UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

 

For the quarterly period ended September 30, 2024

 

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

 

For the transition period from __________ to __________

 

Commission File Number: 001-36833

 

VOLITIONRX LIMITED

(Exact name of registrant as specified in its charter)

 

Delaware

91-1949078

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

1489 West Warm Springs Road, Suite 110

Henderson, Nevada

89014

(Address of principal executive offices)

(Zip Code)

 

+1 (646) 650–1351

(Registrant’s telephone number, including area code)

 

N/A

(Former name, former address and former fiscal year, if changed since last report)

 

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

 

Title of Each Class

Trading Symbol(s)

Name of Each Exchange on Which Registered

Common Stock, par value $0.001 per share

VNRX

NYSE American, LLC

 

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

 

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

 

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

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

 

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

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes     ☒ No

 

As of November 6, 2024, there were 92,664,812 shares of the registrant’s $0.001 par value common stock issued and outstanding.

 

 

 

 

VOLITIONRX LIMITED

 

QUARTERLY REPORT ON FORM 10-Q

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2024

 

TABLE OF CONTENTS

 

PART I

FINANCIAL INFORMATION

PAGE

 

 

 

 

 

 

Item 1.

FINANCIAL STATEMENTS (UNAUDITED)

4

 

Item 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

31

 

Item 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

39

 

Item 4.

CONTROLS AND PROCEDURES

39

 

 

 

 

 

 

PART II

OTHER INFORMATION

 

 

 

 

 

 

Item 1.

LEGAL PROCEEDINGS

41

 

Item 1A.

RISK FACTORS

41

 

Item 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

41

 

Item 3.

DEFAULTS UPON SENIOR SECURITIES

41

 

Item 4.

MINE SAFETY DISCLOSURES

41

 

Item 5.

OTHER INFORMATION

41

 

Item 6.

EXHIBITS

42

 

 

 

 

 

 

SIGNATURES

44

 

 

Use of Terms

 

Except as otherwise indicated by the context, references in this Quarterly Report on Form 10-Q to the “Company,” “VolitionRx,” “Volition,” “we,” “us,” and “our” are references to VolitionRx Limited and its wholly owned subsidiaries, Volition Global Services SRL, Singapore Volition Pte. Limited, Belgian Volition SRL, Volition Diagnostics UK Limited, Volition America, Inc., and its majority-owned subsidiary, Volition Veterinary Diagnostics Development LLC. Additionally, unless otherwise specified, all references to “$” refer to the legal currency of the United States of America.

 

NucleosomicsTM, Capture-PCRTM, Nu.Q® and their respective logos are trademarks and/or service marks of VolitionRx and its subsidiaries. All other trademarks, service marks and trade names referred to herein are the property of their respective owners.

 

 
2

Table of Contents

 

 

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024, or this Report, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which statements are subject to considerable risks and uncertainties. These forward-looking statements are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact included in this Report or incorporated by reference into this Report are forward-looking statements. These statements include, among other things, statements regarding predictions of earnings, revenues, expenses or other financial items; plans or expectations with respect to our development activities or business strategy; clinical studies and results; industry trends; anticipated demand for our products, or the products of our competitors; manufacturing forecasts, and the potential impact of our relationship with contract manufacturers and original equipment manufacturers on our business; the commercialization of our products and the relationships and anticipated outcome of our engagements with our licensors; the future cost and potential benefits of our research and development efforts; forecasts of our liquidity position or available cash resources; our anticipated use of our cash reserves; the impact of pending litigation; and statements relating to the assumptions underlying any of the foregoing. Throughout this Report, we have attempted to identify forward-looking statements by using words such as “may,” “believe,” “will,” “could,” “project,” “anticipate,” “expect,” “estimate,” “should,” “continue,” “potential,” “plan,” “forecasts,” “goal,” “seek,” “intend,” other forms of these words or similar words or expressions or the negative thereof (although not all forward-looking statements contain these words).

 

We have based our forward-looking statements on our current expectations and projections about trends affecting our business and industry and other future events. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Forward-looking statements are subject to substantial risks and uncertainties that could cause our future business, financial condition, results of operations or performance, to differ materially from our historical results or those expressed or implied in any forward-looking statement contained in this Report.

 

Some significant factors that may impact our estimates and forward-looking statements include, but are not limited to:

 

·

Our inability to generate any significant revenues or achieve profitability;

·

Our need to raise additional capital in the future;

·

Our expansion of our product development and sales and marketing capabilities could give rise to difficulties in managing our growth;

·

Our dependence on third-party distributors;

·

Our limited experience with sales and marketing;

·

The possibility that we may not be able to continue to operate, as indicated by the “going concern” opinion from our auditors;

·

Our ability to successfully develop, manufacture, market, and sell our future products;

·

Our ability to timely obtain necessary regulatory clearances or approvals to distribute and market our future products;

·

The acceptance by the marketplace of our future products;

·

The highly competitive and rapidly changing nature of the diagnostics market;

·

Protection of our patents, intellectual property and trade secrets;

·

Our reliance on third parties to manufacture and supply our intended products, and such manufacturers’ dependence on third-party suppliers;

·

Pressures related to macroeconomic and geopolitical conditions;

·

The material weaknesses in our internal control over financial reporting that we have identified; and

·

Other risks identified elsewhere in this Report, as well as in our other filings with the Securities and Exchange Commission or (the “SEC”).

 

 In addition, actual results may differ as a result of additional risks and uncertainties of which we are currently unaware or which we do not currently view as material to our business. For these reasons, readers are cautioned not to place undue reliance on any forward-looking statements. Our actual financial condition and results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed in the sections entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” within this Report, as well as in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the SEC on March 25, 2024, or our Annual Report, in the documents that we file as exhibits to this Report and the documents that we incorporate by reference into this Report, with the understanding that our future results may be materially different from what we currently expect. The forward-looking statements we make speak only as of the date on which they are made. Except as required by law or the listing rules of the NYSE American Market, we expressly disclaim any intent or obligation to update any forward-looking statements after the date hereof. If we do update or correct any forward-looking statements, readers should not conclude that we will make additional updates or corrections. We qualify all of our forward-looking statements with these cautionary statements.

 

 
3

Table of Contents

  

PART I FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS (UNAUDITED)

 

 

Page

 

 

 

Condensed Consolidated Balance Sheets

 

5

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

 

6

 

Condensed Consolidated Statements of Stockholders’ Deficit

 

7

 

Condensed Consolidated Statements of Cash Flows

 

9

 

Notes to the Condensed Consolidated Financial Statements

 

10

 

 

 
4

Table of Contents

  

VOLITIONRX LIMITED

Condensed Consolidated Balance Sheets

(Expressed in United States Dollars, except share numbers)

 

 

 

September 30,

 

 

December 31,

 

 

 

2024

 

 

2023

 

 

 

$

 

 

$

 

ASSETS

 

(UNAUDITED)

 

 

 

 

Current Assets

 

 

 

 

 

 

Cash and cash equivalents

 

 

5,414,146

 

 

 

20,729,983

 

Accounts receivable

 

 

312,611

 

 

 

242,617

 

Prepaid expenses

 

 

689,995

 

 

 

521,370

 

Other current assets

 

 

384,189

 

 

 

360,125

 

Total Current Assets

 

 

6,800,941

 

 

 

21,854,095

 

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

4,908,148

 

 

 

5,523,013

 

Operating lease right-of-use assets

 

 

635,857

 

 

 

549,504

 

Intangible assets, net

 

 

335,309

 

 

 

23,886

 

Total Assets

 

 

12,680,255

 

 

 

27,950,498

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

 

2,485,077

 

 

 

3,211,287

 

Accrued liabilities

 

 

3,480,207

 

 

 

3,928,761

 

Deferred revenue

 

 

22,893,400

 

 

 

23,000,000

 

Management and directors’ fees payable

 

 

24,851

 

 

 

59,625

 

Current portion of long-term debt

 

 

965,021

 

 

 

1,207,007

 

Current portion of finance lease liabilities

 

 

49,990

 

 

 

48,570

 

Current portion of operating lease liabilities

 

 

219,060

 

 

 

199,323

 

Current portion of grant repayable

 

 

65,646

 

 

 

55,855

 

Warrant liability

 

 

96,225

 

 

 

126,649

 

Total Current Liabilities

 

 

30,279,477

 

 

 

31,837,077

 

 

 

 

 

 

 

 

 

 

Long-term debt, net of current portion

 

 

3,837,950

 

 

 

3,624,860

 

Finance lease liabilities, net of current portion

 

 

366,175

 

 

 

400,022

 

Operating lease liabilities, net of current portion

 

 

448,045

 

 

 

378,054

 

Grant repayable, net of current portion

 

 

388,898

 

 

 

422,707

 

Total Long-Term Liabilities

 

 

5,041,068

 

 

 

4,825,643

 

Total Liabilities

 

 

35,320,545

 

 

 

36,662,720

 

 

 

 

 

 

 

 

 

 

Stockholders' Deficit

 

 

 

 

 

 

 

 

Common Stock

 

 

 

 

 

 

 

 

Authorized: 175,000,000 shares of common stock, at $0.001 par value per share

 

 

 

 

 

 

 

 

Issued and outstanding: 92,392,570 shares and 81,898,321 shares, respectively

 

 

92,393

 

 

 

81,898

 

Additional paid-in capital

 

 

202,014,277

 

 

 

194,448,414

 

Accumulated other comprehensive income

 

 

140,272

 

 

 

243,940

 

Accumulated deficit

 

 

(223,750,970)

 

 

(202,576,507)

Total VolitionRx limited Stockholders' Deficit

 

 

(21,504,028)

 

 

(7,802,255)

Non-controlling interest

 

 

(1,136,262)

 

 

(909,967)

Total Stockholders’ Deficit

 

 

(22,640,290)

 

 

(8,712,222)

 

 

 

 

 

 

 

 

 

Total Liabilities and Stockholders’ Deficit

 

 

12,680,255

 

 

 

27,950,498

 

 

 

 

 

 

 

 

 

 

(The accompanying notes are an integral part of these condensed consolidated financial statements)

 

 
5

Table of Contents

  

VOLITIONRX LIMITED

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

(Expressed in United States Dollars, except share numbers)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

$

 

 

$

 

 

$

 

 

$

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

Services

 

 

68,434

 

 

 

37,688

 

 

 

155,713

 

 

 

93,207

 

Product

 

 

406,088

 

 

 

127,523

 

 

 

886,141

 

 

 

438,122

 

Total Revenues

 

 

474,522

 

 

 

165,211

 

 

 

1,041,854

 

 

 

531,329

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,473,782

 

 

 

4,650,658

 

 

 

11,819,106

 

 

 

15,007,623

 

General and administrative

 

 

1,815,863

 

 

 

2,599,908

 

 

 

6,353,647

 

 

 

7,826,568

 

Sales and marketing

 

 

1,053,584

 

 

 

1,567,700

 

 

 

4,112,731

 

 

 

4,944,259

 

Total Operating Expenses

 

 

6,343,229

 

 

 

8,818,266

 

 

 

22,285,484

 

 

 

27,778,450

 

Operating Loss

 

 

(5,868,707)

 

 

(8,653,055)

 

 

(21,243,630)

 

 

(27,247,121)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Income (Expenses)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant income

 

 

85,378

 

 

 

48,656

 

 

 

85,378

 

 

 

214,451

 

Loss on disposal of fixed assets

 

 

(1,195)

 

 

(15,913)

 

 

(34,693)

 

 

(15,913)

Interest income

 

 

530

 

 

 

230

 

 

 

9,634

 

 

 

84,987

 

Interest expense

 

 

(89,456)

 

 

(53,980)

 

 

(247,871)

 

 

(163,623)

Gain on change in fair value of warrant liability

 

 

4,872

 

 

 

220,874

 

 

 

30,424

 

 

 

249,845

 

Total Other Income (Expenses)

 

 

129

 

 

 

199,867

 

 

 

(157,128)

 

 

369,747

 

Net Loss

 

 

(5,868,578)

 

 

(8,453,188)

 

 

(21,400,758)

 

 

(26,877,374)

Net Loss Attributable to Non-Controlling Interest

 

 

47,049

 

 

 

82,887

 

 

 

226,295

 

 

 

256,546

 

Net Loss Attributable to VolitionRx Limited Stockholders

 

 

(5,821,529)

 

 

(8,370,301)

 

 

(21,174,463)

 

 

(26,620,828)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Comprehensive Income (Loss)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

(141,980)

 

 

31,291

 

 

 

(103,668)

 

 

12,525

 

Net Comprehensive Loss

 

 

(6,010,558)

 

 

(8,421,897)

 

 

(21,504,426)

 

 

(26,864,849)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss Per Share – Basic and Diluted Attributable to VolitionRx Limited

 

 

(0.07)

 

 

(0.11)

 

 

(0.25)

 

 

(0.39)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted Average Shares Outstanding– Basic and Diluted

 

 

87,886,012

 

 

 

78,176,859

 

 

 

84,165,579

 

 

 

68,494,766

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(The accompanying notes are an integral part of these condensed consolidated financial statements)

 

 
6

Table of Contents

  

VOLITIONRX LIMITED

Condensed Consolidated Statements of Stockholders’ Deficit (Unaudited)

(Expressed in United States Dollars, except share numbers)

 

For the Nine Months Ended September 30, 2024 and September 30, 2023

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Non -

 

 

 

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Controlling

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income

 

 

Deficit

 

 

Interest

 

 

Total

 

 

 

#

 

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

Balance, December 31, 2023

 

 

81,898,321

 

 

 

81,898

 

 

 

194,448,414

 

 

 

243,940

 

 

 

(202,576,507)

 

 

(909,967)

 

 

(8,712,222)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock issued for cash, net of issuance costs

 

 

13,350

 

 

 

13

 

 

 

15,721

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

15,734

 

Common stock issued for settlement of RSUs

 

 

68,169

 

 

 

69

 

 

 

(69)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Common stock issued in lieu of license fee

 

 

129,132

 

 

 

129

 

 

 

125,129

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

125,258

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

411,220

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

411,220

 

Tax withholdings paid related to stock-based compensation

 

 

-

 

 

 

-

 

 

 

(3,062)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(3,062)

Foreign currency translation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

15,026

 

 

 

-

 

 

 

-

 

 

 

15,026

 

Net loss for the period

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(8,367,388)

 

 

(104,617)

 

 

(8,472,005)

Balance, March 31, 2024

 

 

82,108,972

 

 

 

82,109

 

 

 

194,997,353

 

 

 

258,966

 

 

 

(210,943,895)

 

 

(1,014,584)

 

 

(16,620,051)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock issued for cash, net of issuance costs

 

 

734,155

 

 

 

734

 

 

 

588,754

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

589,488

 

Common stock issued for settlement of RSUs

 

 

85,187

 

 

 

85

 

 

 

(85)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

208,046

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

208,046

 

Tax withholdings paid related to stock-based compensation

 

 

-

 

 

 

-

 

 

 

(38,205)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(38,205)

Foreign currency translation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

23,286

 

 

 

-

 

 

 

-

 

 

 

23,286

 

Net loss for the period

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(6,985,546)

 

 

(74,629)

 

 

(7,060,175)

Balance, June 30, 2024

 

 

82,928,314

 

 

 

82,928

 

 

 

195,755,863

 

 

 

282,252

 

 

 

(217,929,441)

 

 

(1,089,213)

 

 

(22,897,611)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock issued for cash, net of issuance costs

 

 

9,170,000

 

 

 

9,170

 

 

 

5,951,030

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

5,960,200

 

Common stock issued for settlement of RSUs

 

 

294,256

 

 

 

295

 

 

 

(295)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

323,539

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

323,539

 

Tax withholdings paid related to stock-based compensation

 

 

-

 

 

 

-

 

 

 

(15,860)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(15,860)

Foreign currency translation

 

 

-

 

 

 

-

 

 

 

 

 

 

 

(141,980)

 

 

-

 

 

 

-

 

 

 

(141,980)

Net loss for the period

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

 

 

(5,821,529)

 

 

(47,049)

 

 

(5,868,578)

Balance, September 30, 2024

 

 

92,392,570

 

 

 

92,393

 

 

 

202,014,277

 

 

 

140,272

 

 

 

(223,750,970)

 

 

(1,136,262)

 

 

(22,640,290)

 

(The accompanying notes are an integral part of these condensed consolidated financial statements)

 

 
7

Table of Contents

  

VOLITIONRX LIMITED

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)

(Expressed in United States Dollars, except share numbers)

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Non -

 

 

 

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Controlling

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Interest

 

 

Total

 

 

 

#

 

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

 

$

 

Balance, December 31, 2022

 

 

57,873,379

 

 

 

57,873

 

 

 

164,397,468

 

 

 

227,097

 

 

 

(167,257,429)

 

 

(551,971)

 

 

(3,126,962)

Common stock issued for cash, net of issuance costs

 

 

5,225,703

 

 

 

5,225

 

 

 

8,422,430

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

8,427,655

 

Common stock issued for settlement of RSUs

 

 

26,978

 

 

 

27

 

 

 

(27)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

693,657

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

693,657

 

Tax withholdings paid related to stock-based compensation

 

 

-

 

 

 

-

 

 

 

(14,336)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(14,336)

Common stock repurchased

 

 

(13,294)

 

 

(13)

 

 

(31,759)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(31,772)

Foreign currency translation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(56,478)

 

 

-

 

 

 

-

 

 

 

(56,478)

Net loss for the period

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(8,779,548)

 

 

(93,361)

 

 

(8,872,909)

Balance, March 31, 2023

 

 

63,112,766

 

 

 

63,112

 

 

 

173,467,433

 

 

 

170,619

 

 

 

(176,036,977)

 

 

(645,332)

 

 

(2,981,145)

Common stock issued for cash, net of issuance costs

 

 

14,950,000

 

 

 

14,950

 

 

 

17,071,656

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

17,086,606

 

Common stock issued for settlement of RSUs

 

 

74,598

 

 

 

75

 

 

 

(75)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

592,174

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

592,174

 

Tax withholdings paid related to stock-based compensation

 

 

-

 

 

 

-

 

 

 

(65,895)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(65,895)

Foreign currency translation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

37,712

 

 

 

-

 

 

 

-

 

 

 

37,712

 

Net loss for the period

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(9,470,979)

 

 

(80,298)

 

 

(9,551,277)

Balance, June 30, 2023

 

 

78,137,364

 

 

 

78,137

 

 

 

191,065,293

 

 

 

208,331

 

 

 

(185,507,956)

 

 

(725,630)

 

 

5,118,175

 

Issuance costs

 

 

-

 

 

 

-

 

 

 

(12,501)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(12,501)

Common stock issued for settlement of RSUs

 

 

206,053

 

 

 

206

 

 

 

(206)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

Stock-based compensation

 

 

-

 

 

 

-

 

 

 

537,980

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

537,980

 

Tax withholdings paid related to stock-based compensation

 

 

-

 

 

 

-

 

 

 

(73,066)

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(73,066)

Foreign currency translation

 

 

-

 

 

 

-

 

 

 

-

 

 

 

31,291

 

 

 

-

 

 

 

-

 

 

 

31,291

 

Net loss for the period

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(8,370,301)

 

 

(82,887)

 

 

(8,453,188)

Balance, September 30, 2023

 

 

78,343,417

 

 

 

78,343

 

 

 

191,517,500

 

 

 

239,622

 

 

 

(193,878,257)

 

 

(808,517)

 

 

(2,851,309)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(The accompanying notes are an integral part of these condensed consolidated financial statements)

 

 
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VOLITIONRX LIMITED

Condensed Consolidated Statements of Cash Flows (Unaudited)

(Expressed in United States Dollars)

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

 

$

 

 

$

 

Operating Activities

 

 

 

 

 

 

Net loss

 

 

(21,400,758)

 

 

(26,877,374)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

817,542

 

 

 

855,947

 

Amortization of operating lease right-of-use assets

 

 

169,273

 

 

 

194,036

 

Loss on disposal of fixed assets

 

 

34,693

 

 

 

15,913

 

Stock-based compensation

 

 

942,805

 

 

 

1,823,811

 

Gain on change in fair value of warrant liability

 

 

(30,424)

 

 

(249,845)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses

 

 

(168,625)

 

 

(2,402)

Accounts receivable

 

 

(69,992)

 

 

(34,441)

Other current assets

 

 

(24,064)

 

 

(45,785)

Deferred revenue, current and non-current

 

 

(106,600)

 

 

-

 

Accounts payable and accrued liabilities

 

 

(416,167)

 

 

12,128

 

Management and directors’ fees payable

 

 

(34,774)

 

 

(11,137)

Right-of-use assets operating leases liabilities

 

 

(174,758)

 

 

(191,586)

Net Cash Used In Operating Activities

 

 

(20,461,849)

 

 

(24,510,735)

Investing Activities

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(204,898)

 

 

(775,027)

Purchase of License

 

 

(171,095)

 

 

-

 

Net Cash Used In Investing Activities

 

 

(375,993)

 

 

(775,027)

Financing Activities

 

 

 

 

 

 

 

 

Net proceeds from issuances of common stock

 

 

6,565,422

 

 

 

25,795,654

 

Tax withholdings paid related to stock-based compensation

 

 

(57,127)

 

 

(80,231)

Common stock repurchased

 

 

-

 

 

 

(31,772)

Proceeds from grants repayable

 

 

-

 

 

 

27,052

 

Proceeds from long-term debt

 

 

754,457

 

 

 

216,908

 

Payments on long-term debt

 

 

(831,542)

 

 

(680,325)

Payments on grants repayable

 

 

(28,213)

 

 

-

 

Payments on finance lease obligations

 

 

(35,621)

 

 

(35,071)

Net Cash Provided By Financing Activities

 

 

6,367,376

 

 

 

25,212,215

 

Effect of foreign exchange on cash

 

 

(845,371)

 

 

15,244

 

Net change in cash and cash equivalents

 

 

(15,315,837)

 

 

(58,303)

Cash and cash equivalents – beginning of the period

 

 

20,729,983

 

 

 

10,867,050

 

Cash and cash equivalents – End of Period

 

 

5,414,146

 

 

 

10,808,747

 

 

 

 

 

 

 

 

 

 

Supplemental Disclosures of Cash Flow Information

 

 

 

 

 

 

 

 

Interest paid

 

 

247,871

 

 

 

163,623

 

Non-Cash Financing Activities

 

 

 

 

 

 

 

 

Common stock issued upon cashless exercises of stock options and settlement of vested RSUs

 

 

578

 

 

 

308

 

Offering costs from issuance of common stock

 

 

245,107

 

 

 

239,772

 

Fair value of warrants issued in connection with public offering

 

 

-

 

 

 

366,960

 

Common stock issued for License rights

 

 

125,258

 

 

 

-

 

Non-cash note payable

 

 

294,603

 

 

 

356,258

 

 

 

 

 

 

 

 

 

 

(The accompanying notes are an integral part of these condensed consolidated financial statements)

 

 
9

Table of Contents

  

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 1 – Basis of Presentation and Summary of Significant Accounting Policies

 

Basis of Presentation and use of estimates

 

The accompanying unaudited condensed consolidated financial statements of VolitionRx Limited (the “Company” or “VolitionRx”) have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q of Regulation S-X. They do not include all the information and footnotes required by GAAP for complete financial statements. The December 31, 2023 consolidated balance sheet data was derived from audited financial statements but does not include all disclosures required by GAAP. However, except as disclosed herein, there has been no material change in the information disclosed in the notes to the audited consolidated financial statements and accompanying notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March 25, 2024 (the “Annual Report”). The interim unaudited condensed consolidated financial statements should be read in conjunction with those audited consolidated financial statements included in the Annual Report. In the opinion of management, all adjustments considered necessary for a fair presentation of the financial statements, consisting solely of normal recurring adjustments, have been made. Operating results for the nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024.

 

The preparation of the Company's Condensed Consolidated Financial Statements requires management to make certain estimates and assumptions about future events. These estimates and the underlying assumptions affect the amounts of assets and liabilities reported and reported amounts of revenues and expenses. Such estimates include impairment of long-lived assets, accounts receivable, useful lives of intangible assets and property and equipment, fair values of stock-based awards, income taxes among others. These estimates and assumptions are based on management’s judgment. Estimates and underlying assumptions are reviewed on an ongoing basis. Changes in accounting estimates may be necessary if there are changes in the circumstances or experiences on which the estimate was based or as a result of new information. Changes in estimates, including those resulting from changes in the economic environment, are reflected in the period in which the change in estimate occurs.

 

Reclassifications

 

Certain reclassifications within operating expenses have been made to the prior period’s financial statements to conform to the current period financial statement presentation. There is no impact in total to the results of operations and cash flows in all periods presented.

 

Recently Issued Accounting Pronouncements

 

In November 2023, the Financial Accounting Standards Board (the “FASB” issued Accounting Standards Update (“ASU”) 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures,” which requires a public entity to disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods all disclosures about reportable segment’s profit or loss and assets that are currently required annually. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. These amendments are to be applied retrospectively. The Company is currently evaluating the impact this standard will have on its annual and interim consolidated financial statements.

 

In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures,” which enhances the transparency and decision usefulness of income tax disclosures by requiring: (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. These amendments are to be applied prospectively, with retrospective application permitted. The Company is currently evaluating the impact this standard will have on its annual and interim consolidated financial statements.

 

The Company currently believes there are no other issued and not yet effective accounting standards that are materially relevant to its condensed consolidated financial statements.

 

 
10

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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 1 - Basis of Presentation and Summary of Significant Accounting Policies (continued)

 

Fair Value Measurements

 

Pursuant to ASC 820, “Fair Value Measurements and Disclosures,” an entity is required to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 establishes a fair value hierarchy based on the level of independent, objective evidence surrounding the inputs used to measure fair value. A financial instrument’s categorization within the fair value hierarchy is based upon the lowest level of input that is significant to the fair value measurement. ASC 820 prioritizes the inputs into three levels that may be used to measure fair value:

 

Level 1

Level 1 applies to assets or liabilities for which there are quoted prices in active markets for identical assets or liabilities.

