0001493152-21-012491.txt : 20210521 0001493152-21-012491.hdr.sgml : 20210521 20210521151904 ACCESSION NUMBER: 0001493152-21-012491 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 49 CONFORMED PERIOD OF REPORT: 20210331 FILED AS OF DATE: 20210521 DATE AS OF CHANGE: 20210521 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Bone Biologics Corp CENTRAL INDEX KEY: 0001419554 STANDARD INDUSTRIAL CLASSIFICATION: ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES [3842] IRS NUMBER: 421743430 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-53078 FILM NUMBER: 21948705 BUSINESS ADDRESS: STREET 1: 2 BURLINGTON WOODS DRIVE, STREET 2: SUITE 100, CITY: BURLINGTON STATE: MA ZIP: 01803 BUSINESS PHONE: (781) 552-4452 MAIL ADDRESS: STREET 1: 2 BURLINGTON WOODS DRIVE, STREET 2: SUITE 100, CITY: BURLINGTON STATE: MA ZIP: 01803 FORMER COMPANY: FORMER CONFORMED NAME: Bone Biologics, Corp. DATE OF NAME CHANGE: 20140924 FORMER COMPANY: FORMER CONFORMED NAME: AFH ACQUISITION X, INC. DATE OF NAME CHANGE: 20071127 10-Q 1 form10-q.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2021

[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _________ to _________

Commission File No. 000-53078

Bone Biologics Corporation

(Exact name of registrant as specified in its charter)

Delaware

42-1743430

(State or other jurisdiction of

incorporation or formation)

(I.R.S. employer

identification number)

2 Burlington Woods Drive, Ste 100, Burlington, MA 01803

(Address of principal executive offices and Zip Code)

(781) 552-4452

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
N/A		N/A		N/A

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the issuer was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

[X] Yes [ ] No

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

[X] Yes [ ] No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in rule 12b-2 of the Exchange Act.

Large accelerated filer	[ ]	Accelerated filer	[ ]
Non-accelerated filer	[ ]	Smaller reporting company	[X]
Emerging growth company	[X]

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

[ ] Yes [X] No

As of May 10, 2021, there were 30,682,590 shares of the issuer’s common stock, $0.001 par value, outstanding.

Bone Biologics Corporation

- INDEX -

	Page
PART I – FINANCIAL INFORMATION:

Item 1.	F-1

Unaudited Condensed Consolidated Financial Statements

Unaudited Condensed Consolidated Balance Sheets	F-1

Unaudited Condensed Consolidated Statements of Operations	F-2

Consolidated Statement of Stockholders’ Deficit	F-3

Unaudited Condensed Consolidated Statements of Cash Flows	F-5

Notes to Unaudited Condensed Consolidated Financial Statements	F-6

Item 2. Management’s Discussion and Analysis or Plan of Operation	4

Item 3. Quantitative and Qualitative Disclosures about Market Risk	8

Item 4. Controls and Procedures	8

PART II – OTHER INFORMATION:

Item 1. Legal Proceedings	9

Item 1A. Risk Factors	10

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	10

Item 3. Defaults Upon Senior Securities	10

Item 4. Mine Safety Disclosures	10

Item 5. Other Information	10

Item 6. Exhibits	10

Signatures	11

NOTE ON FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (this “Form 10-Q”) contains forward-looking statements. Such forward-looking statements include those that express plans, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These forward-looking statements are based on our current expectations and projections about future events and they are subject to risks and uncertainties known and unknown that could cause actual results and developments to differ materially from those expressed or implied in such statements. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. For a more detailed listing of some of the risks and uncertainties facing the Company, please see our Current Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the Securities and Exchange Commission (“SEC”) on April 15, 2021.

All statements other than historical facts contained in this report, including statements regarding our future financial position, capital expenditures, cash flows, business strategy and plans and objectives of management for future operations are forward-looking statements. The words “anticipated,” “believe,” “expect,” “plan,” “intend,” “seek,” “estimate,” “project,” “could,” “may,” and similar expressions are intended to identify forward-looking statements. These statements include, among others, information regarding future operations, future capital expenditures, and future net cash flow. Such statements reflect our management’s current views with respect to future events and financial performance and involve risks and uncertainties, including, without limitation, our ability to raise additional capital to fund our operations, obtaining Food and Drug Administration (“FDA”) and other regulatory authorization to market our drug and biological products, successful completion of our clinical trials, our ability to achieve regulatory authorization to market our lead product NELL-1, our reliance on third party manufacturers for our drug products, market acceptance of our products, our dependence on licenses for certain of our products, our reliance on the expected growth in demand for our products, exposure to product liability and defect claims, development of a public trading market for our securities, and various other matters, many of which are beyond our control.

Should one or more of these risks or uncertainties occur, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated or otherwise indicated. Consequently, all of the forward-looking statements made in this Annual Report are qualified by these cautionary statements and accordingly there can be no assurances made with respect to the actual results or developments. We undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements.

Unless expressly indicated or the context requires otherwise, the terms “Company,” “we,” “us,” and “our” in this document refer to Bone Biologics Corporation, a Delaware corporation, and, its wholly owned subsidiary as defined under the heading “Management’s Discussion and Analysis” in this Form 10-Q.

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements.

Bone Biologics Corporation

Condensed Consolidated Balance Sheets

	March 31, 2021			December 31, 2020
		(unaudited)
Assets

Current assets
Cash	$	71,165		$	-

Total assets	$	71,165		$	-

Liabilities and Stockholders’ Deficit

Current liabilities
Bank overdraft	$	-		$	10,609
Accounts payable and accrued expenses		503,337			465,396
Current portion of notes payable – related party		11,921,936			11,712,179
Interest payable – related party		1,502,449			1,251,626
Deferred compensation		267,500			252,500

Total liabilities	$	14,195,222		$	13,692,310

Commitments and Contingencies

Stockholders’ deficit
Preferred Stock, $0.001 par value per share; 20,000,000 shares authorized; none issued or outstanding at March 31, 2021 and December 31, 2020		-			-
Common stock, $0.001 par value per share; 100,000,000 shares authorized; 30,682,590 shares issued and outstanding at March 31, 2021 and December 31, 2020		30,682			30,682
Additional paid-in capital		55,141,930			55,141,930
Accumulated deficit		(69,296,669	)		(68,864,922	)

Total stockholders’ deficit		(14,124,057	)		(13,692,310	)

Total liabilities and stockholders’ deficit	$	71,165		$	-

See accompanying notes to unaudited condensed consolidated financial statements.

F-1

Bone Biologics Corporation

Condensed Consolidated Statements of Operations

	Three Months Ended March 31, 2021			Three Months Ended March 31, 2020
	(unaudited)			(unaudited)
Revenues	$	-		$	-

Cost of revenues		-			-

Gross profit		-			-

Operating expenses
Research and development		45,500			167,101
General and administrative		135,424			172,949

Total operating expenses		180,924			340,050

Loss from operations		(180,924	)		(340,050	)

Interest expense – related party		(250,823	)		(255,250	)

Loss before provision for income taxes		(431,747	)		(595,300	)

Provision for income taxes		-			1,600

Net Loss	$	(431,747	)	$	(596,900	)

Weighted average shares outstanding – basic and diluted		7,278,334			7,278,334

Net Loss per share – basic and diluted	$	(0.06	)	$	(0.08	)

See accompanying notes to unaudited condensed consolidated financial statements.

F-2

Bone Biologics Corporation

Consolidated Statement of Stockholders’ Deficit

For the three months ended March 31, 2021

(unaudited)

	Common Stock				Additional Paid-in		Accumulated			Total Stockholders’
	Shares		Amount		Capital		Deficit			Deficit

Balance at December 31, 2020		30,682,590	$	30,682	$	55,141,930	$	(68,864,922	)	$	(13,692,310	)

Net Loss		-		-		-		(431,747	)		(431,747	)

Balance at March 31, 2021		30,682,590	$	30,682	$	55,141,930	$	(69,296,669	)	$	(14,124,057	)

See accompanying notes to unaudited condensed consolidated financial statements.

F-3

Bone Biologics Corporation

Consolidated Statement of Stockholders’ Deficit

For the three months ended March 31, 2020

(unaudited)

	Common Stock				Additional Paid-in		Accumulated			Total Stockholders’
	Shares		Amount		Capital		Deficit			Deficit

Balance at December 31, 2019		30,682,590	$	30,682	$	55,141,930	$	(67,040,232	)	$	(11,867,620	)

Net Loss		-		-		-		(596,900	)		(596,900	)

Balance at March 31, 2020		30,682,590	$	30,682	$	55,141,930	$	(67,637,132	)	$	(12,464,520	)

See accompanying notes to unaudited condensed consolidated financial statements.

F-4

Bone Biologics Corporation

Condensed Consolidated Statements of Cash Flows

	Three Months Ended March 31, 2021			Three Months Ended March 31, 2020

Cash flows from operating activities
Net loss	$	(431,747	)	$	(596,900	)
Adjustments to reconcile net loss to net cash used in operating activities:
Interest payable – related party		250,823			255,250
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		-			2,150
Accounts payable and accrued expenses		37,941			174,622
Deferred compensation		15,000			15,000

Net cash used in operating activities		(127,983	)		(149,878	)

Cash flows from financing activities
Bank overdraft		(10,609	)		-
Proceeds from credit facilities – related party		209,757			128,165

Net cash provided by financing activities		199,148			128,165

Net increase (decrease) in cash		71,165			(21,713	)

Cash, beginning of period		-			24,145
Cash, end of period	$	71,165		$	2,432

Supplemental information
Interest paid - related party	$	-		$	-
Income taxes paid	$	-		$	-

See accompanying notes to unaudited condensed consolidated financial statements.

F-5

Bone Biologics Corporation

Notes to Unaudited Condensed Consolidated Financial Statements

For the three months ended March 31, 2021

1. The Company

Bone Biologics Corporation (the “Company”) was incorporated under the laws of the State of Delaware on October 18, 2007 as AFH Acquisition X, Inc. Pursuant to a Merger Agreement, dated September 19, 2014, by and among the Company, its wholly-owned subsidiary, Bone Biologics Acquisition Corp., a Delaware corporation (“Merger Sub”), and Bone Biologics, Inc. Merger Sub merged with and into Bone Biologics Inc., with Bone Biologics Inc. remaining as the surviving corporation in the merger. Upon the consummation of the merger, the separate existence of Merger Sub ceased. On September 22, 2014, the Company officially changed its name to “Bone Biologics Corporation” to more accurately reflect the nature of its business and Bone Biologics, Inc. became a wholly owned subsidiary of the Company. Bone Biologics, Inc. was incorporated in California on September 9, 2004.

On July 16, 2018, the Company closed a rights offering in which Hankey Capital purchased 3,539,654 shares of the Company’s Common Stock and executed amendments (the “Amendments”) to the convertible promissory notes (the “Existing Convertible Notes”) payable to Hankey Capital and dated October 24, 2014, May 4, 2015 and February 24, 2016. The Amendments reduced the conversion price of the Existing Convertible Notes from $15.80 per share to $1.00 per share and extended the maturity date of the Existing Convertible Notes. As a result of the share issuance and Amendments, Hankey Capital and Don Hankey, the Chairman of the Company’s Board of Directors, acquired a majority of the voting common shares issued and outstanding and thus effective control of the Company.

We are a medical device company that is currently focused on bone regeneration in spinal fusion using the recombinant human protein, known as NELL-1/DBX®. The NELL-1/DBX® combination product is an osteostimulative recombinant protein that provides target specific control over bone regeneration. The protein, as part of the UCB-1 technology platform, has been licensed exclusively for worldwide applications to us through a technology transfer from UCLA Technology Development Group on behalf of UC Regents (“UCLA TDG”). UCLA TDG and the Company received guidance from the FDA that NELL-1/DBX® will be classified as a combination product with a device lead.

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, which we refer to as the JOBS Act. We would cease to be an emerging growth company upon the earliest of: (i) the last day of the first fiscal year in which our annual gross revenues are $1.07 billion or more; (ii) the end of any fiscal year in which the market value of our common stock held by non-affiliates exceeded $700.0 million as of the end of the second quarter of that fiscal year; or (iii) the date on which we have, during the previous three-year period, issued more than $1.07 billion in non-convertible debt securities. An emerging growth company may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. We have elected to take advantage of these reduced disclosure obligations, and may elect to take advantage of other reduced reporting obligations in the future.

The JOBS Act permits an emerging growth company like us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We are choosing to irrevocably “opt out” of this provision and, as a result, we will comply with new or revised accounting standards as required when they are adopted.

The production and marketing of the Company’s products and its ongoing research and development activities will be subject to extensive regulation by numerous governmental authorities in the United States. Prior to marketing in the United States, any combination product developed by the Company must undergo rigorous preclinical (animal) and clinical (human) testing and an extensive regulatory approval process implemented by the FDA under the Food, Drug and Cosmetic Act. There can be no assurance that the Company will not encounter problems in clinical trials that will cause the Company or the FDA to delay or suspend clinical trials.

F-6

The Company’s success will depend in part on its ability to obtain patents and product license rights, maintain trade secrets, and operate without infringing on the proprietary rights of others, both in the United States and other countries. There can be no assurance that patents issued to or licensed by the Company will not be challenged, invalidated, or circumvented, or that the rights granted thereunder will provide proprietary protection or competitive advantages to the Company.

Going Concern and Liquidity

The Company has no significant operating history and since inception to March 31, 2021 has incurred accumulated losses of approximately $69.3 million. The Company will continue to incur significant expenses for development activities for their lead product NELL-1/DBX®. Operating expenditures for the next twelve months are estimated at $6.6 million. The accompanying consolidated financial statements for the period ended March 31, 2021 have been prepared assuming the Company will continue as a going concern. As reflected in the financial statements, the Company had a stockholders’ deficit of $14,124,057 at March 31, 2021, and incurred a net loss of $431,747, and used net cash in operating activities of $127,983 during the three months ended March 31, 2021. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. In addition, our independent accounting firm, in its audit report to the financial statements included in our Annual Report for the year ended December 31, 2020, expressed substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

The Company will continue to attempt to raise additional debt and/or equity financing to fund future operations and to provide additional working capital. However, there is no assurance that such financing will be consummated or obtained in sufficient amounts necessary to meet the Company’s needs. If cash resources are insufficient to satisfy the Company’s on-going cash requirements, the Company will be required to scale back or discontinue its product development programs, or obtain funds if available (although there can be no certainties) through strategic alliances that may require the Company to relinquish rights to its technology, substantially reduce or discontinue its operations entirely. No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.

For the past several years, we have depended on our relationship with Hankey Capital for working capital to fund our operations, which has been raised in the form of both debt and equity capital. Hankey Capital, directly and indirectly, controls approximately 89% of our issued and outstanding shares of common stock (including collateral shares) and has been issued convertible notes payable with an aggregate principal balance of $11,921,936 at March 31, 2021. Representatives of Hankey Capital also currently serve as directors of the Company. No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.

At March 31, 2021, the Company had $178,064 available under the Second credit facility with Hankey Capital.

Pursuant to the October 2016 Note Purchase Agreement, the Company’s management has agreed to defer 20% of earned compensation and the Board of Directors has authorized a change in director compensation to defer 50% of the directors’ cash compensation until at least $5,000,000 has been received in cumulative funding from non-current stockholders.

F-7

2. Summary of Significant Accounting Policies

Basis of Presentation

The interim condensed consolidated financial statements included herein reflect all material adjustments (consisting of normal recurring adjustments and reclassifications and non-recurring adjustments) which, in the opinion of management, are ordinary and necessary for a fair presentation of results for the interim periods. Certain information and footnote disclosures required under the accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The Company believes that the disclosures are adequate to make the information presented not misleading. The condensed consolidated balance sheet information as of December 31, 2020 was derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on April 15, 2021 (the “2020 Annual Report”). These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2020 and notes thereto included in the 2020 Annual Report.

The results of operations for the three months ended March 31, 2021 are not necessarily indicative of the results to be expected for the entire fiscal year ended December 31, 2021 or for any other period.

Use of Estimates

The preparation of the accompanying consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of expenses during the reporting period. Significant estimates include the assumptions used in the accrual for potential liabilities, the valuation of stock options and warrants issued for services, and deferred tax valuation allowances. Actual results could differ from those estimates.

Impact of the Novel Coronavirus (COVID-19) on the Company’s Business Operations

The global outbreak of the novel coronavirus (COVID-19) has led to severe disruptions in general economic activities worldwide, as businesses and governments have taken broad actions to mitigate this public health crisis. In light of the uncertain and continually evolving situation relating to the spread of COVID-19, this pandemic could pose a risk to the Company. The extent to which the coronavirus may impact the Company’s business operations will depend on future developments, which are highly uncertain and cannot be predicted at this time. The Company intends to continue to monitor the situation and may adjust its current business plans as more information and guidance become available.

The coronavirus pandemic presents a challenge to medical facilities worldwide. As the Company’s clinical trials will be conducted on an outpatient basis, it is not currently possible to predict the full impact of this developing health crisis on such clinical trials, which could include delays in and increased costs of such clinical trials. Current indications from the clinical research organizations conducting the clinical trials for the Company are that such clinical trials are being delayed or extended for several months as a result of the coronavirus pandemic.

There is also significant uncertainty as to the effect that the coronavirus may have on the amount and type of financing available to the Company in the future.

