1 unchanged sentence
BALANCE SHEETS
−Removed: SEPTEMBER 30, 2020 (UNAUDITED) AND DECEMBER 31, 2019
−Removed: SEPTEMBER 30,
+Added: 31, 2021 (UNAUDITED) AND DECEMBER 31, 2020
Current Assets
−Removed: Prepaid expenses
−Removed: Total Current Assets
−Removed: LIABILITIES AND STOCKHOLDERS’
+Added: AND STOCKHOLDERS’
+Added: EQUITY (DEFICIT)
+Added: payable and accrued expenses
+Added: party accounts payable
+Added: interest payable
+Added: liabilities payable
+Added: notes payable, related party, net
+Added: notes payable, net
+Added: notes payable, net of discount
+Added: party promissory note
Current Liabilities
−Removed: Accounts payable and accrued expenses
−Removed: Related party accounts payable
−Removed: Accrued interest payable
−Removed: Payroll liabilities payable
−Removed: Convertible notes payable, related party, net
−Removed: Convertible notes payable, net
−Removed: Promissory notes payable, net of discount
−Removed: Related party promissory note
−Removed: Total Current Liabilities
−Removed: Total Liabilities
−Removed: Commitments and contingencies
+Added: and contingencies
STOCKHOLDERS’
−Removed: Preferred stock, par value, $0.001, 20,000,000 shares authorized, Series A
−Removed: Convertible Preferred, 5,000,000 shares authorized, 2,552,642 shares issued and outstanding, respectively
−Removed: Additional paid in capital - Series A Convertible preferred stock
−Removed: Series B Convertible Preferred, 5,000,000 shares authorized, 1,013,245 and
−Removed: 1,113,245 shares issued and outstanding, respectively
−Removed: Additional paid in capital - Series B Convertible preferred stock
−Removed: Series C Convertible Preferred, 5,000,000 shares authorized, 385,302 and
−Removed: 821,292 shares issued and outstanding, respectively
−Removed: Additional paid in capital - Series C Convertible preferred stock
−Removed: Common stock, par value, $0.001, 950,000,000 shares authorized, 234,700,228
−Removed: and 184,845,821 issued and outstanding, respectively
−Removed: Additional paid in capital - common stock
−Removed: Shares to be issued
−Removed: Accumulated deficit
+Added: EQUITY (DEFICIT)
+Added: stock, par value, $0.001, 20,000,000 shares authorized, Series A Convertible Preferred, 5,000,000 shares authorized, 2,171,006
+Added: and 2,171,006 shares issued and outstanding, respectively
+Added: paid in capital - Series A Convertible preferred stock
+Added: B Convertible Preferred, 5,000,000 shares authorized, 436,653 and 436,653 shares issued and outstanding, respectively
+Added: paid in capital - Series B Convertible preferred stock
+Added: C Convertible Preferred, 5,000,000 shares authorized, 385,302 and 385,302 shares issued and outstanding, respectively
+Added: paid in capital - Series C Convertible preferred stock
+Added: stock, par value, $0.001, 950,000,000 shares authorized, 320,292,714 and 292,278,591 issued and outstanding, respectively
+Added: paid in capital - common stock
(74,846,290 )
(74,558,101 )
−Removed: Total Stockholders’
−Removed: TOTAL LIABILITIES AND STOCKHOLDERS’
+Added: Stockholders’
+Added: Equity (Deficit)
+Added: LIABILITIES AND STOCKHOLDERS’
+Added: EQUITY (DEFICIT)
accompanying notes are an integral part of these financial statements.
−Removed: CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)
−Removed: FOR THE NINE AND THREE MONTHS ENDED SEPTEMBER 30, 2020 AND 2019
−Removed: NINE MONTHS ENDED
−Removed: THREE MONTHS ENDED
−Removed: SEPTEMBER 30,
−Removed: SEPTEMBER 30,
−Removed: SEPTEMBER 30,
−Removed: SEPTEMBER 30,
−Removed: Consulting revenues, net
+Added: STATEMENTS OF OPERATIONS (UNAUDITED)
+Added: THE THREE MONTHS ENDED MARCH 31, 2021 AND 2020
+Added: Revenues, net
+Added: Cost of Goods Sold
OPERATING EXPENSES
8 unchanged sentences
Interest expense
+Added: Forgiveness of debt
+Added: Loss on debt extinguishment
Total Non-Operating Income (Expenses)
1 unchanged sentence
Provision for income taxes
−Removed: $ (1,106,059 )
Net loss per share - basic and diluted
1 unchanged sentence
accompanying notes are an integral part of these financial statements.
−Removed: OF CHANGES IN STOCKHOLDERS' DEFICIT
−Removed: THE NINE MONTHS ENDED SEPTEMBER 30, 2020 (UNAUDITED) AND DECEMBER 31, 2019
−Removed: - December 31, 2018
−Removed: $ (71,991,012 )
−Removed: of preferred stock into common stock
−Removed: of Series B Preferred into Series C Preferred
−Removed: issued with notes payable (discount)
−Removed: and warrants issued for services
−Removed: loss for the period
−Removed: - March 31, 2019
−Removed: (72,227,394 )
−Removed: of preferred stock into common stock
−Removed: for fractional shares in reverse split
−Removed: issued with notes payable (discount)
−Removed: and warrants issued for services
−Removed: loss for the period
−Removed: - June 30, 2019
+Added: STATEMENT OF CHANGES IN STOCKHOLDERS’
+Added: EQUITY (DEFICIT) (UNAUDITED)
+Added: THE THREE MONTHS ENDED MARCH 31, 2021 AND 2020
+Added: (Subscription
+Added: Capital - Series A
+Added: Capital - Series B
+Added: Capital - Series C
+Added: Paid-In Capital -
+Added: Receivable) / Shares to be
+Added: Balance - December 31, 2019
$ (73,601,109 )
−Removed: issued with notes payable (discount)
−Removed: issued for extension of notes payable
−Removed: issued for settlement of accounts payable
−Removed: and warrants issued for services
−Removed: recognized on convertible notes
−Removed: loss for the period
−Removed: - September 30, 2019
$ (1,479,689 )
−Removed: of preferred stock into common stock
−Removed: of restricted stock units into common stock
−Removed: issued with notes payable (discount)
−Removed: issued in settlement of litgation
−Removed: issued for settlement of payables
−Removed: and warrants issued for services
−Removed: loss for the period
−Removed: - December 31, 2019
+Added: Stock issued for:
+Added: Note conversions
+Added: Redemption of preferred stock in convertible note agreement
+Added: Conversion of preferred stock into common stock
+Added: Warrants issued with notes payable (discount)
+Added: Options and warrants issued for services
+Added: Share adjustment
+Added: Net loss for the period
+Added: Balance - March 31, 2020
$ (73,961,340 )
−Removed: of preferred stock in convertible note agreement
−Removed: of preferred stock into common stock
−Removed: issued with notes payable (discount)
−Removed: and warrants issued for services
−Removed: loss for the period
−Removed: - March 31, 2020
$ (1,250,572 )
−Removed: conversions/settlements
−Removed: purchased for cash
−Removed: and warrants issued for services
−Removed: loss for the period
−Removed: - June 30, 2020
+Added: Balance - December 31, 2020
$ (74,558,101 )
−Removed: conversions/settlements
−Removed: loss for the period
−Removed: - September 30, 2020
+Added: Stock issued for:
+Added: Note conversions/settlements
+Added: Accounts payable
+Added: Warrant exercises
+Added: Warrants purchased for cash
+Added: Net loss for the year
+Added: Balance - March 31, 2021
$ (74,269,912 )
accompanying notes are an integral part of these financial statements.
−Removed: OF CASH FLOWS
−Removed: THE NINE MONTHS ENDED SEPTEMBER 30, 2020 AND 2019 (UNAUDITED)
+Added: STATEMENTS OF CASH FLOWS (UNAUDITED)
+Added: THE THREE MONTHS ENDED MARCH 31, 2021 AND 2020
CASH FLOW FROM OPERTING ACTIVIITES
−Removed: $ (1,106,059 )
Adjustments to reconcile net loss to net cash used in operating activities
1 unchanged sentence
Amortization of BCF discount
−Removed: Common stock issued for services
−Removed: Stock options and warrants for services
+Added: Loss on conversion of debt
Forgiveness of debt
9 unchanged sentences
Net cash used in operating activities
−Removed: CASH FLOWS FROM FINANCING ACTIVITES
−Removed: Proceeds from related party notes payable
+Added: CASH FLOWS FROM FINANCING ACTIVITIES
Redemption of preferred stock
−Removed: Proceeds from sale of preferred stock
−Removed: Proceeds from sale of common stock
Proceeds from sale of common stock and warrants
Proceeds from convertible debt
−Removed: Proceeds from promnissory notes
−Removed: Payment of notes payable
+Added: Proceeds from promissory notes - related party, net of repayments
Net cash provided by financing activities
6 unchanged sentences
Conversion of preferred stock into common stock
−Removed: Conversion of convertible preferred B into convertible preferred C
Recognition of debt discount at inception of notes payable
Conversion of notes payable and accrued interest into common stock
−Removed: Recognition of BCF discount at inception of notes payable
−Removed: Common stock issued in settlement of accounts payable
−Removed: Stock options issued in settlement of accounts payable
−Removed: Reclassification of notes payable and accrued interest into common stock
+Added: Common stock issued in cashless exercise of warrants
accompanying notes are an integral part of these financial statements.
8 unchanged sentences
the results of operations of the Company for the period presented.
−Removed: The results of operations for the six months ended June 30,
+Added: The results of operations for the three months ended March
31, 2021, are not necessarily indicative of the results that may be expected for any future period or the fiscal year ending December
31, 2021 and should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31,
−Removed: 2019, filed with the Securities and Exchange Commission on April 28, 2020.
−Removed: June 28, 2019, FINRA approved the Company’s reverse 1 for 8 stock-split.
−Removed: The reverse stock split will enable the Company
−Removed: to issue additional shares now that there is availability to do so.
−Removed: All share and per-share figures herein have been restated
−Removed: to take effect for this reverse stock-split.
−Removed: April of 2017, the Company filed a Certificate of Merger with the Delaware Division of Corporations in order to merge the Company’s
−Removed: wholly-owned subsidiary, IsoPet Solutions Corporation, with and into the Company.
−Removed: The Company therefore no longer prepares Consolidated
−Removed: Financial Statements.
+Added: 2020, filed with the Securities and Exchange Commission on March 24, 2021.
+Added: Company was incorporated under the laws of Delaware on December 23, 1994 as Savage Mountain Sports Corporation (“
+Added: SMSC ”).
+Added: On September 6, 2006, the Company changed its name to Advanced Medical Isotope Corporation, and on December 28, 2017, the Company
+Added: began operating as Vivos Inc.
+Added: The Company has authorized capital of 950,000,000 shares of common stock, $0.001 par value per share,
+Added: and 20,000,000 shares of preferred stock, $0.001 par value per share.
+Added: principal place of business is located at 719 Jadwin Avenue, Richland, WA 99352.
+Added: Our telephone number is (509) 736-4000.
+Added: Our corporate
+Added: website address is http://www.radiogel.com.
+Added: Our common stock is currently quoted on the OTC Pink Marketplace under the symbol
+Added: “RDGL.”
Company is a radiation oncology medical device company engaged in the development of its yttrium-90 based brachytherapy device,
−Removed: RadioGel™
−Removed: for the treatment of non-resectable tumors.
+Added: RadioGel™, for the treatment of non-resectable tumors.
A prominent team of radiochemists, scientists and engineers, collaborating
2 unchanged sentences
with new isotope technologies that offer safe and effective treatments for cancer.
−Removed: Company’s current focus is on the development of its RadioGel™
−Removed: RadioGel™
−Removed: is an injectable particle-gel,
−Removed: for brachytherapy radiation treatment of cancerous tumors in people and animals.
−Removed: RadioGel™
−Removed: is comprised of a hydrogel, or
−Removed: a substance that is liquid at room temperature and then gels when reaching body temperature after injection into a tumor.
−Removed: gel are small, one micron, yttrium-90 phosphate particles (“
−Removed: Y-90 ”).
−Removed: Once injected, these inert particles are
−Removed: locked in place inside the tumor by the gel, delivering a very high local radiation dose.
−Removed: The radiation is beta, consisting of
−Removed: high-speed electrons.
−Removed: These electrons only travel a short distance so the device can deliver high radiation to the tumor with
−Removed: minimal dose to the surrounding tissue.
−Removed: Optimally, patients can go home immediately following treatment without the risk of radiation
−Removed: exposure to family members.
−Removed: Since Y-90 has a half-life of 2.7 days, the radioactively drops to 5% of its original value after
−Removed: Company’s lead brachytherapy products, including RadioGel™, incorporate patented technology developed for Battelle
−Removed: Memorial Institute (“
−Removed: Battelle ”) at Pacific Northwest National Laboratory, a leading research institute for
−Removed: government and commercial customers.
−Removed: Battelle has granted the Company an exclusive license to patents covering the manufacturing,
−Removed: processing and applications of RadioGel™
−Removed: Battelle License ”).
−Removed: Other intellectual property protection
−Removed: includes proprietary production processes and trademark protection in 17 countries.
−Removed: The Company plans to continue efforts to develop
−Removed: new refinements on the production process, and the product and application hardware, as a basis for future patents.
−Removed: Company is currently focusing on obtaining approval from the Food and Drug Administration ( “FDA”
−Removed: and sell RadioGel™
−Removed: as a Class II medical device.
−Removed: The Company first requested FDA approval of RadioGel™
−Removed: in June 2013,
−Removed: at which time the FDA classified RadioGel™
−Removed: as a medical device.
−Removed: The Company then followed with a 510(k) submission which
−Removed: the FDA responded, in turn, with a request for a physician letter of substantial equivalence and a reformatted 510(k) summary,
−Removed: which the Company provided in January 2014.
−Removed: February 2014, the FDA ruled the device as not substantially equivalent due to a lack of a predicate device and it was therefore
−Removed: classified as a Class III device.
−Removed: Class III devices are generally the highest risk devices and are therefore subject to the highest
−Removed: level of regulatory review, control and oversight.
−Removed: Class III devices must typically be approved by the FDA before they are marketed.
−Removed: Class II devices represent lower risk devices than Class III and require fewer regulatory controls to provide reasonable assurance
−Removed: of the device’s safety and effectiveness.
−Removed: In contrast, Class I devices are deemed to be lower risk than Class II or III
−Removed: and are therefore subject to the least regulatory controls.
−Removed: Company is currently developing test plans to address issues raised by the FDA in connection with the Company’s previous
−Removed: submissions regarding RadioGel™, including developing specific test plans and specific indication of use.
−Removed: The Company intends
−Removed: to request that the FDA grant approval to re-apply for de novo classification of RadioGel™, which would reclassify
−Removed: the device from a Class III device to a Class II device, further simplifying the path to FDA approval.
−Removed: In the event the FDA denies
−Removed: the Company’s application and subsequently determines during the de novo review that RadioGel™
−Removed: cannot be classified
−Removed: as a Class I or Class I1 device, the Company will then need to submit a pre-market approval application to obtain the necessary
−Removed: regulatory approval as a Class III device.