 

Level 2

Level 2 applies to assets or liabilities for which there are inputs other than quoted prices that are observable for the assets or liabilities such as quoted prices for similar assets or liabilities in active markets; quoted prices for identical assets or liabilities in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which significant inputs are observable or can be derived principally from, or corroborated by, observable market data.

 

Level 3

Level 3 applies to assets or liabilities for which there are unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of the assets or liabilities.

 

The financial instruments of the Company consist primarily of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, debt, and a warrant liability. These items are considered Level 1 due to their short-term nature and their market interest rates, except for the warrant liability, which is considered Level 2 and is recorded at fair value at the end of each reporting period.

 

Included in the following table are the Company’s major categories of assets and liabilities measured at fair value on a recurring basis as of September 30, 2024.

 

Fair Value Measurements at September 30, 2024

Description

Level 1

Level 2

Level 3

Total

$

$

$

$

Liabilities

Warrant liability

-96,225-96,225

 

As of December 31, 2023, the warrant liability was $126,649. The following table provides a roll-forward of the warrant liability measured at fair value on a recurring basis for the nine months ended September 30, 2024.

 

Warrant Liability

Total

$

Balance at December 31, 2023

126,649

Gain on change in fair value of warrant liability

(30,424)

Balance at September 30, 2024

96,225

  

Basic and Diluted Net Loss Per Share

 

The Company computes net loss per share in accordance with ASC 260, “Earnings Per Share,” which requires presentation of both basic and diluted earnings per share (“EPS”) on the face of the statement of operations and comprehensive loss. Basic EPS is computed by dividing net loss available to common stockholders (numerator) by the weighted average number of shares outstanding (denominator) during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method. In computing diluted EPS, the average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of stock options or warrants. As of September 30, 2024, 38,147,734 potential common shares equivalents from warrants, options, and restricted stock units (“RSUs”) were excluded from the diluted EPS calculations as their effect is anti-dilutive.

 

 
11

Table of Contents

 

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 2 – Liquidity and Going Concern Assessment

 

The Company's condensed consolidated financial statements are prepared using GAAP applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. Management assesses liquidity and going concern uncertainty in the Company’s consolidated financial statements to determine whether there is sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from the date the financial statements are issued, which is referred to as the “look-forward period,” as defined in GAAP. As part of this assessment, based on conditions that are known and reasonably knowable to management, management considered various scenarios, forecasts, projections, estimates and made certain key assumptions, including the timing and nature of projected cash expenditures or programs, its ability to delay or curtail expenditures or programs and its ability to raise additional capital, if necessary, among other factors.

 

For the nine months ended September 30, 2024, the Company incurred a net loss of $21.4 million and used cash flows in operating activities of $20.5 million. As of September 30, 2024, the Company had cash and cash equivalents of $5.4 million and an accumulated deficit of $223.8 million.

 

The Company has generated operating losses and has experienced negative cash flows from operations since inception. The Company has not generated significant revenues and expects to incur further losses in the future, particularly from continued development of its clinical-stage diagnostic tests and commercialization activities. The future of the Company as an operating business will depend on its ability to obtain sufficient capital contributions or, financing, and/or generate revenues as may be required to sustain its operations. Management plans to address the above as needed by, (a) granting licenses and/or distribution rights to third parties in exchange for specified up-front and/or back-end payments, (b) obtaining additional financing through debt or equity transactions, (c) securing additional grant funds, and (d) developing and commercializing its products in an efficient manner. Management continues to exercise tight cost controls to conserve cash. As part of the Company’s cash conservation efforts, directors and certain employees have elected to exchange a portion of their fees earned or paid in cash or salary, respectively, for RSUs in the Company for a period of up to six months.

 

The ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish the plans described in the preceding paragraph and to eventually attain profitable operations.

 

Management assessed the mitigating effect of these plans to determine if it is probable that the plans would be effectively implemented within one year after the condensed consolidated financial statements are issued and when implemented, would mitigate the relevant conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern. These plans are subject to market conditions and reliance on third parties, and there is no assurance that effective implementation of the Company’s plans will result in the necessary funding to continue current operations and satisfy current and expected debt obligations. The Company has implemented short-term cash preservation and cost-saving initiatives to conserve cash. The Company concluded that these plans do not alleviate the substantial doubt about the Company’s ability to continue as a going concern beyond one year from the date the condensed consolidated financial statements are issued.

 

The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The accompanying consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets and their carrying amounts, or the amounts and classification of liabilities that may result should the Company be unable to continue as a going concern. If the Company is unable to obtain adequate capital, it could be forced to cease operations.

 

 
12

Table of Contents

 

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 3 - Property and Equipment

 

The Company’s property and equipment consisted of the following amounts as of September 30, 2024 and December 31, 2023:

 

September 30, 2024

December 31, 2023

Useful Life

Cost $

Cost $

Computer hardware and software

3 years

751,488724,534

Laboratory equipment

5 years

4,847,6224,753,253

Office furniture and equipment

5 years

382,970378,800

Buildings

30 years

2,132,9272,113,031

Building improvements

5-15 years

1,690,2681,610,016

Land

Not amortized

133,715132,468

Total property and equipment

9,938,9909,712,102

Less accumulated depreciation

5,030,8424,189,089

Total property and equipment, net

4,908,1485,523,013

 

During the nine-month periods ended September 30, 2024 and September 30, 2023, the Company recognized $815,824 and $792,232, respectively, in depreciation expense.

 

 
13

Table of Contents

 

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 4 - Intangible Assets

 

The Company’s intangible assets consist of patents, mainly acquired in the acquisition of Belgian Volition. The patents are being amortized over the assets’ estimated useful lives, which range from 8 to 20 years.

 

September 30, 2024

December 31, 2023

Cost $

Cost $

Patents

1,148,9691,130,936

Licenses

296,353-

Total Patents and Licenses

1,445,3221,130,936

Less accumulated amortization

1,110,0131,107,050

Total patents and Licenses, net

335,30923,886

 

During the nine-month periods ended September 30, 2024 and September 30, 2023, the Company recognized $(6,742) and $63,715, respectively, in amortization expense.

 

The Company amortizes the patents and licenses on a straight-line basis with terms ranging from 8 to 20 years. The annual estimated amortization schedule over the next five years is as follows:

 

2024

$5,187

2025

$20,748

2026

$20,748

2027

$20,748

2028

$20,748

Greater than 5 years

$247,130

Total Intangible Assets

$335,309

 

The Company periodically reviews its long-lived assets to ensure that their carrying value does not exceed their fair market value. The Company carried out such a review in accordance with ASC 360, “Property, Plant and Equipment,” as of December 31, 2023. The result of this review confirmed that the ongoing value of the patents was not impaired as of December 31, 2023.

 

Note 5 - Related-Party Transactions

 

See Note 6, Common Stock, for common stock issued to related parties and Note 7, Stock-Based Compensation, for stock options, warrants and RSUs issued to related parties. The Company has agreements with related parties for the purchase of consultancy services which are accrued under management and directors’ fees payable (see condensed consolidated balance sheets).

 

 
14

Table of Contents

 

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 6 - Common Stock

 

As of September 30, 2024, the Company was authorized to issue 175 million shares of common stock, par value $0.001 per share, of which 92,392,570 and 81,898,321 shares were issued and outstanding as of September 30, 2024 and December 31, 2023, respectively.

 

Stock Option Exercises

 

During the nine months ended September 30, 2024, no shares of common stock were issued pursuant to the exercise of stock options.

 

Stock Options Expired / Cancelled

 

On April 16, 2024, 36,821 vested stock options previously granted to an employee were cancelled and returned as authorized shares under the 2015 Stock Incentive Plan (the “2015 Plan”) on the expiration of the exercise period following the resignation of such employee.

 

RSU Settlements

 

Below is a table summarizing the RSUs that vested and settled during the nine months ended September 30, 2024, all of which were issued pursuant to the 2015 Plan.

 

Equity Incentive Plan

RSUs Vested (#)

Vest Date

Shares Issued (#)

Shares Withheld for Taxes (#)

2015

21,582

Feb 8, 2024

21,582-

2015

9,000

Mar 1, 2024

6,0572,943

2015

44,217

Mar 27, 2024

40,5303,687

2015

51,000

Apr 4, 2024

32,33718,663

2015

50,000

May 1, 2024

34,49615,504

2015

11,500

Jun 1, 2024

6,6704,830

2015

14,962

Jun 15, 2024

11,6843,278

2015

4,667

Jul 13, 2024

3,1651,502

2015

29,000

Aug 15, 2024

21,2917,709

2015

2,000

Sep 11, 2024

2,000-

2015

2,500

Sep 21, 2024

2,500-

2015

332,775

Sep 28, 2024

265,30067,475
573,203447,612125,591

 

 
15

Table of Contents

 

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 6 - Common Stock (continued)

 

2023 Equity Capital Raise

 

In connection with the June 2023 underwritten public offering of the Company’s common stock under the Company’s Registration Statement on Form S-3 (File No. 333-259783) effective November 8, 2021 (the “2021 Form S-3”), and pursuant to the underwriting agreement with Prime Executions, Inc, doing business as Freedom Capital Markets (“Freedom”), dated June 1, 2023, (the “2023” Equity Capital Raise”) the Company issued as compensation to Freedom warrants to purchase an aggregate of 448,500 shares of Company common stock at an exercise price of $2.00 per share. The Company evaluated the warrants as either equity-classified or liability-classified instruments based on an assessment of the specific terms of the warrants and applicable authoritative guidance in ASC 480 and ASC 815-40. The Company determined the warrants issued to Freedom failed the indexation guidance under ASC 815-40, specifically, the warrants provide for a Black-Scholes value calculation in the event of certain transactions, which includes a floor on volatility utilized in the value calculation at 100% or greater. The Company has determined that this provision introduces leverage to the holders of the warrants that could result in a value that would be greater than the settlement amount of a fixed-for-fixed option on the Company’s own equity shares. Accordingly, pursuant to ASC 815-40, the Company has classified the fair value of the warrants as a liability upon issuance and marked to market each reporting period in the Company’s consolidated statement of operations until their exercise or expiration.

 

The fair value of the warrants issued in the 2023 Equity Capital Raise as of September 30, 2024, and December 31, 2023, were $96,225 and $126,649 respectively. The warrant liability was estimated using the Black-Scholes pricing model with the following assumptions.

 

September 30, 2024

December 31, 2023

Risk-free interest rate

3.58%3.89%

Expected volatility

84.85%76.30%

Expected life (years)

3.694.44

Expected dividend yield

--

Total fair value

$96,225$126,649

 

The fair value of the warrants issued in the 2023 Equity Capital Raise was deemed to be a liability, due to certain contingent put features, and was determined using the Black-Scholes option pricing model, which was deemed to be an appropriate model due to the terms of the warrants issued, including a fixed term and exercise price.

 

 
16

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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 6 - Common Stock (continued)

 

2024 Equity Capital Raise

 

On August 8, 2024, the Company entered into a securities purchase agreement with a purchaser pursuant to which the Company issued and sold to such purchaser, in a registered direct offering under the 2021 Form S-3 (the “2024 Equity Capital Raise”), an aggregate of 9,170,000 shares of the Company’s common stock, pre-funded warrants to purchase up to 3,557,273 shares of the Company’s common stock (the “Pre-Funded Warrants”), Series A common stock warrants to purchase up to 12,727,273 shares of the Company’s common stock (the “Series A Warrants”) and Series B common stock warrants to purchase up to 12,727,273 shares of the Company’s common stock (the “Series B Warrants” and, together with the Series A Warrants, the “Common Warrants” and, together with the shares of common stock offered in the 2024 Equity Capital Raise and the Pre-Funded Warrants, the “Securities”). The exercise prices of the Pre-Funded Warrants and the Common Warrants is $0.001 per share and $0.57 per share, respectively. H.C. Wainwright & Co. acted as the exclusive placement agent for the Company in the offering. The combined offering price for a share of common stock and accompanying Common Warrants was $0.55 and the combined offering price for a Pre-Funded Warrant and accompanying Common Warrants was $0.549. The net proceeds received by the Company for the issuance and sale of the Securities was $6.4 million, before deducting offering expenses of $0.1 million paid by the Company. In addition, the Company issued warrants to the placement agent to purchase an aggregate of 381,818 shares of Company common stock on substantially the same terms as the Series B Warrants at an exercise price of $0.6875 per share. The net proceeds above assumes the exercise of the Pre-Funded Warrants but excludes any proceeds arising from the exercise of the Common Warrants or the placement agent warrants.

 

Common Stock Issued for EpiCypher License Agreement

 

On March 12, 2024, the Company issued 129,132 shares of restricted common stock to EpiCypher, Inc. at a price of $0.97 per share as partial consideration for license rights in connection with a License Agreement between EpiCypher and Belgian Volition.

 

Equity Distribution Agreement

 

On May 20, 2022, the Company entered into an equity distribution agreement (the “2022 EDA”) with Jefferies LLC (“Jefferies”) to sell shares of the Company’s common stock, with an aggregate offering price of up to $25.0 million, from time to time through an “at the market” offering pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-259783) effective November 8, 2021 (the “2021 Form S-3”) through Jefferies acting as the Company’s agent and/or principal. The Company is not obligated to sell any shares under the 2022 EDA.

 

During the nine months ended September 30, 2024, the Company raised aggregate net proceeds (net of broker commissions and fees) of approximately $605,221 under the 2022 EDA through the sale of 747,505 shares of its common stock. As of September 30, 2024, the Company has raised aggregate net proceeds (net of broker commissions and fees) of approximately $2.1 million under the 2022 EDA through the sale of 1,378,037 shares of its common stock.

 

 
17

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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 7 – Stock-Based Compensation

 

a) (i) Common Stock Warrants

 

The following table summarizes the changes in common stock warrants of the Company outstanding during the nine-month period ended September 30, 2024.

 

Number of Warrants

Weighted Average Exercise Price ($)

Outstanding at December 31, 2023

862,5003.050

Granted

3,557,2730.001

Expired/Cancelled

--

Outstanding at September 30, 2024

4,419,7730.597

Exercisable at September 30, 2024

4,419,7730.597

 

Below is a table summarizing the common stock warrants issued and outstanding as of September 30, 2024, which have an aggregate weighted average remaining contractual life of 0.60 years. The proceeds if exercised assume the warrants are exercised for cash.

 

Number Outstanding

Number Exercisable

Exercise Price ($)

Weighted Average Remaining Contractual Life (Years)

Proceeds to

Company if Exercised ($)

3,557,273

3,557,2730.001-3,557

448,500

448,5002.0003.71897,000

54,000

54,0003.0504.01164,700

50,000

50,0003.4501.42172,500

125,000

125,0003.9502.25493,750

185,000

185,0004.9002.34906,500

4,419,773

4,419,7732,638,007

 

Stock-based compensation expense related to warrants of $5,238 and $25,447 was recorded in the nine months ended September 30, 2024 and September 30, 2023, respectively. Total remaining unrecognized compensation cost related to non-vested warrants is $nil. As of September 30, 2024, the total intrinsic value of warrants outstanding was $nil.

 

 
18

Table of Contents

 

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 7 – Stock-Based Compensation (continued)

 

a) (ii) Warrants – Series A and Series B Common Stock Warrants

 

The following table summarizes the changes in Series A and Series B common stock warrants of the Company outstanding during the nine-month period ended September 30, 2024.

 

Number of Warrants

Weighted Average Exercise Price ($)

Outstanding at December 31, 2023

--

Granted

25,836,3640.57

Exercised

--

Expired/Cancelled

--

Outstanding at September 30, 2024

25,836,3640.57

Exercisable at September 30, 2024

--

 

Below is a table summarizing the Series A and Series B common stock warrants issued and outstanding as of September 30, 2024, which have a maximum aggregate weighted average remaining contractual life of 3.88 years (assuming that certain Company milestones set forth in the warrants are not achieved). The proceeds if exercised as reflected in the table below assume the warrants are exercised for cash.

 

Description

Number

Outstanding

Number

Exercisable

Exercise

Price ($)

Weighted Average Remaining Contractual Life (Years)

Proceeds to Company if Exercised ($)

Investor A Warrants

12,727,273-0.57002.367,254,546

Investor B Warrants

12,727,273-0.57005.367,254,546

Placement Agent Series B Warrants

381,818-0.68754.86262,500
25,836,364-14,771,591

 

b) Options

 

The following table summarizes the changes in options outstanding of the Company during the nine-month period ended September 30, 2024.

 

 

 

Number

of Options

 

 

Weighted

Average

Exercise

Price ($)

 

Outstanding at December 31, 2023

 

 

4,699,569

 

 

 

3.87

 

Expired/Cancelled

 

 

(36,821)

 

 

3.40

 

Outstanding at September 30, 2024

 

 

4,662,748

 

 

 

3.88

 

 

 

 

 

 

 

 

 

 

Exercisable at September 30, 2024

 

 

4,662,748

 

 

 

3.88

 

 

 
19

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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 7 – Stock-Based Compensation (continued)

 

b) Options (continued)

 

Below is a table summarizing the options issued and outstanding as of September 30, 2024, all of which were issued pursuant to the Company’s 2011 Equity Incentive Plan (for option issuances prior to 2016) or the 2015 Plan (for option and RSU issuances commencing in 2016)and which have an aggregate weighted average remaining contractual life of 3.46 years. As of September 30, 2024, an aggregate of 9,700,000 shares of common stock were authorized for issuance under the 2015 Plan, of which 603,502 shares of common stock remained available for future issuance thereunder. At the Annual Meeting on July 2, 2024, the stockholders approved and adopted the Company’s 2024 Stock Incentive Plan (the “2024 Plan”) which authorizes up to 7,500,000 shares of common stock for issuance pursuant to awards granted under the 2024 Plan. The 2024 Plan had previously been approved by the Board of Directors of the Company on April 24, 2024. As of September 30, 2024, no shares of common stock have been granted under the 2024 Plan.

 

Number

Outstanding

 

 

Number

Exercisable

 

 

Exercise

Price ($)

 

 

Weighted Average Remaining

Contractual Life (Years)

 

 

Proceeds to

Company if Exercised ($)

 

 

585,000

 

 

 

585,000

 

 

 

3.25

 

 

 

0.36

 

 

 

1,901,250

 

 

944,748

 

 

 

944,748

 

 

 

3.40

 

 

 

6.84

 

 

 

3,212,143

 

 

740,000

 

 

 

740,000

 

 

 

3.60

 

 

 

5.61

 

 

 

2,664,000

 

 

1,607,837

 

 

 

1,607,837

 

 

 

4.00

 

 

 

1.98

 

 

 

6,431,348

 

 

89,163

 

 

 

89,163

 

 

 

4.38

 

 

 

3.32

 

 

 

390,534

 

 

50,000

 

 

 

50,000

 

 

 

4.80

 

 

 

2.25

 

 

 

240,000

 

 

646,000

 

 

 

646,000

 

 

 

5.00

 

 

 

2.49

 

 

 

3,230,000

 

 

4,662,748

 

 

 

4,662,748

 

 

 

 

 

 

 

 

 

 

 

18,069,275

 

 

Stock-based compensation expense related to stock options of $nil and $287,013 was recorded in the nine months ended September 30, 2024 and September 30, 2023, respectively. Total remaining unrecognized compensation cost related to non-vested stock options is $nil. As of September 30, 2024, the total intrinsic value of stock options outstanding was $nil.

 

c) Restricted Stock Units

 

Below is a table summarizing the RSUs issued and outstanding as of September 30, 2024, all of which were issued pursuant to the 2015 Plan.

 

 

 

RSUs (#)

 

 

Weighted Average Grant Date Fair Value Share Price ($)

 

Outstanding at December 31, 2023

 

 

3,634,952

 

 

 

1.01

 

Granted

 

 

844,313

 

 

 

0.71

 

Vested/Settled

 

 

(573,203)

 

 

1.40

 

Cancelled / Forfeited

 

 

(677,213)

 

 

0.83

 

Outstanding at September 30, 2024

 

 

3,228,849

 

 

 

0.90

 

 

 
20

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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 7 – Stock-Based Compensation (continued)

 

c) Restricted Stock Units (continued)

 

Below is a table summarizing the RSUs granted during the nine months ended September 30, 2024, all of which were issued pursuant to the 2015 Plan. The RSUs vest equally over periods stated on the dates noted, subject to the recipient’s continued service to the Company, and will result in the RSU compensation expense stated. On June 1, 2024, the Company granted 297,340 RSUs of common stock to certain directors and employees in exchange for their election to reduce their cash compensation for a period of three months for services provided to the Company. These RSUs will vest on May 1, 2025, subject to continued service by the recipient. On July 1, 2024, the Company granted 38,198 RSUs of common stock to an employee in exchange for the employee’s election to reduce their cash compensation for a period of three months for services provided to the Company. These RSUs will vest on June 1, 2025, subject to continued service by the recipient. On July 8, 2024, the Company granted 21,583 RSUs of common stock to a consultant in exchange for advisory services. These RSUs will vest on January 1, 2025, subject to continued service to the Company by the recipient. On September 1, 2024, the Company granted 343,192 RSUs of common stock to certain directors and employees in exchange for their election to reduce their cash compensation for a period of three months for services provided to the Company. These RSUs will vest on June 1, 2025, subject to continued service by the recipient. On September 30, 2024, the Company granted 15,000 RSUs to a non-employee director, vesting in three equal installments on the first, second and third anniversaries of the date of grant, subject to continued services by the recipient.

 

Equity Incentive Plan

RSUs Granted (#)

Grant Date

Vesting Period

First Vesting Date

Second Vesting Date

Third Vesting Date

RSU Expense ($)

2015

14,000

Feb 22, 2024

36 Months

Feb 22, 2025

Feb 22, 2026

Feb 22, 2027

13,589

2015

115,000

May 23, 2024

36 Months

May 23, 2025

May 23, 2026

May 23, 2027

85,389

2015

297,340

Jun 1, 2024

11 Months

May 1, 2025

N/A

N/A

209,832

2015

38,198

Jul 1, 2024

11 Months

Jun 1, 2025

N/A

N/A

23,645

2015

21,583

Jul 8, 2024

6 Months

Jan 1, 2025

N/A

N/A

13,209

2015

343,192

Sep 1, 2024

9 Months

Jun 1, 2025

N/A

N/A

247,098

2015

15,000

Sep 30, 2024

36 Months

Sep 30, 2025

Sep 30, 2026

Sep 30, 2027

9,015

844,313

601,777

 

 
21

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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 7 – Stock-Based Compensation (continued)

 

c) Restricted Stock Units (continued)

 

Below is a table summarizing the RSUs vested and settled during the nine months ended September 30, 2024, all of which were issued pursuant to the 2015 Plan.

 

Equity Incentive Plan

 

RSUs Vested (#)

 

 

Vest Date

 

Shares Issued (#)

 

 

Shares Withheld for Taxes (#)

 

2015

 

 

21,582

 

 

Feb 8, 2024

 

 

21,582

 

 

 

-

 

2015

 

 

9,000

 

 

Mar 1, 2024

 

 

6,057

 

 

 

2,943

 

2015

 

 

44,217

 

 

Mar 27, 2024

 

 

40,530

 

 

 

3,687

 

2015

 

 

51,000

 

 

Apr 4, 2024

 

 

32,337

 

 

 

18,663

 

2015

 

 

50,000

 

 

May 1, 2024

 

 

34,496

 

 

 

15,504

 

2015

 

 

11,500

 

 

Jun 1, 2024

 

 

6,670

 

 

 

4,830

 

2015

 

 

14,962

 

 

Jun 15, 2024

 

 

11,684

 

 

 

3,278

 

2015

 

 

4,667

 

 

Jul 13, 2024

 

 

3,165

 

 

 

1,502

 

2015

 

 

29,000

 

 

Aug 15, 2024

 

 

21,291

 

 

 

7,709

 

2015

 

 

2,000

 

 

Sep 11, 2024

 

 

2,000

 

 

 

-

 

2015

 

 

2,500

 

 

Sep 21, 2024

 

 

2,500

 

 

 

-

 

2015

 

 

332,775

 

 

Sep 28, 2024

 

 

265,300

 

 

 

67,475

 

 

 

 

573,203

 

 

 

 

 

447,612

 

 

 

125,591

 

 

 
22

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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 7 – Stock-Based Compensation (continued)

 

c) Restricted Stock Units (continued)

 

Below is a table summarizing the RSUs cancelled during the nine months ended September 30, 2024, all of which were originally issued pursuant to the 2015 Plan.

