Form 10-Q - Quarterly report [Sections 13 or 15(d)]

United States

Securities and Exchange Commission

Washington, D.C. 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended September 30, 2024

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

For the transition period from _________ to _________.

Commission File Number: 001-40449

Zivo Bioscience, Inc.

(Exact name of registrant as specified in its charter)

Nevada		87-0699977
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

21 East Long Lake Road, Ste. 100, Bloomfield Hills MI		48304
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: 248-452-9866

______________________________

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

Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, par value $0.001 per share	ZIVO	OTCQB
Warrants to purchase shares of Common Stock, par value $0.001 per share	ZIVOW	OTC Pink

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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	☒
Emerging growth company	☐

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 ☐ No ☒

At November 8, 2024, there were 3,546,335 shares of common stock issued and outstanding.

FORM 10-Q

ZIVO BIOSCIENCE, INC.

INDEX

		Page
PART I - FINANCIAL INFORMATION		3

Item 1.	Financial Statements (Unaudited)	3

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	25

Item 4.	Controls and Procedures	25

PART II - OTHER INFORMATION		28

Item 1.	Legal Proceedings	28

Item 1A.	Risk Factors	28

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	28

Item 3.	Defaults upon Senior Securities	28

Item 4.	Mine Safety Disclosures	28

Item 5.	Other Information	28

Item 6.	Exhibits	29

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PART I - FINANCIAL INFORMATION

Item 1 - Financial Statements

ZIVO BIOSCIENCE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEET

(UNAUDITED)

	September 30,			December 31,
	2024			2023
ASSETS

CURRENT ASSETS:
Cash	$	159,403		$	274,380
Accounts receivable		27,794			3,735
Prepaid expenses		249,348			147,262
Total current assets		436,545			425,377
OTHER ASSETS:
Operating lease - right of use asset		22,305			98,280
Security deposit		36,739			32,058
Total other assets		59,043			130,338
TOTAL ASSETS	$	495,587		$	555,715

CURRENT LIABILITIES:
Accounts payable	$	787,599		$	993,090
Accounts payable – related party		136,261			172,670
Customer deposits		45,000			-
Current portion of long-term operating lease		22,027			106,342
Convertible debentures payable		240,000			240,000
Loan Payable		115,014			-
Accrued interest		102,481			100,686
Accrued liabilities – employee bonus		1,130,274			1,148,770
Total current liabilities		2,578,656			2,761,558
LONG TERM LIABILITIES:		-			-
TOTAL LIABILITIES		2,578,656			2,761,558
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ EQUITY (DEFICIT):
Common stock, $0.001 par value, 25,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 3,490,396 and 2,382,356 issued and outstanding at September 30, 2024, and December 31, 2023, respectively		3,490			2,382
Additional paid-in capital		133,278,605			121,373,488
Accumulated deficit		(135,365,164	)		(123,581,713	)
Total stockholders’ equity (deficit)		(2,083,069	)		(2,205,843	)
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)	$	495,587		$	555,715

See accompanying notes to unaudited condensed consolidated financial statements.

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ZIVO BIOSCIENCE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

	For the Three Months ended September 30, 2024			For the Three Months ended September 30, 2023			For the Nine Months ended September 30, 2024			For the Nine Months ended September 30, 2023
REVENUES:
Product revenue	$	31,500		$	11,800		$	67,220		$	15,850
Total revenues		31,500			11,800			67,220			15,850

COSTS OF GOODS SOLD
Product costs		22,050			7,670			45,268			8,371
Total cost of goods sold		22,050			7,670			45,268			8,371

GROSS MARGIN		9,450			4,130			21,952			7,479

COSTS AND EXPENSES:
General and Administrative		1,943,127			1,355,865			8,895,978			4,309,343
Research and Development		326,361			220,653			2,891,452			1,064,563

Total costs and expenses		2,269,487			1,576,518			11,787,430			5,373,906

LOSS FROM OPERATIONS		(2,260,037	)		(1,572,388	)		(11,765,478	)		(5,366,427	)

OTHER (EXPENSE)
Interest expense		(8,560	)		(32,736	)		(17,973	)		(67,498	)
Amortization of debt discount		-			(219,798	)		-			(434,712	)
Total other expense		(8,560	)		(252,534	)		(17,973	)		(502,210	)

NET LOSS	$	(2,268,597	)	$	(1,824,922	)	$	(11,783,451	)	$	(5,868,637	)

BASIC AND DILUTED LOSS PER SHARE	$	(0.67	)	$	(1.05	)	$	(3.87	)	$	(3.64	)
WEIGHTED AVERAGE BASIC AND DILUTED SHARES OUTSTANDING		3,410,444			1,735,887			3,041,466			1,610,861

See accompanying notes to unaudited condensed consolidated financial statements.

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ZIVO BIOSCIENCE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2024 AND SEPTEMBER 30, 2023

(UNAUDITED)

					Additional
	Common Stock				Paid in		Accumulated
	Shares		Amount		Capital		Deficit			Total

Balance, June 30, 2023		1,569,943	$	1,570		116,701,842	$	(119,848,244	)	$	(3,144,832	)
Private offering issuance of stock and warrants		171,666		172		3,634,791		-			3,634,963
Employee and director equity-based compensation		-		-		240,749		-			240,749
Net loss for the three months ended September 30, 2023		-		-		-		(1,824,922	)		(1,824,922	)
Balance, September 30, 2023		1,741,609	$	1,742	$	120,577,382	$	(121,673,166	)	$	(1,094,042	)

					Additional
	Common Stock				Paid in		Accumulated
	Shares		Amount		Capital		Deficit			Total

Balance, June 30, 2024		3,319,032	$	3,319		130,797,634	$	(133,096,568	)	$	(2,295,615	)
Private offering issuance of stock and warrants		125,958		126		1,036,247		-			1,036,373
Private offering issuance of stock and warrants – related parties		45,406		45		378,056		-			378,101
Employee and director equity-based compensation		-		-		1,066,668		-			1,066,668
Net loss for the three months ended September 30, 2024		-		-		-		(2,268,597	)		(2,268,597	)
Balance, September 30, 2024		3,490,396	$	3,490	$	133,278,605	$	(135,365,164	)	$	(2,083,069	)

See accompanying notes to unaudited condensed consolidated financial statements.

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ZIVO BIOSCIENCE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2024 AND SEPTEMBER 30, 2023

(UNAUDITED)

					Additional Paid in		Accumulated
	Shares		Amount		Capital		Deficit			Total
Balance, December 31, 2022		1,569,943	$	1,570	$	115,792,337	$	(115,804,529	)	$	(10,622	)
Private offering issuance of stock and warrants		171,666		172		3,634,791		-			3,634,963
Employee and director equity-based compensation		-		-		710,661		-			710,661
Warrants issued with related party note		-		-		439,593		-			439,593
Net loss for the nine months ended September 30, 2023		-		-		-		(5,868,637	)		(5,868,637	)
Balance, September 30, 2023		1,741,609	$	1,742	$	120,577,382	$	(121,673,166	)	$	(1,094,042	)

					Additional Paid in		Accumulated
	Shares		Amount		Capital		Deficit			Total
Balance, December 31, 2023		2,382,356	$	2,382	$	121,373,488	$	(123,581,713	)	$	(2,205,843	)
Private offering issuance of stock and warrants		476,591		477		2,008,439		-			2,008,916
Private offering issuance of stock and warrants – related parties		185,959		186		1,168,696		-			1,168,882
Employee and director equity-based compensation		445,490		445		8,727,982		-			8,728,427
Net loss for the nine months ended September 30, 2024		-		-		-		(11,783,451	)		(11,783,451	)
Balance, September 30, 2024		3,490,396	$	3,490	$	133,278,605	$	(135,365,164	)	$	(2,083,069	)

See accompanying notes to unaudited condensed consolidated financial statements.

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ZIVO BIOSCIENCE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

(UNAUDITED)

	For the Nine Months Ended September 30, 2024			For the Nine Months Ended September 30, 2023
Cash Flows for Operating Activities:
Net loss	$	(11,783,451	)	$	(5,868,637	)
Adjustments to reconcile net loss to net cash used by operating activities:
Non cash lease expense		75,978			67,172
Amortization of deferred R&D obligations participation agreements		-			(624,110	)
Amortization of debt discount		-			434,712
Employee and director equity compensation		8,728,427			710,661
Changes in assets and liabilities:
Prepaid expenses		(102,086	)		(358,217	)
Accounts payable		(205,491	)		(99,536	)
Accounts payable – related parties		(36,409	)		-
Lease liabilities		(84,315	)		(72,752	)
Customer deposits		45,000			-
Security deposits		(4,681	)		-
Accounts receivable		(24,059	)		(2,593	)
Accrued liabilities		(16,701	)		729,140
Net cash (used in) operating activities	$	(3,407,788	)	$	(5,084,160	)

Cash Flows from Investing Activities:
Net cash provided by investing activities	$	-		$	-

Cash Flow from Financing Activities:
Proceeds from notes payable, other		517,560			605,600
Payments on notes payable, other		(402,547	)		(471,023	)
Proceeds from note payable, related party		-			1,000,000
Net proceeds from sales of common stock and warrants		2,008,916			3,634,963
Net proceeds from sales of common stock and warrants – related parties		1,168,882			-
Net cash provided by financing activities	$	3,292,811		$	4,769,540

Decrease in Cash		(114,977	)		(314,620	)
Cash at Beginning of Period		274,380			1,799,264
Cash at End of Period	$	159,403		$	1,484,644

Supplemental Disclosures of Cash Flow Information:
Cash paid during the period for:
Interest	$	14,391		$	16,639
Income Taxes	$	-		$	-

See accompanying notes to unaudited condensed consolidated financial statements.

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ZIVO BIOSCIENCE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS (Continued)

Supplemental Disclosure of Non-Cash Investing and Financing Activities:

Nine months Ended September 30, 2024:

During the nine months ended September 30, 2024, the Company exchanged $172,670 in accounts payable to related parties for 261,619 shares of common stock (see NOTE 5 - STOCKHOLDERS’ EQUITY (DEFICIT) – Equity Compensation – Restricted Stock Awards – Stock Award in Lieu of Unpaid Directors’ Fees). In addition, the Company exchanged options to buy 50,251 shares of common stock for an accrued bonus payable of $400,000 to the Company’s CEO (see NOTE 5 - STOCKHOLDERS’ EQUITY (DEFICIT) – Equity Compensation – Common Stock Options – CEO 2023 Equity Award).

Nine months Ended September 30, 2023:

During the nine months ended September 30, 2023, the Company had no non-cash investing or financing transactions.

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ZIVO BIOSCIENCE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

NOTE 1 - BASIS OF PRESENTATION

The accompanying unaudited condensed consolidated financial statements include the accounts of Zivo Bioscience, Inc. and its wholly owned subsidiaries (collectively, “we,” “our,” “us,” “ZIVO,” or the “Company”). All significant intercompany accounts and transactions have been eliminated in consolidation. In the opinion of the Company’s management, the financial statements contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the information set forth therein. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”). The condensed consolidated financial statements have also been prepared on a basis substantially consistent with and should be read in conjunction with the Company’s audited consolidated financial statements for the year ended December 31, 2023, and the notes thereto, included in its Annual Report on Form 10-K that was filed with the Securities and Exchange Commission on March 15, 2024.

Going Concern

The Company has incurred net losses since inception, experienced negative cash flows from operations for the quarter ended September 30, 2024, and has an accumulated deficit of $135,365,164. The Company has historically financed its operations primarily through the issuance of common stock, warrants, and debt.

The Company expects to continue to incur operating losses and net cash outflows until such time as it generates a level of revenue to support its cost structure. There is no assurance that the Company will achieve profitable operations, and, if achieved, whether it will be sustained on a continued basis. The Company intends to fund ongoing activities by utilizing its current cash on hand and by raising additional capital through equity and/or debt financings. There can be no assurance that the Company will be successful in raising that additional capital or that such capital, if available, will be on terms that are acceptable to the Company. If the Company is unable to raise sufficient additional capital, the Company may be compelled to reduce the scope of its operations and planned capital expenditures.

These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued. The Company’s condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and satisfaction of liabilities in the ordinary course of business; no adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern.

NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Stock Based Compensation

The Company accounts for stock-based compensation in accordance with FASB ASC 718, Compensation - Stock Compensation. Under the provisions of FASB ASC 718, stock-based compensation cost is estimated at the grant date based on the award’s fair value and is recognized as expense over the requisite service period. The Company, from time to time, issues restricted common stock awards or grants common stock options to its employees, consultants and board members. At the date of grant, the Company determines the fair value of the stock option award and recognizes compensation expense over the requisite service period. Issuances of restricted common stock are valued at the closing market price on the date of issuance and the fair value of any stock option or warrant awards is calculated using the Black Scholes option pricing model and employing the simplified term method as the Company does not have a historical basis to determine the expected term. The Company expenses the awards based on the vesting schedule as detailed pursuant to each individual award agreement. The Company records forfeiture of options when they occur.