Fair Value of Financial Instruments

The Company’s consolidated financial instruments are cash, accounts payable and notes payable. The recorded values of cash and accounts payable approximate their values based on their short-term nature. The fair value of convertible notes payable approximate their fair value since the current interest rates and terms on these obligations are the same as prevailing market rates.

The Company defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable and the last is considered unobservable:

Level 1: Quoted prices in active markets for identical assets or liabilities.

F-8

Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3 assumptions: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities including liabilities resulting from embedded derivatives associated with certain warrants to purchase common stock.

Stock Based Compensation

ASC 718, Compensation – Stock Compensation, prescribes accounting and reporting standards for all share-based payment transactions in which employee services are acquired. Transactions include incurring liabilities, or issuing or offering to issue shares, options, and other equity instruments such as employee stock ownership plans and stock appreciation rights. Share-based payments to employees, including grants of employee stock options, are recognized as compensation expense in the consolidated financial statements based on their fair values. That expense is recognized over the period during which an employee is required to provide services in exchange for the award, known as the requisite service period (usually the vesting period). The Company adopted ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, effective January 1, 2019, which aligns the accounting treatment of nonemployee awards with employee awards.

Collateral Shares

The Company accounts for the common shares issued as collateral for convertible promissory notes, whether upon original issuance or upon the required annual adjustment, as debt issuance costs in the form of a loan processing fee, which is determined by reference to the par value of the Company’s common stock, with a corresponding charge to operations when such collateral shares are issued. The collateral shares are subject to significant contractual restrictions limiting their sale or transfer. As these common shares have been issued to and are held by the lender, and are contingently returnable to the Company under certain conditions, such shares are considered as issued and outstanding on the Company’s balance sheet, but are not included in earnings per share calculations for all periods presented.

In the event of an uncured event of default, the Company will record a charge to operations to recognize that the collateral shares are no longer owned or controlled by the Company, and such prospective charge to operations would be based on the fair market value of the collateral shares at that time, and which would be classified as a cost of debt capital and recognized as a charge to operations.

Loss per Common Share

The Company utilizes FASB ASC Topic No. 260, Earnings per Share. Basic loss per share is computed by dividing loss available to common shareholders by the weighted-average number of common shares outstanding. Shares issued for collateral for outstanding loans of 23,404,255 are excluded from weighted average shares outstanding. Diluted loss per share is computed similar to basic loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. Diluted loss per common share reflects the potential dilution that could occur if convertible debentures, options and warrants were to be exercised or converted or otherwise resulted in the issuance of common stock that then shared in the earnings of the entity.

Since the effects of outstanding options, warrants, and the conversion of convertible debt are anti-dilutive for the three months ended March 31, 2021 and 2020, shares of common stock underlying these instruments have been excluded from the computation of loss per common share.

The following sets forth the number of shares of common stock underlying outstanding options, warrants, and convertible debt as of March 31, 2021 and 2020:

	March 31,
	2021		2020
Warrants		83,259		489,475
Stock options		480,703		566,045
Convertible promissory notes		11,921,936		11,448,165
		12,485,898		12,503,685

F-9

New Accounting Standards

In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06). ASU 2020-06 simplifies the accounting for convertible debt by eliminating the beneficial conversion and cash conversion accounting models. Upon adoption of ASU 2020-06, convertible debt proceeds, unless issued with a substantial premium or an embedded conversion feature that is not clearly and closely related to the host contract, will no longer be allocated between debt and equity components. This modification will reduce the issue discount and result in less non-cash interest expense in financial statements. ASU 2020-06 also updates the earnings per share calculation and requires entities to assume share settlement when the convertible debt can be settled in cash or shares. ASU 2020-06 will be effective January 1, 2024, and a cumulative-effect adjustment to the opening balance of retained earnings is required upon adoption. Early adoption is permitted, but no earlier than January 1, 2021, including interim periods within that year. The Company adopted ASU 2020-06 effective January 1, 2021. The adoption of ASU 2020-06 did not have any impact on the Company’s consolidated financial statement presentation or disclosures.

Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statements.

3. Notes Payable - Related Party

Hankey Capital LLC (Hankey Capital)

Hankey Capital holds certain convertible notes of the Company as discussed below. Don Hankey, the CEO and Chairman of Hankey Group, is our non-independent Chairman of the Board and a significant shareholder. Bret Hankey, the president of Hankey Capital, is a non-independent board member. The Hankey Group is an affiliate of Hankey Capital.

Note Type	Issue Date	Maturity Date	Interest Rate			March 31, 2021		December 31, 2020

(A) First Secured Convertible Note	10/24/14	12/31/21		8.5	%	$	5,000,000	$	5,000,000

(A) Second Secured Convertible Note	5/4/15	12/31/21		8.5	%		2,000,000		2,000,000

(B) Third Secured Convertible Note	2/24/16	12/31/21		8.5	%		2,000,000		2,000,000

(C) First Credit Facility	7/24/18	12/31/21		8.5	%		2,000,000		2,000,000

(D) Second Credit Facility	9/19/19	12/31/21		8.5	%		921,936		712,179
Notes payable						$	11,921,936	$	11,712,179

F-10

First and Second Secured Convertible Notes and Warrants

(A)

On October 24, 2014 and May 4, 2015, the Company issued two convertible promissory notes in the aggregate amount of $7,000,000 to Hankey Capital. Don Hankey, the CEO and Chairman of Hankey Group, is our non-independent Chairman of the Board and a significant shareholder. Bret Hankey, the president of Hankey Capital, is a non-independent board member. The Convertible Notes mature on December 31, 2021 and bear interest at an annual rate of interest of the “prime rate” plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears. Prior to the Maturity Date, Hankey Capital has a right, in its sole discretion, to convert the Convertible Notes into shares of the Company’s Common Stock, at a conversion rate equal to $1.00 per share. The Company also issued warrants to Hankey Capital for an aggregate of 585,443 shares of Common Stock at an exercise price per share of $15.80 that expire five years from the dates of issuance. In connection with the Convertible Notes, the Company paid commitment fees in the amount of $210,000 (3.0% of the original principal amount of the loans) to Hankey Capital and other aggregate offering costs of $594,550. The aggregate value of the warrants and offering costs totaling $2,891,409 was considered to be a debt discount upon issuance of the notes and was fully amortized as of December 31, 2018. The notes are secured by 886,975 collateral shares as described below.

Third Convertible Secured Term Note and Warrants

(B)

On February 24, 2016, the Company issued a convertible promissory note in the amount of $2,000,000 to Hankey Capital. The Third Convertible Note matures on December 31, 2021 (the “Maturity Date”) and bears interest at an annual rate of interest at the “prime rate” plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears. Prior to the Maturity Date, Hankey Capital has a right, in its sole discretion, to convert the Convertible Note into shares of the Company’s common stock (the “Conversion Shares”), at a conversion rate equal to $1.00 per share and issued a warrant to Hankey Capital for 146,342 shares of Common Stock at an exercise price per share of $20.50. The Warrant will expire on February 23, 2021. In connection with the Convertible Note, the Company paid a commitment fee in the amount of $40,000 (2.0% of the original principal amount of the Loan) and other offering costs totaling $77,532. The aggregate value of the warrant, beneficial conversion feature and offering costs of $2,000,000 was considered a debt discount upon issuance of the note and was fully amortized as of December 31, 2018. The note is secured by 253,165 collateral shares as described below.

During 2018, the Company issued an additional 18,009,696 collateral shares pursuant to the First, Second and Third Secured Convertible Notes.

First Credit Facility Convertible Secured Term Note

(C)	On July 24, 2018, the Company and Hankey Capital entered into an agreement under which Hankey Capital provided a credit facility of $2,000,000 to the Company to be drawn down by the Company upon notice to Hankey Capital. The credit facility is evidenced by a convertible secured note convertible prior to the maturity date at $1.00 per share and due on December 31, 2021. Draws bear interest at an annual rate of interest at the “prime rate” (as quoted in the “Money Rates” section of The Wall Street Journal) plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears. At December 31, 2019, the Company had used all funds available under the facility. The note is secured by collateral shares as described below.

	During 2020, the Company issued 4,255,319 Collateral Shares pursuant to the agreement.

Second Credit Facility Convertible Secured Term Note

(D)

On September 19, 2019, the Company and Hankey Capital entered into an agreement under which Hankey Capital provided a credit facility of $1,100,000 to the Company to be drawn down by the Company upon notice to Hankey Capital. The credit facility is evidenced by a convertible secured note convertible prior to the maturity date at $1.00 per share and due on December 31, 2021. All personal property and assets of the Company secure the note. Draws bear interest at an annual rate of interest at the “prime rate” (as quoted in the “Money Rates” section of The Wall Street Journal) plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears. At March 31, 2021, the Company had been advanced $921,936 and had $178,064 available under the facility. At December 31, 2020, the Company had been advanced $712,179 and had $387,821 available under the facility. No Collateral Shares are required pursuant to this convertible secured note.

F-11

Collateral

The Convertible Notes (A), (B) and (C) are secured by an aggregate of 23,404,255 collateral shares of Common Stock issued by the Company in the name of Hankey Capital, in such amount so as to maintain a loan to value ratio equal to 50% (the “Collateral Shares”) as of March 31, 2021 and December 31, 2020. The Collateral Shares shall be adjusted on a yearly basis. The principal amount of the loans are pre-payable in whole or in part at any time, without premium or penalty. Upon any voluntary partial prepayment of outstanding principal, Hankey Capital will return Collateral shares to the Company in the amount necessary, if any, to maintain the loan to value ratio at no less than 50%. Upon a full payment of the outstanding principal, all Collateral Shares shall be returned and cancelled. Hankey Capital will also return Collateral Shares under the same terms in case of partial or full conversion of the Convertible Notes. All of the Company’s personal property further secure the aggregate Convertible Notes, including collateral assignments of all the Company’s license agreements and the MTF Sygnal Option Agreement.

Interest payable – related party on the above notes was $1,502,449 and $1,251,626 as of March 31, 2021 and December 31, 2020, respectively.

4. Stockholders’ Deficit

Preferred Stock

The Company’s amended and restated certificate of incorporation authorizes the Company to issue a total of 20,000,000 shares of preferred stock. No shares have been issued.

Common Stock

The Company’s amended and restated certificate of incorporation authorizes the Company to issue a total of 100,000,000 shares of common stock. As of March 31, 2021 and December 31, 2020, the Company had an aggregate of 30,682,590 shares of common stock outstanding.

Common Stock Warrants

A summary of warrant activity for the period ended March 31, 2021 is presented below:

	Number of			Weighted Average Exercise		Weighted Average
Subject to Exercise	Warrants			Price		Life (Years)
Outstanding as of December 31, 2020		229,601		$	5.95		0.34
Granted – 2021		-			-		-
Forfeited/Expired – 2021		(146,342	)		-		-
Exercised – 2021		-			-		-
Outstanding as of March 31, 2021		83,259		$	14.65		0.43

F-12

As of March 31, 2021, the Company had outstanding vested and unexercised Common Stock Warrants as follows:

Date Issued	Exercise Price		Number of Warrants		Expiration date
September 2014	$	16.20		62,500	August 31, 2021
September 2014	$	10.00		11,800	September 18, 2021
September 2014	$	10.00		8,959	September 29, 2021

Total outstanding warrants at December 31, 2020				83,259

There were no common stock warrants exercised and 146,342 warrants expired during the period ended March 31, 2021. The intrinsic value of the outstanding warrants on March 31, 2021 is $-0-.

5. Stock-based Compensation

2015 Equity Incentive Plan

The Company has 1,400,000 shares of Common Stock authorized and reserved for issuance under our 2015 Equity Incentive Plan for option awards. This reserve may be increased by the Board each year by up to the number of shares of stock equal to 5% of the number of shares of stock issued and outstanding on the immediately preceding December 31. Appropriate adjustments will be made in the number of authorized shares and other numerical limits in our 2015 Equity Incentive Plan and in outstanding awards to prevent dilution or enlargement of participants’ rights in the event of a stock split or other change in our capital structure. Shares subject to awards granted under our 2015 Equity Incentive Plan which expire, are repurchased or are cancelled or forfeited will again become available for issuance under our 2015 Equity Incentive Plan. The shares available will not be reduced by awards settled in cash. Shares withheld to satisfy tax withholding obligations will not again become available for grant. The gross number of shares issued upon the exercise of stock appreciation rights or options exercised by means of a net exercise or by tender of previously owned shares will be deducted from the shares available under our 2015 Equity Incentive Plan.

Awards may be granted under our 2015 Equity Incentive Plan to our employees, including officers, director or consultants, and our present or future affiliated entities. While we may grant incentive stock options only to employees, we may grant non-statutory stock options, stock appreciation rights, restricted stock purchase rights or bonuses, restricted stock units, performance shares, performance units and cash-based awards or other stock based awards to any eligible participant.

The 2015 Equity Incentive Plan is administered by our compensation committee. Subject to the provisions of our 2015 Equity Incentive Plan, the compensation committee determines, in its discretion, the persons to whom, and the times at which, awards are granted, as well as the size, terms and conditions of each award. All awards are evidenced by a written agreement between us and the holder of the award. The compensation committee has the authority to construe and interpret the terms of our 2015 Equity Incentive Plan and awards granted under our 2015 Equity Incentive Plan.

A summary of stock option activity for the period ended March 31, 2021, is presented below:

	Number of			Weighted Average Exercise		Weighted Average		Aggregate Intrinsic
Subject to Exercise	Options			Price		Life (Years)		Value
Outstanding as of December 31, 2020		566,045		$	14.80		4.60	$	-
Granted – 2021		-			-		-		-
Forfeited/Expired – 2021		(85,342	)		16.19		-		-
Exercised – 2021		-			-		-		-
Outstanding as of March 31, 2021		480,703		$	14.55		5.15	$	-

F-13

As of March 31, 2021, the Company had vested and unexercised outstanding stock options as follows:

Date Issued	Exercise Price		Number of Options		Expiration date
August 2015	$	15.90		104,060	December 27, 2025
September 2015	$	15.90		20,000	December 27, 2025
November 2015	$	15.90		122,464	December 27, 2025
December 2015	$	15.90		5,569	December 27, 2025
January 2016	$	15.90		127,581	January 9, 2026
May 2016	$	20.50		26,915	May 26, 2026
September 2016	$	20.50		9,933	May 31, 2026
January 2017	$	20.50		5,356	January 1, 2027
January 2018	$	19.70		3,916	January 1, 2028
January 2019	$	0.94		54,909	January 1, 2029

Total outstanding options at March 31, 2021				480,703

The aggregate intrinsic value in the table above represents the total pre-tax intrinsic value (i.e. , the difference between our closing stock price on the respective date and the exercise price, times the number of shares) that would have been received by the option holders had all option holders exercised their options. No options were exercised and none cancelled during the period ended March 31, 2021.

F-14

As of March 31, 2021, there was no unrecognized compensation cost related to unvested stock options.

6. Deferred Compensation

Pursuant to an October 2016 Note Purchase Agreement, the Company’s management had agreed to defer 20% of earned compensation until at least $5,000,000 has been received in cumulative funding from non-current stockholders.

As of March 31, 2021 and December 31, 2020, deferred compensation was $267,500 and $252,500, respectively.

7. Commitments and Contingencies

UCLA TDG Exclusive License Agreement

Effective April 9, 2019, the Company entered into an Amended and Restated Exclusive License Agreement dated as of March 21, 2019 (the “Amended License Agreement”) with the UCLA Technology Development Group on behalf of UC Regents (“UCLA TDG”). The Amended License Agreement amends and restates the Amended and Restated Exclusive License Agreement, dated as of June 19, 2017 (the “2017 Agreement”). The 2017 Agreement amended and restated the Exclusive License Agreement, effective March 15, 2006, between the Company and UCLA TDG, as amended by ten amendments. Under the terms of the Amended License Agreement, the Regents have continued to grant the Company exclusive rights to develop and commercialize NELL-1 (the “Licensed Product”) for spinal fusion, osteoporosis and trauma applications. The Licensed Product is a recombinant human protein growth factor that is essential for normal bone development.

We have agreed to pay an annual maintenance fee to UCLA TDG of $10,000 as well as to pay certain royalties to UCLA TDG under the Restated License Agreement at the rate of 3.0% of net sales of licensed products. We must pay the royalties to UCLA TDG on a quarterly basis. Upon a first commercial sale, we also must pay between $50,000 and $250,000, depending on the calendar year that is after the first commercial sale. If we are required to pay any third party any royalties as a result of us making use of UCLA TDG patents, then we may reduce the royalty owed to UCLA TDG by 0.333% for every percentage point paid to a third party. If we grant sublicense rights to a third party to use the UCLA TDG patent, then we will pay to UCLA TDG 10% to 20% of the sublicensing income we receive from such sublicense.

We are obligated to make the following milestone payments to UCLA TDG for each Licensed Product or Licensed Method:

	●	$100,000 upon enrollment of the first subject in a Feasibility Study;

	●	$250,000 upon enrollment of the first subject in a Pivotal Study:

	●	$500,000 upon Pre-Market Approval of a Licensed Product or Licensed Method; and

	●	$1,000,000 upon the First Commercial Sale of a Licensed Product or Licensed Method.

F-15

We are also obligated to pay UCLA TDG a cash milestone payment within thirty (30) days of a Liquidity Event (including a Change of Control Transaction and a payment election by UCLA TDG exercisable after December 22, 2016, such payment to equal the greater of:

	●	$500,000; or

	●	2% of all proceeds in connection with a Change of Control Transaction.