 

Equity Incentive Plan

 

RSUs (#)

 

 

Cancellation Date

 

Vesting Date

 

RSUs Cancelled (#)

 

2015

 

 

8,000

 

 

Jan 16, 2024

 

Sep 28, 2024

 

 

8,000

 

2015

 

 

6,000

 

 

Jan 16, 2024

 

Oct 4, 2024

 

 

6,000

 

2015

 

 

8,000

 

 

Jan 16, 2024

 

Sep 28, 2025

 

 

8,000

 

2015

 

 

6,000

 

 

Jan 16, 2024

 

Oct 4, 2025

 

 

6,000

 

2015

 

 

8,000

 

 

Jan 16, 2024

 

Sep 28, 2026

 

 

8,000

 

2015

 

 

667

 

 

Feb 9, 2024

 

Jun 15, 2024

 

 

667

 

2015

 

 

667

 

 

Feb 9, 2024

 

Jun 15, 2025

 

 

667

 

2015

 

 

666

 

 

Feb 9, 2024

 

Jun 15, 2026

 

 

666

 

2015

 

 

1,775

 

 

Mar 25, 2024

 

Mar 27, 2024

 

 

1,775

 

2015

 

 

2,098

 

 

Mar 25, 2024

 

Jun 15, 2024

 

 

2,098

 

2015

 

 

2,667

 

 

May 17, 2024

 

Oct 4, 2024

 

 

2,667

 

2015

 

 

2,666

 

 

May 17, 2024

 

Oct 4, 2025

 

 

2,666

 

2015

 

 

1,000

 

 

May 17, 2024

 

Mar 27, 2025

 

 

1,000

 

2015

 

 

1,000

 

 

May 17, 2024

 

Mar 27, 2026

 

 

1,000

 

2015

 

 

3,334

 

 

May 17, 2024

 

Sep 28, 2024

 

 

3,334

 

2015

 

 

3,333

 

 

May 17, 2024

 

Sep 28, 2025

 

 

3,333

 

2015

 

 

3,333

 

 

May 17, 2024

 

Sep 28, 2026

 

 

3,333

 

2015

 

 

9,334

 

 

May 31, 2024

 

Sep 11, 2024

 

 

9,334

 

2015

 

 

9,333

 

 

May 31, 2024

 

Sep 11, 2025

 

 

9,333

 

2015

 

 

9,333

 

 

May 31, 2024

 

Sep 11, 2026

 

 

9,333

 

2015

 

 

3,333

 

 

Jul 12, 2024

 

Oct 4, 2024

 

 

3,333

 

2015

 

 

3,333

 

 

Jul 12, 2024

 

Oct 4, 2025

 

 

3,333

 

2015

 

 

5,666

 

 

Aug 4, 2024

 

Oct 4, 2025

 

 

5,666

 

2015

 

 

10,000

 

 

Aug 4, 2024

 

Sep 21, 2024

 

 

10,000

 

2015

 

 

5,667

 

 

Aug 4, 2024

 

Oct 4, 2024

 

 

5,667

 

2015

 

 

178,909

 

 

Aug 15, 2024

 

Sep 28, 2024

 

 

178,909

 

2015

 

 

178,894

 

 

Aug 15, 2024

 

Sep 28, 2025

 

 

178,894

 

2015

 

 

178,872

 

 

Aug 15, 2024

 

Sep 28, 2026

 

 

178,872

 

2015

 

 

8,000

 

 

Aug 31, 2024

 

Mar 27, 2025

 

 

8,000

 

2015

 

 

8,000

 

 

Aug 31, 2024

 

Mar 27, 2026

 

 

8,000

 

2015

 

 

4,667

 

 

Aug 31, 2024

 

Oct 4, 2024

 

 

4,667

 

2015

 

 

4,666

 

 

Aug 31, 2024

 

Oct 4, 2025

 

 

4,666

 

 

 

 

677,213

 

 

 

 

 

 

 

677,213

 

 

 
23

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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 7 – Stock-Based Compensation (continued)

 

c) Restricted Stock Units (continued)

 

Below is a table summarizing the RSUs issued and outstanding as of September 30, 2024 and which have an aggregate weighted average remaining contractual life of 1.23 years.

 

RSUs Outstanding (#)

 

 

Weighted Average Grant Date Fair Value Share Price ($)

 

 

Weighted Average Remaining Contractual Life (Years)

 

 

40,000

 

 

 

0.58

 

 

 

1.12

 

 

15,000

 

 

 

0.60

 

 

 

2.00

 

 

21,583

 

 

 

0.61

 

 

 

0.25

 

 

38,198

 

 

 

0.62

 

 

 

0.67

 

 

450,000

 

 

 

0.68

 

 

 

2.55

 

 

450,000

 

 

 

0.69

 

 

 

1.51

 

 

665,550

 

 

 

0.70

 

 

 

1.00

 

 

297,340

 

 

 

0.71

 

 

 

0.58

 

 

343,192

 

 

 

0.72

 

 

 

0.67

 

 

115,000

 

 

 

0.74

 

 

 

1.64

 

 

14,000

 

 

 

0.97

 

 

 

1.40

 

 

4,000

 

 

 

1.31

 

 

 

0.97

 

 

9,333

 

 

 

1.32

 

 

 

0.86

 

 

675,322

 

 

 

1.46

 

 

 

0.49

 

 

17,332

 

 

 

1.58

 

 

 

0.60

 

 

38,333

 

 

 

1.72

 

 

 

0.92

 

 

666

 

 

 

2.15

 

 

 

0.66

 

 

34,000

 

 

 

2.95

 

 

 

0.13

 

 

3,228,849

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense related to RSUs of $937,567 and $1,511,351 was recorded in the nine months ended September 30, 2024 and September 30, 2023, respectively. Total remaining unrecognized compensation cost related to non-vested RSUs is $1,031,071.

 

 
24

Table of Contents

 

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Commitments and Contingencies

 

a) Finance Lease Obligations

 

The following is a schedule showing the future minimum lease payments under finance leases by years and the present value of the minimum payments as of September 30, 2024.

 

2024 - Remaining

 

$14,983

 

2025

 

$59,934

 

2026

 

$59,934

 

2027

 

$59,934

 

2028

 

$59,933

 

Greater than 5 years

 

$202,259

 

Total

 

$456,977

 

Less: Amount representing interest

 

$(40,812)

Present value of minimum lease payments

 

$416,165

 

 

b) Operating Lease Right-of-Use Obligations

 

Operating leases as of September 30, 2024, and December 31, 2023, consisted of the following:

 

 

 

September 30, 2024

 

 

December 31, 2023

 

 

 

$

 

 

$

 

Operating right-of-use assets

 

 

635,857

 

 

 

549,504

 

 

 

 

 

 

 

 

 

 

Operating lease liabilities, current portion

 

 

190,099

 

 

 

199,323

 

Operating lease liabilities, long term

 

 

350,810

 

 

 

378,054

 

Total operating lease liabilities

 

 

540,909

 

 

 

577,377

 

 

 

 

 

 

 

 

 

 

Weighted average remaining lease (months)

 

 

47

 

 

 

33

 

Weighted average discount rate

 

 

3.70%

 

 

3.02%

 

During the nine months ended September 30, 2024, cash paid for amounts included for the measurement of lease liabilities was $185,692 and the Company recorded operating lease expense of $167,465.

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Commitments and Contingencies (continued)

 

b) Operating Lease Right-of-Use Obligations (continued)

 

The following is a schedule showing the future minimum lease payments under operating leases by years and the present value of the minimum payments as of September 30, 2024.

 

For the Nine Months Ending September 30, 2024

 

Amount

 

 

 

$

 

2024 - Remaining

 

 

61,552

 

2025

 

 

241,924

 

2026

 

 

225,368

 

2027

 

 

144,593

 

2028

 

 

44,059

 

Total

 

 

717,496

 

Less: imputed interest

 

 

(50,391)

Total Operating Lease Liabilities

 

 

667,105

 

 

The Company’s office space leases are short-term and the Company has elected under the short-term recognition exemption not to recognize them on the balance sheet. During the nine months ended September 30, 2024, the Company recognized $45,161 in short-term lease costs associated with office space leases. The annual payments remaining for short-term office leases were as follows:

 

For the Nine Months Ending September 30, 2024

 

Amount

 

 

 

$

 

2024 - Remaining

 

 

27,481

 

2025

 

 

12,373

 

Total Operating Lease Liabilities

 

 

39,854

 

 

c) Grants Repayable

 

As of September 30, 2024, the total grant balance repayable was $454,544 and the payments remaining were as follows:

 

For the Nine Months Ending September 30, 2024

 

Amount

 

 

 

$

 

2024 - Remaining

 

 

27,857

 

2025

 

 

37,789

 

2026

 

 

45,545

 

2027

 

 

50,564

 

2028

 

 

54,073

 

Greater than 5 years

 

 

238,716

 

Total Grants Repayable

 

 

454,544

 

 

 
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Table of Contents

 

VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Commitments and Contingencies (continued)

 

d) Long-Term Debt

 

As of September 30, 2024, the total balance for long-term debt payable was $4,802,971 and the payments remaining were as follows:

 

For the Nine Months Ending September 30, 2024

 

Amount

 

 

 

$

 

2024 - Remaining

 

 

551,774

 

2025

 

 

1,046,366

 

2026

 

 

813,844

 

2027

 

 

607,484

 

2028

 

 

2,536,778

 

Greater than 5 years

 

 

326,851

 

Total

 

 

5,883,097

 

Less: amount representing interest

 

 

(1,080,126)

Total Long-Term Debt

 

 

4,802,971

 

 

e) Collaborative Agreement Obligations

 

In 2018, the Company entered into a research collaboration agreement with the University of Taiwan for a three-year research period for a cost to the Company of up to $2.55 million payable over such period. As of September 30, 2024, $510,000 is still to be paid by the Company under this agreement. As of September 30, 2024, $510,000 is due by the Company under this agreement.

 

In 2022, the Company entered into a sponsored research agreement with The University of Texas MD Anderson Cancer Center to evaluate the role of neutrophil extracellular traps ("NETs") in cancer patients with sepsis for a cost to the Company of $327,092. As of September 30, 2024, $327,092 is still to be paid by the Company under this agreement. As of September 30, 2024, $138,971 is due by the Company under this agreement.

 

In July 2023, the Company entered into a research agreement with Xenetic Biosciences Inc and CLS Therapeutics Ltd to evaluate the anti-tumoral effects of Nu.Q® CAR T cells for a cost to the Company of $107,589. As of September 30, 2024, $81,447 is still to be paid by the Company under this agreement and as of September 30, 2024, $26,142 is due by the Company under this agreement.

 

In August 2023, the Company entered into a project research agreement with Guy’s and St Thomas’ NHS Foundation Trust to evaluate the practical clinical utility of the Nu.Q® H3.1 nucleosome levels in adult patients with sepsis to facilitate early diagnosis and prognostication for a cost to the Company of $217,464. As of September 30, 2024, $217,464 is still to be paid by the Company under this agreement. As of September 30, 2024, $0 is due by the Company under this agreement.

 

In January 2024, the Company entered into an agreement with the University Medical Centre Amsterdam (“UMC”). UMC will perform a retrospective study to evaluate the diagnostic potential of the Nu.Q® H3.1 nucleosomes as diagnostic, prognostic and phenotyping biomarkers in sepsis for a cost to the Company of $96,260. As of September 30, 2024, $96,260 is still to be paid by the Company under this agreement. As of September 30, 2024, $48,106 is due by the Company under this agreement.

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Commitments and Contingencies (continued)

 

e) Collaborative Agreement Obligations (continued)

 

As of September 30, 2024, the total amount to be paid for future research and collaboration commitments was $1,232,263 and the payments remaining were as follows:

 

 

 

Total Amount Remaining

 

 

2024 - Remaining

 

 

2025

 

 

 

$

 

 

$

 

 

$

 

National University of Taiwan

 

 

510,000

 

 

 

510,000

 

 

 

-

 

MD Anderson Cancer Center

 

 

327,092

 

 

 

163,546

 

 

 

163,546

 

Guys and St Thomas

 

 

217,464

 

 

 

65,239

 

 

 

152,225

 

Xenetic Biosciences

 

 

81,447

 

 

 

26,142

 

 

 

55,305

 

UMC

 

 

96,260

 

 

 

48,058

 

 

 

48,202

 

Total Collaborative Obligations

 

 

1,232,263

 

 

 

812,985

 

 

 

419,278

 

 

f) Other Commitments

 

Volition Germany

 

As of September 30, 2024, $218 is payable under the royalty agreement with the founder of Volition’s former German subsidiary based on sales to date towards the Company’s aggregate minimum royalty obligation of $122,572.

 

Volition America

 

Effective February 10, 2024 the Company and Diagnostic Oncology CRO, LLC (“DXOCRO”) further amended and restated the August 2022 amended and restated Master Agreement by and between the Company and DXOCRO to expand the scope of DXOCRO’s consultant services provided thereunder (the “Second A&R Master Agreement”). The Second A&R Master Agreement requires DXOCRO to conduct a prospective optimization/range finding study of Volition’s Nu.Q® H3.1 in vitro diagnostic test proposed for use in sepsis. The study is an extension of the sepsis monitoring clinical trial that was previously covered under a separate exhibit. The Company anticipates DXOCRO’s additional services under this agreement will be completed by the end of the third quarter of 2024 at a total additional cost to the Company of up to $0.7 million. The Company’s payment obligations accrue upon delivery of projects under the agreement. The Company may terminate the agreement or any project thereunder upon at least 30 days’ prior written notice. Unless earlier terminated, the Second A&R Master Agreement terminates on the later of December 31, 2025 or the date upon which all services have been completed. As of September 30, 2024, $138,971 is payable under the Second A&R Master Agreement, and up to $0 may be payable by the Company in future periods for services rendered.

 

VolitionRx

 

On February 5, 2024, the Company entered into a 9-month loan agreement with First Insurance Funding for a maximum of $294,603 with fixed interest rate of 8.42%, maturing in November 2024. As of September 30, 2024, the maximum has been drawn down under this agreement and the principal balance payable was $65,467. The agreement is in relation to the directors and officers insurance policy.

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 8 – Commitments and Contingencies (continued)

 

g) Legal Proceedings

 

In the ordinary course of business, the Company may be subject to claims, counter-claims, lawsuits and other litigation of the type that generally arise from the conduct of its business. The Company knows of no legal proceedings which the Company believes will have a material adverse effect on its financial position.

 

h) Commitments in Respect of Corporate Goals and Performance-Based Awards

 

As of September 30, 2024, the Company has recognized total compensation expense of $1,396,638 of which $527,940 is in relation to RSUs from grants in 2022 that vested in 2023, $513,394 is in relation to RSUs from such grants that will vest in 2024, and $355,304 is in relation to RSUs from such grants that will vest in 2025. The Company has unrecognized compensation expense of $168,518 in relation to such RSUs, based on the outcomes related to the prescribed performance targets on the outstanding awards.

 

Total

 

 

Vesting

 

Amortized

 

 

Amortized

 

 

Amortized

 

 

Un-Amortized

 

Award

 

 

Year

 

2024

 

 

2023

 

 

2022

 

 

 

 

$

 

 

 

 

$

 

 

$

 

 

$

 

 

$

 

 

527,940

 

 

2023

 

 

-

 

 

 

393,853

 

 

 

134,087

 

 

 

-

 

 

516,040

 

 

2024

 

 

188,187

 

 

 

260,119

 

 

 

65,088

 

 

 

2,646

 

 

521,176

 

 

2025

 

 

131,034

 

 

 

177,584

 

 

 

46,686

 

 

 

165,872

 

 

1,565,156

 

 

 

 

 

319,221

 

 

 

831,556

 

 

 

245,861

 

 

 

168,518

 

 

In September 2023, the Compensation Committee of the Board of Directors of the Company approved the granting of cash bonuses, payable upon achievement of various corporate goals focused around revenue, operations and regulatory, to various personnel including directors, executives, members of management, consultants and employees of the Company and/or its subsidiaries. Pursuant to the terms of the grants, conditional upon the achievement by December 31, 2023 and June 30, 2024 of specified corporate goals as set forth in the minutes of the Compensation Committee, as well as continued service by the award recipients to the Company, the Company at the sole discretion of the Chief Executive Officer and the Chief Financial Officer would pay a cash bonus to such award recipients. As of September 30, 2024, the Company has accrued compensation expense of $536,535 in relation to cash bonuses payable on the achievement of specified corporate goals based on the expected outcomes related to the prescribed performance targets. To the extent this is payable, this cash bonus compensation payment has currently been deferred indefinitely.

 

As of September 30, 2024, the Company had recognized total compensation expense of $447,008. The Company has unrecognized compensation expense of $270,104 in relation to the RSUs from grants in 2023, of which $0 is in relation to RSUs that will vest in 2024, $115,517 in relation to RSUs that will vest in 2025, and $154,587 in relation to RSUs that will vest in 2026 based on the outcomes related to the prescribed performance targets on the outstanding awards.

 

Total

 

 

Vesting

 

Amortized

 

 

Amortized

 

 

Un-Amortized

 

Award

 

 

Year

 

2024

 

 

2023

 

 

2024

 

$

 

 

 

 

$

 

 

$

 

 

$

 

 

242,902

 

 

2024

 

 

148,132

 

 

 

94,770

 

 

 

-

 

 

237,936

 

 

2025

 

 

74,906

 

 

 

47,513

 

 

 

115,517

 

 

236,274

 

 

2026

 

 

49,984

 

 

 

31,703

 

 

 

154,587

 

 

717,112

 

 

 

 

 

273,022

 

 

 

173,986

 

 

 

270,104

 

 

 
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VOLITIONRX LIMITED

Notes to the Condensed Consolidated Financial Statements (Unaudited)

($ expressed in United States Dollars)

 

Note 9 – Subsequent Events

 

Settlement of RSUs

 

On October 4, 2024, 337,666 RSUs previously granted to various employees vested and resulted in the issuance of 272,242 shares of common stock. 65,424 shares of common stock were withheld for taxes and returned to the 2015 Plan.

 

RSUs Granted

 

Effective October 1, 2024, the Company granted RSUs of 33,503 shares of common stock under the Company’s 2015 Plan to an employee of the Company in exchange their valid election to reduce their cash compensation for a period of three months for services provided to the Company. These RSUs will vest on July 1, 2025, subject to continued service by the employee.

 

Effective November 6, 2024, the Company granted aggregate RSUs of 400,000 shares of common stock under the Company’s 2015 Plan to a director of the Company and/or its subsidiaries in exchange for services provided to the Company and/or its subsidiaries. These RSUs vest over three years, with one-third vesting on each of November 6, 2025, November 6, 2026 and November 6, 2027, subject to continued service, and will result in total compensation expense of $240,800.

 

Effective November 6, 2024, the Company granted aggregate RSUs of 1,000,000 shares of common stock under the Company’s 2024 Plan to a director in exchange for services provided to the Company. These RSUs vest in two equal installments following the achievement of a closing stock price target above $2.50 per share and above $5.00 per share, respectively, of the Company’s common stock for a minimum of thirty consecutive trading days prior to November 6, 2027 (but no earlier than November 2025), and also subject to time-based vesting in a single installment six months after the timely achievement of each stock price target, if at all, and subject to continued service. The estimated fair value of the RSUs that include a market vesting condition will be measured on the grant date using a Monte Carlo Simulation of a Geometric Brownian Motion stock path model and incorporating the probability of vesting occurring. The estimated fair value of these awards will be recognized over the derived service period (as determined by the valuation model), with such recognition occurring regardless of whether the market condition is met.

 

Cancellation of Stock Options

 

On November 4 2024, 25,000 vested stock options previously granted to an employee were cancelled and returned as authorized shares under the 2015 Plan on the expiration of the exercise period following the resignation of such employee.

 

Long-Term Debt

 

On October 29, 2024, the Company entered into a 4-year loan agreement with Namur Invest Preface for an amount of €577,975 with fixed interest rate of 7.00%, maturing September 2028.

 

Appointment of Director and Non-Executive Chairman

 

On November 6, 2024 the Board, pursuant to the Company’s bylaws, passed a resolution to increase the size of the Board to eight (8) members and appointed Mr. Timothy I. Still to fill the new vacancy on the Board and fill the role of Non-Executive Chairman effective as of November 6, 2024. Mr. Still will have an initial term expiring at the Company’s 2025 annual meeting of stockholders, subject to his future nomination by the Nominations and Governance Committee and election by the Company’s stockholders. In connection with his appointment, Mr. Still and the Company entered into an Independent Director Agreement, pursuant to which Mr. Still will continue to serve as a member of the Board subject to any necessary approval by the Company’s stockholders as required by applicable law and the Company’s governing documents. In exchange for his services, pursuant to the terms of the Independent Director Agreement Mr. Still shall receive (i) $30,000 per calendar quarter commencing November 6, 2024; (ii) $1,000 per day for any services performed as a member of a committee of the Company, if any, (iii) a grant of RSUs under the Company’s 2015 Stock Incentive Plan to receive an aggregate of four hundred thousand (400,000) shares of the Company’s common stock underlying the RSUs (as described above under the heading “RSUs Granted”). and (iv) a grant of RSUs under the Company’s 2024 Stock Incentive Plan to receive an aggregate of one million (1,000,000) shares of the Company’s common stock underlying the RSUs, (as described above under the heading “RSUs Granted”). The Independent Director Agreement provides that in the event that the Company undergoes a Change of Control (as defined below), the vesting of the RSUs in (iv) above shall be accelerated to fully-vest the rights to such RSUs provided that the purchase price per share of the Company’s common stock in such transaction exceeds $2.50 per share. “Change of Control” shall mean the consummation of a merger or consolidation of the Company with any other corporation, other than a merger or consolidation which would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or its parent) at least fifty percent (50%) of the total voting power represented by the voting securities of the Company or such surviving entity or its parent outstanding immediately after such merger or consolidation. The Independent Director Agreement also provides that Mr. Still shall be awarded RSUs to receive three hundred thousand (300,000) shares of the Company’s common stock on an annual basis, the vesting of which will be subject to the timely achievement by the Company, or one of its affiliates, of certain corporate goals as determined by the Board or a designated committee in its absolute discretion and upon the terms and conditions set forth in the award agreement and, if applicable, the governing plan. The grant of these annual RSU awards shall be subject to availability of shares under the governing plan and be made concurrently with the grant of RSUs, on equivalent terms, to the other members of the Board.

 

END NOTES TO FINANCIALS

 

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

 

The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited condensed consolidated financial statements and the related notes included elsewhere in this Report and in our Annual Report. This discussion and analysis contains forward-looking statements that are based on our current expectations and reflect our plans, estimates and anticipated future financial performance. These statements involve numerous risks and uncertainties. Our actual results may differ materially from those expressed or implied by these forward-looking statements as a result of many factors, including those set forth in the section entitled “Risk Factors” in this Report and in our Annual Report, as well as our other public filings with the SEC. Please refer to the section of this Report entitled “Cautionary Note Regarding Forward-Looking Statements” for additional information.

 

Overview

 

Volition is a multi-national epigenetics company. It has patented technologies that use chromosomal structures, such as nucleosomes, and transcription factors as biomarkers in cancers and other diseases. The tests in the Company’s product portfolio detect certain characteristic changes that occur from the earliest stages of disease, enabling early detection and offering a better way to monitor disease progression and a patient’s response to treatment.

 

The tests offered by Volition and its subsidiaries are designed to diagnose and monitor a range of life-altering diseases, including certain cancers, and diseases associated with NETosis, such as sepsis. Early diagnosis and monitoring have the potential to not only prolong the life of patients but also improve their quality of life.

 

Our key pillars of focus are:

 

 

·

Nu.Q® Vet - cost-effective, easy-to-use blood tests for dogs and other companion animals. The Nu.Q® Vet Cancer Test is commercially available as a cancer screening test in dogs.

 

·

Nu.Q® NETs - monitoring the immune system to save lives.

 

·

Nu.Q® Discover - a complete solution to profiling nucleosomes.

 

·

Nu.Q® Cancer - monitoring disease progression, response to treatment and minimal residual disease.

 

·

Capture-PCRTM - isolating and capturing circulating tumor derived DNA from plasma samples for early cancer detection.

 

Commercialization Strategy

 

Our commercialization strategy is guided by the following underlying principles ensuring our products:

 

 

·

Result in low capital expenditures for licensors and end users and low operating expenses for Volition,

 

·

Are affordable, and

 

·

Are accessible worldwide.

 

The principles above inform our overall commercialization strategy for our products, which is driven by the following:

 

 

·

Conducting research and development in-house and through our research partners;

 

·

Monetizing our intellectual property (“IP”) with upfront payments, milestone payments, royalties, and sales of kits and key components; and

 

·

Commercializing our products via global players and in fragmented markets through third party regional companies.

 

We partner with established diagnostic companies to market, sell, and process our tests, leveraging their networks and expertise.

 

We believe, given the global prevalence of cancer and diseases associated with NETosis, and the low-cost, accessible and routine nature of our tests, they could potentially be used throughout the world.

 

We aim to remain an IP powerhouse in the epigenetic space and expect to monetize our IP and technologies through licensing and distribution contracts with companies that have established distribution networks and expertise on a worldwide or regional basis, in both human and animal care across platforms (centralized labs and point-of-care / in-house diagnostics).

 

 
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To this end, on March 28, 2022, Volition entered into a master license and product supply agreement with Heska Corporation (“Heska”). In exchange for granting Heska exclusive worldwide rights to sell our Nu.Q® Vet Cancer Test at the point of care for companion animals, Volition received a $10.0 million upfront payment upon signing, received $13.0 million based upon the achievement of two milestones and is eligible to receive up to an additional $5.0 million based upon the achievement of a final milestone upon the earlier of the first commercial sale by or on behalf of Heska of a screening or monitoring test for lymphoma in felines, or the nine-month anniversary of the first peer reviewed paper evidencing clinical utility for the screening or monitoring of lymphoma in felines being published in any one of a number of periodicals identified by the parties. In addition, Volition has granted Heska non-exclusive rights to sell the Nu.Q® Vet Cancer Test as a kit for companion animals through Heska’s network of central reference laboratories. In June 2023 Heska was acquired by Mars Petcare and became part of it’s Antech Diagnostics division. In April 2024, Antech announced the launch of the in-clinic version of the Nu.Q® Canine Cancer test in the US and Europe. During the nine months of 2024, Volition supplied key components for 105,000 tests to Antech.

 

In addition, in October 2022, we entered into a licensing and supply agreement with IDEXX Laboratories, Inc. (“IDEXX”), a global leader in pet healthcare innovation. This contract provides for worldwide customer reach through IDEXX’s global reference laboratory network as we continue to commercialize our transformational Nu.Q® technology within the companion animal healthcare sector and capitalize on the significant opportunities available. IDEXX launched the IDEXX Nu.Q® Canine Cancer Test in January 2023.

 

In November 2023, we launched the Nu.Q® Vet Cancer Test in the UK and Ireland through our distributor, the Veterinary Pathology Group, and in the UK through Nationwide Laboratories. In March 2024, Fujifilm Vet Systems announced the launch of the Nu.Q® Vet Cancer Test in Japan. In July 2024, VetLab announced the launch of the Nu.Q® Vet Cancer Test in Poland. The tests are now available in sixteen countries.

 

Liquidity and Capital Resources

 

We have financed our operations since inception primarily through private placements and public offerings of our common stock. As of September 30, 2024, we had cash and cash equivalents of approximately $5.4 million.

 

Net cash used in operating activities was $20.5 million for the nine months ended September 30, 2024 and $24.5 million for the nine months ended September 30, 2023. The decrease in cash used in operating activities for the period ended September 30, 2024 when compared to same period in 2023 can be attributed a reduction in clinical trial expenditure.

 

Net cash used in investing activities was $0.4 million and $0.8 million for the nine months ended September 30, 2024 and September 30, 2023, respectively. The decrease was mainly due to a reduction in purchases of laboratory equipment, partly offset by increased additions of licenses.

