cancelled / forfeited | shares | (1,250) |
Weighted Average Grant Date Fair Value, Cancelled / forfeited | $ / shares | $ 25.8 |
Number of Shares, Outstanding at ending balance | shares | 7,875 |
Weighted Average Grant Date Fair Value, Outstanding at ending balance | $ / shares | $ 10.96 |
Stock Compensation (Details) _2
Stock Compensation (Details) - Schedule of Stock Option Activity | 9 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | |
Stock Compensation [Abstract] | |
Number of Stock Options, Outstanding at beginning balance | shares | 35,992 |
Weighted Average Exercise Price Per Share, Outstanding at beginning balance | $ / shares | $ 39.25 |
Weighted Average Remaining Contractual Life in Years, Outstanding at beginning balance | 6 years 6 months |
Aggregate Intrinsic Value, Outstanding at beginning balance | $ | $ 20,578 |
Number of Stock Options, Outstanding at ending balance | shares | 31,361 |
Weighted Average Exercise Price Per Share, Outstanding at ending balance | $ / shares | $ 36.28 |
Weighted Average Remaining Contractual Life in Years, Outstanding at ending balance | 7 years |
Aggregate Intrinsic Value, Outstanding at ending balance | $ | $ 5,141 |
Number of Stock Options, Exercisable | shares | 26,405 |
Weighted Average Exercise Price Per Share, Exercisable | $ / shares | $ 35.1 |
Weighted Average Remaining Contractual Life in Years, Exercisable | 6 years 9 months 18 days |
Aggregate Intrinsic Value, Exercisable | $ | $ 5,141 |
Number of Stock Options, Granted | shares | 1,000 |
Weighted Average Exercise Price Per Share, Granted | $ / shares | $ 10.6 |
Number of Stock Options, Exercised | shares | |
Weighted Average Exercise Price Per Share, Exercised | $ / shares | |
Number of Stock Options, Cancelled / forfeited | shares | (5,631) |
Weighted Average Exercise Price Per Share, Cancelled / forfeited | $ / shares | $ 50.66 |
Stock Compensation (Details) _3
Stock Compensation (Details) - Schedule of Grant-Date Fair Value of Stock Option Awards Granted | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Schedule of Grant-Date Fair Value of Share-Based Awards Granted [Line Items] | ||
Risk-free interest rate | 3.63% | |
Expected dividend yield | 0% | 0% |
Volatility factor | 108.78% | |
Expected life of option (in years) | 6 years | |
Minimum [Member] | ||
Schedule of Grant-Date Fair Value of Share-Based Awards Granted [Line Items] | ||
Risk-free interest rate | 1.58% | |
Volatility factor | 102.03% | |
Expected life of option (in years) | 5 years 4 months 13 days | |
Maximum [Member] | ||
Schedule of Grant-Date Fair Value of Share-Based Awards Granted [Line Items] | ||
Risk-free interest rate | 3.06% | |
Volatility factor | 140.40% | |
Expected life of option (in years) | 6 years |
Stock Compensation (Details) _4
Stock Compensation (Details) - Schedule of Stock-Based Compensation Expense - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Feb. 28, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Schedule of Stock-Based Compensation Expense [Line Items] | |||||
Total stock-based compensation | $ 164,860 | $ (42,482) | $ 113,219 | $ 204,810 | $ 345,418 |
Research and development [Member] | |||||
Schedule of Stock-Based Compensation Expense [Line Items] | |||||
Total stock-based compensation | 9,393 | 20,528 | 54,389 | 54,231 | |
General and administrative [Member] | |||||
Schedule of Stock-Based Compensation Expense [Line Items] | |||||
Total stock-based compensation | (30,275) | 92,531 | 157,971 | 290,397 | |
Sales and Marketing [Member] | |||||
Schedule of Stock-Based Compensation Expense [Line Items] | |||||
Total stock-based compensation | $ (21,600) | $ 160 | $ (7,550) | $ 790 |
Related Party Transactions (Det
Related Party Transactions (Details) | 12 Months Ended |
Dec. 31, 2021 | |
NanoHybrids Inc. [Member] | |
Related Party Transactions (Details) [Line Items] | |
Bill rate additional cost percentage | 10% |
Related Party Transactions (D_2
Related Party Transactions (Details) - Schedule of Due from Related Parties - NanoHybrids [Member] - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Related Party Transaction [Line Items] | ||||
Income from NanoHybrids included in Other Income | $ 42,649 | $ 136,773 | $ 118,575 | |
Cash receipts from NanoHybrids | $ 35,040 | $ 156,504 | $ 75,926 |
Related Party Transactions (D_3
Related Party Transactions (Details) - Schedule of Balance Due - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
NanoHybrids Inc. [Member] | ||
Related Party Transactions (Details) - Schedule of Balance Due [Line Items] | ||
Amounts receivable from NanoHybrids included in Prepaids and Other Current Assets | $ 19,731 |
Property and Equipment (Details
Property and Equipment (Details) | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Property and Equipment [Abstract] | |
Depreciation | $ 431,740 |
Property and Equipment (Detai_2