		As of March 31, 2021, none of the above milestones has been met.

We are obligated to diligently proceed with developing and commercializing licensed products under UCLA patents set forth in the Restated License Agreement. UCLA TDG has the right to either terminate the license or reduce the license to a non-exclusive license if we do not meet certain diligence milestone deadlines set forth in the Restated License Agreement.

We must reimburse or pre-pay UCLA TDG for patent prosecution and maintenance costs incurred during the term of the Restated License Agreement. We have the right to bring infringement actions against third party infringers of the Restated License Agreement, UCLA TDG may join voluntarily, at its own expense, or, at our expense, be joined involuntarily to the action. We are required to indemnify UCLA TDG against any third party claims arising out of our exercise of the rights under the Restated License Agreement or any sublicense.

On August 13, 2020, the Company and UCLA TDG entered into a First Amendment to the Amended and Restated License Agreement pursuant to which the due dates for certain Development Milestones was updated to better reflect delays caused by the COVID-19 Pandemic and to address the Company’s failure to pay certain amounts with regard to patent prosecution, cost reimbursement, maintenance fees, and late fees, and in connection therewith, a revised payment schedule was set forth.

Payments to UCLA TDG under the Restated License Agreement for the three months ended March 31, 2021 and 2020 were $45,500 and $-0-, respectively.

Contingencies

The Company is subject to claims and assessments from time to time in the ordinary course of business. The Company’s management does not believe that any such matters, individually or in the aggregate, will have a material adverse effect on the Company’s business, financial condition, results of operations or cash flows.

In July 2019, Dr. Bessie (Chia) Soo and Dr. Kang (Eric) Ting (“Plaintiffs”) filed a complaint (the “Complaint”) in federal court in Massachusetts against the Company, Bruce Stroever (“Stroever”), John Booth (“Booth”), Stephen LaNeve (“LaNeve”, and together with Stroever and Booth, the “Individual Defendants”), and MTF Biologics (f/k/a The Musculoskeletal Transplant Foundation, Inc.) (“MTF”). The Complaint alleges claims for breach of contract against the Company and tortious interference with contract against the Individual Defendants and MTF arising from the termination of the Professional Service Agreements, dated as of January 8, 2016, between the Company and each of the Plaintiffs. The Individual Defendants have been sued for actions taken by them in connection with their service to the Company as directors and/or officers of the Company. As such, the Company has certain indemnification obligations to the Individual Defendants. The Company and the Individual Defendants intend to vigorously defend against the allegations in the Complaint. Based on the very early stage of the litigation, it is not possible to estimate the amount or range of any possible loss arising from the expenditure of defense fees, a judgment or settlement of the matter.

8. Subsequent Events

From March 31, 2021 through May 14, 2021, the Company has drawn an additional of $50,317 against the Second credit facility.

F-16

Item 2. Management’s Discussion and Analysis.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q and audited consolidated financial statements for the years ended December 31, 2020 and 2019 and the related notes included in our Annual Report on Form 10-K filed for the fiscal year ended December 31, 2020, with the SEC on April 15, 2021. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See “Note Regarding Forward-Looking Statements” for a discussion of the uncertainties, risks and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors.

Overview

We are a medical device company that is currently focused on bone regeneration in spinal fusion using the recombinant human protein, known as NELL-1/DBX®. The NELL-1/DBX® combination product is an osteostimulative recombinant protein that provides target specific control over bone regeneration. The protein, as part of the UCB-1 technology platform has been licensed exclusively for worldwide applications to us through a technology transfer from UCLA Technology Development Group on behalf of UC Regents (“UCLA TDG”). UCLA TDG and the Company received guidance from the FDA that NELL-1/DBX® will be classified as a combination product with a device lead.

The Company was founded by University of California professors in collaboration with an Osaka University professor and a University of Southern California surgeon in 2004 as a privately-held company with proprietary, patented technology that has been validated in sheep and non-human primate models to facilitate bone growth. Our platform technology has application in delivering improved outcomes in the surgical specialties of spinal, orthopedic, general orthopedic, plastic reconstruction, neurosurgery, interventional radiology, and sports medicine. Lead product development and clinical studies are targeted on spinal fusion surgery, one of the larger segments in the orthopedic market.

Our success will depend in part on our ability to obtain patents and product license rights, maintain trade secrets, and operate without infringing on the proprietary rights of others, both in the United States and other countries. There can be no assurance that patents issued to or licensed by us will not be challenged, invalidated, or circumvented, or that the rights granted thereunder will provide proprietary protection or competitive advantages to us.

UCLA TDG Exclusive License Agreement

We have agreed to pay an annual maintenance fee to UCLA TDG of $10,000 as well as to pay certain royalties to UCLA TDG under the Amended License Agreement at the rate of 3.0% of net sales of licensed products. We must pay the royalties to UCLA TDG on a quarterly basis. Upon a first commercial sale, we also must pay between $50,000 and $250,000, depending on the calendar year which is after the first commercial sale. If we are required to pay any third party any royalties as a result of us making use of UCLA TDG patents, then we may reduce the royalty owed to UCLA TDG by 0.333% for every percentage point paid to a third party. If we grant sublicense rights to a third party to use the UCLA TDG patent, then we will pay to UCLA TDG 10% to 20% of the sublicensing income we receive from such sublicense.

We are obligated to make the following milestone payments to UCLA TDG for each Licensed Product or Licensed Method:

	●	$100,000 upon enrollment of the first subject in a Feasibility Study;

	●	$250,000 upon enrollment of the first subject in a Pivotal Study:

	●	$500,000 upon Pre-Market Approval of a Licensed Product or Licensed Method; and

	●	$1,000,000 upon the First Commercial Sale of a Licensed Product or Licensed Method.

	●	$500,000; or

	●	2% of all proceeds in connection with a Change of Control Transaction.

We are obligated to diligently proceed with developing and commercializing licensed products under UCLA patents set forth in the Amended License Agreement. UCLA TDG has the right to either terminate the license or reduce the license to a non-exclusive license if we do not meet certain diligence milestone deadlines set forth in the Amended License Agreement.

We must reimburse or pre-pay UCLA TDG for patent prosecution and maintenance costs incurred during the term of the Amended License Agreement. We have the right to bring infringement actions against third party infringers of the Amended License Agreement, UCLA TDG may join voluntarily, at its own expense, or, at our expense, be joined involuntarily to the action. We are required to indemnify UCLA TDG against any third party claims arising out of our exercise of the rights under the Amended License Agreement or any sublicense.

The Amended License Agreement provided a PEGylated Licensed Product/Licensed Method (“Newly Added Patent Rights”) for which Company has agreed to assume a series of new development obligations, which conclude with a First Commercial Sale of such PEGylated Licensed Product/Licensed Method by the end of 2031.

The Amended License Agreement added the following financial terms with respect to Newly Added Patent Rights:

	●	30% sharing of any Sublicense Income received by the Company and attributable to those Newly Added Patent Rights;

	●	Four new Development Milestones corresponding to a PEGylated Licensed Product/Licensed Method that is covered by the Newly Added Patent Rights and

	●	3% royalty on Net Sales of such a Licensed Product/Licensed Method covered by the Newly Added Patent Rights

Results of Operations

Impact of the Novel Coronavirus (COVID-19) on the Company’s Business Operations

There is also significant uncertainty as to the effect that the coronavirus may have on the amount and type of financing available to the Company in the future.

Since our inception, we devoted substantially all of our efforts and funding to the development of the NELL-1 protein and raising capital. We have not yet generated revenues from our planned operations.

Three Months ended March 31, 2021 compared to the Three Months ended March 31, 2020

	Three-months ended March 31, 2021			Three-months ended March 31, 2020			% Change
Operating expenses
Research and development	$	45,500		$	167,101			(72.77	)%
General and administrative		135,424			172,949			(21.70	)%

Total operating expenses		180,924			340,050			(46.79	)%

Loss from operations		(180,924	)		(340,050	)		(46.79	)%

Interest expense, related party		(250,823	)		(255,250	)		(1.73	)%

Provision for income taxes		-			(1,600	)		(100.00	)%

Net loss	$	(431,747	)	$	(596,900	)		(27.67	)%

Beginning in 2020, Bone Biologics had to curtail operations due to lack of necessary funds, which the company hopes to address with future financing.

The lack of capital occurring simultaneously during the COVID-19 pandemic has caused a delay in R&D activities, and a scale back in all operations other than fund raising. As a result, the company engaged in cost-cutting measures in an attempt to extend our cash resources as long as possible.

The source, timing and availability of any future financing will depend principally upon market conditions and the status of our scientific development programs.

Research and Development

Our research and development decreased from $167,101 during the three months ended March 31, 2020 to $45,500 during the three months ended March 31, 2021. The $121,601 decrease was due to the curtailing of operations. We will continue to incur significant expenses for development activities for NELL-1 in the future.

General and Administrative

Our general and administrative expenses decreased from $172,949 during the three months ended March 31, 2020 to $135,424 during the three months ended March 31, 2021. The $37,525 decrease was due to the curtailing of operations.

Interest Expense

Our interest expense decreased from $255,250 for the three months ended March 31, 2020 to $250,823 during the three months ended March 31, 2021. The decrease of $4,427 resulted from the decrease in the interest rate in March 2020.

Liquidity and Capital Resources

For the past several years, we have depended on our relationship with Hankey Capital for working capital to fund our operations, which has been raised in the form of both debt and equity capital. Hankey Capital, directly and indirectly, controls approximately 89% of our issued and outstanding shares of common stock (including collateral shares) and as of May 10, 2021 has been issued convertible notes payable with an aggregate principal balance of $11,972,253. Representatives of Hankey Capital also currently serve as directors of the Company. No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.

At May 10, 2021, the Company had $127,747 available under the Second credit facility with Hankey Capital.

As of March 31, 2021 and December 31, 2020, we had cash of $71,165 and $-0-, respectively.

Cash Flows

Operating activities

During the three months ended March 31, 2021 and 2020, cash used in operating activities was $127,983 and $149,878, respectively. Cash expenditures for the three months ended March 31, 2021 decreased primarily due to the curtailing of operations.

Financing activities

During the three months ended March 31, 2021, cash provided by financing activities of $199,148 resulted from draws on our second credit facility with Hankey Capital. During the three months ended March 31, 2020, cash provided by financing activities of $128,165 resulted from draws on our second credit facility with Hankey Capital.

Off-Balance Sheet Arrangements

The Company does not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on the Company’s financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

Not applicable.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our Chief Financial Officer and Chief Executive Officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (Exchange Act)) as of March 31, 2021. Based upon that evaluation, our Chief Financial Officer and Chief Executive Officer concluded that as of March 31, 2021, our disclosure controls and procedures were not effective.

As of March 31, 2021, management assessed the effectiveness of our internal control over financial reporting and based on that assessment, we identified a material weakness in internal controls over financial reporting as of March 31, 2021 as further described below.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.

Insufficient staffing for the preparation and review procedures of the Company’s financial statements and required SEC filings. During 2020, Bone Biologics had to curtail operations due to lack of necessary funds. The lack of capital occurring simultaneously during the COVID-19 pandemic has caused a scale back in operations. As a result, the company engaged in cost-cutting measures in an attempt to extend our cash resources as long as possible. We do not have sufficient staffing for the preparation and review procedures of the Company’s financial statements and required SEC filings. During the three months ended March 31, 2021, we had limited personnel that performed nearly all aspects of our financial reporting process, including, but not limited to, access to the underlying accounting records and systems, the ability to post and record journal entries and responsibility for the preparation of the financial statements. As a result, the Company was not timely with the interim filings.

Changes in Internal Controls

There were no changes in our internal control over financial reporting that occurred during the quarter ended March 31, 2021 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II – OTHER INFORMATION

Item 1. Legal Proceedings.

In the normal course of our business, we may periodically become subjected to various lawsuits. However, there are currently no legal actions pending against us or, to our knowledge, are any such proceedings contemplated.

Item 1A. Risk Factors.

Not applicable.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None

Item 3. Defaults Upon Senior Securities.

None

Item 4. Mine Safety Disclosures.

Not Applicable

Item 5. Other Information.

None

Item 6. Exhibits.

(a) Exhibits required by Item 601 of Regulation S-K.

Exhibit		Description
31.1		Certification of the Company’s Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, with respect to the registrant’s Report on Form 10-Q for the quarter ended March 31, 2021.*

31.2		Certification of the Company’s Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, with respect to the registrant’s Report on Form 10-Q for the quarter ended March 31, 2021.*

32.1		Certification of the Company’s Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*

32.2		Certification of the Company’s Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*

101.INS		XBRL Instance Document*
101.SCH		XBRL Taxonomy Extension Schema Document*
101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEF		XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB		XBRL Taxonomy Extension Label Linkbase Document*
101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document*

* Filed Herewith

SIGNATURES

In accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	BONE BIOLOGICS CORPORATION

Dated: May 21, 2021	By:	/s/ Jeffrey Frelick
	Name:	Jeffrey Frelick
	Title:	Chief Executive Officer

EX-31.1 2 ex31-1.htm

Exhibit 31.1

Certification of Principal Executive Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

and Securities and Exchange Commission Release 34-46427

I, Jeffrey Frelick, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Bone Biologics Corporation

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. As the registrant’s Principal Financial Officer, I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and I have:

a) designed such disclosure controls and procedures or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this report is being prepared;

b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) disclosed in this report any change in registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of the annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):

a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 21, 2021	/s/ Jeffrey Frelick
	Jeffrey Frelick
	Principal Executive Officer

EX-31.2 3 ex31-2.htm

Exhibit 31.2

Certification of Principal Financial Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

and Securities and Exchange Commission Release 34-46427

I, Deina H. Walsh, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Bone Biologics Corporation

b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 21, 2021	/s/ Deina H. Walsh
	Deina H. Walsh
	Principal Financial Officer

EX-32.1 4 ex32-1.htm

Exhibit 32.1

Certification of Principal Executive Officer

Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to

Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the Report of Bone Biologics Corporation (the “Company”) on Form 10-Q for the period ended March 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Jeffrey Frelick, Principal Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

	/s/ Jeffrey Frelick
	Jeffrey Frelick
	Principal Executive Officer

	May 21, 2021

EX-32.2 5 ex32-2.htm

Exhibit 32.2

Certification of Principal Financial Officer

Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to

Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the Report of Bone Biologics Corporation (the “Company”) on Form 10-Q for the period ended March 31, 2021 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Deina H. Walsh, Principal Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

