UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

(Mark One) [X]	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
	For the quarterly period ended December 31, 2020
	Or
[  ]	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
	For the transition period _______ to _______

 

Commission file number 000-56008

 

PREDICTIVE TECHNOLOGY GROUP, INC.

(Exact name of registrant as specified in its charter)

 

Nevada		90-1139372
(State or other jurisdiction of incorporation or organization)		(I.R.S. employer identification number)
2735 Parleys Way, Suite 205, Salt Lake City, Utah		84109
(Address of principal executive offices)		(Zip Code)

+1 (888) 407-9761

(Registrant's telephone number, including area code)

 

-i-

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

 

Title of each class

Common Stock, $.001 Par Value Per Share

 

Indicate by check 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 [X ] No [ ] 

 

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

 

Larger Accelerated Filer [  ]	Accelerated Filer [  ]
Non-Accelerated Filer [  ] (Do not check if a smaller reporting company)	Smaller Reporting Company [X]
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 [X]

 

The number of shares of Predictive common stock outstanding as of February 15, 2021 was 299,596,808.

 

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PREDICTIVE TECHNOLOGY GROUP, INC.

QUARTERLY REPORT ON FORM 10-Q FOR THE QUARTER ENDED DECEMBER 31, 2020

 

INDEX

 

	PART I - FINANCIAL INFORMATION
Item 1.	Financial Statements	2
	Unaudited Condensed Consolidated Balance Sheets as of December 31, 2020 and June 30, 2020	2
	Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended December 31, 2020 and 2019	3
	Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended December 31, 2020 and 2019	4
	Unaudited Condensed Consolidated Statements of Stockholders' Equity for the three and six months ended December 31, 2020 and 2019	6
	Unaudited Notes to Condensed Consolidated Financial Statements	7
Item 2.	Management's Discussion and Analysis of Financial Condition and Results of Operations	26
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	33
Item 4.	Controls and Procedures	33
	PART II - OTHER INFORMATION	35
Item 1.	Legal Proceedings	35
Item 1A.	Risk Factors	36
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	36
Item 3.	Defaults Upon Senior Securities	36
Item 4.	Mine Safety Disclosures	36
Item 5.	Other Information	36
Item 6.	Exhibits	36

 

-1-

PART I - FINANCIAL INFORMATION

Item 1. FINANCIAL STATEMENTS

 

PREDICTIVE TECHNOLOGY GROUP, INC.

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

 

 See accompanying notes 

-2-

PREDICTIVE TECHNOLOGY GROUP, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND

COMPREHENSIVE LOSS

 

	Three months ended December 31,						Six months ended December 31,
	2020			2019			2020			2019
Revenue	$	4,067,488		$	7,336,640		$	9,158,492		$	15,595,898
Cost of goods sold, exclusive of depreciation & amortization shown below		2,828,692			5,840,256			6,293,829			13,022,246
Operating expenses:
Selling and marketing		872,156			3,049,593			1,933,954			6,201,563
General and administrative		4,910,346			7,034,770			10,167,845			13,413,647
Research and development		557,381			2,364,350			928,223			4,192,700
Depreciation and amortization		1,751,562			2,775,073			4,235,645			5,385,318
Loss on impairment		-			-			7,015,326			-
Total operating expenses		8,091,445			15,223,786			24,280,993			29,193,228
Operating loss		(6,852,649)			(13,727,402)			(21,416,330)			(26,619,576)
Gain (loss) on equity method investment		26,020			(16,249,252)			(743,825)			(16,388,552)
Interest expense		(304,774)			(297,736)			(483,658)			(371,218)
Gain on disposal of asset		-			-			21,318			-
Total other loss		(278,754)			(16,546,988)			(1,206,165)			(16,759,770)
Loss before income taxes		(7,131,403)			(30,274,390)			(22,622,495)			(43,379,346)
Benefit from (provision for) income taxes		(5,000)			4,239,780			(6,052)			9,448,195
Net loss & comprehensive loss	$	(7,136,403)		$	(26,034,610)		$	(22,628,547)		$	(33,931,151)
Net loss attributable to non-controlling interest		(31,602)			(31,941)			(63,682)			(63,875)
Net loss attributable to common shareholders	$	(7,104,801)		$	(26,002,669)		$	(22,564,865)		$	(33,867,276)
Weighted average common shares outstanding, basic & diluted		299,596,808			283,126,298			299,596,808			282,203,748
Basic & diluted loss per share attributable to common shareholders	$	(0.02)		$	(0.09)		$	(0.08)		$	(0.12)

See accompanying notes

-3-

PREDICTIVE TECHNOLOGY GROUP, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS  

(Continued)

 

-4-

PREDICTIVE TECHNOLOGY GROUP, INC.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

The following is a summary of supplemental cash flow activities:

		Six months ended December 31,
		2020		2019
Right-of-use assets obtained in exchange for new operating lease liabilities	$	-	$	1,903,222
Capital expenditures in accounts payable		136,955		-
Finance lease payments in accounts payable		143,172		-

 

See accompanying notes

(Concluded)

 

 

 

-5-

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY

	Common Stock				Additional		Non-Controlling		Accumulated		Stockholders'
	Shares		Amount		Paid in Capital		Interest		Deficit		Equity
BALANCES AT JUNE 30, 2019	273,761,955	$	273,762	$	153,604,830	$	(239,280)	$	(41,102,849)	$	112,536,463
Share based compensation					4,994,600						4,994,600
Cashless exercise of warrants	9,223,605		9,224		(9,224)
Net loss							(31,934)		(7,864,607)		(7,896,541)
BALANCES AT SEPTEMBER 30, 2019	282,985,560	$	282,986	$	158,590,206	$	(271,214)	$	(48,967,456)	$	109,634,522
Share based compensation					4,634,069						4,634,069
Net Loss							(31,941)		(26,002,669)		(26,034,610)
BALANCES AT DECEMBER 31, 2019	282,985,560	$	282,986	$	163,224,275	$	(303,155)	$	(74,970,125)	$	88,233,981
	Common Stock				Additional		Non-Controlling		Accumulated		Stockholders'
	Shares		Amount		Paid in Capital		Interest		Deficit		Equity
BALANCES AT JUNE 30, 2020	299,596,808	$	299,597	$	181,862,823	$	(367,023)	$	(126,872,115)	$	54,923,282
Share based compensation					2,936,580						2,936,580
Net loss							(32,080)		(15,460,064)		(15,492,144)
BALANCES AT SEPTEMBER 30, 2020	299,596,808	$	299,597	$	184,799,403	$	(399,103)	$	(142,332,179)	$	42,367,718
Share based compensation					2,649,889						2,649,889
Net Loss							(31,602)		(7,104,801)		(7,136,403)
BALANCES AT   DECEMBER 31, 2020	299,596,808		299,597		187,449,292		(430,705)		(149,436,980)	$	37,881,204

 

See accompanying notes

-6-

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

NOTE 1- BUSINESS DESCRIPTION AND SIGNIFICANT ACCOUNTING POLICIES

 

BUSINESS DESCRIPTION:

 

Predictive Technology Group, Inc. together with its subsidiaries (collectively, "PTG" or the "Company") develops and commercializes discoveries and technologies involved in novel molecular diagnostic, therapeutic, and Human Cellular and Tissue-Based Products ("HCT/Ps"). The Company uses this information as the cornerstone in the development of new diagnostics that assess a person's risk of disease and develop pharmaceutical therapeutics and HCT/Ps for use by healthcare professionals to improve outcomes in their patients.  The Company's corporate headquarters are located in Salt Lake City, Utah.

 

SEGMENT INFORMATION:

 

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker (CODM) in making decisions regarding resource allocation and assessing performance.  The Company operates in two reportable segments, which are differentiated by product.  The HCT/P segment offers minimally manipulated tissue products intended for homologous use, prepared utilizing proprietary extraction methods that reduce the loss of important scaffolding, growth factors and cytokines.  The Company's Diagnostics and Therapeutics segment uses data analytics for disease identification and subsequent therapeutic intervention through novel gene-based diagnostics, and companion therapeutics. Lastly, the "Unallocated Corporate" column in the table below represents those headquarters activities that do not qualify as operating segments and which are not allocated to operating segments in information provided to the CODM. We currently operate and sell our products exclusively in the United States.

Segment information was as follows during the periods presented:

		HCT/Ps		Diagnostics & Therapeutics			Unallocated Corporate	Total
Three months ended December 31, 2020
Revenues		$	2,654,565	$	1,412,923	$	-	$	4,067,488
Depreciation and amortization			192,201		1,469,968		89,393		1,751,562
Share based compensation			445,733		140,769		2,063,387		2,649,889
Segment operating loss			(2,407,999)		(2,137,781)		(2,306,869)		(6,852,649)
Three months ended December 31, 2019
Revenues		$	7,289,265	$	47,375	$	-	$	7,336,640
Depreciation and amortization			937,923		1,756,560		80,590		2,775,073
Share based compensation			1,242,875		254,353		3,136,841		4,634,069
Segment operating loss			(7,067,094)		(3,261,117)		(3,399,191)		(13,727,402)
Six months ended December 31, 2020
Revenues		$	6,523,823	$	2,634,669	$	-	$	9,158,492
Depreciation and amortization			1,160,265		2,950,927		178,453		4,235,645
Share based compensation			803,906		281,539		4,501,024		5,586,469
Segment operating loss			(11,574,824)		(4,449,239)		(5,392,267)		(21,416,330)
Six months ended December 31, 2019
Revenues		$	15,473,896	$	122,002	$	-	$	15,595,898
Depreciation and amortization			1,836,868		3,387,858		160,592		5,385,318
Share based compensation			2,914,331		704,454		6,009,884		9,628,669
Segment operating loss			(13,611,080)		(6,489,756)		(6,518,740)		(26,619,576)

 

-7-

	Three months ended December 31,
											Six months ended December 31,
	2020			2019							2020			2019
Total operating loss for reportable segments	$	(4,545,780)		$	(10,328,211)					$	(16,024,063)		$	(20,100,836)
Unallocated amounts:
Unallocated Corporate		(2,306,869)			(3,399,191)						(5,392,267)			(6,518,740)
Other loss		(278,754)			(16,546,988)						(1,206,165)			(16,759,770)
Loss before income taxes	$	(7,131,403)		$	(30,274,390)					$	(22,622,495)		$	(43,379,346)

 

		As of December 31,		As of June 30,
Total Assets		2020		2020
HCT/Ps	$	4,136,183	$	11,980,175
Diagnostics and therapeutics		65,286,919		70,394,152
Unallocated corporate		1,029,370		1,468,088
Total Assets	$	70,452,472	$	83,842,415

 

BASIS OF PRESENTATION:

 

The accompanying condensed consolidated financial statements have been prepared by Predictive Technology Group, Inc. in accordance with U.S. generally accepted accounting principles ("GAAP") for financial information and pursuant to the applicable rules and regulations of the Securities and Exchange Commission ("SEC"). The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries.  All intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying financial statements contain all adjustments (consisting of normal and recurring accruals) necessary to present fairly all financial statements in accordance with U.S. GAAP.  

 

The condensed consolidated financial statements herein should be read in conjunction with the Company's audited consolidated financial statements and notes thereto for the fiscal year ended June 30, 2020, included in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2020. Operating results for the three and six months ended December 31, 2020 may not necessarily be indicative of results to be expected for any other interim period or for the full fiscal year.

 

-8-

Fiscal Year End

 

The Company operates on a fiscal year basis with the fiscal year ending on June 30.

 

Cash Equivalents

 

The Company considers all highly-liquid investments with a maturity of three months or less, when purchased, to be cash equivalents.  The Company places its temporary cash investments with high-quality financial institutions.  

 

Going Concern

 

The accompanying condensed consolidated financial statements have been prepared under the assumption that the Company will continue to operate as a going concern, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. The condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts of liabilities that may result from any inability of the Company to continue as a going concern.

 

The Company incurred a net loss attributable to common stockholders of $22,564,865 and net cash outflows from operations of $2,972,152 for the six months ended December 31, 2020. At December 31, 2020, the Company had $134,376 of cash and negative working capital of $23,020,768. The Company's historical and current use of cash in operations combined with limited liquidity resources raise substantial doubt regarding the Company's ability to continue as a going concern. Management may seek additional capital through debt financings, collaborative or other funding arrangements with partners, sale of assets, or through other sources of financing. Should the Company seek additional financing from outside sources, the Company may not be able to raise such financing on terms acceptable to the Company or at all to mitigate the substantial doubt that exists. If the Company is unable to raise additional capital when required or on acceptable terms, this could have a material adverse effect on liquidity. In such a case, the Company may be required to scale back or to discontinue the promotion of currently available products, scale back or discontinue the advancement of product candidates, reduce headcount, file for bankruptcy, reorganize, merge with another entity, or cease operations.