 

Net cash provided by financing activities was $6.4 million for the nine months ended September 30, 2024 and $25.2 million for the comparable period ended September 30, 2023. The decrease in cash provided by financing activities for the period ended September 30, 2024 when compared to same period in 2023 was primarily due to $17.6 million in net cash received from the issuance of shares of common stock in a registered public offering in June 2023, and $8.0 million in net cash received from the issuance of shares of common stock in a registered public offering in February 2023, as compared to $0.6 million in net cash received from the issuance of shares of common stock under our “at-the-market” facility during the period ended September 30, 2024 together with $6.3 million in net cash received from the issuance and sale of the shares of common stock, pre-funded warrants and the common warrants registered direct offering that closed in August 2024 with H.C. Wainwright & Co. acting as exclusive placement agent.

 

For additional information on our “at-the-market” facility, and the August 2024 registered direct offering, refer to Note 6, Common Stock –Equity Distribution Agreement, and 2024 Equity Capital Raise, of the notes to the condensed consolidated financial statements included within this Report.

 

 
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The following table summarizes our approximate contractual payments due by year as of September 30, 2024.

 

Approximate Payments (Including Interest) Due by Year

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

 

2024 - Remaining

 

 

2025 - 2028

 

Greater than 5 years

 

Description

 

$

 

 

$

 

 

$

 

 

$

 

Financing lease liabilities

 

 

456,977

 

 

 

14,983

 

 

 

239,735

 

 

 

202,259

 

Operating lease liabilities and short-term lease

 

 

757,350

 

 

 

89,033

 

 

 

668,317

 

 

 

-

 

Grants repayable

 

 

454,544

 

 

 

27,857

 

 

 

187,971

 

 

 

238,716

 

Long-term debt

 

 

5,883,097

 

 

 

551,774

 

 

 

5,004,472

 

 

 

326,851

 

Collaborative agreements obligations

 

 

1,232,263

 

 

 

812,985

 

 

 

419,278

 

 

 

-

 

Total

 

 

8,784,231

 

 

 

1,496,632

 

 

 

6,519,773

 

 

 

767,826

 

 

We intend to use our cash reserves to predominantly fund further research and development, and commercialization activities. We do not have any substantial source of revenues and expect to rely on additional future financing, through the sale of licensing or distribution rights, grant funding and the sale of equity or debt securities to provide sufficient funding to execute our strategic plan. There is no assurance that we will be successful in raising further funds.

 

In the event additional financing is delayed, we will prioritize the completion of clinical validation studies for the purpose of the sale of licensing or distribution rights, and the maintenance of our patent rights. In the event of an ongoing lack of financing, it may be necessary to discontinue operations, which will adversely affect the value of our common stock.

 

We have not attained profitable operations and are dependent upon obtaining financing to pursue any extensive activities. For these reasons, our auditors included in their report on our audited financial statements for the year ended December 31, 2023, an explanatory paragraph regarding factors that raise substantial doubt that we will be able to continue as a going concern. For additional information regarding our going concern assessment, refer to Note 2, Liquidity and Going Concern Assessment, of the notes to the condensed consolidated financial statements included within this Report.

 

 
33

Table of Contents

 

Results of Operations

 

Comparison of the Three Months Ended September 30, 2024 and September 30, 2023

 

The following table sets forth our results of operations for the three months ended September 30, 2024 and September 30, 2023.

 

 

 

Three Months Ended September 30,

 

 

 

 

 

 

 

 

 

2024

 

 

2023

 

 

Change

 

 

Change

 

 

 

$

 

 

$

 

 

$

 

 

%

 

Service

 

 

68,434

 

 

 

37,688

 

 

 

30,746

 

 

 

82%

Product

 

 

406,088

 

 

 

127,523

 

 

 

278,565

 

 

>100%

Total Revenues

 

 

474,522

 

 

 

165,211

 

 

 

309,311

 

 

>100%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,473,782

 

 

 

4,650,658

 

 

 

(1,176,876)

 

(25

%)

General and administrative

 

 

1,815,863

 

 

 

2,599,908

 

 

 

(784,045)

 

(30

%)

Sales and marketing

 

 

1,053,584

 

 

 

1,567,700

 

 

 

(514,116)

 

(33

%)

Total Operating Expenses

 

 

6,343,229

 

 

 

8,818,266

 

 

 

(2,475,037)

 

(28

%)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant income

 

 

85,378

 

 

 

48,656

 

 

 

36,722

 

 

 

75%

Loss on disposal of fixed assets

 

 

(1,195)

 

 

(15,913)

 

 

14,718

 

 

(92

%)

Interest income

 

 

530

 

 

 

230

 

 

 

300

 

 

>100%

Interest expense

 

 

(89,456)

 

 

(53,980)

 

 

(35,476)

 

 

66%

Gain on change in fair value of warrant liability

 

 

4,872

 

 

 

220,874

 

 

 

(216,002)

 

(98

%)

Total Other Income (Expenses)

 

 

129

 

 

 

199,867

 

 

 

(199,738)

 

(>100

%)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

 

(5,868,578)

 

 

(8,453,188)

 

 

(2,584,610)

 

(31

%)

 

Revenues

 

Our operations are transitioning from a research and development stage to a commercialization stage. Revenues during the three-months ended September 30, 2024 were $474,522, compared with $165,211 for the three-months ended September 30, 2023. Our main source of revenues during the three months ended September 30, 2024 and September 30, 2023 was product revenues from sales of the Nu.Q® Vet Cancer Test. The year on year increase in revenues was primarily driven by sales of key components of the Nu.Q® Vet Cancer Test to Antech.

 

 
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Table of Contents

 

Operating Expenses

 

Total operating expenses decreased to $6.3 million for the three months ended September 30, 2024 from $8.8 million for the three months ended September 30, 2023, as a result of the factors described below.

 

Research and Development Expenses

 

Research and development expenses decreased to $3.5 million from $4.7 million for the three-months ended September 30, 2024, and September 30, 2023, respectively. This decrease was primarily related to decreased personnel expenses, lower direct research and development expenses from reduced clinical trial activity and reduced stock-based compensation. The number of full-time equivalent (“FTE”) personnel we employed in this division decreased by 12 to 59 compared to the prior year period.

 

 

 

Three Months Ended September 30,

 

 

 

 

 

 

2024

 

 

2023

 

 

Change

 

 

 

$

 

 

$

 

 

$

 

Personnel expenses

 

 

1,694,457

 

 

 

2,373,968

 

 

 

(679,511)

Stock-based compensation

 

 

49,643

 

 

 

162,651

 

 

 

(113,008)

Direct research and development expenses

 

 

984,541

 

 

 

1,677,977

 

 

 

(693,436)

Other research and development

 

 

464,762

 

 

 

148,033

 

 

 

316,729

 

Depreciation and amortization

 

 

280,379

 

 

 

288,029

 

 

 

(7,650)

Total research and development expenses

 

 

3,473,782

 

 

 

4,650,658

 

 

 

(1,176,876)

 

General and Administrative Expenses

 

General and administrative expenses decreased to $1.8 million from $2.6 million for the three-months ended September 30, 2024, and September 30, 2023, respectively. The reduction is due to lower personnel expenses and legal costs during the period. The FTE personnel number within this division decreased by 2 to 20 compared to the prior year period.

 

 

 

Three Months Ended September 30,

 

 

 

 

 

 

2024

 

 

2023

 

 

Change

 

 

 

$

 

 

$

 

 

$

 

Personnel expenses

 

 

994,909

 

 

 

1,437,615

 

 

 

(442,706)

Stock-based compensation

 

 

217,334

 

 

 

214,833

 

 

 

2,501

 

Legal and professional fees

 

 

260,586

 

 

 

517,955

 

 

 

(257,369)

Other general and administrative

 

 

302,663

 

 

 

368,047

 

 

 

(65,384)

Depreciation and amortization

 

 

40,371

 

 

 

61,458

 

 

 

(21,087)

Total general and administrative expenses

 

 

1,815,863

 

 

 

2,599,908

 

 

 

(784,045)

 

Sales and Marketing Expenses

 

Sales and marketing expenses decreased to $1.1 million from $1.6 million for the three-months ended September 30, 2024, and September 30, 2023, respectively. The reduction is due to lower personnel expenses and stock-based compensation, partly offset by increased direct marketing and professional fees during the period. The FTE personnel number within this division decreased by 4 to 17 compared to the prior year period.

 

 

 

Three Months Ended September 30,

 

 

 

 

 

 

2024

 

 

2023

 

 

Change

 

 

 

$

 

 

$

 

 

$

 

Personnel expenses

 

 

693,690

 

 

 

1,237,449

 

 

 

(543,759)

Stock-based compensation

 

 

56,562

 

 

 

160,496

 

 

 

(103,934)

Direct marketing and professional fees

 

 

291,268

 

 

 

156,775

 

 

 

134,493

 

Depreciation and amortization

 

 

12,064

 

 

 

12,980

 

 

 

(916)

Total sales and marketing expenses

 

 

1,053,584

 

 

 

1,567,700

 

 

 

(514,116)

 

 
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Table of Contents

 

Other Income (Expenses)

 

For the three-months ended September 30, 2024, the Company’s other income was $129 compared to $199,867 for the three-months ended September 30, 2023. This decrease in other income was primarily due to a gain on change in fair value of warrants in the prior year period.

 

Net Loss

 

For the three months ended September 30, 2024, the Company’s net loss was approximately $5.9 million in comparison to a net loss of $8.5 million for the three months ended September 30, 2023. The change was primarily a result of reduced personnel costs and clinical trial activity, partly reflecting the completion of certain research and development projects.

 

Comparison of the Nine Months Ended September 30, 2024 and September 30, 2023

 

The following table sets forth our results of operations for the nine months ended September 30, 2024 and September 30, 2023:

 

 

 

Nine Months Ended September 30,

 

 

 

 

 

 

 

 

 

2024

 

 

2023

 

 

Change

 

 

Change

 

 

 

$

 

 

$

 

 

$

 

 

%

 

Service

 

 

155,713

 

 

 

93,207

 

 

 

62,506

 

 

 

67%

Product

 

 

886,141

 

 

 

438,122

 

 

 

448,019

 

 

>100%

Total Revenues

 

 

1,041,854

 

 

 

531,329

 

 

 

510,525

 

 

 

96%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

11,819,106

 

 

 

15,007,623

 

 

 

(3,188,517)

 

(21

%)

General and administrative

 

 

6,353,647

 

 

 

7,826,568

 

 

 

(1,472,921)

 

(19

%)

Sales and marketing

 

 

4,112,731

 

 

 

4,944,259

 

 

 

(831,528)

 

(17

%)

Total Operating Expenses

 

 

22,285,484

 

 

 

27,778,450

 

 

 

(5,492,966)

 

(20

%)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant income

 

 

85,378

 

 

 

214,451

 

 

 

(129,073)

 

(60

%)

Loss on disposal of fixed assets

 

 

(34,693)

 

 

(15,913)

 

 

(18,780)

 

(>100

%)

Interest income

 

 

9,634

 

 

 

84,987

 

 

 

(75,353)

 

(89

%)

Interest expense

 

 

(247,871)

 

 

(163,623)

 

 

(84,248)

 

 

51%

Gain on change in fair value of warrant liability

 

 

30,424

 

 

 

249,845

 

 

 

(219,421)

 

(88

%)

Total Other Income (Expenses)

 

 

(157,128)

 

 

369,747

 

 

 

(526,875)

 

(>100

%)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

 

(21,400,758)

 

 

(26,877,374)

 

 

(5,476,616)

 

(20

%)

 

Revenues

 

Our operations are transitioning from a research and development stage to a commercialization stage. Revenues during the nine-months ended September 30, 2024 were $1,041,854, compared with $531,329 for the nine-months ended September 30, 2023. Our main source of revenue during the nine-months ended September 30, 2024 and nine-months ended September 30, 2023 was product revenues from sales of the Nu.Q® Vet Cancer Test. The year on year increase in revenues was primarily driven by sales of key components of the Nu.Q® Vet Cancer Test to Antech and sales of Nu.Q® Discover services.

 

Operating Expenses

 

Total operating expenses decreased to $22.3 million from $27.8 million for the nine months ended September 30, 2024 and September 30, 2023, respectively, as a result of the factors described below.

 

 
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Table of Contents

 

Research and Development Expenses

 

Research and development expenses decreased to $11.8 million for the nine months ended September 30, 2024, from $15.0 million for the nine months ended September 30, 2023. This decrease was primarily related to decreased direct research and development expenses as a result of reduced clinical trial activity with DXOCRO, reduced personnel expenses and reduced stock-based compensation. The FTE personnel number decreased by 12 to 59 compared to the prior year period.

 

 

 

Nine Months Ended September 30,

 

 

 

 

 

 

2024

 

 

2023

 

 

Change

 

 

 

$

 

 

$

 

 

$

 

Personnel expenses

 

 

5,986,037

 

 

 

6,783,623

 

 

 

(797,586)

Stock-based compensation

 

 

212,217

 

 

 

455,125

 

 

 

(242,908)

Direct research and development expenses

 

 

3,822,868

 

 

 

6,240,312

 

 

 

(2,417,444)

Other research and development

 

 

980,462

 

 

 

700,654

 

 

 

279,808

 

Depreciation and amortization

 

 

817,522

 

 

 

827,909

 

 

 

(10,387)

Total research and development expenses

 

 

11,819,106

 

 

 

15,007,623

 

 

 

(3,188,517)

 

General and Administrative Expenses

 

General and administrative expenses decreased to $6.4 million from $7.8 million for the nine months ended September 30, 2024 and September 30, 2023, respectively. This decrease was primarily due to lower personnel expenses, stock-based compensation and legal and professional fees during the period. The FTE personnel number decreased by 2 to 20 compared to the prior year period.

 

 

 

Nine Months Ended September 30,

 

 

 

 

 

 

2024

 

 

2023

 

 

Change

 

 

 

$

 

 

$

 

 

$

 

Personnel expenses

 

 

3,253,311

 

 

 

4,105,660

 

 

 

(852,349)

Stock-based compensation

 

 

512,096

 

 

 

777,482

 

 

 

(265,386)

Legal and professional fees

 

 

1,433,252

 

 

 

1,674,613

 

 

 

(241,361)

Other general and administrative

 

 

1,030,511

 

 

 

1,087,346

 

 

 

(56,835)

Depreciation and amortization

 

 

124,477

 

 

 

181,467

 

 

 

(56,990)

Total general and administrative expenses

 

 

6,353,647

 

 

 

7,826,568

 

 

 

(1,472,921)

 

Sales and Marketing Expenses

 

Sales and marketing expenses decreased to $4.1 million compared to $4.9 million for the nine months ended September 30, 2024 and September 30, 2023. This decrease was due to reduced personnel expenses and stock-based compensation during the period. The FTE personnel number decreased by 4 to 17 compared to the prior year period.

 

 

 

Nine Months Ended September 30,

 

 

 

 

 

 

2024

 

 

2023

 

 

Change

 

 

 

$

 

 

$

 

 

$

 

Personnel expenses

 

 

3,150,406

 

 

 

3,674,191

 

 

 

(523,785)

Stock-based compensation

 

 

218,492

 

 

 

591,204

 

 

 

(372,712)

Direct marketing and professional fees

 

 

707,474

 

 

 

639,528

 

 

 

67,946

 

Depreciation and amortization

 

 

36,359

 

 

 

39,336

 

 

 

(2,977)

Total sales and marketing expenses

 

 

4,112,731

 

 

 

4,944,259

 

 

 

(831,528)

 

Other Income (Expenses)

 

For the nine months ended September 30, 2024, the Company’s other expenses were $157,128 compared to other income of $369,747 for the nine months ended September 30, 2023. The increase in other expenses is due to increased interest paid partly offset by a reduction in grant income, interest received and a gain on change in fair value of warrants in the prior year period.

 

 
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Table of Contents

 

Net Loss

 

For the nine months ended September 30, 2024, the Company’s net loss was approximately $21.4 million in comparison to a net loss of $26.9 million for the nine months ended September 30, 2023. The change was primarily a result of reduced clinical trial activity and personnel costs.

 

Going Concern

 

We have not attained profitable operations on an ongoing basis and are dependent upon obtaining external financing to continue to pursue our operational and strategic plans. For these reasons, management has determined that there is substantial doubt that the business will be able to continue as a going concern without further financing.

 

Off-Balance Sheet Arrangements

 

There have been no material changes to our off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to stockholders.

 

Future Financings

 

We may seek to obtain additional capital through the sale of debt or equity securities if we deem it desirable or necessary. These sales may include the sale of equity securities from time to time through an “at the market offering program” under our Equity Distribution Agreement with Jefferies LLC or through other equity or debt financings. See Note 6, Common Stock – Equity Distribution Agreement, of the notes to the condensed consolidated financial statements. However, we may be unable to obtain such additional capital when needed, or on terms favorable to us or our stockholders, if at all. If we raise additional funds by issuing equity securities, the percentage ownership of our stockholders will be reduced, stockholders may experience additional dilution, or such equity securities may provide for rights, preferences or privileges senior to those of the holders of our common stock. If additional funds are raised through the issuance of debt securities, the terms of such securities may place restrictions on our ability to operate our business.

 

Critical Accounting Policies and Estimates

 

Our interim condensed consolidated financial statements and accompanying notes have been prepared in accordance with United States generally accepted accounting principles, (“GAAP”), applied on a consistent basis. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods.

 

We also regularly evaluate estimates and assumptions related to deferred income tax asset valuation allowances, useful lives of property and equipment and intangible assets, borrowing rate used in operating lease right-of-use asset and liability valuations, impairment analysis of intangible assets, valuations of stock-based compensation and deferred revenue.

 

We base our estimates and assumptions on current facts, historical experiences, information from third party professionals and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from our estimates. To the extent there are material differences between the estimates and the actual results, future results of operations could be affected.

 

We regularly evaluate the accounting policies and estimates that we use to prepare our financial statements. A summary of these policies is included in the notes to our financial statements. There have been no material changes to the critical accounting policies and key estimates and assumptions disclosed in the section titled “Critical Accounting Policies and Estimates” in Part II, Item 7 within our Annual Report.

 

Recently Issued Accounting Pronouncements

 

The Company has implemented all applicable new accounting pronouncements that are in effect. The Company does not believe that there are any other applicable new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.

 

 
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Table of Contents

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

We are a smaller reporting company and are not required to disclose this information.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Disclosure Controls and Procedures

 

Disclosure controls and procedures are controls and procedures that are designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by our company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including our Principal Executive and Principal Financial Officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

 

Our management carried out an evaluation, under the supervision and with the participation of our Principal Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based upon that evaluation, our Principal Executive Officer and Principal Financial Officer have concluded, as they previously concluded as of December 31, 2023, that our disclosure controls and procedures were not effective as of September 30, 2024, because of material weaknesses in our internal control over financial reporting, as referenced below and described in detail in our Annual Report.

 

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

 

We identified a material weakness in our internal controls over financial reporting. In particular we do not have sufficient written documentation of our internal control policies and procedures, including written policies and procedures to ensure the correct application of accounting and financial reporting with respect to the current requirements of GAAP and SEC disclosure requirements.

 

Notwithstanding the material weakness, we believe that our financial statements contained in this Report fairly present our financial position, results of operations and cash flows for the periods covered by this Report in all material respects.

 

Our management, with the oversight of our audit committee, has initiated steps and plans to take additional measures to remediate the underlying causes of the material weakness, which we currently believe will be primarily through revising precision level management review controls and gaining additional assurance regarding our outside service providers’ quality control procedures. It is possible that we may determine that additional remediation steps will be necessary in the future.

 

 
39

Table of Contents

 

Planned Remediation of Material Weakness

 

Our management has been actively engaged in developing and implementing remediation plans to address material weakness described above. These remediation efforts are ongoing and include or are expected to include:

 

 

·

engaging internal control consultants to assist us in performing a financial reporting risk assessment as well as identifying and designing our system of internal controls necessary to mitigate the risks identified;

 

 

 

 

·

preparation of written documentation of our internal control policies and procedures;

 

 

 

 

·

increasing personnel resources and technical accounting expertise within the accounting function to replace our outside service providers; and

 

 

 

 

·

until we have sufficient technical accounting resources, we have engaged external consultants to provide support and to assist us in our evaluation of more complex applications of GAAP.

  

We continue to enhance corporate oversight over process-level controls and structures to ensure that there is appropriate assignment of authority, responsibility, and accountability to enable remediation of our material weakness. We believe that our remediation plan will be sufficient to remediate the identified material weakness and strengthen our internal control over financial reporting. As we continue to evaluate, and work to improve, our internal control over financial reporting, management may determine that additional measures to address control deficiencies or modifications to the remediation plan are necessary.

 

Changes in Internal Control over Financial Reporting

 

Except for the ongoing remediation of the material weakness in internal controls over financial reporting noted above, no changes in our internal control over financial reporting were made during the nine months ended September 30, 2024, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

Limitations of the Effectiveness of Disclosure Controls and Internal Controls

 

Our management, including our Principal Executive Officer and Principal Financial Officer, does not expect that our disclosure controls and internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control.

 

The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving our stated goals under all potential future conditions; over time, a control may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

 
40

Table of Contents

 

PART II OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

In the ordinary course of business, we may be subject to claims, counter claims, lawsuits and other litigation of the type that generally arise from the conduct of our business. We know of no material, existing or pending legal proceedings against our company, nor are we involved as a plaintiff in any material proceeding or pending litigation. There are no proceedings in which our directors, officers or any affiliates, or any registered or beneficial stockholders, is an adverse party or has a material interest adverse to our interest.

 

ITEM 1A. RISK FACTORS

 

There have been no material changes in our assessment of risk factors affecting our business since those presented in Part I, Item 1A of our Annual Report.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

Recent Sales of Unregistered Securities

 

None.

 

Repurchase of Equity Securities

 

No equity securities were repurchased during the third quarter of 2024.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

 

None.

 

 
41

Table of Contents

 

ITEM 6. EXHIBITS

 

 

 

 

 

Incorporated by Reference

 

 

Exhibit Number

 

Exhibit Description

 

Form

 

File No.

 

Exhibit

 

Filing Date

 

Filed

Herewith

3.1

 

Second Amended and Restated Certificate of Incorporation, as amended and currently in effect.

 

S-8

 

333-280974

 

4.2

 

7/24/24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3.2

 

Amended and Restated Bylaws, as amended and currently in effect.

 

10-Q

 

001-36833

 

3.2

 

5/13/24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1

 

Form of Pre-Funded Warrant.

 

8-K

 

001-36833

 

4.1

 

8/12/24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.2

 

Form of Series A Common Stock Warrant.

 

8-K

 

001-36833

 

4.2

 

8/12/24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.3

 

Form of Series B Common Stock Warrant.

 

8-K

 

001-36833

 

4.3

 

8/12/24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10.1#

 

2024 Stock Incentive Plan.

 

8-K

 

001-36833

 

10.1

 

7/3/24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10.1(a)#

 

 

Form of Notice of Stock Option Grant and Stock Option Agreement under the 2024 Stock Incentive Plan.

 

S-8

 

 

333-280974

 

 

99.1(a)

 

 

7/24/24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10.1(b)#

 

Form of Notice of Performance Shares Award and Performance Shares Agreement under the 2024 Stock Incentive Plan.

 

S-8

 

 

333-280974

 

 

99.1(b)

 

 

7/24/24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10.1(c)#

 

Form of Notice of Restricted Stock Award and Restricted Stock Agreement under the 2024 Stock Incentive Plan.

 

S-8

 

 

333-280974

 

 

99.1(c)

 

 

7/24/24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10.1(d)#

 

Form of Notice of Restricted Stock Unit Award and Restricted Stock Unit Agreement under the 2024 Stock Incentive Plan.

 

S-8

 

 

333-280974

 

 

99.1(d)

 

 

7/24/24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10.1(e)#

 

Form of Notice of Stock Appreciation Right Award and Stock Appreciation Right Award Agreement under the 2024 Stock Incentive Plan.

 

S-8

 

 

333-280974

 

 

99.1(e)

 

 

7/24/24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10.1(f)#

 

Form of Notice of Stock Bonus Award and Stock Bonus Award Agreement under the 2024 Stock Incentive Plan.

 

S-8

 

333-280974

 

 

99.1(f)

 

 

7/24/24

 

 

 

 
42

Table of Contents

 

10.2

 

Form of Securities Purchase Agreement, dated August 8, 2024, by and among the Company and the purchaser party thereto.

 

8-K

 

001-36833

 

10.1

 

8/12/24

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10.3#†

 

Permanent employment contract, by and among Belgian Volition SPRL and Gaetan Michel, effective September 2, 2024.

 

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

10.4#†

 

First amendment to Consulting Services Agreement, between Volition Global Services SRL and 3F Management SPRL, effective September 1, 2024.

 

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

31.1

 

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

 

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

31.2

 

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

 

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

32.1*

 

Certifications of Chief Executive Officer and Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.INS

 

Inline XBRL Instance Document.

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document.

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document.

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document.

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

104

 

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

 

 

 

 

 

 

 

 

X

 

#

Indicates a management contract or compensatory plan or arrangement.

 

 

Portions of this exhibit are redacted pursuant to Item 601(a)(6) and/or Item 601(b)(10)(iv) under Regulation S-K. The registrant agrees to furnish supplementally any omitted schedules to the SEC upon request.

 

 

*

The certifications attached as Exhibit 32.1 accompany this Quarterly Report pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the registrant for purposes of Section 18 of the Exchange Act and are not to be incorporated by reference into any of the registrant’s filings under the Securities Act or the Exchange Act, irrespective of any general incorporation language contained in any such filing.