	/s/ Deina H. Walsh
	Deina H. Walsh
	Principal Financial Officer

	May 21, 2021

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The Hankey Group is an affiliate of Hankey Capital.   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="border-bottom: black 1.5pt solid; text-align: center">Note Type</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid; text-align: center">Issue Date</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid; text-align: center">Maturity Date</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Interest Rate</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">March 31, 2021</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">December 31, 2020</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td> </td> <td> </td> <td style="text-align: center"> </td> <td> </td> <td style="text-align: center"> </td> <td> </td> <td colspan="2" style="text-align: right"> </td> <td> </td> <td> </td> <td colspan="2" style="text-align: right"> </td> <td> </td> <td> </td> <td colspan="2"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 37%; padding-left: 10pt">(A) First Secured Convertible Note</td> <td style="width: 1%"> </td> <td style="width: 9%; text-align: right">10/24/14</td> <td style="width: 1%"> </td> <td style="width: 9%; text-align: right">12/31/21</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 10%; text-align: right">8.5</td> <td style="width: 1%">%</td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 12%; text-align: right">5,000,000</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 12%; text-align: right">5,000,000</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-left: 10pt">(A) Second Secured Convertible Note</td> <td> </td> <td style="text-align: right">5/4/15</td> <td> </td> <td style="text-align: right">12/31/21</td> <td> </td> <td> </td> <td style="text-align: right">8.5</td> <td>%</td> <td> </td> <td> </td> <td style="text-align: right">2,000,000</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">2,000,000</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-left: 10pt">(B) Third Secured Convertible Note</td> <td> </td> <td style="text-align: right">2/24/16</td> <td> </td> <td style="text-align: right">12/31/21</td> <td> </td> <td> </td> <td style="text-align: right">8.5</td> <td>%</td> <td> </td> <td> </td> <td style="text-align: right">2,000,000</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">2,000,000</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-left: 10pt">(C) First Credit Facility</td> <td> </td> <td style="text-align: right">7/24/18</td> <td> </td> <td style="text-align: right">12/31/21</td> <td> </td> <td> </td> <td style="text-align: right">8.5</td> <td>%</td> <td> </td> <td> </td> <td style="text-align: right">2,000,000</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">2,000,000</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-bottom: 1.5pt; padding-left: 10pt">(D) Second Credit Facility</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt; text-align: right">9/19/19</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt; text-align: right">12/31/21</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt; text-align: right">8.5</td> <td style="padding-bottom: 1.5pt">%</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">921,936</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">712,179</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="padding-bottom: 2.5pt">Notes payable</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt; text-align: right"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt; text-align: right"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt; text-align: right"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double">$</td> <td style="border-bottom: black 2.25pt double; text-align: right">11,921,936</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double">$</td> <td style="border-bottom: black 2.25pt double; text-align: right">11,712,179</td> <td style="padding-bottom: 2.5pt"> </td></tr> </table>    First and Second Secured Convertible Notes and Warrants   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 24px">(A)</td> <td style="text-align: justify">On October 24, 2014 and May 4, 2015, the Company issued two convertible promissory notes in the aggregate amount of $7,000,000 to Hankey Capital. Don Hankey, the CEO and Chairman of Hankey Group, is our non-independent Chairman of the Board and a significant shareholder. Bret Hankey, the president of Hankey Capital, is a non-independent board member. The Convertible Notes mature on December 31, 2021 and bear interest at an annual rate of interest of the “prime rate” plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears. Prior to the Maturity Date, Hankey Capital has a right, in its sole discretion, to convert the Convertible Notes into shares of the Company’s Common Stock, at a conversion rate equal to $1.00 per share. The Company also issued warrants to Hankey Capital for an aggregate of 585,443 shares of Common Stock at an exercise price per share of $15.80 that expire five years from the dates of issuance. In connection with the Convertible Notes, the Company paid commitment fees in the amount of $210,000 (3.0% of the original principal amount of the loans) to Hankey Capital and other aggregate offering costs of $594,550. The aggregate value of the warrants and offering costs totaling $2,891,409 was considered to be a debt discount upon issuance of the notes and was fully amortized as of December 31, 2018. The notes are secured by 886,975 collateral shares as described below.</td></tr> </table>   Third Convertible Secured Term Note and Warrants   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 24px">(B)</td> <td style="text-align: justify">On February 24, 2016, the Company issued a convertible promissory note in the amount of $2,000,000 to Hankey Capital. The Third Convertible Note matures on December 31, 2021 (the “Maturity Date”) and bears interest at an annual rate of interest at the “prime rate” plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears. Prior to the Maturity Date, Hankey Capital has a right, in its sole discretion, to convert the Convertible Note into shares of the Company’s common stock (the “Conversion Shares”), at a conversion rate equal to $1.00 per share and issued a warrant to Hankey Capital for 146,342 shares of Common Stock at an exercise price per share of $20.50. The Warrant will expire on February 23, 2021. In connection with the Convertible Note, the Company paid a commitment fee in the amount of $40,000 (2.0% of the original principal amount of the Loan) and other offering costs totaling $77,532. The aggregate value of the warrant, beneficial conversion feature and offering costs of $2,000,000 was considered a debt discount upon issuance of the note and was fully amortized as of December 31, 2018. The note is secured by 253,165 collateral shares as described below.</td></tr> </table>   During 2018, the Company issued an additional 18,009,696 collateral shares pursuant to the First, Second and Third Secured Convertible Notes.   First Credit Facility Convertible Secured Term Note   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 24px">(C)</td> <td style="text-align: justify">On July 24, 2018, the Company and Hankey Capital entered into an agreement under which Hankey Capital provided a credit facility of $2,000,000 to the Company to be drawn down by the Company upon notice to Hankey Capital. The credit facility is evidenced by a convertible secured note convertible prior to the maturity date at $1.00 per share and due on December 31, 2021. Draws bear interest at an annual rate of interest at the “prime rate” (as quoted in the “Money Rates” section of The Wall Street Journal) plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears. At December 31, 2019, the Company had used all funds available under the facility. The note is secured by collateral shares as described below.</td></tr> <tr style="vertical-align: top"> <td> </td> <td> </td></tr> <tr style="vertical-align: top"> <td> </td> <td>During 2020, the Company issued 4,255,319 Collateral Shares pursuant to the agreement.</td></tr> </table>   Second Credit Facility Convertible Secured Term Note   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 24px">(D)</td> <td style="text-align: justify">On September 19, 2019, the Company and Hankey Capital entered into an agreement under which Hankey Capital provided a credit facility of $1,100,000 to the Company to be drawn down by the Company upon notice to Hankey Capital. The credit facility is evidenced by a convertible secured note convertible prior to the maturity date at $1.00 per share and due on December 31, 2021. All personal property and assets of the Company secure the note. Draws bear interest at an annual rate of interest at the “prime rate” (as quoted in the “Money Rates” section of The Wall Street Journal) plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears. At March 31, 2021, the Company had been advanced $921,936 and had $178,064 available under the facility. At December 31, 2020, the Company had been advanced $712,179 and had $387,821 available under the facility. No Collateral Shares are required pursuant to this convertible secured note.</td></tr> </table>

A summary of warrant activity for the period ended March 31, 2021 is presented below:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td> </td> <td> </td> <td colspan="2" style="text-align: center">Number of</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center">Weighted Average Exercise</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center">Weighted Average</td> <td> </td></tr> <tr style="vertical-align: bottom"> <td style="border-bottom: black 1.5pt solid">Subject to Exercise</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Warrants</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Price</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Life (Years)</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 49%">Outstanding as of December 31, 2020</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 14%; text-align: right">229,601</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 14%; text-align: right">5.95</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 14%; text-align: right">0.34</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>Granted – 2021</td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td>Forfeited/Expired – 2021</td> <td> </td> <td> </td> <td style="text-align: right">(146,342</td> <td>)</td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="padding-bottom: 1.5pt">Exercised – 2021</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">-</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">-</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">-</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-bottom: 2.5pt">Outstanding as of March 31, 2021</td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">83,259</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double">$</td> <td style="border-bottom: black 2.25pt double; text-align: right">14.65</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">0.43</td> <td style="padding-bottom: 2.5pt"> </td></tr> </table>

As of March 31, 2021, the Company had outstanding vested and unexercised Common Stock Warrants as follows:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="border-bottom: black 1.5pt solid">Date Issued</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Exercise Price</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Number of Warrants</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid; text-align: center">Expiration date</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 51%">September 2014</td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 11%; text-align: right">16.20</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 11%; text-align: right">62,500</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 20%; text-align: right">August 31, 2021</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>September 2014</td> <td> </td> <td>$</td> <td style="text-align: right">10.00</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">11,800</td> <td> </td> <td> </td> <td style="text-align: right">September 18, 2021</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-bottom: 1.5pt">September 2014</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt">$</td> <td style="padding-bottom: 1.5pt; text-align: right">10.00</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">8,959</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt; text-align: right">September 29, 2021</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td style="text-align: right"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-bottom: 2.5pt">Total outstanding warrants at December 31, 2020</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt; text-align: right"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">83,259</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt; text-align: right"> </td></tr> </table>

A summary of stock option activity for the period ended March 31, 2021, is presented below:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td> <td> </td> <td colspan="2" style="text-align: center">Number of</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center">Weighted Average Exercise</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center">Weighted Average</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center">Aggregate Intrinsic</td> <td> </td></tr> <tr style="vertical-align: bottom"> <td style="border-bottom: black 1.5pt solid">Subject to Exercise</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Options</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Price</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Life (Years)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Value</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 44%">Outstanding as of December 31, 2020</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 11%; text-align: right">566,045</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 11%; text-align: right">14.80</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 11%; text-align: right">4.60</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 11%; text-align: right">-</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>Granted – 2021</td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td>Forfeited/Expired – 2021</td> <td> </td> <td> </td> <td style="text-align: right">(85,342</td> <td>)</td> <td> </td> <td> </td> <td style="text-align: right">16.19</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="padding-bottom: 1.5pt">Exercised – 2021</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">-</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">-</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">-</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">-</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-bottom: 2.5pt">Outstanding as of March 31, 2021</td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">480,703</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double">$</td> <td style="border-bottom: black 2.25pt double; text-align: right">14.55</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">5.15</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double">$</td> <td style="border-bottom: black 2.25pt double; text-align: right">-</td> <td style="padding-bottom: 2.5pt"> </td></tr> </table>

As of March 31, 2021, the Company had outstanding stock options as follows:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="border-bottom: black 1.5pt solid">Date Issued</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Exercise Price</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Number of Options</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid; text-align: center">Expiration date</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 40%">August 2015</td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 11%; text-align: right">15.90</td> <td style="width: 1%"> </td> <td style="width: 5%"> </td> <td style="width: 1%"> </td> <td style="width: 16%; text-align: right">104,060</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 22%; text-align: right">December 27, 2025</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>September 2015</td> <td> </td> <td>$</td> <td style="text-align: right">15.90</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">20,000</td> <td> </td> <td> </td> <td style="text-align: right">December 27, 2025</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td>November 2015</td> <td> </td> <td>$</td> <td style="text-align: right">15.90</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">122,464</td> <td> </td> <td> </td> <td style="text-align: right">December 27, 2025</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>December 2015</td> <td> </td> <td>$</td> <td style="text-align: right">15.90</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">5,569</td> <td> </td> <td> </td> <td style="text-align: right">December 27, 2025</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td>January 2016</td> <td> </td> <td>$</td> <td style="text-align: right">15.90</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">127,581</td> <td> </td> <td> </td> <td style="text-align: right">January 9, 2026</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>May 2016</td> <td> </td> <td>$</td> <td style="text-align: right">20.50</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">26,915</td> <td> </td> <td> </td> <td style="text-align: right">May 26, 2026</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td>September 2016</td> <td> </td> <td>$</td> <td style="text-align: right">20.50</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">9,933</td> <td> </td> <td> </td> <td style="text-align: right">May 31, 2026</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>January 2017</td> <td> </td> <td>$</td> <td style="text-align: right">20.50</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">5,356</td> <td> </td> <td> </td> <td style="text-align: right">January 1, 2027</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td>January 2018</td> <td> </td> <td>$</td> <td style="text-align: right">19.70</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">3,916</td> <td> </td> <td> </td> <td style="text-align: right">January 1, 2028</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="padding-bottom: 1.5pt">January 2019</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt">$</td> <td style="padding-bottom: 1.5pt; text-align: right">0.94</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">54,909</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt; text-align: right">January 1, 2029</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="padding-bottom: 2.5pt">Total outstanding options at March 31, 2021</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt; text-align: right"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">480,703</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt; text-align: right"> </td></tr> </table>

1. The Company   Bone Biologics Corporation (the “Company”) was incorporated under the laws of the State of Delaware on October 18, 2007 as AFH Acquisition X, Inc. Pursuant to a Merger Agreement, dated September 19, 2014, by and among the Company, its wholly-owned subsidiary, Bone Biologics Acquisition Corp., a Delaware corporation (“Merger Sub”), and Bone Biologics, Inc. Merger Sub merged with and into Bone Biologics Inc., with Bone Biologics Inc. remaining as the surviving corporation in the merger. Upon the consummation of the merger, the separate existence of Merger Sub ceased. On September 22, 2014, the Company officially changed its name to “Bone Biologics Corporation” to more accurately reflect the nature of its business and Bone Biologics, Inc. became a wholly owned subsidiary of the Company. Bone Biologics, Inc. was incorporated in California on September 9, 2004.   On July 16, 2018, the Company closed a rights offering in which Hankey Capital purchased 3,539,654 shares of the Company’s Common Stock and executed amendments (the “Amendments”) to the convertible promissory notes (the “Existing Convertible Notes”) payable to Hankey Capital and dated October 24, 2014, May 4, 2015 and February 24, 2016. The Amendments reduced the conversion price of the Existing Convertible Notes from $15.80 per share to $1.00 per share and extended the maturity date of the Existing Convertible Notes. As a result of the share issuance and Amendments, Hankey Capital and Don Hankey, the Chairman of the Company’s Board of Directors, acquired a majority of the voting common shares issued and outstanding and thus effective control of the Company.   We are a medical device company that is currently focused on bone regeneration in spinal fusion using the recombinant human protein, known as NELL-1/DBX®. The NELL-1/DBX® combination product is an osteostimulative recombinant protein that provides target specific control over bone regeneration. The protein, as part of the UCB-1 technology platform, has been licensed exclusively for worldwide applications to us through a technology transfer from UCLA Technology Development Group on behalf of UC Regents (“UCLA TDG”). UCLA TDG and the Company received guidance from the FDA that NELL-1/DBX® will be classified as a combination product with a device lead.   We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, which we refer to as the JOBS Act. We would cease to be an emerging growth company upon the earliest of: (i) the last day of the first fiscal year in which our annual gross revenues are $1.07 billion or more; (ii) the end of any fiscal year in which the market value of our common stock held by non-affiliates exceeded $700.0 million as of the end of the second quarter of that fiscal year; or (iii) the date on which we have, during the previous three-year period, issued more than $1.07 billion in non-convertible debt securities. An emerging growth company may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. We have elected to take advantage of these reduced disclosure obligations, and may elect to take advantage of other reduced reporting obligations in the future.   The JOBS Act permits an emerging growth company like us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We are choosing to irrevocably “opt out” of this provision and, as a result, we will comply with new or revised accounting standards as required when they are adopted.   The production and marketing of the Company’s products and its ongoing research and development activities will be subject to extensive regulation by numerous governmental authorities in the United States. Prior to marketing in the United States, any combination product developed by the Company must undergo rigorous preclinical (animal) and clinical (human) testing and an extensive regulatory approval process implemented by the FDA under the Food, Drug and Cosmetic Act. There can be no assurance that the Company will not encounter problems in clinical trials that will cause the Company or the FDA to delay or suspend clinical trials.   The Company’s success will depend in part on its ability to obtain patents and product license rights, maintain trade secrets, and operate without infringing on the proprietary rights of others, both in the United States and other countries. There can be no assurance that patents issued to or licensed by the Company will not be challenged, invalidated, or circumvented, or that the rights granted thereunder will provide proprietary protection or competitive advantages to the Company.   Going Concern and Liquidity   The Company has no significant operating history and since inception to March 31, 2021 has incurred accumulated losses of approximately $69.3 million. The Company will continue to incur significant expenses for development activities for their lead product NELL-1/DBX®. Operating expenditures for the next twelve months are estimated at $6.6 million. The accompanying consolidated financial statements for the period ended March 31, 2021 have been prepared assuming the Company will continue as a going concern. As reflected in the financial statements, the Company had a stockholders’ deficit of $14,124,057 at March 31, 2021, and incurred a net loss of $431,747, and used net cash in operating activities of $127,983 during the three months ended March 31, 2021. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. In addition, our independent accounting firm, in its audit report to the financial statements included in our Annual Report for the year ended December 31, 2020, expressed substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.   The Company will continue to attempt to raise additional debt and/or equity financing to fund future operations and to provide additional working capital. However, there is no assurance that such financing will be consummated or obtained in sufficient amounts necessary to meet the Company’s needs. If cash resources are insufficient to satisfy the Company’s on-going cash requirements, the Company will be required to scale back or discontinue its product development programs, or obtain funds if available (although there can be no certainties) through strategic alliances that may require the Company to relinquish rights to its technology, substantially reduce or discontinue its operations entirely. No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.   For the past several years, we have depended on our relationship with Hankey Capital for working capital to fund our operations, which has been raised in the form of both debt and equity capital. Hankey Capital, directly and indirectly, controls approximately 89% of our issued and outstanding shares of common stock (including collateral shares) and has been issued convertible notes payable with an aggregate principal balance of $11,921,936 at March 31, 2021. Representatives of Hankey Capital also currently serve as directors of the Company. No assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.   At March 31, 2021, the Company had $178,064 available under the Second credit facility with Hankey Capital.   Pursuant to the October 2016 Note Purchase Agreement, the Company’s management has agreed to defer 20% of earned compensation and the Board of Directors has authorized a change in director compensation to defer 50% of the directors’ cash compensation until at least $5,000,000 has been received in cumulative funding from non-current stockholders.