 

Trade Accounts Receivable and Allowance for Doubtful Accounts

 

Trade accounts receivable are primarily comprised of amounts due from sales of the Company's HCT/P products and sales of medical diagnostic testing services that are recorded at the invoiced amount, as well as deposits in transit from credit card processors. The allowance for doubtful accounts is based on the Company's best estimate of the amount of probable losses in the Company's existing accounts receivable, which is based on historical write-off experience, customer creditworthiness, facts and circumstances specific to outstanding balances, and payment terms. Account balances are charged against the allowance after all means of collection have been exhausted and the potential for recovery is considered remote. The Company does not have any off-balance-sheet credit exposure related to its customers and does not require collateral.

 

Inventories

 

Inventories consist primarily of laboratory supplies used in genetic testing performed by Predictive Laboratories, Inc. ("Predictive Labs") and HCT/Ps produced by Predictive Biotech, Inc. ("Predictive Biotech"). We value inventory at the lower of cost or net realizable value. We determine the cost of inventory using the standard cost method, which approximates actual cost based on a first-in, first-out method.  All other costs, including administrative costs, are expensed as incurred.   

 

We analyze our inventory levels at least quarterly and write down inventory that has a cost basis in excess of its expected net realizable value, or that is considered in excess of normal operating levels, as determined by management.  We also reserve for the quantity of quarantined (WIP) inventory that is not expected to pass quality control based on historical averages. The related costs are recognized as cost of goods sold in the condensed consolidated statements of operations.

 

Prepaid Expenses

 

Amounts paid in advance for expenses are accounted for as prepaid expenses and classified as current assets if such amounts are to be recognized as expense within one year from the balance sheet date.

 

-9-

Property, Plant and Equipment

 

Lab equipment, furniture and computer equipment are stated at cost less accumulated depreciation. Depreciation is computed using the straight-line method based on the lesser of estimated useful lives of the related assets or the underlying lease term. Lab equipment items have depreciable lives of 5 years, furniture items have depreciable lives of 5 to 7 years, and computer equipment items have depreciable lives of 3 years. Repair and maintenance costs are charged to expense as incurred. Amortization of assets recorded under finance leases is included in depreciation expense.

 

The Company reviews property and equipment for impairment. Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Recoverability of these assets is measured by comparison of their carrying amounts to future undiscounted cash flows the assets are expected to generate. If property and equipment are considered to be impaired, the impairment to be recognized equals the amount by which the carrying value of the assets exceeds its fair market value.

 

Leases

 

We have entered into operating and finance lease agreements primarily for office and laboratory facilities and laboratory equipment located in Salt Lake City, Utah with lease periods expiring between 2021 and 2023.

 

We determine if an arrangement is a lease at inception. For all classes of underlying assets, we elect not to recognize right of use assets or lease liabilities when a lease has a lease term of 12 months or less at the commencement date and does not include an option to purchase the underlying asset that we are reasonably certain to exercise. Finance lease assets are included in property, plant, and equipment, net.

 

Operating lease assets and liabilities are recognized at the present value of the future lease payments at the lease commencement date. The interest rate used to determine the present value of the future lease payments is our incremental borrowing rate, because the interest rate implicit in most of our leases is not readily determinable. Our incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, and in economic environments where the leased asset is located. Operating lease assets also include any prepaid lease payments and lease incentives. Our lease terms include periods under options to extend or terminate the lease when it is reasonably certain that we will exercise that option. We generally use the base, non-cancelable, lease term when determining the lease assets and liabilities. Operating lease expense is recognized on a straight-line basis over the lease term.

 

Our lease agreements generally contain lease and non-lease components. Non-lease components primarily include payments for maintenance and utilities. We combine fixed payments for non-lease components with our lease payments and account for them together.

 

Intangible Assets and Other Long-Lived Assets

 

Intangible and other long-lived assets are comprised of acquired patents, licenses, trade secrets and other intellectual property.  Acquired intangible assets are recorded at fair value and amortized over the shorter of the contractual life or the estimated useful life.

 

The Company reviews definite-lived intangible assets for impairment. Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Recoverability of these assets is measured by comparison of their carrying amounts to future undiscounted cash flows the assets are expected to generate. If identifiable intangibles are considered to be impaired, the impairment to be recognized equals the amount by which the carrying value of the assets exceeds its fair market value.

  

As of June 30, 2020, the Company had identified indicators of impairment for certain of its long-lived assets for certain of its long-lived assets and performed an impairment test related to those long-lived assets. An impairment charge of $10,041,556 was recorded related to assets acquired with Regenerative Medical Technologies, Inc. (see Note 3).

 

In October 2020, the Company stopped selling its CoreCyte product in connection with the decision to accelerate the Company's previously existing plan to file an Investigational New Drug (IND) application for CoreCyte with the FDA. The Company submitted documentation to begin the process of filing the IND on October 30, 2020, in which CoreCyte is indicated for the treatment of osteoarthritis of the knee. On December 29, 2020, the FDA completed the Pre-IND meeting. As the sequence of events that led to this decision began with the receipt of a Warning Letter from the FDA in August 2020, it was determined that the decision to stop selling CoreCyte was an indicator of impairment as of September 30, 2020.  Impairment charges of $0 and $1,760,875 were recognized related to the trade secrets in the HCT/P segment in the three and six months ended December 31, 2020, respectively (see Note 3).   There were no impairments for the three and six months ended December 31, 2019.

 

-10-

Additional delays in the commercial launch of the Company's diagnostic products such as those that may result from a prolongation of the COVID-19 pandemic would adversely affect our business and potentially lead to additional impairment charges in the future.

 

Certain of the Company's patents are currently subject to litigation (see Note 11) to determine whether the seller of the patents had faithfully represented the nature of their ownership of patents that were sold to the Company. The seller of the patents represented that all rights, title, and interest to the patents was transferred to the Company as part of the sale.  However, the Company and its patent counsel have identified information in the US Patent and Trademark Office's (USPTO's) registry that calls into question whether the seller of the patents had all rights, title, and interest in the patents when they were sold to the Company. The Company raised these concerns with the seller of the patents but was unable to secure clear and satisfactory proof on a voluntary basis. These patents have a carrying value of $5,726,034 on our condensed consolidated balance sheet as of December 31, 2020. While there is some question as to whether the Company has full title to these patents, we believe that we have at least partial ownership and can develop products based on the patents.

 

Revenue Recognition

 

We derive our revenue primarily from two sources.  One source is the sales of HCT/P products to clinicians. The majority of our contracts with customers have a single performance obligation, and all of our contracts with customers have a duration of less than one year. Revenue is recognized when control of the product passes to the customer, typically upon confirmation of delivery of the product to the customer. As our products must remain frozen during transit, we typically ship our products overnight. Revenue is recognized in an amount that reflects the expected consideration to be received in exchange for such goods or services. As such, customer orders are recorded as deferred revenue prior to delivery of products or services ordered.

 

The other source of revenue is from the sale of our Assurance VR™ COVID-19 RT-PCR test.  Our contracts with customers have a single performance obligation, and all of our contracts with customers have a duration of less than one year. Revenue is recognized when a valid test result is passed to the customer, which is done electronically.  Revenue is recognized in an amount that reflects the expected consideration to be received in exchange for test results. 

 

Generally, we require authorization from a credit card or verification of receipt of payment before we ship products to customers for HCT/P related revenues. From time to time we grant credit to these customers with normal credit terms (typically 30 days). For Assurance VR™ COVID-19 RT-PCR test related revenues we typically send an invoice the same or next day once valid test results have been sent electronically.  Payment terms are based on normal credit terms (typically 10 to 30 days).  We do not recognize assets associated with costs to obtain or fulfill a contract with a customer, as the amortization period for any such costs if capitalized would be one year or less.

Shipping and handling is considered a fulfillment activity, as it takes place prior to the customer obtaining control of the product, and fees charged to customers are included in net revenue upon completion of our performance obligation. Shipping and handling expenses are included in cost of sales. We present revenue net of sales taxes, discounts, and expected returns.

 

Goodwill

 

In October 2020, the Company stopped selling its CoreCyte product in connection with the decision to accelerate the Company's previously existing plan to file an Investigational New Drug (IND) application for CoreCyte with the FDA. The Company submitted documentation to begin the process of filing the IND on October 30, 2020, in which CoreCyte is indicated for the treatment of osteoarthritis of the knee. On December 29, 2020, the FDA completed the Pre-IND meeting. As the sequence of events that led to this decision began with the receipt of a Warning Letter from the FDA in August 2020, it was determined that the decision to stop selling CoreCyte was an indicator of impairment as of September 30, 2020.  Impairment charges of $0 and $5,254,451 were recognized related to the goodwill in the HCT/P segment in the three and six months ended December 31, 2020, respectively (see Note 3).   There were no impairment charges for the three and six months ended December 31, 2019.

 

Equity Method Investment

 

We apply the equity method of accounting for investments in which we have significant influence but not a controlling interest. The Company reviews equity method investments for impairment whenever events or changes in circumstances indicate that the carrying amount of the investment may not be recoverable in accordance with generally accepted accounting principles. This determination requires significant judgment. In making this judgment, the Company considers available quantitative and qualitative evidence in evaluating potential impairment of these investments. If it is determined that an indicator of impairment exists, the Company assesses whether the carrying value exceeds the fair value of the asset. If the carrying value of the investment exceeds its fair value, the Company will evaluate, among other factors, general market conditions, the duration and extent to which the carrying value is greater than the fair value, and the Company's intent and ability to hold, or plans to sell, the investment. The Company also considers specific adverse conditions related to the financial health of and business outlook for the investee, including industry and sector performance, changes in technology, and operational and financing cash flow factors. Once a decline in fair value is determined to be other-than-temporary, an impairment charge will be recorded and a new carrying basis in the investment will be established. The Company recorded impairment charges totaling $37,907,283 related to our equity method investment in Juneau Biosciences, LLC for the year ended June 30, 2020 (see Note 4). There were no impairments for the three and six months ended December 31, 2020.  The Company recorded an impairment loss of $15,932,106 for the three and six months ended December 31, 2019.

 

-11-

Paycheck Protection Program Loan

 

On May 6, 2020, Company received loan proceeds of $1,665,985 under the Paycheck Protection Program ("PPP") under a promissory note from a commercial bank (the "PPP Loan"). The PPP, established as part of the CARES Act, provides for loans to qualifying businesses for amounts up to 2.5 times the average monthly payroll expenses of the qualifying business. As amended, the CARES act provides that the loans and accrued interest are forgivable after twenty-four weeks as long as the borrower uses the loan proceeds for eligible purposes, including payroll, benefits, rent and utilities, and maintains its payroll levels. The PPP Loan is included in notes payable in the condensed consolidated balance sheets. Should all or part of the PPP Loan be forgiven, the amount forgiven will be derecognized through other income in the period when forgiveness is granted by the governing authority.

 

Deferred Revenue

 

We recognize a contract liability when customer payment precedes the completion of our performance obligations.

The following table provides information about deferred revenue from contracts with customers, including significant changes in deferred revenue balances during the period.

 

		Six months ended December 31,
		2020		2019
Deferred revenue – beginning balance	$	381,889	$	469,376
Increase due to deferral of revenue at period end		748,017		512,280
Decrease due to beginning contract liabilities recognized as revenue		(381,889)		(469,376)
Deferred revenue – ending balance	$	748,017	$	512,280

 

Research and Product Development Costs

 

The Company expenses research and product development costs as incurred.

 

Product Liability and Warranty Costs

 

The Company maintains product liability insurance and has not experienced any related claims from its product offerings. The Company also offers a warranty to customers providing that its products will be delivered free of any material defects.  There have been no material costs incurred since inception based on estimated return rates.  The Company reviews the adequacy of its accrual on a quarterly basis.

 

Share-Based Compensation

 

The Company issues share-based compensation awards in the form of stock option grants. We use the Black-Scholes-Merton option pricing model to estimate the fair value of options granted under our equity incentive plans. The Black-Scholes-Merton option valuation model requires the use of assumptions, including the expected term of the award and the expected share price volatility. The Company uses the "simplified" method to estimate the expected option term. Stock-based compensation is measured at the grant date for all stock-based awards made to employees and non-employees based on the fair value of the awards. Stock-based compensation is recognized as expense on a straight-line basis over the requisite service period, which is generally the vesting period.