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Warrants

The Company accounts for warrants in accordance with FASB ASC 815 – Derivatives and Hedging. The fair value of the Company’s warrants is determined at the time of issuance using the Black Scholes option valuation model based on a market price and the remaining term of the warrant obligation. The warrants are not subject to remeasurement through the term. For the Company’s outstanding warrants, the number of shares and the exercise price shall be adjusted for standard anti-dilution events such as stock splits, combinations, reorganizations, or issue shares as part of a stock dividend. Upon a change of control, the warrant holder will have the right to receive securities, cash or other properties it would have been entitled to receive had the warrant been exercised.

Recently Announced Accounting Standards

In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses, requiring additional disclosures about specified categories of expenses included in certain expense captions presented on the face of the income statement. This standard will be effective for the Company as of and for the year ending December 31, 2027, and may be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the impact of adopting this guidance on the Company's consolidated financial statements.

NOTE 3 - DEBT

On March 5, 2024, the Company entered into a short-term unsecured loan agreement to finance a portion of the Company's directors' and officers', and employment practices liability insurance premiums. The note in the amount of $517,560 carries an 8.5% annual percentage rate and will be paid down in nine equal monthly payments of $59,562 beginning on March 10, 2024. As of September 30, 2024, a principal balance of $115,014 remains outstanding.

On February 14, 2023, the Company entered into a short-term unsecured loan agreement to finance a portion of the Company's directors' and officers', and employment practices liability insurance premiums. The note in the amount of $605,600 carried an 8.4% annual percentage rate and was paid down in nine equal monthly payments of $69,666 beginning on March 10, 2023. As of November 9, 2023, the loan was fully paid.

NOTE 4 - DEFERRED R&D OBLIGATIONS - PARTICIPATION AGREEMENTS

For the three months ended September 30, 2024, and 2023, the Company recognized $0 and $189,680, respectively, as a contra R&D expense related to personnel and third-party expenses to develop the subject technology, respectively. For the three months ended September 30, 2024, and 2023, $0 and $47,445, respectively, of this total contra R&D expense was attributed to deferred R&D obligations funded by related parties.

For the nine months ended September 30, 2024, and 2023, the Company recognized $0 and $624,110, respectively, as a contra R&D expense related to personnel and third-party expenses to develop the subject technology, respectively. For the nine months ended September 30, 2024, and 2023, $0 and $156,027, respectively, of this total contra R&D expense was attributed to deferred R&D obligations funded by related parties.

NOTE 5 - STOCKHOLDERS’ EQUITY (DEFICIT)

Equity Sales

During the three months ended September 30, 2024, the Company sold common stock in 9 private unregistered transactions to investors resulting in the issuance of 171,364 shares of common stock and total proceeds of $1,414,474 including $1,336,373 in cash and $78,101 in accounts payable. Included in the totals are 45,406 shares of common stock sold to related parties for total proceeds of $378,101 including $300,000 in cash and $78,101 in related party accounts payable. In the three months ended September 30, 2023, the Company, closed on a securities purchase agreement with a single institutional investor, pursuant to which the investor agreed to purchase from the Company, in a registered direct offering 171,666 shares of the Company's common stock for proceeds of $2,750,089.

During the nine months ended September 30, 2024, the Company sold common stock in 38 private unregistered transactions to investors resulting in the issuance of 662,550 shares of common stock and total proceeds of $3,177,798 including $3,099,697 in cash and $78,101 in accounts payable. Included in the totals are 185,959 shares of common stock sold to related parties for total proceeds of $1,168,882 including $1,090,781 in cash and $78,101 in related party accounts payable. In the nine months ended September 30, 2023, the Company, closed on a securities purchase agreement with a single institutional investor, pursuant to which the investor agreed to purchase from the Company, in a registered direct offering 171,666 shares of the Company's common stock for proceeds of $2,750,089.

Warrants

In the three months ended September 30, 2024 the Company issued warrants to purchase 17,134 shares of common stock to investors under a board approved private fund raising program. Included in the total were warrants for 4,540 shares issued to related parties.

In the three months ended September 30, 2023, the Company issued pre-funded warrants to purchase 78,021 shares of common stock, and issued warrants to purchase 499,376 shares of common stock to a single investor in a private transaction.

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In the nine months ended September 30, 2024 the Company issued warrants to purchase 17,832 shares of common stock to investors under a board approved private fund raising program. Included in the total were warrants for 5,238 shares issued to related parties.

In the nine months ended September 30, 2023 the Company issued pre-funded warrants to purchase 78,021 shares of common stock, issued warrants to purchase 499,376 shares of common stock to a single investor in a private transaction, and issued warrants to purchase 65,000 shares of common stock as part of a loan agreement with the Company’s CEO.

Equity Compensation

Stock Based Compensation

For the quarter ended September 30, 2024, the Company recognized a total stock based compensation expense of $1,066,668 for equity compensation to members of the Board of Directors and certain employees for restricted stock awards and option grants. The total expense amount was related to new equity grants in the present period plus equity awards from prior periods. $106,236 of the total expense for the quarter was related to R&D and the remaining $960,432 was for general and administrative expenses (G&A). During the three months ended September 30, 2023, no options were granted to each of the non-employee directors of the Company. The Company recorded compensation expense for prior issued grants during the three months ended September 30, 2023 of $240,750.

For the nine months ended September 30, 2024, the Company expensed $8,728,427 for equity compensation to members of the Board of Directors and certain employees for restricted stock awards and option grants. The total expense amount was related to new equity grants in the present period plus equity awards from prior periods. $2,166,464 of the total expense for the quarter was related to R&D and the remaining $6,561,963 was for general and administrative expenses (G&A). During the nine months ended September 30, 2023, 10,878 options were granted to each of the non-employee directors of the Company. As a result of these and previous grants, the Company recorded compensation expense of $710,661 for that period.

Restricted Stock Awards

During the three months ended September 30, 2024, the Company issued no new Restricted Stock Awards (RSAs). For three months ended September 30, 2024, the Company recognized $554,321 in directors’ compensation expense for vesting of previously awarded RSAs.

During the nine months ended September 30, 2024 the Board of Directors awarded 445,490 RSAs to the non-employee directors of the Company under the Equity Incentive Plan for Non-Employee Directors. Of this total 18,819 RSAs were issued to non-employee directors on June 11, 2024 pursuant to the Amended Non-Employee Director Compensation Policy whereby each non-employee director receives $50,000 in value of RSAs calculated from the closing price of the Company’s common stock on that day. The RSAs vest 25% on each of the 3 month, 6 month, and 9 month anniversaries of the award, and 25% on the day prior to the Company's 2025 annual shareholder meeting. For the three months ended September 30, 2024, the Company recognized $95,977 in directors compensation expense for these awards. For the nine months ended September 30, 2024, the Company recognized $112,165 in directors compensation expense for these awards. The remaining 426,671 RSAs were awarded by the Board to the non-employee directors of the Board under several Board approved equity compensation actions.

Director Stock Option Replacement Program

The Company had issued stock options to its non-employee directors pursuant to the 2021 Equity Incentive Plan (the “2021 Plan”). The 2021 Plan provides that the Board may cancel outstanding options and make a substitute grant of new options or other equity-based awards under the 2021 Plan or another equity plan of the Company (the “Director Stock Option Replacement Program”). On June 5, 2024, pursuant to the Director Stock Option Replacement Program, 127,364 shares of restricted stock were granted under a newly adopted 2024 Equity Incentive Plan for Non-Employee Directors (the "Director Equity Plan") to replace all 62,451 outstanding options that were previously granted to non-employee directors under the 2021 Plan. The RSAs vested immediately on the date of the grant. The Company recognized $697,501 of expense in the nine months ended September 30, 2024.

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Stock Award Grant

On May 31, 2024, the Board granted common stock RSAs with an approximate value of $300,000 under the Director Equity Plan to director Alison Cornell. The 37,688 RSA shares awarded were determined based on the closing price of the Company’s stock on the date of grant of $7.96 per share. The Company recognized an expense of $299,996 for this RSA grant. The Board determined that this award to Ms. Cornell is an award for special or extraordinary services and was exempt from the annual limitation on awards to non-employee directors set forth in the Director Equity Plan.

Stock Award in Lieu of Unpaid Directors’ Fees

On May 31, 2024, the Board approved a Stock in Lieu of Unpaid Director's fees that would allow for the granting of a total of 261,619 common stock RSAs to the non-employee Board members in lieu of unpaid non-employee director service fees earned during the calendar year ending December 31, 2023. In aggregate the Company owed the three non-employee board members $172,670 in fees. These unpaid amounts were grossed up for taxes at an assumed tax rate of 45% and the number of shares was determined based on the Company’s closing stock price on December 29, 2023 of $1.20 per share.

The value of the shares granted to the non-employee directors pursuant to this exchange of stock in lieu of unpaid cash fees were exempted from the annual limitation of awards to non-employee directors set forth in the Director Equity Plan. These shares awards will be issued under the Director Equity Plan and will be subject to provisions thereof. The RSAs issued under this program vested 50% immediately on the date of grant, and the remaining 50% will vest on January 1, 2025.

The Company determined the value of these awards based on the market price on the grant date of $7.96 per share and recognized $458,344 of expense in the three months ended September 30, 2024, for the portion of these awards vesting on January 1, 2025. The Company recognized $1,619,184 of expense for the nine months ended September 30, 2024 for the vested and unvested awards.

No RSAs were issued by the Company in the three months and nine months ended September 30, 2023.

Common Stock Options

During the three months ended September 30, 2024, the Company issued no new option awards. The Company recognized compensation expense for options that were previously granted to executives and employees of $512,347 for the three month period ended September 30, 2024.

During the nine months ended September 30, 2024, the Company awarded options underlying 1,031,425 shares of common stock to executives and employees under the 2021 Plan. The Company recognized compensation expense for these awards and options that were previously granted to executives and employees of $5,999,589 for the nine month period ended September 30, 2024.

CEO 2023 Equity Award

On June 5, 2024, the Board awarded 50,251 common stock options to the Company’s Chief Executive Officer in exchange for a prior agreed to cash payment yet unpaid in the amount of $400,000. The strike price of $7.96 was set as the closing market price on the grant date and the options vested immediately upon issuance. The Company used the Black Scholes option pricing model to determine the compensation expense of $338,815 for the award grant. The Black Scholes pricing model used the following assumptions: term of 5 years; volatility 122.46%; annual rate of dividends 0%; discount rate 4.29%.

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Employee Stock Option Replacement Program

On June 5, 2024, pursuant to the Employee Stock Option Replacement Program, 981,174 common stock option shares were approved by the Board of Directors from the 2021 Plan to replace all 230,064 outstanding options that were previously granted to executive and employees under both the 2019 Plan and the 2021 Plan. Replacement shares were granted under the existing 2021 Plan. The Company used the Black Scholes option pricing model to determine the compensation expense of $512,347 for these award grants for the three months ending September 30, 2024. For the nine months ended September 30, 2024, the Company recorded compensation expense for these awards of $5,660,774. The Company determined the new options awarded under the Employee Stock Option Replacement Program to be modifications of existing awards and as such the Company will account for the awards by continuing to expense the original option awards as well as expensing the value of the new awards less the value of the old awards revalued at the conditions at the time of new awards. The Company valued the new awards using the Black Scholes pricing model with the following assumptions: option agreement term of 10 years; volatility 122.46%; annual rate of dividends 0%; discount rate 4.29%.

In the three months ending September 30, 2023, 10,878 options were granted to each of the non-employee directors of the Company. The Company recorded compensation expense for issued grants during the three months ended September 30, 2023, and for previous grants in the amount of $240,750 for this period. During the nine months ended September 30, 2023, 10,878 stock options were granted to each of the non-employee directors of the Company. As a result of these and previous grants, the Company recorded compensation expense of $710,661 in that nine month period.

The fair value of stock options was estimated on the date of grant using the Black-Scholes option-pricing model based on the following weighted average assumptions:

	Nine months Ended September 30,
	2024			2023
Expected volatility		122.46	%		112.28	%
Expected dividends		-			-
Expected term	5.0-5.2 years			5.3 years
Risk free rate		4.29	%		3.88	%

The Black-Scholes option-pricing model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable. In addition, option-pricing models require the input of highly subjective assumptions, including the expected stock price volatility. In considering the expected term of the options, the Company employs the simplified method. The Company uses this method as it does not have a history of option exercises to establish a robust estimated term based on experience. The simplified term is used for the determination of expected volatility as well as the identification of the risk-free rate.