 

 
43

Table of Contents

 

SIGNATURES

 

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

 

 

VOLITIONRX LIMITED

 

 

 

 

 

 

 

 

 

Dated: November 14, 2024

By:

/s/ Cameron Reynolds

 

Cameron Reynolds

 

President and Chief Executive Officer

(Authorized Signatory and Principal Executive Officer)

 

 

 

 

Dated: November 14, 2024

By:

/s/ Terig Hughes

 

Terig Hughes

 

Chief Financial Officer and Treasurer

(Authorized Signatory and Principal Financial and Accounting Officer)

 

 

 
44

 

nullnullnullnullnullv3.24.3
Cover - shares
9 Months Ended
Sep. 30, 2024
Nov. 06, 2024
Cover [Abstract]    
Entity Registrant Name VOLITIONRX LIMITED  
Entity Central Index Key 0000093314  
Document Type 10-Q  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Entity Small Business true  
Entity Shell Company false  
Entity Emerging Growth Company false  
Entity Current Reporting Status Yes  
Document Period End Date Sep. 30, 2024  
Entity Filer Category Non-accelerated Filer  
Document Fiscal Period Focus Q3  
Document Fiscal Year Focus 2024  
Entity Common Stock Shares Outstanding   92,664,812
Entity File Number 001-36833  
Entity Incorporation State Country Code DE  
Entity Tax Identification Number 91-1949078  
Entity Address Address Line 1 1489 West Warm Springs Road  
Entity Address Address Line 2 Suite 110  
Entity Address City Or Town Henderson  
Entity Address State Or Province NV  
Entity Address Postal Zip Code 89014  
City Area Code 646  
Local Phone Number 650–1351  
Security 12b Title Common Stock, par value $0.001 per share  
Trading Symbol VNRX  
Security Exchange Name NYSE  
Document Quarterly Report true  
Document Transition Report false  
Entity Interactive Data Current Yes  
v3.24.3
Condensed Consolidated Balance Sheets - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Current Assets    
Cash and cash equivalents $ 5,414,146 $ 20,729,983
Accounts receivable 312,611 242,617
Prepaid expenses 689,995 521,370
Other current assets 384,189 360,125
Total Current Assets 6,800,941 21,854,095
Property and equipment, net 4,908,148 5,523,013
Operating lease right-of-use assets 635,857 549,504
Intangible assets, net 335,309 23,886
Total Assets 12,680,255 27,950,498
Current Liabilities    
Accounts payable 2,485,077 3,211,287
Accrued liabilities 3,480,207 3,928,761
Deferred revenue 22,893,400 23,000,000
Management and directors' fees payable 24,851 59,625
Current portion of long-term debt 965,021 1,207,007
Current portion of finance lease liabilities 49,990 48,570
Current portion of operating lease liabilities 219,060 199,323
Current portion of grant repayable 65,646 55,855
Warrant liability 96,225 126,649
Total Current Liabilities 30,279,477 31,837,077
Long-term debt, net of current portion 3,837,950 3,624,860
Finance lease liabilities, net of current portion 366,175 400,022
Operating lease liabilities, net of current portion 448,045 378,054
Grant repayable, net of current portion 388,898 422,707
Total Long-Term Liabilities 5,041,068 4,825,643
Total Liabilities 35,320,545 36,662,720
Stockholders' Deficit    
Common Stock Authorized: 175,000,000 shares of common stock, at $0.001 par value per shareIssued and outstanding: 92,392,570 shares and 81,898,321 shares, respectively 92,393 81,898
Additional paid-in capital 202,014,277 194,448,414
Accumulated other comprehensive income 140,272 243,940
Accumulated deficit (223,750,970) (202,576,507)
Total VolitionRx limited Stockholders' Deficit (21,504,028) (7,802,255)
Non-controlling interest (1,136,262) (909,967)
Total Stockholders' Deficit (22,640,290) (8,712,222)
Total Liabilities and Stockholders' Deficit $ 12,680,255 $ 27,950,498
v3.24.3
Condensed Consolidated Balance Sheets(Parenthetical) - $ / shares
Sep. 30, 2024
Dec. 31, 2023
Condensed Consolidated Balance Sheets    
Common Stock, Shares Par Value $ 0.001 $ 0.001
Common Stock, Shares Authorized 175,000,000 175,000,000
Common Stock, Shares Issued 92,392,570 81,898,321
Common Stock, Shares Outstanding 92,392,570 81,898,321
v3.24.3
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Revenues        
Services $ 68,434 $ 37,688 $ 155,713 $ 93,207
Product 406,088 127,523 886,141 438,122
Total Revenues 474,522 165,211 1,041,854 531,329
Operating Expenses        
Research and development 3,473,782 4,650,658 11,819,106 15,007,623
General and administrative 1,815,863 2,599,908 6,353,647 7,826,568
Sales and marketing 1,053,584 1,567,700 4,112,731 4,944,259
Total Operating Expenses 6,343,229 8,818,266 22,285,484 27,778,450
Operating Loss (5,868,707) (8,653,055) (21,243,630) (27,247,121)
Other Income (Expenses)        
Grant income 85,378 48,656 85,378 214,451
Loss on disposal of fixed assets (1,195) (15,913) (34,693) (15,913)
Interest income 530 230 9,634 84,987
Interest expense (89,456) (53,980) (247,871) (163,623)
Gain on change in fair value of warrant liability 4,872 220,874 30,424 249,845
Total Other Income (Expenses) 129 199,867 (157,128) 369,747
Net Loss (5,868,578) (8,453,188) (21,400,758) (26,877,374)
Net Loss Attributable to Non-Controlling Interest 47,049 82,887 226,295 256,546
Net Loss Attributable to VolitionRx Limited Stockholders (5,821,529) (8,370,301) (21,174,463) (26,620,828)
Other Comprehensive Income (Loss)        
Foreign currency translation adjustments (141,980) 31,291 (103,668) 12,525
Net Comprehensive Loss $ (6,010,558) $ (8,421,897) $ (21,504,426) $ (26,864,849)
Net Loss Per Share - Basic and Diluted Attributable to VolitionRx Limited $ (0.07) $ (0.11) $ (0.25) $ (0.39)
Weighted Average Shares Outstanding- Basic and Diluted $ 87,886,012 $ 78,176,859 $ 84,165,579 $ 68,494,766
v3.24.3
Condensed Consolidated Statements of Stockholders Equity (Unaudited) - USD ($)
Total
Common stock
Additional Paid-in Capital
Accumulated Other Comprehensive Income (Loss)
Accumulated Deficit
Noncontrolling Interest
Balance, shares at Dec. 31, 2022   57,873,379        
Balance, amount at Dec. 31, 2022 $ (3,126,962) $ 57,873 $ 164,397,468 $ 227,097 $ (167,257,429) $ (551,971)
Common stock issued for cash, net of issuance costs, shares   5,225,703        
Common stock issued for cash, net of issuance costs, amount 8,427,655 $ 5,225 8,422,430 0 0 0
Common stock issued for settlement of RSUs, shares   26,978        
Common stock issued for settlement of RSUs, amount 0 $ 27 (27) 0 0 0
Stock-based compensation 693,657 0 693,657 0 0 0
Tax withholdings paid related to stock-based compensation (14,336) $ 0 (14,336) 0 0 0
Common stock repurchased, shares   (13,294)        
Common stock repurchased, amount (31,772) $ (13) (31,759) 0 0 0
Foreign currency translation (56,478) 0 0 (56,478) 0 0
Net loss for the period (8,872,909) $ 0 0 0 (8,779,548) (93,361)
Balance, shares at Mar. 31, 2023   63,112,766        
Balance, amount at Mar. 31, 2023 (2,981,145) $ 63,112 173,467,433 170,619 (176,036,977) (645,332)
Balance, shares at Dec. 31, 2022   57,873,379        
Balance, amount at Dec. 31, 2022 (3,126,962) $ 57,873 164,397,468 227,097 (167,257,429) (551,971)
Balance, shares at Sep. 30, 2023   78,343,417        
Balance, amount at Sep. 30, 2023 (2,851,309) $ 78,343 191,517,500 239,622 (193,878,257) (808,517)
Balance, shares at Mar. 31, 2023   63,112,766        
Balance, amount at Mar. 31, 2023 (2,981,145) $ 63,112 173,467,433 170,619 (176,036,977) (645,332)
Common stock issued for cash, net of issuance costs, shares   14,950,000        
Common stock issued for cash, net of issuance costs, amount 17,086,606 $ 14,950 17,071,656 0 0 0
Common stock issued for settlement of RSUs, shares   74,598        
Common stock issued for settlement of RSUs, amount 0 $ 75 (75) 0 0 0
Stock-based compensation 592,174 0 592,174 0 0 0
Tax withholdings paid related to stock-based compensation (65,895) 0 (65,895) 0 0 0
Foreign currency translation 37,712 0 0 37,712 0 0
Net loss for the period (9,551,277) $ 0 0 0 (9,470,979) (80,298)
Balance, shares at Jun. 30, 2023   78,137,364        
Balance, amount at Jun. 30, 2023 5,118,175 $ 78,137 191,065,293 208,331 (185,507,956) (725,630)
Common stock issued for cash, net of issuance costs, amount (12,501) $ 0 (12,501) 0 0 0
Common stock issued for settlement of RSUs, shares   206,053        
Common stock issued for settlement of RSUs, amount 0 $ 206 (206) 0 0 0
Stock-based compensation 537,980 0 537,980 0 0 0
Tax withholdings paid related to stock-based compensation (73,066) 0 (73,066) 0 0 0
Foreign currency translation 31,291 0 0 31,291 0 0
Net loss for the period (8,453,188) $ 0 0 0 (8,370,301) (82,887)
Balance, shares at Sep. 30, 2023   78,343,417        
Balance, amount at Sep. 30, 2023 (2,851,309) $ 78,343 191,517,500 239,622 (193,878,257) (808,517)
Balance, shares at Dec. 31, 2023   81,898,321        
Balance, amount at Dec. 31, 2023 (8,712,222) $ 81,898 194,448,414 243,940 (202,576,507) (909,967)
Common stock issued for cash, net of issuance costs, shares   13,350        
Common stock issued for cash, net of issuance costs, amount 15,734 $ 13 15,721 0 0 0
Common stock issued for settlement of RSUs, shares   68,169        
Common stock issued for settlement of RSUs, amount 0 $ 69 (69) 0 0 0
Stock-based compensation 411,220 0 411,220 0 0 0
Tax withholdings paid related to stock-based compensation (3,062) 0 (3,062) 0 0 0
Foreign currency translation 15,026 0 0 15,026 0 0
Net loss for the period (8,472,005) $ 0 0 0 (8,367,388) (104,617)
Common stock issued in lieu of license fee, shares   129,132        
Common stock issued in lieu of license fee, amount 125,258 $ 129 125,129 0 0 0
Balance, shares at Mar. 31, 2024   82,108,972        
Balance, amount at Mar. 31, 2024 (16,620,051) $ 82,109 194,997,353 258,966 (210,943,895) (1,014,584)
Balance, shares at Dec. 31, 2023   81,898,321        
Balance, amount at Dec. 31, 2023 (8,712,222) $ 81,898 194,448,414 243,940 (202,576,507) (909,967)
Balance, shares at Sep. 30, 2024   92,392,570        
Balance, amount at Sep. 30, 2024 (22,640,290) $ 92,393 202,014,277 140,272 (223,750,970) (1,136,262)
Balance, shares at Mar. 31, 2024   82,108,972        
Balance, amount at Mar. 31, 2024 (16,620,051) $ 82,109 194,997,353 258,966 (210,943,895) (1,014,584)
Common stock issued for cash, net of issuance costs, shares   734,155        
Common stock issued for cash, net of issuance costs, amount 589,488 $ 734 588,754 0 0 0
Common stock issued for settlement of RSUs, shares   85,187        
Common stock issued for settlement of RSUs, amount 0 $ 85 (85) 0 0 0
Stock-based compensation 208,046 0 208,046 0 0 0
Tax withholdings paid related to stock-based compensation (38,205) 0 (38,205) 0 0 0
Foreign currency translation 23,286 0 0 23,286 0 0
Net loss for the period (7,060,175) $ 0 0 0 (6,985,546) (74,629)
Balance, shares at Jun. 30, 2024   82,928,314        
Balance, amount at Jun. 30, 2024 (22,897,611) $ 82,928 195,755,863 282,252 (217,929,441) (1,089,213)
Common stock issued for cash, net of issuance costs, shares   9,170,000        
Common stock issued for cash, net of issuance costs, amount 5,960,200 $ 9,170 5,951,030 0 0 0
Common stock issued for settlement of RSUs, shares   294,256        
Common stock issued for settlement of RSUs, amount 0 $ 295 (295) 0 0 0
Stock-based compensation 323,539 0 323,539 0 0 0
Tax withholdings paid related to stock-based compensation (15,860) 0 (15,860) 0 0 0
Foreign currency translation (141,980) 0   (141,980) 0 0
Net loss for the period (5,868,578) $ 0 0   (5,821,529) (47,049)
Balance, shares at Sep. 30, 2024   92,392,570        
Balance, amount at Sep. 30, 2024 $ (22,640,290) $ 92,393 $ 202,014,277 $ 140,272 $ (223,750,970) $ (1,136,262)
v3.24.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Operating Activities    
Net loss $ (21,400,758) $ (26,877,374)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 817,542 855,947
Amortization of operating lease right-of-use assets 169,273 194,036
Loss on disposal of fixed assets 34,693 15,913
Stock-based compensation 942,805 1,823,811
Gain on change in fair value of warrant liability (30,424) (249,845)
Changes in operating assets and liabilities:    
Prepaid expenses (168,625) (2,402)
Accounts receivable (69,992) (34,441)
Other current assets (24,064) (45,785)
Deferred revenue, current and non-current (106,600) 0
Accounts payable and accrued liabilities (416,167) 12,128
Management and directors' fees payable (34,774) (11,137)
Right-of-use assets operating leases liabilities (174,758) (191,586)
Net Cash Used In Operating Activities (20,461,849) (24,510,735)
Investing Activities    
Purchases of property and equipment (204,898) (775,027)
Purchase of License (171,095) 0
Net Cash Used In Investing Activities (375,993) (775,027)
Financing Activities    
Net proceeds from issuances of common stock 6,565,422 25,795,654
Tax withholdings paid related to stock-based compensation (57,127) (80,231)
Common stock repurchased 0 (31,772)
Proceeds from grants repayable 0 27,052
Proceeds from long-term debt 754,457 216,908
Payments on long-term debt (831,542) (680,325)
Payments on grants repayable (28,213) 0
Payments on finance lease obligations (35,621) (35,071)
Net Cash Provided By Financing Activities 6,367,376 25,212,215
Effect of foreign exchange on cash (845,371) 15,244
Net change in cash and cash equivalents (15,315,837) (58,303)
Cash and cash equivalents - beginning of the period 20,729,983 10,867,050
Cash and cash equivalents - End of Period 5,414,146 10,808,747
Supplemental Disclosures of Cash Flow Information    
Interest paid 247,871 163,623
Non-Cash Financing Activities    
Common stock issued upon cashless exercises of stock options and settlement of vested RSUs 578 308
Offering costs from issuance of common stock 245,107 239,772
Fair value of warrants issued in connection with public offering 0 366,960
Common stock issued for License rights 125,258 0
Non-cash note payable $ 294,603 $ 356,258
v3.24.3
Basis of Presentation and Summary of Significant Accounting Policies
9 Months Ended
Sep. 30, 2024
Basis of Presentation and Summary of Significant Accounting Policies  
Basis of Presentation and Summary of Significant Accounting Policies

Note 1 – Basis of Presentation and Summary of Significant Accounting Policies

 

Basis of Presentation and use of estimates

 

The accompanying unaudited condensed consolidated financial statements of VolitionRx Limited (the “Company” or “VolitionRx”) have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q of Regulation S-X. They do not include all the information and footnotes required by GAAP for complete financial statements. The December 31, 2023 consolidated balance sheet data was derived from audited financial statements but does not include all disclosures required by GAAP. However, except as disclosed herein, there has been no material change in the information disclosed in the notes to the audited consolidated financial statements and accompanying notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March 25, 2024 (the “Annual Report”). The interim unaudited condensed consolidated financial statements should be read in conjunction with those audited consolidated financial statements included in the Annual Report. In the opinion of management, all adjustments considered necessary for a fair presentation of the financial statements, consisting solely of normal recurring adjustments, have been made. Operating results for the nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024.

 

The preparation of the Company's Condensed Consolidated Financial Statements requires management to make certain estimates and assumptions about future events. These estimates and the underlying assumptions affect the amounts of assets and liabilities reported and reported amounts of revenues and expenses. Such estimates include impairment of long-lived assets, accounts receivable, useful lives of intangible assets and property and equipment, fair values of stock-based awards, income taxes among others. These estimates and assumptions are based on management’s judgment. Estimates and underlying assumptions are reviewed on an ongoing basis. Changes in accounting estimates may be necessary if there are changes in the circumstances or experiences on which the estimate was based or as a result of new information. Changes in estimates, including those resulting from changes in the economic environment, are reflected in the period in which the change in estimate occurs.

 

Reclassifications

 

Certain reclassifications within operating expenses have been made to the prior period’s financial statements to conform to the current period financial statement presentation. There is no impact in total to the results of operations and cash flows in all periods presented.

 

Recently Issued Accounting Pronouncements

 

In November 2023, the Financial Accounting Standards Board (the “FASB” issued Accounting Standards Update (“ASU”) 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures,” which requires a public entity to disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods all disclosures about reportable segment’s profit or loss and assets that are currently required annually. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. These amendments are to be applied retrospectively. The Company is currently evaluating the impact this standard will have on its annual and interim consolidated financial statements.

 

In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures,” which enhances the transparency and decision usefulness of income tax disclosures by requiring: (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. These amendments are to be applied prospectively, with retrospective application permitted. The Company is currently evaluating the impact this standard will have on its annual and interim consolidated financial statements.

 

The Company currently believes there are no other issued and not yet effective accounting standards that are materially relevant to its condensed consolidated financial statements.

Note 1 - Basis of Presentation and Summary of Significant Accounting Policies (continued)

 

Fair Value Measurements

 

Pursuant to ASC 820, “Fair Value Measurements and Disclosures,” an entity is required to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 establishes a fair value hierarchy based on the level of independent, objective evidence surrounding the inputs used to measure fair value. A financial instrument’s categorization within the fair value hierarchy is based upon the lowest level of input that is significant to the fair value measurement. ASC 820 prioritizes the inputs into three levels that may be used to measure fair value:

 

Level 1

Level 1 applies to assets or liabilities for which there are quoted prices in active markets for identical assets or liabilities.

 

Level 2

Level 2 applies to assets or liabilities for which there are inputs other than quoted prices that are observable for the assets or liabilities such as quoted prices for similar assets or liabilities in active markets; quoted prices for identical assets or liabilities in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which significant inputs are observable or can be derived principally from, or corroborated by, observable market data.

 

Level 3

Level 3 applies to assets or liabilities for which there are unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of the assets or liabilities.

 

The financial instruments of the Company consist primarily of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, debt, and a warrant liability. These items are considered Level 1 due to their short-term nature and their market interest rates, except for the warrant liability, which is considered Level 2 and is recorded at fair value at the end of each reporting period.

 

Included in the following table are the Company’s major categories of assets and liabilities measured at fair value on a recurring basis as of September 30, 2024.

 

Fair Value Measurements at September 30, 2024

Description

Level 1

Level 2

Level 3

Total

$

$

$

$

Liabilities

Warrant liability

-96,225-96,225

 

As of December 31, 2023, the warrant liability was $126,649. The following table provides a roll-forward of the warrant liability measured at fair value on a recurring basis for the nine months ended September 30, 2024.

 

Warrant Liability

Total

$

Balance at December 31, 2023

126,649

Gain on change in fair value of warrant liability

(30,424)

Balance at September 30, 2024

96,225

  

Basic and Diluted Net Loss Per Share

 

The Company computes net loss per share in accordance with ASC 260, “Earnings Per Share,” which requires presentation of both basic and diluted earnings per share (“EPS”) on the face of the statement of operations and comprehensive loss. Basic EPS is computed by dividing net loss available to common stockholders (numerator) by the weighted average number of shares outstanding (denominator) during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method. In computing diluted EPS, the average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of stock options or warrants. As of September 30, 2024, 38,147,734 potential common shares equivalents from warrants, options, and restricted stock units (“RSUs”) were excluded from the diluted EPS calculations as their effect is anti-dilutive.

v3.24.3
Liquidity and Going Concern Assessment
9 Months Ended
Sep. 30, 2024
Liquidity and Going Concern Assessment  
Liquidity and Going Concern Assessment

Note 2 – Liquidity and Going Concern Assessment

 

The Company's condensed consolidated financial statements are prepared using GAAP applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. Management assesses liquidity and going concern uncertainty in the Company’s consolidated financial statements to determine whether there is sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from the date the financial statements are issued, which is referred to as the “look-forward period,” as defined in GAAP. As part of this assessment, based on conditions that are known and reasonably knowable to management, management considered various scenarios, forecasts, projections, estimates and made certain key assumptions, including the timing and nature of projected cash expenditures or programs, its ability to delay or curtail expenditures or programs and its ability to raise additional capital, if necessary, among other factors.

 

For the nine months ended September 30, 2024, the Company incurred a net loss of $21.4 million and used cash flows in operating activities of $20.5 million. As of September 30, 2024, the Company had cash and cash equivalents of $5.4 million and an accumulated deficit of $223.8 million.

 

The Company has generated operating losses and has experienced negative cash flows from operations since inception. The Company has not generated significant revenues and expects to incur further losses in the future, particularly from continued development of its clinical-stage diagnostic tests and commercialization activities. The future of the Company as an operating business will depend on its ability to obtain sufficient capital contributions or, financing, and/or generate revenues as may be required to sustain its operations. Management plans to address the above as needed by, (a) granting licenses and/or distribution rights to third parties in exchange for specified up-front and/or back-end payments, (b) obtaining additional financing through debt or equity transactions, (c) securing additional grant funds, and (d) developing and commercializing its products in an efficient manner. Management continues to exercise tight cost controls to conserve cash. As part of the Company’s cash conservation efforts, directors and certain employees have elected to exchange a portion of their fees earned or paid in cash or salary, respectively, for RSUs in the Company for a period of up to six months.

 

The ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish the plans described in the preceding paragraph and to eventually attain profitable operations.

 

Management assessed the mitigating effect of these plans to determine if it is probable that the plans would be effectively implemented within one year after the condensed consolidated financial statements are issued and when implemented, would mitigate the relevant conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern. These plans are subject to market conditions and reliance on third parties, and there is no assurance that effective implementation of the Company’s plans will result in the necessary funding to continue current operations and satisfy current and expected debt obligations. The Company has implemented short-term cash preservation and cost-saving initiatives to conserve cash. The Company concluded that these plans do not alleviate the substantial doubt about the Company’s ability to continue as a going concern beyond one year from the date the condensed consolidated financial statements are issued.

 

The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The accompanying consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets and their carrying amounts, or the amounts and classification of liabilities that may result should the Company be unable to continue as a going concern. If the Company is unable to obtain adequate capital, it could be forced to cease operations.

v3.24.3
Property and Equipment
9 Months Ended
Sep. 30, 2024
Property and Equipment  
Property And Equipment

Note 3 - Property and Equipment

 

The Company’s property and equipment consisted of the following amounts as of September 30, 2024 and December 31, 2023:

 

September 30, 2024

December 31, 2023

Useful Life

Cost $

Cost $

Computer hardware and software

3 years

751,488724,534

Laboratory equipment

5 years

4,847,6224,753,253

Office furniture and equipment

5 years

382,970378,800

Buildings

30 years

2,132,9272,113,031

Building improvements

5-15 years

1,690,2681,610,016

Land

Not amortized

133,715132,468

Total property and equipment

9,938,9909,712,102

Less accumulated depreciation

5,030,8424,189,089

Total property and equipment, net

4,908,1485,523,013

 

During the nine-month periods ended September 30, 2024 and September 30, 2023, the Company recognized $815,824 and $792,232, respectively, in depreciation expense.

v3.24.3
Intangible Assets
9 Months Ended
Sep. 30, 2024
Intangible Assets  
Intangible Assets

Note 4 - Intangible Assets

 

The Company’s intangible assets consist of patents, mainly acquired in the acquisition of Belgian Volition. The patents are being amortized over the assets’ estimated useful lives, which range from 8 to 20 years.

 

September 30, 2024

December 31, 2023

Cost $

Cost $

Patents

1,148,9691,130,936

Licenses

296,353-

Total Patents and Licenses

1,445,3221,130,936

Less accumulated amortization

1,110,0131,107,050

Total patents and Licenses, net

335,30923,886

 

During the nine-month periods ended September 30, 2024 and September 30, 2023, the Company recognized $(6,742) and $63,715, respectively, in amortization expense.

 

The Company amortizes the patents and licenses on a straight-line basis with terms ranging from 8 to 20 years. The annual estimated amortization schedule over the next five years is as follows:

 

2024

$5,187

2025

$20,748

2026

$20,748

2027

$20,748

2028

$20,748

Greater than 5 years

$247,130

Total Intangible Assets

$335,309

 

The Company periodically reviews its long-lived assets to ensure that their carrying value does not exceed their fair market value. The Company carried out such a review in accordance with ASC 360, “Property, Plant and Equipment,” as of December 31, 2023. The result of this review confirmed that the ongoing value of the patents was not impaired as of December 31, 2023.

v3.24.3
Related Party Transactions
9 Months Ended
Sep. 30, 2024
Related Party Transactions  
Related-Party Transactions

Note 5 - Related-Party Transactions

 

See Note 6, Common Stock, for common stock issued to related parties and Note 7, Stock-Based Compensation, for stock options, warrants and RSUs issued to related parties. The Company has agreements with related parties for the purchase of consultancy services which are accrued under management and directors’ fees payable (see condensed consolidated balance sheets).

v3.24.3
Common Stock
9 Months Ended
Sep. 30, 2024
Common Stock  
Common Stock

Note 6 - Common Stock

 

As of September 30, 2024, the Company was authorized to issue 175 million shares of common stock, par value $0.001 per share, of which 92,392,570 and 81,898,321 shares were issued and outstanding as of September 30, 2024 and December 31, 2023, respectively.

 

Stock Option Exercises

 

During the nine months ended September 30, 2024, no shares of common stock were issued pursuant to the exercise of stock options.

 

Stock Options Expired / Cancelled

 

On April 16, 2024, 36,821 vested stock options previously granted to an employee were cancelled and returned as authorized shares under the 2015 Stock Incentive Plan (the “2015 Plan”) on the expiration of the exercise period following the resignation of such employee.

