Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common stock, par value $0.001		FEMY		NASDAQ Capital Market

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

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establishment registration and device listing;

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the Quality System Regulation, or QSR, which requires manufacturers, including third-party contract manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;

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labeling regulations and the FDA prohibitions against the promotion of products for uncleared or unapproved uses (“off-label” uses) and other requirements related to promotional activities, including the advertising of restricted devices;

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medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury, or if their device malfunctioned and the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur;

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corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the FDCA that may present a risk to health; and

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post market surveillance regulations, which apply to certain Class II or III devices when necessary to protect the public health or to provide additional safety and efficacy data for the device.

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warning or untitled letters, fines, injunctions, consent decrees and civil penalties; customer notifications, voluntary or mandatory recall or seizure of our products;

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operating restrictions, partial suspension or total shutdown of production;

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delay in processing submissions or applications for new products or modifications to existing products;

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withdrawing PMA approvals that have already been granted; and

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criminal prosecution.

Item 1A.

Risk Factors.

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The initiation, scope, rate of enrollment, progress, success, and cost of our current or future clinical trials;

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The cost of our research and development activities;

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The acceptance of our clinical trial data by the FDA or foreign regulatory authorities;

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Patient, physician and market acceptance of our intrauterine artificial insemination product and permanent birth control system women-specific medical product solutions;

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The cost of filing and prosecuting patent applications and defending and enforcing our patent or other intellectual property rights;

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The cost of defending, in litigation or otherwise, any claims that we infringe third-party patents or other intellectual property rights;

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The cost and timing of additional regulatory clearances, de novo grants or approvals;

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The cost and timing of establishing additional sales and marketing capabilities;

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Costs associated with any product recall that may occur;

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The effect of competing technological and market developments;

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The extent to which we acquire or invest in products, technologies and businesses, although we currently have no commitments or agreements relating to any of these types of transactions; and

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The costs of operating as a public company.

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Patient and physician adoption of our FemBloc system, if approved to market;

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Patient and physician adoption of our FemaSeed product;

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Changes in coverage policies by third-party payors that affect the reimbursement of procedures using our products;

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Unanticipated pricing pressure;

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The hiring, retention and continued productivity of sales representatives;

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Our ability to expand the geographic reach of our sales and marketing efforts;

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Our ability to obtain regulatory clearance or approval for any products in development or for our current products for additional indications or in additional countries outside the United States;

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Results of clinical research and trials on our existing products and products in development;

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Delays in receipt of anticipated purchase orders;

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Delays in, or failure of, component and raw material deliveries by our suppliers; and

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Positive or negative coverage in the media or clinical publications of our products or products of our competitors or our industry.

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We may not be able to demonstrate to the FDA’s satisfaction that our product is safe and effective for its intended use;

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The FDA may disagree that our clinical data supports the label and use that we are seeking;

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The FDA may disagree that the data from our preclinical studies and clinical trials is sufficient to support marketing authorization; and

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The manufacturing process and facilities we use may not meet applicable requirements.

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greater company, product and brand recognition;

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superior product safety, reliability and durability;

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better quality and larger volume of clinical data;

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more effective marketing to and education of patients and physicians;

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more sales force experience and greater market access;

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better product support and service;

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more advanced technological innovation, product enhancements and speed of innovation;

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more effective pricing and revenue strategies;

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lower procedure costs to patients;

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more effective reimbursement teams and strategies;

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dedicated practice development; and

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more effective clinical training teams.

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properly identify and anticipate physician and patient needs;

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develop and introduce new products and product enhancements in a timely manner;

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avoid infringing upon the intellectual property rights of third-parties;

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demonstrate, if required, the safety and effectiveness of new products with data from preclinical studies and clinical trials;

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obtain the necessary regulatory clearances, grants or approvals for expanded indications, new products or product modifications;

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be fully FDA-compliant with marketing of new products or modified products;

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provide adequate training to potential users of our products;

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receive adequate coverage and reimbursement for procedures performed with our products; and

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develop an effective and dedicated sales and marketing team.