Equity Incentive Plan for Non-Employee Directors

On May 31, 2024, the Board of Directors adopted the 2024 Equity Incentive Plan for Non-Employee Directors (the “Director Equity Plan”). Material features of the Director Equity Plan are:

	·	The maximum number of shares of common stock to be issued under the Director Equity Plan is 875,000 shares, which number will automatically increase on January 1 of each year commencing on January 1, 2025, in an amount equal to 5% of the total number of shares of the Common Stock outstanding on December 31 of the preceding year.
	·	Shares reacquired by the Company to satisfy the exercise, strike or purchase price of any award or any shares that are reacquired to satisfy a tax withholding obligation in connection with the award will be added back to the share reserve under the Director Equity Plan. The withholding of shares that would otherwise be issued by the Company to satisfy the exercise, strike or purchase price of an award or the withholding of shares that would otherwise be issued by the Company to satisfy a tax withholding obligation in connection with an award will not be added back to the share reserve.
	·	The award of non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock-based awards is permitted.
	·	The aggregate value of all compensation granted or paid to any non-employee director with respect to any calendar year, including awards granted and cash fees paid by the Company to such non-employee director, will not exceed $750,000 in total value or, in the event such non-employee director is first appointed or elected to the Board during such calendar year, $1,000,000 in total value. These annual limits do not apply to (i) any awards made to replace stock options that were cancelled by the Board, (ii) awards made to a non-employee director for special or extraordinary services, as determined by the Board, or (iii) awards made in 2024 to compensate non-employee directors for services performed in 2023.
	·	All awards granted under the Director Equity Plan are subject to recoupment in accordance with the Company’s clawback policy.

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Non-employee directors are eligible to participate in the Director Equity Plan. As of September 30, 2024, 429,510 shares remain available to be issued under the Director Equity Plan.

2021 Equity Incentive Plan

On October 12, 2021, after approval from the stockholders at the Company’s 2021 annual meeting of stockholders, the Company adopted the 2021 Plan for the purpose of enhancing the Company’s ability to attract and retain highly qualified directors, officers, key employees and other persons and to motivate such persons to improve the business results and earnings of the Company by providing an opportunity to acquire or increase a direct proprietary interest in the operations and future success of the Company. The 2021 Plan is administered by the compensation committee of the Board who will, amongst other duties, have full power and authority to take all actions and to make all determinations required or provided for under the 2021 Plan. Pursuant to the 2021 Plan, the Company may grant options, share appreciation rights, restricted shares, restricted share units, unrestricted shares and dividend equivalent rights. The 2021 Plan has a duration of 10 years.

Subject to adjustment as described in the 2021 Plan, the aggregate number of shares of common stock available for issuance under the 2021 Plan was 166,666 shares (following a reverse stock split); this number is automatically increased each January 1st by an amount equal to 5% of the number of common stock shares outstanding at that date, resulting in an increase in available shares under the 2021 Plan at January 1, 2024 of 119,117. On May 31, 2024, the Company’s Board of Directors amended the 2021 Plan such that the total number of shares of common stock available for issuance under the 2021 Plan was increased to 1,000,000 shares.

On June 5, 2024, pursuant to a proposed equity compensation exchange approved by the Board of Directors, various option awards underlying 292,515 shares of common stock were forfeited by employees and members of the Board of Directors in exchange for replacement equity awards as approved by the Board of Directors. As of September 30, 2024, 1,031,425 options have been issued under the 2021 Plan, and 261,090 shares remained available for issuance.

2019 Omnibus Long-Term Incentive Plan

Prior to the adoption of the 2021 Equity Incentive Plan, the Company maintained a 2019 Omnibus Long-Term Incentive Plan (the “2019 Plan”). Following the approval by the shareholders of the 2021 Plan, no additional awards have been or will be made under the 2019 Plan. As of September 30, 2024, all options issued under the 2019 Plan have been forfeited and no options remain outstanding. On May 31, 2024 the Company’s Board of Directors formally terminated the 2019 Plan.

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Common Stock Options

A summary of the status of the Company’s options issued under the Company’s equity incentive plans is presented below. As of September 30, 2024 there is no intrinsic value in any of the Company's outstanding options as the market price of the Company's common stock is in all cases lower than the exercise price of options:

	September 30, 2024					September 30, 2023
	Number of Options			Weighted Average Exercise Price		Number of Options		Weighted Average Exercise Price
Outstanding, beginning of year		292,515		$	35.56		281,637	$	36.29
Forfeited		(292,515	)		35.56		-		-
Issued		1,031,425			7.96		10,878		16.74
Outstanding, end of period		1,031,425		$	7.96		292,515	$	35.56

Options outstanding and exercisable by price range as of September 30, 2024, were as follows:

Outstanding Options						Exercisable Options
Range of Exercise Price		Number		Average Weighted Remaining Contractual Life in Years		Range of Exercise Price		Number		Weighted Average Exercise Price
$	6.00-11.99		1,031,425		9.68	$	6.00-11.99		910,966	$	7.96

			1,031,425		9.68				910,966	$	7.96

Common Stock Warrants - Unregistered

A summary of the status of the Company’s unregistered warrants is presented below:

	September 30, 2024					September 30, 2023
	Number of Warrants			Weighted Average Exercise Price		Number of Warrants			Weighted Average Exercise Price

Outstanding, beginning of year		671,448		$	21.59		267,013		$	47.10
Issued		17,832			8.24		642,397			14.82
Exercised		-			-		-			-
Cancelled		-			-		-			-
Expired		(25,690	)		46.05		(105,390	)		47.24
Outstanding, end of period		663,590		$	20.28		804,020		$	21.29

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Unregistered warrants outstanding and exercisable by price range as of September 30, 2024, were as follows:

Outstanding Warrants						Exercisable Warrants
Range of		Number		Average Weighted Remaining Contractual Life in Years		Exercise Price		Number		Weighted Average Exercise Price

$	6.00-11.99		17,832		4.87	$	6.00-11.99		17,832		8.24
12.00-17.99			564,376		2.18	12.00-17.99			564,376		16.88
30.00-35.99			36,800		1.67	30.00.35.99			36,800		33.00
36.00-41.99			104		0.08	36.00-41.99			104		38.40
48.00-53.99			4,165		0.80	48.00-53.99			4,165		51.60
54.00-55.99			38,543		0.95	54.00-55.99			38,543		57.60
60.00-65.99			281		1.62	60.00-65.99			281		62.40
66.00-71.99			656		1.32	66.00-71.99			656		67.20
84.00-89.99			833		0.24	84.00-89.99			833		86.40
			663,590		2.14				663,590	$	20.28

Common Stock Warrants - Registered

A summary of the status of the Company’s registered warrants is presented below:

	September 30, 2024				September 30, 2023
	Number of Registered Warrants		Weighted Average Exercise Price		Number of Registered Warrants		Weighted Average Exercise Price
Outstanding, beginning of year		495,917	$	33.00		495,917	$	33.00
Issued		-		-		-		-
Exercised		-		-		-		-
Cancelled		-		-		-		-
Expired		-		-		-		-
Outstanding, end of period		495,917	$	33.00		495,917	$	33.00

Registered warrants outstanding and exercisable by price range as of September 30, 2024, were as follows:

Outstanding Registered Warrants						Exercisable Registered Warrants
Exercise Price		Number		Average Weighted Remaining Contractual Life in Years		Exercise Price		Number		Weighted Average Exercise Price

$	33.00		495,917		1.67	$	33.00		495,917		33.00
			495,917		1.67				495,917	$	33.00

NOTE 6 - COMMITMENTS AND CONTINGENCIES

Employment Agreements

At September 30, 2024, the Company had compensation agreements with its President / Chief Executive Officer, and Chief Financial Officer.

Leases

On September 13, 2024, the Company entered into a 63-month lease agreement for a corporate office space in Troy, Michigan that has not yet commenced. The Company intends to relocate its headquarters to that facility upon the commencement of the lease agreement which is planned to begin on January 1, 2025, contingent on the landlord completing agreed to modifications to the leased property. The lease agreement provides for a total rent of $298,135 over the full lease period. Occupancy of the property will commence with the property availability, there will be a 3-month rent holiday at the beginning of the lease which will be amortized as a reduction of lease expense over the full term of the lease.The Company paid a security deposit of $4,851. The future lease payments will be $4,681 per month from April 1, 2025 to March 31, 2026; $4,820 from April 1, 2026 to March 31, 2027; $4,964 from April 1, 2027 to March 31, 2028; $5,113 from April 1, 2028 to March 31, 2029; and $5,267 from April 1, 2029 to March 31, 2030. The Company has reviewed the terms of the agreement and will classify the lease as an operating lease under ASC 842.

Legal Contingencies

The Company may become a party to litigation in the normal course of business. To the knowledge of management, there are no pending legal matters involving the Company that would have a material adverse effect upon the Company’s financial condition, results of operation or cash flows.

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NOTE 7 - INCOME TAX

The Company and its subsidiaries are subject to US federal and state income taxes. Income tax expense is the total of the current year income tax due or refundable and the change in deferred tax assets and liabilities. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry-forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance when, in the opinion of Management, it is more likely than not that some portion, or all, of the deferred tax asset will not be realized. The Company does not expect to realize the net deferred tax asset and as such has recorded a full valuation allowance.

Income tax expense for the three months and nine months ended September 30, 2024 and 2023 is based on the estimated annual effective tax rate. Based on the Company’s effective tax rate and full valuation allocation, tax expense is expected to be $0 for 2024.

NOTE 8 - SUBSEQUENT EVENTS

Debt Restructuring

On November 12, 2024, the Company finalized a restructuring of the outstanding convertible debt of $240,000 principal and accrued interest of $36,853. The original debt was a group of 12 separate convertible notes with three parties controlled by one lender and issued between 2008 and 2011. The notes were all past their original maturity dates and the lender allowed for rolling 30-day extensions until notice would be given by the lender to the Company to the contrary. The Company and the lender have now agreed to terminate all these existing notes on November 30, 2024, in favor of three new notes with an aggregate principal balance at November 30, 2024, of $277,254. The new notes have a term of 24 months, and annual interest rate of 1% percent, will be paid off in 24 equal payments beginning November 30, 2024 and ending October 31, 2026. The new notes are not convertible into equity and may be repaid early with no prepayment penalty.

Equity Sales

The Company sold and issued common stock and warrants in five private transactions since October 1, 2024, for a total issuance of 55,939 shares and warrants for an additional 5,592 shares of common stock to 5 individual investors for proceeds of $910,000. Two of these transactions were with two related parties resulting in the issuance of 9,476 shares and warrants for an additional 947 shares of common stock for proceeds of $150,000

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

Some of the statements contained in this report are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements involve known and unknown risks, uncertainties and other factors which may cause our or our industry’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to statements regarding:

·	our ability to raise the funds we need to continue our operations;
·	our goal to generate revenues and become profitable;
·	regulation of our product;
·	market acceptance of our product and derivatives thereof;
·	the results of current and future testing of our product;
·	the anticipated performance and benefits of our product;
·	the ability to generate licensing fees; and
·	our financial condition or results of operations.

In some cases, you can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “would”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “projects”, “predicts”, “potential”, “likely” and similar expressions intended to identify forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by such forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this report. Except as otherwise required by law, we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement contained in this report to reflect any change in our expectations or any change in events, conditions or circumstances on which any of our forward-looking statements are based. We qualify all of our forward-looking statements by these cautionary statements.

You should refer to the section entitled “Risk Factors” of the Company’s Annual Report on Form 10-K for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements will prove to be accurate. No forward-looking statement is a guarantee of future performance.

Overview:

We are a research and development company operating in both the biotech and agtech sectors, with an intellectual property portfolio comprised of proprietary algal and bacterial strains, biologically active molecules and complexes, production techniques, cultivation techniques and patented or patent-pending inventions for applications in human and animal health.

Biotech – ZIVO Product Candidates

ZIVO is developing bioactive compounds derived from its proprietary algal culture, targeting human and animal diseases, such as poultry coccidiosis, bovine mastitis, human cholesterol, and canine osteoarthritis. As part of its therapeutic strategy, ZIVO will continue to seek strategic partners for late stage development, regulatory preparation and commercialization of its products in key global markets.

Review of isolated active materials derived from our proprietary algal culture and their potential treatment applications led us to identify a product candidate for treating coccidiosis in broiler chickens as the best option for most rapidly generating significant revenue because coccidiosis is a global poultry industry issue, and because the clinical testing cycle for chickens is shorter than for other species. Most of the global animal health companies have products for the coccidiosis market; however, they are mostly antibiotic- or ionophore-based with essentially no new technology having been introduced in the last 60 years.

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Agtech - ZIVO’s Algal Biomass

ZIVO’s algal biomass is currently produced in Peru. ZIVO’s algal biomass contains Vitamin A, protein, iron, important fatty acids, non-starch polysaccharides and other micronutrients that position the product as a viable functional food ingredient and nutritional enhancement for human and animal use and as a viable functional ingredient for skin care products.