−Removed: See also Business –
−Removed: Regulatory History in Part I of the Annual Report
−Removed: on Form 10-K (“
−Removed: Annual Report ”) filed April 28, 2020 for a discussion regarding the Company’s application
−Removed: for FDA approval of RadioGel™.
+Added: January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel TM should be classified
+Added: as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas.
+Added: Additionally, after a legal review, the Company
+Added: believes that the device classification obtained from the Food and Drug Administration (“
+Added: FDA ”) Center for Veterinary
+Added: Medicine is not limited to canine and feline sarcomas, but rather may be extended to a much broader population of veterinary cancers,
+Added: including all or most solid tumors in animals.
+Added: We expect the result of such classification and label review will be that no additional
+Added: regulatory approvals are necessary for the use of IsoPet ®
+Added: for the treatment of solid tumors in animals.
+Added: does not have premarket authority over devices with a veterinary classification, and the manufacturers are responsible for assuring
+Added: that the product is safe, effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.
+Added: on the FDA’s recommendation, RadioGel TM will be marketed as “IsoPet ®
+Added: for use by veterinarians
+Added: to avoid any confusion between animal and human therapy.
+Added: The Company already has trademark protection for the “IsoPet ®
+Added: and RadioGel TM are used synonymously throughout this document.
+Added: The only distinction between
+Added: and RadioGel TM is the FDA’s recommendation that we use “IsoPet®”
+Added: for veterinarian
+Added: usage, and reserve “RadioGel TM”
+Added: for human therapy.
+Added: Based on these developments, the Company has shifted
+Added: its primary focus to the development and marketing of Isopet®
+Added: for animal therapy, through the Company’s IsoPet®
+Added: Solutions division.
Company’s IsoPet Solutions division was established in May 2016 to focus on the veterinary oncology market, namely engagement
15 unchanged sentences
The criteria were published by an international collaboration including the European Organisation for Research
−Removed: and Treatment of Cancer (EORTC), National Cancer Institute of the United States, and the National Cancer Institute of Canada Clinical
−Removed: Trials Group.
+Added: and Treatment of Cancer (“EORTC”), National Cancer Institute of the United States, and the National Cancer Institute
+Added: of Canada Clinical Trials Group.
testing at the University of Missouri met its objective to demonstrate the safety of IsoPet®.
22 unchanged sentences
in July 2019, the Company recognized its first commercial sale of IsoPet®.
−Removed: brought his cat with a re-occurrent spindle cell sarcoma tumor on his face.
−Removed: The cat had previously received external beam therapy,
−Removed: but now the tumor was growing rapidly.
+Added: A veterinarian from Alaska brought his cat with
+Added: a re-occurrent spindle cell sarcoma tumor on his face.
+Added: The cat had previously received external beam therapy, but now the tumor
+Added: was growing rapidly.
He was given a high dose of 400Gy with heavy therapy at the margins.
−Removed: This sale met the
−Removed: revenue recognition requirements under ASC 606 as the performance obligation was satisfied.
−Removed: The Company completed sales for an
−Removed: additional four animals that received the IsoPet®
+Added: This sale met the revenue recognition
+Added: requirements under ASC 606 as the performance obligation was satisfied.
+Added: The Company completed sales for an additional four animals
+Added: that received the IsoPet®
plan is to incorporate the data assembled from our work with Isopet®
10 unchanged sentences
and then gels when reaching body temperature after injection into a tumor.
−Removed: In the gel are small, one micron, yttrium-90 phosphate
−Removed: particles (“
+Added: In the gel are small, less than two microns, yttrium-90
+Added: phosphate particles (“
Y-90 ”).
−Removed: Once injected, these inert particles are locked in place inside the tumor by the gel, delivering
−Removed: a very high local radiation dose.
+Added: Once injected, these inert particles are locked in place inside the tumor by
+Added: the gel, delivering a very high local radiation dose.
The radiation is beta, consisting of high-speed electrons.
−Removed: These electrons only travel a short
−Removed: distance so the device can deliver high radiation to the tumor with minimal dose to the surrounding tissue.
−Removed: Optimally, patients
−Removed: can go home immediately following treatment without the risk of radiation exposure to family members.
−Removed: Since Y-90 has a half-life
−Removed: of 2.7 days, the radioactivity drops to 5% of its original value after ten days.
+Added: These electrons
+Added: only travel a short distance so the device can deliver high radiation to the tumor with minimal dose to the surrounding tissue.
+Added: Optimally, patients can go home immediately following treatment without the risk of radiation exposure to family members.
+Added: Y-90 has a half-life of 2.7 days, the radioactivity drops to 5% of its original value after ten days.
+Added: the Company modified its Indication for Use from skin cancel to cancerous tissue or solid tumors pathologically associated with
+Added: locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic
+Added: lymph nodes or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require
+Added: post-surgical remnant ablation (for example, after prior incomplete radioiodine therapy).
+Added: Papillary thyroid carcinoma belongs
+Added: to the general class of head and neck tumors for which tumors are accessible by intraoperative direct needle injection.
+Added: The Company’s
+Added: Medical Advisory Board felt that demonstrating efficacy in clinical trials was much easier with this new indication.
Company’s lead brachytherapy products, including RadioGel™, incorporate patented technology developed for Battelle
6 unchanged sentences
This exclusive license is to terminate
−Removed: upon the expiration of the last patent included in this agreement (January 2022).
+Added: upon the expiration of the last patent included in this agreement (March 2022).
Other intellectual property protection includes
2 unchanged sentences
refinements on the production process, and the product and application hardware, as a basis for future patents.
+Added: Company received the Patent Cooperation Treaty (“PCT”) International Search Report on our patent application (No.1811.191).
+Added: Seven of our claims were immediately ruled as having novelty, inventive step and industrial applicability.
+Added: This gives us the basis
+Added: to extend for many years the patent protection for our proprietary Yttrium-90 phosphate particles utilized in Isopet®
+Added: Radiogel™.
+Added: As part of the normal review process, we have also submitted the technical justification for seven additional
+Added: We are in the process of filing patent claims in Canada, UK (Great Britain, Scotland, Wales and Ireland), Japan, Germany,
+Added: Italy, France, Australia, Brazil, China, India, North Countries (Sweden, Norway, Finland, and Denmark).
+Added: accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and
+Added: satisfaction of liabilities in the normal course of business.
+Added: As shown in the accompanying financial statements, the Company has
+Added: suffered recurring losses and used significant cash in support of its operating activities and the Company’s cash position
+Added: is not sufficient to support the Company’s operations.
+Added: Research and development of the Company’s brachytherapy product
+Added: line has been funded with proceeds from the sale of equity and debt securities as well as a series of grants.
+Added: The Company requires
+Added: funding of approximately $2 million annually to maintain current operating activities.
+Added: Company completed its reverse stock split which was approved by FINRA and went effective on June 28, 2019.
+Added: Company’s stock offering under Regulation A+ was qualified by the Securities and Exchange Commission (“SEC”)
+Added: on June 3, 2020.
+Added: Company over the past twelve months has raised approximately $4,000,000 from the sale of shares under Regulation A+, and intends
+Added: to use the proceeds generated as follows:
+Added: the animal therapy market:
+Added: the effort to communicate the benefits of IsoPet ®
+Added: to the veterinary community and the pet parents.
+Added: additional clinical studies to generate more data for the veterinary community
+Added: some IsoPet ®
+Added: therapies, if necessary, to ensure that all viable candidates are treated.
+Added: a new regional clinic with their license and certification training.
+Added: the human market:
+Added: the pedigree of the Quality Management System.
+Added: the previously defined pre-clinical testing and additional testing on an animal model closely aligned with our revised indication
+Added: Report the results to the FDA in a pre-submission meeting.
+Added: the feedback from that meeting to write the IDE (Investigational Device Exemption), which is required to initiate clinical
+Added: and development of the Company’s brachytherapy product line has been funded with proceeds from the sale of equity and debt
+Added: The Company may require additional funding of approximately $2 million annually to maintain current operating activities.
+Added: Over the next 12 to 24 months, the Company believes it will cost approximately $9 million to:
+Added: (1) fund the FDA approval process
+Added: to conduct human clinical trials, (2) conduct Phase I, pilot, clinical trials, (3) activate several regional clinics to administer
+Added: across the county, (4) create an independent production center within the current production site to create
+Added: a template for future international manufacturing, and (5) initiate regulatory approval processes outside of the United States.
+Added: continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional resources
+Added: and personnel.
+Added: The principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24
+Added: months will be the FDA’s classification of the Company’s brachytherapy products as Class II or Class III devices (or
+Added: otherwise) and any requirements for additional studies which may possibly include clinical studies.
+Added: Thereafter, the principal
+Added: variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals and
+Added: the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of those
+Added: products and the products’
+Added: success in the U.S.
+Added: and elsewhere.
+Added: The Company intends to fund its activities through strategic
+Added: transactions such as licensing and partnership agreements or additional capital raises.
+Added: receipt of required regulatory approvals and financing, in the U.S., the Company intends to outsource material aspects of manufacturing,
+Added: distribution, sales and marketing.
+Added: Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships
+Added: to facilitate its global commercialization strategy.
+Added: the longer-term, subject to the Company receiving adequate funding, regulatory approval for RadioGel™
+Added: and other brachytherapy
+Added: products, and thereafter being able to successfully commercialize its brachytherapy products, the Company intends to consider
+Added: resuming research efforts with respect to other products and technologies intended to help improve the diagnosis and treatment
+Added: of cancer and other illnesses.
+Added: on the Company’s financial history since inception, the Company’s independent registered public accounting firm has
+Added: expressed substantial doubt as to the Company’s ability to continue as a going concern.
+Added: The Company has limited revenue,
+Added: nominal cash, and has accumulated deficits since inception.
+Added: If the Company cannot obtain sufficient additional capital, the Company
+Added: will be required to delay the implementation of its business strategy and may not be able to continue operations.
+Added: Company has been impacted from the effects of COVID-19.
+Added: The Company’s headquarters are in Northeast Washington however there
+Added: focus of the animal therapy market has been the Northwestern sector of the United States, the initial epicenter of the COVID-19
+Added: outbreak in the United States.
+Added: The Company is hopeful that by the end of the third quarter of 2021, they will be allowed to continue
+Added: their marketing to the animal therapy market and attempt to increase the exposure to their product and generate revenue accordingly.
+Added: of March 31, 2021, the Company has $2,511,845 cash on hand.
+Added: There are currently commitments to vendors for products and services
+Added: To continue the development of the Company’s products, the current level of cash may not be enough to cover the
+Added: fixed and variable obligations of the Company.
+Added: is no guarantee that the Company will be able to raise additional funds or to do so at an advantageous price.
+Added: financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might
+Added: be necessary should the Company be unable to continue as a going concern.
+Added: The Company’s continuation as a going concern
+Added: is dependent upon its ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain
+Added: profitability.
+Added: The Company plans to seek additional funding to maintain its operations through debt and equity financing and to
+Added: improve operating performance through a focus on strategic products and increased efficiencies in business processes and improvements
+Added: to the cost structure.
+Added: There is no assurance that the Company will be successful in its efforts to raise additional working capital
+Added: or achieve profitable operations.
+Added: The financial statements do not include any adjustments that might result from the outcome of
+Added: this uncertainty.
preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates
8 unchanged sentences
maturity of three months or less to be cash equivalents.
−Removed: is reported at the lower of cost or market, determined using the first-in, first-out basis, or net realizable value.
−Removed: All inventories
−Removed: consisted of finished goods.
−Removed: The Company has no inventory for the nine-months ended September 30, 2020 and for the year ended
−Removed: December 31, 2019.
+Added: Company occasionally maintains cash balances in excess of the FDIC insured limit.
+Added: The Company does not consider this risk to be
Value of Financial Instruments
1 unchanged sentence
where it is practicable to estimate that value.
−Removed: As of September 30, 2020 and December 31, 2019, the balances reported for cash,
−Removed: prepaid expenses, accounts receivable, accounts payable, and accrued expenses, approximate the fair value because of their short
+Added: As of March 31, 2021 and December 31, 2020, the balances reported for cash, prepaid
+Added: expenses, accounts receivable, accounts payable, and accrued expenses, approximate the fair value because of their short maturities.
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction
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gains or losses recognized in earnings.
−Removed: Embedded derivatives that are not clearly and closely related to the host contract are
−Removed: bifurcated and are recognized at fair value with changes in fair value recognized as either a gain or loss in earnings.
+Added: derivatives that are not clearly and closely related to the host contract are bifurcated and are recognized at fair value with
+Added: changes in fair value recognized as either a gain or loss in earnings.
result of this accounting treatment is that the fair value of the derivative instrument is marked-to-market each balance sheet
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(1%) to two percent (2%), then on October 8, 2019 to reduce the fee back to one percent (1%).
−Removed: minimum royalties for the years ended December 31 are noted below:
+Added: minimum royalties for the years ending December 31 are noted below:
Royalties per
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future operating cash flows to be derived from such assets are less than their carrying value.
−Removed: 2020 fee was paid in January 2020.
+Added: 2021 fee was paid in December 2020.
and Intellectual Property
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operating results and projected and expected undiscounted future cash flows.
−Removed: have been no such capitalized costs in the nine-months ended June 30, 2020 and 2019, respectively.
−Removed: However, a patent was filed
−Removed: on July 1, 2019 (No.
−Removed: 1811.191) filed by Michael Korenko and David Swanberg and assigned to the Company based on the Company’s
−Removed: proprietary particle manufacturing process.
−Removed: The timing of this filing was important given the Company’s plans to make IsoPet®
+Added: have been no such capitalized costs in the three months ended March 31, 2021 or years ended December 31, 2020 and 2019, respectively.
+Added: However, a patent was filed on July 1, 2019 (No.
+Added: 1811.191) filed by Michael Korenko and David Swanberg and assigned to the Company
+Added: based on the Company’s proprietary particle manufacturing process.
+Added: The timing of this filing was important given the Company’s
+Added: plans to make IsoPet®
commercially available, which it did on or about July 9, 2019.
−Removed: This additional patent protection will strengthen the Company’s
−Removed: competitive position.
−Removed: It is the Company’s intention to further extend this patent protection to several key countries within
−Removed: one year, as permitted under international patent laws and treaties.
+Added: This additional patent protection will
+Added: strengthen the Company’s competitive position.
+Added: It is the Company’s intention to further extend this patent protection
+Added: to several key countries within one year, as permitted under international patent laws and treaties.
May 2014, the Financial Accounting Standards Board (“F ASB ”) issued Accounting Standard Update (“
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performance obligation.
−Removed: revenue generated during the nine months ended September 30, 2020 and year ended December 31, 2019 related to sales of product.