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difficulties in securing distribution partnerships and managing our international relationships;

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increased competition as a result of more products and procedures receiving regulatory approval or otherwise free to market in international markets;

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longer accounts receivable payment cycles and difficulties in collecting accounts receivable;

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reduced or varied protection for intellectual property rights in some countries;

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export restrictions, trade regulations, and foreign tax laws;

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fluctuations in currency exchange rates;

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foreign certification and regulatory clearance or approval requirements;

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customs clearance and shipping delays;

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political, social, and economic instability abroad, terrorist attacks, and security concerns in general;

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preference for locally produced products;

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potentially adverse tax consequences, including the complexities of foreign value-added tax systems;

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the burdens of complying with a wide variety of foreign laws and different legal standards; and

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increased financial accounting and reporting burdens and complexities.

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costs of litigation;

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distraction of management’s attention from our primary business;

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the inability to commercialize our current and future products;

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decreased demand for our current and future products;

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damage to our business reputation;

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product recalls or withdrawals from the market;

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withdrawal of clinical trial participants;

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substantial monetary awards to patients or other claimants; or

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loss of sales.

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identifying, recruiting, integrating, maintaining and motivating additional employees;

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managing our internal development efforts effectively, including the clinical and FDA application preparation for our product candidates, while complying with our contractual obligations to contractors and other third parties; and

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improving our operational, financial and management controls, reporting systems and procedures.

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our inability to demonstrate to the satisfaction of the FDA or the applicable regulatory entity or notified body that our products are safe or effective for their intended uses or, for a 510(k) device, that they are substantially equivalent to the predicate;

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the disagreement of the FDA or the applicable foreign regulatory body with the design or implementation of our clinical trials or the interpretation of data from preclinical studies or clinical trials;

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serious and unexpected adverse device effects experienced by participants in our clinical trials;

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the data from our preclinical studies and clinical trials may be insufficient to support approval, de novo classification or clearance where required;

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our inability to demonstrate that the clinical and other benefits of the device outweigh the risks;

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the manufacturing process or facilities we use may not meet applicable requirements; and

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the potential for approval policies or regulations of the FDA or applicable foreign regulatory bodies to change significantly in a manner rendering our clinical data or regulatory filings insufficient to support a marketing authorization.

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untitled letters or warning letters;

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fines, injunctions, consent decrees and civil penalties;

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recalls, termination of distribution, administrative detention, or seizure of our products;

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customer notifications or repair, replacement or refunds;

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operating restrictions or partial suspension or total shutdown of production;

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delays in or refusal to grant our requests for future PMA approvals or foreign regulatory approvals of new products, new intended uses, or modifications to existing products;

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withdrawals or suspensions of our current PMA or foreign regulatory approvals, resulting in prohibitions on sales of our products;

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FDA refusal to issue certificates to foreign governments needed to export products for sale in other countries; and

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criminal prosecution.

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warning letters or untitled letters;

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fines, injunctions or civil penalties;

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suspension or withdrawal of approvals;

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seizures or recalls of our products;

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total or partial suspension of production or distribution;

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administrative or judicially imposed sanctions;

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the FDA’s refusal to grant pending or future approvals for our products;

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clinical holds; refusal to permit the import or export of our products; and

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criminal prosecution of us or our employees.

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strengthen the rules on placing devices on the market and reinforce surveillance once they are available;

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establish explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of devices placed on the market;

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improve the traceability of medical devices throughout the supply chain to the end-user or patient through a unique identification number;

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set up a central database to provide patients, healthcare professionals and the public with comprehensive information on products available in the EU;

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strengthen rules for the assessment of certain high-risk devices, such as implants, which may have to undergo an additional check by experts before they are placed on the market.