Through our direction and technology, a site in Peru has been successful in consistently producing our proprietary algae. Our team has been working toward building commercial-scale algae ponds using a ZIVO proprietary design, and we are in the middle of a project to grow our algae in a penultimate scale pond. Once we are successful at this scale, we plan to invest in full commercial-scale ponds and product processing equipment.

The Company currently has contracts for the sale and production of its algal biomass. ZIVO has engaged an independent distributor, ZWorldwide, Inc., who has begun to sell the product, branded Zivolife^TM, with an initial focus on the North American green powder food market with the product being grown in Peru.

Additional Indications

Pending additional funding, ZIVO may also pursue the following indications:

Biotech:

	o	Bovine Mastitis: ZIVO is developing a treatment for bovine mastitis derived from its proprietary algal culture and the bioactive agents contained within.

	o	Canine Joint Health: Studies have indicated the potential of a chondroprotective property when a compound fraction was introduced into ex vivo canine joint tissues.

	o	Human Immune Modulation: Early human immune cell in vitro and in vivo studies have indicated that one of the isolated and characterized biologically active molecules in the Company’s portfolio may serve as an immune modulator with potential application in multiple disease situations.

Agtech:

	o	Companion Animal Food Ingredient: The self-affirmed GRAS process was completed for ZIVO algal biomass in late 2018 and updated in early 2023 to validate its suitability for human consumption as an ingredient in foods and beverages. We plan to leverage this work into viable food and nutritional supplements for companion animals.

	o	Skin Health: ZIVO is developing its algal biomass as a skin health ingredient, the Company has engaged in some limited topical skin product testing started in the third quarter of 2020, and we plan to perform clinical efficacy claim studies planned for ingestible and topical products.

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Results of Operations for the three months ended September 30, 2024 and 2023

The following table summarizes ZIVO’s operating results for the periods indicated:

	Quarter ended September 30,
	2024			2023
Total revenue:	$	31,500		$	11,800
Total cost of goods sold		22,050			7,670
Gross margin		9,450			4,130
Costs and expenses:
Research and development		326,361			220,653
General and administrative		1,943,127			1,355,865
Total costs and expenses		2,269,487			1,576,518
Loss from operations		(2,260,037	)		(1,572,388	)
Other (expense):
Total other expense		(8,560	)		(252,534	)
Net loss	$	(2,268,597	)	$	(1,824,922	)

Revenue

During the three months ended September 30, 2024, the Company recorded $31,500 in commercial revenue relating to sales of the Company’s dried algal biomass product as a human food or food ingredient. This is an approximately $20,000 increase from the same period last year. The $20,000 increase is the result of increased product volume sold in the three months ended September 30, 2024 versus the same quarter last year. This increase in volume can be fully attributable to production capacity increases at our contract grower in Peru.

Costs of Goods Sold

Cost of goods sold for the quarter ended September 30, 2024 was $22,050. This is approximately $14,000 higher than the same period last year, the increase was attributable to increased product volumes.

General and Administrative Expenses

General and administrative expenses were approximately $1.9 million for the three months ended September 30, 2024, as compared to approximately $1.4 million for the comparable prior year period. The increase of approximately $600,000 in general and administrative expense during 2024 is due to an increase in labor related expenses of $295,000, an increase in professional services of $370,000, partially offset by a $75,000 decrease in other overhead costs. The $295,000 increase in labor related costs is fully explained by an increase in non-cash equity related compensation awarded by the Board of Directors to certain Company employees. The $370,000 year over year increase in professional services expense is primarily due to an increase in equity compensation awarded to the Board of Directors totaling approximately $500,000, which was partially offset by lower legal and consulting expenses of approximately $120,000. The $75,000 decrease in other overhead spending is attributable mostly to lower insurance, filing, and listing fees.

Research and Development Expenses

For the three months ended September 30, 2024, the Company incurred approximately $325,000 in research and development expenses, as compared to approximately $220,000 for the comparable period in 2023. In the three months ended September 30, 2024, the Company’s research and development spending included no amortization of deferred research and development. In the comparable prior year period the spending included approximately $190,000 of amortization of deferred research and development obligations for the participation agreements.

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In the quarter ended September 30, 2024, excluding this amortization, the Company had gross research and development spending of approximately $325,000; an $85,000 increase in spending from the third quarter of 2023. Of these costs in the third quarter of 2024, $290,000 was attributable to labor and other internal research and development costs, a decrease of approximately $30,000 from the comparable prior year. The reduction is due $70,000 lower cash compensation and $10,000 in lower travel and entertainment and internal lab costs, partially offset by $50,000 higher non-cash compensation expense. Third party research and development spending of approximately $36,000 was $52,000 lower than the comparable prior year period due to a reduction in third party research studies.

	Quarter ended September 30,		Quarter ended September 30,
	2024		2023
Labor and other internal expenses	$	290,245	$	321,866
External research expenses		36,116		88,467
Total gross R&D expenses		326,361		410,333
Less contra-expense for amortization of deferred R&D obligation - participation agreements		-		(189,680	)
Research and development	$	326,361	$	220,653

Results of Operations for the nine months ended September 30, 2024 and 2023

The following table summarizes ZIVO’s operating results for the periods indicated:

	Nine months ended September 30,
	2024			2023
Total revenue:	$	67,220		$	15,850
Total costs of goods sold		45,268			8,371
Gross margin		21,952			7,479
Costs and expenses:
Research and development		2,891,452			1,064,563
General and administrative		8,895,978			4,309,343
Total costs and expenses		11,787,430			5,373,906
Loss from operations		(11,765,478	)		(5,366,427	)
Other (expense):
Total other expense		(17,973	)		(502,210	)
Net loss	$	(11,783,451	)	$	(5,868,637	)

Revenue

In the nine months ended on September 30, 2024 the Company recorded commercial revenue of $67,220 for sales of the Company’s dried algal biomass product as a human food or food ingredient. The $67,220 for the nine months ending September 30, 2024 is an increase over the $15,850 in revenue in the same nine month period ended September 30, 2023. The approximately $51,500 increase is due to higher sales volumes fully attributable to production capacity increases at our contract grower in Peru.

Costs of Goods Sold

Cost of goods sold for the nine months ended September 30, 2024 was $45,268. This is approximately $37,000 higher than the same period last year, explained by the increase in sales volume.

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General and Administrative Expenses

General and administrative expenses were approximately $8.9 million for the nine months ended September 30, 2024, an increase from the $4.3 million in the comparable prior year period. The increase of approximately $4.6 million in general and administrative expense during 2024 is explained by higher labor related costs of approximately $3.1 million and an increase in $1.7 million of professional services, partially offset by a reduction in other overhead of $190,000. The $3.1 million increase in labor related expenses is attributable to an increase in non-cash equity related employee compensation of $3.4 million partially offset by a reductions in bonus expense of $400,000. Professional services expense increases of $1.7 million were due to directors’ compensation increases of $2.4 million partially offset by lower legal ($610,000) and accounting ($135,000) that were elevated in the nine months ending September 30, 2023 as the Company undertook funding activities. The approximately $190,000 reduction in other overhead is attributable to a $70,000 reduction in insurance expense, lower filing and listing costs of $85,000, and a significant reduction in travel and entertainment expense of $30,000.

Research and Development Expenses

For the nine months ended September 30, 2024, the Company incurred approximately $2.9 million in research and development expenses, as compared to approximately $1.1 million in the comparable period in 2023. In the nine months ended September 30, 2024, the Company’s research and development spending included no amortization of deferred research and development. In the comparable prior year period the spending included approximately $625,000 of amortization of deferred research and development obligations for the participation agreements.

In the nine months ended September 30, 2024, excluding this amortization, the Company had gross research and development spending of approximately $2.9 million; a $1.2 million increase in spending from the first nine months of 2023. Of these costs in the first nine months of 2024, approximately $2.8 million was related to labor and other internal lab costs, an increase of approximately $1.8 million from the comparable prior year, primarily attributable to an increase in non-cash compensation of $2.0 million. Third party research and development spending of approximately $65,000 was $635,000 lower than the comparable prior year period due to a pause in third party research studies.

	Nine months ended September 30,		Nine months ended September 30,
	2024		2023
Labor and other internal expenses	$	2,826,060	$	986,534
External research expenses		65,392		702,139
Total gross R&D expenses		2,891,452		1,688,673
Less contra-expense for amortization of deferred R&D obligation - participation agreements		-		(624,110	)
Research and development	$	2,891,452	$	1,064,563

Capital Resources

As of September 30, 2024, ZIVO’s principal source of liquidity consisted of cash of $159,403. The Company expects to continue to incur significant expenses and increasing operating and net losses for the foreseeable future until and unless we generate an adequate level of revenue from potential commercial sales to cover expenses. The sources of cash to date have been limited proceeds from the issuance of notes with warrants, common stock with and without warrants and unsecured loans. In the nine months ended September 30, 2024, the Company raised approximately $3.2 million from direct sale of 662,550 shares of common stock in private transactions to qualified individuals.

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June 2023 Registered Direct Offering and Private Placement

In June 2023, the Company sold 171,666 shares of common stock, par value $0.001 per share, at an offering price of $16.02 per share, and pre-funded warrants to purchase up to an aggregate of 78,021 shares of Common Stock at an offering price of $16.0194 per pre-funded warrant, to a single institutional investor. In a concurrent private placement, the Company also directly sold to the purchaser Series A Common Warrants to purchase up to an aggregate of 249,688 shares of common stock, at an exercise price of $16.80 per share and Series B Common Warrants to purchase up to an aggregate of 249,688 shares of Common Stock, at an exercise price of $16.80 per share. The Series A Common Warrants are immediately exercisable, subject to a beneficial ownership limitation of the holder provided in the Series A Common Warrants, at any time on or after the date of issuance and will expire two years from the initial exercise date. The Series B Common Warrants are immediately exercisable, subject to a beneficial ownership limitation of the holder provided in the Series B Common Warrants, at any time on or after the date of issuance and will expire five years from the initial exercise date. The gross proceeds to the Company from the registered direct offering and concurrent private placement were approximately $4.0 million (before deducting the placement agent’s fees and other estimated offering expenses payable by the Company).

2023 and 2024 Private Direct Offerings

In November 2023, the Board of Directors approved a direct private offering to raise capital to fund the Company’s operations, the 2023 Private Offering. The funding program targeted a small number of existing investors and offered common stock for to be purchased at the market price as reported on the OTCQB exchange. Between December 5, 2023 and June 13, 2024 the Company sold 1,047,214 shares of stock in 37 separate transactions for proceeds of $2,348,325, an average of $2.24 per share. Of this total, related parties participated in 15 transactions for the purchase of 571,257 shares of stock yielding proceeds to the Company of $1,220,781, an average of $2.14 per share. None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering.

On June 10, 2024, the Board of Directors appointed a pricing committee of the board to establish an enhanced private direct offering which resulted in the 2024 Private Offering. This offering has a stock price based on the prior 30-day average closing price as reported on the OTCQB, and each investor will receive warrants to purchase common stock at a rate of 1 warrant share for every 10 common shares purchased. The warrants have the same strike price as the common stock for each purchase agreement, have a life of five years, and have provisions to allow for a cashless exercise. Since June 28, 2024, the Company has entered into 9 transactions under the 2024 Private Offering, resulting in the sale of 171,364 shares of commons stock and 17,134 warrant shares for proceeds of $1,414,474, an average of $8.25 per share. Three of these transactions were with related parties for 45,406 shares of common stock, 4,540 warrant shares, resulting in proceeds of $378,101, an average of $8.33 per share. None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering.

Participation Agreements

From April 13, 2020, through May 14, 2021, the Company entered into twenty-one License Co-Development Participation Agreements (the “Participation Agreements”) with certain accredited investors (“Participants”) for an aggregate of $2,985,000 in proceeds. The Participation Agreements provide for the issuance of warrants to such Participants and allows the Participants to participate in the fees (the “Fees”) from licensing or selling bioactive ingredients or molecules derived from ZIVO’s algae cultures. Specifically, ZIVO has agreed to provide to the Participants a 44.775% “Revenue Share” of all license fees generated by ZIVO from any licensee.

The Participation Agreements allow the Company the option to buy back the right, title and interest in the Revenue Share for an amount equal to the amount funded plus a forty percent (40%) premium, if the option is exercised less than 18 months following execution, and for either forty (40%) or fifty percent (50%) if the option is exercised more than 18 months following execution. Pursuant to the terms of twelve of the Participation Agreements, the Company may not exercise its option until it has paid the Participants a revenue share equal to a minimum of thirty percent (30%) of the amount such Participant’s total payment amount. Pursuant to the terms of the one of the Participation Agreements, the Company may not exercise its option until it has paid the Participant a revenue share equal to a minimum of one hundred forty percent (140%) of the amount such Participant’s total payment amount. Five of the Participation Agreements have no minimum threshold payment. Once this minimum threshold is met, the Company may exercise its option by delivering written notice to a Participant of its intent to exercise the option, along with repayment terms of the amount funded, which may be paid, in the Company’s sole discretion, in one lump sum or in four (4) equal quarterly payments. If the Company does not make such quarterly payments timely for any quarter, then the Company shall pay the prorate Revenue Share amount, retroactive on the entire remaining balance owed, that would have been earned during such quarter until the default payments have been made and the payment schedule is no longer in default.