Company accounts for its loss per common share by replacing primary and fully diluted earnings per share with basic and diluted
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For the given periods of loss,
−Removed: of the periods ended in the nine months ended September 30, 2020 and 2019, the basic earnings per share equals the diluted earnings
−Removed: following represent common stock equivalents that could be dilutive in the future as of September 30, 2020 and December 31, 2019,
+Added: of the periods ended in the three months ended March 31, 2021 and 2020, the basic earnings per share equals the diluted earnings
+Added: following represent common stock equivalents that could be dilutive in the future as of March 31, 2021 and December 31, 2020,
which include the following:
−Removed: September 30, 2020
+Added: March 31, 2021
December 31, 2020
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and development is classified as research and development expense in the year computed.
−Removed: Company incurred $31,809 and $62,194 research and development costs for the nine months ended September 30, 2020, and 2019, respectively,
−Removed: all of which were recorded in the Company’s operating expenses noted on the statements of operations for the nine months
+Added: Company incurred $71,700 and $1,028 research and development costs for the three months ended March 31, 2021 and 2020, respectively,
+Added: all of which were recorded in the Company’s operating expenses noted on the statements of operations for the periods then
and Marketing Costs
and marketing costs are expensed as incurred except for the cost of tradeshows which are deferred until the tradeshow occurs.
−Removed: During the nine months ended September 30, 2020 and 2019, the Company incurred $6,182 and $0, respectively, in advertising and
−Removed: marketing costs.
−Removed: and Handling Costs
−Removed: and handling costs are expensed as incurred and included in cost of materials.
+Added: During the three months ended March 31, 2021 and 2020, the Company incurred no advertising and marketing costs.
Contingencies
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The Company has entered into various agreements that require them to pay certain fees to consultants and/or employees
−Removed: that have been fully accrued for as of September 30, 2020 and December 31, 2019.
+Added: that have been fully accrued for as of March 31, 2021 and December 31, 2020.
address accounting for uncertainty in tax positions, the Company clarifies the accounting for income taxes by prescribing a minimum
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federal jurisdiction.
−Removed: The Company did not have any tax expense for the nine months
−Removed: ended September 30, 2020 and 2019.
−Removed: The Company did not have any deferred tax liability or asset on its balance sheet on September
+Added: The Company did not have any tax expense for the three months
+Added: ended March 31, 2021 and 2020.
+Added: The Company did not have any deferred tax liability or asset on its balance sheet on March 31,
2021 and December 31, 2020.
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respectively, in the Company’s financial statements.
−Removed: For the nine months ended September 30, 2020 and 2019, the Company
−Removed: did not recognize any interest or penalty expense related to income taxes.
+Added: For the three months ended March 31, 2021 and 2020, the Company did
+Added: not recognize any interest or penalty expense related to income taxes.
The Company believes that it is not reasonably possible
for the amounts of unrecognized tax benefits to significantly increase or decrease within the next twelve months.
−Removed: Company recognizes compensation costs to employees under FASB ASC Topic 718, Compensation –
−Removed: Stock Compensation.
−Removed: 718, companies are required to measure the compensation costs of share-based compensation arrangements based on the
−Removed: grant-date fair value and recognize the costs in the financial statements over the period during which employees are required
−Removed: to provide services.
−Removed: Share based compensation arrangements include stock options, restricted share plans, performance-based awards,
−Removed: share appreciation rights and employee share purchase plans.
−Removed: As such, compensation cost is measured on the date of grant at their
−Removed: Such compensation amounts, if any, are amortized over the respective vesting periods of the option grant.
+Added: Company recognizes compensation costs under FASB ASC Topic 718, Compensation –
+Added: Stock Compensation and ASU 2018-07.
+Added: are required to measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and
+Added: recognize the costs in the financial statements over the period during which employees are required to provide services.
+Added: based compensation arrangements include stock options, restricted share plans, performance-based awards, share appreciation rights
+Added: and employee share purchase plans.
+Added: As such, compensation cost is measured on the date of grant at their fair value.
+Added: Such compensation
+Added: amounts, if any, are amortized over the respective vesting periods of the option grant.
May 2017, the FASB issued ASU 2017-09, “Compensation - Stock Compensation.”
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condition, results of operations, cash flows or disclosures.
−Removed: GOING CONCERN
−Removed: accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and
−Removed: satisfaction of liabilities in the normal course of business.
−Removed: As shown in the accompanying financial statements, the Company has
−Removed: suffered recurring losses and used significant cash in support of its operating activities and the Company’s cash position
−Removed: is not sufficient to support the Company’s operations.
−Removed: Research and development of the Company’s brachytherapy product
−Removed: line has been funded with proceeds from the sale of equity and debt securities as well as a series of grants.
−Removed: The Company requires
−Removed: funding of approximately $1.5 to $2.0 million annually to maintain current operating activities.
−Removed: Company’s stock offering under Regulation A+ was qualified by the Securities and Exchange Commission (“SEC”)
−Removed: on June 3, 2020 and have issued the first tranche of shares under the Regulation A+ on June 10, 2020.
−Removed: The intent is to raise up
−Removed: to $4,050,000 over the next 12-18 months, which may be completed in separate closings.
−Removed: Company intends to use the proceeds generated from the sale of shares under Regulation A+ as follows:
−Removed: the animal therapy market:
−Removed: the effort to communicate the benefits of IsoPet ®
−Removed: to the veterinary community and the pet parents.
−Removed: additional clinical studies to generate more data for the veterinary community
−Removed: some IsoPet ®
−Removed: therapies, if necessary, to ensure that all viable candidates are treated.
−Removed: a new regional clinic with their license and certification training.
−Removed: the human market:
−Removed: the pedigree of the Quality Management System.
−Removed: the pre-clinical testing that has been previously defined and report the bulk of the results to the FDA in a pre-submission
−Removed: the feedback from that meeting to write the IDE (Investigational Device Exemption), which is required to initiate clinical
−Removed: Company received $497,880 which were deposited into the Company’s accounts between April and June 2020.
−Removed: Following the clearance
−Removed: of the Regulation A+ offering by the SEC on June 3, 2020, the common shares for these proceeds were issued.
−Removed: In addition, the Company
−Removed: exchanged their outstanding convertible notes payable of $525,000, $27,536 in accrued interest and $98,508 in an exchange premium
−Removed: stipulated in the note agreements into shares of common stock through September 30, 2020.
−Removed: the next 12 to 24 months, the Company believes it will cost approximately $5.0 million to $10.0 million to:
−Removed: (1) fund the FDA approval
−Removed: process and initial deployment of the brachytherapy products, and (2) initiate regulatory approval processes outside of the United
−Removed: The continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional
−Removed: resources and personnel.
−Removed: The principal variables in the timing and amount of spending for the brachytherapy products in the next
−Removed: 12 to 24 months will be the FDA’s classification of the Company’s brachytherapy products as Class II or Class III
−Removed: devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies.
−Removed: Thereafter, the
−Removed: principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals
−Removed: and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of
−Removed: those products and the products’
−Removed: success in the U.S.
−Removed: and elsewhere.
−Removed: The Company intends to fund its activities through strategic
−Removed: transactions such as licensing and partnership agreements or additional capital raises.
−Removed: receipt of required regulatory approvals and financing, in the U.S., the Company intends to outsource material aspects of manufacturing,
−Removed: distribution, sales and marketing.
−Removed: Outside of the U.S., the Company intends to pursue licensing arrangements and/or partnerships
−Removed: to facilitate its global commercialization strategy.
−Removed: the longer-term, subject to the Company receiving adequate funding, regulatory approval for RadioGel™
−Removed: and other brachytherapy
−Removed: products, and thereafter being able to successfully commercialize its brachytherapy products, the Company intends to consider
−Removed: resuming research efforts with respect to other products and technologies intended to help improve the diagnosis and treatment
−Removed: of cancer and other illnesses.
−Removed: on the Company’s financial history since inception, the Company’s independent registered public accounting firm has
−Removed: expressed substantial doubt as to the Company’s ability to continue as a going concern.
−Removed: The Company has limited revenue,
−Removed: nominal cash, and has accumulated deficits since inception.
−Removed: If the Company cannot obtain sufficient additional capital, the Company
−Removed: will be required to delay the implementation of its business strategy and may not be able to continue operations.
−Removed: Company has been impacted from the effects of COVID-19.
−Removed: The Company’s headquarters are in Northeast Washington however there
−Removed: focus of the animal therapy market has been the Northwestern sector of the United States, the initial epicenter of the COVID-19
−Removed: outbreak in the United States.
−Removed: In addition to a slow down in the marketing of the services, the volatility of the stock market
−Removed: has contributed to a lack of funds that ordinarily may have been available to the Company.
−Removed: The Company is hopeful that by the
−Removed: end of 2020 into the first quarter of 2021, they will be allowed to continue their marketing to the animal therapy market and
−Removed: attempt to increase the exposure to their product and generate revenue accordingly.
−Removed: financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might
−Removed: be necessary should the Company be unable to continue as a going concern.
−Removed: The Company’s continuation as a going concern
−Removed: is dependent upon its ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain
−Removed: profitability.
−Removed: The Company plans to seek additional funding to maintain its operations through debt and equity financing and to
−Removed: improve operating performance through a focus on strategic products and increased efficiencies in business processes and improvements
−Removed: to the cost structure.
−Removed: There is no assurance that the Company will be successful in its efforts to raise additional working capital
−Removed: or achieve profitable operations.
−Removed: The financial statements do not include any adjustments that might result from the outcome of
−Removed: this uncertainty.
−Removed: of September 30, 2020, the Company has $14,934 cash on hand.
−Removed: There are currently commitments to vendors for products and services
−Removed: purchased that will necessitate liquidation of the Company if it is unable to raise additional capital.
−Removed: The current level of cash
−Removed: is not enough to cover the fixed and variable obligations of the Company.
−Removed: The Company was able to execute the following transactions
−Removed: to improve their balance sheet and decrease the liabilities incurred and increase their cash flow:
−Removed: November 2019, the Company had its Regulation A+ initially qualified by the SEC for an offering up to 150 million shares of
−Removed: common stock.
−Removed: On April 30, 2020, the Company filed a post-effective Amendment, which was qualified by the SEC on June 3, 2020.
−Removed: the Company’s second and third fiscal quarters, the Company secured approximately $300,000 in convertible promissory
−Removed: notes, which have subsequently been converted into shares of common stock and raised approximately $500,000 from the sales
−Removed: of common stock under the Regulation A+..
−Removed: Company recognized initial sales of IsoPet ®
−Removed: the Company is successful in the Company’s sales/development effort, it believes that it will be able to raise additional
−Removed: funds through strategic agreements or the sale of the Company’s stock to either current or new stockholders.
−Removed: guarantee that the Company will be able to raise additional funds or to do so at an advantageous price.
−Removed: financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might
−Removed: be necessary should the Company be unable to continue as a going concern.
−Removed: The Company’s continuation as a going concern
−Removed: is dependent upon its ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain
−Removed: profitability.
−Removed: The Company plans to seek additional funding to maintain its operations through debt and equity financing and to
−Removed: improve operating performance through a focus on strategic products and increased efficiencies in business processes and improvements
−Removed: to the cost structure.
−Removed: There is no assurance that the Company will be successful in its efforts to raise additional working capital
−Removed: or achieve profitable operations.
−Removed: The financial statements do not include any adjustments that might result from the outcome of
−Removed: this uncertainty.
−Removed: assets consist of the following at September 30, 2020 (unaudited) and December 31, 2019:
−Removed: accumulated depreciation
−Removed: is no depreciation expense for the above fixed assets for the nine months ended September 30, 2020 and 2019, respectively.
−Removed: June 2019, the Company sold the one piece of equipment still held for $0.
−Removed: The basis of this piece of equipment was also $0, resulting
−Removed: in no gain or loss on the sale.
RELATED PARTY TRANSACTIONS
Party Convertible Notes Payable
−Removed: of September 30, 2020 and December 31, 2019, the Company had the following related party convertible notes outstanding:
−Removed: September 30, 2020
−Removed: December 31, 2019
−Removed: September 2019 $15,000 Note, 8% interest, due January 2020
−Removed: Other related party notes
−Removed: March 2017 $332,195 Note, 10% interest, due May 2017
−Removed: Total Convertible Notes Payable, Net
−Removed: Debt Discount
−Removed: March 2017, the Company combined Outstanding Notes owed to a director and major stockholder, along with $51,576 of accrued interest
−Removed: payable, into one promissory note (the “
−Removed: Related Party Note ”).
−Removed: The Related Party Note accrues interest at a
−Removed: rate of 10% and was due and payable on December 31, 2017.
−Removed: The note holder agreed to an extension of the due date until May 9,
−Removed: On August 9, 2018 the Company entered into a Path Forward and Restructuring Agreement whereby this Convertible Note would
−Removed: convert at a conversion price of $0.032 per share concurrently with a funding of at least $500,000 (the “
−Removed: Qualified Financing ”).
−Removed: The Qualified Financing occurred on October 10, 2018 at which time this note was fully converted into 6,250,000 shares of Company
−Removed: common stock, 385,302 Series B Convertible Preferred shares of the Company, and 5,533,138 warrants that are exercisable into common
−Removed: shares with an exercise price of $0.08.
−Removed: The Company valued this transaction at a price of $0.104 per share as the conversion occurred
−Removed: October 19, 2018 upon board approval.
−Removed: Company has outstanding accrued interest in the amount of $1,054 from old related party notes that the principal had been paid
Company from time to time receives non-interest bearing advancers from its Chief Executive Officer that are due on demand.
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amortized over the life of the note through January 15, 2020.
−Removed: The Company is in default of this note.
+Added: The Company was in default of this note.
As a result of the default,
the interest rate charged was changed to 12.5% through conversion of this note in April 2020.
−Removed: expense for the nine months ended September 30, 2020 and 2019 on the related party convertible notes payable amounted to $298
−Removed: and $0, respectively.
+Added: expense for the three months ended March 31, 2021 and 2020 on the related party convertible notes payable amounted to $0 and $298,
+Added: respectively.
Party Notes Payable
−Removed: of September 30, 2020 and December 31, 2019, the Company had the following related party notes outstanding:
−Removed: September 30, 2020
+Added: of March 31, 2021 and December 31, 2020, the Company had the following related party notes outstanding:
+Added: March 31, 2021
December 31, 2020
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an annual rate of 8%.
−Removed: On November 25, 2019 the Company entered into a note payable with a trust related to one of our directors
−Removed: in the amount of $50,000.
−Removed: The note is for a one-year period maturing November 25, 2020 and bears interest at an annual rate of
−Removed: Interest expense for these notes for the nine months ended September 30, 2020 and 2019 was $14,194 and $7,155, respectively
−Removed: and accrued interest at September 30, 2020 is $25,502.
−Removed: Company borrowed $87,000 in the nine months ended September 30, 2020 from its CEO and repaid these amounts in full.
+Added: The Company is in default of this note.
+Added: On November 25, 2019 the Company entered into a note payable with
+Added: a trust related to one of our directors in the amount of $50,000.
+Added: The note is for a one-year period maturing November 25, 2020
+Added: and bears interest at an annual rate of 8%.
+Added: The Company is in default of this note.
+Added: Interest expense for these notes for the three
+Added: months ended March 31, 2021 and 2020 was $4,662 and $4,715, respectively and accrued interest at March 31, 2021 is $34,829.