 

The estimated fair value of performance-contingent equity awards is expensed using an accelerated method over the term of the award once we have determined that it is probable that performance milestones will be achieved. Compensation expense for equity awards that contain performance conditions is based on the grant date fair value of the award. Compensation expense is recorded over the requisite service period based on management's best estimate as to whether it is probable that the shares awarded are expected to vest. We assess the probability of the performance milestones being met on a continuous basis.

 

Income Taxes

 

In order to determine the Company's quarterly provision for income taxes, the Company uses an estimated annual effective tax rate that is based on expected annual income and applicable federal and state tax rates.  Deferred tax assets and liabilities are recorded to reflect the future tax consequences attributable to the effects of differences between the carrying amounts of existing assets and liabilities for financial reporting and for income tax purposes. Deferred taxes are calculated by applying enacted statutory tax rates and tax laws to future years in which temporary differences are expected to reverse. The impact on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that the rate change is enacted.  

 

-12-

Other Comprehensive Loss

 

Comprehensive loss is comprised of net loss and other comprehensive loss. Other comprehensive loss is equal to net loss for the three and six months ended December 31, 2020 and 2019.

 

Measurement of Fair Value

 

The fair value of a financial instrument is the amount that could be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Financial assets are marked to bid prices and financial liabilities are marked to offer prices. Fair value measurements do not include transaction costs. A fair value hierarchy is used to prioritize the quality and reliability of the information used to determine fair values.  Categorization within the fair value hierarchy is based on the lowest level of input that is significant to the fair value measurement. The fair value hierarchy is defined in the following three categories:

 

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

Level 2: Observable market-based inputs or inputs that are corroborated by market data.

Level 3: Unobservable inputs that are not corroborated by market data.

 

During the three and six months ended December 31, 2020 and 2019, we did not have any remeasurements of non-financial assets measured at fair value on a non-recurring basis subsequent to their initial recognition.

 

Use of Estimates

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of sales and expenses during the reporting periods.  Key estimates in the accompanying unaudited condensed consolidated financial statements include, among others, allowances for doubtful accounts and product returns, provisions for obsolete inventory, valuation of long-lived assets, and deferred income tax asset valuation allowances.  Actual results could differ materially from these estimates.

 

Recently Issued Accounting Pronouncements

 

In June 2016, the FASB issued ASU 2016-13, "Financial Instruments – Credit Losses (Topic 326)" which introduces new guidance for the accounting for credit losses on instruments within its scope. The new guidance introduces an approach based on expected losses to estimate credit losses on certain types of financial instruments. For trade receivables, the Company will be required to use a forward-looking expected loss model rather than the incurred loss model for recognizing credit losses which reflects losses that are probable. After the issuance of ASU 2019-10, the guidance is effective for smaller reporting companies for fiscal years beginning after December 15, 2022, including interim periods within those years. Early application of the guidance is permitted for all entities for fiscal years beginning after December 15, 2018, including the interim periods within those fiscal years. Application of the amendments is through a cumulative-effect adjustment to retained earnings as of the effective date. The Company is currently evaluating the impact of this update on the condensed consolidated financial statements.

 

In December 2019, the FASB issued ASU 2019-12, "Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes" (ASU 2019-12), which eliminates certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocation and calculating income taxes in interim periods. This ASU also includes guidance to reduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. ASU 2019-12 is effective for annual and interim periods in fiscal years beginning after December 15, 2020. Early adoption is permitted. The Company is currently assessing the impact of ASU 2019-12 on its consolidated financial statements.

 

-13-

NOTE 2 PROPERTY, PLANT AND EQUIPMENT, NET

 

The composition of property, plant, and equipment is as follows:

		As of		As of
		December 31,		June 30,
		2020		2020
Computer equipment	$	779,105	$	759,192
Furniture		230,747		230,747
Lab equipment		2,610,555		2,215,409
Software		1,008,713		1,008,713
Leasehold improvements		1,006,215		1,006,215
Other fixed assets in progress		18,943		91,195
Lab equipment subject to finance lease		2,774,907		2,774,907
Total property, plant, and equipment		8,429,185		8,086,378
Accumulated depreciation		(2,669,102)		(2,002,744)
Accumulated depreciation – leased assets		(1,187,210)		(758,535)
Property, plant and equipment, net	$	4,572,873	$	5,305,099

 

Depreciation expense for the three month periods ended December 31, 2020 and 2019 was $524,620 and $546,714, respectively. Depreciation expense for the six month periods ended December 31, 2020 and 2019 was $1,075,033 and $928,601, respectively.

 

NOTE 3 GOODWILL & INTANGIBLE ASSETS

 

Intangible assets primarily consist of amortizable purchased licenses, patents, and trade secrets.  The following summarizes the amounts reported as intangible assets:

 

			Carrying Amount			Accumulated Amortization				Net		Weighted Average Remaining Amortization Period (Years)
At December 31, 2020:
Licenses			$	21,337,981		$	(6,303,954)		$	15,034,027		7.5
Patents				9,750,000			(4,023,966)			5,726,034		7.5
Trade Secrets				32,547,380			(6,805,944)			25,741,436		10.5
Other				411,000			(151,236)			259,764		9.5
Goodwill				-			N/A			-		N/A
Total intangible assets			$	64,046,361		$	(17,285,100)		$	46,761,261		9.1
			Carrying Amount			Accumulated Amortization				Net		Weighted Average Remaining Amortization Period (Years)
At June 30, 2020:
Licenses			$	21,337,981		$	(5,273,253)		$	16,064,728		8.0
Patents				9,750,000			(3,664,215)			6,085,785		8.0
Trade Secrets				46,634,380			(17,397,933)			29,236,447		7.9
Other				411,000			(115,212)			295,788		10.0
Goodwill				5,254,451			N/A			5,254,451		N/A
Total intangible assets			$	83,387,812		$	(26,450,613)		$	56,937,199		8.0

 

-14-

Estimated future amortization expense related to intangible assets consists of the following as of December 31, 2020:

 

Year Ending June 30,		Amount
2021	$	2,430,070
2022		4,860,141
2023		4,860,141
2024		4,860,141
2025		4,860,141
Thereafter		24,890,627

 

Total amortization expense for the three months ended December 31, 2020 and 2019 was $1,226,942 and $2,228,359 respectively. Total amortization expense for the six months ended December 31, 2020 and 2019 was $3,160,612 and $4,456,717 respectively.

 

Impairment of Trade Secrets

 

As of June 30, 2020, the Company identified indicators of impairment related to the assets acquired with Regenerative Medical Technologies, Inc. Specifically, development of the assets acquired has proceeded significantly more slowly than originally planned due to the departure of key personnel and related difficulties in obtaining patient consent required to use the acquired assets in the Company's research activities. The Company determined the fair value of the assets acquired to be $334,000 using the cost to recreate method, which resulted in an impairment charge of $10,041,556 for the year ended June 30, 2020. This valuation approach uses inputs that qualify as Level 3 in the fair value hierarchy. The impaired assets and the related impairment charge are included in the Diagnostics and Therapeutics segment.

 

In October 2020, the Company stopped selling its CoreCyte product in connection with the decision to accelerate the Company's previously existing plan to file an Investigational New Drug (IND) application for CoreCyte with the FDA. The Company submitted documentation to begin the process of filing the IND on October 30, 2020 in which CoreCyte is indicated for the treatment of osteoarthritis of the knee. On December 29, 2020, the FDA completed the Pre-IND meeting. As the sequence of events that led to this decision began with the receipt of a Warning Letter from the FDA in August 2020, it was determined that the decision to stop selling CoreCyte was an indicator of impairment as of September 30, 2020. The Company estimated the fair value of the reporting unit using the discounted cash flow method, as the forecasted cash flows during the remaining economic life of the trade secrets (less than one year) were forecasted to be negative. This valuation approach uses inputs that qualify as Level 3 in the fair value hierarchy. As a result, impairment charges of $0 and $1,760,875 were recognized related to the trade secrets in the HCT/P segment in loss on impairment in the condensed consolidated statement of operations and comprehensive loss for the three and six months ended December 31, 2020, respectively. There were no impairment charges for the three and six months ended December 31, 2019.

 

Endometriosis license

 

On December 28, 2016, Predictive Therapeutics and Juneau amended and restated the license agreement dated July 9, 2015. The license granted the Company the right to market the Company's diagnostic testing products in the field of fertility and use the patents underlying those products. The license was subsequently amended in March 2018 to expand the scope of the license to include the entire field of endometriosis and pelvic pain. The term of the license is equal to the life of the licensed patents.

 

An additional license fee of $2,000,000 is due and payable once the Company has received profits of $25,000,000 related to the intellectual property licensed under the agreement.

 

Under the license, as amended, (i) upon the commercial sale of the rights to the ARTguide™ or a license thereof we are required to issue to Juneau common stock with a market value of $2,500,000, (ii) Juneau receives a royalty of 50% of net profits as defined in the license agreement, (iii) we must have minimum sales of $12.5 million in the twelve month period beginning nine months after commercial launch, (iv) during the second year following launch we must have minimum sales of $30 million, and (v) during the third year following launch and each year thereafter we must have minimum annual sales of $60 million. If we fail to meet these metrics the license is null and void unless Predictive (a) presents written plan to Juneau describing how Predictive will use reasonable commercial efforts to improve sales and (b) Predictive agrees to spend an amount equal to the difference between the projected minimum sales and actual sales on an enhanced sales and marketing effort over the next year.

 

-15-

Companion diagnostic license

 

In addition to the license for the commercialization of assays and related services for the prognosis and monitoring of endometriosis in the infertility market, the Company entered into a license agreement with Juneau to use the assay as a companion diagnostic test in conjunction with endometriosis therapeutics that may be developed from intellectual property owned by the Company and Juneau. This license agreement was amended and restated on August 1, 2016.

 

The agreement initially required a $250,000 license fee which was paid during 2013 and 2014.  A subsequent milestone payment of 250,000 shares of Company stock was paid to Juneau on October 19, 2016. If FDA approval is granted on any companion diagnostic test, a final milestone payment of $250,000 is due.

 

The agreement requires a 2% royalty to be paid to Juneau on the sale of patented therapeutic products specifically covered by the agreement. The Company amortizes the licenses over the life of the underlying patent.

 

Goodwill

 

We recorded goodwill of $5,254,451 from the acquisition of Predictive Biotech, Inc. (formerly Renovo Biotech, Inc.) that was completed on March 28, 2016.

 

In October 2020, the Company stopped selling its CoreCyte product in connection with the decision to accelerate the Company's previously existing plan to file an Investigational New Drug (IND) application for CoreCyte with the FDA. The Company submitted documentation to begin the process of filing the IND on October 30, 2020, in which CoreCyte is indicated for the treatment of osteoarthritis of the knee. On December 29, 2020, the FDA completed the Pre-IND meeting. As the sequence of events that led to this decision began with the receipt of a Warning Letter from the FDA in August 2020, it was determined that the decision to stop selling CoreCyte was an indicator of impairment as of September 30, 2020.  The Company estimated the fair value of the reporting unit using the discounted cash flow method. This valuation approach uses inputs that qualify as Level 3 in the fair value hierarchy.  The fair value of the reporting unit was determined to have fallen below its carrying value, which resulted in impairment charges of $0 and $5,254,451 that were recognized in the HCT/P segment in loss on impairment in the condensed consolidated statement of operations and comprehensive loss for the three and six months ended December 31, 2020, respectively. There were no impairments of goodwill for the three and six months ended December 31, 2019.

 

Changes in the goodwill balance during the six months ended December 31, 2020 were as follows.