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Funding Requirements

Management has noted the existence of substantial doubt about our ability to continue as a going concern. Our existing cash will not be sufficient to fund our operating expenses through at least twelve months from the date of this filing. To continue to fund operations, we will need to secure additional funding through public or private equity or debt financings, through collaborations or partnerships with other companies or other sources. We may not be able to raise additional capital on terms acceptable to us, or at all. Any failure to raise capital when needed could compromise our ability to execute on our business plan. If we are unable to raise additional funds, or if our anticipated operating results are not achieved, we believe planned expenditures may need to be reduced in order to extend the time period that existing resources can fund our operations. If we are unable to obtain the necessary capital, it may have a material adverse effect on our operations and the development of our technology, or we may have to cease operations altogether.

Our material cash requirements relate to the funding of our ongoing product development and for payment of significant levels of accounts payable and accrued executive and employee bonuses. The development of our product candidates is subject to numerous uncertainties, and we could use our cash resources sooner than we expect. Additionally, the process of development is costly, and the timing of progress in pre-clinical tests and clinical trials is uncertain. Our ability to successfully transition to profitability will be dependent upon achieving further regulatory approvals and achieving a level of product sales adequate to support our cost structure. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities.

Statement of Cash Flows

Cash Flows from Operating Activities. During the nine months ended September 30, 2024, our operating activities used $3.4 million in cash, a decrease of cash used of approximately $1.7 million from the comparable prior year period when the Company used approximately $5.1 million for operating activities. After adjusting the comparison period’s net income for non-cash expenses including equity-based compensation and amortization of lease liabilities, the Company incurred approximately $2.3 million less of additional cash net loss than in the comparable prior year period. In addition, for the nine months ended September 30, 2024, the Company generated about $600,000 less cash than the prior year period through net total changes in working capital accounts.

Cash Flows from Investing Activities. During the nine months ended September 30, 2024 and 2023, there were no investing activities.

Cash Flows from Financing Activities. During the nine months ended September 30, 2024, our financing activities generated approximately $3.3 million, a decrease of approximately $1.5 million from the comparable prior year period when the Company generated approximately $4.8 million from financing activities. In the nine months ended September 30, 2024, the Company received net proceeds of $3.2 million from direct sales of common equity to investors, and raised a net $100,000 from proceeds of a short term financing agreement. In the nine months ending September 30, 2023, the Company raised a net $100,000 from proceeds of a short term financing agreement, received $3.6 million in proceeds from the sale of equity, and received $1.0 million from a short term loan from the Company’s CEO.

	Nine months ended September 30,
	2024			2023
Net cash provided by (used in):
Operating activities	$	(3,407,788	)	$	(5,084,160	)
Investing activities		-			-
Financing activities		3,292,811			4,769,540
Net increase (decrease) in Cash	$	(114,977	)	$	(314,620	)

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We estimate that we would require approximately $6.0 million in cash over the next 12 months in order to fund our basic operations, excluding our research and development initiatives. Based on this cash requirement, we have a near term need for additional funding to continue to develop our products and intellectual property. Historically, we have had substantial difficulty raising funds from external sources. If we are unable to raise the required capital, we will be forced to curtail our business operations, including our research and development activities.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP. The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the balance sheets and the reported amounts of revenue and expenses during the reporting periods. In accordance with GAAP, we base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances at the time such estimates are made. Actual results may differ materially from our estimates and judgments under different assumptions or conditions. We periodically review our estimates in light of changes in circumstances, facts and experience. The effects of material revisions in estimates are reflected in our financial statements prospectively from the date of the change in estimate.

For a discussion of our critical accounting estimates, please read Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 15, 2024. There have been no material changes to the critical accounting estimates previously disclosed in our Annual Report on Form 10-K.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Not applicable for smaller reporting companies.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act) are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission and to ensure that information required to be disclosed is accumulated and communicated to management, including our principal executive and financial officers, to allow timely decisions regarding disclosure. The Chief Executive Officer, as our principal executive officer, and the Chief Financial Officer, as our principal financial and accounting officer, have reviewed the effectiveness of our disclosure controls and procedures and, based on their evaluation, have concluded that the disclosure controls and procedures were not effective as the material weaknesses identified as of December 31, 2023 in our Annual Report on Form 10-K and described below, continue to exist as of September 30, 2024.

Management’s Report on Internal Control Over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act. Our internal control over financial reporting is a process designed under the supervision of our Chief Executive Officer and Chief Financial Officer 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.

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Because of its inherent limitations, internal control over financial reporting may not detect or prevent misstatements. Also, projections of any evaluation of the effectiveness to future periods are subject to risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Management utilized the criteria established in the Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) to conduct an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2023. As previously reported, we identified material weaknesses that continued to exist at December 31, 2023. In addition, in connection with the audit of our consolidated financial statements for the year ended December 31, 2023, we identified additional material weaknesses in internal control over financial reporting, as described below. The material weakness has not been remediated as of September 30, 2024.

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 our annual or interim financial statements will not be prevented or detected on a timely basis.

Material Weaknesses in Internal Control Over Financial Reporting

Management has determined that the Company had the following material weaknesses in its internal control over financial reporting:

Control Environment, Risk Assessment, and Monitoring

As previously discussed in our Annual Report for the year ended December 31, 2023, management had concluded that our internal control over financial reporting was not effective as of December 31, 2023, due to: (i) lack of structure and responsibility, insufficient number of qualified resources, and inadequate oversight and accountability over the performance of controls, (ii) ineffective identification and assessment or risks impacting internal control over financial reporting, and (iii) ineffective evaluation and determination as to whether the components of internal control were present and functioning.

Control Activities and Information and Communication

These material weaknesses contributed to the following additional material weaknesses within certain business processes and the information technology environment:

·	Management did not design and maintain appropriate information technology general controls in the areas of user access, vendor management controls, and segregation of duties, including controls over the recording and review of journal entries, related to certain information technology systems that support the Company’s financial reporting process.

·	Management did not design, implement, and retain appropriate documentation of formal accounting policies, procedures, and controls across substantially all of the company's business processes over; (i) the financial reporting process, including management review controls over key disclosures and financial statement support schedules, (ii) the monthly financial close process, including journal entries and account reconciliations and (iii) the completeness and accuracy of information used by control owners in the operation of certain controls, to achieve timely, complete, accurate financial accounting, reporting.

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Management did not design and implement controls over the accounting, classification, and application of United States Generally Accounting Principles (“US GAAP”) relating to income taxes, stock-based compensation, and deferred research and development obligations - participation agreements accounting. Specifically:

	·	Management did not identify controls over the review of the tax provision, including the valuation analysis related to deferred tax assets, considerations for uncertain tax positions, the preparation of the income tax footnote and required disclosures and selecting and applying accounting policies;

	·	Management did not identify controls over the accounting and classification of deferred research and development obligations - participation agreements; and

	·	Management did not identify controls over the valuation of stock-based compensation for option awards to employees and members of the board of directors.

Based on the assessment and identification of the material weaknesses described above, management has concluded that, as of September 30, 2024, our internal control over financial reporting was not effective and could lead to a material misstatement of account balances or disclosures. Accordingly, management has concluded that these control deficiencies constitute material weaknesses.

However, after giving full consideration to these material weaknesses, and the additional analyses and other procedures that we performed to ensure that our consolidated financial statements included in this Quarterly Report on Form 10-Q were prepared in accordance with U.S. GAAP, our management has concluded that our consolidated financial statements present fairly, in all material respects, our financial position, results of operations and cash flows for the periods disclosed in conformity with U.S. GAAP.

Remediation Plans

Management has been implementing and continues to implement measures designed to ensure that control deficiencies contributing to the material weaknesses are remediated, such that these controls are designed, implemented, and operating effectively. The remediation actions include:

·	Developing a training program and educating control owners concerning the principles of the Internal Control - Integrated Framework (2013) issued by COSO;

·	Implementing a risk assessment process by which management identifies risks of misstatement related to all account balances;

·	Developing internal controls documentation, including comprehensive accounting policies and procedures over financial processes and related disclosures;

·	Enhancing policies and procedures to retain adequate documentary evidence for certain management review controls over certain business processes including precision of review and evidence of review procedures performed to demonstrate effective operation of such controls;

·	Engaging outside resources for complex accounting matters and drafting and retaining position papers for all complex, non-recurring transactions;

·	Developing monitoring activities and protocols that will allow us to timely assess the design and the operating effectiveness of controls over financial reporting and make necessary changes to the design of controls, if any;

·	Segregating key functions within our financial and information technology processes supporting our internal controls over financial reporting;

·	Reassessing and formalizing the design of certain accounting and information technology policies relating to security and change management controls, including user access reviews, including assessing the need for implementing a more robust information technology system; and

·	Continuing to enhance and formalize our accounting, business operations, and information technology policies, procedures, and controls to achieve complete, accurate, and timely financial accounting, reporting and disclosures.

Changes in Internal Control Over Financial Reporting

Except as discussed above, there was no other change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ending September 30, 2024, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II - OTHER INFORMATION

Item 1. Legal Proceedings

From time to time, we may be subject to litigation and claims arising in the ordinary course of business.

To our knowledge, we are not currently a party to any other material legal proceedings, and we are not aware of any pending or threatened legal proceeding.

Item 1A. Risk Factors

There have been no material changes in our risk factors previously disclosed in Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023. You should carefully consider the risks and uncertainties described therein.

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

The following is a summary of all securities that we have issued beginning on July 1, 2024 without registration under the Securities Act of 1933, as amended (the “Securities Act”):

Common Stock:

Name	Form	Date	Amount Received	Common Stock Shares
Strome Mezzanine Fund II LP	Purchase of Common Stock	07-Jul-24	$156,800.00	20,000
Strome Mezzanine Fund II LP	Purchase of Common Stock	24-Jul-24	$201,250.00	25,000
Erik Klein	Purchase of Common Stock	22-Aug-24	$250,000.00	29,976
Brenden Storm	Purchase of Common Stock	22-Aug-24	$150,000.00	17,985
Sean Sanford	Purchase of Common Stock	22-Aug-24	$25,000.00	2,997
Strome Mezzanine Fund II LP	Purchase of Common Stock	27-Aug-24	$253,322.60	30,000
Erik Klein	Purchase of Common Stock	17-Oct-24	$525,000.00	32,196
Grant Glitz	Purchase of Common Stock	17-Oct-24	$50,000.00	3,066
Brenden Storm	Purchase of Common Stock	18-Oct-24	$185,000.00	11,201

Common Stock – Related Parties:

Name	Form	Date	Amount Received	Common Stock Shares
Chris Maggiore	Exchange for Accounts Payable	24-Jul-24	-	2,080
Alison Cornell	Purchase of Common Stock	22-Aug-24	$100,000.00	11,990
Chris Maggiore	Purchase of Common Stock and Exchange for Accounts Payable	22-Aug-24	$200,000.00	31,336
John B. Payne	Purchase of Common Stock	16-Oct-24	$100,000.00	6,343
HEP Investments, LLC	Purchase of Common Stock	16-Oct-24	$50,000.00	3,133

None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering. We believe the offers, sales and issuances of the above securities were exempt from registration under the Securities Act by virtue of Section 4(a)(2) of the Securities Act because the issuance of securities to the recipients did not involve a public offering. The recipients of the securities in each of these transactions represented their intentions to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends were placed upon the stock certificates issued in these transactions. All recipients had adequate access, through their relationships with us, to information about Zivo. The sales of these securities were made without any general solicitation or advertising. The funds were used for general corporate purposes.

Item 3. Defaults upon Senior Securities

Not applicable.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

None.