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the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce either the referral of an individual or furnishing or arranging for a good or service, for which payment may be made, in whole or in part, under federal healthcare programs, such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation. The U.S. government has interpreted this law broadly to apply to the marketing and sales activities of manufacturers. Moreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Violations of the federal Anti-Kickback Statute may result in civil monetary penalties. Civil penalties for such conduct can further be assessed under the federal False Claims Act. Violations can also result in criminal penalties. Similarly, violations can result in exclusion from participation in government healthcare programs, including Medicare and Medicaid. On November 20, 2020, the Department of Health and Human Services’ Office of the Inspector General, or OIG, finalized further modifications to the federal Anti-Kickback Statute. Under the final rules, the OIG added safe harbor protections under the Anti-Kickback Statute for certain coordinated care and value-based arrangements among clinicians, providers, and others. These rules (with exceptions) became effective January 19, 2021. We continue to evaluate what effect, if any, these rules will have on our business;

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the federal civil and criminal false claims laws and civil monetary penalties laws, including the federal civil False Claims Act, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal healthcare programs that are false or fraudulent. These laws can apply to manufacturers who provide information on coverage, coding, and reimbursement of their products to persons who bill third-party payers. Private individuals can bring False Claims Act “qui tam” actions, on behalf of the government and such individuals, commonly known as “whistleblowers,” may share in amounts paid by the entity to the government in fines or settlement. When an entity is determined to have violated the federal civil False Claims Act, the government may impose civil fines and penalties, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;

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the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier;

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the Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal statutes that prohibit, among other things, executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;

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the federal Physician Sunshine Act under the ACA, which require certain applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, or CHIP, to report annually to the DHHS Centers for Medicare and Medicaid Services, or CMS, information related to payments and other transfers of value to physicians, which is defined broadly to include other healthcare providers and teaching hospitals, and applicable manufacturers and group purchasing organizations, to report annually ownership and investment interests held by physicians and their immediate family members. Applicable manufacturers are required to submit annual reports to CMS. Failure to submit required information may result in civil monetary penalties for all payments, transfers of value or ownership or investment interests that are not timely, accurately, and completely reported in an annual submission, and may result in liability under other federal laws or regulations. We have not, to date, submitted reports under the Physician Sunshine Act under the ACA;

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HIPAA, as amended by the HITECH Act, and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses as well as their business associates that perform services for them that involve individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization, including mandatory contractual terms as well as directly applicable privacy and security standards and requirements. Failure to comply with the HIPAA privacy and security standards can result in civil monetary penalties, and, in certain circumstances, criminal penalties. State attorneys general can also bring a civil action to enjoin a HIPAA violation or to obtain statutory damages on behalf of residents of his or her state;

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analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers or patients; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm customers, foreign and state laws, including the EU General Data Protection Regulation, governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; federal government price reporting laws, which may require calculations and reporting of complex pricing metrics in an accurate and timely manner to government programs; and state laws related to insurance fraud in the case of claims involving private insurers; and

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California recently enacted the California Consumer Privacy Act (CCPA) which creates new individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households. The CCPA will require covered companies to provide certain disclosures to consumers about its data collection, use and sharing practices, and to provide affected California residents with ways to opt-out of certain sales or transfers of personal information. The CCPA went into effect on January 1, 2020, and the California State Attorney General submitted final regulations for review on June 2, 2020, which were finalized and are now effective. The California State Attorney General has commenced enforcement actions against violators as of July 1, 2020. Further, a new California privacy law, the California Privacy Rights Act (CPRA) was passed by California voters on November 3, 2020. The CPRA created obligations relating to consumer data beginning on January 1, 2022 and enforcement of the law begins on July 1, 2023. We will continue to monitor developments related to the CPRA and anticipate additional costs and expenses associated with CPRA compliance. Laws similar to the CCPA and CPRA have been enacted in Virginia (the Virginia Consumer Data Protection Act, or VCDPA, which went into effect on January 1, 2023), Colorado (the Colorado Privacy Act, or CPA, which goes into effect on July 1, 2023), Utah (the Utah Consumer Privacy Act, or UCPA, which goes into effect on December 31, 2023) and Connecticut (the Connecticut Data Privacy Act, or CDPA, which goes into effect on July 1, 2023). The California Age-Appropriate Design Code Act (CAADCA), which expands the CPRA for businesses with websites that are likely to be accessed by children, was signed into law on September 15, 2022 and goes into effect on July 1, 2024. While the CCPA and CPRA contain an exception for certain activities involving PHI under HIPAA, we cannot yet determine the impact the CCPA, CPRA or other such future laws, regulations and standards may have on our business.