 

		Goodwill		Accumulated Impairment Losses
As of June 30, 2020	$	5,254,451	$	-
Impairment of Goodwill		-		(5,254,451)
As of December 31, 2020	$	5,254,451	$	(5,254,451)

 

NOTE 4 EQUITY METHOD INVESTMENT

 

Juneau Biosciences, LLC

The Company's investment in Juneau is accounted for under the equity method. The following table summarizes the investment:

 

	As of December 31,  2020			As of June 30, 2020
Carrying amount	$	11,987,558		$	12,731,383
Ownership percentage		48.3%			48.3%

 

In December 2017, the Company and Juneau reached verbal agreement on a stock subscription arrangement. The Company agreed to purchase 15,681,818 Class A Units of Juneau at a price of $1.10 per unit. In early 2018, the terms were finalized and memorialized in a subscription agreement executed by the Company and Juneau. Under the terms of the agreement (as amended), the subscription is to be paid in installments through September 30, 2021. The Company has the option to cancel the subscription.  If this option is exercised, any units of Juneau issued to the Company but not paid will be cancelled. The agreement includes certain restrictions on the use of funds provided under the subscription agreement and grants the Company the right to appoint a minority of Juneau's Board of Managers. Should the Company elect not to fund the entire subscription, Juneau's obligations to the Company that are not related to the license agreements (see Note 3) will terminate.

 

-16-

On September 25, 2019, the Company and Juneau executed an amendment to the subscription agreement. The amendment reduced the total number of Class A Units purchased to 13,000,000 and changed the schedule of payments due under the subscription agreement. In addition, a receivable due from Juneau in the amount of $184,443 was applied to the subscription payable balance.

 

On February 10, 2020, the Company and Juneau Biosciences, LLC, its equity method investee, executed an amendment to the agreement captioned "Third Amended and Restated Subscription Agreement." Under the terms of the agreement, the Company issued common stock, par value $0.001, with a value of $2,430,000 (the "Equity Payment") based on the closing market price on the agreement date that was applied against the subscription payable. The amendment also changed the schedule of cash payments due under the subscription agreement to purchase units of Juneau. The schedule of payments as of December 31, 2020 under the amended agreement is as follows:

 

Year Ending June 30		Amount
2021		5,150,000
2022		2,056,610
	$	7,206,610

 

The Company is currently $2,150,000 in arrears on payment on the subscription. Should Juneau declare the Company in default and cancel the subscription, our unpaid units of Juneau would be cancelled.

 

Impairment

 

The Company reviews its equity method investment on a quarterly basis to determine whether a triggering event has occurred that could necessitate an impairment test. During the three months ended December 31, 2019, the Company's stock price declined from $1.67 per share to $0.73 per share, which was determined to qualify as a triggering event for impairment tests of our reporting units, intangible assets, and equity method investments. In addition, there had been delays in the commercialization of product licensed from Juneau. At June 30, 2020, the COVID-19 pandemic caused impediments to clinical research which are expected to further delay the commercialization of our genetic testing products. These factors triggered a second impairment test as of June 30, 2020.

 

For each of the impairment tests as of December 31, 2019 and June 30, 2020, we engaged a third-party valuation firm to assist us in determining whether the carrying value of our equity method investment had fallen below the carrying value. The valuations were performed using a combination of the cost approach, the income approach, and calibration of the fair values of the Company's operating segments and equity method investment to the Company's overall market capitalization. These valuation approaches use inputs that qualify as Level 3 in the fair value hierarchy. As a result of the valuation, it was determined that the fair value of our equity method investment had fallen to $35,329,167 at December 31, 2019, necessitating an impairment charge of $15,932,016 during the three months ended December 31, 2019.  At June 30, 2020, it was determined that the fair value of our equity method investment had fallen to $12,731,383, necessitating a further impairment charge of $21,975,267. The total impairment charges of $37,907,283 are included in loss on equity method investment in the consolidated statement of operations for the year ended June 30, 2020. The impairments were determined to be other than temporary based on the magnitude of the decline in fair value. 

 

There were no impairments during the six months ended December 31, 2020.

 

NOTE 5 ACCRUED LIABILITIES

 

Accrued liabilities at December 31, 2020 and June 30, 2020 were as follows:

 

		As of		As of
		December 31,		June 30,
		2020		2020
Employee compensation and benefits	$	582,244	$	1,493,484
Income tax payable		115,649		110,649
Customer deposit		5,000,000		5,000,000
Other		1,817,924		1,442,681
Total accrued liabilities	$	7,515,817	$	8,046,814

 

-17-

The customer deposit of $5,000,000 relates to a partial deposit received from the distributor of the Company's Assurance AB™ product. Under the terms of the agreement with the distributor, the purchase order may not be cancelled and product may only be returned if damaged in transit or subject to a recall order. In an effort to expeditiously satisfy the Company's obligations under the agreement with the distributor, the Company paid the full amount of the partial deposit to the Company's U.S. supplier. The deposit paid to the supplier is included in other current assets on the condensed consolidated balance sheets. If the Assurance AB test does not receive Emergency Use Authorization from the FDA, the deposit paid to the Company's supplier may become impaired. As of the date of this filing, the Company has withdrawn its original EUA application and is planning on filing a new EUA application for a version of the product designed to meet testing needs anticipated during the vaccination phase of the pandemic. The Company will fulfill the purchase order upon receipt of the remaining deposit amount due from the distributor under the distribution agreement. As of the date of the financial statements, no additional deposits have been made. The customer has requested a refund of the deposit. See further discussion in Note 11.

 

NOTE 6 DEBT

 

Notes payable were as follows:

 

		As of		As of
		December 31,		June 30,
		2020		2020
Promissory notes	$	6,710,234	$	3,305,234
Revolving line of credit		200,000		200,000
Paycheck Protection Program Loan		1,665,985		1,665,985
Total notes payable	$	8,576,219	$	5,171,219
Less: Current portion		(6,364,309)		(705,234)
Total long-term notes payable	$	2,211,910	$	4,465,985

 

Future maturities of notes payable are as follows:

 

Year Ending June 30		Amount
2021		4,616,447
2022		3,129,289
2023		637,548
2024		192,935
	$	8,576,219

Promissory notes

 

As of December 31, 2020, unsecured promissory notes with a face value of $2,600,000 were outstanding. The notes bear 12% simple interest and mature from November 2021 to March 2022.  

 

On June 4, 2020, trade payables due to a vendor in the amount of $705,234 were converted into an unsecured note payable due on November 15, 2020. The note bears interest at 3% per annum, increasing to 5% if the note is not paid when otherwise due. As of December 31, 2020 the note holder has increased the interest to 5%.

 

In July and August 2020, the Company issued promissory notes to an accredited investor in the amount of $1,000,000. The notes bear interest at 15% per annum and mature on September 21, 2020. The notes are secured by the revenues arising from the Company's Assurance VR™ COVID-19 RT-PCR test.

 

On September 25, 2020, the Company and the same accredited investor amended and restated the outstanding notes and increased the principal amount by $2,000,000 to a total of $3,000,000. The amended promissory note bears 15% simple interest. No payments on the amended promissory note are due until September 2021, at which time monthly payments equal to 1/36^th of the outstanding principal and interest amount shall commence. Interest accruing prior to September 2021 will be added to the principal amount. Any remaining principal and interest shall be due on September 30, 2022. The amended promissory note is secured by the revenues arising from the Company's Assurance VR™ COVID-19 RT-PCR test and may be prepaid without penalty.

 

-18-

On December 18, 2020, the Company issued a promissory note with a face value of $405,000.  The note is secured by the revenues arising from the Company's Assurance VR™ COVID-19 RT-PCR test.  The note bears interest at 5% per annum and matures sixty days from execution.

 

The Company entered into a Consulting Agreement with the same accredited investor on the same date that the promissory notes were amended. The Company will provide various services in connection with the accredited investor's COVID-19 testing business, including technical consultation and sales lead generation. The Company may earn up to $1,000,000 in milestone payments and shall earn a commission of 5% of the accredited investor's sales generated from sales leads provided by the Company. Amounts earned under the Consulting Agreement shall first be applied to any balance outstanding under the amended promissory notes. The Company's total compensation under the Consulting Agreement is capped at $4,000,000. The agreement may be cancelled by the accredited investor without penalty.  See Note 12 regarding an update to this Consulting Agreement.

 

Revolving line of credit  

 

In September 2019, the Company and an accredited investor entered into a Revolving Loan Agreement whereby the accredited investor agreed to lend the Company up to $3,000,000. At December 31, 2020, $200,000 is outstanding and $2,800,000 is available. Amounts drawn under the revolving loan will be charged interest at a rate of 12% and may be repaid at any time. All amounts outstanding under the revolving loan are due upon the expiration of the revolving loan facility on September 30, 2021.

 

Paycheck Protection Program Loan

 

On May 6, 2020, Company received loan proceeds of $1,665,985 under the Paycheck Protection Program ("PPP") under a promissory note from a commercial bank (the "PPP Loan"). The PPP, established as part of the CARES Act, provides for loans to qualifying businesses for amounts up to 2.5 times the average monthly payroll expenses of the qualifying business. The loans and accrued interest are forgivable after eight weeks as long as the borrower uses the loan proceeds for eligible purposes, including payroll, benefits, rent and utilities, and maintains its payroll levels.

 

The application for these funds requires the Company to, in good faith, certify that the current economic uncertainty made the loan request necessary to support the ongoing operations of the Company. Some of the uncertainties related to the Company's operations that are directly related to COVID-19 include, but are not limited to, the severity of the virus, the duration of the outbreak, governmental, business or other actions (which could include limitations on operations or mandates to provide products or services), impacts on the supply chain, and the effect on customer demand or changes to operations. In addition, the health of the Company's workforce and its ability to meet staffing needs are uncertain and is vital to its operations.

 

The PPP Loan certification further requires the Company to take into account our current business activity and our ability to access other sources of liquidity sufficient to support ongoing operations in a manner that is not significantly detrimental to the business. While the Company does have availability under its Revolving Loan Agreement, the $2.8 million that is available is in place to support working capital needs, along with current cash on hand. Further, the Company has a lack of history of being able to access the capital markets. As a result, the Company believes it meets the certification requirements.

 

The receipt of these funds, and the forgiveness of the loan attendant to these funds, is dependent on the Company having initially qualified for the loan and qualifying for the forgiveness of such loan based on our future adherence to the forgiveness criteria.

 

The term of the Company's PPP Loan is two years. The annual interest rate on the PPP Loan is 1% and no payments of principal or interest are due during the six-month period beginning on the date of the PPP Loan. The PPP Loan is subject to any new guidance and new requirements released by the Department of the Treasury.

 

Fair value

 

The fair value of the Company's outstanding debt obligations as of December 31, 2020 was $7,497,000, which was determined based on a discounted cash flow model using an estimated market rate of interest of 15.00%, which is classified as Level 2 within the fair value hierarchy.

 

NOTE 7 INCOME TAXES

 

The Company recognized income tax expense (benefit) of $5,000 and ($4,239,780) for the three-month periods ended December 31, 2020 and 2019, respectively, and income tax expense (benefit) of $6,052 and ($9,448,195) for the six-month periods ended December 31, 2020 and 2019, respectively. The Company's recognized effective tax rate differs from the U.S. federal statutory rate for the six months ended December 31, 2020 primarily due to state income taxes and share based compensation, offset by changes in the valuation allowance in deferred tax assets. The Company's recognized effective tax rate differs from the U.S. federal statutory rate for the six months ended December 31, 2019 primarily due to state income taxes, share based compensation and excess tax benefits arising from the exercise of commons stock warrants during the period.

 

-19-

NOTE 8 STOCKHOLDER'S EQUITY

 

The Company has issued various warrants exercisable for our common stock outside of the 2015 Stock Option Plan (see Note 10). The warrants were issued to raise capital, as compensation for acquisitions of intellectual property, and as compensation for services.

 

The following is a summary of warrant activity from June 30, 2020 through December 31, 2020:

 

				Number of Warrants		Weighted Average Exercise Price		Weighted Average Remaining Contractual Life (Years)
Warrant:
Outstanding June 30, 2020				53,093,520	$	0.78		3.6
	Granted			-		-		-
	Exercised			-		-		-
	Forfeited/ Cancelled			-		-		-
Outstanding December 31, 2020				53,093,520	$	0.78		3.1

 

The Company recognizes expense for warrants issued for services that are subject to graded vesting on a straight-line basis. Share based compensation expense related to warrants issued for services for the three months ended December 31, 2020 and 2019 was $16,500 and $1,361,172, respectively.  Share based compensation expense related to warrants issued for services for the six months ended December 31, 2020 and 2019 was $458,191 and $3,251,384, respectively.  