 

RSU Settlements

 

Below is a table summarizing the RSUs that vested and settled during the nine months ended September 30, 2024, all of which were issued pursuant to the 2015 Plan.

 

Equity Incentive Plan

RSUs Vested (#)

Vest Date

Shares Issued (#)

Shares Withheld for Taxes (#)

2015

21,582

Feb 8, 2024

21,582-

2015

9,000

Mar 1, 2024

6,0572,943

2015

44,217

Mar 27, 2024

40,5303,687

2015

51,000

Apr 4, 2024

32,33718,663

2015

50,000

May 1, 2024

34,49615,504

2015

11,500

Jun 1, 2024

6,6704,830

2015

14,962

Jun 15, 2024

11,6843,278

2015

4,667

Jul 13, 2024

3,1651,502

2015

29,000

Aug 15, 2024

21,2917,709

2015

2,000

Sep 11, 2024

2,000-

2015

2,500

Sep 21, 2024

2,500-

2015

332,775

Sep 28, 2024

265,30067,475
573,203447,612125,591

2023 Equity Capital Raise

 

In connection with the June 2023 underwritten public offering of the Company’s common stock under the Company’s Registration Statement on Form S-3 (File No. 333-259783) effective November 8, 2021 (the “2021 Form S-3”), and pursuant to the underwriting agreement with Prime Executions, Inc, doing business as Freedom Capital Markets (“Freedom”), dated June 1, 2023, (the “2023” Equity Capital Raise”) the Company issued as compensation to Freedom warrants to purchase an aggregate of 448,500 shares of Company common stock at an exercise price of $2.00 per share. The Company evaluated the warrants as either equity-classified or liability-classified instruments based on an assessment of the specific terms of the warrants and applicable authoritative guidance in ASC 480 and ASC 815-40. The Company determined the warrants issued to Freedom failed the indexation guidance under ASC 815-40, specifically, the warrants provide for a Black-Scholes value calculation in the event of certain transactions, which includes a floor on volatility utilized in the value calculation at 100% or greater. The Company has determined that this provision introduces leverage to the holders of the warrants that could result in a value that would be greater than the settlement amount of a fixed-for-fixed option on the Company’s own equity shares. Accordingly, pursuant to ASC 815-40, the Company has classified the fair value of the warrants as a liability upon issuance and marked to market each reporting period in the Company’s consolidated statement of operations until their exercise or expiration.

 

The fair value of the warrants issued in the 2023 Equity Capital Raise as of September 30, 2024, and December 31, 2023, were $96,225 and $126,649 respectively. The warrant liability was estimated using the Black-Scholes pricing model with the following assumptions.

 

September 30, 2024

December 31, 2023

Risk-free interest rate

3.58%3.89%

Expected volatility

84.85%76.30%

Expected life (years)

3.694.44

Expected dividend yield

--

Total fair value

$96,225$126,649

 

The fair value of the warrants issued in the 2023 Equity Capital Raise was deemed to be a liability, due to certain contingent put features, and was determined using the Black-Scholes option pricing model, which was deemed to be an appropriate model due to the terms of the warrants issued, including a fixed term and exercise price.

2024 Equity Capital Raise

 

On August 8, 2024, the Company entered into a securities purchase agreement with a purchaser pursuant to which the Company issued and sold to such purchaser, in a registered direct offering under the 2021 Form S-3 (the “2024 Equity Capital Raise”), an aggregate of 9,170,000 shares of the Company’s common stock, pre-funded warrants to purchase up to 3,557,273 shares of the Company’s common stock (the “Pre-Funded Warrants”), Series A common stock warrants to purchase up to 12,727,273 shares of the Company’s common stock (the “Series A Warrants”) and Series B common stock warrants to purchase up to 12,727,273 shares of the Company’s common stock (the “Series B Warrants” and, together with the Series A Warrants, the “Common Warrants” and, together with the shares of common stock offered in the 2024 Equity Capital Raise and the Pre-Funded Warrants, the “Securities”). The exercise prices of the Pre-Funded Warrants and the Common Warrants is $0.001 per share and $0.57 per share, respectively. H.C. Wainwright & Co. acted as the exclusive placement agent for the Company in the offering. The combined offering price for a share of common stock and accompanying Common Warrants was $0.55 and the combined offering price for a Pre-Funded Warrant and accompanying Common Warrants was $0.549. The net proceeds received by the Company for the issuance and sale of the Securities was $6.4 million, before deducting offering expenses of $0.1 million paid by the Company. In addition, the Company issued warrants to the placement agent to purchase an aggregate of 381,818 shares of Company common stock on substantially the same terms as the Series B Warrants at an exercise price of $0.6875 per share. The net proceeds above assumes the exercise of the Pre-Funded Warrants but excludes any proceeds arising from the exercise of the Common Warrants or the placement agent warrants.

 

Common Stock Issued for EpiCypher License Agreement

 

On March 12, 2024, the Company issued 129,132 shares of restricted common stock to EpiCypher, Inc. at a price of $0.97 per share as partial consideration for license rights in connection with a License Agreement between EpiCypher and Belgian Volition.

 

Equity Distribution Agreement

 

On May 20, 2022, the Company entered into an equity distribution agreement (the “2022 EDA”) with Jefferies LLC (“Jefferies”) to sell shares of the Company’s common stock, with an aggregate offering price of up to $25.0 million, from time to time through an “at the market” offering pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-259783) effective November 8, 2021 (the “2021 Form S-3”) through Jefferies acting as the Company’s agent and/or principal. The Company is not obligated to sell any shares under the 2022 EDA.

 

During the nine months ended September 30, 2024, the Company raised aggregate net proceeds (net of broker commissions and fees) of approximately $605,221 under the 2022 EDA through the sale of 747,505 shares of its common stock. As of September 30, 2024, the Company has raised aggregate net proceeds (net of broker commissions and fees) of approximately $2.1 million under the 2022 EDA through the sale of 1,378,037 shares of its common stock.

v3.24.3
Stock Based Compensation
9 Months Ended
Sep. 30, 2024
Stock Based Compensation  
Stock-based Compensation

Note 7 – Stock-Based Compensation

 

a) (i) Common Stock Warrants

 

The following table summarizes the changes in common stock warrants of the Company outstanding during the nine-month period ended September 30, 2024.

 

Number of Warrants

Weighted Average Exercise Price ($)

Outstanding at December 31, 2023

862,5003.050

Granted

3,557,2730.001

Expired/Cancelled

--

Outstanding at September 30, 2024

4,419,7730.597

Exercisable at September 30, 2024

4,419,7730.597

 

Below is a table summarizing the common stock warrants issued and outstanding as of September 30, 2024, which have an aggregate weighted average remaining contractual life of 0.60 years. The proceeds if exercised assume the warrants are exercised for cash.

 

Number Outstanding

Number Exercisable

Exercise Price ($)

Weighted Average Remaining Contractual Life (Years)

Proceeds to

Company if Exercised ($)

3,557,273

3,557,2730.001-3,557

448,500

448,5002.0003.71897,000

54,000

54,0003.0504.01164,700

50,000

50,0003.4501.42172,500

125,000

125,0003.9502.25493,750

185,000

185,0004.9002.34906,500

4,419,773

4,419,7732,638,007

 

Stock-based compensation expense related to warrants of $5,238 and $25,447 was recorded in the nine months ended September 30, 2024 and September 30, 2023, respectively. Total remaining unrecognized compensation cost related to non-vested warrants is $nil. As of September 30, 2024, the total intrinsic value of warrants outstanding was $nil.

a) (ii) Warrants – Series A and Series B Common Stock Warrants

 

The following table summarizes the changes in Series A and Series B common stock warrants of the Company outstanding during the nine-month period ended September 30, 2024.

 

Number of Warrants

Weighted Average Exercise Price ($)

Outstanding at December 31, 2023

--

Granted

25,836,3640.57

Exercised

--

Expired/Cancelled

--

Outstanding at September 30, 2024

25,836,3640.57

Exercisable at September 30, 2024

--

 

Below is a table summarizing the Series A and Series B common stock warrants issued and outstanding as of September 30, 2024, which have a maximum aggregate weighted average remaining contractual life of 3.88 years (assuming that certain Company milestones set forth in the warrants are not achieved). The proceeds if exercised as reflected in the table below assume the warrants are exercised for cash.

 

Description

Number

Outstanding

Number

Exercisable

Exercise

Price ($)

Weighted Average Remaining Contractual Life (Years)

Proceeds to Company if Exercised ($)

Investor A Warrants

12,727,273-0.57002.367,254,546

Investor B Warrants

12,727,273-0.57005.367,254,546

Placement Agent Series B Warrants

381,818-0.68754.86262,500
25,836,364-14,771,591

 

b) Options

 

The following table summarizes the changes in options outstanding of the Company during the nine-month period ended September 30, 2024.

 

 

 

Number

of Options

 

 

Weighted

Average

Exercise

Price ($)

 

Outstanding at December 31, 2023

 

 

4,699,569

 

 

 

3.87

 

Expired/Cancelled

 

 

(36,821)

 

 

3.40

 

Outstanding at September 30, 2024

 

 

4,662,748

 

 

 

3.88

 

 

 

 

 

 

 

 

 

 

Exercisable at September 30, 2024

 

 

4,662,748

 

 

 

3.88

 

b) Options (continued)

 

Below is a table summarizing the options issued and outstanding as of September 30, 2024, all of which were issued pursuant to the Company’s 2011 Equity Incentive Plan (for option issuances prior to 2016) or the 2015 Plan (for option and RSU issuances commencing in 2016)and which have an aggregate weighted average remaining contractual life of 3.46 years. As of September 30, 2024, an aggregate of 9,700,000 shares of common stock were authorized for issuance under the 2015 Plan, of which 603,502 shares of common stock remained available for future issuance thereunder. At the Annual Meeting on July 2, 2024, the stockholders approved and adopted the Company’s 2024 Stock Incentive Plan (the “2024 Plan”) which authorizes up to 7,500,000 shares of common stock for issuance pursuant to awards granted under the 2024 Plan. The 2024 Plan had previously been approved by the Board of Directors of the Company on April 24, 2024. As of September 30, 2024, no shares of common stock have been granted under the 2024 Plan.

 

Number

Outstanding

 

 

Number

Exercisable

 

 

Exercise

Price ($)

 

 

Weighted Average Remaining

Contractual Life (Years)

 

 

Proceeds to

Company if Exercised ($)

 

 

585,000

 

 

 

585,000

 

 

 

3.25

 

 

 

0.36

 

 

 

1,901,250

 

 

944,748

 

 

 

944,748

 

 

 

3.40

 

 

 

6.84

 

 

 

3,212,143

 

 

740,000

 

 

 

740,000

 

 

 

3.60

 

 

 

5.61

 

 

 

2,664,000

 

 

1,607,837

 

 

 

1,607,837

 

 

 

4.00

 

 

 

1.98

 

 

 

6,431,348

 

 

89,163

 

 

 

89,163

 

 

 

4.38

 

 

 

3.32

 

 

 

390,534

 

 

50,000

 

 

 

50,000

 

 

 

4.80

 

 

 

2.25

 

 

 

240,000

 

 

646,000

 

 

 

646,000

 

 

 

5.00

 

 

 

2.49

 

 

 

3,230,000

 

 

4,662,748

 

 

 

4,662,748

 

 

 

 

 

 

 

 

 

 

 

18,069,275

 

 

Stock-based compensation expense related to stock options of $nil and $287,013 was recorded in the nine months ended September 30, 2024 and September 30, 2023, respectively. Total remaining unrecognized compensation cost related to non-vested stock options is $nil. As of September 30, 2024, the total intrinsic value of stock options outstanding was $nil.

 

c) Restricted Stock Units

 

Below is a table summarizing the RSUs issued and outstanding as of September 30, 2024, all of which were issued pursuant to the 2015 Plan.

 

 

 

RSUs (#)

 

 

Weighted Average Grant Date Fair Value Share Price ($)

 

Outstanding at December 31, 2023

 

 

3,634,952

 

 

 

1.01

 

Granted

 

 

844,313

 

 

 

0.71

 

Vested/Settled

 

 

(573,203)

 

 

1.40

 

Cancelled / Forfeited

 

 

(677,213)

 

 

0.83

 

Outstanding at September 30, 2024

 

 

3,228,849

 

 

 

0.90

 

c) Restricted Stock Units (continued)

 

Below is a table summarizing the RSUs granted during the nine months ended September 30, 2024, all of which were issued pursuant to the 2015 Plan. The RSUs vest equally over periods stated on the dates noted, subject to the recipient’s continued service to the Company, and will result in the RSU compensation expense stated. On June 1, 2024, the Company granted 297,340 RSUs of common stock to certain directors and employees in exchange for their election to reduce their cash compensation for a period of three months for services provided to the Company. These RSUs will vest on May 1, 2025, subject to continued service by the recipient. On July 1, 2024, the Company granted 38,198 RSUs of common stock to an employee in exchange for the employee’s election to reduce their cash compensation for a period of three months for services provided to the Company. These RSUs will vest on June 1, 2025, subject to continued service by the recipient. On July 8, 2024, the Company granted 21,583 RSUs of common stock to a consultant in exchange for advisory services. These RSUs will vest on January 1, 2025, subject to continued service to the Company by the recipient. On September 1, 2024, the Company granted 343,192 RSUs of common stock to certain directors and employees in exchange for their election to reduce their cash compensation for a period of three months for services provided to the Company. These RSUs will vest on June 1, 2025, subject to continued service by the recipient. On September 30, 2024, the Company granted 15,000 RSUs to a non-employee director, vesting in three equal installments on the first, second and third anniversaries of the date of grant, subject to continued services by the recipient.

 

Equity Incentive Plan

RSUs Granted (#)

Grant Date

Vesting Period

First Vesting Date

Second Vesting Date

Third Vesting Date

RSU Expense ($)

2015

14,000

Feb 22, 2024

36 Months

Feb 22, 2025

Feb 22, 2026

Feb 22, 2027

13,589

2015

115,000

May 23, 2024

36 Months

May 23, 2025

May 23, 2026

May 23, 2027

85,389

2015

297,340

Jun 1, 2024

11 Months

May 1, 2025

N/A

N/A

209,832

2015

38,198

Jul 1, 2024

11 Months

Jun 1, 2025

N/A

N/A

23,645

2015

21,583

Jul 8, 2024

6 Months

Jan 1, 2025

N/A

N/A

13,209

2015

343,192

Sep 1, 2024

9 Months

Jun 1, 2025

N/A

N/A

247,098

2015

15,000

Sep 30, 2024

36 Months

Sep 30, 2025

Sep 30, 2026

Sep 30, 2027

9,015

844,313

601,777

c) Restricted Stock Units (continued)

 

Below is a table summarizing the RSUs vested and settled during the nine months ended September 30, 2024, all of which were issued pursuant to the 2015 Plan.

 

Equity Incentive Plan

 

RSUs Vested (#)

 

 

Vest Date

 

Shares Issued (#)

 

 

Shares Withheld for Taxes (#)

 

2015

 

 

21,582

 

 

Feb 8, 2024

 

 

21,582

 

 

 

-

 

2015

 

 

9,000

 

 

Mar 1, 2024

 

 

6,057

 

 

 

2,943

 

2015

 

 

44,217

 

 

Mar 27, 2024

 

 

40,530

 

 

 

3,687

 

2015

 

 

51,000

 

 

Apr 4, 2024

 

 

32,337

 

 

 

18,663

 

2015

 

 

50,000

 

 

May 1, 2024

 

 

34,496

 

 

 

15,504

 

2015

 

 

11,500

 

 

Jun 1, 2024

 

 

6,670

 

 

 

4,830

 

2015

 

 

14,962

 

 

Jun 15, 2024

 

 

11,684

 

 

 

3,278

 

2015

 

 

4,667

 

 

Jul 13, 2024

 

 

3,165

 

 

 

1,502

 

2015

 

 

29,000

 

 

Aug 15, 2024

 

 

21,291

 

 

 

7,709

 

2015

 

 

2,000

 

 

Sep 11, 2024

 

 

2,000

 

 

 

-

 

2015

 

 

2,500

 

 

Sep 21, 2024

 

 

2,500

 

 

 

-

 

2015

 

 

332,775

 

 

Sep 28, 2024

 

 

265,300

 

 

 

67,475

 

 

 

 

573,203

 

 

 

 

 

447,612

 

 

 

125,591

 

c) Restricted Stock Units (continued)

 

Below is a table summarizing the RSUs cancelled during the nine months ended September 30, 2024, all of which were originally issued pursuant to the 2015 Plan.

 

Equity Incentive Plan

 

RSUs (#)

 

 

Cancellation Date

 

Vesting Date

 

RSUs Cancelled (#)

 

2015

 

 

8,000

 

 

Jan 16, 2024

 

Sep 28, 2024

 

 

8,000

 

2015

 

 

6,000

 

 

Jan 16, 2024

 

Oct 4, 2024

 

 

6,000

 

2015

 

 

8,000

 

 

Jan 16, 2024

 

Sep 28, 2025

 

 

8,000

 

2015

 

 

6,000

 

 

Jan 16, 2024

 

Oct 4, 2025

 

 

6,000

 

2015

 

 

8,000

 

 

Jan 16, 2024

 

Sep 28, 2026

 

 

8,000

 

2015

 

 

667

 

 

Feb 9, 2024

 

Jun 15, 2024

 

 

667

 

2015

 

 

667

 

 

Feb 9, 2024

 

Jun 15, 2025

 

 

667

 

2015

 

 

666

 

 

Feb 9, 2024

 

Jun 15, 2026

 

 

666

 

2015

 

 

1,775

 

 

Mar 25, 2024

 

Mar 27, 2024

 

 

1,775

 

2015

 

 

2,098

 

 

Mar 25, 2024

 

Jun 15, 2024

 

 

2,098

 

2015

 

 

2,667

 

 

May 17, 2024

 

Oct 4, 2024

 

 

2,667

 

2015

 

 

2,666

 

 

May 17, 2024

 

Oct 4, 2025

 

 

2,666

 

2015

 

 

1,000

 

 

May 17, 2024

 

Mar 27, 2025

 

 

1,000

 

2015

 

 

1,000

 

 

May 17, 2024

 

Mar 27, 2026

 

 

1,000

 

2015

 

 

3,334

 

 

May 17, 2024

 

Sep 28, 2024

 

 

3,334

 

2015

 

 

3,333

 

 

May 17, 2024

 

Sep 28, 2025

 

 

3,333

 

2015

 

 

3,333

 

 

May 17, 2024

 

Sep 28, 2026

 

 

3,333

 

2015

 

 

9,334

 

 

May 31, 2024

 

Sep 11, 2024

 

 

9,334

 

2015

 

 

9,333

 

 

May 31, 2024

 

Sep 11, 2025

 

 

9,333

 

2015

 

 

9,333

 

 

May 31, 2024

 

Sep 11, 2026

 

 

9,333

 

2015

 

 

3,333

 

 

Jul 12, 2024

 

Oct 4, 2024

 

 

3,333

 

2015

 

 

3,333

 

 

Jul 12, 2024

 

Oct 4, 2025

 

 

3,333

 

2015

 

 

5,666

 

 

Aug 4, 2024

 

Oct 4, 2025

 

 

5,666

 

2015

 

 

10,000

 

 

Aug 4, 2024

 

Sep 21, 2024

 

 

10,000

 

2015

 

 

5,667

 

 

Aug 4, 2024

 

Oct 4, 2024

 

 

5,667

 

2015

 

 

178,909

 

 

Aug 15, 2024

 

Sep 28, 2024

 

 

178,909

 

2015

 

 

178,894

 

 

Aug 15, 2024

 

Sep 28, 2025

 

 

178,894

 

2015

 

 

178,872

 

 

Aug 15, 2024

 

Sep 28, 2026

 

 

178,872

 

2015

 

 

8,000

 

 

Aug 31, 2024

 

Mar 27, 2025

 

 

8,000

 

2015

 

 

8,000

 

 

Aug 31, 2024

 

Mar 27, 2026

 

 

8,000

 

2015

 

 

4,667

 

 

Aug 31, 2024

 

Oct 4, 2024

 

 

4,667

 

2015

 

 

4,666

 

 

Aug 31, 2024

 

Oct 4, 2025

 

 

4,666

 

 

 

 

677,213

 

 

 

 

 

 

 

677,213

 

c) Restricted Stock Units (continued)

 

Below is a table summarizing the RSUs issued and outstanding as of September 30, 2024 and which have an aggregate weighted average remaining contractual life of 1.23 years.

 

RSUs Outstanding (#)

 

 

Weighted Average Grant Date Fair Value Share Price ($)

 

 

Weighted Average Remaining Contractual Life (Years)

 

 

40,000

 

 

 

0.58

 

 

 

1.12

 

 

15,000

 

 

 

0.60

 

 

 

2.00

 

 

21,583

 

 

 

0.61

 

 

 

0.25

 

 

38,198

 

 

 

0.62

 

 

 

0.67

 

 

450,000

 

 

 

0.68

 

 

 

2.55

 

 

450,000

 

 

 

0.69

 

 

 

1.51

 

 

665,550

 

 

 

0.70

 

 

 

1.00

 

 

297,340

 

 

 

0.71

 

 

 

0.58

 

 

343,192

 

 

 

0.72

 

 

 

0.67

 

 

115,000

 

 

 

0.74

 

 

 

1.64

 

 

14,000

 

 

 

0.97

 

 

 

1.40

 

 

4,000

 

 

 

1.31

 

 

 

0.97

 

 

9,333

 

 

 

1.32

 

 

 

0.86

 

 

675,322

 

 

 

1.46

 

 

 

0.49

 

 

17,332

 

 

 

1.58

 

 

 

0.60

 

 

38,333

 

 

 

1.72

 

 

 

0.92

 

 

666

 

 

 

2.15

 

 

 

0.66

 

 

34,000

 

 

 

2.95

 

 

 

0.13

 

 

3,228,849

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense related to RSUs of $937,567 and $1,511,351 was recorded in the nine months ended September 30, 2024 and September 30, 2023, respectively. Total remaining unrecognized compensation cost related to non-vested RSUs is $1,031,071.

v3.24.3
Commitments and Contingencies
9 Months Ended
Sep. 30, 2024
Commitments and Contingencies  
Commitments And Contingencies

Note 8 – Commitments and Contingencies

 

a) Finance Lease Obligations

 

The following is a schedule showing the future minimum lease payments under finance leases by years and the present value of the minimum payments as of September 30, 2024.

 

2024 - Remaining

 

$14,983

 

2025

 

$59,934

 

2026

 

$59,934

 

2027

 

$59,934

 

2028

 

$59,933

 

Greater than 5 years

 

$202,259

 

Total

 

$456,977

 

Less: Amount representing interest

 

$(40,812)

Present value of minimum lease payments

 

$416,165

 

 

b) Operating Lease Right-of-Use Obligations

 

Operating leases as of September 30, 2024, and December 31, 2023, consisted of the following:

 

 

 

September 30, 2024

 

 

December 31, 2023

 

 

 

$

 

 

$

 

Operating right-of-use assets

 

 

635,857

 

 

 

549,504

 

 

 

 

 

 

 

 

 

 

Operating lease liabilities, current portion

 

 

190,099

 

 

 

199,323

 

Operating lease liabilities, long term

 

 

350,810

 

 

 

378,054

 

Total operating lease liabilities

 

 

540,909

 

 

 

577,377

 

 

 

 

 

 

 

 

 

 

Weighted average remaining lease (months)

 

 

47

 

 

 

33

 

Weighted average discount rate

 

 

3.70%

 

 

3.02%

 

During the nine months ended September 30, 2024, cash paid for amounts included for the measurement of lease liabilities was $185,692 and the Company recorded operating lease expense of $167,465.

b) Operating Lease Right-of-Use Obligations (continued)

 

The following is a schedule showing the future minimum lease payments under operating leases by years and the present value of the minimum payments as of September 30, 2024.

 

For the Nine Months Ending September 30, 2024

 

Amount

 

 

 

$

 

2024 - Remaining

 

 

61,552

 

2025

 

 

241,924

 

2026

 

 

225,368

 

2027

 

 

144,593

 

2028

 

 

44,059

 

Total

 

 

717,496

 

Less: imputed interest

 

 

(50,391)

Total Operating Lease Liabilities

 

 

667,105

 

 

The Company’s office space leases are short-term and the Company has elected under the short-term recognition exemption not to recognize them on the balance sheet. During the nine months ended September 30, 2024, the Company recognized $45,161 in short-term lease costs associated with office space leases. The annual payments remaining for short-term office leases were as follows:

 

For the Nine Months Ending September 30, 2024

 

Amount

 

 

 

$

 

2024 - Remaining

 

 

27,481

 

2025

 

 

12,373

 

Total Operating Lease Liabilities

 

 

39,854

 

 

c) Grants Repayable

 

As of September 30, 2024, the total grant balance repayable was $454,544 and the payments remaining were as follows:

 

For the Nine Months Ending September 30, 2024

 

Amount

 

 

 

$

 

2024 - Remaining

 

 

27,857

 

2025

 

 

37,789

 

2026

 

 

45,545

 

2027

 

 

50,564

 

2028

 

 

54,073

 

Greater than 5 years

 

 

238,716

 

Total Grants Repayable

 

 

454,544

 

d) Long-Term Debt

 

As of September 30, 2024, the total balance for long-term debt payable was $4,802,971 and the payments remaining were as follows:

 

For the Nine Months Ending September 30, 2024

 

Amount

 

 

 

$

 

2024 - Remaining

 

 

551,774

 

2025

 

 

1,046,366

 

2026

 

 

813,844

 

2027

 

 

607,484

 

2028

 

 

2,536,778

 

Greater than 5 years

 

 

326,851

 

Total

 

 

5,883,097

 

Less: amount representing interest

 

 

(1,080,126)

Total Long-Term Debt

 

 

4,802,971

 

 

e) Collaborative Agreement Obligations

 

In 2018, the Company entered into a research collaboration agreement with the University of Taiwan for a three-year research period for a cost to the Company of up to $2.55 million payable over such period. As of September 30, 2024, $510,000 is still to be paid by the Company under this agreement. As of September 30, 2024, $510,000 is due by the Company under this agreement.