+Added: Company borrowed $15,000 in March 2020 from its CEO and repaid this amount in April 2020.
Party Payables
Company periodically receives advances for operating funds from related parties or has related parties make payments on the Company’s
−Removed: As a result of these activities the Company had related party payables of $32,110 and $32,110 as of September 30, 2020
−Removed: and December 31, 2019, respectively.
+Added: As a result of these activities the Company had related party payables of $32,110 and $32,110 as of March 31, 2021 and
+Added: December 31, 2020, respectively.
and Common Shares Issued to Officers and Directors
5 unchanged sentences
These shares were issued
−Removed: on June 10, 2020 following the qualification of the Regulation A+.
+Added: on June 10, 2020 following the qualification of the Regulation A+ and are reflected as shares to be issued as of March 31, 2020.
+Added: Company’s Chief Executive Officer exercised 2,500,000 stock options for $60,000 in December 2020.
CONVERTIBLE NOTES PAYABLE
−Removed: of September 30, 2020 and December 31, 2019, the Company had the following convertible notes outstanding:
−Removed: September 30, 2020
−Removed: December 31, 2019
−Removed: Accrued Interest
−Removed: Accrued Interest
−Removed: July and August 2012 $1,060,000 Notes convertible into common stock at $4.60 per share, 12% interest, due December 2013 and January 2014
−Removed: May through October 2015 $605,000 Notes convertible into preferred stock at $1 per share, 8-10% interest, due September 30, 2015
−Removed: October through December 2015 $613,000 Notes convertible into preferred stock at $1 per share, 8% interest, due June 30, 2016, net of debt discount of $0 and $560,913, respectively
−Removed: January through March 2016 $345,000 Notes convertible into preferred stock at $1 per share, 8% interest, due June 30, 2016
−Removed: May 2019 $60,000 Note convertible into common shares at $0.04 per share, 8% interest, due October 30, 2019
−Removed: July 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
−Removed: September 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
−Removed: September 2019 $38,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
−Removed: September 2019 $25,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
−Removed: September 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
−Removed: September 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
−Removed: September 2019 $37,000 Note convertible into common shares at $0.04 per share, 8% interest, due January 15, 2020
−Removed: December 2019 $50,000 Note convertible into common shares at $0.04 per share, 8% interest, due March 31, 2020
−Removed: January 2020 $100,000 Note convertible into common shares at $0,04 per share, 8% interest, due March 31, 2020
−Removed: Penalties on notes in default
+Added: of March 31, 2021 and December 31, 2020, the Company had the following convertible notes outstanding:
+Added: July and August 2012 $1,060,000
+Added: Notes convertible into common stock at $4.60 per share, 12% interest, due December 2013 and January 2014
+Added: November 2020 $50,000 Note convertible
+Added: into common shares at $0.04, 6% interest, due May 30, 2021
+Added: notes in default
Total Convertible Notes Payable, Net
Debt Discount
−Removed: expense for the nine months ended September 30, 2020 and 2019 on the convertible notes payable amounted to $19,783 and $7,509,
−Removed: respectively.
−Removed: May 2017 notes totaling $3,136,506, $2,419,240 after debt discounts, had a December 2017 due date which was extended to May 2018.
Company entered into a $50,000 convertible promissory note dated May 31, 2019, that was to mature October 30, 2019.
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over the life of the notes.
−Removed: For the nine months ended September 30, 2020 and 2019, the Company recognized $6,187 and $0, in amortization
−Removed: of the BCF discount.
to the conversion of these notes, the Company was in default of these notes.
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$.06 exercise price and an expiration date of March 31, 2022, the note was converted in June 2020.
+Added: Company issued a convertible note in January 2020 in the amount of $100,000 to an accredited investor.
+Added: The note bears interest
+Added: at 8% per annum and matured March 31, 2020.
+Added: The Company granted 1,250,000 warrants with an exercise price of $0.06 per share and
+Added: a term of two years with this note and amended 1,312,500 previously issued warrants held by the investor to provide for a $.06
+Added: exercise price and an expiration date of March 31, 2022.
+Added: Company entered into a $50,000 convertible promissory note on November 30, 2020, that matures May 30, 2021.
+Added: The convertible promissory
+Added: notes bear interest at a rate of 6%, The convertible promissory note is convertible into shares of common stock at a price of
+Added: $0.04 per share.
+Added: Upon the closing of an equity financing pursuant to an effective registration statement with gross proceeds to
+Added: the Company totaling at least $350,000 exclusive of any exchanges (“Qualified Financing”), the outstanding principal
+Added: amount of this convertible promissory notes together with all accrued and unpaid interest shall be exchanged into such securities
+Added: as are issued in the Qualified Financing at a rate of 1.20.
+Added: Upon an exchange, the Payee shall be granted all rights afforded to
+Added: an investor in the Qualified Financing.
+Added: The Company along with the noteholder agreed to exchange 1,867,500 warrants into 933,750
+Added: common shares.
+Added: These shares were issued in December 2020.
+Added: The convertible note was converted into shares of common stock in January
+Added: expense for the three months ended March 31, 2021 and 2020 on the convertible notes payable amounted to $1,444 and $14,961, respectively.
PROMISSORY NOTES PAYABLE
−Removed: of September 30, 2020 and December 31, 2019, the Company had the following promissory notes outstanding:
−Removed: September 30, 2020
−Removed: December 31, 2019
−Removed: February 2019, two promissory notes for $50,000 each (total of $100,000), maturing August 2019, extended to February 2020, at 8.00% interest (originally) and now 15% interest and extended to August 20, 2020
−Removed: Debt discount
−Removed: Total Promissory Notes Payable, Net
Company issued two separate promissory notes on February 20, 2019 at $50,000 each (total of $100,000) that were to mature on August
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amortized the discount over the life of the note (6 months).
−Removed: Amortization of debt discount for the year ended December 31, 2019
−Removed: was $28,721 and is recorded as interest expense on the statement of operations for the year ended December 31, 2019.
August 20, 2019, the two noteholders agreed to extend these notes another six-months to February 20, 2020, then amended again
−Removed: for six-months and the notes now mature August 20, 2020.
+Added: for six-months and the notes were to mature August 20, 2020.
In consideration for the extension, the note holders received 750,000
warrants (375,000 each) and the interest rate on the notes increased from 8% to 15% per annum.
−Removed: The interest expense on these notes
−Removed: for the nine months ended September 30, 2020 and 2019 amounted to $8,032 and $5,640, and $0 is accrued for as of September 30,
−Removed: Company repaid $50,00 of these notes plus $13,442 in accrued interest, and settled the remaining $50,000 into 1,851,852 shares
−Removed: of common stock effective July 14, 2020.
+Added: interest expense on these notes for the three months ended March 31, 2021 and 2020 amounted to $0 and $3,726.
+Added: Company repaid $50,000 of these notes plus $13,442 in accrued interest in July 2020 and settled the remaining $50,000 into 1,851,852
+Added: shares of common stock effective July 14, 2020.
STOCKHOLDERS’
−Removed: Company has 950,000,000 shares of common stock authorized, with a par value of $0.001, and as of September 30, 2020 and December
+Added: Company has 950,000,000 shares of common stock authorized, with a par value of $0.001, and as of March 31, 2021 and December 31,
2020, the Company has 320,292,714 and 292,278,591 shares issued and outstanding, respectively.
2 unchanged sentences
The reverse stock split went effective by FINRA on June 28, 2019.
−Removed: of September 30, 2020 and December 31, 2019, the Company has 20,000,000 shares of Preferred stock authorized with a par value
−Removed: The Company’s Board of Directors is authorized to provide for the issuance of shares of preferred stock in one
−Removed: or more series, fix or alter the designations, preferences, rights, qualifications, limitations or restrictions of the shares
−Removed: of each series, including the dividend rights, dividend rates, conversion rights, voting rights, term of redemption including
−Removed: sinking fund provisions, redemption price or prices, liquidation preferences and the number of shares constituting any series
−Removed: or designations of such series without further vote or action by the shareholders.
−Removed: The issuance of preferred stock may have the
−Removed: effect of delaying, deferring or preventing a change in control of management without further action by the shareholders and may
−Removed: adversely affect the voting and other rights of the holders of common stock.
−Removed: The issuance of preferred stock with voting and conversion
−Removed: rights may adversely affect the voting power of the holders of common stock, including the loss of voting control to others.
+Added: of March 31, 2021 and December 31, 2020, the Company has 20,000,000 shares of Preferred stock authorized with a par value of $0.001.
+Added: The Company’s Board of Directors is authorized to provide for the issuance of shares of preferred stock in one or more series,
+Added: fix or alter the designations, preferences, rights, qualifications, limitations or restrictions of the shares of each series,
+Added: including the dividend rights, dividend rates, conversion rights, voting rights, term of redemption including sinking fund provisions,
+Added: redemption price or prices, liquidation preferences and the number of shares constituting any series or designations of such series
+Added: without further vote or action by the shareholders.
+Added: The issuance of preferred stock may have the effect of delaying, deferring
+Added: or preventing a change in control of management without further action by the shareholders and may adversely affect the voting
+Added: and other rights of the holders of common stock.
+Added: The issuance of preferred stock with voting and conversion rights may adversely
+Added: affect the voting power of the holders of common stock, including the loss of voting control to others.
October 8, 2018 the Company created out of the shares of Preferred Stock, par value $0.001 per share, of the Company, as authorized
133 unchanged sentences
Company representing more than fifty percent 50% of the outstanding voting securities of the Company), the Company, at its option,
−Removed: will have the right to redeem all or a portion of the outstanding Series B Convertible Preferred in cash at a price per share
+Added: will have the right to redeem all or a portion of the outstanding Series C Convertible Preferred in cash at a price per share
of Series C Convertible Preferred equal to 100% of the Liquidation Preference.
30 unchanged sentences
and Preferred Stock Issuances - 2021
+Added: January 2021, the Company issued 384,445 shares of common stock in a settlement of accounts payable valued at $50,000.
+Added: January 2021, the Company issued 1,259,250 shares of common stock in conversion of a note payable and accrued interest totaling
+Added: The conversion resulted in a loss on conversion of $176,295 that is reflected in the Condensed Statement of Operations
+Added: for the three months ended March 31, 2021.
+Added: March 2021, the Company issued 22,500,000 shares of common stock along with 11,237,500 warrants under the Regulation A+ for cash
+Added: proceeds of $1,800,000 for the common stock and the warrants were purchased for $11,238.
+Added: January 8, 2021 and January 29, 2021, the Company issued 3,870,428 shares of common stock in the cashless exercise of 5,430,000
+Added: and Preferred Stock Issuances - 2020
Company in January 2020 paid $50,000 to redeem 100,000 shares of Series B Convertible Preferred Stock.
2 unchanged sentences
January 2020, the Company converted 435,990 shares of Series C Convertible Preferred stock into 5,449,875 shares of common stock.
−Removed: March through June 2020, the Company entered into agreements to issue 18,440,000 shares of common stock conditioned upon the qualification
−Removed: of the offer and sale of such shares under Regulation A+ for $497,880.
+Added: March 2020, the Company entered into agreements to issue 4,640,000 shares of common stock conditioned upon the qualification of
+Added: the offer and sale of such shares under Regulation A+ for $125,280.
Additionally, the Company agreed to issue 2,320,000 warrants
with a term of two years and an exercise price of $.045 for a purchase price of $1,243.
−Removed: These shares were issued in June 2020
−Removed: and July 2020 following the qualification of the Regulation A+.
−Removed: March through June 2020, certain holders of convertible promissory notes entered into agreements to exchange certain notes totaling
−Removed: $651,044, including $525,000 in principal amount, $27,536 in accrued interest and an exchange premium as provided for in the note
−Removed: agreements of $98,508 into 21,770,668 shares of common stock effective upon the qualification of the offer and sale of such shares
−Removed: under Regulation A+.
+Added: These shares were issued on June 10, 2020
+Added: following the qualification of the Regulation A+ and are reflected as shares to be issued as of March 31, 2020.
+Added: March 2020, certain holders of convertible promissory notes entered into agreements to exchange certain notes totaling $526,113,
+Added: including $425,000 in principal amount, $23,430 in accrued interest and an exchange premium as provided for in the note agreements
+Added: of $77,683 into 19,485,668 shares of common stock effective upon the qualification of the offer and sale of such shares under
+Added: Regulation A+.
In connection with the holder’s agreement to enter into the exchange, the Company intends to issue 2,200,000
−Removed: 2,200,000 warrants with a two-year term and an exercise price of $0.045 per share and amend 4,400,000 previously issued warrants
−Removed: to provide for a $.045 exercise price and an expiration date of March 31, 2022.
−Removed: These shares were issued on June 10, 2020 following
−Removed: the qualification of the Regulation A+.
−Removed: the three months ended September 30, 2020, the Company issued 1,851,852 shares of common stock to settle $50,000 in promissory
−Removed: and Preferred Stock Issuances - 2019
−Removed: January 2019, the Company received $100,000 in gross proceeds resulting from the issuance to accredited investors of 1,250,000
−Removed: shares of common stock, 100,000 shares of Series B Convertible Preferred and warrants to purchase 1,250,000 shares of common stock.
−Removed: Company issued 13,015,225 shares of common stock in consideration for the conversion of 1,041,218 shares of Series B Convertible
−Removed: Company issued 821,292 shares of Series C Convertible Preferred in exchange for 821,292 shares of Series B Convertible Preferred.
−Removed: Company issued 562,500 shares of common stock in a settlement of accounts payable valued at $22,500.
−Removed: Company issued 312,500 shares of common stock for services rendered in connection with the raising of debt instruments valued
+Added: warrants with a two-year term and an exercise price of $0.045 per share and amend 4,400,000 previously issued warrants to provide
+Added: for a $.045 exercise price and an expiration date of March 31, 2022.
+Added: These shares were issued on June 10, 2020 following the qualification
+Added: of the Regulation A+ and are reflected as shares to be issued as of March 31, 2020.
COMMON STOCK OPTIONS, WARRANTS AND RESTRICTED STOCK UNITS
6 unchanged sentences
following schedule summarizes the changes in the Company’s stock options:
−Removed: Options Outstanding
Balance at December 31, 2020
3 unchanged sentences
Options expired
−Removed: Balance at September 30, 2020
+Added: Balance at March 31, 2021
$ 0.024-120.00
−Removed: Exercisable at September 30, 2020
+Added: Exercisable at March 31, 2021
$ 0.024-120.00
−Removed: June 2019, the Company issued 382,500 stock options to consultants that vest through June 30, 2020.
−Removed: The grant date of these options
−Removed: was June 17, 2019, the date of board approval.
−Removed: On June 21, 2019, 46,250 stock options expired that were issued June 21, 2016.
−Removed: There was $6,529 expensed in 2019 and $2,176 remaining to be expensed through June 30, 2020 for these options.
−Removed: Company has granted 21,000,000 stock options under the Company’s 2015 Omnibus Securities and Incentive Plan to Dr.
−Removed: The granting of the stock options occurs 10 days after the approval of the Company’s recent 1 for 8 reverse stock split
−Removed: that occurred on June 28, 2018.