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Item 6. Exhibits

Exhibit Number		Description

3.1		Articles of Incorporation of the Registrant as amended (incorporated by reference to Exhibit 3.1 to the Registrant's Quarterly Report on Form 10-Q filed on August 22, 2011)

3.2		Certificate of Amendment to Articles of Incorporation dated October 16, 2014 (incorporated by reference to Exhibit 3.12 to the Registrant's Quarterly Report on Form 10-Q filed on November 14, 2014)

3.3		Certificate of Amendment effective May 28, 2021 (incorporated by reference to Exhibit 3.1 to the Registrant's Current Report on Form 8-K filed on June 2, 2021)

3.4		Second Amended and Restated By-laws of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant's Current Report on Form 8-K filed on July 7, 2022)

4.1		Note (incorporated by reference to Exhibit 4.1 to the Registrant's Current Report on Form 8-K filed on April 5, 2023)

4.2		Warrant (incorporated by reference to Exhibit 4.2 to the Registrant's Current Report on Form 8-K filed on April 5, 2023)

4.3		Form of Series A Common Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed on July 6, 2023)

4.4		Form of Series B Common Warrant (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed on July 6, 2023)

4.5		Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K filed on July 6, 2023)

10.1		2024 Equity Incentive Plan for Non-Employee Directors and Form Grant Agreements (incorporated by reference to Exhibit 3.1 to the Registrant's Quarterly Report on Form 8-K filed on June 6, 2024)

10.2		Amended Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 3.1 to the Registrant's Quarterly Report on Form 8-K filed on June 6, 2024)

10.3		First Amendment to 2021 Equity Incentive Plan (incorporated by reference to Exhibit 3.1 to the Registrant's Quarterly Report on Form 8-K filed on June 6, 2024)

31.1		Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended

31.2		Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended

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

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

101.INS		Inline XBRL Instance Document
101.SCH		Inline XBRL Taxonomy Extension Schema Document
101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document
104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

*Furnished herewith (all other exhibits are deemed filed)

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	ZIVO BIOSCIENCE, INC.
Date: November 14, 2024

	By:	/s/ John B. Payne
		John B. Payne
		Chief Executive Officer

	By:	/s/ Keith R. Marchiando
		Keith R. Marchiando
		Chief Financial Officer

nullnullnullnull

Cover - shares	9 Months Ended
Cover - shares	Sep. 30, 2024	Nov. 08, 2024
Document Information Line Items
Entity Registrant Name	Zivo Bioscience, Inc.
Entity Central Index Key	0001101026
Document Type	10-Q
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Small Business	true
Entity Shell Company	false
Entity Emerging Growth Company	false
Entity Current Reporting Status	Yes
Document Period End Date	Sep. 30, 2024
Entity Filer Category	Non-accelerated Filer
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2024
Entity Common Stock Shares Outstanding		3,546,335
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-40449
Entity Incorporation State Country Code	NV
Entity Tax Identification Number	87-0699977
Entity Address Address Line 1	21 East Long Lake Road
Entity Address Address Line 2	Ste. 100
Entity Address City Or Town	Bloomfield Hills
Entity Address State Or Province	MI
Entity Address Postal Zip Code	48304
City Area Code	248
Local Phone Number	452-9866
Entity Interactive Data Current	Yes
Common Stock, par value
Document Information Line Items
Security 12b Title	Common Stock, par value $0.001 per share
Trading Symbol	ZIVO
Warrants Purchase of Common Stock
Document Information Line Items
Security 12b Title	Warrants to purchase shares of Common Stock, par value $0.001 per share
Trading Symbol	ZIVOW

CONDENSED CONSOLIDATED BALANCE SHEET - USD ($)	Sep. 30, 2024	Dec. 31, 2023
CURRENT ASSETS:
Cash	$ 159,403	$ 274,380
Accounts receivable	27,794	3,735
Prepaid expenses	249,348	147,262
Total current assets	436,545	425,377
OTHER ASSETS:
Operating lease - right of use asset	22,305	98,280
Security deposit	36,739	32,058
Total other assets	59,043	130,338
TOTAL ASSETS	495,587	555,715
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT):
Accounts payable	787,599	993,090
Accounts payable - related party	136,261	172,670
Customer deposits	45,000	0
Current portion of long-term operating lease	22,027	106,342
Convertible debentures payable	240,000	240,000
Loan Payable	115,014	0
Accrued interest	102,481	100,686
Accrued liabilities - employee bonus	1,130,274	1,148,770
Total current liabilities	2,578,656	2,761,558
LONG TERM LIABILITIES:	0	0
TOTAL LIABILITIES	2,578,656	2,761,558
STOCKHOLDERS' EQUITY (DEFICIT):
Common stock, $0.001 par value, 25,000,000 and 25,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 2,789,655 and 2,382,356 issued and outstanding at March 31, 2024, and December 31, 2023, respectively	3,490	2,382
Additional paid-in capital	133,278,605	121,373,488
Accumulated deficit	(135,365,164)	(123,581,713)
Total stockholders' equity (deficit)	(2,083,069)	(2,205,843)
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)	$ 495,587	$ 555,715

CONDENSED CONSOLIDATED BALANCE SHEET (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
CONDENSED CONSOLIDATED BALANCE SHEET
Common Stock, Par Value	$ 0.001	$ 0.001
Common Stock, Shares Authorized	25,000,000	25,000,000
Common Stock, Shares Issued	3,490,396	2,382,356
Common Stock, Shares Outstanding	3,490,396	2,382,356

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
REVENUES:
Product revenue	$ 31,500	$ 11,800	$ 67,220	$ 15,850
Total revenues	31,500	11,800	67,220	15,850
COSTS OF GOODS SOLD
Product costs	22,050	7,670	45,268	8,371
Total cost of goods sold	22,050	7,670	45,268	8,371
GROSS MARGIN	9,450	4,130	21,952	7,479
COSTS AND EXPENSES:
General and Administrative	1,943,127	1,355,865	8,895,978	4,309,343
Research and Development	326,361	220,653	2,891,452	1,064,563
Total costs and expenses	2,269,487	1,576,518	11,787,430	5,373,906
LOSS FROM OPERATIONS	(2,260,037)	(1,572,388)	(11,765,478)	(5,366,427)
OTHER (EXPENSE)
Interest expense	(8,560)	(32,736)	(17,973)	(67,498)
Amortization of debt discount	0	(219,798)	0	(434,712)
Total other expense	(8,560)	(252,534)	(17,973)	(502,210)
NET LOSS	$ (2,268,597)	$ (1,824,922)	$ (11,783,451)	$ (5,868,637)
BASIC AND DILUTED LOSS PER SHARE	$ (0.67)	$ (1.05)	$ (3.87)	$ (3.64)
WEIGHTED AVERAGE BASIC AND DILUTED SHARES OUTSTANDING	3,410,444	1,735,887	3,041,466	1,610,861

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS EQUITY (DEFICIT) (UNAUDITED) - USD ($)	Total	Common Stock	Additional Paid-In Capital	Retained Earnings (Accumulated Deficit)
Balance, shares at Dec. 31, 2022		1,569,943
Balance, amount at Dec. 31, 2022	$ (10,622)	$ 1,570	$ 115,792,337	$ (115,804,529)
Private offering issuance of stock and warrants, shares		171,666
Private offering issuance of stock and warrants, amount	3,634,963	$ 172	3,634,791	0
Employee and director equity-based compensation	710,661	0	710,661	0
Warrants issued with related party note	439,593	0	439,593	0
Net loss for the period	(5,868,637)	$ 0	0	(5,868,637)
Balance, shares at Sep. 30, 2023		1,741,609
Balance, amount at Sep. 30, 2023	(1,094,042)	$ 1,742	120,577,382	(121,673,166)
Balance, shares at Jun. 30, 2023		1,569,943
Balance, amount at Jun. 30, 2023	(3,144,832)	$ 1,570	116,701,842	(119,848,244)
Private offering issuance of stock and warrants, shares		171,666
Private offering issuance of stock and warrants, amount	3,634,963	$ 172	3,634,791	0
Employee and director equity-based compensation	240,749	0	240,749	0
Net loss for the period	(1,824,922)	$ 0	0	(1,824,922)
Balance, shares at Sep. 30, 2023		1,741,609
Balance, amount at Sep. 30, 2023	(1,094,042)	$ 1,742	120,577,382	(121,673,166)
Balance, shares at Dec. 31, 2023		2,382,356
Balance, amount at Dec. 31, 2023	(2,205,843)	$ 2,382	121,373,488	(123,581,713)
Private offering issuance of stock and warrants, shares		476,591
Private offering issuance of stock and warrants, amount	2,008,916	$ 477	2,008,439	0
Net loss for the period	(11,783,451)	$ 0	0	(11,783,451)
Private offering issuance of stock and warrants - related parties, shares		185,959
Private offering issuance of stock and warrants - related parties, amount	1,168,882	$ 186	1,168,696	0
Employee and director equity-based compensation, shares		445,490
Employee and director equity-based compensation, amount	8,728,427	$ 445	8,727,982	0
Balance, shares at Sep. 30, 2024		3,490,396
Balance, amount at Sep. 30, 2024	(2,083,069)	$ 3,490	133,278,605	(135,365,164)
Balance, shares at Jun. 30, 2024		3,319,032
Balance, amount at Jun. 30, 2024	(2,295,615)	$ 3,319	130,797,634	(133,096,568)
Private offering issuance of stock and warrants, shares		125,958
Private offering issuance of stock and warrants, amount	1,036,373	$ 126	1,036,247	0
Employee and director equity-based compensation	1,066,668	0	1,066,668	0
Net loss for the period	(2,268,597)	$ 0	0	(2,268,597)
Private offering issuance of stock and warrants - related parties, shares		45,406
Private offering issuance of stock and warrants - related parties, amount	378,101	$ 45	378,056	0
Balance, shares at Sep. 30, 2024		3,490,396
Balance, amount at Sep. 30, 2024	$ (2,083,069)	$ 3,490	$ 133,278,605	$ (135,365,164)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash Flows for Operating Activities:
Net loss	$ (11,783,451)	$ (5,868,637)
Adjustments to reconcile net loss to net cash used by operating activities:
Non cash lease expense	75,978	67,172
Amortization of deferred R&D obligations participation agreements	0	(624,110)
Amortization of debt discount	0	434,712
Employee and director equity compensation	8,728,427	710,661
Changes in assets and liabilities:
Prepaid expenses	(102,086)	(358,217)
Accounts payable	(205,491)	(99,536)
Accounts payable - related parties	(36,409)	0
Lease liabilities	(84,315)	(72,752)
Customer deposits	45,000	0
Security deposits	(4,681)	0
Accounts receivable	(24,059)	(2,593)
Accrued liabilities	(16,701)	729,140
Net cash (used in) operating activities	(3,407,788)	(5,084,160)
Cash Flows from Investing Activities:
Net cash provided by investing activities	0	0
Cash Flow from Financing Activities:
Proceeds from notes payable, other	517,560	605,600
Payments on notes payable, other	(402,547)	(471,023)
Proceeds from note payable, related party	0	1,000,000
Net proceeds from sales of common stock and warrants	2,008,916	3,634,963
Net proceeds from sales of common stock and warrants - related parties	1,168,882	0
Net cash provided by financing activities	3,292,811	4,769,540
Decrease in Cash	(114,977)	(314,620)
Cash at Beginning of Period	274,380	1,799,264
Cash at End of Period	159,403	1,484,644
Cash paid during the period for:
Interest	14,391	16,639
Income Taxes	$ 0	$ 0

BASIS OF PRESENTATION

9 Months Ended

Sep. 30, 2024

BASIS OF PRESENTATION

BASIS OF PRESENTATION

NOTE 1 - BASIS OF PRESENTATION

Going Concern

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

9 Months Ended

Sep. 30, 2024

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Stock Based Compensation

Warrants

Recently Announced Accounting Standards

DEBT

9 Months Ended

Sep. 30, 2024

DEBT

DEBT

NOTE 3 - DEBT

DEFERRED RD OBLIGATIONS PARTICIPATION AGREEMENTS

9 Months Ended

Sep. 30, 2024

DEFERRED RD OBLIGATIONS PARTICIPATION AGREEMENTS

DEFERRED RD OBLIGATIONS - PARTICIPATION AGREEMENTS

NOTE 4 - DEFERRED R&D OBLIGATIONS - PARTICIPATION AGREEMENTS

STOCKHOLDERS' EQUITY

9 Months Ended

Sep. 30, 2024

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY

NOTE 5 - STOCKHOLDERS’ EQUITY (DEFICIT)

Equity Sales

Warrants

Equity Compensation

Stock Based Compensation

Restricted Stock Awards

Director Stock Option Replacement Program

Stock Award Grant

Stock Award in Lieu of Unpaid Directors’ Fees

No RSAs were issued by the Company in the three months and nine months ended September 30, 2023.