2. Summary of Significant Accounting Policies   Basis of Presentation   The interim condensed consolidated financial statements included herein reflect all material adjustments (consisting of normal recurring adjustments and reclassifications and non-recurring adjustments) which, in the opinion of management, are ordinary and necessary for a fair presentation of results for the interim periods. Certain information and footnote disclosures required under the accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The Company believes that the disclosures are adequate to make the information presented not misleading. The condensed consolidated balance sheet information as of December 31, 2020 was derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on April 15, 2021 (the “2020 Annual Report”). These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2020 and notes thereto included in the 2020 Annual Report.   The results of operations for the three months ended March 31, 2021 are not necessarily indicative of the results to be expected for the entire fiscal year ended December 31, 2021 or for any other period.   Use of Estimates   The preparation of the accompanying consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of expenses during the reporting period. Significant estimates include the assumptions used in the accrual for potential liabilities, the valuation of stock options and warrants issued for services, and deferred tax valuation allowances. Actual results could differ from those estimates.   Impact of the Novel Coronavirus (COVID-19) on the Company’s Business Operations   The global outbreak of the novel coronavirus (COVID-19) has led to severe disruptions in general economic activities worldwide, as businesses and governments have taken broad actions to mitigate this public health crisis. In light of the uncertain and continually evolving situation relating to the spread of COVID-19, this pandemic could pose a risk to the Company. The extent to which the coronavirus may impact the Company’s business operations will depend on future developments, which are highly uncertain and cannot be predicted at this time. The Company intends to continue to monitor the situation and may adjust its current business plans as more information and guidance become available.   The coronavirus pandemic presents a challenge to medical facilities worldwide. As the Company’s clinical trials will be conducted on an outpatient basis, it is not currently possible to predict the full impact of this developing health crisis on such clinical trials, which could include delays in and increased costs of such clinical trials. Current indications from the clinical research organizations conducting the clinical trials for the Company are that such clinical trials are being delayed or extended for several months as a result of the coronavirus pandemic.   There is also significant uncertainty as to the effect that the coronavirus may have on the amount and type of financing available to the Company in the future.   Fair Value of Financial Instruments   The Company’s consolidated financial instruments are cash, accounts payable and notes payable. The recorded values of cash and accounts payable approximate their values based on their short-term nature. The fair value of convertible notes payable approximate their fair value since the current interest rates and terms on these obligations are the same as prevailing market rates.   The Company defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable and the last is considered unobservable:   Level 1: Quoted prices in active markets for identical assets or liabilities.   Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.   Level 3 assumptions: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities including liabilities resulting from embedded derivatives associated with certain warrants to purchase common stock.   Stock Based Compensation   ASC 718, Compensation – Stock Compensation, prescribes accounting and reporting standards for all share-based payment transactions in which employee services are acquired. Transactions include incurring liabilities, or issuing or offering to issue shares, options, and other equity instruments such as employee stock ownership plans and stock appreciation rights. Share-based payments to employees, including grants of employee stock options, are recognized as compensation expense in the consolidated financial statements based on their fair values. That expense is recognized over the period during which an employee is required to provide services in exchange for the award, known as the requisite service period (usually the vesting period). The Company adopted ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, effective January 1, 2019, which aligns the accounting treatment of nonemployee awards with employee awards.   Collateral Shares   The Company accounts for the common shares issued as collateral for convertible promissory notes, whether upon original issuance or upon the required annual adjustment, as debt issuance costs in the form of a loan processing fee, which is determined by reference to the par value of the Company’s common stock, with a corresponding charge to operations when such collateral shares are issued. The collateral shares are subject to significant contractual restrictions limiting their sale or transfer. As these common shares have been issued to and are held by the lender, and are contingently returnable to the Company under certain conditions, such shares are considered as issued and outstanding on the Company’s balance sheet, but are not included in earnings per share calculations for all periods presented.   In the event of an uncured event of default, the Company will record a charge to operations to recognize that the collateral shares are no longer owned or controlled by the Company, and such prospective charge to operations would be based on the fair market value of the collateral shares at that time, and which would be classified as a cost of debt capital and recognized as a charge to operations.   Loss per Common Share   The Company utilizes FASB ASC Topic No. 260, Earnings per Share. Basic loss per share is computed by dividing loss available to common shareholders by the weighted-average number of common shares outstanding. Shares issued for collateral for outstanding loans of 23,404,255 are excluded from weighted average shares outstanding. Diluted loss per share is computed similar to basic loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. Diluted loss per common share reflects the potential dilution that could occur if convertible debentures, options and warrants were to be exercised or converted or otherwise resulted in the issuance of common stock that then shared in the earnings of the entity.   Since the effects of outstanding options, warrants, and the conversion of convertible debt are anti-dilutive for the three months ended March 31, 2021 and 2020, shares of common stock underlying these instruments have been excluded from the computation of loss per common share.   The following sets forth the number of shares of common stock underlying outstanding options, warrants, and convertible debt as of March 31, 2021 and 2020:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: black 1.5pt solid; text-align: center">March 31,</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">2021</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">2020</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 62%">Warrants</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 16%; text-align: right">83,259</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 16%; text-align: right">489,475</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>Stock options</td> <td> </td> <td> </td> <td style="text-align: right">480,703</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">566,045</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-bottom: 1.5pt">Convertible promissory notes</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">11,921,936</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">11,448,165</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">12,485,898</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">12,503,685</td> <td style="padding-bottom: 2.5pt"> </td></tr> </table>   New Accounting Standards   In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06). ASU 2020-06 simplifies the accounting for convertible debt by eliminating the beneficial conversion and cash conversion accounting models. Upon adoption of ASU 2020-06, convertible debt proceeds, unless issued with a substantial premium or an embedded conversion feature that is not clearly and closely related to the host contract, will no longer be allocated between debt and equity components. This modification will reduce the issue discount and result in less non-cash interest expense in financial statements. ASU 2020-06 also updates the earnings per share calculation and requires entities to assume share settlement when the convertible debt can be settled in cash or shares. ASU 2020-06 will be effective January 1, 2024, and a cumulative-effect adjustment to the opening balance of retained earnings is required upon adoption. Early adoption is permitted, but no earlier than January 1, 2021, including interim periods within that year. The Company adopted ASU 2020-06 effective January 1, 2021. The adoption of ASU 2020-06 did not have any impact on the Company’s consolidated financial statement presentation or disclosures.   Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statements.

3. Notes Payable - Related Party   Hankey Capital LLC (Hankey Capital)   Hankey Capital holds certain convertible notes of the Company as discussed below. Don Hankey, the CEO and Chairman of Hankey Group, is our non-independent Chairman of the Board and a significant shareholder. Bret Hankey, the president of Hankey Capital, is a non-independent board member. The Hankey Group is an affiliate of Hankey Capital.   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="border-bottom: black 1.5pt solid; text-align: center">Note Type</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid; text-align: center">Issue Date</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid; text-align: center">Maturity Date</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Interest Rate</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">March 31, 2021</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">December 31, 2020</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td> </td> <td> </td> <td style="text-align: center"> </td> <td> </td> <td style="text-align: center"> </td> <td> </td> <td colspan="2" style="text-align: right"> </td> <td> </td> <td> </td> <td colspan="2" style="text-align: right"> </td> <td> </td> <td> </td> <td colspan="2"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 37%; padding-left: 10pt">(A) First Secured Convertible Note</td> <td style="width: 1%"> </td> <td style="width: 9%; text-align: right">10/24/14</td> <td style="width: 1%"> </td> <td style="width: 9%; text-align: right">12/31/21</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 10%; text-align: right">8.5</td> <td style="width: 1%">%</td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 12%; text-align: right">5,000,000</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 12%; text-align: right">5,000,000</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-left: 10pt">(A) Second Secured Convertible Note</td> <td> </td> <td style="text-align: right">5/4/15</td> <td> </td> <td style="text-align: right">12/31/21</td> <td> </td> <td> </td> <td style="text-align: right">8.5</td> <td>%</td> <td> </td> <td> </td> <td style="text-align: right">2,000,000</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">2,000,000</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-left: 10pt">(B) Third Secured Convertible Note</td> <td> </td> <td style="text-align: right">2/24/16</td> <td> </td> <td style="text-align: right">12/31/21</td> <td> </td> <td> </td> <td style="text-align: right">8.5</td> <td>%</td> <td> </td> <td> </td> <td style="text-align: right">2,000,000</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">2,000,000</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-left: 10pt">(C) First Credit Facility</td> <td> </td> <td style="text-align: right">7/24/18</td> <td> </td> <td style="text-align: right">12/31/21</td> <td> </td> <td> </td> <td style="text-align: right">8.5</td> <td>%</td> <td> </td> <td> </td> <td style="text-align: right">2,000,000</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">2,000,000</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-bottom: 1.5pt; padding-left: 10pt">(D) Second Credit Facility</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt; text-align: right">9/19/19</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt; text-align: right">12/31/21</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt; text-align: right">8.5</td> <td style="padding-bottom: 1.5pt">%</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">921,936</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">712,179</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="padding-bottom: 2.5pt">Notes payable</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt; text-align: right"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt; text-align: right"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt; text-align: right"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double">$</td> <td style="border-bottom: black 2.25pt double; text-align: right">11,921,936</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double">$</td> <td style="border-bottom: black 2.25pt double; text-align: right">11,712,179</td> <td style="padding-bottom: 2.5pt"> </td></tr> </table>   First and Second Secured Convertible Notes and Warrants   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 24px">(A)</td> <td style="text-align: justify">On October 24, 2014 and May 4, 2015, the Company issued two convertible promissory notes in the aggregate amount of $7,000,000 to Hankey Capital. Don Hankey, the CEO and Chairman of Hankey Group, is our non-independent Chairman of the Board and a significant shareholder. Bret Hankey, the president of Hankey Capital, is a non-independent board member. The Convertible Notes mature on December 31, 2021 and bear interest at an annual rate of interest of the “prime rate” plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears. Prior to the Maturity Date, Hankey Capital has a right, in its sole discretion, to convert the Convertible Notes into shares of the Company’s Common Stock, at a conversion rate equal to $1.00 per share. The Company also issued warrants to Hankey Capital for an aggregate of 585,443 shares of Common Stock at an exercise price per share of $15.80 that expire five years from the dates of issuance. In connection with the Convertible Notes, the Company paid commitment fees in the amount of $210,000 (3.0% of the original principal amount of the loans) to Hankey Capital and other aggregate offering costs of $594,550. The aggregate value of the warrants and offering costs totaling $2,891,409 was considered to be a debt discount upon issuance of the notes and was fully amortized as of December 31, 2018. The notes are secured by 886,975 collateral shares as described below.</td></tr> </table>   Third Convertible Secured Term Note and Warrants   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 24px">(B)</td> <td style="text-align: justify">On February 24, 2016, the Company issued a convertible promissory note in the amount of $2,000,000 to Hankey Capital. The Third Convertible Note matures on December 31, 2021 (the “Maturity Date”) and bears interest at an annual rate of interest at the “prime rate” plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears. Prior to the Maturity Date, Hankey Capital has a right, in its sole discretion, to convert the Convertible Note into shares of the Company’s common stock (the “Conversion Shares”), at a conversion rate equal to $1.00 per share and issued a warrant to Hankey Capital for 146,342 shares of Common Stock at an exercise price per share of $20.50. The Warrant will expire on February 23, 2021. In connection with the Convertible Note, the Company paid a commitment fee in the amount of $40,000 (2.0% of the original principal amount of the Loan) and other offering costs totaling $77,532. The aggregate value of the warrant, beneficial conversion feature and offering costs of $2,000,000 was considered a debt discount upon issuance of the note and was fully amortized as of December 31, 2018. The note is secured by 253,165 collateral shares as described below.</td></tr> </table>   During 2018, the Company issued an additional 18,009,696 collateral shares pursuant to the First, Second and Third Secured Convertible Notes.   First Credit Facility Convertible Secured Term Note   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 24px">(C)</td> <td style="text-align: justify">On July 24, 2018, the Company and Hankey Capital entered into an agreement under which Hankey Capital provided a credit facility of $2,000,000 to the Company to be drawn down by the Company upon notice to Hankey Capital. The credit facility is evidenced by a convertible secured note convertible prior to the maturity date at $1.00 per share and due on December 31, 2021. Draws bear interest at an annual rate of interest at the “prime rate” (as quoted in the “Money Rates” section of The Wall Street Journal) plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears. At December 31, 2019, the Company had used all funds available under the facility. The note is secured by collateral shares as described below.</td></tr> <tr style="vertical-align: top"> <td> </td> <td> </td></tr> <tr style="vertical-align: top"> <td> </td> <td>During 2020, the Company issued 4,255,319 Collateral Shares pursuant to the agreement.</td></tr> </table>   Second Credit Facility Convertible Secured Term Note   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 24px">(D)</td> <td style="text-align: justify">On September 19, 2019, the Company and Hankey Capital entered into an agreement under which Hankey Capital provided a credit facility of $1,100,000 to the Company to be drawn down by the Company upon notice to Hankey Capital. The credit facility is evidenced by a convertible secured note convertible prior to the maturity date at $1.00 per share and due on December 31, 2021. All personal property and assets of the Company secure the note. Draws bear interest at an annual rate of interest at the “prime rate” (as quoted in the “Money Rates” section of The Wall Street Journal) plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears. At March 31, 2021, the Company had been advanced $921,936 and had $178,064 available under the facility. At December 31, 2020, the Company had been advanced $712,179 and had $387,821 available under the facility. No Collateral Shares are required pursuant to this convertible secured note.</td></tr> </table>   Collateral   The Convertible Notes (A), (B) and (C) are secured by an aggregate of 23,404,255 collateral shares of Common Stock issued by the Company in the name of Hankey Capital, in such amount so as to maintain a loan to value ratio equal to 50% (the “Collateral Shares”) as of March 31, 2021 and December 31, 2020. The Collateral Shares shall be adjusted on a yearly basis. The principal amount of the loans are pre-payable in whole or in part at any time, without premium or penalty. Upon any voluntary partial prepayment of outstanding principal, Hankey Capital will return Collateral shares to the Company in the amount necessary, if any, to maintain the loan to value ratio at no less than 50%. Upon a full payment of the outstanding principal, all Collateral Shares shall be returned and cancelled. Hankey Capital will also return Collateral Shares under the same terms in case of partial or full conversion of the Convertible Notes. All of the Company’s personal property further secure the aggregate Convertible Notes, including collateral assignments of all the Company’s license agreements and the MTF Sygnal Option Agreement.   Interest payable – related party on the above notes was $1,502,449 and $1,251,626 as of March 31, 2021 and December 31, 2020, respectively.

4. Stockholders’ Deficit   Preferred Stock   The Company’s amended and restated certificate of incorporation authorizes the Company to issue a total of 20,000,000 shares of preferred stock. No shares have been issued.   Common Stock   The Company’s amended and restated certificate of incorporation authorizes the Company to issue a total of 100,000,000 shares of common stock. As of March 31, 2021 and December 31, 2020, the Company had an aggregate of 30,682,590 shares of common stock outstanding.   Common Stock Warrants   A summary of warrant activity for the period ended March 31, 2021 is presented below:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td> </td> <td> </td> <td colspan="2" style="text-align: center">Number of</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center">Weighted Average Exercise</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center">Weighted Average</td> <td> </td></tr> <tr style="vertical-align: bottom"> <td style="border-bottom: black 1.5pt solid">Subject to Exercise</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Warrants</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Price</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Life (Years)</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 49%">Outstanding as of December 31, 2020</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 14%; text-align: right">229,601</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 14%; text-align: right">5.95</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 14%; text-align: right">0.34</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>Granted – 2021</td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td>Forfeited/Expired – 2021</td> <td> </td> <td> </td> <td style="text-align: right">(146,342</td> <td>)</td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="padding-bottom: 1.5pt">Exercised – 2021</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">-</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">-</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">-</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-bottom: 2.5pt">Outstanding as of March 31, 2021</td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">83,259</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double">$</td> <td style="border-bottom: black 2.25pt double; text-align: right">14.65</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">0.43</td> <td style="padding-bottom: 2.5pt"> </td></tr> </table>   As of March 31, 2021, the Company had outstanding vested and unexercised Common Stock Warrants as follows:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="border-bottom: black 1.5pt solid">Date Issued</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Exercise Price</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Number of Warrants</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid; text-align: center">Expiration date</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 51%">September 2014</td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 11%; text-align: right">16.20</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 11%; text-align: right">62,500</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 20%; text-align: right">August 31, 2021</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>September 2014</td> <td> </td> <td>$</td> <td style="text-align: right">10.00</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">11,800</td> <td> </td> <td> </td> <td style="text-align: right">September 18, 2021</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-bottom: 1.5pt">September 2014</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt">$</td> <td style="padding-bottom: 1.5pt; text-align: right">10.00</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">8,959</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt; text-align: right">September 29, 2021</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td style="text-align: right"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-bottom: 2.5pt">Total outstanding warrants at December 31, 2020</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt; text-align: right"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">83,259</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt; text-align: right"> </td></tr> </table>   There were no common stock warrants exercised and 146,342 warrants expired during the period ended March 31, 2021. The intrinsic value of the outstanding warrants on March 31, 2021 is $-0-.