−Removed: The vesting of the options are as follows:
−Removed: (i) 50% vested in equal amounts at the end of each
−Removed: of the two successive calendar quarters (25% for each of the quarters September 30, 2019, and December 31, 2019);
−Removed: (ii) 25% upon
−Removed: the Company filing a patent (completed on July 1, 2019);
−Removed: and (iii) 25% upon the first commercial sale of IsoPet ®
−Removed: The first commercial sale occurred in July 2019.
−Removed: The value of these options in the aggregate is $585,144.
−Removed: September 2019, the Company granted 1,000,000 stock options in a settlement agreement for past due legal fees.
−Removed: The options have
−Removed: a ten-year life and vest immediately.
−Removed: These options were valued at $33,829 which offset accounts payable.
−Removed: The Company recognized
−Removed: a gain of $34,106 on this transaction which is included in the net (gain) loss on debt extinguishment in the statement of operations
−Removed: for the year ended December 31, 2019.
−Removed: September 2019, the Company granted 500,000 stock options to a consultant for services rendered.
−Removed: The options have a ten-year life
−Removed: and vest immediately.
−Removed: These options were valued at $16,915.
−Removed: December 2019, the Company granted 370,309 stock options to consultants for accounts payable.
−Removed: The options have a ten-year life
−Removed: and vest immediately.
−Removed: These options were valued at $14,812.
−Removed: the nine months ended September 30, 2020 and 2019, the Company recognized $2,176 and $460,125, respectively, worth of stock based
−Removed: compensation related to the vesting of it stock options.
+Added: the three months ended March 31, 2021 and 2020, the Company recognized $0 and $0, respectively, worth of stock based compensation
+Added: related to the vesting of it stock options.
Stock Warrants
following schedule summarizes the changes in the Company’s stock warrants:
−Removed: Warrants Outstanding
−Removed: Weighted Average
−Removed: Weighted Average
−Removed: Remaining Contractual
−Removed: Aggregate Intrinsic
+Added: Average Remaining
+Added: Price Per Share
Balance at December 31, 2020
2 unchanged sentences
Warrants expired/cancelled
−Removed: Balance at September 30, 2020
−Removed: Exercisable at September 30, 2020
−Removed: the year ended December 31, 2019, the Company granted 1,250,000 warrants in the issuance of common and preferred shares issued
−Removed: for cash to accredited investors, 5,650,000 warrants in the issuance of promissory notes (recorded as a debt discount valued at
−Removed: $151,048), 750,000 warrants for the extension of promissory notes, recorded as interest expense valued at $25,656, 500,000 warrants
−Removed: for settlement of accounts payable valued at $18,500 (see Note 9) and 84,375 warrants issued for consulting services valued at
+Added: Balance at March 31, 2021
+Added: Exercisable at March 31, 2021
+Added: to these inputs could produce a significantly higher or lower fair value measurement.
+Added: The fair value of each option/warrant is
+Added: estimated using the Black-Scholes valuation model.
+Added: The following assumptions were used for the periods as follows:
+Added: Expected term
+Added: Expected volatility
+Added: Expected dividend yield
+Added: Risk-free interest rate
Company issued a convertible note in the amount of $100,000 to an accredited investor.
4 unchanged sentences
and an expiration date of March 31, 2022.
+Added: This issuance resulted in a debt discount of $28,482.
March through June 2020, the Company entered into agreements to issue 18,440,000 shares of common stock conditioned upon the qualification
8 unchanged sentences
under Regulation A+.
−Removed: In connection with the holder’s agreement to enter into the exchange, the Company intends to issue
−Removed: 2,200,000 warrants with a two-year term and an exercise price of $0.045 per share and amend 4,400,000 previously issued warrants
−Removed: to provide for a $.045 exercise price and an expiration date of March 31, 2022.
−Removed: These shares were issued on June 10, 2020 following
−Removed: the qualification of the Regulation A+.
+Added: In connection with the holder’s agreement to enter into the exchange, the Company issued 2,200,000
+Added: warrants with a two-year term and an exercise price of $0.045 per share and amend 4,400,000 previously issued warrants to provide
+Added: for a $.045 exercise price and an expiration date of March 31, 2022.
+Added: These shares were issued on June 10, 2020 following the qualification
+Added: of the Regulation A+.
+Added: The issuance of the warrants resulted in $77,883 in additional warrant expense.
+Added: November 30, 2020 and December 2, 2020 the Company sold 19,200,000 warrants for $19,200.
+Added: These warrants have a two-year term and
+Added: have an exercise price of $0.06 per share.
+Added: November 30, 2020, the Company exchanged 1,867,500 warrants into 933,750 shares of common stock, and between December 14, 2020
+Added: and December 28, 2020, there were cashless exercises of 6,860,000 warrants into 4,759,435 shares of common stock.
+Added: the Company’s quarter ended December 31, 2020, 22,364,972 warrants expired.
+Added: January 8, 2021 and January 29, 2021, the Company issued 3,870,428 shares of common stock in the cashless exercise of 5,430,000
+Added: March 2021 the Company sold 11,237,500 warrants for $11,238.
+Added: These warrants have a two-year term and have an exercise price of
+Added: $0.10 per share.
+Added: the Company’s quarter ended March 31, 2021, 709,375 warrants expired.
following schedule summarizes the changes in the Company’s restricted stock units:
3 unchanged sentences
RSU’s forfeited
−Removed: Balance at September 30, 2020
−Removed: the nine months ended September 30.
−Removed: 2020 and 2019, the Company recognized $0 and $0 worth of expense related to the vesting of
−Removed: its RSU’s.
−Removed: As of September 30, 2020, the Company had $155,400 worth of expense yet to be recognized for RSU’s not
+Added: Balance at March 31, 2021
+Added: the three months ended March 31.
+Added: 2021 and 2020, the Company recognized $0 and $0 worth of expense related to the vesting of its
+Added: As of March 31, 2021, the Company had $155,400 worth of expense yet to be recognized for RSU’s not yet vested.
+Added: On May 3, 2021, the Company has granted
+Added: 12,000,000 RSUs to a consultant that vest on the grant date.
+Added: On May 3, 2021, as part of an Employment
+Added: Agreement with the CEO, the Company granted 30,000,000 RSUs to the CEO.
+Added: Of the 30,000,000 RSUs, 15,000,000 of them vest as follows:
+Added: 5,000,000 on the grant date, 5,000,000 on the first anniversary and 5,000,000 on the second anniversary.
+Added: The remaining 15,000,000
+Added: RSUs vest as performance-based grants, with the Board of Directors determining the criteria of each 5,000,000 RUSs at the nine-month
+Added: anniversary, eighteen-month anniversary and twenty-seven month anniversary intervals.
+Added: The Board of Directors has 90 days from
+Added: May 3, 2021 to determine the performance criteria.
LEGAL MATTERS
14 unchanged sentences
November 25, 2019, the Company and its current and former directors entered into a Settlement Agreement with the Plaintiff.
−Removed: the terms of the Settlement Agreement, the Company has agreed to issue 500,000 shares of common stock and 500,000 warrants to
−Removed: the Plaintiff, make an initial payment of $33,503 by December 4, 2019 and beginning on December 16, 2019, the Company will make
−Removed: payments of $10,000 per month for 10 months in full satisfaction of the Separation Agreement and General Release originally entered
−Removed: into on July 21, 2017.
−Removed: The Company has paid this liability in full as of September 11, 2020.
+Added: the terms of the Settlement Agreement, the Company issued 500,000 shares of common stock and 500,000 warrants to the Plaintiff,
+Added: made an initial payment of $33,503 by December 4, 2019 and beginning on December 16, 2019, the Company made payments of $10,000
+Added: per month for 10 months in full satisfaction of the Separation Agreement and General Release originally entered into on July 21,
June 4, 2019, the Company entered into an Executive Employment Agreement (“Employment Agreement”) with Dr.
3 unchanged sentences
is extended, unless terminated earlier as set forth in the Employment Agreement.
−Removed: the terms of the Employment Agreement, the Company shall pay to Dr.
+Added: The Company on December 31, 2020 extended this
+Added: agreement through December 31, 2021 while renegotiating terms of a new Employment Agreement.
+Added: On May 3, 2021, the Company and
+Added: the Chief Executive Officer agreed the terms of a new Employment Agreement with an effective date of January 1, 2021 that has
+Added: a term of three years and expires December 31, 2023.
+Added: Under the terms of the Employment Agreement,
+Added: the Company shall pay to Dr.
Korenko a base compensation of $225,000.
−Removed: Of this amount, $120,000
−Removed: is booked in monthly intervals and the remaining balance is only paid upon the Company achieving a cash balance that exceeds $1,000,000.
−Removed: The Company has elected to record the compensation as $120,000, and upon achieving the milestone of $1,000,000 in cash balances,
−Removed: will record the deferred compensation at that time.
+Added: In addition, there is a discretionary bonus to be earned
+Added: in the amount of $7,500 per quarter upon the satisfaction of conditions to be determined by the Board of Directors of the Company.
SUBSEQUENT EVENTS
−Removed: has evaluated subsequent events, in accordance with FASB ASC Topic 855, “Subsequent Events”, through the date which
−Removed: the financial statements were available to be issued and there are no material subsequent events to report.
+Added: On May 3, 2021, the Company and the Chief
+Added: Executive Officer agreed the terms of a new Employment Agreement with an effective date of January 1, 2021 that has a term of
+Added: three years and expires December 31, 2023.
+Added: On May 3, 2021, the Company has granted
+Added: 12,000,000 RSUs to a consultant that vest on the grant date.
+Added: On May 3, 2021, as part of an Employment
+Added: Agreement with the CEO, the Company granted 30,000,000 RSUs to the CEO.
+Added: Of the 30,000,000 RSUs, 15,000,000 of them vest as follows:
+Added: 5,000,000 on the grant date, 5,000,000 on the first anniversary and 5,000,000 on the second anniversary.
+Added: The remaining 15,000,000
+Added: RSUs vest as performance-based grants, with the Board of Directors determining the criteria of each 5,000,000 RUSs at the nine-month
+Added: anniversary, eighteen-month anniversary and twenty-seven month anniversary intervals.
+Added: The Board of Directors has 90 days from
+Added: May 3, 2021 to determine the performance criteria.
+Added: On May 5, 2021, the Company’s CEO
+Added: surrendered 8,120,152 stock options.
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
28 unchanged sentences
and financial position.
−Removed: Statement of Business
−Removed: Company ”
−Removed: we ”) was incorporated under the laws of Delaware on December 23,
−Removed: 1994 as Savage Mountain Sports Corporation (“
−Removed: SMSC ”).
−Removed: On December 28, 2017, the Company changed its name from
−Removed: Advanced Medical Isotope Corp.
−Removed: to Vivos Inc.
−Removed: June 25, 2019, the Company amended their Certificate of Incorporation amending their authorized common shares to 950,000,000 from
−Removed: 2,000,000,000 shares.
−Removed: In addition, the 1 for 8 reverse stock-split was effective on June 28, 2019.
−Removed: The reverse stock-split reduced
−Removed: the number of common shares issued and outstanding from 1,421,687,688 to 177,710,961 shares.
−Removed: The par value for the common shares
−Removed: remained $0.001 per share, The Company did not amend their preferred stock which is 20,000,000 shares of preferred stock authorized,
−Removed: $0.001 par value per share.
−Removed: principal place of business is located at 719 Jadwin Avenue, Richland, Washington 99352.
−Removed: Our telephone number is (509) 736-4000.
−Removed: Our corporate website address is http://www.radiogel.com.
−Removed: Our common stock is currently listed for quotation on the OTCQB Marketplace
−Removed: under the symbol “RDGL.”
−Removed: Company is a radiation oncology medical device company engaged in the development of its yttrium-90 based brachytherapy device,
−Removed: RadioGel™, for the treatment of non-resectable tumors.
−Removed: A prominent team of radiochemists, scientists and engineers, collaborating
−Removed: with strategic partners, including national laboratories, universities and private corporations, lead the Company’s development
−Removed: The Company’s overall vision is to globally empower physicians, medical researchers and patients by providing them
−Removed: with new isotope technologies that offer safe and effective treatments for cancer.
+Added: is a radiation oncology medical device company engaged in the development of its yttrium-90 (“Y-90”) based brachytherapy
+Added: device, RadioGel™, for the treatment of non-resectable tumors.
+Added: A prominent team of radiochemists, scientists and engineers,
+Added: collaborating with strategic partners, including national laboratories, universities and private corporations, lead the Company’s
+Added: development efforts.
+Added: The Company’s overall vision is to globally empower physicians, medical researchers and patients by
+Added: providing them with new isotope technologies that offer safe and effective treatments for cancer.
+Added: 2013 the FDA issued the determination that RadioGel™
+Added: is a device for human therapy for non-resectable cancers in humans.
+Added: This should result in a faster path than a drug for final approval.
January 2018, the Center for Veterinary Medicine Product Classification Group ruled that RadioGel TM should be classified
41 unchanged sentences
The criteria were published by an international collaboration including the European Organisation for Research
−Removed: and Treatment of Cancer (EORTC), National Cancer Institute of the United States, and the National Cancer Institute of Canada Clinical
−Removed: Trials Group.
+Added: and Treatment of Cancer (“EORTC”), National Cancer Institute of the United States, and the National Cancer Institute
+Added: of Canada Clinical Trials Group.
testing at the University of Missouri met its objective to demonstrate the safety of IsoPet®.
22 unchanged sentences
in July 2019, the Company recognized its first commercial sale of IsoPet®.
−Removed: brought his cat with a re-occurrent spindle cell sarcoma tumor on his face.
−Removed: The cat had previously received external beam therapy,
−Removed: but now the tumor was growing rapidly.
+Added: A veterinarian
+Added: from Alaska brought his cat with a re-occurrent spindle cell sarcoma tumor on his face.
+Added: The cat had previously received external
+Added: beam therapy, but now the tumor was growing rapidly.
He was given a high dose of 400Gy with heavy therapy at the margins.
−Removed: This sale met the
−Removed: revenue recognition requirements under ASC 606 as the performance obligation was satisfied.
−Removed: The Company completed sales for an
−Removed: additional four animals that received the IsoPet®
+Added: sale met the revenue recognition requirements under ASC 606 as the performance obligation was satisfied.
+Added: The Company completed
+Added: sales for an additional four animals that received the IsoPet®
plan is to incorporate the data assembled from our work with Isopet®
10 unchanged sentences
and then gels when reaching body temperature after injection into a tumor.
−Removed: In the gel are small, one micron, yttrium-90 phosphate
−Removed: particles (“
−Removed: Y-90 ”).
−Removed: Once injected, these inert particles are locked in place inside the tumor by the gel, delivering
−Removed: a very high local radiation dose.
+Added: In the gel are small, less than two microns, Y-90 phosphate
+Added: Once injected, these inert particles are locked in place inside the tumor by the gel, delivering a very high local
+Added: radiation dose.
The radiation is beta, consisting of high-speed electrons.
−Removed: These electrons only travel a short
−Removed: distance so the device can deliver high radiation to the tumor with minimal dose to the surrounding tissue.
−Removed: Optimally, patients
−Removed: can go home immediately following treatment without the risk of radiation exposure to family members.