 

In 2022, the Company entered into a sponsored research agreement with The University of Texas MD Anderson Cancer Center to evaluate the role of neutrophil extracellular traps ("NETs") in cancer patients with sepsis for a cost to the Company of $327,092. As of September 30, 2024, $327,092 is still to be paid by the Company under this agreement. As of September 30, 2024, $138,971 is due by the Company under this agreement.

 

In July 2023, the Company entered into a research agreement with Xenetic Biosciences Inc and CLS Therapeutics Ltd to evaluate the anti-tumoral effects of Nu.Q® CAR T cells for a cost to the Company of $107,589. As of September 30, 2024, $81,447 is still to be paid by the Company under this agreement and as of September 30, 2024, $26,142 is due by the Company under this agreement.

 

In August 2023, the Company entered into a project research agreement with Guy’s and St Thomas’ NHS Foundation Trust to evaluate the practical clinical utility of the Nu.Q® H3.1 nucleosome levels in adult patients with sepsis to facilitate early diagnosis and prognostication for a cost to the Company of $217,464. As of September 30, 2024, $217,464 is still to be paid by the Company under this agreement. As of September 30, 2024, $0 is due by the Company under this agreement.

 

In January 2024, the Company entered into an agreement with the University Medical Centre Amsterdam (“UMC”). UMC will perform a retrospective study to evaluate the diagnostic potential of the Nu.Q® H3.1 nucleosomes as diagnostic, prognostic and phenotyping biomarkers in sepsis for a cost to the Company of $96,260. As of September 30, 2024, $96,260 is still to be paid by the Company under this agreement. As of September 30, 2024, $48,106 is due by the Company under this agreement.

e) Collaborative Agreement Obligations (continued)

 

As of September 30, 2024, the total amount to be paid for future research and collaboration commitments was $1,232,263 and the payments remaining were as follows:

 

 

 

Total Amount Remaining

 

 

2024 - Remaining

 

 

2025

 

 

 

$

 

 

$

 

 

$

 

National University of Taiwan

 

 

510,000

 

 

 

510,000

 

 

 

-

 

MD Anderson Cancer Center

 

 

327,092

 

 

 

163,546

 

 

 

163,546

 

Guys and St Thomas

 

 

217,464

 

 

 

65,239

 

 

 

152,225

 

Xenetic Biosciences

 

 

81,447

 

 

 

26,142

 

 

 

55,305

 

UMC

 

 

96,260

 

 

 

48,058

 

 

 

48,202

 

Total Collaborative Obligations

 

 

1,232,263

 

 

 

812,985

 

 

 

419,278

 

 

f) Other Commitments

 

Volition Germany

 

As of September 30, 2024, $218 is payable under the royalty agreement with the founder of Volition’s former German subsidiary based on sales to date towards the Company’s aggregate minimum royalty obligation of $122,572.

 

Volition America

 

Effective February 10, 2024 the Company and Diagnostic Oncology CRO, LLC (“DXOCRO”) further amended and restated the August 2022 amended and restated Master Agreement by and between the Company and DXOCRO to expand the scope of DXOCRO’s consultant services provided thereunder (the “Second A&R Master Agreement”). The Second A&R Master Agreement requires DXOCRO to conduct a prospective optimization/range finding study of Volition’s Nu.Q® H3.1 in vitro diagnostic test proposed for use in sepsis. The study is an extension of the sepsis monitoring clinical trial that was previously covered under a separate exhibit. The Company anticipates DXOCRO’s additional services under this agreement will be completed by the end of the third quarter of 2024 at a total additional cost to the Company of up to $0.7 million. The Company’s payment obligations accrue upon delivery of projects under the agreement. The Company may terminate the agreement or any project thereunder upon at least 30 days’ prior written notice. Unless earlier terminated, the Second A&R Master Agreement terminates on the later of December 31, 2025 or the date upon which all services have been completed. As of September 30, 2024, $138,971 is payable under the Second A&R Master Agreement, and up to $0 may be payable by the Company in future periods for services rendered.

 

VolitionRx

 

On February 5, 2024, the Company entered into a 9-month loan agreement with First Insurance Funding for a maximum of $294,603 with fixed interest rate of 8.42%, maturing in November 2024. As of September 30, 2024, the maximum has been drawn down under this agreement and the principal balance payable was $65,467. The agreement is in relation to the directors and officers insurance policy.

g) Legal Proceedings

 

In the ordinary course of business, the Company may be subject to claims, counter-claims, lawsuits and other litigation of the type that generally arise from the conduct of its business. The Company knows of no legal proceedings which the Company believes will have a material adverse effect on its financial position.

 

h) Commitments in Respect of Corporate Goals and Performance-Based Awards

 

As of September 30, 2024, the Company has recognized total compensation expense of $1,396,638 of which $527,940 is in relation to RSUs from grants in 2022 that vested in 2023, $513,394 is in relation to RSUs from such grants that will vest in 2024, and $355,304 is in relation to RSUs from such grants that will vest in 2025. The Company has unrecognized compensation expense of $168,518 in relation to such RSUs, based on the outcomes related to the prescribed performance targets on the outstanding awards.

 

Total

 

 

Vesting

 

Amortized

 

 

Amortized

 

 

Amortized

 

 

Un-Amortized

 

Award

 

 

Year

 

2024

 

 

2023

 

 

2022

 

 

 

 

$

 

 

 

 

$

 

 

$

 

 

$

 

 

$

 

 

527,940

 

 

2023

 

 

-

 

 

 

393,853

 

 

 

134,087

 

 

 

-

 

 

516,040

 

 

2024

 

 

188,187

 

 

 

260,119

 

 

 

65,088

 

 

 

2,646

 

 

521,176

 

 

2025

 

 

131,034

 

 

 

177,584

 

 

 

46,686

 

 

 

165,872

 

 

1,565,156

 

 

 

 

 

319,221

 

 

 

831,556

 

 

 

245,861

 

 

 

168,518

 

 

In September 2023, the Compensation Committee of the Board of Directors of the Company approved the granting of cash bonuses, payable upon achievement of various corporate goals focused around revenue, operations and regulatory, to various personnel including directors, executives, members of management, consultants and employees of the Company and/or its subsidiaries. Pursuant to the terms of the grants, conditional upon the achievement by December 31, 2023 and June 30, 2024 of specified corporate goals as set forth in the minutes of the Compensation Committee, as well as continued service by the award recipients to the Company, the Company at the sole discretion of the Chief Executive Officer and the Chief Financial Officer would pay a cash bonus to such award recipients. As of September 30, 2024, the Company has accrued compensation expense of $536,535 in relation to cash bonuses payable on the achievement of specified corporate goals based on the expected outcomes related to the prescribed performance targets. To the extent this is payable, this cash bonus compensation payment has currently been deferred indefinitely.

 

As of September 30, 2024, the Company had recognized total compensation expense of $447,008. The Company has unrecognized compensation expense of $270,104 in relation to the RSUs from grants in 2023, of which $0 is in relation to RSUs that will vest in 2024, $115,517 in relation to RSUs that will vest in 2025, and $154,587 in relation to RSUs that will vest in 2026 based on the outcomes related to the prescribed performance targets on the outstanding awards.

 

Total

 

 

Vesting

 

Amortized

 

 

Amortized

 

 

Un-Amortized

 

Award

 

 

Year

 

2024

 

 

2023

 

 

2024

 

$

 

 

 

 

$

 

 

$

 

 

$

 

 

242,902

 

 

2024

 

 

148,132

 

 

 

94,770

 

 

 

-

 

 

237,936

 

 

2025

 

 

74,906

 

 

 

47,513

 

 

 

115,517

 

 

236,274

 

 

2026

 

 

49,984

 

 

 

31,703

 

 

 

154,587

 

 

717,112

 

 

 

 

 

273,022

 

 

 

173,986

 

 

 

270,104

 

v3.24.3
Subsequent Events
9 Months Ended
Sep. 30, 2024
Subsequent Events  
Subsequent Events

Note 9 – Subsequent Events

 

Settlement of RSUs

 

On October 4, 2024, 337,666 RSUs previously granted to various employees vested and resulted in the issuance of 272,242 shares of common stock. 65,424 shares of common stock were withheld for taxes and returned to the 2015 Plan.

 

RSUs Granted

 

Effective October 1, 2024, the Company granted RSUs of 33,503 shares of common stock under the Company’s 2015 Plan to an employee of the Company in exchange their valid election to reduce their cash compensation for a period of three months for services provided to the Company. These RSUs will vest on July 1, 2025, subject to continued service by the employee.

 

Effective November 6, 2024, the Company granted aggregate RSUs of 400,000 shares of common stock under the Company’s 2015 Plan to a director of the Company and/or its subsidiaries in exchange for services provided to the Company and/or its subsidiaries. These RSUs vest over three years, with one-third vesting on each of November 6, 2025, November 6, 2026 and November 6, 2027, subject to continued service, and will result in total compensation expense of $240,800.

 

Effective November 6, 2024, the Company granted aggregate RSUs of 1,000,000 shares of common stock under the Company’s 2024 Plan to a director in exchange for services provided to the Company. These RSUs vest in two equal installments following the achievement of a closing stock price target above $2.50 per share and above $5.00 per share, respectively, of the Company’s common stock for a minimum of thirty consecutive trading days prior to November 6, 2027 (but no earlier than November 2025), and also subject to time-based vesting in a single installment six months after the timely achievement of each stock price target, if at all, and subject to continued service. The estimated fair value of the RSUs that include a market vesting condition will be measured on the grant date using a Monte Carlo Simulation of a Geometric Brownian Motion stock path model and incorporating the probability of vesting occurring. The estimated fair value of these awards will be recognized over the derived service period (as determined by the valuation model), with such recognition occurring regardless of whether the market condition is met.

 

Cancellation of Stock Options

 

On November 4 2024, 25,000 vested stock options previously granted to an employee were cancelled and returned as authorized shares under the 2015 Plan on the expiration of the exercise period following the resignation of such employee.

 

Long-Term Debt

 

On October 29, 2024, the Company entered into a 4-year loan agreement with Namur Invest Preface for an amount of €577,975 with fixed interest rate of 7.00%, maturing September 2028.

 

Appointment of Director and Non-Executive Chairman

 

On November 6, 2024 the Board, pursuant to the Company’s bylaws, passed a resolution to increase the size of the Board to eight (8) members and appointed Mr. Timothy I. Still to fill the new vacancy on the Board and fill the role of Non-Executive Chairman effective as of November 6, 2024. Mr. Still will have an initial term expiring at the Company’s 2025 annual meeting of stockholders, subject to his future nomination by the Nominations and Governance Committee and election by the Company’s stockholders. In connection with his appointment, Mr. Still and the Company entered into an Independent Director Agreement, pursuant to which Mr. Still will continue to serve as a member of the Board subject to any necessary approval by the Company’s stockholders as required by applicable law and the Company’s governing documents. In exchange for his services, pursuant to the terms of the Independent Director Agreement Mr. Still shall receive (i) $30,000 per calendar quarter commencing November 6, 2024; (ii) $1,000 per day for any services performed as a member of a committee of the Company, if any, (iii) a grant of RSUs under the Company’s 2015 Stock Incentive Plan to receive an aggregate of four hundred thousand (400,000) shares of the Company’s common stock underlying the RSUs (as described above under the heading “RSUs Granted”). and (iv) a grant of RSUs under the Company’s 2024 Stock Incentive Plan to receive an aggregate of one million (1,000,000) shares of the Company’s common stock underlying the RSUs, (as described above under the heading “RSUs Granted”). The Independent Director Agreement provides that in the event that the Company undergoes a Change of Control (as defined below), the vesting of the RSUs in (iv) above shall be accelerated to fully-vest the rights to such RSUs provided that the purchase price per share of the Company’s common stock in such transaction exceeds $2.50 per share. “Change of Control” shall mean the consummation of a merger or consolidation of the Company with any other corporation, other than a merger or consolidation which would result in the voting securities of the Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or its parent) at least fifty percent (50%) of the total voting power represented by the voting securities of the Company or such surviving entity or its parent outstanding immediately after such merger or consolidation. The Independent Director Agreement also provides that Mr. Still shall be awarded RSUs to receive three hundred thousand (300,000) shares of the Company’s common stock on an annual basis, the vesting of which will be subject to the timely achievement by the Company, or one of its affiliates, of certain corporate goals as determined by the Board or a designated committee in its absolute discretion and upon the terms and conditions set forth in the award agreement and, if applicable, the governing plan. The grant of these annual RSU awards shall be subject to availability of shares under the governing plan and be made concurrently with the grant of RSUs, on equivalent terms, to the other members of the Board.

v3.24.3
Basis of Presentation and Summary of Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2024
Basis of Presentation and Summary of Significant Accounting Policies  
Basis of Presentation and use of estimates

The accompanying unaudited condensed consolidated financial statements of VolitionRx Limited (the “Company” or “VolitionRx”) have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q of Regulation S-X. They do not include all the information and footnotes required by GAAP for complete financial statements. The December 31, 2023 consolidated balance sheet data was derived from audited financial statements but does not include all disclosures required by GAAP. However, except as disclosed herein, there has been no material change in the information disclosed in the notes to the audited consolidated financial statements and accompanying notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March 25, 2024 (the “Annual Report”). The interim unaudited condensed consolidated financial statements should be read in conjunction with those audited consolidated financial statements included in the Annual Report. In the opinion of management, all adjustments considered necessary for a fair presentation of the financial statements, consisting solely of normal recurring adjustments, have been made. Operating results for the nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024.

 

The preparation of the Company's Condensed Consolidated Financial Statements requires management to make certain estimates and assumptions about future events. These estimates and the underlying assumptions affect the amounts of assets and liabilities reported and reported amounts of revenues and expenses. Such estimates include impairment of long-lived assets, accounts receivable, useful lives of intangible assets and property and equipment, fair values of stock-based awards, income taxes among others. These estimates and assumptions are based on management’s judgment. Estimates and underlying assumptions are reviewed on an ongoing basis. Changes in accounting estimates may be necessary if there are changes in the circumstances or experiences on which the estimate was based or as a result of new information. Changes in estimates, including those resulting from changes in the economic environment, are reflected in the period in which the change in estimate occurs.

Reclassifications

Certain reclassifications within operating expenses have been made to the prior period’s financial statements to conform to the current period financial statement presentation. There is no impact in total to the results of operations and cash flows in all periods presented.

Recently Issued Accounting Pronouncements

In November 2023, the Financial Accounting Standards Board (the “FASB” issued Accounting Standards Update (“ASU”) 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures,” which requires a public entity to disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods all disclosures about reportable segment’s profit or loss and assets that are currently required annually. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. These amendments are to be applied retrospectively. The Company is currently evaluating the impact this standard will have on its annual and interim consolidated financial statements.

 

In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures,” which enhances the transparency and decision usefulness of income tax disclosures by requiring: (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. These amendments are to be applied prospectively, with retrospective application permitted. The Company is currently evaluating the impact this standard will have on its annual and interim consolidated financial statements.

 

The Company currently believes there are no other issued and not yet effective accounting standards that are materially relevant to its condensed consolidated financial statements.

Fair Value Measurements

Pursuant to ASC 820, “Fair Value Measurements and Disclosures,” an entity is required to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 establishes a fair value hierarchy based on the level of independent, objective evidence surrounding the inputs used to measure fair value. A financial instrument’s categorization within the fair value hierarchy is based upon the lowest level of input that is significant to the fair value measurement. ASC 820 prioritizes the inputs into three levels that may be used to measure fair value:

 

Level 1

Level 1 applies to assets or liabilities for which there are quoted prices in active markets for identical assets or liabilities.

 

Level 2

Level 2 applies to assets or liabilities for which there are inputs other than quoted prices that are observable for the assets or liabilities such as quoted prices for similar assets or liabilities in active markets; quoted prices for identical assets or liabilities in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which significant inputs are observable or can be derived principally from, or corroborated by, observable market data.

 

Level 3

Level 3 applies to assets or liabilities for which there are unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of the assets or liabilities.

 

The financial instruments of the Company consist primarily of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, debt, and a warrant liability. These items are considered Level 1 due to their short-term nature and their market interest rates, except for the warrant liability, which is considered Level 2 and is recorded at fair value at the end of each reporting period.

 

Included in the following table are the Company’s major categories of assets and liabilities measured at fair value on a recurring basis as of September 30, 2024.

 

Fair Value Measurements at September 30, 2024

Description

Level 1

Level 2

Level 3

Total

$

$

$

$

Liabilities

Warrant liability

-96,225-96,225

 

As of December 31, 2023, the warrant liability was $126,649. The following table provides a roll-forward of the warrant liability measured at fair value on a recurring basis for the nine months ended September 30, 2024.

 

Warrant Liability

Total

$

Balance at December 31, 2023

126,649

Gain on change in fair value of warrant liability

(30,424)

Balance at September 30, 2024

96,225
Basic And Diluted Net Loss Per Share

The Company computes net loss per share in accordance with ASC 260, “Earnings Per Share,” which requires presentation of both basic and diluted earnings per share (“EPS”) on the face of the statement of operations and comprehensive loss. Basic EPS is computed by dividing net loss available to common stockholders (numerator) by the weighted average number of shares outstanding (denominator) during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method. In computing diluted EPS, the average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of stock options or warrants. As of September 30, 2024, 38,147,734 potential common shares equivalents from warrants, options, and restricted stock units (“RSUs”) were excluded from the diluted EPS calculations as their effect is anti-dilutive.

v3.24.3
Basis of Presentation and Summary of Significant Accounting Policies (Tables)
9 Months Ended
Sep. 30, 2024
Basis of Presentation and Summary of Significant Accounting Policies  
Schedule Of assets and liabilities measured at fair value on a recurring basis

Fair Value Measurements at September 30, 2024

Description

Level 1

Level 2

Level 3

Total

$

$

$

$

Liabilities

Warrant liability

-96,225-96,225
Schedule Of warrant liability measured at fair value

Warrant Liability

Total

$

Balance at December 31, 2023

126,649

Gain on change in fair value of warrant liability

(30,424)

Balance at September 30, 2024

96,225
v3.24.3
Property and Equipment (Tables)
9 Months Ended
Sep. 30, 2024
Property and Equipment  
Schedule Of Property And Equipment

September 30, 2024

December 31, 2023

Useful Life

Cost $

Cost $

Computer hardware and software

3 years

751,488724,534

Laboratory equipment

5 years

4,847,6224,753,253

Office furniture and equipment

5 years

382,970378,800

Buildings

30 years

2,132,9272,113,031

Building improvements

5-15 years

1,690,2681,610,016

Land

Not amortized

133,715132,468

Total property and equipment

9,938,9909,712,102

Less accumulated depreciation

5,030,8424,189,089

Total property and equipment, net

4,908,1485,523,013
v3.24.3
Intangible Assets (Tables)
9 Months Ended
Sep. 30, 2024
Intangible Assets  
Schedule Of Intangible Assets

September 30, 2024

December 31, 2023

Cost $

Cost $

Patents

1,148,9691,130,936

Licenses

296,353-

Total Patents and Licenses

1,445,3221,130,936

Less accumulated amortization

1,110,0131,107,050

Total patents and Licenses, net

335,30923,886
Schedule Of Annual Estimated Amortization

2024

$5,187

2025

$20,748

2026

$20,748

2027

$20,748

2028

$20,748

Greater than 5 years

$247,130

Total Intangible Assets

$335,309
v3.24.3
Common Stock (Tables)
9 Months Ended
Sep. 30, 2024
Common Stock  
Summary of RSUs vested and settled during period

Equity Incentive Plan

RSUs Vested (#)

Vest Date

Shares Issued (#)

Shares Withheld for Taxes (#)

2015

21,582

Feb 8, 2024

21,582-

2015

9,000

Mar 1, 2024

6,0572,943

2015

44,217

Mar 27, 2024

40,5303,687

2015

51,000

Apr 4, 2024

32,33718,663

2015

50,000

May 1, 2024

34,49615,504

2015

11,500

Jun 1, 2024

6,6704,830

2015

14,962

Jun 15, 2024

11,6843,278

2015

4,667

Jul 13, 2024

3,1651,502

2015

29,000

Aug 15, 2024

21,2917,709

2015

2,000

Sep 11, 2024

2,000-

2015

2,500

Sep 21, 2024

2,500-

2015

332,775

Sep 28, 2024

265,30067,475
573,203447,612125,591
Schedule of fair value of the warrants

September 30, 2024

December 31, 2023

Risk-free interest rate

3.58%3.89%

Expected volatility

84.85%76.30%

Expected life (years)

3.694.44

Expected dividend yield

--

Total fair value

$96,225$126,649
v3.24.3
Stock Based Compensation (Tables)
9 Months Ended
Sep. 30, 2024
Stock Based Compensation  
Summary Of Changes In Warrants Outstanding

Number of Warrants

Weighted Average Exercise Price ($)

Outstanding at December 31, 2023

862,5003.050

Granted

3,557,2730.001

Expired/Cancelled

--

Outstanding at September 30, 2024

4,419,7730.597

Exercisable at September 30, 2024

4,419,7730.597

Number of Warrants

Weighted Average Exercise Price ($)

Outstanding at December 31, 2023

--

Granted

25,836,3640.57

Exercised

--

Expired/Cancelled

--

Outstanding at September 30, 2024

25,836,3640.57

Exercisable at September 30, 2024

--
Summarizing The Warrants Issued And Outstanding

Number Outstanding

Number Exercisable

Exercise Price ($)

Weighted Average Remaining Contractual Life (Years)

Proceeds to

Company if Exercised ($)

3,557,273

3,557,2730.001-3,557

448,500

448,5002.0003.71897,000

54,000

54,0003.0504.01164,700

50,000

50,0003.4501.42172,500

125,000

125,0003.9502.25493,750

185,000

185,0004.9002.34906,500

4,419,773

4,419,7732,638,007

Number

Outstanding

 

 

Number

Exercisable

 

 

Exercise

Price ($)

 

 

Weighted Average Remaining

Contractual Life (Years)

 

 

Proceeds to

Company if Exercised ($)

 

 

585,000

 

 

 

585,000

 

 

 

3.25

 

 

 

0.36

 

 

 

1,901,250

 

 

944,748

 

 

 

944,748

 

 

 

3.40

 

 

 

6.84

 

 

 

3,212,143

 

 

740,000

 

 

 

740,000

 

 

 

3.60

 

 

 

5.61

 

 

 

2,664,000

 

 

1,607,837

 

 

 

1,607,837

 

 

 

4.00

 

 

 

1.98

 

 

 

6,431,348

 

 

89,163

 

 

 

89,163

 

 

 

4.38

 

 

 

3.32

 

 

 

390,534

 

 

50,000

 

 

 

50,000

 

 

 

4.80

 

 

 

2.25

 

 

 

240,000

 

 

646,000

 

 

 

646,000

 

 

 

5.00

 

 

 

2.49

 

 

 

3,230,000

 

 

4,662,748

 

 

 

4,662,748

 

 

 

 

 

 

 

 

 

 

 

18,069,275

 

Summarizes The Changes In Options Outstanding

 

 

Number

of Options

 

 

Weighted

Average

Exercise

Price ($)

 

Outstanding at December 31, 2023

 

 

4,699,569

 

 

 

3.87

 

Expired/Cancelled

 

 

(36,821)

 

 

3.40

 

Outstanding at September 30, 2024

 

 

4,662,748

 

 

 

3.88

 

 

 

 

 

 

 

 

 

 

Exercisable at September 30, 2024

 

 

4,662,748

 

 

 

3.88

 

Summarizes The warrants are exercised for cash

Description

Number

Outstanding

Number

Exercisable

Exercise

Price ($)

Weighted Average Remaining Contractual Life (Years)

Proceeds to Company if Exercised ($)

Investor A Warrants

12,727,273-0.57002.367,254,546

Investor B Warrants

12,727,273-0.57005.367,254,546

Placement Agent Series B Warrants

381,818-0.68754.86262,500
25,836,364-14,771,591
Summarizing The Rsus Issued And Outstanding

 

 

RSUs (#)

 

 

Weighted Average Grant Date Fair Value Share Price ($)

 

Outstanding at December 31, 2023

 

 

3,634,952

 

 

 

1.01

 

Granted

 

 

844,313

 

 

 

0.71

 

Vested/Settled

 

 

(573,203)

 

 

1.40

 

Cancelled / Forfeited

 

 

(677,213)

 

 

0.83

 

Outstanding at September 30, 2024

 

 

3,228,849

 

 

 

0.90

 

Schedule of RSUs granted during period

Equity Incentive Plan

RSUs Granted (#)

Grant Date

Vesting Period

First Vesting Date

Second Vesting Date

Third Vesting Date

RSU Expense ($)

2015

14,000

Feb 22, 2024

36 Months

Feb 22, 2025

Feb 22, 2026

Feb 22, 2027

13,589

2015

115,000

May 23, 2024

36 Months

May 23, 2025

May 23, 2026

May 23, 2027

85,389

2015

297,340

Jun 1, 2024

11 Months

May 1, 2025

N/A

N/A

209,832

2015

38,198

Jul 1, 2024

11 Months

Jun 1, 2025

N/A

N/A

23,645

2015

21,583

Jul 8, 2024

6 Months

Jan 1, 2025

N/A

N/A

13,209

2015

343,192

Sep 1, 2024

9 Months

Jun 1, 2025

N/A

N/A

247,098

2015

15,000

Sep 30, 2024

36 Months

Sep 30, 2025

Sep 30, 2026

Sep 30, 2027

9,015

844,313

601,777

Schedule of RSUs vested and settled during period

Equity Incentive Plan

 

RSUs Vested (#)

 

 

Vest Date

 

Shares Issued (#)

 

 

Shares Withheld for Taxes (#)

 

2015

 

 

21,582

 

 

Feb 8, 2024

 

 

21,582

 

 

 

-

 

2015

 

 

9,000

 

 

Mar 1, 2024

 

 

6,057

 

 

 

2,943

 

2015

 

 

44,217

 

 

Mar 27, 2024

 

 

40,530

 

 

 

3,687

 