Common Stock Options

CEO 2023 Equity Award

Employee Stock Option Replacement Program

The fair value of stock options was estimated on the date of grant using the Black-Scholes option-pricing model based on the following weighted average assumptions:

	Nine months Ended September 30,
	2024			2023
Expected volatility		122.46	%		112.28	%
Expected dividends		-			-
Expected term	5.0-5.2 years			5.3 years
Risk free rate		4.29	%		3.88	%

Equity Incentive Plan for Non-Employee Directors

On May 31, 2024, the Board of Directors adopted the 2024 Equity Incentive Plan for Non-Employee Directors (the “Director Equity Plan”). Material features of the Director Equity Plan are:

	·	The maximum number of shares of common stock to be issued under the Director Equity Plan is 875,000 shares, which number will automatically increase on January 1 of each year commencing on January 1, 2025, in an amount equal to 5% of the total number of shares of the Common Stock outstanding on December 31 of the preceding year.
	·	Shares reacquired by the Company to satisfy the exercise, strike or purchase price of any award or any shares that are reacquired to satisfy a tax withholding obligation in connection with the award will be added back to the share reserve under the Director Equity Plan. The withholding of shares that would otherwise be issued by the Company to satisfy the exercise, strike or purchase price of an award or the withholding of shares that would otherwise be issued by the Company to satisfy a tax withholding obligation in connection with an award will not be added back to the share reserve.
	·	The award of non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock-based awards is permitted.
	·	The aggregate value of all compensation granted or paid to any non-employee director with respect to any calendar year, including awards granted and cash fees paid by the Company to such non-employee director, will not exceed $750,000 in total value or, in the event such non-employee director is first appointed or elected to the Board during such calendar year, $1,000,000 in total value. These annual limits do not apply to (i) any awards made to replace stock options that were cancelled by the Board, (ii) awards made to a non-employee director for special or extraordinary services, as determined by the Board, or (iii) awards made in 2024 to compensate non-employee directors for services performed in 2023.
	·	All awards granted under the Director Equity Plan are subject to recoupment in accordance with the Company’s clawback policy.

Non-employee directors are eligible to participate in the Director Equity Plan. As of September 30, 2024, 429,510 shares remain available to be issued under the Director Equity Plan.

2021 Equity Incentive Plan

2019 Omnibus Long-Term Incentive Plan

Common Stock Options

	September 30, 2024					September 30, 2023
	Number of Options			Weighted Average Exercise Price		Number of Options		Weighted Average Exercise Price
Outstanding, beginning of year		292,515		$	35.56		281,637	$	36.29
Forfeited		(292,515	)		35.56		-		-
Issued		1,031,425			7.96		10,878		16.74
Outstanding, end of period		1,031,425		$	7.96		292,515	$	35.56

Options outstanding and exercisable by price range as of September 30, 2024, were as follows:

Outstanding Options						Exercisable Options
Range of Exercise Price		Number		Average Weighted Remaining Contractual Life in Years		Range of Exercise Price		Number		Weighted Average Exercise Price
$	6.00-11.99		1,031,425		9.68	$	6.00-11.99		910,966	$	7.96

			1,031,425		9.68				910,966	$	7.96

Common Stock Warrants - Unregistered

A summary of the status of the Company’s unregistered warrants is presented below:

	September 30, 2024					September 30, 2023
	Number of Warrants			Weighted Average Exercise Price		Number of Warrants			Weighted Average Exercise Price

Outstanding, beginning of year		671,448		$	21.59		267,013		$	47.10
Issued		17,832			8.24		642,397			14.82
Exercised		-			-		-			-
Cancelled		-			-		-			-
Expired		(25,690	)		46.05		(105,390	)		47.24
Outstanding, end of period		663,590		$	20.28		804,020		$	21.29

Table of Contents

Unregistered warrants outstanding and exercisable by price range as of September 30, 2024, were as follows:

Outstanding Warrants						Exercisable Warrants
Range of		Number		Average Weighted Remaining Contractual Life in Years		Exercise Price		Number		Weighted Average Exercise Price

$	6.00-11.99		17,832		4.87	$	6.00-11.99		17,832		8.24
12.00-17.99			564,376		2.18	12.00-17.99			564,376		16.88
30.00-35.99			36,800		1.67	30.00.35.99			36,800		33.00
36.00-41.99			104		0.08	36.00-41.99			104		38.40
48.00-53.99			4,165		0.80	48.00-53.99			4,165		51.60
54.00-55.99			38,543		0.95	54.00-55.99			38,543		57.60
60.00-65.99			281		1.62	60.00-65.99			281		62.40
66.00-71.99			656		1.32	66.00-71.99			656		67.20
84.00-89.99			833		0.24	84.00-89.99			833		86.40
			663,590		2.14				663,590	$	20.28

Common Stock Warrants - Registered

A summary of the status of the Company’s registered warrants is presented below:

	September 30, 2024				September 30, 2023
	Number of Registered Warrants		Weighted Average Exercise Price		Number of Registered Warrants		Weighted Average Exercise Price
Outstanding, beginning of year		495,917	$	33.00		495,917	$	33.00
Issued		-		-		-		-
Exercised		-		-		-		-
Cancelled		-		-		-		-
Expired		-		-		-		-
Outstanding, end of period		495,917	$	33.00		495,917	$	33.00

Registered warrants outstanding and exercisable by price range as of September 30, 2024, were as follows:

Outstanding Registered Warrants						Exercisable Registered Warrants
Exercise Price		Number		Average Weighted Remaining Contractual Life in Years		Exercise Price		Number		Weighted Average Exercise Price

$	33.00		495,917		1.67	$	33.00		495,917		33.00
			495,917		1.67				495,917	$	33.00

COMMITMENTS AND CONTINGENCIES

9 Months Ended

Sep. 30, 2024

Commitments And Contingencies Disclosure Abstract

COMMITMENTS AND CONTINGENCIES

NOTE 6 - COMMITMENTS AND CONTINGENCIES

Employment Agreements

At September 30, 2024, the Company had compensation agreements with its President / Chief Executive Officer, and Chief Financial Officer.

Leases

Legal Contingencies

INCOME TAX

9 Months Ended

Sep. 30, 2024

INCOME TAX

INCOME TAX

NOTE 7 - INCOME TAX

SUBSEQUENT EVENTS

9 Months Ended

Sep. 30, 2024

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

NOTE 8 - SUBSEQUENT EVENTS

Debt Restructuring

Equity Sales

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	9 Months Ended
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	Sep. 30, 2024
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Stock Based Compensation	The Company accounts for stock-based compensation in accordance with FASB ASC 718, Compensation - Stock Compensation. Under the provisions of FASB ASC 718, stock-based compensation cost is estimated at the grant date based on the award’s fair value and is recognized as expense over the requisite service period. The Company, from time to time, issues restricted common stock awards or grants common stock options to its employees, consultants and board members. At the date of grant, the Company determines the fair value of the stock option award and recognizes compensation expense over the requisite service period. Issuances of restricted common stock are valued at the closing market price on the date of issuance and the fair value of any stock option or warrant awards is calculated using the Black Scholes option pricing model and employing the simplified term method as the Company does not have a historical basis to determine the expected term. The Company expenses the awards based on the vesting schedule as detailed pursuant to each individual award agreement. The Company records forfeiture of options when they occur.
Warrants	The Company accounts for warrants in accordance with FASB ASC 815 – Derivatives and Hedging. The fair value of the Company’s warrants is determined at the time of issuance using the Black Scholes option valuation model based on a market price and the remaining term of the warrant obligation. The warrants are not subject to remeasurement through the term. For the Company’s outstanding warrants, the number of shares and the exercise price shall be adjusted for standard anti-dilution events such as stock splits, combinations, reorganizations, or issue shares as part of a stock dividend. Upon a change of control, the warrant holder will have the right to receive securities, cash or other properties it would have been entitled to receive had the warrant been exercised.
Recently Announced Accounting Standards	In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses, requiring additional disclosures about specified categories of expenses included in certain expense captions presented on the face of the income statement. This standard will be effective for the Company as of and for the year ending December 31, 2027, and may be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the impact of adopting this guidance on the Company's consolidated financial statements.

STOCKHOLDERS EQUITY (DEFICIT) (Tables)

9 Months Ended

Sep. 30, 2024

STOCKHOLDERS' EQUITY

Schedule Of Stock Based Compensation

	Nine months Ended September 30,
	2024			2023
Expected volatility		122.46	%		112.28	%
Expected dividends		-			-
Expected term	5.0-5.2 years			5.3 years
Risk free rate		4.29	%		3.88	%

Summary of the status of the Company's Options related to the 2019 Incentive Plan

	September 30, 2024					September 30, 2023
	Number of Options			Weighted Average Exercise Price		Number of Options		Weighted Average Exercise Price
Outstanding, beginning of year		292,515		$	35.56		281,637	$	36.29
Forfeited		(292,515	)		35.56		-		-
Issued		1,031,425			7.96		10,878		16.74
Outstanding, end of period		1,031,425		$	7.96		292,515	$	35.56

Schedule of Options outstanding and exercisable

Outstanding Options						Exercisable Options
Range of Exercise Price		Number		Average Weighted Remaining Contractual Life in Years		Range of Exercise Price		Number		Weighted Average Exercise Price
$	6.00-11.99		1,031,425		9.68	$	6.00-11.99		910,966	$	7.96

			1,031,425		9.68				910,966	$	7.96

Summary of unregistered warrants

A summary of the status of the Company’s unregistered warrants is presented below:

	September 30, 2024					September 30, 2023
	Number of Warrants			Weighted Average Exercise Price		Number of Warrants			Weighted Average Exercise Price

Outstanding, beginning of year		671,448		$	21.59		267,013		$	47.10
Issued		17,832			8.24		642,397			14.82
Exercised		-			-		-			-
Cancelled		-			-		-			-
Expired		(25,690	)		46.05		(105,390	)		47.24
Outstanding, end of period		663,590		$	20.28		804,020		$	21.29

Schedule of unregistered warrants outstanding and exercisable by price range

Unregistered warrants outstanding and exercisable by price range as of September 30, 2024, were as follows:

Outstanding Warrants						Exercisable Warrants
Range of		Number		Average Weighted Remaining Contractual Life in Years		Exercise Price		Number		Weighted Average Exercise Price

$	6.00-11.99		17,832		4.87	$	6.00-11.99		17,832		8.24
12.00-17.99			564,376		2.18	12.00-17.99			564,376		16.88
30.00-35.99			36,800		1.67	30.00.35.99			36,800		33.00
36.00-41.99			104		0.08	36.00-41.99			104		38.40
48.00-53.99			4,165		0.80	48.00-53.99			4,165		51.60
54.00-55.99			38,543		0.95	54.00-55.99			38,543		57.60
60.00-65.99			281		1.62	60.00-65.99			281		62.40
66.00-71.99			656		1.32	66.00-71.99			656		67.20
84.00-89.99			833		0.24	84.00-89.99			833		86.40
			663,590		2.14				663,590	$	20.28

Schedule of Common Stock Warrants - Registered

	September 30, 2024				September 30, 2023
	Number of Registered Warrants		Weighted Average Exercise Price		Number of Registered Warrants		Weighted Average Exercise Price
Outstanding, beginning of year		495,917	$	33.00		495,917	$	33.00
Issued		-		-		-		-
Exercised		-		-		-		-
Cancelled		-		-		-		-
Expired		-		-		-		-
Outstanding, end of period		495,917	$	33.00		495,917	$	33.00

Schedule of registered warrants outstanding and exercisable by price range

Outstanding Registered Warrants						Exercisable Registered Warrants
Exercise Price		Number		Average Weighted Remaining Contractual Life in Years		Exercise Price		Number		Weighted Average Exercise Price

$	33.00		495,917		1.67	$	33.00		495,917		33.00
			495,917		1.67				495,917	$	33.00

BASIS OF PRESENTATION (Details Narrative) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
BASIS OF PRESENTATION
Accumulated Deficit	$ (135,365,164)	$ (123,581,713)

DEBT (Details Narrative) - Short Term Debt [Member] - USD ($) $ in Millions		1 Months Ended
	Mar. 05, 2024	Feb. 14, 2023	Sep. 30, 2024
Principal amount			$ 115,014
Monthly down payment	$ 59,562	$ 69,666
Short term laon	$ 517,560	$ 605,600
Annual interest rate	8.50%	8.40%

DEFERRED RD OBLIGATIONS PARTICIPATION AGREEMENTS (Details Narrative) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
DEFERRED RD OBLIGATIONS PARTICIPATION AGREEMENTS
Research and development expense	$ 0	$ 189,680	$ 0	$ 624,110
Contra R&D expense related to personnel and third-party expenses	$ 0	$ 47,445	$ 0	$ 156,027

STOCKHOLDERS EQUITY (DEFICIT) (Details)	9 Months Ended
STOCKHOLDERS EQUITY (DEFICIT) (Details)	Sep. 30, 2024	Sep. 30, 2023
Expected Volatility	122.46%	112.28%
Expected Dividends	0.00%	0.00%
Expected Term		5 years 3 months 18 days
Risk Free Rate	4.29%	3.88%
Minimum [Member]
Expected Term	5 years
Maximum [Member]
Expected Term	5 years 2 months 12 days