−Removed: Since Y-90 has a half-life
−Removed: of 2.7 days, the radioactivity drops to 5% of its original value after ten days.
+Added: These electrons only travel a short distance so the
+Added: device can deliver high radiation to the tumor with minimal dose to the surrounding tissue.
+Added: Optimally, patients can go home immediately
+Added: following treatment without the risk of radiation exposure to family members.
+Added: Since Y-90 has a half-life of 2.7 days, the radioactivity
+Added: drops to 5% of its original value after ten days.
+Added: the Company modified its Indication for Use from skin cancel to cancerous tissue or solid tumors pathologically associated with
+Added: locoregional papillary thyroid carcinoma and recurrent papillary thyroid carcinoma having discernable tumors associated with metastatic
+Added: lymph nodes or extranodal disease in patients who are not surgical candidates or who have declined surgery, or patients who require
+Added: post-surgical remnant ablation (for example, after prior incomplete radioiodine therapy).
+Added: Papillary thyroid carcinoma belongs
+Added: to the general class of head and neck tumors for which tumors are accessible by intraoperative direct needle injection.
+Added: The Company’s
+Added: Medical Advisory Board felt that demonstrating efficacy in clinical trials was much easier with this new indication.
Company’s lead brachytherapy products, including RadioGel™, incorporate patented technology developed for Battelle
6 unchanged sentences
This exclusive license is to terminate
−Removed: upon the expiration of the last patent included in this agreement (January 2022).
+Added: upon the expiration of the last patent included in this agreement (May 2022).
Other intellectual property protection includes
proprietary production processes and trademark protection in 17 countries.
−Removed: The Company plans to continue efforts to develop new
−Removed: refinements on the production process, and the product and application hardware, as a basis for future patents.
+Added: Company plans to continue efforts to develop new refinements on the production process, and the product and application hardware,
+Added: as a basis for future patents.
+Added: Company received the Patent Cooperation Treaty (“PCT”) International Search
+Added: Report on our patent application (No.1811.191).
+Added: Seven of our claims were immediately ruled as having novelty, inventive
+Added: step and industrial applicability.
+Added: This gives us the basis to extend for many years the patent protection for our proprietary
+Added: Yttrium-90 phosphate particles utilized in Isopet®
+Added: and Radiogel™.
+Added: As part of the normal review process, we have also
+Added: submitted the technical justification for seven additional claims.
+Added: We are in the process of filing patent claims in Canada, UK
+Added: (Great Britain, Scotland, Wales and Ireland), Japan, Germany, Italy, France, Australia, Brazil, China, India, North Countries
+Added: (Sweden, Norway, Finland, and Denmark).
Veterinary Hospital
2 unchanged sentences
It is good management practice to implement and learn from a pilot program before spreading to regional clinics across the country.
−Removed: Vista is located in the Tri-Cities Washington area which is convenient for interactions with key personnel of Vista Inc.
−Removed: is being used to
+Added: Vista is located in the Tri-Cities Washington area which is convenient for interactions with key personnel of the Company.
+Added: pilot is being used to
the Memorandum of Understanding to define all the germane interfaces, roles and liabilities between Vista Inc and the private
11 unchanged sentences
communication material and a liability document for the pet owners;
+Added: refine the therapy techniques for advanced cancers.
Veterinary Hospital has done well on two audits by the Washington State Department of Health.
13 unchanged sentences
have been 63 expressions of interest in IsoPet ®
−Removed: therapy from across the United States, but only four of these were
−Removed: treated and they were very advanced cases.
+Added: therapy from across the United States, but only about 10% of these
+Added: were treated and they were very advanced cases.
The reasons are instructive.
−Removed: Most of the cases were for so advanced that the pet parents
−Removed: found out about IsoPet ®
+Added: Most of the cases were for so advanced that the pet
+Added: parents found out about IsoPet ®
on the Internet as a last hope.
−Removed: Several others were internal cancers that could not be
−Removed: reached, for example deep in the throat.
−Removed: Four cases were treatable, but the pets weighed more than 20 pounds and the pet parents
−Removed: were not willing to fly them in the “Safe Cargo”
−Removed: Those patients would have been treated by regional clinics
−Removed: once we implement that strategy.
−Removed: Three cases were mast cell cancers.
−Removed: The Company is confident that those tumors could have been
−Removed: treated, but once killed they release mast cells in a process called granulation.
+Added: Several others were internal cancers that could
+Added: not be reached, for example deep in the throat.
+Added: Several cases were treatable, but the pets weighed more than 20 pounds and the
+Added: pet parents were not willing to fly them in the “Safe Cargo”
+Added: Those patients would have been treated by regional
+Added: clinics once we implement that strategy.
+Added: Several cases were mast cell cancers.
+Added: The Company is confident that those tumors could
+Added: have been treated, but once killed they release mast cells in a process called granulation.
This could cause a shock to the animal’s
The Company will focus one of our clinical studies on the optimum approach for those therapies.
−Removed: Veterinary Hospital accepted four advanced cancer cases.
−Removed: The first cat was terminally ill and had previously had external beam,
−Removed: surgery and chemotherapy.
−Removed: The facial tumor was treated with 400 Gy and the biopsy confirmed that the cancer was killed.
−Removed: seven months the cancer returned in the throat and could not be treated so the cat had to be put down.
−Removed: Buader, the veterinarian
−Removed: pet parent, was still elated about the life extension and is asking us to use him as a reference.
−Removed: Two other cases were also very
−Removed: advanced with multiple tumors and they recurred since they had already spread before therapy.
+Added: Veterinary Hospital accepted advanced cancer cases and has gained experience to extend the animal’s lives.
+Added: The first cat
+Added: was terminally ill and had previously had external beam, surgery and chemotherapy.
+Added: The facial tumor was treated with 400 Gy and
+Added: the biopsy confirmed that the cancer was killed.
+Added: In about seven months the cancer returned in the throat and could not be treated
+Added: so the cat had to be put down.
+Added: Bauder, the veterinarian pet parent, was still elated about the life extension and is asking
+Added: us to use him as a reference.
+Added: The other cases were also very advanced with multiple tumors and they recurred since they had already
+Added: spread before therapy.
+Added: One animal, Yukon had a large tumor on his leg that was recommended for amputation.
+Added: The tumor size decreased
+Added: 50% after the first treatment, but then stopped decreasing.
+Added: For the first time a second therapy was administered and the tumor
+Added: has continued to decrease in size.
Company’s efforts are now to obtain more early-stage cancer patients.
60 unchanged sentences
(2) notable advantage over current therapies; and (3) probability of wide-spread acceptance by the medical community.
+Added: November 2020 the Company submitted a request for a Breakthrough Device Designation.
+Added: Ultimately, this was denied, but the FDA
+Added: acknowledged, “The FDA does believe that RadioGel™
+Added: meets criterion #2a:
+Added: Device represents breakthrough technology.
+Added: Your device does meet this criterion because it is a novel application of a brachytherapy device outside of the liver.”
+Added: More importantly the process resulted in a rapid review of our existing data and approach.
+Added: It led to a redirection of our efforts
+Added: on writing the IDE and saved the Company much time in the review of that future application.
MAB selected eighteen applications for RadioGel™, each of which meet the criteria described above.
2 unchanged sentences
The Company’s application establishes
−Removed: a single Indication for Use - treatment of basal cell and squamous cell skin cancers.
−Removed: We anticipate that this initial application
−Removed: will facilitate each subsequent application for additional Indications for Use, and the testing for many of the subsequent applications
−Removed: could be conducted in parallel, depending on available resources.
−Removed: of Operations
−Removed: of the Nine Months Ended September 30, 2020 and 2019
−Removed: following table sets forth information from our statements of operations for the nine months ended September 30, 2020 and 2019:
−Removed: Nine Months Ended
−Removed: September 30, 2020
−Removed: Nine Months Ended
−Removed: September 30, 2019
−Removed: Operating expenses
−Removed: Operating loss
−Removed: Non-operating income (expense):
−Removed: Interest expense
−Removed: $ (1,106,059 )
−Removed: was $7,000 and $8,000 for the nine months ended September 30, 2020 and 2019, respectively.
−Removed: expenses for the nine months ended September 30, 2020 and 2019, respectively consists of the following:
−Removed: Nine months ended
−Removed: September 30, 2020
−Removed: Nine months ended
−Removed: September 30, 2019
−Removed: Professional fees
−Removed: Stock based compensation
−Removed: Payroll expenses
−Removed: Research and development
−Removed: General and administrative expenses
−Removed: Total operating expenses
−Removed: expenses for the nine months ended September 30, 2020 and 2019 was $384,267 and $1,013,426, respectively.
−Removed: The decrease in operating
−Removed: expenses from 2019 to 2020 can be attributed to the decrease in professional fees ($170,771 for the nine months ended September
−Removed: 30, 2020 versus $356,248 for the nine months ended September 30, 2020) as the Company utilized less services due to cash flow
−Removed: the decrease in stock based compensation ($2,176 for the nine months ended September 30, 2020 versus $463,917 for
−Removed: the nine months ended September 30, 2019) and the increase in general and administrative expense ($41,067 for the nine months
−Removed: ended September 30, 2019 versus $85,482 for the nine months ended September 30, 2020) as the Company continued to incur reasonable
−Removed: administrative costs to run the Company.
−Removed: Non-Operating
−Removed: Income (Expense)
−Removed: Non-operating
−Removed: income (expense) for the nine months ended September 30, 2020 and 2019 consists of the following:
−Removed: Nine months ended
−Removed: September 30, 2020
−Removed: Nine months ended
−Removed: September 30, 2019
−Removed: Interest expense
−Removed: Non-operating income (expense)
−Removed: Non-operating
−Removed: income (expense) for the nine months ended September 30, 2020 varied from the nine months ended September 30, 2019 primarily due
−Removed: to an increase in interest expense from as a result of the debt increase from 2019 to 2020 prior to conversion of this debt.
−Removed: majority of the interest recorded by the Company consists of amortization of debt discount, BCF discount and the exchange premium
−Removed: resulting in additional shares to the noteholders on conversion.
−Removed: net loss for the nine months ended September 30, 2020 and 2019 was $(654,909) and $(1,106,059), respectively.
−Removed: of the Three Months Ended September 30, 2020 and 2019
−Removed: following table sets forth information from our statements of operations for the three months ended September 30, 2020 and 2019:
−Removed: Three Months Ended
−Removed: September 30, 2020
−Removed: Three Months Ended
−Removed: September 30, 2019
−Removed: Operating expenses
−Removed: Operating loss
−Removed: Non-operating income (expense):
−Removed: Interest expense
−Removed: was $7,000 and $8,000 for the three months ended September 30, 2020 and 2019, respectively.
−Removed: expenses for the three months ended September 30, 2020 and 2019, respectively consists of the following:
−Removed: Three months ended
−Removed: September 30, 2020
−Removed: Three months ended
−Removed: September 30, 2019
−Removed: Professional fees
−Removed: Stock based compensation
−Removed: Payroll expenses
−Removed: Research and development
−Removed: General and administrative expenses
−Removed: Total operating expenses
−Removed: expenses for the three months ended September 30, 2020 and 2019 was $135,440 and $615,207, respectively.
−Removed: The decrease in operating
−Removed: expenses from 2019 to 2020 can be attributed to the decrease in professional fees ($59,502 for the three months ended September
−Removed: 30, 2020 versus $87,075 for the three months ended September 30, 2019) as the Company utilized less services due to cash flow
−Removed: the decrease in stock based compensation ($0 in the three months ended September 30, 2020 versus $457,949 for the
−Removed: three months ended September 30, 2020) and the increase in general and administrative expense ($21,691 for the three months ended
−Removed: September 30, 2019 versus $27,526 for the three months ended September 30, 2020) as the Company continued to incur reasonable
−Removed: administrative costs to run the Company.
−Removed: Non-Operating
−Removed: Income (Expense)
−Removed: Non-operating
−Removed: income (expense) for the three months ended September 30, 2020 and 2019 consists of the following:
−Removed: Three months ended
−Removed: September 30, 2020
−Removed: Three months ended
−Removed: September 30, 2019
−Removed: Interest expense
−Removed: Non-operating income (expense)
−Removed: Non-operating
−Removed: income (expense) for the three months ended September 30, 2020 varied from the three months ended September 30, 2019 primarily
−Removed: due to an increase in interest expense from as a result of the debt increase from 2019 to 2020 prior to conversion of this debt.
−Removed: The majority of the interest recorded by the Company consists of amortization of debt discount, BCF discount and the exchange
−Removed: premium resulting in additional shares to the noteholders on conversion.
−Removed: net loss for the three months ended September 30, 2020 and 2019 was $(135,591) and $(669,372), respectively.
−Removed: and Capital Resources
−Removed: September 30, 2020, the Company had a working capital deficit of $870,233 as compared to $1,479,689 at December 31, 2019.
−Removed: the nine months ended September 30, 2020 the Company experienced negative cash flow from operations of $510,227 and it received
−Removed: $0 for investing activities while adding $504,780 of cash flows from financing activities.
−Removed: As of September 30, 2020, the Company
−Removed: had no commitments for capital expenditures.
−Removed: used in operating activities was primarily a result of the Company’s net loss, and the adjustments to reconcile the net
−Removed: loss to net cash which included the amortization of discounts as well as expense related to the warrants granted to note holders
−Removed: and the exchange premium recognized for the conversion of notes.
−Removed: Additionally there were increases in accrued payroll and accrued
−Removed: The Company had no investing activities for the nine-month periods ended September 30, 2020 and 2019, respectively.
−Removed: In the nine months ended September 30, 2020 and 2019, the Company had cash provided by financing activities of $504,780 and $737,000,
−Removed: respectively.
−Removed: These activities were the result of proceeds received from notes payable (both related and unrelated parties) as
−Removed: well as from sales of common stock and preferred stock.
−Removed: Company has generated material operating losses since inception.
−Removed: The Company had a net loss of $654,909 for the nine months ended
−Removed: September 30, 2020, and a net loss of $1,106,059 for the nine months ended September 30, 2019.
−Removed: The Company expects to continue
−Removed: to experience net operating losses.
−Removed: Historically, the Company has relied upon investor funds to maintain its operations and develop
−Removed: the Company’s business.
−Removed: Company received $497,880 which were deposited into the Company’s accounts between April and June 2020.
−Removed: Following the clearance
−Removed: of the Regulation A+ offering by the SEC on June 3, 2020, the common shares for these proceeds were issued.
−Removed: In addition, the Company
−Removed: exchanged their outstanding convertible notes payable of $525,000, $27,536 in accrued interest and $98,508 in an exchange premium
−Removed: stipulated in the note agreements into shares of common stock through September 30, 2020, and repaid $50,000 in promissory notes
−Removed: the next 12 to 24 months, the Company believes it will cost approximately $5.0 million to $10.0 million to:
−Removed: (1) fund the FDA approval
−Removed: process and initial deployment of the brachytherapy products, and (2) initiate regulatory approval processes outside of the United
−Removed: The continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional
−Removed: resources and personnel.