5. Stock-based Compensation   2015 Equity Incentive Plan   The Company has 1,400,000 shares of Common Stock authorized and reserved for issuance under our 2015 Equity Incentive Plan for option awards. This reserve may be increased by the Board each year by up to the number of shares of stock equal to 5% of the number of shares of stock issued and outstanding on the immediately preceding December 31. Appropriate adjustments will be made in the number of authorized shares and other numerical limits in our 2015 Equity Incentive Plan and in outstanding awards to prevent dilution or enlargement of participants’ rights in the event of a stock split or other change in our capital structure. Shares subject to awards granted under our 2015 Equity Incentive Plan which expire, are repurchased or are cancelled or forfeited will again become available for issuance under our 2015 Equity Incentive Plan. The shares available will not be reduced by awards settled in cash. Shares withheld to satisfy tax withholding obligations will not again become available for grant. The gross number of shares issued upon the exercise of stock appreciation rights or options exercised by means of a net exercise or by tender of previously owned shares will be deducted from the shares available under our 2015 Equity Incentive Plan.   Awards may be granted under our 2015 Equity Incentive Plan to our employees, including officers, director or consultants, and our present or future affiliated entities. While we may grant incentive stock options only to employees, we may grant non-statutory stock options, stock appreciation rights, restricted stock purchase rights or bonuses, restricted stock units, performance shares, performance units and cash-based awards or other stock based awards to any eligible participant.   The 2015 Equity Incentive Plan is administered by our compensation committee. Subject to the provisions of our 2015 Equity Incentive Plan, the compensation committee determines, in its discretion, the persons to whom, and the times at which, awards are granted, as well as the size, terms and conditions of each award. All awards are evidenced by a written agreement between us and the holder of the award. The compensation committee has the authority to construe and interpret the terms of our 2015 Equity Incentive Plan and awards granted under our 2015 Equity Incentive Plan.   A summary of stock option activity for the period ended March 31, 2021, is presented below:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td> <td> </td> <td colspan="2" style="text-align: center">Number of</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center">Weighted Average Exercise</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center">Weighted Average</td> <td> </td> <td> </td> <td colspan="2" style="text-align: center">Aggregate Intrinsic</td> <td> </td></tr> <tr style="vertical-align: bottom"> <td style="border-bottom: black 1.5pt solid">Subject to Exercise</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Options</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Price</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Life (Years)</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Value</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 44%">Outstanding as of December 31, 2020</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 11%; text-align: right">566,045</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 11%; text-align: right">14.80</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 11%; text-align: right">4.60</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 11%; text-align: right">-</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>Granted – 2021</td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td>Forfeited/Expired – 2021</td> <td> </td> <td> </td> <td style="text-align: right">(85,342</td> <td>)</td> <td> </td> <td> </td> <td style="text-align: right">16.19</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">-</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="padding-bottom: 1.5pt">Exercised – 2021</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">-</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">-</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">-</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">-</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-bottom: 2.5pt">Outstanding as of March 31, 2021</td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">480,703</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double">$</td> <td style="border-bottom: black 2.25pt double; text-align: right">14.55</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">5.15</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double">$</td> <td style="border-bottom: black 2.25pt double; text-align: right">-</td> <td style="padding-bottom: 2.5pt"> </td></tr> </table>   As of March 31, 2021, the Company had vested and unexercised outstanding stock options as follows:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="border-bottom: black 1.5pt solid">Date Issued</td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Exercise Price</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">Number of Options</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid; text-align: center">Expiration date</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 40%">August 2015</td> <td style="width: 1%"> </td> <td style="width: 1%">$</td> <td style="width: 11%; text-align: right">15.90</td> <td style="width: 1%"> </td> <td style="width: 5%"> </td> <td style="width: 1%"> </td> <td style="width: 16%; text-align: right">104,060</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 22%; text-align: right">December 27, 2025</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>September 2015</td> <td> </td> <td>$</td> <td style="text-align: right">15.90</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">20,000</td> <td> </td> <td> </td> <td style="text-align: right">December 27, 2025</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td>November 2015</td> <td> </td> <td>$</td> <td style="text-align: right">15.90</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">122,464</td> <td> </td> <td> </td> <td style="text-align: right">December 27, 2025</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>December 2015</td> <td> </td> <td>$</td> <td style="text-align: right">15.90</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">5,569</td> <td> </td> <td> </td> <td style="text-align: right">December 27, 2025</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td>January 2016</td> <td> </td> <td>$</td> <td style="text-align: right">15.90</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">127,581</td> <td> </td> <td> </td> <td style="text-align: right">January 9, 2026</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>May 2016</td> <td> </td> <td>$</td> <td style="text-align: right">20.50</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">26,915</td> <td> </td> <td> </td> <td style="text-align: right">May 26, 2026</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td>September 2016</td> <td> </td> <td>$</td> <td style="text-align: right">20.50</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">9,933</td> <td> </td> <td> </td> <td style="text-align: right">May 31, 2026</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>January 2017</td> <td> </td> <td>$</td> <td style="text-align: right">20.50</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">5,356</td> <td> </td> <td> </td> <td style="text-align: right">January 1, 2027</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td>January 2018</td> <td> </td> <td>$</td> <td style="text-align: right">19.70</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">3,916</td> <td> </td> <td> </td> <td style="text-align: right">January 1, 2028</td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="padding-bottom: 1.5pt">January 2019</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt">$</td> <td style="padding-bottom: 1.5pt; text-align: right">0.94</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">54,909</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt; text-align: right">January 1, 2029</td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td> <td style="text-align: right"> </td> <td> </td> <td> </td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="padding-bottom: 2.5pt">Total outstanding options at March 31, 2021</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt; text-align: right"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">480,703</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt; text-align: right"> </td></tr> </table>   The aggregate intrinsic value in the table above represents the total pre-tax intrinsic value (i.e. , the difference between our closing stock price on the respective date and the exercise price, times the number of shares) that would have been received by the option holders had all option holders exercised their options. No options were exercised and none cancelled during the period ended March 31, 2021.   As of March 31, 2021, there was no unrecognized compensation cost related to unvested stock options.

7. Commitments and Contingencies   UCLA TDG Exclusive License Agreement   Effective April 9, 2019, the Company entered into an Amended and Restated Exclusive License Agreement dated as of March 21, 2019 (the “Amended License Agreement”) with the UCLA Technology Development Group on behalf of UC Regents (“UCLA TDG”). The Amended License Agreement amends and restates the Amended and Restated Exclusive License Agreement, dated as of June 19, 2017 (the “2017 Agreement”). The 2017 Agreement amended and restated the Exclusive License Agreement, effective March 15, 2006, between the Company and UCLA TDG, as amended by ten amendments. Under the terms of the Amended License Agreement, the Regents have continued to grant the Company exclusive rights to develop and commercialize NELL-1 (the “Licensed Product”) for spinal fusion, osteoporosis and trauma applications. The Licensed Product is a recombinant human protein growth factor that is essential for normal bone development.   We have agreed to pay an annual maintenance fee to UCLA TDG of $10,000 as well as to pay certain royalties to UCLA TDG under the Restated License Agreement at the rate of 3.0% of net sales of licensed products. We must pay the royalties to UCLA TDG on a quarterly basis. Upon a first commercial sale, we also must pay between $50,000 and $250,000, depending on the calendar year that is after the first commercial sale. If we are required to pay any third party any royalties as a result of us making use of UCLA TDG patents, then we may reduce the royalty owed to UCLA TDG by 0.333% for every percentage point paid to a third party. If we grant sublicense rights to a third party to use the UCLA TDG patent, then we will pay to UCLA TDG 10% to 20% of the sublicensing income we receive from such sublicense.   We are obligated to make the following milestone payments to UCLA TDG for each Licensed Product or Licensed Method:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 24px; text-align: justify"> </td> <td style="width: 24px; text-align: justify">●</td> <td style="text-align: justify">$100,000 upon enrollment of the first subject in a Feasibility Study;</td></tr> <tr style="vertical-align: top"> <td style="text-align: justify"> </td> <td style="text-align: justify"> </td> <td style="text-align: justify"> </td></tr> <tr style="vertical-align: top"> <td style="text-align: justify"> </td> <td style="text-align: justify">●</td> <td style="text-align: justify">$250,000 upon enrollment of the first subject in a Pivotal Study:</td></tr> <tr style="vertical-align: top"> <td style="text-align: justify"> </td> <td style="text-align: justify"> </td> <td style="text-align: justify"> </td></tr> <tr style="vertical-align: top"> <td style="text-align: justify"> </td> <td style="text-align: justify">●</td> <td style="text-align: justify">$500,000 upon Pre-Market Approval of a Licensed Product or Licensed Method; and</td></tr> <tr style="vertical-align: top"> <td style="text-align: justify"> </td> <td style="text-align: justify"> </td> <td style="text-align: justify"> </td></tr> <tr style="vertical-align: top"> <td style="text-align: justify"> </td> <td style="text-align: justify">●</td> <td style="text-align: justify">$1,000,000 upon the First Commercial Sale of a Licensed Product or Licensed Method.</td></tr> </table>   We are also obligated to pay UCLA TDG a cash milestone payment within thirty (30) days of a Liquidity Event (including a Change of Control Transaction and a payment election by UCLA TDG exercisable after December 22, 2016, such payment to equal the greater of:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 24px"> </td> <td style="width: 24px">●</td> <td style="text-align: justify">$500,000; or</td></tr> <tr style="vertical-align: top"> <td> </td> <td> </td> <td style="text-align: justify"> </td></tr> <tr style="vertical-align: top"> <td> </td> <td>●</td> <td style="text-align: justify">2% of all proceeds in connection with a Change of Control Transaction.</td></tr> <tr style="vertical-align: top"> <td> </td> <td> </td> <td style="text-align: justify"> </td></tr> <tr style="vertical-align: top"> <td> </td> <td> </td> <td style="text-align: justify">As of March 31, 2021, none of the above milestones has been met.</td></tr> </table>   We are obligated to diligently proceed with developing and commercializing licensed products under UCLA patents set forth in the Restated License Agreement. UCLA TDG has the right to either terminate the license or reduce the license to a non-exclusive license if we do not meet certain diligence milestone deadlines set forth in the Restated License Agreement.   We must reimburse or pre-pay UCLA TDG for patent prosecution and maintenance costs incurred during the term of the Restated License Agreement. We have the right to bring infringement actions against third party infringers of the Restated License Agreement, UCLA TDG may join voluntarily, at its own expense, or, at our expense, be joined involuntarily to the action. We are required to indemnify UCLA TDG against any third party claims arising out of our exercise of the rights under the Restated License Agreement or any sublicense.   On August 13, 2020, the Company and UCLA TDG entered into a First Amendment to the Amended and Restated License Agreement pursuant to which the due dates for certain Development Milestones was updated to better reflect delays caused by the COVID-19 Pandemic and to address the Company’s failure to pay certain amounts with regard to patent prosecution, cost reimbursement, maintenance fees, and late fees, and in connection therewith, a revised payment schedule was set forth.   Payments to UCLA TDG under the Restated License Agreement for the three months ended March 31, 2021 and 2020 were $45,500 and $-0-, respectively.   Contingencies   The Company is subject to claims and assessments from time to time in the ordinary course of business. The Company’s management does not believe that any such matters, individually or in the aggregate, will have a material adverse effect on the Company’s business, financial condition, results of operations or cash flows.   In July 2019, Dr. Bessie (Chia) Soo and Dr. Kang (Eric) Ting (“Plaintiffs”) filed a complaint (the “Complaint”) in federal court in Massachusetts against the Company, Bruce Stroever (“Stroever”), John Booth (“Booth”), Stephen LaNeve (“LaNeve”, and together with Stroever and Booth, the “Individual Defendants”), and MTF Biologics (f/k/a The Musculoskeletal Transplant Foundation, Inc.) (“MTF”). The Complaint alleges claims for breach of contract against the Company and tortious interference with contract against the Individual Defendants and MTF arising from the termination of the Professional Service Agreements, dated as of January 8, 2016, between the Company and each of the Plaintiffs. The Individual Defendants have been sued for actions taken by them in connection with their service to the Company as directors and/or officers of the Company. As such, the Company has certain indemnification obligations to the Individual Defendants. The Company and the Individual Defendants intend to vigorously defend against the allegations in the Complaint. Based on the very early stage of the litigation, it is not possible to estimate the amount or range of any possible loss arising from the expenditure of defense fees, a judgment or settlement of the matter.

New Accounting Standards   In August 2020, the FASB issued ASU 2020-06, Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06). ASU 2020-06 simplifies the accounting for convertible debt by eliminating the beneficial conversion and cash conversion accounting models. Upon adoption of ASU 2020-06, convertible debt proceeds, unless issued with a substantial premium or an embedded conversion feature that is not clearly and closely related to the host contract, will no longer be allocated between debt and equity components. This modification will reduce the issue discount and result in less non-cash interest expense in financial statements. ASU 2020-06 also updates the earnings per share calculation and requires entities to assume share settlement when the convertible debt can be settled in cash or shares. ASU 2020-06 will be effective January 1, 2024, and a cumulative-effect adjustment to the opening balance of retained earnings is required upon adoption. Early adoption is permitted, but no earlier than January 1, 2021, including interim periods within that year. The Company adopted ASU 2020-06 effective January 1, 2021. The adoption of ASU 2020-06 did not have any impact on the Company’s consolidated financial statement presentation or disclosures.   Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statements.

Basis of Presentation   The interim condensed consolidated financial statements included herein reflect all material adjustments (consisting of normal recurring adjustments and reclassifications and non-recurring adjustments) which, in the opinion of management, are ordinary and necessary for a fair presentation of results for the interim periods. Certain information and footnote disclosures required under the accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The Company believes that the disclosures are adequate to make the information presented not misleading. The condensed consolidated balance sheet information as of December 31, 2020 was derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC on April 15, 2021 (the “2020 Annual Report”). These condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2020 and notes thereto included in the 2020 Annual Report.   The results of operations for the three months ended March 31, 2021 are not necessarily indicative of the results to be expected for the entire fiscal year ended December 31, 2021 or for any other period.

Use of Estimates   The preparation of the accompanying consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of expenses during the reporting period. Significant estimates include the assumptions used in the accrual for potential liabilities, the valuation of stock options and warrants issued for services, and deferred tax valuation allowances. Actual results could differ from those estimates.

Impact of the Novel Coronavirus (COVID-19) on the Company’s Business Operations   The global outbreak of the novel coronavirus (COVID-19) has led to severe disruptions in general economic activities worldwide, as businesses and governments have taken broad actions to mitigate this public health crisis. In light of the uncertain and continually evolving situation relating to the spread of COVID-19, this pandemic could pose a risk to the Company. The extent to which the coronavirus may impact the Company’s business operations will depend on future developments, which are highly uncertain and cannot be predicted at this time. The Company intends to continue to monitor the situation and may adjust its current business plans as more information and guidance become available.   The coronavirus pandemic presents a challenge to medical facilities worldwide. As the Company’s clinical trials will be conducted on an outpatient basis, it is not currently possible to predict the full impact of this developing health crisis on such clinical trials, which could include delays in and increased costs of such clinical trials. Current indications from the clinical research organizations conducting the clinical trials for the Company are that such clinical trials are being delayed or extended for several months as a result of the coronavirus pandemic.   There is also significant uncertainty as to the effect that the coronavirus may have on the amount and type of financing available to the Company in the future.

Fair Value of Financial Instruments   The Company’s consolidated financial instruments are cash, accounts payable and notes payable. The recorded values of cash and accounts payable approximate their values based on their short-term nature. The fair value of convertible notes payable approximate their fair value since the current interest rates and terms on these obligations are the same as prevailing market rates.   The Company defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable and the last is considered unobservable:   Level 1: Quoted prices in active markets for identical assets or liabilities.   Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.   Level 3 assumptions: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities including liabilities resulting from embedded derivatives associated with certain warrants to purchase common stock.

Stock Based Compensation   ASC 718, Compensation – Stock Compensation, prescribes accounting and reporting standards for all share-based payment transactions in which employee services are acquired. Transactions include incurring liabilities, or issuing or offering to issue shares, options, and other equity instruments such as employee stock ownership plans and stock appreciation rights. Share-based payments to employees, including grants of employee stock options, are recognized as compensation expense in the consolidated financial statements based on their fair values. That expense is recognized over the period during which an employee is required to provide services in exchange for the award, known as the requisite service period (usually the vesting period). The Company adopted ASU 2018-07, Improvements to Nonemployee Share-Based Payment Accounting, effective January 1, 2019, which aligns the accounting treatment of nonemployee awards with employee awards.

Collateral Shares   The Company accounts for the common shares issued as collateral for convertible promissory notes, whether upon original issuance or upon the required annual adjustment, as debt issuance costs in the form of a loan processing fee, which is determined by reference to the par value of the Company’s common stock, with a corresponding charge to operations when such collateral shares are issued. The collateral shares are subject to significant contractual restrictions limiting their sale or transfer. As these common shares have been issued to and are held by the lender, and are contingently returnable to the Company under certain conditions, such shares are considered as issued and outstanding on the Company’s balance sheet, but are not included in earnings per share calculations for all periods presented.   In the event of an uncured event of default, the Company will record a charge to operations to recognize that the collateral shares are no longer owned or controlled by the Company, and such prospective charge to operations would be based on the fair market value of the collateral shares at that time, and which would be classified as a cost of debt capital and recognized as a charge to operations.

Loss per Common Share   The Company utilizes FASB ASC Topic No. 260, Earnings per Share. Basic loss per share is computed by dividing loss available to common shareholders by the weighted-average number of common shares outstanding. Shares issued for collateral for outstanding loans of 23,404,255 are excluded from weighted average shares outstanding. Diluted loss per share is computed similar to basic loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. Diluted loss per common share reflects the potential dilution that could occur if convertible debentures, options and warrants were to be exercised or converted or otherwise resulted in the issuance of common stock that then shared in the earnings of the entity.   Since the effects of outstanding options, warrants, and the conversion of convertible debt are anti-dilutive for the three months ended March 31, 2021 and 2020, shares of common stock underlying these instruments have been excluded from the computation of loss per common share.   The following sets forth the number of shares of common stock underlying outstanding options, warrants, and convertible debt as of March 31, 2021 and 2020:   <table cellspacing="0" cellpadding="0" style="font: 12pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: black 1.5pt solid; text-align: center">March 31,</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">2021</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: black 1.5pt solid; text-align: center">2020</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="width: 62%">Warrants</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 16%; text-align: right">83,259</td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 1%"> </td> <td style="width: 16%; text-align: right">489,475</td> <td style="width: 1%"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td>Stock options</td> <td> </td> <td> </td> <td style="text-align: right">480,703</td> <td> </td> <td> </td> <td> </td> <td style="text-align: right">566,045</td> <td> </td></tr> <tr style="vertical-align: bottom; background-color: #CCEEFF"> <td style="padding-bottom: 1.5pt">Convertible promissory notes</td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">11,921,936</td> <td style="padding-bottom: 1.5pt"> </td> <td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: black 1.5pt solid"> </td> <td style="border-bottom: black 1.5pt solid; text-align: right">11,448,165</td> <td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: white"> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">12,485,898</td> <td style="padding-bottom: 2.5pt"> </td> <td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: black 2.25pt double"> </td> <td style="border-bottom: black 2.25pt double; text-align: right">12,503,685</td> <td style="padding-bottom: 2.5pt"> </td></tr> </table>

6. Deferred Compensation   Pursuant to an October 2016 Note Purchase Agreement, the Company’s management had agreed to defer 20% of earned compensation until at least $5,000,000 has been received in cumulative funding from non-current stockholders.   As of March 31, 2021 and December 31, 2020, deferred compensation was $267,500 and $252,500, respectively.