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imposed an annual excise tax of 2.3% on any entity that manufactures or imports medical devices offered for sale in the United States, with limited exceptions (described in more detail below), although the effective rate paid may be lower. Through a series of legislative amendments, the tax was suspended for 2016 through 2019. Absent further legislative action, the device excise tax was to be reinstated on medical device sales starting January 1, 2020. The Further Consolidated Appropriations Act, 2020 H.R. 1865 (Pub.L.116-94), signed into law on December 20, 2019, has repealed the medical device excise tax previously imposed by Internal Revenue Code section 4191. Prior to the repeal, the tax was on a 4-year moratorium. As a result of the repeal and the prior moratorium, sales of taxable medical devices after December 31, 2015, are not subject to the tax. It is impossible to determine whether similar taxes could be instated in the future;

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established a new Patient-Centered Outcomes Research Institute to oversee and identify priorities in comparative clinical efficacy research in an effort to coordinate and develop such research;

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implemented payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficiency of certain healthcare services through bundled payment models; and

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expanded the eligibility criteria for Medicaid programs.

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any of our patents, or any of our pending patent applications, if issued, will include claims having a scope sufficient to protect our FemBloc system and FemaSeed product;

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any of our pending patent applications will issue as patents;

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we will be able to successfully commercialize our products on a substantial scale, if approved, before our relevant patents we may have expire;

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we were the first to make the inventions covered by each of our patents and pending patent applications;

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we were the first to file patent applications for these inventions;

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others will not develop similar or alternative technologies that do not infringe our patents; any of our patents will be found to ultimately be valid and enforceable;

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any patents issued to us will provide a basis for an exclusive market for our commercially viable products, will provide us with any competitive advantages or will not be challenged by third parties;

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we will develop additional proprietary technologies or products that are separately patentable; or

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our commercial activities or products will not infringe upon the patents of others.

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stop making, selling or using products or technologies that allegedly infringe the asserted intellectual property;

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lose the opportunity to license our technology to others or to collect royalty payments based upon successful protection and assertion of our intellectual property rights against others; incur significant legal expenses;

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pay substantial damages or royalties to the party whose intellectual property rights we may be found to be infringing;

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pay the attorney’s fees and costs of litigation to the party whose intellectual property rights we may be found to be infringing;

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redesign those products that contain the allegedly infringing intellectual property, which could be costly, disruptive and infeasible; and

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attempt to obtain a license to the relevant intellectual property from third parties, which may not be available on reasonable terms or at all, or from third parties who may attempt to license rights that they do not have.

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being permitted to present only two years of audited financial statements and only two years of related management’s discussion and analysis of financial condition and results of operations;

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not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act;

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an exemption from compliance with any new requirements adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotations;

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reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and

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exemptions from the requirement to hold a nonbinding advisory vote on executive compensation and to obtain stockholder approval of any golden parachute payments not previously approved.

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a prohibition on actions by our stockholders by written consent;

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advance notice requirements for election to our board of directors and for proposing matters that can be acted upon at stockholder meetings;

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a requirement that directors may only be removed “for cause”;

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a requirement that only the board of directors may change the number of directors and fill vacancies on the board;

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division of our board of directors into three classes, serving staggered terms of three years each; and

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the authority of the board of directors to issue preferred stock with such terms as the board of directors may determine.