−Removed: The principal variables in the timing and amount of spending for the brachytherapy products in the next
−Removed: 12 to 24 months will be the FDA’s classification of the Company’s brachytherapy products as Class II or Class III
−Removed: devices (or otherwise) and any requirements for additional studies which may possibly include clinical studies.
−Removed: Thereafter, the
−Removed: principal variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals
−Removed: and the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of
−Removed: those products and the products’
+Added: a single Indication for Use - treatment of cancerous tissue or solid tumors pathologically associated with locoregional papillary
+Added: thyroid carcinoma and recurrent papillary thyroid carcinoma.
+Added: We anticipate that this initial application will facilitate each
+Added: subsequent application for additional Indications for Use, and the testing for many of the subsequent applications could be conducted
+Added: in parallel, depending on available resources.
+Added: Company’s stock offering under Regulation A+ was qualified by the Securities and Exchange Commission (“SEC”)
+Added: on June 3, 2020.
+Added: Company over the past twelve months has raised approximately $4,000,000 from the sale of shares under Regulation A+, and intends
+Added: to use the proceeds generated as follows:
+Added: the animal therapy market:
+Added: the effort to communicate the benefits of IsoPet ®
+Added: to the veterinary community and the pet parents.
+Added: additional clinical studies to generate more data for the veterinary community
+Added: some IsoPet ®
+Added: therapies, if necessary, to ensure that all viable candidates are treated.
+Added: a new regional clinic with their license and certification training.
+Added: the human market:
+Added: the pedigree of the Quality Management System.
+Added: the previously defined pre-clinical testing and additional testing on an animal model closely aligned with our revised indication
+Added: Report the results to the FDA in a pre-submission meeting.
+Added: the feedback from that meeting to write the IDE (Investigational Device Exemption), which is required to initiate clinical
+Added: and development of the Company’s brachytherapy product line has been funded with proceeds from the sale of equity and debt
+Added: The Company may require additional funding of approximately $2 million annually to maintain current operating activities.
+Added: Over the next 12 to 24 months, the Company believes it will cost approximately $9 million to:
+Added: (1) fund the FDA approval process
+Added: to conduct human clinical trials, (2) conduct Phase I, pilot, clinical trials, (3) activate several regional clinics to administer
+Added: across the county, (4) create an independent production center within the current production site to create
+Added: a template for future international manufacturing, and (5) initiate regulatory approval processes outside of the United States.
+Added: continued deployment of the brachytherapy products and a worldwide regulatory approval effort will require additional resources
+Added: and personnel.
+Added: The principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24
+Added: months will be the FDA’s classification of the Company’s brachytherapy products as Class II or Class III devices (or
+Added: otherwise) and any requirements for additional studies which may possibly include clinical studies.
+Added: Thereafter, the principal
+Added: variables in the amount of the Company’s spending and its financing requirements would be the timing of any approvals and
+Added: the nature of the Company’s arrangements with third parties for manufacturing, sales, distribution and licensing of those
+Added: products and the products’
success in the U.S.
21 unchanged sentences
outbreak in the United States.
−Removed: In addition to a slow down in the marketing of the services, the volatility of the stock market
−Removed: has contributed to a lack of funds that ordinarily may have been available to the Company.
−Removed: The Company is hopeful that by the
−Removed: end of the third quarter of 2020, they will be allowed to continue their marketing to the animal therapy market and attempt to
−Removed: increase the exposure to their product and generate revenue accordingly.
−Removed: financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might
−Removed: be necessary should the Company be unable to continue as a going concern.
−Removed: The Company’s continuation as a going concern
−Removed: is dependent upon its ability to generate sufficient cash flow to meet its obligations on a timely basis and ultimately to attain
−Removed: profitability.
−Removed: The Company plans to seek additional funding to maintain its operations through debt and equity financing and to
−Removed: improve operating performance through a focus on strategic products and increased efficiencies in business processes and improvements
−Removed: to the cost structure.
−Removed: There is no assurance that the Company will be successful in its efforts to raise additional working capital
−Removed: or achieve profitable operations.
−Removed: The financial statements do not include any adjustments that might result from the outcome of
−Removed: this uncertainty.
+Added: The Company is hopeful that by the end of the third quarter of 2021, they will be allowed to continue
+Added: their marketing to the animal therapy market and attempt to increase the exposure to their product and generate revenue accordingly.
+Added: of March 31, 2021, the Company has $2,511,845 cash on hand.
+Added: There are currently commitments to vendors for products and services
+Added: To continue the development of the Company’s products, the current level of cash may not be enough to cover the
+Added: fixed and variable obligations of the Company.
+Added: is no guarantee that the Company will be able to raise additional funds or to do so at an advantageous price.
+Added: Company’s RadioGel™
+Added: device has the following product features:
+Added: particles only travel a short distance so the device can deliver high radiation to the tumor with minimal dose to the nearby
+Added: normal tissues.
+Added: In medical terms Y-90 beta emitter has a high efficacy rate;
+Added: from the short penetration distance, the patient can go home immediately with no fear of exposure to family members, and there
+Added: is a greatly reduced radiation risk to the doctor.
+Added: A simple plastic tube around the syringe, gloves and safety glasses are
+Added: all that is required.
+Added: Other gamma emitting products require much more protection;
+Added: 2.7-day half-life means that only 5% of the radiation remains after ten days.
+Added: This is in contrast to the industry-standard
+Added: gamma irradiation product, which has a half-life of 17 days;
+Added: short half-life also means that any medical waste can be stored for thirty days then disposed as normal hospital waste;
+Added: RadioGel™
+Added: can be administered with small diameter needles (27-gauge) so there is minimal damage to the normal tissue.
+Added: This is in contrast
+Added: to the injection of metal seeds, which does considerable damage;
+Added: about 120 days the gel resorbs by a normal biological cycle, called the Krebs Cycle.
+Added: The only remaining evidence of the treatment
+Added: are phosphate particles so small in diameter that it requires a high-resolution microscope to find them.
+Added: This is in contrast
+Added: to permanent presence of metal seeds.
+Added: from Production to Therapy
+Added: the next two years, the Company intends to outsource material aspects of manufacturing and distribution.
+Added: As future product volume
+Added: increases, the Company will reassess its make-buy decision on manufacturing and will analyze the cost/benefit of a centrally located
+Added: of the Hydrogel
+Added: RadioGel™
+Added: is manufactured with a proprietary process under ventilated sterile hood by following strict Good Laboratory Practices (“
+Added: It is made in large batches that are frozen for up to three months.
+Added: When the product is ready to ship, a small quantity
+Added: of the gel is dissolved in a sterile saline solution.
+Added: It is then passed through an ultra-fine filter to ensure sterility.
+Added: of the Yttrium-90 Phosphate Particles
+Added: Y-90 particles are produced with simple ingredients via a proprietary process, again following strict GLP procedures.
+Added: then mixed into a phosphate-buffered saline solution.
+Added: They can be produced in large batches for several shipments.
+Added: of particles per shipment is determined by the dose prescribed by the doctor.
+Added: RadioGel™
+Added: is shipped in two containers, one with a solution of the gel and the other with a solution of the particles.
+Added: Before shipment they
+Added: are subjected to sterility testing, again by strict procedures.
+Added: The vial with the Y-90 is put through a special radiation calibrator,
+Added: which measures beta particles.
+Added: The vials can be shipped via FedEx or UPS by following the proper protocols.
+Added: user receives the two vials.
+Added: The solution containing the RadioGel™
+Added: is mixed with the solution containing the Y-90 particles.
+Added: This is then shaken to ensure homogeneity and withdrawn into a syringe.
+Added: The quantities that are mixed are calculated from the
+Added: information on the product label.
+Added: specific injection technique depends on the Indication for Use.
+Added: For small tumors, one centimeter in diameter or less, the cancer
+Added: is treated with a single injection.
+Added: For larger tumors, the cancer is treated with a series of small injections from the same syringe
+Added: or multiple syringes.
+Added: Company is currently pursuing two synergistic business sectors, medical and veterinary, each of which are summarized below.
+Added: RadioGel™
+Added: is currently fully developed, requiring only FDA approval before commercialization.
+Added: The Company has been seeking FDA approval
+Added: of RadioGel™
+Added: for almost five years.
+Added: Recent progress has been delayed due to a lack of adequate funding.
+Added: The principal issue
+Added: preventing approval is that the Company attempted to obtain regulatory approval for a broad range of Indications for Use, including
+Added: all non-resectable cancers, without sufficient supporting data.
+Added: on the FDA’s ruling of RadioGel™
+Added: as a device, the Company is currently developing test plans to address issues raised
+Added: in the Company’s prior FDA submittal regarding RadioGel™.
+Added: The Company intends to request FDA approval to submit RadioGel™
+Added: for de novo classification, which would reclassify the device from a Class III device to a Class II device and accelerate
+Added: the regulatory approval path.
+Added: analyzing the Company’s data and the last five years of communication from the FDA, the Company has taken the following
+Added: new leadership, the Company is implementing all past recommendations from the FDA.
+Added: The Company intends to narrow the Indications
+Added: for Use, will provide test plans for FDA review to respond to answer all previous FDA questions, and will request a pre-submission
+Added: a pre-submission request document and FDA meeting request to obtain feedback on the test plans in order to initiate testing,
+Added: to present the proposed content for the final application and to request permission to submit a de novo;
+Added: an Investigational Device Exemption (“
+Added: IDE ”) to obtain permission to conduct human clinical studies;
+Added: a de novo or Pre-Market Approval application.
+Added: critical path is the required testing –
+Added: in vitro, animal testing, human clinical studies –
+Added: all of which is resource
+Added: previous submittals, the Company proposed applying a very broad range of cancer therapies, referred to as Indications for Use,
+Added: to RadioGel™.
+Added: The FDA has strongly advised the Company to reduce its Indications for Use.
+Added: To comply with that request, the
+Added: Company has expanded its MAB, consisting of Drs.
+Added: Pressman (Chairman), Albert DeNittis, and Howard Sandler.
+Added: MAB evaluated the candidate cancer therapies based on three criteria:
+Added: (i) the potential for FDA approval and successful therapy;
+Added: (ii) notable advantages of RadioGel™
+Added: over current therapies;
+Added: and (iii) the likelihood that RadioGel™
+Added: can be widely
+Added: accepted by the medical community and profitably commercialized.
+Added: MAB selected eighteen Indications for Use for RadioGel™, each of which meets the above-mentioned criteria.
+Added: These eighteen
+Added: Indications for Use are listed below.
+Added: This large number confirms the wide applicability of the device and defines the path for
+Added: future growth.
+Added: The Company intends to apply to the FDA for a single Indication for Use, followed by subsequent applications for
+Added: additional Indications for Use.
+Added: The initial application should facilitate each subsequent application, and the testing for many
+Added: of the subsequent applications could be conducted in parallel, depending on available resources.
+Added: Non-dendritic
+Added: cancers –
+Added: several types
+Added: Gynecological
+Added: and neck (including sino-nasal and oropharyngeal)
+Added: cancer resection cavity
+Added: thorough review to prioritize indications, the MAB has selected basal cell and squamous cell carcinoma (skin cancers) as the first
+Added: Indication for Use to be presented to the FDA.
+Added: According to American Cancer Society, one out of every three new cancers diagnosed
+Added: is a cancerous skin lesion of this type, representing 5.5 million tumors annually.
+Added: The MAB believes RadioGel™
+Added: will be the preferred treatment in a reasonable number of cases in a very large market.
+Added: are approximately 150 million pet dogs and cats in the United States.
+Added: Nearly one-half of dogs and one-third of cats are diagnosed
+Added: with cancer at some point in their lifetime.
+Added: The Veterinary Oncology & Hematology Center in Norwalk, Connecticut, reports
+Added: that cancer is the number one natural cause of death in older cats and dogs, accounting for nearly 50 percent of pet deaths each
+Added: The American Veterinary Medical Association reports that half of the dogs ten years or older will die because of cancer.
+Added: The National Cancer Institute reports that about six million dogs are diagnosed with cancer each year, translating to more than
+Added: 16,000 a day.
+Added: Company’s IsoPet ®
+Added: operating division focuses on the veterinary oncology market.
+Added: Alice Villalobos, a founding
+Added: member of the Veterinary Cancer Society and the Chair of our Veterinary Medicine Advisory Board, has been providing guidance to
+Added: management regarding this market.
+Added: The Veterinary Medicine Advisory Board gives us recommendations regarding the overall strategy
+Added: for our animal business sector.
+Added: Specially, they recommended the university veterinary hospitals for demonstration therapies, the
+Added: specific cancers to be treated, and have provided business contact information to the private clinics.
+Added: of the product and application techniques and animal testing is allowed under FDA regulation.
+Added: Commercial sales of RadioGel TM
+Added: for animals requires confirmation by the FDA Center for Veterinary Medicine (“
+Added: CVM ”).
+Added: In January 2018,
+Added: the Center for Veterinary Medicine Product Classification Group, the entity within the CVM that is responsible for determining
+Added: the classification of a product, ruled that RadioGel TM should be classified as a device for animal therapy of feline
+Added: sarcomas and canine soft tissue sarcomas.
+Added: Additionally,
+Added: after a legal review, the Company believes that the device classification obtained from the FDA Center for Veterinary Medicine
+Added: is not limited to canine and feline sarcomas, but rather may be extended to a much broader population of veterinary cancers, including
+Added: all or most all solid tumors in animals.
+Added: We expect the result of such classification and label approval will be that no additional
+Added: regulatory approvals are necessary for the use of RadioGel TM for the treatment of solid tumors in animals.
+Added: does not have premarket authority over devices with a veterinary classification, and the manufacturers are responsible for assuring
+Added: that the product is safe, effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.
+Added: Company currently intends to utilize university veterinary hospitals for therapy development, given that veterinary hospitals
+Added: offer superior and plentiful veterinarians and students, a large number of animal patients, radioactive material handling licenses,
+Added: and are respected by private veterinary centers and hospitals.
+Added: to the terms of the grant with Washington State University, it was responsible for conducting studies regarding in vivo dosimetry
+Added: and toxicity of intralesional Y-90 phosphate nanoparticles for the treatment of spontaneous feline and canine sarcomas.
+Added: of the grant was October 1, 2016 through January 31, 2018.
+Added: The Company provided the university with the RadioGel TM
+Added: required to complete the studies, as well as technical support for dosimetry calculations.
+Added: All payments provided to Washington
+Added: State University in relation to the grant were made by Washington State Life Sciences Discovery Fund pursuant to a grant and were
+Added: not paid by the Company.
+Added: To compliment the grant, additional scope was added to explore the option of pre-mixing the vials prior
+Added: to shipment and the Company was reimbursed $17,583 as a separate contract to the grant.
+Added: to the terms of the contract with the University of Missouri, it was responsible for conducting studies regarding in vivo dosimetry
+Added: and toxicity of intralesional Y-90 phosphate nanoparticles for the treatment of soft tissue carcinoma and equine sarcoids.
+Added: term of the contract was initially from November 1, 2017 through October 31, 2018, but it has recently been working to extend
+Added: this contract through testing completion on canine soft tissue sarcoma and equine sarcoids, plus additional tumors of interest
+Added: defined by the University of Missouri principal investigators.