 

As of December 31, 2020, unrecognized compensation cost related to warrants issued for services was $66,000 and is expected to be recognized over a weighted average period of 1.08 years

 

NOTE 9 EARNINGS PER COMMON SHARE (EPS)

 

The computation of weighted average shares outstanding and the basic and diluted earnings per common share for the following periods consisted of the following:

 

		Net		Weighted Average Shares		Per Share
		Loss		Outstanding		Amount
Three months ended December 31, 2020
Basic and diluted EPS attributable to common shareholders		(7,104,801)		299,596,808		$(0.02)
Three months ended December 31, 2019
Basic and diluted EPS attributable to common shareholders		(26,002,669)		283,126,298		$(0.09)
	Six months ended December 31, 2020
	Basic and diluted EPS attributable to common shareholders	(22,564,865)		299,596,808		$(0.08)
	Six months ended December 31, 2019
	Basic and diluted EPS attributable to common shareholders	(33,867,276)		282,203,748		$(0.12)

 

Potentially dilutive securities that would be excluded from the calculation of diluted net loss per common share because to include them would be anti-dilutive are as follows:

 

		As of December 31,
		2020	2019
Warrants for common stock		53,093,520	58,443,520
Options for common stock		27,635,400	25,921,050
		80,728,920	84,364,570

 

-20-

NOTE 10 STOCK OPTION PLAN

 

In 2015, a Stock Option Plan was adopted to advance the interests of the Company and its shareholders by helping the Company obtain and retain the services of employees, officers, consultants, independent contractors and directors, upon whose judgment, initiative and efforts the Company is substantially dependent, and to provide those persons with further incentives to advance the interests of the Company. Eligible participants include employees, officers, certain consultants, or directors of the Company or its subsidiaries.  

 

The number of shares, terms, and vesting periods are determined by the Company's Board of Directors or a committee thereof on an award-by-award basis. Awards provided under the Plan generally vest in three equal annual installments. The maximum term of options issued under the plan is 10 years from the date of grant. The aggregate number of shares of Option Stock that may be issued pursuant to the exercise of Options granted under this Plan will not exceed fifteen percent (15%) of the total outstanding shares of the Company's common stock. The Company settles exercises of stock option awards by issuing new shares. Forfeitures are recognized as they occur.

 

A summary of option activity is as follows for the six months ended December 31, 2020:

 

		Number of shares		Weighted average exercise price
Options outstanding at June 30, 2020		30,014,704	$	1.47
Options granted		15,000		0.44
Less:
	Options exercised	-		-
	Options canceled or expired	(2,394,304)		1.32
Options outstanding at December 31, 2020		27,635,400	$	1.48

 

Share based compensation expense related to options issued under the 2015 Plan for the three months ended December 31, 2020 and 2019 was $2,633,389 and $3,272,897, respectively, and for the six months ended December 31, 2020 and 2019 was $5,128,278 and $6,377,285, respectively.

 

The Company recognizes expense for awards subject to graded vesting on a straight-line basis. As of December 31, 2020, there was $14,341,473 of total unrecognized share-based compensation expense related to stock options issued under the 2015 Stock Option Plan that will be recognized over a weighted-average period of 1.53 years.

 

NOTE 11 COMMITMENTS AND CONTINGENCIES

 

Licenses

 

The Company has commitments under license agreements which are described in Note 3.

 

Leases

 

On October 10, 2019, substantially all of the Company's operating leases of office and laboratory space were amended to extend the expiration dates of the leases to September 30, 2021. The Company also leased an additional 6,711 square feet of office and storage space that commenced on November 1, 2019 and expires on September 30, 2021.

 

In March 2019, the Company entered into finance leases of laboratory equipment.  The validation process for the leased equipment was completed and payments commenced in October 2019.  The leases expire in September 2023, at which time the Company has the option to purchase the leased equipment for one dollar.  

 

-21-

The table below presents the future maturities of lease obligations under operating and finance leases:

 

Year Ending June 30,		Operating		Finance		Total
2021		493,775		317,959		811,734
2022		246,888		740,798		987,686
2023		-		167,719		167,719
2024		-		-		-
2025		-		-		-
Total cash payments		740,663		1,226,476		1,967,139
Less: Imputed interest		(24,320)		(42,742)		(67,061)
Total lease liability	$	716,343		1,183,734		1,900,078

 

Lease information for the three and six months ended December 31, 2020 and 2019 is as follows:

 

 

			Three Months Ended December 31, 2020		Three Months Ended December 31, 2019
Lease cost
Finance lease cost
	Amortization of right of use assets	$	217,971	$	156,057
	Interest on lease liabilities		26,357		40,488
Operating lease cost			236,683		223,051
Short-term lease cost			5,985		450
Total lease cost		$	486,996	$	420,046
Cash paid for amounts included in the measurement of
lease liabilities
	Operating cash flows from finance leases	$	26,357	$	40,488
	Operating cash flows from operating leases		194,525		224,088
	Financing cash flows from finance leases		166,590		156,057

 

 

			Six Months Ended December 31, 2020		Six Months Ended December 31, 2019
Lease cost
Finance lease cost
	Amortization of right of use assets	$	432,309	$	180,469
	Interest on lease liabilities		55,961		44,901
Operating lease cost			473,366		327,455
Short-term lease cost			8,739		64,787
Total lease cost		$	970,375	$	617,612
Cash paid for amounts included in the measurement of
lease liabilities
	Operating cash flows from finance leases	$	55,961	$	44,901
	Operating cash flows from operating leases		431,208		329,515
	Financing cash flows from finance leases		329,749		180,918
Weighted average remaining lease term - finance leases (Years)			1.47
Weighted average remaining lease term - operating leases (Years)			0.75
Weighted average discount rate - finance leases			8.10%
Weighted average discount rate - operating leases			8.63%

 

-22-

Purchase commitments

 

In March 2019, in connection with the lease of laboratory equipment described above, the Company agreed to purchase a fixed quantity of the consumables used by the equipment for a total of $1,386,710. The Company is obligated to pay for the consumables in twelve fixed monthly installments beginning in October 2019. At December 31, 2020, the Company had taken delivery of consumables worth $93,909 in excess of the installment amounts paid. The amount due for goods that have been delivered is included in accrued liabilities on the condensed consolidated balance sheet. Remaining payments due under the purchase commitment total $577,795 during the year ending June 30, 2021.

 

Legal proceedings

 

On or about July 13, 2018, RTJ, LLC and two of its principals filed a lawsuit against Predictive Therapeutics LLC, Predictive Biotech, Inc., both subsidiaries of Predictive Technology Group, Inc., and Jack Turner, Jr., an employee of Predictive Biotech, Inc. The plaintiffs had acted in a distributor capacity. The relationship was terminated. Plaintiffs are alleging breach of contract, promissory estoppel, unjust enrichment, fraud, breach of fiduciary duty, defamation, false light, and tortious interference. Based on the information available to us, we do not believe any of the RTJ proceedings will have a material adverse effect on our business, results of operations, financial position, or liquidity. Further, we deny the allegations in the complaint, have not discovered any evidence of wrongdoing with respect to the allegations and will vigorously defend against these allegations.

 

On or about May 1, 2019, Surgenex, LLC and one of its principals filed a lawsuit against Predictive Therapeutics LLC, Predictive Biotech, Inc., both subsidiaries of Predictive Technology Group, Inc., and Doug Schmid, an employee of Predictive Biotech, Inc. In 2014 Surgenex contracted with Utah Cord Bank, Inc., a former employer of Doug Schmid, to assist Surgenex in the doing work relating to allograft tissue. Schmid was later hired by Predictive Biotech, Inc. In connection with Schmid's employment with Predictive Biotech, Surgenex has filed a lawsuit alleging unjust enrichment, conspiracy, conversion, tortious interference with contractual and business relations, violations of trade secrets act, and other claims. Based on the information available to us, we do not believe the Surgenex proceedings will have a material adverse effect on our business, results of operations, financial position, or liquidity. Further, we deny the allegations in the complaint, have not discovered any evidence of wrongdoing with respect to the allegations and will vigorously defend against these allegations.

 

On or about July 12, 2019, Predictive Technology Group, Inc. and Predictive Therapeutics, LLC, a subsidiary of Predictive Technology Group, Inc. filed a lawsuit against Michael Schramm (Schramm). Schramm entered into an agreement to sell us certain patents and patent applications in consideration for equity securities. Schramm represented that he owned all rights, title, and interest in and to the intellectual property. We were subsequently advised by our patent counsel that, while the patents are registered with the US Patent and Trademark Office in the Company's name, the Company may not have a full interest in the patents. An unrelated third-party law firm placed a lien on the patents due to non-payment of legal fees by a third-party entity to whom certain assets were sold by another third-party entity that originally owned the patents.  The Company raised these concerns with Schramm, who did not provide satisfactory evidence confirming that the Company had sole title to the patents.  We sued Schramm for breach of contract, conversion and on other legal theories and are seeking, among other things, rescission of the purchase and sale transaction. While there is some question as to whether the Company has full title to these patents, we believe that we have at least partial ownership and can develop products based on the said patents. Schramm filed a counterclaim against us and Bradley C. Robinson, our Chief Executive Officer and Transfer Online, Inc., our transfer agent. Schramm is alleging he did not make any false representations. He is alleging, among other things, that various parties involved in the transaction committed breach of contract, conversion, violations of Nevada state law for failure to transfer securities, breach of fiduciary duty, tortious interference, and civil conspiracy.  Based on the information available to us, we do not believe the Schramm proceedings will have a material adverse effect on our business, results of operations, financial position, or liquidity. Further, we deny the allegations in the counterclaim, have not discovered any evidence of wrongdoing with respect to the allegations in the counterclaim and will vigorously prosecute our claims against Schramm.

 

On or about March 18, 2020, Predictive Biotech, Inc. filed a lawsuit in the Utah District Court against Auxocell Laboratories, Inc. ("Auxocell") for breach of contract, product liability, breach of warranty, negligent misrepresentation and other claims relating to defects in laboratory equipment Auxocell sold to Predictive Biotech. Alleged damages include wasted umbilical cord tissue, lost inventory, costs associated with particulate testing, reputational injury, and related claims. On or about August 24, 2020, Auxocell answered the Complaint by denying the claims and asserting counterclaims of its own for breach of a confidentiality clause and failure to pay for devices. The Company answered and denied the counterclaims on December 14, 2020. Initial discovery has commenced and the current schedule has a discovery cut-off date of April 1, 2021. The litigation is still in discovery and as such we provide no opinion or assessment of the likely outcome of the litigation.

 

On or about November 11, 2020, Mackey Investment, LLLP ("Mackey") filed a lawsuit in Utah District Court against Predictive Technology Group, Inc and several officers of the Company. Mackey subscribed for and purchased 500,000 shares of Predictive common stock for $480,000 on or about January 29, 2020. Mackey was given all of the Company's SEC filings as part of his due diligence. Mackey is alleging that Predictive failed to disclose material information in connection with its investment and is alleging breach of contract, fraudulent inducement, violations of the Utah Uniform Securities Act, and conspiracy. The suit also seeks civil penalties and treble and punitive damages. The Company filed an answer denying the claims in the Complaint on or about December 4, 2020. Discovery has commenced, but we have not received discovery responses. We deny the allegations in the complaint and will vigorously defend against these allegations.

 

-23-

On or about April 30, 2020, Equitas Bio/Pharma Solutions, LLC ("Equitas") filed a lawsuit against Predictive Technology Group in New York District Court alleging nonpayment of "at least $551,080" in amounts owing under Master Service Agreement and Project Work Orders as of the date of filing. The claims are for breach of contract, breach of covenant of good faith and fair dealing and fraud. The basis of the fraud claim alleges that Predictive "made specific statements to Equitas that it was able to and intend to perform its obligations under the agreements" and at "the time Predictive made these promises it had no intention of keeping them." We agree that amounts are owed under the agreements, but we deny all allegations in the complaint relating to breach of covenant of good faith and fraud. Amounts due as of December 31, 2020 are included in accounts payable in the condensed consolidated balance sheets.

 

In June 2020, Wellgistics, LLC, the distributor of the Company's Assurance AB product, requested that the partial deposit paid on their non-cancellable purchase order of $5 million (see Note 5) be returned. As the purchase order is contractually non-cancellable and the Company performed on the order in good faith by transmitting the deposit to the Company's supplier, the request to return the deposit was not honored. To date there has been no legal action taken by either party.

 

As of December 31, 2020, we did not record a liability related to these matters (other than amounts recorded in accounts payable as described above) as it was determined that an unfavorable resolution is either not currently probable or that an amount or relevant range is not reasonably estimable, or both. However, litigation is inherently unpredictable and it is possible that losses may occur. Any unfavorable resolution of any of these matters could materially affect our condensed consolidated financial position, cash flows, or results of operations. All legal costs associated with litigation are expensed as incurred.