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announcements of regulatory approval or disapproval of our FemBloc system or the FDA’s decision to grant or decline any future approvals or clearances for enhancements to our products;

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adverse results from or delays in clinical trial of our FemBloc system;

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unanticipated safety concerns related to the use of our FemBloc system;

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FDA or other U.S. or foreign regulatory or legal actions or changes affecting us or our industry;

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our ability to develop, obtain regulatory clearance or approval for, and market new and enhanced medical products on a timely basis;

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any voluntary or mandated product recalls;

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adverse developments concerning our suppliers or any future strategic partnerships;

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the volume and timing of sales of our products;

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the introduction of new products or product enhancements by us or others in our industry;

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disputes or other developments with respect to our or others’ intellectual property rights;

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product liability claims or other litigation;

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quarterly variations in our results of operations or those of others in our industry;

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media exposure of our products or of those of others in our industry;

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changes in governmental regulations or in reimbursement;

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changes in earnings estimates or recommendations by securities analysts;

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changes in financial estimates or guidance, including our ability to meet our future revenue and operating profit or loss estimates or guidance;

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the public’s reaction to our earnings releases, other public announcements and filings with the SEC;

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sales of substantial amounts of our stock by directors, officers or significant stockholders, or the expectation that such sales might occur;

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operating and stock performance of other companies that investors deem comparable to us and overall performance of the equity markets;

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additions or departures of key personnel;

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changes in our capital structure, such as future issuances of securities and the incurrence of debt;

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general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors; and

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other factors described in this “Risk Factors” section.

Item 1B.

Unresolved Staff Comments.

Item 2.

Properties.

Item 3.

Legal Proceedings.

Item 4.

Mine Safety Disclosures.

Item 5.

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Item 6.

[Reserved]

Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

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Commencement and conduct of clinical trials for our product candidates. We must successfully recruit and enroll clinical trial participants in our clinical trial for FemBloc, which is further complicated by the after effects and public health concerns of the COVID-19 pandemic, in order to have the requisite data for regulatory submissions, both to the FDA and to international regulatory bodies, for marketing authorization.

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Regulatory approval of our product candidates. We must successfully obtain timely approvals, de novo classifications or clearances for our product candidates. For our sales to grow, we will need to receive FDA approval for the FemBloc system for permanent birth control, and will need to obtain regulatory approval, grant, clearance or marketing authorization of our other pipeline products in the United States and in international markets.

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Clinical results. Publications of clinical results by us, our competitors and other third parties can have a significant influence on whether, and the degree to which, our products are used by physicians and the procedures and treatments those physicians choose to provide.

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Commercialization and market acceptance. The success of our business will ultimately depend on our ability to commercialize our approved products and gain broad market acceptance of our products, which will require an extensive education process for both physicians and patients of the benefits of our products, engagement of a robust sales force infrastructure and increased manufacturing capacity.

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Competition. Our industry has a number of large, well-capitalized companies. We must continue to successfully compete in light of our competitors’ existing and future products and related pricing and their resources to successfully market to the physicians who use our products.

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cost of clinical trials to support our product candidates and product enhancements, including expenses for activities conducted by third-party services providers, primarily clinical research organizations, or CROs, and site payments;

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certain personnel-related expenses, including salaries, benefits and stock-based compensation;

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materials and supplies used for internal R&D and clinical activities;

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allocated overhead information technology expenses; and

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cost of outside consultants, who assist with technology development, regulatory affairs, clinical affairs and quality assurance, and testing fees.

		Year Ended December 31,
		2023				2022				Change				% Change
Sales		$	1,071,970				1,206,218				(134,248	)			-11.1	%
Cost of sales (excluding depreciation expense)			380,069				441,938				(61,869	)			-14.0	%
Operating expenses:
Research and development			7,208,701				5,813,755				1,394,946				24.0	%
Sales and marketing			650,126				558,852				91,274				16.3	%
General and administrative			6,858,008				5,430,704				1,427,304				26.3	%
Depreciation and amortization			483,481				561,233				(77,752	)			-13.9	%
Total operating expenses			15,200,316				12,364,544				2,835,772				22.9	%
Loss from operations			(14,508,415	)			(11,600,264	)			(2,908,151	)			25.1	%
Other income (expense):
Interest income			431,019				228,164				202,855				88.9	%
Interest expense			(165,390	)			(13,464	)			(151,926	)			1128.4	%
Other expense			—				(2,306	)			2,306				-100.0	%
Other income (expense), net			265,629				212,394				53,235				25.1	%
Loss before income taxes		$	(14,242,786	)			(11,387,870	)			(2,854,916	)			25.1	%
Income tax expense			4,338				6,300				(1,962	)			-31.1	%
Net loss		$	(14,247,124	)			(11,394,170	)			(2,852,954	)			25.0	%