+Added: This extension is dependent upon keeping current with paying for
+Added: the expenses of the ongoing therapies.
+Added: Company competes in a market characterized by technological innovation, extensive research efforts, and significant competition.
+Added: pharmaceutical and biotechnology industries are intensely competitive and subject to rapid and significant technological changes.
+Added: A number of companies are pursuing the development of pharmaceuticals and products that target the same diseases and conditions
+Added: that our products target.
+Added: We cannot predict with accuracy the timing or impact of the introduction of potentially competitive
+Added: products or their possible effect on our sales.
+Added: Certain potentially competitive products to our products may be in various stages
+Added: of development.
+Added: Also, there may be many ongoing studies with currently marketed products and other developmental products, which
+Added: may yield new data that could adversely impact the use of our products in their current and potential future Indications for Use.
+Added: The introduction of competitive products could significantly reduce our sales, which, in turn would adversely impact our financial
+Added: and operating results.
+Added: are a wide variety of cancer treatments approved and marketed in the U.S.
+Added: and globally.
+Added: General categories of treatment include
+Added: surgery, chemotherapy, radiation therapy and immunotherapy.
+Added: These products have a diverse set of success rates and side effects.
+Added: The Company’s products, including RadioGel™, fall into the brachytherapy treatment category.
+Added: There are a number of
+Added: brachytherapy devices currently marketed in the U.S.
+Added: and globally.
+Added: The traditional iodine-125 (I-125) and palladium-103 (Pd-103)
+Added: technologies for brachytherapy are well entrenched with powerful market players controlling the market.
+Added: The industry-standard
+Added: I-125-based therapy was developed by Oncura, which is a unit of General Electric Company.
+Added: Additionally, C.R.
+Added: Bard, a major industry
+Added: player competes in the I-125 brachytherapy marketplace.
+Added: These market competitors are also involved in the distribution of Pd-103
+Added: based products.
+Added: Cs-131 brachytherapy products are sold by IsoRay.
+Added: Several Y-90 therapies have been FDA approved including SIR-Spheres
+Added: by Sirtex, TheraSphere by Biocompatibles UK and Zevalin by Spectrum Pharmaceuticals.
+Added: Company currently subcontracts the manufacturing of RadioGel TM at IsoTherapeutics.
+Added: Eckert and Ziegler the only supplier
+Added: of Y-90 in the United States, is the sole supplier of the Y-90 used by IsoTherapeutics to manufacture the Company’s RadioGel™.
+Added: The Company obtains supplies, hardware, handling equipment and packaging from several different U.S.
+Added: Company anticipates that potential customers for our potential brachytherapy products likely would include those institutions
+Added: and individuals that currently purchase brachytherapy products or other oncology treatment products.
+Added: Company’s present and future intended activities in the development, manufacturing and sale of cancer therapy products,
+Added: including RadioGel™, are subject to extensive laws, regulations, regulatory approvals and guidelines.
+Added: Within the United
+Added: States, the Company’s therapeutic radiological devices must comply with the U.S.
+Added: Federal Food, Drug and Cosmetic Act, which
+Added: is enforced by FDA.
+Added: The Company is also required to adhere to applicable FDA Quality System Regulations, also known as the Good
+Added: Manufacturing Practices, which include extensive record keeping and periodic inspections of manufacturing facilities.
+Added: the United States, the FDA regulates, among other things, new product clearances and approvals to establish the safety and efficacy
+Added: of these products.
+Added: We are also subject to other federal and state laws and regulations, including the Occupational Safety and
+Added: Health Act and the Environmental Protection Act.
+Added: Federal Food, Drug, and Cosmetic Act and other federal statutes and regulations govern or influence the research, testing, manufacture,
+Added: safety, labeling, storage, record keeping, approval, distribution, use, reporting, advertising and promotion of such products.
+Added: Noncompliance with applicable requirements can result in civil penalties, recall, injunction or seizure of products, refusal of
+Added: the government to approve or clear product approval applications, disqualification from sponsoring or conducting clinical investigations,
+Added: preventing us from entering into government supply contracts, withdrawal of previously approved applications, and criminal prosecution.
+Added: the United States, medical devices are classified into three different categories over which the FDA applies increasing levels
+Added: of regulation:
+Added: Class I, Class II, and Class III.
+Added: Most Class I devices are exempt from premarket notification 510(k);
+Added: II devices require premarket notification 510(k);
+Added: and most Class III devices require premarket approval.
+Added: RadioGel™
+Added: classified as a Class III device.
+Added: of new Class III medical devices is a lengthy procedure and can take a number of years and require the expenditure of significant
+Added: There is a shorter FDA review and clearance process for Class II medical devices, the premarket notification or 510(k)
+Added: process, whereby a company can market certain Class II medical devices that can be shown to be substantially equivalent to other
+Added: legally marketed devices.
+Added: Company intends to apply for a de novo with an anticipated expenditure of $10.0 million over the next four years.
+Added: expenditure estimate includes anticipated costs associated with in vitro and in vivo pre-clinical testing, our application for
+Added: an Investigational Device Exemption, Phase I and Phase II clinical trials and our application for a de novo .
+Added: a registered medical device manufacturer with the FDA, we are subject to inspection to ensure compliance with FDA’s current
+Added: Good Manufacturing Practices, or cGMP.
+Added: These regulations require that we and any of our contract manufacturers design, manufacture
+Added: and service products, and maintain documents in a prescribed manner with respect to manufacturing, testing, distribution, storage,
+Added: design control, and service activities.
+Added: Modifications or enhancements that could significantly affect the safety or effectiveness
+Added: of a device or that constitute a major change to the intended use of the device require a new 510(k) premarket notification for
+Added: any significant product modification.
+Added: Medical Device Reporting regulation requires that we provide information to the FDA on deaths or serious injuries alleged to be
+Added: associated with the use of our devices, as well as product malfunctions that are likely to cause or contribute to death or serious
+Added: injury if the malfunction were to recur.
+Added: Labeling and promotional activities are regulated by the FDA and, in some circumstances,
+Added: by the Federal Trade Commission.
+Added: a medical device manufacturer, we are also subject to laws and regulations administered by governmental entities at the federal,
+Added: state and local levels.
+Added: For example, our facility is licensed as a medical device manufacturing facility in the State of Washington
+Added: and is subject to periodic state regulatory inspections.
+Added: Our customers are also subject to a wide variety of laws and regulations
+Added: that could affect the nature and scope of their relationships with us.
+Added: the United States, as a manufacturer of medical devices and devices utilizing radioactive byproduct material, we are subject to
+Added: extensive regulation by not only federal governmental authorities, such as the FDA and FAA, but also by state and local governmental
+Added: authorities, such as the Washington State Department of Health, to ensure such devices are safe and effective.
+Added: In Washington State,
+Added: the Department of Health, by agreement with the federal Nuclear Regulatory Commission (“
+Added: NRC ”), regulates the
+Added: possession, use, and disposal of radioactive byproduct material as well as the manufacture of radioactive sealed sources to ensure
+Added: compliance with state and federal laws and regulations.
+Added: RadioGel™
+Added: constitutes both medical devices and radioactive sealed
+Added: sources and are subject to these regulations.
+Added: our use, management, and disposal of certain radioactive substances and wastes are subject to regulation by several federal and
+Added: state agencies depending on the nature of the substance or waste material.
+Added: We believe that we are in compliance with all federal
+Added: and state regulations for this purpose.
+Added: Environmental
+Added: business does not require us to comply with any extraordinary environmental regulations.
+Added: Our RadioGel™
+Added: product is manufactured
+Added: in an independently owned and operated facility.
+Added: Any environmental effects or contamination event that could result would be from
+Added: the shipping company during shipment and misuse by the treatment facility upon arrival.
+Added: of March 31, 2021, the Company had one full-time personnel.
+Added: The Company utilizes several independent contractors to assist with
+Added: its operations.
+Added: The Company does not have a collective bargaining agreement with any of its personnel and believes its relations
+Added: with its personnel are good.
+Added: of Operations
+Added: of the Three Months Ended March 31, 2021 and 2020
+Added: following table sets forth information from our statements of operations for the three months ended March 31, 2021 and 2020:
+Added: March 31, 2021
+Added: March 31, 2020
+Added: Operating loss
+Added: Non-operating income (expense):
+Added: Interest expense
+Added: was $0 for the three months ended March 31, 2021 and 2020, respectively.
+Added: expenses for the three months ended March 31, 2021 and 2020, respectively consists of the following:
+Added: March 31, 2021
+Added: March 31, 2020
+Added: Professional fees
+Added: Payroll expenses
+Added: Research and development
+Added: General and administrative
+Added: Total operating
+Added: expenses for the three months ended March 31, 2021 and 2020 was $235,090 and $120,373, respectively.
+Added: The increase in operating
+Added: expenses from 2020 to 2021 can be attributed to the increase in professional fees ($53,992 for the three months ended March 31,
+Added: 2020 versus $78,214 for the three months ended March 31, 2021) as the Company utilized more services due to amending their Regulation
+Added: A+ and the fees incurred for the consultants engaged;
+Added: the increase in general and administrative expense ($35,353 for the three
+Added: months ended March 31, 2020 versus $35,835 for the three months ended March 31, 2021);
+Added: the increase in research and development
+Added: ($1,028 for the three months ended March 31, 2020 versus $71,700 for the three months ended March 31, 2021) as the Company ramped
+Added: up the development of their products with the recent raising of capital , and an increase in payroll expenses ($30,000 for the
+Added: three months ended March 31, 2020 versus $49,341 for the three months ended March 31, 2021) related to the deferred compensation
+Added: criteria in the CEOs employment contract taking effect.
+Added: Non-Operating
+Added: Income (Expense)
+Added: Non-operating
+Added: income (expense) for the three months ended March 31, 2021 and 2020 consists of the following:
+Added: March 31, 2021
+Added: March 31, 2020
+Added: Interest expense
+Added: Forgiveness of debt
+Added: extinguishment
+Added: Non-operating
+Added: income (expense)
+Added: Non-operating
+Added: income (expense) for the three months ended March 31, 2021 varied from the three months ended March 31, 2020 primarily due to
+Added: a decrease in interest expense from $239,858 for the three months ended March 31, 2020 to $6,549 for the three months ended March
+Added: 31, 2021 as a result of conversions of notes payable.
+Added: The majority of the interest recorded by the Company consists of amortization
+Added: of debt discount, BCF discount and the exchange premium resulting in additional shares to the noteholders on conversion.
+Added: the Company converted a note in January 2021 which resulted in a loss on conversion and recognized a gain on forgiveness of debt
+Added: on old payables as they satisfied the agreement with this vendor to pay a portion of the payable with the remaining amount forgiven.
+Added: net loss for the three months ended March 31, 2021 and 2020 was $(288,189) and $(360,231), respectively.
+Added: and Capital Resources
+Added: March 31, 2021, the Company had working capital of $1,831,748, as compared to working capital of $32,034 at December 31, 2020.
+Added: During the three months ended March 31, 2021, the Company experienced negative cash flow from operations of $203,097 and realized
+Added: $1,811,238 of cash flows from financing activities.
+Added: As of March 31, 2021, the Company did not have any commitments for capital
+Added: expenditures.
+Added: used in operating activities increased from $87,247 for the three months ended March 31, 2020 to $203,097 for the three months
+Added: ended March 31, 2021.
+Added: Cash used in operating activities was primarily a result of the Company’s non-cash items, such as
+Added: loss from operations, loss conversion of debt as well as forgiveness of debt as well as the changes in prepaid expenses and accounts
+Added: Cash provided from financing activities increased from $71,870 for the three months ended March 31, 2020 to $1,811,238
+Added: for the three months ended March 31, 2021.
+Added: The increase in cash provided from financing activities was primarily a result of increase
+Added: in proceeds from the Regulation A+ where the Company raised $1,811,238 from common stock and warrant issuances in 2021 versus,
+Added: the proceeds from convertible notes and related party notes of $115,000, proceeds from the sale of common stock of $6,870 and
+Added: payment on the redemption of preferred stock of $50,000 in 2020.
+Added: Company has generated material operating losses since inception.
+Added: The Company had a net loss of $288,189 for the three months ended
+Added: March 31, 2021, and a net loss of $360,231 for the three months ended March 31, 2020.
+Added: The Company expects to continue to experience
+Added: net operating losses for the foreseeable future.
+Added: Historically, the Company has relied upon investor funds to maintain its operations
+Added: and develop the Company’s business.
+Added: The Company anticipates raising additional capital within the next twelve months for
+Added: working capital as well as business expansion, although the Company can provide no assurance that additional capital will be available
+Added: on terms acceptable to the Company, if at all.
+Added: If the Company is unable to obtain additional financing to meet its working capital
+Added: requirements, it may have to curtail its business or cease all operations.
+Added: the next 12 to 24 months, the Company believes it will cost approximately $2 million to fund:
+Added: (1) fund the FDA approval process
+Added: to conduct human clinical trials, (2) conduct Phase I, pilot, clinical trials, (3) activate several regional clinics to administer
+Added: across the county, (4) create an independent production center within the current production site to create
+Added: a template for future international manufacturing, and (5) initiate regulatory approval processes outside of the United States.
+Added: principal variables in the timing and amount of spending for the brachytherapy products in the next 12 to 24 months will be the
+Added: FDA’s classification of the Company’s brachytherapy products as Class II or Class III devices (or otherwise) and any
+Added: requirements for additional studies, which may possibly include clinical studies.
+Added: Thereafter, the principal variables in the amount
+Added: of the Company’s spending and its financing requirements would be the timing of any approvals and the nature of the Company’s
+Added: arrangements with third parties for manufacturing, sales, distribution and licensing of those products and the products’
+Added: success in the U.S.
+Added: and elsewhere.
+Added: The Company intends to fund its activities through strategic transactions such as licensing
+Added: and partnership agreements or additional capital raises.
+Added: the Company is seeking to raise additional capital and has engaged in numerous discussions with investment bankers and investors,
+Added: to date, the Company has not received firm commitments for the required funding.
+Added: Based upon its discussions, the Company anticipates
+Added: that if the Company is able to obtain the funding required to retire outstanding debt, pay past due payables and maintain its
+Added: current operating activities, that the terms associated with such funding will result in material dilution to existing shareholders.
+Added: geopolitical events, including the inherent instability and volatility in global capital markets, as well as the lack of liquidity
+Added: in the capital markets, could impact the Company’s ability to obtain financing and its ability to execute its business plan.
Policies and Estimates
6 unchanged sentences
estimates under different assumptions or conditions.
−Removed: During the period ended September 30, 2020, we believe there have been no
−Removed: significant changes to the items disclosed as significant accounting policies in management’s notes to the financial statements
−Removed: in our annual report on Form 10-K for the year ended December 31, 2019, filed on April 28, 2020.
+Added: During the period ended March 31, 2021, we believe there have been no significant
+Added: changes to the items disclosed as significant accounting policies in management’s notes to the consolidated financial statements
+Added: in our annual report on Form 10-K for the year ended December 31, 2020, filed on March 24, 2021.
Sheet Arrangements
4 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.