STOCKHOLDERS EQUITY (DEFICIT) (Details 1) - $ / shares	9 Months Ended
STOCKHOLDERS EQUITY (DEFICIT) (Details 1) - $ / shares	Sep. 30, 2024	Sep. 30, 2023
Unregistered warrants [Member]
Number of options outstanding, beginning	671,448	267,013
Number of options issued	17,832	642,397
Number of options outstanding, ending	663,590	804,020
Weighted average exercise price outstanding, beginning	$ 21.59	$ 47.10
Weighted average exercise price issued	8.24	14.82
Weighted average exercise price outstanding, ending	$ 20.28	$ 21.29
Number of options exercised	0	0
Number of options expired	(25,690)	(105,390)
Weighted average exercise price expired	$ 46.05	$ 47.24
Warrant Registered
Number of options outstanding, beginning	495,917	495,917
Number of options outstanding, ending	495,917	495,917
Weighted average exercise price outstanding, beginning	$ 33.00	$ 33.00
Weighted average exercise price outstanding, ending	$ 33.00	$ 33.00
2019 Stock Incentive Plan
Number of options outstanding, beginning	292,515	281,637
Number of options Forfeited	(292,515)	0
Number of options issued	1,031,425	10,878
Number of options outstanding, ending	1,031,425	292,515
Weighted average exercise price outstanding, beginning	$ 35.56	$ 36.29
Weighted average exercise price Forfeited	35.56	0
Weighted average exercise price issued	7.96	16.74
Weighted average exercise price outstanding, ending	$ 7.96	$ 35.56

STOCKHOLDERS EQUITY (DEFICIT) (Details 2)	9 Months Ended
STOCKHOLDERS EQUITY (DEFICIT) (Details 2)	Sep. 30, 2024 $ / shares shares
Number of exercisable options	495,917
Weighted average exercise price exercisable \| $ / shares	$ 33.00
Unregistered Warrant [Member]
Number of options outstanding	663,590
Average weighted remaining contructual life in years	2 years 1 month 20 days
Number of exercisable options	663,590
Weighted average exercise price exercisable \| $ / shares	$ 20.28
Unregistered Warrant [Member] \| 54.00-55.99
Number of options outstanding	38,543
Average weighted remaining contructual life in years	11 months 12 days
Number of exercisable options	38,543
Weighted average exercise price exercisable \| $ / shares	$ 57.60
Exercise price range	54.00-55.99
Unregistered Warrant [Member] \| 60.00-65.99
Number of options outstanding	281
Average weighted remaining contructual life in years	1 year 7 months 13 days
Number of exercisable options	281
Weighted average exercise price exercisable \| $ / shares	$ 62.40
Exercise price range	60.00-65.99
Unregistered Warrant [Member] \| 84.00-89.99
Number of options outstanding	833
Average weighted remaining contructual life in years	2 months 26 days
Number of exercisable options	833
Weighted average exercise price exercisable \| $ / shares	$ 86.40
Exercise price range	84.00-89.99
Unregistered Warrant [Member] \| 6.00-11.99
Number of options outstanding	17,832
Average weighted remaining contructual life in years	4 years 10 months 13 days
Number of exercisable options	17,832
Weighted average exercise price exercisable \| $ / shares	$ 8.24
Exercise price range	6.00-11.99
Unregistered Warrant [Member] \| 12.00-17.99
Number of options outstanding	564,376
Average weighted remaining contructual life in years	2 years 2 months 4 days
Number of exercisable options	564,376
Weighted average exercise price exercisable \| $ / shares	$ 16.88
Exercise price range	12.00-17.99
Unregistered Warrant [Member] \| 30.00-35.99
Number of options outstanding	36,800
Average weighted remaining contructual life in years	1 year 8 months 1 day
Number of exercisable options	36,800
Weighted average exercise price exercisable \| $ / shares	$ 33.00
Exercise price range	30.00.35.99
Unregistered Warrant [Member] \| 36.00-41.99
Number of options outstanding	104
Average weighted remaining contructual life in years	29 days
Number of exercisable options	104
Weighted average exercise price exercisable \| $ / shares	$ 38.40
Exercise price range	36.00-41.99
Unregistered Warrant [Member] \| 48.00-53.99
Number of options outstanding	4,165
Average weighted remaining contructual life in years	9 months 18 days
Number of exercisable options	4,165
Weighted average exercise price exercisable \| $ / shares	$ 51.60
Exercise price range	48.00-53.99
Unregistered Warrant [Member] \| 66.00-71.99
Number of options outstanding	656
Average weighted remaining contructual life in years	1 year 3 months 25 days
Number of exercisable options	656
Weighted average exercise price exercisable \| $ / shares	$ 67.20
Exercise price range	66.00-71.99

STOCKHOLDERS EQUITY (DEFICIT) (Details 3)	9 Months Ended
STOCKHOLDERS EQUITY (DEFICIT) (Details 3)	Sep. 30, 2024 $ / shares shares
Number of exercisable options	495,917
Weighted average exercise price exercisable \| $ / shares	$ 33.00
Option Outstanding and exercisable [Member]
Number of options outstanding	1,031,425
Weighted average remaining contractual life (in years)	9 years 8 months 4 days
Number of exercisable options	910,966
Weighted average exercise price exercisable \| $ / shares	$ 7.96
Exercise price range	6.00-11.99
2019 Stock Incentive Plan
Number of options outstanding	1,031,425
Weighted average remaining contractual life (in years)	9 years 8 months 4 days
Number of exercisable options	910,966
Weighted average exercise price exercisable \| $ / shares	$ 7.96
Exercise price range	6.00-11.99

STOCKHOLDERS EQUITY (DEFICIT) (Details 4)	9 Months Ended
STOCKHOLDERS EQUITY (DEFICIT) (Details 4)	Sep. 30, 2024 $ / shares shares
Number of exercisable Register warrant	495,917
Number of exercisable options	495,917
Weighted average exercise price exercisable term	1 year 8 months 1 day
Weighted average exercise price exercisable \| $ / shares	$ 33.00
Registered Warrant \| 33.00
Exercise price range	33.00
Number of exercisable Register warrant	495,917
Number of exercisable options	495,917
Weighted average exercise price exercisable term	1 year 8 months 1 day
Weighted average exercise price exercisable \| $ / shares	$ 33.00

STOCKHOLDERS EQUITY (DEFICIT) (Details Narrative) - USD ($)			1 Months Ended	3 Months Ended		9 Months Ended
	Jun. 11, 2024	Jun. 05, 2024	May 31, 2024	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Expected Volatility						122.46%	112.28%
Compensation expense						$ 5,660,774
Expected Dividends						0.00%	0.00%
Expected Term							5 years 3 months 18 days
Risk Free Rate						4.29%	3.88%
Expenses for General and Administration				$ 1,943,127	$ 1,355,865	$ 8,895,978	$ 4,309,343
Expenses for Research and Developement				326,361	220,653	2,891,452	$ 1,064,563
Stock options granted							10,878
Related party accounts payable				78,101	78,101	78,101	$ 78,101
Related party cash				300,000	1,090,781	300,000	$ 1,090,781
Proceed from related party				$ 378,101		$ 1,168,882
Employee Stock Option Replacement Program [Member]
Expected Volatility						122.46%
Restricted stock were granted under the director equity plan						10,878
Outstanding number of option		230,064
Compensation expense					$ 240,750	$ 710,661
Common stock option shares approved		981,174
Compensation expense award grant				512,347
Expected Dividends						0.00%
Expected Term						10 years
Risk Free Rate						4.29%
Equity Incentive Plan the 2021 Plan [Member]
Proceed from stock issuances			$ 875,000
Incentive plan, description			the Company to such non-employee director, will not exceed $750,000 in total value or, in the event such non-employee director is first appointed or elected to the Board during such calendar year, $1,000,000 in total value
2021 Incentive Plan [Member]
Shares remain available to be issued		261,090
Stock options, issued		292,515		1,031,425		1,031,425
Incentive plan, description						the aggregate number of shares of common stock available for issuance under the 2021 Plan was 166,666 shares (following a reverse stock split); this number is automatically increased each January 1st by an amount equal to 5% of the number of common stock shares outstanding at that date, resulting in an increase in available shares under the 2021 Plan at January 1, 2024 of 119,117. On May 31, 2024, the Company’s Board of Directors amended the 2021 Plan such that the total number of shares of common stock available for issuance under the 2021 Plan was increased to 1,000,000 shares
2021 [Member] \| Black Scholes Pricing Model [Member]
Average weighted remaining contructual life in years						10 years
Common Stock Options [Member] \| Equity Incentive Plan the 2021 Plan [Member]
Awarded number of restricted stock						1,031,425
Compensation expense						$ 5,999,589
Common Stock Options [Member] \| CEO 2023 Equity Award [Member]
Expected Volatility						122.46%
Awarded number of restricted stock		50,251
Awarded number of restricted stock per share		$ 7.96
Due amount for exchange of stock option		$ 400,000
Compensation expense						$ 338,815
Expected Dividends						0.00%
Expected Term						5 years
Risk Free Rate						4.29%
Warrant [Member]
Shares issued to related parties				4,540		5,238
Common stock shares issuance				17,134		17,832
Pre-funded warrants to purchase					78,021		78,021
Warrants to purchase					499,376		499,376
38 Private Investors [Member]
Common stock shares sold to related parties						185,959
Common stock shares issuance						662,550
Cash				$ 3,099,697		$ 3,099,697
Accounts payable				$ 78,101		78,101
Proceed from related party						$ 3,177,798
Public offereing share							171,666
Proceeds from public offereing							$ 2,750,089
Director Equity Plan [Member]
Shares remain available to be issued				429,510		429,510
9 Private Investors [Member]
Common stock shares sold to related parties				45,406
Common stock shares issuance				171,364
Cash				$ 1,336,373		$ 1,336,373
Accounts payable				78,101		78,101
Proceed from related party				1,414,474
Public offereing share					171,666
Proceeds from public offereing					$ 2,750,089
Director [Member]
Compensation expense				554,321
Executives And Employee [Member]
Compensation expense				512,347
Options granted							10,878
CEO [Member]
Warrants to purchase							65,000
Stock Compensation Plan [Member]
Compensation expense				1,066,668	$ 240,750	8,728,427	$ 710,661
Expenses for General and Administration				960,432		6,561,963
Expenses for Research and Developement				106,236		2,166,464
Restricted Stock Awards [Member]
Awarded number of restricted stock issue values						$ 50,000
Awarded number of restricted stock			37,688			445,490
Awarded number of restricted stock per share			$ 7.96
Awarded number of restricted stock issue to non-employee directors	18,819					426,671
Restricted stock expense			$ 299,996
Restricted Stock Awards [Member] \| Director Stock Option Replacement Program [Member]
Restricted stock were granted under the director equity plan		127,364
Outstanding number of option		62,451
Recognized expense stock option replacement program				697,501
Awarded number of restricted stock issue values			$ 300,000
Compensation expense						$ 112,165
Restricted Stock Awards [Member] \| Stock Award in Lieu of Unpaid Directors Fees [Member]
Restricted stock were granted under the director equity plan			261,619
Recognized expense stock option replacement program				$ 458,344		$ 1,619,184
Awarded number of restricted stock per share						$ 7.96
Non-employee board members fee			$ 172,670
Description related to unpaid director fees						unpaid amounts were grossed up for taxes at an assumed tax rate of 45% and the number of shares was determined based on the Company’s closing stock price on December 29, 2023 of $1.20 per share

COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)	Sep. 13, 2024	Sep. 30, 2024	Dec. 31, 2023
Security deposit		$ 36,739	$ 32,058
Leases [Member]
Total rent	$ 298,135
Rent payments description	The future lease payments will be $4,681 per month from April 1, 2025 to March 31, 2026; $4,820 from April 1, 2026 to March 31, 2027; $4,964 from April 1, 2027 to March 31, 2028; $5,113 from April 1, 2028 to March 31, 2029; and $5,267 from April 1, 2029 to March 31, 2030
Security deposit	$ 4,851
Lease agreement	63 months

INCOME TAX (Details Narrative) - USD ($)	9 Months Ended
INCOME TAX (Details Narrative) - USD ($)	Sep. 30, 2024	Sep. 30, 2023
INCOME TAX
Income tax expense	$ 0	$ 0

SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event [Member] - USD ($)			1 Months Ended
	Nov. 12, 2024	Oct. 02, 2024	Nov. 30, 2024	Oct. 01, 2024
Outstanding convertible debt of principal amount	$ 240,000
Accrued interest	$ 36,853
Aggregate principal balance			$ 277,254
Annual interest rate			1.00%
Private Transactions Second [Member]
Proceeds from issue of share and warrant		$ 150,000
Warrant shares issued				947
Private Transactions Third [Member]
Proceeds from issue of share and warrant		$ 910,000
Warrant shares issued				9,476
5 individual investors [Member]
Additional warrant shares issued				5,592
Private Transactions One [Member]
Common shares issued				55,939

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