		Year Ended December 31,
		2023				2022
Compensation and related personnel costs		$	3,733,928				2,935,580
Clinical-related costs			1,702,985				1,839,643
Material and development costs			1,091,930				548,623
Professional and outside consultant costs			570,628				344,701
Other costs			109,230				145,208
Total research and development expenses		$	7,208,701				5,813,755

•

the cost, timing and results of our clinical trials and regulatory reviews;

•

the cost and timing of establishing sales, marketing and distribution capabilities;

•

the timing, receipt and amount of sales from our current and potential products;

•

our ability to continue manufacturing our products and product candidates and to secure the components, services and supplies needed in their production;

•

the degree of success we experience in commercializing our products;

•

the emergence of competing or complementary technologies;

•

the cost of preparing, filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights; and

•

the extent to which we acquire or invest in businesses, products or technologies, although we currently have no commitments or agreements relating to any of these types of transactions.

		Year Ended December 31,
		2023				2022
Net cash used in operating activities		$	(11,280,546	)			(10,731,973	)
Net cash used in investing activities			(143,917	)			(407,475	)
Net cash provided by (used in) financing activities			20,178,604				(681,645	)
Net change in cash and cash equivalents		$	8,754,141				(11,821,093	)

Assets		December 31, 2023				December 31, 2022
Current assets:
Cash and cash equivalents		$	21,716,077				12,961,936
Accounts receivable, net			98,906				77,470
Inventory, net			667,118				436,723
Prepaid and other current assets			695,879				655,362
Total current assets			23,177,980				14,131,491
Property and equipment, at cost:
Leasehold improvements			1,212,417				1,195,637
Office equipment			47,308				99,344
Furniture and fixtures			414,303				419,303
Machinery and equipment			2,559,356				2,572,243
Construction in progress			423,077				413,843
			4,656,461				4,700,370
Less accumulated depreciation			(3,545,422	)			(3,217,319	)
Net property and equipment			1,111,039				1,483,051
Long-term assets:
Lease right-of-use assets, net			2,380,225				319,557
Intangible assets, net of accumulated amortization			—				3,294
Other long-term assets			1,086,581				958,177
Total long-term assets			3,466,806				1,281,028
Total assets		$	27,755,825				16,895,570

Liabilities and Stockholders’ Equity		December 31, 2023				December 31, 2022
Current liabilities:
Accounts payable		$	1,137,823				510,758
Accrued expenses			1,444,296				456,714
Note payable			—				141,298
Clinical holdback – current portion			65,300				45,206
Lease liabilities – current portion			406,636				373,833
Total current liabilities			3,054,055				1,527,809
Long-term liabilities:
Clinical holdback – long-term portion			54,935				96,658
Convertible notes payable, net (including related parties)			4,258,179				—
Lease liabilities – long-term portion			2,036,067				28,584
Total long-term liabilities			6,349,181				125,242
Total liabilities			9,403,236				1,653,051
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par, 200,000,000 authorized, 21,774,604 shares issued and 21,657,381 outstanding as of December 31, 2023; and 11,986,927 shares issued and 11,869,704 outstanding as of December 31, 2022			21,775				11,987
Treasury stock, 117,223 common shares			(60,000	)			(60,000	)
Warrants			2,787,137				567,972
Additional paid-in-capital			123,985,306				108,857,065
Accumulated deficit			(108,381,629	)			(94,134,505	)
Total stockholders’ equity			18,352,589				15,242,519
Total liabilities and stockholders’ equity		$	27,755,825				16,895,570