8. Subsequent Events   From March 31, 2021 through May 14, 2021, the Company has drawn an additional of $50,317 against the Second credit facility.

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Document and Entity Information - shares	Mar. 31, 2021	May 10, 2021
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Document Type	10-Q
Document Period End Date	Mar. 31, 2021
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Condensed Consolidated Balance Sheets - USD ($)	Mar. 31, 2021	Dec. 31, 2020
Current assets
Cash	$ 71,165
Total assets	71,165
Current liabilities
Bank Overdraft		10,609
Accounts payable and accrued expenses	503,337	465,396
Current portion of notes payable - related party	11,921,936	11,712,179
Interest payable - related party	1,502,449	1,251,626
Deferred compensation	267,500	252,500
Total liabilities	14,195,222	13,692,310
Commitments and Contingencies
Stockholders' deficit
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Common stock, $0.001 par value per share; 100,000,000 shares authorized; 30,682,590 shares issued and outstanding at March 31, 2021 and December 31, 2020	30,682	30,682
Additional paid-in capital	55,141,930	55,141,930
Accumulated deficit	(69,296,669)	(68,864,922)
Total stockholders' deficit	(14,124,057)	(13,692,310)
Total liabilities and stockholders' deficit	$ 71,165

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Preferred stock, shares issued
Preferred stock, shares outstanding
Common stock, par value	$ 0.001	$ 0.001
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Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended
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Income Statement [Abstract]
Revenues
Cost of revenues
Gross profit
Operating expenses
Research and development	45,500	167,101
General and administrative	135,424	172,949
Total operating expenses	180,924	340,050
Loss from operations	(180,924)	(340,050)
Interest expense - related party	(250,823)	(255,250)
Loss before provision for income taxes	(431,747)	(595,300)
Provision for income taxes		1,600
Net loss	$ (431,747)	$ (596,900)
Weighted average shares outstanding - basic and diluted	7,278,334	7,278,334
Net Loss per share - basic and diluted	$ (0.06)	$ (0.08)

XML 16 R5.htm IDEA: XBRL DOCUMENT

Consolidated Statement of Stockholders' Deficit (Unaudited) - USD ($)	Common Stock [Member]	Additional Paid-in Capital [Member]	Accumulated Deficit [Member]	Total
Balance at Dec. 31, 2019	$ 30,682	$ 55,141,930	$ (67,040,232)	$ (11,867,620)
Balance, shares at Dec. 31, 2019	30,682,590
Net Loss			(596,900)	(596,900)
Balance at Mar. 31, 2020	$ 30,682	55,141,930	(67,637,132)	(12,464,520)
Balance, shares at Mar. 31, 2020	30,682,590
Balance at Dec. 31, 2020	$ 30,682	55,141,930	(68,864,922)	(13,692,310)
Balance, shares at Dec. 31, 2020	30,682,590
Net Loss			(431,747)	(431,747)
Balance at Mar. 31, 2021	$ 30,682	$ 55,141,930	$ (69,296,669)	$ (14,124,057)
Balance, shares at Mar. 31, 2021	30,682,590

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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- Definition

Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity.

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Condensed Consolidated Statements of Cash Flows - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Cash flows from operating activities
Net loss	$ (431,747)	$ (596,900)
Adjustments to reconcile net loss to net cash used in operating activities:
Interest payable - related party	250,823	255,250
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		2,150
Accounts payable and accrued expenses	37,941	174,622
Deferred compensation	15,000	15,000
Net cash used in operating activities	(127,983)	(149,878)
Cash flows from financing activities
Bank Overdraft	(10,609)
Proceeds from credit facilities - related party	209,757	128,165
Net cash provided by financing activities	199,148	128,165
Net increase (decrease) in cash	71,165	(21,713)
Cash, beginning of period		24,145
Cash, end of period	71,165	2,432
Supplemental information
Interest paid - related party
Income taxes paid

XML 18 R7.htm IDEA: XBRL DOCUMENT

The Company

3 Months Ended

Mar. 31, 2021

Organization, Consolidation and Presentation of Financial Statements [Abstract]

The Company

1. The Company

Going Concern and Liquidity

At March 31, 2021, the Company had $178,064 available under the Second credit facility with Hankey Capital.

XML 19 R8.htm IDEA: XBRL DOCUMENT

Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2021

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Basis of Presentation

Use of Estimates

Impact of the Novel Coronavirus (COVID-19) on the Company’s Business Operations

There is also significant uncertainty as to the effect that the coronavirus may have on the amount and type of financing available to the Company in the future.

Fair Value of Financial Instruments

Level 1: Quoted prices in active markets for identical assets or liabilities.

Stock Based Compensation

Collateral Shares

Loss per Common Share

The following sets forth the number of shares of common stock underlying outstanding options, warrants, and convertible debt as of March 31, 2021 and 2020:

	March 31,
	2021		2020
Warrants		83,259		489,475
Stock options		480,703		566,045
Convertible promissory notes		11,921,936		11,448,165
		12,485,898		12,503,685

New Accounting Standards

XML 20 R9.htm IDEA: XBRL DOCUMENT

Notes Payable - Related Party

3 Months Ended

Mar. 31, 2021

Debt Disclosure [Abstract]

Notes Payable - Related Party

3. Notes Payable - Related Party

Hankey Capital LLC (Hankey Capital)

Note Type	Issue Date	Maturity Date	Interest Rate			March 31, 2021		December 31, 2020

(A) First Secured Convertible Note	10/24/14	12/31/21		8.5	%	$	5,000,000	$	5,000,000

(A) Second Secured Convertible Note	5/4/15	12/31/21		8.5	%		2,000,000		2,000,000

(B) Third Secured Convertible Note	2/24/16	12/31/21		8.5	%		2,000,000		2,000,000

(C) First Credit Facility	7/24/18	12/31/21		8.5	%		2,000,000		2,000,000

(D) Second Credit Facility	9/19/19	12/31/21		8.5	%		921,936		712,179
Notes payable						$	11,921,936	$	11,712,179

First and Second Secured Convertible Notes and Warrants

(A)

Third Convertible Secured Term Note and Warrants

(B)

During 2018, the Company issued an additional 18,009,696 collateral shares pursuant to the First, Second and Third Secured Convertible Notes.

First Credit Facility Convertible Secured Term Note

(C)	On July 24, 2018, the Company and Hankey Capital entered into an agreement under which Hankey Capital provided a credit facility of $2,000,000 to the Company to be drawn down by the Company upon notice to Hankey Capital. The credit facility is evidenced by a convertible secured note convertible prior to the maturity date at $1.00 per share and due on December 31, 2021. Draws bear interest at an annual rate of interest at the “prime rate” (as quoted in the “Money Rates” section of The Wall Street Journal) plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears. At December 31, 2019, the Company had used all funds available under the facility. The note is secured by collateral shares as described below.

	During 2020, the Company issued 4,255,319 Collateral Shares pursuant to the agreement.

Second Credit Facility Convertible Secured Term Note

(D)

Collateral

Interest payable – related party on the above notes was $1,502,449 and $1,251,626 as of March 31, 2021 and December 31, 2020, respectively.

XML 21 R10.htm IDEA: XBRL DOCUMENT

Stockholders' Deficit

3 Months Ended

Mar. 31, 2021

Equity [Abstract]

Stockholders' Deficit

4. Stockholders’ Deficit

Preferred Stock

The Company’s amended and restated certificate of incorporation authorizes the Company to issue a total of 20,000,000 shares of preferred stock. No shares have been issued.

Common Stock

Common Stock Warrants

A summary of warrant activity for the period ended March 31, 2021 is presented below:

	Number of			Weighted Average Exercise		Weighted Average
Subject to Exercise	Warrants			Price		Life (Years)
Outstanding as of December 31, 2020		229,601		$	5.95		0.34
Granted – 2021		-			-		-
Forfeited/Expired – 2021		(146,342	)		-		-
Exercised – 2021		-			-		-
Outstanding as of March 31, 2021		83,259		$	14.65		0.43

As of March 31, 2021, the Company had outstanding vested and unexercised Common Stock Warrants as follows:

Date Issued	Exercise Price		Number of Warrants		Expiration date
September 2014	$	16.20		62,500	August 31, 2021
September 2014	$	10.00		11,800	September 18, 2021
September 2014	$	10.00		8,959	September 29, 2021

Total outstanding warrants at December 31, 2020				83,259

There were no common stock warrants exercised and 146,342 warrants expired during the period ended March 31, 2021. The intrinsic value of the outstanding warrants on March 31, 2021 is $-0-.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

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-URI http://asc.fasb.org/extlink&oid=123467817&loc=SL123496171-112644

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=123467817&loc=SL123496189-112644

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 16
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=123467817&loc=SL123496180-112644

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (i)
-URI http://asc.fasb.org/extlink&oid=123467817&loc=SL123496158-112644

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
-URI http://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

XML 22 R11.htm IDEA: XBRL DOCUMENT

Stock-based Compensation

3 Months Ended

Mar. 31, 2021

Share-based Payment Arrangement [Abstract]

Stock-based Compensation

5. Stock-based Compensation

2015 Equity Incentive Plan

A summary of stock option activity for the period ended March 31, 2021, is presented below:

	Number of			Weighted Average Exercise		Weighted Average		Aggregate Intrinsic
Subject to Exercise	Options			Price		Life (Years)		Value
Outstanding as of December 31, 2020		566,045		$	14.80		4.60	$	-
Granted – 2021		-			-		-		-
Forfeited/Expired – 2021		(85,342	)		16.19		-		-
Exercised – 2021		-			-		-		-
Outstanding as of March 31, 2021		480,703		$	14.55		5.15	$	-

As of March 31, 2021, the Company had vested and unexercised outstanding stock options as follows:

Date Issued	Exercise Price		Number of Options		Expiration date
August 2015	$	15.90		104,060	December 27, 2025
September 2015	$	15.90		20,000	December 27, 2025
November 2015	$	15.90		122,464	December 27, 2025
December 2015	$	15.90		5,569	December 27, 2025
January 2016	$	15.90		127,581	January 9, 2026
May 2016	$	20.50		26,915	May 26, 2026
September 2016	$	20.50		9,933	May 31, 2026
January 2017	$	20.50		5,356	January 1, 2027
January 2018	$	19.70		3,916	January 1, 2028
January 2019	$	0.94		54,909	January 1, 2029

Total outstanding options at March 31, 2021				480,703

As of March 31, 2021, there was no unrecognized compensation cost related to unvested stock options.

XML 23 R12.htm IDEA: XBRL DOCUMENT

Deferred Compensation

3 Months Ended

Mar. 31, 2021

Deferred Compensation

Deferred Compensation

6. Deferred Compensation

As of March 31, 2021 and December 31, 2020, deferred compensation was $267,500 and $252,500, respectively.

XML 24 R13.htm IDEA: XBRL DOCUMENT

Commitments and Contingencies

3 Months Ended

Mar. 31, 2021

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

7. Commitments and Contingencies

UCLA TDG Exclusive License Agreement

We are obligated to make the following milestone payments to UCLA TDG for each Licensed Product or Licensed Method:

	●	$100,000 upon enrollment of the first subject in a Feasibility Study;

	●	$250,000 upon enrollment of the first subject in a Pivotal Study:

	●	$500,000 upon Pre-Market Approval of a Licensed Product or Licensed Method; and

	●	$1,000,000 upon the First Commercial Sale of a Licensed Product or Licensed Method.

	●	$500,000; or

	●	2% of all proceeds in connection with a Change of Control Transaction.

		As of March 31, 2021, none of the above milestones has been met.

Payments to UCLA TDG under the Restated License Agreement for the three months ended March 31, 2021 and 2020 were $45,500 and $-0-, respectively.

Contingencies

XML 25 R14.htm IDEA: XBRL DOCUMENT

Subsequent Events

3 Months Ended

Mar. 31, 2021

Subsequent Events [Abstract]

Subsequent Events

8. Subsequent Events

From March 31, 2021 through May 14, 2021, the Company has drawn an additional of $50,317 against the Second credit facility.

XML 26 R15.htm IDEA: XBRL DOCUMENT

Summary of Significant Accounting Policies (Policies)

3 Months Ended

Mar. 31, 2021

Accounting Policies [Abstract]

Basis of Presentation

Basis of Presentation

Use of Estimates

Use of Estimates

Impact of the Novel Coronavirus (COVID-19) on the Company's Business Operations

Impact of the Novel Coronavirus (COVID-19) on the Company’s Business Operations

There is also significant uncertainty as to the effect that the coronavirus may have on the amount and type of financing available to the Company in the future.

Fair Value of Financial Instruments

Fair Value of Financial Instruments

Level 1: Quoted prices in active markets for identical assets or liabilities.

Stock Based Compensation

Stock Based Compensation

Collateral Shares

Collateral Shares

Loss Per Common Share

Loss per Common Share

The following sets forth the number of shares of common stock underlying outstanding options, warrants, and convertible debt as of March 31, 2021 and 2020:

	March 31,
	2021		2020
Warrants		83,259		489,475
Stock options		480,703		566,045
Convertible promissory notes		11,921,936		11,448,165
		12,485,898		12,503,685

New Accounting Standards

New Accounting Standards

XML 27 R16.htm IDEA: XBRL DOCUMENT

Summary of Significant Accounting Policies (Tables)

3 Months Ended

Mar. 31, 2021

Accounting Policies [Abstract]

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share

The following sets forth the number of shares of common stock underlying outstanding options, warrants, and convertible debt as of March 31, 2021 and 2020:

	March 31,
	2021		2020
Warrants		83,259		489,475
Stock options		480,703		566,045
Convertible promissory notes		11,921,936		11,448,165
		12,485,898		12,503,685

XML 28 R17.htm IDEA: XBRL DOCUMENT

Notes Payable - Related Party (Tables)

3 Months Ended

Mar. 31, 2021

Debt Disclosure [Abstract]

Schedule of Notes Payable

The Hankey Group is an affiliate of Hankey Capital.

Note Type	Issue Date	Maturity Date	Interest Rate			March 31, 2021		December 31, 2020

(A) First Secured Convertible Note	10/24/14	12/31/21		8.5	%	$	5,000,000	$	5,000,000

(A) Second Secured Convertible Note	5/4/15	12/31/21		8.5	%		2,000,000		2,000,000

(B) Third Secured Convertible Note	2/24/16	12/31/21		8.5	%		2,000,000		2,000,000

(C) First Credit Facility	7/24/18	12/31/21		8.5	%		2,000,000		2,000,000

(D) Second Credit Facility	9/19/19	12/31/21		8.5	%		921,936		712,179
Notes payable						$	11,921,936	$	11,712,179

First and Second Secured Convertible Notes and Warrants

(A)

Third Convertible Secured Term Note and Warrants

(B)

During 2018, the Company issued an additional 18,009,696 collateral shares pursuant to the First, Second and Third Secured Convertible Notes.

First Credit Facility Convertible Secured Term Note

(C)	On July 24, 2018, the Company and Hankey Capital entered into an agreement under which Hankey Capital provided a credit facility of $2,000,000 to the Company to be drawn down by the Company upon notice to Hankey Capital. The credit facility is evidenced by a convertible secured note convertible prior to the maturity date at $1.00 per share and due on December 31, 2021. Draws bear interest at an annual rate of interest at the “prime rate” (as quoted in the “Money Rates” section of The Wall Street Journal) plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears. At December 31, 2019, the Company had used all funds available under the facility. The note is secured by collateral shares as described below.

	During 2020, the Company issued 4,255,319 Collateral Shares pursuant to the agreement.