 

COVID-19

 

On March 11, 2020, the World Health Organization declared the novel coronavirus ("COVID-19"), a respiratory illness first identified in Wuhan, China, a pandemic. The global spread of COVID-19 has created significant volatility, uncertainty, and economic disruption. Governments in affected regions have implemented, and may continue to implement, safety precautions which include quarantines, travel restrictions, business closures, cancellations of public gatherings and other measures as they deem necessary. Many organizations and individuals, including the Company and its employees, are taking additional steps to avoid or reduce infection, including limiting travel and working from home. These measures are disrupting normal business operations both in and outside of affected areas and have had significant negative impacts on businesses and financial markets worldwide.

 

The Company experienced operational and financial impacts from the COVID-19 pandemic beginning late in the third quarter of fiscal 2020, including the impact of stay-at-home mandates and related safety measures such as the delay of elective medical procedures, resulting in a decline in the volume of procedures using the Company's products.

 

The long- term severity of the material impact of the COVID-19 pandemic on the Company's business will continue to depend on a number of factors, including, but not limited to, the further duration and severity of the pandemic, including the effects of the new COVID-19 variants, and the continued extent and severity of the impact on the Company's customers and suppliers, all of which are uncertain and cannot be predicted. The impact of COVID-19 on the Company's results of operations and cash flows has been material and is expected to continue to be material for the remainder of this calendar year. Given the dynamic nature of this situation, the Company is currently unable to accurately predict the impact of COVID-19 on its future operations and financial results or cash flows for the foreseeable future and whether the impact of COVID-19 could lead to potential impairments.

 

FDA Warning Letter

 

We received a Warning Letter from the FDA on August 17, 2020 regarding the marketing of our allograft product, CoreCyte. The letter alleges inappropriate marketing of CoreCyte as a treatment for COVID-19 and challenges the eligibility of CoreCyte for regulation under section 361 of the Public Health Service Act. Products regulated solely under section 361 of the Public Health Service Act do not require premarket approval. The Company is currently working with the FDA to address the concerns raised in the Warning Letter to the FDA's satisfaction. The Company believes that it has complied with all applicable regulations to date.

 

Past due payments

 

As of December 31, 2020, many of the Company's obligations were significantly past due. As a result, our creditors may have grounds to take adverse action against the Company, including but not limited to lawsuits and seizure of collateral. Any such actions taken by our creditors could have material adverse impact on our operations or financial condition.

 

-24-

NOTE 12 SUBSEQUENT EVENTS

 

Management has evaluated subsequent events through February 15, 2020, the date on which the financial statements were available to be issued.

 

On January 14, 2021, the Company entered into an amended and restated Promissory Note and Security Agreement with Prophase Labs, Inc.  This amendment modified the terms as described in Note 6 above. The Company received additional proceeds in the amount of $1,000,000, which raised the outstanding amount to $4,000,000, less $250,000, recognized as earned under the consulting agreement, for a total outstanding amount of $3,750,000. The amended promissory note bears 15% simple interest. Payments are to be made on a per test basis based on volume starting the 10^th of the following month after recording a monthly sales volume, beginning March 10^th for February sales.  Payments will not exceed the aggregate amounts due on the note, and will be applied first to interest, then principal. No other payments are due on the promissory note until September 2021, at which time monthly payments equal to 1/36^th of the outstanding principal and interest amount shall commence.  If payments being made based on testing volume are greater, those will govern repayment. Unpaid interest accruing prior to September 2021 will be added to the principal amount. Any remaining principal and interest shall be due on September 30, 2022. The amended promissory note is secured by the revenues arising from the Company's Assurance VR™ COVID-19 RT-PCR test and may be prepaid without penalty

 

On January 14, 2021, the Company terminated its consulting agreement with ProPhase Labs, Inc. (see Note 6) in order to facilitate the closing of the amended and restated note as described above.

 

On February 9, 2021, Company received loan proceeds of an additional $1.7 million under the Paycheck Protection Program ("PPP") under a new promissory note from a commercial bank (the "PPP Second Loan"). The PPP, established as part of the CARES Act, provides for loans to qualifying businesses for amounts up to 2.5 times the average monthly payroll expenses of the qualifying business. The loans and accrued interest are forgivable after eight weeks as long as the borrower uses the loan proceeds for eligible purposes, including payroll, benefits, rent and utilities, and maintains its payroll levels.

 

The application for these funds requires the Company to, in good faith, certify that the current economic uncertainty made the loan request necessary to support the ongoing operations of the Company. Some of the uncertainties related to the Company's operations that are directly related to COVID-19 include, but are not limited to, the severity of the virus, the duration of the outbreak, governmental, business or other actions (which could include limitations on operations or mandates to provide products or services), impacts on the supply chain, and the effect on customer demand or changes to operations. In addition, the health of the Company's workforce and its ability to meet staffing needs are uncertain and is vital to its operations.

 

The PPP Second Loan certification further requires the Company to take into account our current business activity and our ability to access other sources of liquidity sufficient to support ongoing operations in a manner that is not significantly detrimental to the business. While the Company does have availability under its Revolving Loan Agreement, the $2.8 million that is available is in place to support working capital needs, along with current cash on hand. Further, the Company has a lack of history of being able to access the capital markets, exacerbated by our stock not being listed on a national exchange. As a result, the Company believes it meets the certification requirements.

 

The receipt of these funds, and the forgiveness of the loan attendant to these funds, is dependent on the Company having initially qualified for the loan and qualifying for the forgiveness of such loan based on our future adherence to the forgiveness criteria. The term of the Company's PPP Second Loan is five years. The annual interest rate on the PPP Loan is 1% and no payments of principal or interest are due during the six-month period beginning on the date of the PPP Loan. The PPP Loan is subject to any new guidance and new requirements released by the Department of the Treasury.

 

-25-

Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

General

 

The following discussion and analysis should be read in conjunction with the audited Condensed consolidated Financial Statements and accompanying notes thereto included in the Company's Annual Report on Form 10-K as of and for the fiscal year ended June 30, 2020.  Unless otherwise noted, all of the financial information in this Report is condensed consolidated financial information for the Company.

 

General

 

Predictive Technology Group, Inc., a Salt Lake City, UT life sciences company, is a leader in the use of data analytics for disease identification and subsequent therapeutic intervention through unique novel gene-based diagnostics, biotechnology treatments and companion therapeutics. Through its' wholly-owned subsidiaries, Predictive Biotech, Predictive Laboratories, and Predictive Therapeutics, the company focuses on clinical categories such as: Endometriosis, Degenerative Disc Disease and Human Cell and Tissue Products ("HCT/P"). In addition to Predictive Biotech's efforts to advance regenerative medicine, Predictive Laboratories is committed to assisting women in overcoming the devastating consequences of endometriosis via appropriate early-stage diagnosis and subsequent treatment. During the three and six months ended December 31, 2020 we reported total revenues of $4,067,488 and $9,158,492, respectively. We reported net losses attributable to common shareholders of $7,104,801 and $22,564,865, resulting in net losses per common share of $(0.02) and $(0.08), respectively. During the three and six months ended December 31, 2019 we reported total revenues of $7,336,640 and $15,595,898, respectively. We reported net losses attributable to common shareholders of $26,002,669 and $33,867,276, resulting in net losses per common share of $(0.09) and $(0.12), respectively.  

 

Our business units have been aligned with how the Chief Operating Decision Maker reviews performance and makes decisions in managing the Company.  The business units have been aggregated into two reportable segments: Human Cell and Tissues Products (HCT/Ps) and diagnostics and therapeutics. Predictive Biotech's HCT/Ps are processed in our FDA registered lab. Our minimally manipulated tissue products are prepared utilizing proprietary extraction methods that reduce the loss of important scaffolding, growth factor and general cytokines and are intended for homologous use.  The diagnostics and therapeutics segment uses data analytics for disease identification and subsequent therapeutic intervention through unique novel gene-based diagnostics, biotechnology treatments and companion therapeutics.

 

Results of Operations for the Three Months Ended December 31, 2020 and 2019 

 

Revenue

 

		Three months ended
		December 31,
		2020				2019				Change
HCT/P		$	2,654,565			$	7,289,265			$	(4,634,700)
Diagnostics and Therapeutics			1,412,923				47,375				1,365,548
Total		$	4,067,488			$	7,336,640			$	(3,269,152)

 

Revenue in the HCT/P segment for the three months ended December 31, 2020 decreased by $4.6 million from $7.3 million for the three months ended December 31, 2019. The decrease is primarily due to the impact of the COVID-19 pandemic, which has caused continued sales declines due to closure of customer clinics and reduced patient visits to those clinics that remain open.

 

In October 2020, the Company notified the FDA that it had suspended sales of the CoreCyte allograft product pending the anticipated filing of an IND application with the FDA. CoreCyte represented 51.0% of the Company's sales for the six months ended December 31, 2020. While commercial success cannot be guaranteed, the Company is executing its transition plan related to the CoreCyte IND application and expects to generate additional sales from new and existing products in the near term.

 

Revenue in the diagnostics and therapeutics segment for the three months ended December 31, 2020 increased by $1.4 million from zero due to the introduction of the Assurance VR COVID-19 RT-PCR viral test during the six months ended December 31, 2020.

 

-26-

Cost of goods sold (Exclusive of Depreciation & Amortization)

 

		Three months ended
		December 31,
Cost of goods sold		2020				2019				Change
HCT/P		$	1,812,339			$	5,840,256			$	(4,027,917)
Diagnostics and Therapeutics			1,016,353				-				1,016,353
Total		$	2,828,692			$	5,840,256			$	(3,011,564)
Cost of goods sold as a % of sales
HCT/P			68.3	%			79.6	%
Diagnostics and Therapeutics			71.9	%			-	%

 

Cost of goods sold in the HCT/P segment for the three months ended December 31, 2020 decreased to $1.8 million from $5.8 million for the three months ended December 31, 2019. Approximately $1.2 million of decrease is due to decreased sales. The remaining decreases are primarily comprised of $1.0 million in scrap expense, $0.5 million in personnel costs, and $0.3 million in freight and transaction costs. Scrap expense for the three months ended December 31, 2019 was abnormally high, primarily due to defective components supplied by a specific vendor (see Note 11 to the accompanying condensed consolidated financial statements for a summary of legal action taken against the vendor). The remaining decreases resulted from decreased sales and decreases in production capacity made in response to the decrease in sales.

 

Cost of goods sold in the diagnostics and therapeutics segment for the three months ended December 31, 2020 increased to $1.0 million from zero due to the introduction of the Assurance VR COVID-19 RT-PCR viral test during the six months ended December 31, 2020. The profitability of the COVID-19 testing business is sensitive to testing volume, with higher marginal profitability per unit after fixed costs are covered.

 

Selling and marketing expenses

 

			Three months ended
			December 31,
			2020				2019				Change
Selling and marketing expense			$	872,156			$	3,049,593			$	(2,177,437)
Selling and marketing expense as a % of sales				21.4	%			41.6	%

 

Selling and marketing expenses for the three months ended December 31, 2020 decreased to $0.9 million from $3.0 million for the three months ended December 31, 2019. The decrease is due to decreases in personnel costs of $0.8 million, commissions expense of $0.7 million, and stock based compensation of $0.3 million.

 

Substantially all of our selling and marketing expenses were incurred in the HCT/P segment.

 

-27-

General and Administrative Expenses

 

			Three months ended
			December 31,
			2020				2019				Change
General and administrative expense			$	4,910,346			$	7,034,770			$	(2,124,424)
General and administrative expense as a % of sales				120.7	%			95.9	%

 

General and administrative expenses for the three months ended December 31, 2020 decreased to $4.9 million from $7.0 million for the three months ended December 31, 2019. Approximately $2.0 million of the decrease is due to decreased share-based compensation expenses.

 

Research and Development Expenses

 

			Three months ended
			December 31,
			2020				2019				Change
Research and development expense			$	557,381			$	2,364,350			$	(1,806,969)
Research and development expense as a % of sales				13.7	%			32.2	%

 

Research and development expenses for the three months ended December 31, 2020 decreased to $0.6 million from $2.4 million for the three months ended December 31, 2019. Approximately $0.1 million of the decrease is due to decreased payroll expense, with the remainder driven by reallocation of resources previously used in R&D to perform the Assurance VR COVID-19 test.