Property and Equipment (Details) - Schedule of Property and Equipment, Net - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, Gross | $ 2,543,784 | $ 1,828,476 |
Less: accumulated depreciation | (1,222,073) | (596,406) |
Property and equipment, net | 1,321,711 | 1,232,070 |
Construction-in-process [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, Gross | 1,067,149 | 375,466 |
Furniture, fixtures, and equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, Gross | $ 141,164 | 136,942 |
Furniture, fixtures, and equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, depreciable lives | 3 | |
Furniture, fixtures, and equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, depreciable lives | 5 | |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, Gross | $ 4,457 | 4,457 |
Software [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, depreciable lives | 3 | |
Software [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, depreciable lives | 5 | |
Lab equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, Gross | $ 1,287,783 | 1,268,380 |
Lab equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, depreciable lives | 3 | |
Lab equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, depreciable lives | 5 | |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, depreciable lives | Shorter of useful life or lease term | |
Property and equipment, Gross | $ 43,231 | $ 43,231 |
Leases (Details) - Schedule of
Leases (Details) - Schedule of Lease Arrangements for Office and Laboratory Space - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Schedule of lease arrangements for office and laboratory space [Abstract] | ||
Weighted average remaining lease term - operating leases (in years) | 3 years 1 month 6 days | 3 years 10 months 24 days |
Weighted average remaining lease term - finance leases (in years) | 4 years 3 months 18 days | 5 years 3 months 18 days |
Weighted average discount rate | 7% | 7% |
Operating cash flows from operating leases | $ 130,692 | $ 113,083 |
Operating cash flows from finance leases | $ 3,605 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of Lease Assets and Liabilities - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Schedule of lease assets and liabilities [Abstract] | ||
Operating lease right-of-use asset | $ 367,248 | $ 465,514 |
Finance leases in Property and Equipment | 21,067 | 21,067 |
Total lease assets | 388,315 | 486,581 |
Current portion of operating lease liability | 168,716 | 168,706 |
Current portion of finance lease liability included in accrued expenses | 4,807 | 4,807 |
Noncurrent operating lease liabilities | 220,093 | 323,915 |
Noncurrent finance lease liabilities | 13,220 | 15,823 |
Total lease liabilities | $ 406,836 | $ 513,251 |
Leases (Details) - Schedule o_3
Leases (Details) - Schedule of Estimated Operating Lease Payments | Sep. 30, 2023 USD ($) | |
Schedule of estimated lease payments [Abstract] | ||
2023* | $ 1,202 | [1] |
2023* | 42,177 | [1] |
2024 | 4,807 | |
2024 | 162,991 | |
2025 | 4,807 | |
2025 | 100,000 | |
2026 | 4,807 | |
2026 | 100,000 | |
2027 | 5,207 | |
2027 | 25,000 | |
Thereafter | ||
Thereafter | ||
Total future lease payments | 20,830 | |
Total future lease payments | 430,168 | |
Less: Imputed interest | 2,803 | |
Less: Imputed interest | 41,359 | |
Present value of lease liability | 18,027 | |
Present value of lease liability | $ 388,809 | |
[1] Excludes the nine months ended September 30, 2023 |
Commitments and Contingencies (
Commitments and Contingencies (Details) | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Commitments and Contingencies (Details) [Line Items] | |
Royalty payments percentage | 15% |
Net sales of the cartridges for the period | 5 years |
Minimum [Member] | |
Commitments and Contingencies (Details) [Line Items] | |
Royalty payment | $ 60,000 |
Maximum [Member] | |
Commitments and Contingencies (Details) [Line Items] | |
Royalty payment | 100,000 |
Contract Manufacturing Organization [Member] | |
Commitments and Contingencies (Details) [Line Items] | |
Non-cancelable purchase commitment amount | 240,000 |
Manufacturing Line Development [Member] | |
Commitments and Contingencies (Details) [Line Items] | |
Non-cancelable purchase commitment amount | $ 240,000 |
Subsequent Events (Details)
Subsequent Events (Details) | 9 Months Ended | |
Oct. 23, 2023 | Sep. 30, 2023 | |
Subsequent Events (Details) [Line Items] | ||
Term of net sales | 10 years | |
Subsequent Event [Member] | ||
Subsequent Events (Details) [Line Items] | ||
Percentage of reduction in royalty rate | 50% | |
Maximum [Member] | Subsequent Event [Member] | ||
Subsequent Events (Details) [Line Items] | ||
Percentage of royalty payments payable | 15% | |
Minimum [Member] | Subsequent Event [Member] | ||
Subsequent Events (Details) [Line Items] | ||
Percentage of royalty payments payable | 7.50% |