Second Credit Facility Convertible Secured Term Note

(D)

XML 29 R18.htm IDEA: XBRL DOCUMENT

Stockholders' Deficit (Tables)

3 Months Ended

Mar. 31, 2021

Equity [Abstract]

Schedule of Warrant Activity

A summary of warrant activity for the period ended March 31, 2021 is presented below:

	Number of			Weighted Average Exercise		Weighted Average
Subject to Exercise	Warrants			Price		Life (Years)
Outstanding as of December 31, 2020		229,601		$	5.95		0.34
Granted – 2021		-			-		-
Forfeited/Expired – 2021		(146,342	)		-		-
Exercised – 2021		-			-		-
Outstanding as of March 31, 2021		83,259		$	14.65		0.43

Schedule of Outstanding Vested and Unexercised Common Stock Warrants

As of March 31, 2021, the Company had outstanding vested and unexercised Common Stock Warrants as follows:

Date Issued	Exercise Price		Number of Warrants		Expiration date
September 2014	$	16.20		62,500	August 31, 2021
September 2014	$	10.00		11,800	September 18, 2021
September 2014	$	10.00		8,959	September 29, 2021

Total outstanding warrants at December 31, 2020				83,259

XML 30 R19.htm IDEA: XBRL DOCUMENT

Stock-based Compensation (Tables)

3 Months Ended

Mar. 31, 2021

Share-based Payment Arrangement [Abstract]

Schedule of Stock Option Activity

A summary of stock option activity for the period ended March 31, 2021, is presented below:

	Number of			Weighted Average Exercise		Weighted Average		Aggregate Intrinsic
Subject to Exercise	Options			Price		Life (Years)		Value
Outstanding as of December 31, 2020		566,045		$	14.80		4.60	$	-
Granted – 2021		-			-		-		-
Forfeited/Expired – 2021		(85,342	)		16.19		-		-
Exercised – 2021		-			-		-		-
Outstanding as of March 31, 2021		480,703		$	14.55		5.15	$	-

Schedule of Outstanding Stock Options

As of March 31, 2021, the Company had outstanding stock options as follows:

Date Issued	Exercise Price		Number of Options		Expiration date
August 2015	$	15.90		104,060	December 27, 2025
September 2015	$	15.90		20,000	December 27, 2025
November 2015	$	15.90		122,464	December 27, 2025
December 2015	$	15.90		5,569	December 27, 2025
January 2016	$	15.90		127,581	January 9, 2026
May 2016	$	20.50		26,915	May 26, 2026
September 2016	$	20.50		9,933	May 31, 2026
January 2017	$	20.50		5,356	January 1, 2027
January 2018	$	19.70		3,916	January 1, 2028
January 2019	$	0.94		54,909	January 1, 2029

Total outstanding options at March 31, 2021				480,703

XML 31 R20.htm IDEA: XBRL DOCUMENT

The Company (Details Narrative) - USD ($)		3 Months Ended
The Company (Details Narrative) - USD ($)	Jul. 16, 2018	Mar. 31, 2021	Mar. 31, 2020	Dec. 31, 2020	Dec. 31, 2019
Gross revenue		$ 1,070,000,000
Market value of common stock		700,000,000
Non-convertible debt securities		$ 1,070,000,000
Cessation as an emerging growth company, description		We would cease to be an emerging growth company upon the earliest of: (i) the last day of the first fiscal year in which our annual gross revenues are $1.07 billion or more; (ii) the end of any fiscal year in which the market value of our common stock held by non-affiliates exceeded $700.0 million as of the end of the second quarter of that fiscal year; or (iii) the date on which we have, during the previous three-year period, issued more than $1.07 billion in non-convertible debt securities
Accumulated losses		$ (69,296,669)		$ (68,864,922)
Estimated operating expenditure		6,600,000
Stockholders' deficit		(14,124,057)	$ (12,464,520)	$ (13,692,310)	$ (11,867,620)
Net loss		(431,747)	(596,900)
Net cash in operating activities		$ (127,983)	$ (149,878)
October 2016 Note Purchase Agreement [Member]
Percentage of earned deferred compensation		20.00%
October 2016 Note Purchase Agreement [Member] \| Directors [Member]
Percentage of earned deferred compensation		50.00%
Cumulative funding to be received		$ 5,000,000
Hankey Capital LLC [Member]
Ownership percentage		89.00%
Debt instrument principal amount		$ 11,921,936
Credit facility		$ 178,064
Existing Convertible Notes [Member] \| Hankey Capital LLC [Member]
Conversion price of convertible notes	$ 15.80	$ 1.00
Rights Offering [Member] \| Existing Convertible Notes [Member] \| Hankey Capital LLC [Member]
Shares purchased in rights offering	3,539,654

XML 32 R21.htm IDEA: XBRL DOCUMENT

Summary of Significant Accounting Policies (Details Narrative) - shares	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Anti-dilutive securities outstanding excluded from computation of diluted net loss per share	12,485,898	12,503,685
Collateral Shares [Member]
Anti-dilutive securities outstanding excluded from computation of diluted net loss per share	23,404,255

XML 33 R22.htm IDEA: XBRL DOCUMENT

Summary of Significant Accounting Policies - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
Anti-dilutive securities outstanding excluded from computation of diluted net loss per share	12,485,898	12,503,685
Warrants [Member]
Anti-dilutive securities outstanding excluded from computation of diluted net loss per share	83,259	489,475
Stock Options [Member]
Anti-dilutive securities outstanding excluded from computation of diluted net loss per share	480,703	566,045
Convertible Promissory Notes [Member]
Anti-dilutive securities outstanding excluded from computation of diluted net loss per share	11,921,936	11,448,165

XML 34 R23.htm IDEA: XBRL DOCUMENT

Notes Payable - Related Party (Details Narrative) - Hankey Capital LLC [Member] - USD ($)						3 Months Ended	12 Months Ended
	Sep. 19, 2019	Jul. 24, 2018	Feb. 24, 2016	May 04, 2015	Oct. 24, 2014	Mar. 31, 2021	Dec. 31, 2020	Dec. 31, 2018
Third Convertible Secured Term Note and Warrants [Member]
Convertible promissory note amount			$ 2,000,000
Debt maturity date			Dec. 31, 2021
Debt instrument conversion price per share			$ 1.00
Warrant to purchase shares of common stock			146,342
Warrant exercise price			$ 20.50
Loan commitment fee amount			$ 40,000
Percentage of commitment fee paid			2.00%
Offering costs			$ 77,532
Debt discount amortization								$ 2,000,000
Secured debt			$ 253,165
Warrant expiration date			Feb. 23, 2021
First, Second and Third Convertible Secured Term Notes [Member]
Number of shares of common stock issued as collateral								18,009,696
First Credit Facility Convertible Secured Term Note [Member]
Debt instrument conversion price per share		$ 1.00
Number of shares of common stock issued as collateral						4,255,319
Line of credit facility, amount		$ 2,000,000
Line of credit facility due date		Dec. 31, 2021
Credit facility, interest rate description		Draws bear interest at an annual rate of interest at the "prime rate" (as quoted in the "Money Rates" section of The Wall Street Journal) plus 4.0%, with a minimum rate of 8.5% per annum until maturity, with interest payable monthly in arrears.
Second Credit Facility Convertible Secured Term Note [Member]
Debt instrument conversion price per share	$ 1.00
Line of credit facility, amount	$ 1,100,000
Line of credit facility due date	Dec. 31, 2021
Line of credit facility in advance						$ 921,936	$ 712,179
Line of credit available under facility						$ 178,064	$ 387,821
First, Second and Third Convertible Secured Term Notes [Member]
Number of shares of common stock issued as collateral						23,404,255	23,404,255
Loan for collateral value ratio percentage						50.00%	50.00%
All Outstanding Notes [Member]
Interest payable related party						$ 1,502,449	$ 1,251,626
Minimum [Member] \| Third Convertible Secured Term Note and Warrants [Member]
Debt instrument interest rate			8.50%
Minimum [Member] \| First Credit Facility Convertible Secured Term Note [Member]
Debt instrument interest rate		8.50%
Minimum [Member] \| Second Credit Facility Convertible Secured Term Note [Member]
Debt instrument interest rate	8.50%
Prime Rate Plus [Member] \| Third Convertible Secured Term Note and Warrants [Member]
Debt instrument interest rate			4.00%
Prime Rate Plus [Member] \| First Credit Facility Convertible Secured Term Note [Member]
Debt instrument interest rate		4.00%
Prime Rate Plus [Member] \| Second Credit Facility Convertible Secured Term Note [Member]
Debt instrument interest rate	4.00%
First and Second Secured Convertible Notes and Warrants [Member]
Convertible promissory note amount				$ 7,000,000	$ 7,000,000
Debt maturity date				Dec. 31, 2021	Dec. 31, 2021
Debt instrument conversion price per share				$ 1.00	$ 1.00
Warrant to purchase shares of common stock				585,443	585,443
Warrant exercise price				$ 15.80	$ 15.80
Warrant maturity				5 years	5 years
Loan commitment fee amount				$ 210,000	$ 210,000
Percentage of commitment fee paid				3.00%	3.00%
Offering costs				$ 594,550	$ 594,550
Debt discount amortization								$ 2,891,409
Secured debt				$ 886,975	$ 886,975
First and Second Secured Convertible Notes and Warrants [Member] \| Minimum [Member]
Debt instrument interest rate				8.50%	8.50%
First and Second Secured Convertible Notes and Warrants [Member] \| Prime Rate Plus [Member]
Debt instrument interest rate				4.00%	4.00%

XML 35 R24.htm IDEA: XBRL DOCUMENT

Notes Payable - Related Party - Schedule of Notes Payable (Details) - USD ($)	3 Months Ended
	Mar. 31, 2021	Dec. 31, 2020
Secured Convertible Note	$ 11,921,936	$ 11,712,179
First Secured Convertible Note [Member]
Issue Date	Oct. 24, 2014
Maturity Date	Dec. 31, 2021
Interest Rate	8.50%	8.50%
Secured Convertible Note	$ 5,000,000	$ 5,000,000
Second Secured Convertible Note [Member]
Issue Date	May 04, 2015
Maturity Date	Dec. 31, 2021
Interest Rate	8.50%	8.50%
Secured Convertible Note	$ 2,000,000	$ 2,000,000
Third Secured Convertible Note [Member]
Issue Date	Feb. 24, 2016
Maturity Date	Dec. 31, 2021
Interest Rate	8.50%	8.50%
Secured Convertible Note	$ 2,000,000	$ 2,000,000
First Credit Facility [Member]
Issue Date	Jul. 24, 2018
Maturity Date	Dec. 31, 2021
Interest Rate	8.50%	8.50%
Secured Convertible Note	$ 2,000,000	$ 2,000,000
Second Credit Facility [Member]
Issue Date	Sep. 19, 2019
Maturity Date	Dec. 31, 2021
Interest Rate	8.50%	8.50%
Secured Convertible Note	$ 921,936	$ 712,179

XML 36 R25.htm IDEA: XBRL DOCUMENT

Stockholders' Deficit (Details Narrative) - USD ($)	3 Months Ended
Stockholders' Deficit (Details Narrative) - USD ($)	Mar. 31, 2021	Dec. 31, 2020
Preferred stock, shares authorized	20,000,000	20,000,000
Preferred stock, shares issued
Common stock, shares authorized	100,000,000	100,000,000
Common stock, shares outstanding	30,682,590	30,682,590
Number of warrants exercised
Number of warrants expired	146,342
Warrants [Member]
Number of warrants exercised
Number of warrants expired	146,342
Intrinsic value of outstanding warrants	$ 0

XML 37 R26.htm IDEA: XBRL DOCUMENT

Stockholders' Deficit - Schedule of Warrant Activity (Details)	3 Months Ended
	Mar. 31, 2021 $ / shares shares
Equity [Abstract]
Number of Warrants Outstanding, Beginning balance \| shares	229,601
Number of Warrants, Granted \| shares
Number of Warrants, Forfeited/Expired \| shares	(146,342)
Number of Warrants, Exercised \| shares
Number of Warrants Outstanding, Ending balance \| shares	83,259
Weighted Average Exercise Price, Outstanding, Beginning \| $ / shares	$ 5.95
Weighted Average Exercise Price, Granted \| $ / shares
Weighted Average Exercise Price, Forfeited/Expired \| $ / shares
Weighted Average Exercise Price, Exercised \| $ / shares
Weighted Average Exercise Price, Outstanding, Ending \| $ / shares	$ 14.65
Weighted Average Life (Years), Outstanding, Beginning	4 months 2 days
Weighted Average Life (Years), Outstanding. Ending	5 months 5 days

XML 38 R27.htm IDEA: XBRL DOCUMENT

Stockholders' Deficit - Schedule of Outstanding Vested and Unexercised Common Stock Warrants (Details) - Vested and Unexercised Common Stock Warrants [Member]	Mar. 31, 2021 $ / shares shares
Number of Warrants	83,259
September 2014 [Member]
Exercise Price \| $ / shares	$ 16.20
Number of Warrants	62,500
Expiration Date	Aug. 31, 2021
September 2014 [Member]
Exercise Price \| $ / shares	$ 10.00
Number of Warrants	11,800
Expiration Date	Sep. 18, 2021
September 2014 [Member]
Exercise Price \| $ / shares	$ 10.00
Number of Warrants	8,959
Expiration Date	Sep. 29, 2021

XML 39 R28.htm IDEA: XBRL DOCUMENT

Stock-based Compensation (Details Narrative) - 2015 Equity Incentive Plan [Member]	3 Months Ended
	Mar. 31, 2021 shares
Shares authorized and reserved for issuance	1,400,000
Percentage of stock issued and outstanding	5.00%

XML 40 R29.htm IDEA: XBRL DOCUMENT

Stock-based Compensation - Schedule of Stock Option Activity (Details)	3 Months Ended
	Mar. 31, 2021 USD ($) $ / shares shares
Share-based Payment Arrangement [Abstract]
Number of Options Outstanding, Beginning balance \| shares	566,045
Number of Options, Granted \| shares
Number of Options, Forfeited/Expired \| shares	(85,342)
Number of Options, Exercised \| shares
Number of Options Outstanding, Ending balance \| shares	480,703
Weighted Average Exercise Price, Outstanding, Beginning balance \| $ / shares	$ 14.80
Weighted Average Exercise Price, Granted \| $ / shares
Weighted Average Exercise Price, Forfeited/Expired \| $ / shares	16.19
Weighted Average Exercise Price, Exercised \| $ / shares
Weighted Average Exercise Price, Outstanding, Ending balance \| $ / shares	$ 14.55
Weighted Average Life (Years), Outstanding, Beginning balance	4 years 7 months 6 days
Weighted Average Life (Years), Outstanding. Ending balance	5 years 1 month 24 days
Aggregate Intrinsic Value, Outstanding, Beginning balance \| $
Aggregate Intrinsic Value, Outstanding, Ending balance \| $

XML 41 R30.htm IDEA: XBRL DOCUMENT

Stock-based Compensation - Schedule of Outstanding Stock Options (Details)	3 Months Ended
	Mar. 31, 2021 $ / shares shares
Number of Options	480,703
August 2015 [Member]
Exercise price \| $ / shares	$ 15.90
Number of Options	104,060
Expiration date	Dec. 27, 2025
September 2015 [Member]
Exercise price \| $ / shares	$ 15.90
Number of Options	20,000
Expiration date	Dec. 27, 2025
November 2015 [Member]
Exercise price \| $ / shares	$ 15.90
Number of Options	122,464
Expiration date	Dec. 27, 2025
December 2015 [Member]
Exercise price \| $ / shares	$ 15.90
Number of Options	5,569
Expiration date	Dec. 27, 2025
January 2016 [Member]
Exercise price \| $ / shares	$ 15.90
Number of Options	127,581
Expiration date	Jan. 09, 2026
May 2016 [Member]
Exercise price \| $ / shares	$ 20.50
Number of Options	26,915
Expiration date	May 26, 2026
September 2016 [Member]
Exercise price \| $ / shares	$ 20.50
Number of Options	9,933
Expiration date	May 31, 2026
January 2017 [Member]
Exercise price \| $ / shares	$ 20.50
Number of Options	5,356
Expiration date	Jan. 01, 2027
January 2018 [Member]
Exercise price \| $ / shares	$ 19.70
Number of Options	3,916
Expiration date	Jan. 01, 2028
January 2019 [Member]
Exercise price \| $ / shares	$ 0.94
Number of Options	54,909
Expiration date	Jan. 01, 2029

XML 42 R31.htm IDEA: XBRL DOCUMENT

Deferred Compensation (Details Narrative) - USD ($)	3 Months Ended
Deferred Compensation (Details Narrative) - USD ($)	Mar. 31, 2021	Dec. 31, 2020
Deferred compensation	$ 267,500	$ 252,500
October 2016 Note Purchase Agreement [Member]
Percentage of earned deferred compensation	20.00%
October 2016 Note Purchase Agreement [Member] \| Non-current Stockholders [Member]
Percentage of earned deferred compensation	20.00%
Cumulative funding to be received	$ 5,000,000

XML 43 R32.htm IDEA: XBRL DOCUMENT

Commitments and Contingencies (Details Narrative) - USD ($)	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2020
UCLA TDG [Member]
License commitment fee	$ 500,000
Percentage of amount raised in private placement	2.00%
License Agreement [Member]
Payment of UCLA TDG annual maintenance fee	$ 10,000
Percentage of commercial sale of the licensed product equal to net sales	3.00%
License Agreement [Member] \| UCLA TDG [Member]
License commitment fee	$ 45,500	$ 0
License Agreement [Member] \| UCLA TDG [Member] \| First Subject in Feasibility Study [Member]
License commitment fee	100,000
License Agreement [Member] \| UCLA TDG [Member] \| First Subject in Pivotal Study [Member]
License commitment fee	250,000
License Agreement [Member] \| UCLA TDG [Member] \| Pre-Market Approval of Licensed Product or Licensed Method [Member]
License commitment fee	500,000
License Agreement [Member] \| UCLA TDG [Member] \| First Commercial Sale of Licensed Product or Licensed Method [Member]
License commitment fee	$ 1,000,000
License Agreement [Member] \| UCLA TDG [Member] \| Minimum [Member]
Percentage of commercial sale of the licensed product equal to net sales	10.00%
License Agreement [Member] \| UCLA TDG [Member] \| Maximum [Member]
Percentage of commercial sale of the licensed product equal to net sales	20.00%
License Agreement [Member] \| Third Party [Member]
Reduced royalty percentage	0.333%
License Agreement [Member] \| First Commercial Sale [Member]
Annual minimum royalty for life of the patent rights	$ 50,000
License Agreement [Member] \| After First Commercial Sale [Member]
Annual minimum royalty for life of the patent rights	$ 250,000

XML 44 R33.htm IDEA: XBRL DOCUMENT

Subsequent Events (Details Narrative)	1 Months Ended
Subsequent Events (Details Narrative)	May 14, 2021 USD ($)
Second Credit Facility [Member] \| Subsequent Event [Member]
Proceeds from line of credit	$ 50,317

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