 

Depreciation and amortization expense

 

			Three months ended
			December 31,
			2020				2019				Change
Depreciation and amortization expense			$	1,751,562			$	2,775,073			$	(1,023,511)
Depreciation and amortization expense as a % of sales				43.1	%			37.8	%

 

Depreciation and amortization expense decreased compared to the same period in the prior fiscal year primarily due to a decrease in our intangible asset portfolio arising from the impairment of RMT described in Note 3 to the accompanying condensed consolidated financial statements.   

 

Other loss

 

		Three months ended
		December 31,
		2020				2019			Change
Other loss		$	278,754			$	16,546,988		$	(16,268,234)

 

Other loss for the three months ended December 31, 2020 decreased to $0.3 million from $16.5 million for the three months ended December 31, 2019. The decrease was primarily driven by the $15.9 million impairment charge recognized in December 2019 related to our equity method investment in Juneau Biosciences, LLC

 

-28-

Results of Operations for the Six Months Ended December 31, 2020 and 2019

 

Revenue

 

		Six months ended
		December 31,
		2020				2019				Change
HCT/P		$	6,523,823			$	15,473,896			$	(8,950,073)
Diagnostics and Therapeutics			2,634,669				122,002				2,512,667
Total		$	9,158,492			$	15,595,898			$	(6,437,406)

 

Revenue in the HCT/P segment for the six months ended December 31, 2020 decreased by $9.0 million from $15.5 million for the six months ended December 31, 2019. The decrease is primarily due to the impact of the COVID-19 pandemic, which has caused continued sales declines due to closure of customer clinics and reduced patient visits to those clinics that remain open.

 

In October 2020, the Company notified the FDA that it had suspended sales of the CoreCyte allograft product pending the anticipated filing of an IND application with the FDA. CoreCyte represented 51.0% of the Company's sales for the six months ended December 31, 2020. While commercial success cannot be guaranteed, the Company is executing its transition plan related to the CoreCyte IND application and expects to generate additional sales from new and existing products in the near term.

 

Revenue in the diagnostics and therapeutics segment for the six months ended December 31, 2020 increased by $2.5 million from $0.1 million due to the introduction of the Assurance VR COVID-19 RT-PCR viral test during the six months ended December 31, 2020

 

Cost of goods sold (Exclusive of Depreciation & Amortization)

 

		Six months ended
		December 31,
Cost of goods sold		2020				2019				Change
HCT/P		$	4,198,999			$	13,022,246			$	(8,823,247)
Diagnostics and Therapeutics			2,094,830				-				2,094,830
Total		$	6,293,829			$	13,022,246			$	(6,728,417)
Cost of goods sold as a % of sales
HCT/P			64.4	%			84.2	%
Diagnostics and Therapeutics			79.5	%			-	%

 

Cost of goods sold in the HCT/P segment for the six months ended December 31, 2020 decreased to $4.2 million from $13.0 million for the six months ended December 31, 2019. Approximately $3.0 million of decrease is due to decreased sales. The remaining decreases are primarily comprised of $1.8 million in scrap expense, $0.5 million in personnel costs, and $0.3 million in freight and transaction costs. Scrap expense for the six months ended December 31, 2019 was abnormally high, primarily due to defective components supplied by a specific vendor (see Note 11 to the accompanying condensed consolidated financial statements for a summary of legal action taken against the vendor). The remaining decreases resulted from decreased sales and decreases in production capacity made in response to the decrease in sales.

 

Cost of goods sold in the diagnostics and therapeutics segment for the six months ended December 31, 2020 increased to $2.1 million from zero due to the introduction of the Assurance VR COVID-19 RT-PCR viral test during the six months ended December 31, 2020. The profitability of the COVID-19 testing business is sensitive to testing volume, with higher marginal profitability per unit after fixed costs are covered

 

-29-

Selling and marketing expenses

 

			Six months ended
			December 31,
			2020				2019				Change
Selling and marketing expense			$	1,933,954			$	6,201,563			$	(4,267,609)
Selling and marketing expense as a % of sales				21.1	%			39.8	%

 

Selling and marketing expenses for the six months ended December 31, 2020 decreased to $1.9 million from $6.2 million for the six months ended December 31, 2019. The decrease is due to decreases in personnel costs of $1.0 million, and a decrease in commissions expense of $3.2 million.

 

Substantially all of our selling and marketing expenses were incurred in the HCT/P segment.

 

General and Administrative Expenses

 

			Six months ended
			December 31,
			2020				2019				Change
General and administrative expense			$	10,167,845			$	13,413,627			$	(3,245,782)
General and administrative expense as a % of sales				111.0	%			86.0	%

 

General and administrative expenses for the six months ended December 31, 2020 decreased to $10.2 million from $13.4 million for the six months ended December 31, 2019. Approximately $3.4 million of the decrease is due to decreased share-based compensation expenses. Personnel costs also decreased by $0.1 million.  The decreases in personnel costs resulted primarily from the April 2020 reduction in force.

 

Research and Development Expenses

 

		Six months ended
		December 31,
		2020				2019			Change
Research and development expense		$	928,223			$	4,192,700		$	(3,264,477)
Research and development expense as a % of sales			10.1	%			26.9	%

 

Research and development expenses for the six months ended December 31, 2020 decreased to $0.9 million from $4.2 million for the six months ended December 31, 2019. Approximately $1.8 million of the decrease is due to decreased share-based compensation expense, with the remainder driven by reallocation of resources previously used in R&D to perform the Assurance VR COVID-19 test.

 

-30-

Depreciation and amortization expense

 

			Six months ended
			December 31,
			2020				2019				Change
Depreciation and amortization expense			$	4,235,645			$	5,385,318			$	(1,149,673)
Depreciation and amortization expense as a % of sales				46.2	%			34.5	%

 

Depreciation and amortization expense decreased compared to the same period in the prior fiscal year primarily due to a decrease in our intangible asset portfolio arising from the impairment of RMT described in Note 3 to the accompanying condensed consolidated financial statements.   

 

Loss on impairment

		Six months ended
		December 31,
		2020				2019			Change
Loss on Impairment		$	7,015,326			$	-		$	7,015,326

 

Loss on impairment for the six months ended December 31, 2020 increased to $7.0 million due to the impairment of $5.2 million in goodwill and $1.8 million in trade secrets in the HCT/P segment (see Note 3 to the accompanying condensed consolidated financial statements).  

 

Other loss

 

		Six months ended
		December 31,
		2020				2019			Change
Other loss		$	1,206,165			$	16,759,770		$	(15,553,605)

 

Other loss for the six months ended December 31, 2020 decreased to $1.2 million from $16.8 million for the six months ended December 31, 2019. The decrease was primarily driven by the $15.9 million impairment charge recognized in December 2019 related to our equity method investment in Juneau Biosciences, LLC.

 

Liquidity and Capital Resources

 

The Company incurred a net loss attributable to common stockholders of $22,564,865 and net cash outflows from operations of $2,972,152 for the six months ended December 31, 2020. At December 31, 2020, the Company had $134,376 of cash and negative working capital of $23,020,768. The Company's historical and current use of cash in operations combined with limited liquidity resources raise substantial doubt regarding the Company's ability to continue as a going concern. Management may seek additional capital through debt financings, collaborative or other funding arrangements with partners, sale of assets, or through other sources of financing. Should the Company seek additional financing from outside sources, the Company may not be able to raise such financing on terms acceptable to the Company or at all to mitigate the substantial doubt that exists. If the Company is unable to raise additional capital when required or on acceptable terms, this could have a material adverse effect on liquidity. In such a case, the Company may be required to scale back or to discontinue the promotion of currently available products, scale back or discontinue the advancement of product candidates, reduce headcount, file for bankruptcy, reorganize, merge with another entity, or cease operations.

 

-31-

Our capital deployment strategy focuses on use of resources in two key areas: research and development, and the commercialization of our HCT/Ps and diagnostic products. We believe that research and development provides the best return on invested capital.  We also allocate capital for acquisitions that support our business strategy.

 

The following table represents the condensed consolidated cash flow statement:

 

	Six months ended
	December 31,
	2020			2019			Change
Cash used in operating activities	$	(2,972,152)		$	(9,914,968)		$	6,942,816
Cash used in investing activities		(299,951)			(946,856)			646,905
Cash provided by financing activities		3,075,251			9,499, 082			(6,423,831)
Net decrease in cash and cash equivalents		(196,852)			(1,362,742)
Cash and cash equivalents at the beginning of the period		331,228			1,618,244
Cash and cash equivalents at the end of the period	$	134,376		$	255,502

 

Cash Flows from Operating Activities

 

The decrease in cash used in operating activities for the six months ended December 31, 2020 compared to the six months ended December 31, 2019 was primarily due to decreases in cash paid to suppliers and employees as a result of reductions in production and production capacity made in response to decreasing sales.

 

Cash Flows from Investing Activities

 

The decrease in cash used in investing activities for the six months ended December 31, 2020 compared to the six months ended December 31, 2019 was primarily due to a decrease in cash paid for equity under our subscription agreement of $0.5 million and a decrease in cash paid for capital expenditures of $0.2 million.

 

Cash Flows from Financing Activities

 

The decrease in cash provided by financing activities for the six months ended December 31, 2020 compared to the six months ended December 31, 2019 was primarily due to the receipt of $3.4 million in proceeds from the issuance of promissory notes, while during last year $9.7 million in proceeds from the issuance of promissory notes was received.  

 

Effects of Inflation

 

We do not believe that inflation has had a material impact on our business, sales, or operating results during the periods presented.

 

Off-Balance Sheet Arrangements

 

We currently do not have any off-balance sheet arrangements or financing activities with special-purpose entities.

 

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Critical Accounting Policies

 

Critical accounting policies are those policies which are both important to the presentation of a company's financial condition and results and require management's most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.  There have been no recent significant changes to our accounting policies during the six months ended December 31, 2020.

 

Certain Factors That May Affect Future Results of Operations

 

The Securities and Exchange Commission encourages companies to disclose forward-looking information so that investors can better understand a company's future prospects and make informed investment decisions. This Quarterly Report on Form 10-Q contains such "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.

 

All statements in this report, other than statements of historical fact, are forward-looking statements for purposes of these provisions, including any projections of earnings, revenues or other financial items, any statements of the plans and objectives of management for future operations, any statements concerning proposed new products or services, any statements regarding future economic conditions or performance, and any statements of assumptions underlying any of the foregoing. All forward-looking statements included in this report are made as of the date hereof and are based on information available to us as of such date. We assume no obligation to update any forward-looking statement. In some cases, forward-looking statements can be identified by the use of terminology such as "may," "will," "expects," "plans," "anticipates," "intends," "believes," "estimates," "potential," or "continue," or the negative thereof or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements contained herein are based upon reasonable assumptions at the time made, there can be no assurance that any such expectations or any forward-looking statement will prove to be correct. Our actual results will vary, and may vary materially, from those projected or assumed in the forward-looking statements. Future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties, many of which we cannot predict with accuracy and some of which we might not anticipate, including, without limitation, product recalls and product liability claims; infringement of our technology or assertion that our technology infringes the rights of other parties; termination of supplier relationships, or failure of suppliers to perform; inability to successfully manage growth; delays in obtaining regulatory approvals or the failure to maintain such approvals; concentration of our revenue among a few customers, products or procedures; development of new products and technology that could render our products obsolete; market acceptance of new products; introduction of products in a timely fashion; price and product competition, availability of labor and materials, cost increases, and fluctuations in and obsolescence of inventory; volatility of the market price of our common stock; foreign currency fluctuations; changes in key personnel; work stoppage or transportation risks; integration of business acquisitions; and other factors referred to in our reports filed with the SEC, including our Registration Statement on Form 10. All subsequent forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by these cautionary statements. Additional factors that may have a direct bearing on our operating results are discussed in Item 1A "Risk Factors" in our Registration Statement on Form 10. In light of these assumptions, risks and uncertainties, the results and events discussed in the forward-looking statements contained in this Quarterly Report or in any document incorporated by reference might not occur. Stockholders are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this Quarterly Report. We are not under any obligation, and we expressly disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise. All subsequent forward-looking statements attributable to us or to any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section.

 

Item 3.  Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable.

 

Item 4.  Controls and Procedures

 

1. Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures (Disclosure Controls) within the meaning of Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Our Disclosure Controls are designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act, such as this Quarterly Report on Form 10-Q, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission's rules and forms. Our Disclosure Controls are also designed to ensure that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our Disclosure Controls, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily applied its judgment in evaluating and implementing possible controls and procedures.

 

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As of the end of the period covered by this Quarterly Report on Form 10-Q, we evaluated the effectiveness of the design and operation of our Disclosure Controls, which was done under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer. Based on the evaluation of our Disclosure Controls, our Chief Executive Officer and Chief Financial Officer have concluded that, as of December 31, 2020, our Disclosure Controls were not effective due to material weaknesses in the Company's internal control over financial reporting as disclosed below.

 

2.	Management's Report on Internal Control Over Financial Reporting

 

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, a company's principal executive and principal financial officers and effected by the Company's board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles.  In making this assessment, management used the criteria established in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO").

 

Based on our assessment, management has concluded that our internal control over financial reporting was not effective as of December 31, 2020, due to the following material weaknesses:

 

·

The Company has a material weakness in the design and operation of its controls regarding its accounting for its equity method investment, including the proper elimination of intercompany profit included in assets acquired by the Company from its equity method investment and possible impairment of the investment. The identification of intercompany profit to be eliminated and the identification and compilation of data, assumptions, and computations used to determine the estimated fair value is not sufficiently precise in its preparation and review to identify misstatements that could become material.

 

·	Separately, the Company has a material weakness in the design and operation of its controls over the timely recording of forfeitures of share-based compensation awards and the application of the amortization method used to recognize expense related to share based compensation awards, which could become material

 

·	The Company has a material weakness in the design and operation of its controls related to the timely execution of contracts.

 

A "material weakness" is a deficiency, or a combination of deficiencies, in Internal Control over Financial Reporting ("ICFR"), 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.

 

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements or prevent or detect all error and fraud. Any control system, no matter how well designed and operated, is based upon certain assumptions, and can provide only reasonable, not absolute, assurance that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

3.	Plan to Remediate Material Weaknesses

 

We plan to enhance existing controls and design and implement new controls applicable to our equity method accounting, to ensure that our equity method investment balances are accurately calculated and appropriately reflected in our financial statements on a timely basis. We are in the process of implementing a software solution to automate the accounting for share based compensation awards. We are also planning to enhance our controls over the recording of forfeitures to ensure that forfeitures are recorded timely. Lastly, we plan to enhance existing controls and design, and implement new controls to ensure that contracts and agreements are executed timely and that executed copies of contracts are retained

 

We plan to devote significant time and attention to remediate the above material weakness as soon as reasonably possible. As we continue to evaluate our controls, we will make the necessary changes to improve the overall design and operation of our controls. We believe these actions will be sufficient to remediate the identified material weakness and strengthen our internal control over financial reporting; however, there can be no guarantee that such remediation will be sufficient. We will continue to monitor the effectiveness of our controls and will make any further changes management determines appropriate.

 

4.	Change in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2020, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II - Other Information

 

Item 1.  Legal Proceedings

 

On or about July 13, 2018, RTJ, LLC and two of its principals filed a lawsuit against Predictive Therapeutics LLC, Predictive Biotech, Inc., both subsidiaries of Predictive Technology Group, Inc., and Jack Turner, Jr., an employee of Predictive Biotech, Inc. The plaintiffs had acted in a distributor capacity. The relationship was terminated. Plaintiffs are alleging breach of contract, promissory estoppel, unjust enrichment, fraud, breach of fiduciary duty, defamation, false light, and tortious interference. Based on the information available to us, we do not believe any of the RTJ proceedings will have a material adverse effect on our business, results of operations, financial position, or liquidity. Further, we deny the allegations in the complaint, have not discovered any evidence of wrongdoing with respect to the allegations and will vigorously defend against these allegations.

 

On or about May 1, 2019, Surgenex, LLC and one of its principals filed a lawsuit against Predictive Therapeutics LLC, Predictive Biotech, Inc., both subsidiaries of Predictive Technology Group, Inc., and Doug Schmid, an employee of Predictive Biotech, Inc. In 2014 Surgenex contracted with Utah Cord Bank, Inc., a former employer of Doug Schmid, to assist Surgenex in the doing work relating to allograft tissue. Schmid was later hired by Predictive Biotech, Inc. In connection with Schmid's employment with Predictive Biotech, Surgenex has filed a lawsuit alleging unjust enrichment, conspiracy, conversion, tortious interference with contractual and business relations, violations of trade secrets act, and other claims. Based on the information available to us, we do not believe the Surgenex proceedings will have a material adverse effect on our business, results of operations, financial position, or liquidity. Further, we deny the allegations in the complaint, have not discovered any evidence of wrongdoing with respect to the allegations and will vigorously defend against these allegations.

 

On or about July 12, 2019, Predictive Technology Group, Inc. and Predictive Therapeutics, LLC, a subsidiary of Predictive Technology Group, Inc. filed a lawsuit against Michael Schramm (Schramm). Schramm entered into an agreement to sell us certain patents and patent applications in consideration for equity securities. Schramm represented that he owned all rights, title, and interest in and to the intellectual property. We were subsequently advised by our patent counsel that, while the patents are registered with the US Patent and Trademark Office in the Company's name, the Company may not have a full interest in the patents. An unrelated third-party law firm placed a lien on the patents due to non-payment of legal fees by a third-party entity to whom certain assets were sold by another third-party entity that originally owned the patents.  The Company raised these concerns with Schramm, who did not provide satisfactory evidence confirming that the Company had sole title to the patents.  We sued Schramm for breach of contract, conversion and on other legal theories and are seeking, among other things, rescission of the purchase and sale transaction. While there is some question as to whether the Company has full title to these patents, we believe that we have at least partial ownership and can develop products based on the said patents. Schramm filed a counterclaim against us and Bradley C. Robinson, our Chief Executive Officer and Transfer Online, Inc., our transfer agent. Schramm is alleging he did not make any false representations. He is alleging, among other things, that various parties involved in the transaction committed breach of contract, conversion, violations of Nevada state law for failure to transfer securities, breach of fiduciary duty, tortious interference, and civil conspiracy.  Based on the information available to us, we do not believe the Schramm proceedings will have a material adverse effect on our business, results of operations, financial position, or liquidity. Further, we deny the allegations in the counterclaim, have not discovered any evidence of wrongdoing with respect to the allegations in the counterclaim and will vigorously prosecute our claims against Schramm.

 

On or about March 18, 2020, Predictive Biotech, Inc. filed a lawsuit in the Utah District Court against Auxocell Laboratories, Inc ("Auxocell") for breach of contract, product liability, breach of warranty, negligent misrepresentation and other claims relating to defects in laboratory equipment Auxocell sold to Predictive Biotech. Alleged damages include wasted umbilical cord tissue, lost inventory, costs associated with particulate testing, reputational injury, and related claims. On or about August 24, 2020, Auxocell answered the Complaint by denying the claims and asserting counterclaims of its own for breach of a confidentiality clause and failure to pay for devices. The Company answered and denied the counterclaims on December 14, 2020. Initial discovery has commenced and the current schedule has a discovery cut-off date of April 1, 2021. The litigation is still in discovery and as such we provide no opinion or assessment of the likely outcome of the litigation.

 

On or about November 11, 2020, Mackey Investment, LLLP ("Mackey") filed a lawsuit in Utah District Court against Predictive Technology Group, Inc and several officers of the Company.  Mackey subscribed for and purchased 500,000 shares of Predictive common stock for $480,000 on or about January 29, 2020. Mackey was given all of the Company's SEC filings as part of his due diligence. Mackey is alleging that Predictive failed to disclose material information in connection with its investment and is alleging breach of contract, fraudulent inducement, violation of the Utah Uniform Securities Act, and conspiracy. The suit also seeks civil penalties and treble and punitive damages. The Company filed an Answer denying the claims in the Complaint on or about December 4, 2020. Discovery has commenced, but we have not received discovery responses. We deny the allegations in the complaint and will vigorously defend against these allegations.

 

On or about April 30, 2020, Equitas Bio/Pharma Solutions, LLC ("Equitas") filed a lawsuit against Predictive Technology Group in New York District Court alleging nonpayment of "at least $551,080" in amounts owing under Master Service Agreement and Project Work Orders as of the date of filing. The claims are for breach of contract, breach of covenant of good faith and fair dealing and fraud. The basis of the fraud claim alleges that Predictive "made specific statements to Equitas that it was able to and intend to perform its obligations under the agreements" and at "the time Predictive made these promises it had no intention of keeping them." We agree that amounts are owed under the agreements, but we deny all allegations in the complaint relating to breach of covenant of good faith and fraud. Amounts due as of December 31, 2020 are included in accounts payable in the condensed consolidated balance sheets.

 

-35-

In June 2020, Wellgistics, LLC, the distributor of the Company's Assurance AB product, requested that the partial deposit paid on their non-cancellable purchase order of $5 million be returned. As the purchase order is contractually non-cancellable and the Company performed on the order in good faith by transmitting the deposit to the Company's supplier, the request to return the deposit was not honored. To date there has been no legal action taken by either party.

 

As of December 31, 2020, we did not record a liability related to these matters (other than amounts recorded in accounts payable as described above) as it was determined that an unfavorable resolution is either not currently probable or that an amount or relevant range is not reasonably estimable, or both. However, litigation is inherently unpredictable and it is possible that losses may occur. Any unfavorable resolution of any of these matters could materially affect our condensed consolidated financial position, cash flows, or results of operations. All legal costs associated with litigation are expensed as incurred.

 

Item 1A. Risk Factors

 

There have been no material changes to the risk factors included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2020. 

 

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

 

None.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

None.

Item 5. Other Information

 

None.

 

Item 6. EXHIBITS

 

Exhibit No.	Identification of Exhibit
31.1	Section 302 Certification of Chief Executive Officer (filed herewith)
31.2	Section 302 Certification of Principal Financial Officer (filed herewith)
32.1	Section 906 Certification of Chief Executive Officer (filed herewith)
32.2	Section 906 Certification of Principal Financial Officer (filed herewith)
101	XBRL Interactive Data Tags

 

-36-

SIGNATURES

 

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

 

	Predictive Technology Group, Inc., (Registrant)
	By:	/s/ Bradley C. Robinson
February 16, 2021		Bradley C. Robinson Chief Executive Officer and Director (Principal Executive Officer)
	By:	/s/ Simon Brewer
February 16, 2021		Simon Brewer Chief Accounting Officer (Principal Accounting and Principal Financial Officer)

 

-37-

EXHIBIT 31.1

CERTIFICATION

I, Bradley C. Robinson, certify that:

1.		I have reviewed this quarterly report of Predictive Technology Group, Inc. ("the registrant") on Form 10-Q;
2.		Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.		Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.		The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
	a)		Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
	b)		Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
	c)		Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
	d)		Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting.
5.		The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
	a)		All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
	b)		Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

	By:	/s/ Bradley C. Robinson
February 16, 2021		Bradley C. Robinson Chief Executive Officer (Principal Executive Officer)

 

-38-

EXHIBIT 31.2

CERTIFICATION

I, Simon Brewer, certify that:

 

1.		I have reviewed this quarterly report of Predictive Technology Group, Inc. ("the registrant") on Form 10-Q;
2.		Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.		Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.		The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
	a)		Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
	b)		Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
	c)		Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
	d)		Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting.
5.		The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
	a)		All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
	b)		Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

	By:	/s/ Simon Brewer
February 16, 2021		Simon Brewer Chief Accounting Officer (Principal Accounting and Principal Financial Officer)

 

-39-

EXHIBIT 32.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

 

Pursuant to 18 U.S.C. Section 1350,

As adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

I, Bradley C. Robinson, certify, to my best knowledge and belief, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report of Predictive Technology Group, Inc., on Form 10-Q for the quarter ended December 31, 2020 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in such Quarterly Report on Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of Predictive Technology Group, Inc.

 

	By:	/s/ Bradley C. Robinson
February 16, 2021		Bradley C. Robinson Chief Executive Officer (Principal Executive Officer)

 

 

-40-

CERTIFICATION OF CHIEF FINANCIAL OFFICER

 

Pursuant to 18 U.S.C. Section 1350,

As adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

I, Simon Brewer, certify, to my best knowledge and belief, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report of Predictive Technology Group, Inc. on Form 10-Q for the quarter ended December 31, 2020, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that information contained in such Quarterly Report on Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of Predictive Technology Group, Inc.

 

	By:	/s/ Simon Brewer
February 16, 2021		Simon Brewer Chief Accounting Officer (Principal Accounting and Principal Financial Officer)

-41-