2015

 

 

51,000

 

 

Apr 4, 2024

 

 

32,337

 

 

 

18,663

 

2015

 

 

50,000

 

 

May 1, 2024

 

 

34,496

 

 

 

15,504

 

2015

 

 

11,500

 

 

Jun 1, 2024

 

 

6,670

 

 

 

4,830

 

2015

 

 

14,962

 

 

Jun 15, 2024

 

 

11,684

 

 

 

3,278

 

2015

 

 

4,667

 

 

Jul 13, 2024

 

 

3,165

 

 

 

1,502

 

2015

 

 

29,000

 

 

Aug 15, 2024

 

 

21,291

 

 

 

7,709

 

2015

 

 

2,000

 

 

Sep 11, 2024

 

 

2,000

 

 

 

-

 

2015

 

 

2,500

 

 

Sep 21, 2024

 

 

2,500

 

 

 

-

 

2015

 

 

332,775

 

 

Sep 28, 2024

 

 

265,300

 

 

 

67,475

 

 

 

 

573,203

 

 

 

 

 

447,612

 

 

 

125,591

 

Schedule of RSUs cancelled

Equity Incentive Plan

 

RSUs (#)

 

 

Cancellation Date

 

Vesting Date

 

RSUs Cancelled (#)

 

2015

 

 

8,000

 

 

Jan 16, 2024

 

Sep 28, 2024

 

 

8,000

 

2015

 

 

6,000

 

 

Jan 16, 2024

 

Oct 4, 2024

 

 

6,000

 

2015

 

 

8,000

 

 

Jan 16, 2024

 

Sep 28, 2025

 

 

8,000

 

2015

 

 

6,000

 

 

Jan 16, 2024

 

Oct 4, 2025

 

 

6,000

 

2015

 

 

8,000

 

 

Jan 16, 2024

 

Sep 28, 2026

 

 

8,000

 

2015

 

 

667

 

 

Feb 9, 2024

 

Jun 15, 2024

 

 

667

 

2015

 

 

667

 

 

Feb 9, 2024

 

Jun 15, 2025

 

 

667

 

2015

 

 

666

 

 

Feb 9, 2024

 

Jun 15, 2026

 

 

666

 

2015

 

 

1,775

 

 

Mar 25, 2024

 

Mar 27, 2024

 

 

1,775

 

2015

 

 

2,098

 

 

Mar 25, 2024

 

Jun 15, 2024

 

 

2,098

 

2015

 

 

2,667

 

 

May 17, 2024

 

Oct 4, 2024

 

 

2,667

 

2015

 

 

2,666

 

 

May 17, 2024

 

Oct 4, 2025

 

 

2,666

 

2015

 

 

1,000

 

 

May 17, 2024

 

Mar 27, 2025

 

 

1,000

 

2015

 

 

1,000

 

 

May 17, 2024

 

Mar 27, 2026

 

 

1,000

 

2015

 

 

3,334

 

 

May 17, 2024

 

Sep 28, 2024

 

 

3,334

 

2015

 

 

3,333

 

 

May 17, 2024

 

Sep 28, 2025

 

 

3,333

 

2015

 

 

3,333

 

 

May 17, 2024

 

Sep 28, 2026

 

 

3,333

 

2015

 

 

9,334

 

 

May 31, 2024

 

Sep 11, 2024

 

 

9,334

 

2015

 

 

9,333

 

 

May 31, 2024

 

Sep 11, 2025

 

 

9,333

 

2015

 

 

9,333

 

 

May 31, 2024

 

Sep 11, 2026

 

 

9,333

 

2015

 

 

3,333

 

 

Jul 12, 2024

 

Oct 4, 2024

 

 

3,333

 

2015

 

 

3,333

 

 

Jul 12, 2024

 

Oct 4, 2025

 

 

3,333

 

2015

 

 

5,666

 

 

Aug 4, 2024

 

Oct 4, 2025

 

 

5,666

 

2015

 

 

10,000

 

 

Aug 4, 2024

 

Sep 21, 2024

 

 

10,000

 

2015

 

 

5,667

 

 

Aug 4, 2024

 

Oct 4, 2024

 

 

5,667

 

2015

 

 

178,909

 

 

Aug 15, 2024

 

Sep 28, 2024

 

 

178,909

 

2015

 

 

178,894

 

 

Aug 15, 2024

 

Sep 28, 2025

 

 

178,894

 

2015

 

 

178,872

 

 

Aug 15, 2024

 

Sep 28, 2026

 

 

178,872

 

2015

 

 

8,000

 

 

Aug 31, 2024

 

Mar 27, 2025

 

 

8,000

 

2015

 

 

8,000

 

 

Aug 31, 2024

 

Mar 27, 2026

 

 

8,000

 

2015

 

 

4,667

 

 

Aug 31, 2024

 

Oct 4, 2024

 

 

4,667

 

2015

 

 

4,666

 

 

Aug 31, 2024

 

Oct 4, 2025

 

 

4,666

 

 

 

 

677,213

 

 

 

 

 

 

 

677,213

 

Schedule of RSUs issued and outstanding and average contractual life

RSUs Outstanding (#)

 

 

Weighted Average Grant Date Fair Value Share Price ($)

 

 

Weighted Average Remaining Contractual Life (Years)

 

 

40,000

 

 

 

0.58

 

 

 

1.12

 

 

15,000

 

 

 

0.60

 

 

 

2.00

 

 

21,583

 

 

 

0.61

 

 

 

0.25

 

 

38,198

 

 

 

0.62

 

 

 

0.67

 

 

450,000

 

 

 

0.68

 

 

 

2.55

 

 

450,000

 

 

 

0.69

 

 

 

1.51

 

 

665,550

 

 

 

0.70

 

 

 

1.00

 

 

297,340

 

 

 

0.71

 

 

 

0.58

 

 

343,192

 

 

 

0.72

 

 

 

0.67

 

 

115,000

 

 

 

0.74

 

 

 

1.64

 

 

14,000

 

 

 

0.97

 

 

 

1.40

 

 

4,000

 

 

 

1.31

 

 

 

0.97

 

 

9,333

 

 

 

1.32

 

 

 

0.86

 

 

675,322

 

 

 

1.46

 

 

 

0.49

 

 

17,332

 

 

 

1.58

 

 

 

0.60

 

 

38,333

 

 

 

1.72

 

 

 

0.92

 

 

666

 

 

 

2.15

 

 

 

0.66

 

 

34,000

 

 

 

2.95

 

 

 

0.13

 

 

3,228,849

 

 

 

 

 

 

 

 

 

v3.24.3
Commitments and Contingencies (Tables)
9 Months Ended
Sep. 30, 2024
Commitments and Contingencies  
Schedule of future minimum lease payments under financing leases

2024 - Remaining

 

$14,983

 

2025

 

$59,934

 

2026

 

$59,934

 

2027

 

$59,934

 

2028

 

$59,933

 

Greater than 5 years

 

$202,259

 

Total

 

$456,977

 

Less: Amount representing interest

 

$(40,812)

Present value of minimum lease payments

 

$416,165

 

Schedule of operating lease

 

 

September 30, 2024

 

 

December 31, 2023

 

 

 

$

 

 

$

 

Operating right-of-use assets

 

 

635,857

 

 

 

549,504

 

 

 

 

 

 

 

 

 

 

Operating lease liabilities, current portion

 

 

190,099

 

 

 

199,323

 

Operating lease liabilities, long term

 

 

350,810

 

 

 

378,054

 

Total operating lease liabilities

 

 

540,909

 

 

 

577,377

 

 

 

 

 

 

 

 

 

 

Weighted average remaining lease (months)

 

 

47

 

 

 

33

 

Weighted average discount rate

 

 

3.70%

 

 

3.02%
Schedule Of Future Minimum Lease Payments Under Operating Leases

For the Nine Months Ending September 30, 2024

 

Amount

 

 

 

$

 

2024 - Remaining

 

 

61,552

 

2025

 

 

241,924

 

2026

 

 

225,368

 

2027

 

 

144,593

 

2028

 

 

44,059

 

Total

 

 

717,496

 

Less: imputed interest

 

 

(50,391)

Total Operating Lease Liabilities

 

 

667,105

 

Schedule Of Recognized In Short-term Lease Costs

For the Nine Months Ending September 30, 2024

 

Amount

 

 

 

$

 

2024 - Remaining

 

 

27,481

 

2025

 

 

12,373

 

Total Operating Lease Liabilities

 

 

39,854

 

Schedule Of Grants Repayable

For the Nine Months Ending September 30, 2024

 

Amount

 

 

 

$

 

2024 - Remaining

 

 

27,857

 

2025

 

 

37,789

 

2026

 

 

45,545

 

2027

 

 

50,564

 

2028

 

 

54,073

 

Greater than 5 years

 

 

238,716

 

Total Grants Repayable

 

 

454,544

 

Schedule Of Long-term Debt Payable

For the Nine Months Ending September 30, 2024

 

Amount

 

 

 

$

 

2024 - Remaining

 

 

551,774

 

2025

 

 

1,046,366

 

2026

 

 

813,844

 

2027

 

 

607,484

 

2028

 

 

2,536,778

 

Greater than 5 years

 

 

326,851

 

Total

 

 

5,883,097

 

Less: amount representing interest

 

 

(1,080,126)

Total Long-Term Debt

 

 

4,802,971

 

Schedule of annual payments Of Collaborative Agreement Obligations

 

 

Total Amount Remaining

 

 

2024 - Remaining

 

 

2025

 

 

 

$

 

 

$

 

 

$

 

National University of Taiwan

 

 

510,000

 

 

 

510,000

 

 

 

-

 

MD Anderson Cancer Center

 

 

327,092

 

 

 

163,546

 

 

 

163,546

 

Guys and St Thomas

 

 

217,464

 

 

 

65,239

 

 

 

152,225

 

Xenetic Biosciences

 

 

81,447

 

 

 

26,142

 

 

 

55,305

 

UMC

 

 

96,260

 

 

 

48,058

 

 

 

48,202

 

Total Collaborative Obligations

 

 

1,232,263

 

 

 

812,985

 

 

 

419,278

 

Schedule of commitments in respect of corporate goals and performance based awards

Total

 

 

Vesting

 

Amortized

 

 

Amortized

 

 

Amortized

 

 

Un-Amortized

 

Award

 

 

Year

 

2024

 

 

2023

 

 

2022

 

 

 

 

$

 

 

 

 

$

 

 

$

 

 

$

 

 

$

 

 

527,940

 

 

2023

 

 

-

 

 

 

393,853

 

 

 

134,087

 

 

 

-

 

 

516,040

 

 

2024

 

 

188,187

 

 

 

260,119

 

 

 

65,088

 

 

 

2,646

 

 

521,176

 

 

2025

 

 

131,034

 

 

 

177,584

 

 

 

46,686

 

 

 

165,872

 

 

1,565,156

 

 

 

 

 

319,221

 

 

 

831,556

 

 

 

245,861

 

 

 

168,518

 

Total

 

 

Vesting

 

Amortized

 

 

Amortized

 

 

Un-Amortized

 

Award

 

 

Year

 

2024

 

 

2023

 

 

2024

 

$

 

 

 

 

$

 

 

$

 

 

$

 

 

242,902

 

 

2024

 

 

148,132

 

 

 

94,770

 

 

 

-

 

 

237,936

 

 

2025

 

 

74,906

 

 

 

47,513

 

 

 

115,517

 

 

236,274

 

 

2026

 

 

49,984

 

 

 

31,703

 

 

 

154,587

 

 

717,112

 

 

 

 

 

273,022

 

 

 

173,986

 

 

 

270,104

 

v3.24.3
Basis of Presentation and Summary of Significant Accounting Policies (Details) - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Warrant liability $ 96,225 $ 126,649
Fair Value Inputs Level 1 [Member]    
Warrant liability 0  
Fair Value Inputs Level 2 [Member]    
Warrant liability 96,225  
Fair Value Inputs Level 3 [Member]    
Warrant liability $ 0  
v3.24.3
Basis of Presentation and Summary of Significant Accounting Policies (Details 1)
9 Months Ended
Sep. 30, 2024
USD ($)
Basis of Presentation and Summary of Significant Accounting Policies  
Warrant Liability beginning balance $ 126,649
Gain on change in fair value of warrant liability (30,424)
Warrant Liability ending balance $ 96,225
v3.24.3
Basis of Presentation and Summary of Significant Accounting Policies (Details Narrative) - USD ($)
9 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Basis of Presentation and Summary of Significant Accounting Policies    
Warrant Liability $ 96,225 $ 126,649
Potentially Dilutive Securities Excluded From The Computation Of Eps 38,147,734  
v3.24.3
Liquidity and Going Concern Assessment (Details Narrative) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2024
Jun. 30, 2024
Mar. 31, 2024
Sep. 30, 2023
Jun. 30, 2023
Mar. 31, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Dec. 31, 2022
Accumulated deficit $ (223,750,970)           $ (223,750,970)   $ (202,576,507)  
Cash and cash equivalents 5,414,146     $ 10,808,747     5,414,146 $ 10,808,747 $ 20,729,983 $ 10,867,050
Cash flows from operating activities             (20,461,849) $ (24,510,735)    
Net Loss (5,868,578) $ (7,060,175) $ (8,472,005) $ (8,453,188) $ (9,551,277) $ (8,872,909)        
Liquidity and Going Concern Assessment [Member]                    
Accumulated deficit (223,800,000)           (223,800,000)      
Cash and cash equivalents $ 5,400,000           5,400,000      
Cash flows from operating activities             20,500,000      
Net Loss             $ (21,400,000)      
v3.24.3
Property and Equipment (Details) - USD ($)
9 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Total property and equipment $ 9,938,990 $ 9,712,102
Less accumulated depreciation 5,030,842 4,189,089
Total property and equipment net 4,908,148 5,523,013
Computer Hardware And Software [Member]    
Total property and equipment $ 751,488 724,534
Estimated useful life 3 years  
Laboratory Equipment [Member]    
Total property and equipment $ 4,847,622 4,753,253
Estimated useful life 5 years  
Office Furniture and Equipment [Member]    
Total property and equipment $ 382,970 378,800
Estimated useful life 5 years  
Buildings [Member]    
Total property and equipment $ 2,132,927 2,113,031
Estimated useful life 30 years  
Building Improvements [Member]    
Total property and equipment $ 1,690,268 1,610,016
Building Improvements [Member] | Minimum [Member]    
Estimated useful life 5 years  
Building Improvements [Member] | Maximum [Member]    
Estimated useful life 15 years  
Land [Member]    
Total property and equipment $ 133,715 $ 132,468
v3.24.3
Property and Equipment (Details Narrative) - USD ($)
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Property and Equipment    
Depreciation Expense $ 815,824 $ 792,232
v3.24.3
Intangible Assets (Details) - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Total Patents and Licenses $ 1,445,322 $ 1,130,936
Less accumulated amortization 1,110,013 1,107,050
Total patents and Licenses, net 335,309 23,886
Patents [Member]    
Total Patents and Licenses 1,148,969 1,130,936
Licenses [Member]    
Total Patents and Licenses $ 296,353 $ 0
v3.24.3
Intangible Assets (Details 1) - USD ($)
Sep. 30, 2024
Dec. 31, 2023
Intangible Assets    
2024 $ 5,187  
2025 20,748  
2026 20,748  
2027 20,748  
2028 20,748  
Greater than 5 years 247,130  
Total Intangible Assets $ 335,309 $ 23,886
v3.24.3
Intangible Assets (Details Narrative) - USD ($)
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Amortization Expense $ (6,742) $ 63,715
Patents And Intellectual Property [Member] | Minimum [Member]    
Amortization Of Patents On Straight Line Basis 8 years  
Patents And Intellectual Property [Member] | Maximum [Member]    
Amortization Of Patents On Straight Line Basis 20 years  
v3.24.3
Common Stock (Details)
9 Months Ended
Sep. 30, 2024
USD ($)
shares
Equity Incentive RSU 573,203
Incentive RSU Issued 447,612
RSUs Held for Taxes | $ $ 125,591
Equity Incentive Plan Eight [Member]  
Equity Incentive RSU 4,667
Incentive RSU Issued 3,165
RSUs Held for Taxes | $ $ 1,502
Incentive Plan 2015
Incentive Vest Date Jul. 13, 2024
Equity Incentive Plan Nine [Member]  
Equity Incentive RSU 29,000
Incentive RSU Issued 21,291
RSUs Held for Taxes | $ $ 7,709
Incentive Plan 2015
Incentive Vest Date Aug. 15, 2024
Equity Incentive Plan One [Member]  
Equity Incentive RSU 21,582
Incentive RSU Issued 21,582
RSUs Held for Taxes | $ $ 0
Incentive Plan 2015
Incentive Vest Date Feb. 08, 2024
Equity Incentive Plan Two [Member]  
Equity Incentive RSU 9,000
Incentive RSU Issued 6,057
RSUs Held for Taxes | $ $ 2,943
Incentive Plan 2015
Incentive Vest Date Mar. 01, 2024
Equity Incentive Plan Three [Member]  
Equity Incentive RSU 44,217
Incentive RSU Issued 40,530
RSUs Held for Taxes | $ $ 3,687
Incentive Plan 2015
Incentive Vest Date Mar. 27, 2024
Equity Incentive Plan Ten [Member]  
Equity Incentive RSU 2,000
Incentive RSU Issued 2,000
RSUs Held for Taxes | $ $ 0
Incentive Plan 2015
Incentive Vest Date Sep. 11, 2024
Equity Incentive Plan Eleven [Member]  
Equity Incentive RSU 2,500
Incentive RSU Issued 2,500
RSUs Held for Taxes | $ $ 0
Incentive Plan 2015
Incentive Vest Date Sep. 21, 2024
Equity Incentive Plan Four [Member]  
Equity Incentive RSU 51,000
Incentive RSU Issued 32,337
RSUs Held for Taxes | $ $ 18,663
Incentive Plan 2015
Incentive Vest Date Apr. 04, 2024
Equity Incentive Plan Five [Member]  
Equity Incentive RSU 50,000
Incentive RSU Issued 34,496
RSUs Held for Taxes | $ $ 15,504
Incentive Plan 2015
Incentive Vest Date May 01, 2024
Equity Incentive Plan Six [Member]  
Equity Incentive RSU 11,500
Incentive RSU Issued 6,670
RSUs Held for Taxes | $ $ 4,830
Incentive Plan 2015
Incentive Vest Date Jun. 01, 2024
Equity Incentive Plan Seven [Member]  
Equity Incentive RSU 14,962
Incentive RSU Issued 11,684
RSUs Held for Taxes | $ $ 3,278
Incentive Plan 2015
Incentive Vest Date Jun. 15, 2024
Equity Incentive Plan Twelve [Member]  
Equity Incentive RSU 332,775
Incentive RSU Issued 265,300
RSUs Held for Taxes | $ $ 67,475
Incentive Plan 2015
Incentive Vest Date Sep. 28, 2024
v3.24.3
Common Stock (Details 1) - USD ($)
9 Months Ended 12 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Common Stock    
Risk-free interest rate 3.58% 3.89%
Expected volatility 84.85% 76.30%
Expected term (years) 3 years 8 months 8 days 4 years 5 months 8 days
Expected dividend yield 0.00% 0.00%
Total fair value $ 96,225 $ 126,649
v3.24.3
Common Stock (Details Narrative) - USD ($)
1 Months Ended 9 Months Ended 12 Months Ended
Aug. 08, 2024
Mar. 12, 2024
Apr. 16, 2024
Jun. 30, 2023
May 20, 2022
Sep. 30, 2024
Dec. 31, 2023
Common stock price per share           $ 0.001  
Common stock, shares authorized           175,000,000  
Common stock, shares issued           92,392,570 81,898,321
Common stock, shares outstanding           92,392,570 81,898,321
Total fair value           $ 96,225 $ 126,649
Underwriting Agreement [Member]              
Total fair value           $ 96,225 $ 126,649
Warrants issued to purchase shares of common stock       448,500      
Exercise price       $ 2.00      
EpiCypher License Agreement [Member]              
Common stock price per share   $ 0.97          
Issuance of restricted common stock   129,132          
Equity Distribution Agreement [Member]              
Common stock shares sold           747,505  
Aggeregate share of common stock offering price         $ 25,000,000.0    
Aggregate net proceeds           $ 605,221  
2022 EDA [Member]              
Common stock shares sold           1,378,037  
Commissions and fee           $ 2,100,000  
2015 [Member]              
Vested stock options     36,821        
Securities Purchase Agreement [Member]              
Pre-Funded Warrants 3,557,273            
Warrants issued to purchase common shares 381,818            
Exercise price $ 0.001            
Offering price $ 0.55            
Offering expenses $ 100,000            
Common stock shares sold 9,170,000            
Securities Purchase Agreement [Member] | Series A Warrants [Member]              
Pre-Funded Warrants 12,727,273            
Exercise price $ 0.57            
Offering price $ 0.549            
Securities Purchase Agreement [Member] | Series B Warrants [Member]              
Pre-Funded Warrants 12,727,273            
Exercise price $ 0.6875            
v3.24.3
StockBased Compensation (Details) - Warrants [Member]
9 Months Ended
Sep. 30, 2024
$ / shares
shares
Number of warrants Outstanding beginning balance | shares 862,500
Granted | shares 3,557,273
Number of warrants outstanding ending balance | shares 4,419,773
Number of Warrants Exercisable | shares 4,419,773
Weighted Average Exercise Price Outstanding balance $ 3.050
Weighted Average Exercise Price, Granted 0.001
Weighted Average Exercise Price, Expired/Cancelled 0
Weighted Average Exercise Price, ending balance 0.597
Weighted Average Exercise Price, exercisable $ 0.597
v3.24.3
StockBased Compensation (Details 1)
9 Months Ended
Sep. 30, 2024
USD ($)
$ / shares
shares
Warrants [Member]  
Number Exercisable 4,419,773
Proceeds to Company if Exercised | $ $ 2,638,007
Number Outstanding 4,419,773
Warrant One [Member]  
Number Exercisable 3,557,273
Exercise Price | $ / shares $ 0.001
Proceeds to Company if Exercised | $ $ 3,557
Weighted Average Remaining Contractual Life (Years) 0 years
Number Outstanding 3,557,273
Warrant Two [Member]  
Number Exercisable 448,500
Exercise Price | $ / shares $ 2.000
Proceeds to Company if Exercised | $ $ 897,000
Weighted Average Remaining Contractual Life (Years) 3 years 8 months 15 days
Number Outstanding 448,500
Warrant Three [Member]  
Number Exercisable 54,000
Exercise Price | $ / shares $ 3.050
Proceeds to Company if Exercised | $ $ 164,700
Weighted Average Remaining Contractual Life (Years) 4 years 3 days
Number Outstanding 54,000
Warrants Four [Member]  
Number Exercisable 50,000
Exercise Price | $ / shares $ 3.450
Proceeds to Company if Exercised | $ $ 172,500
Weighted Average Remaining Contractual Life (Years) 1 year 5 months 1 day
Number Outstanding 50,000
Warrants Five [Member]  
Number Exercisable 125,000
Exercise Price | $ / shares $ 3.950
Proceeds to Company if Exercised | $ $ 493,750
Weighted Average Remaining Contractual Life (Years) 2 years 3 months
Number Outstanding 125,000
Warrants Six [Member]  
Number Exercisable 185,000
Exercise Price | $ / shares $ 4.900
Proceeds to Company if Exercised | $ $ 906,500
Weighted Average Remaining Contractual Life (Years) 2 years 4 months 2 days
Number Outstanding 185,000
v3.24.3
StockBased Compensation (Details 2) - Warrants Series A and Series B [Member]
9 Months Ended
Sep. 30, 2024
$ / shares
shares
Granted | shares 25,836,364
Number of warrants outstanding ending balance | shares 25,836,364
Weighted Average Exercise Price Outstanding balance $ 0
Weighted Average Exercise Price, Granted 0.57
Weighted Average Exercise Price, Expired/Cancelled 0
Weighted Average Exercise Price, ending balance 0.57
Weighted Average Exercise Price, exercisable $ 0
v3.24.3
StockBased Compensation (Details 3)
9 Months Ended
Sep. 30, 2024
USD ($)
$ / shares
shares
Warrants Series A and Series B [Member]  
Proceeds to Company if Exercised | $ $ 14,771,591
Number Outstanding | shares 25,836,364
Investor A Warrants [Member]  
Exercise Price | $ / shares $ 0.5700
Proceeds to Company if Exercised | $ $ 7,254,546
Weighted Average Remaining Contractual Life (Years) 2 years 4 months 9 days
Number Outstanding | shares 12,727,273
Placement Agent Series B Warrants [Member]  
Exercise Price | $ / shares $ 0.6875
Proceeds to Company if Exercised | $ $ 262,500
Weighted Average Remaining Contractual Life (Years) 4 years 10 months 9 days
Number Outstanding | shares 381,818
Investor B Warrants [Member]  
Exercise Price | $ / shares $ 0.5700
Proceeds to Company if Exercised | $ $ 7,254,546
Weighted Average Remaining Contractual Life (Years) 5 years 4 months 9 days
Number Outstanding | shares 12,727,273
v3.24.3
StockBased Compensation (Details 4) - Option [Member]
9 Months Ended
Sep. 30, 2024
USD ($)
$ / shares
shares
Number of options outstanding beginning balance | shares 4,699,569
Number of options, Expired/Cancelled | $ $ (36,821)
Number of option outstanding ending balance | shares 4,662,748
Number of options, exercisable | shares 4,662,748
Weighted Average Exercise Price Outstanding balance $ 3.87
Weighted Average Exercise Price expires/cancelled 3.40
Weighted Average Exercise Price ending balance 3.88
Weighted Average Exercise Price exercisable balance $ 3.88
v3.24.3
StockBased Compensation (Details 5)
9 Months Ended
Sep. 30, 2024
USD ($)
$ / shares
shares
Option Six [Member]  
Number Exercisable, shares 50,000
Exercise Price | $ / shares $ 4.80
Weighted Average Remaining Contractual Life (years) 2 years 3 months
Proceeds to Company if Exercised | $ $ 240,000
Number Outstanding, shares 50,000
Option Seven [Member]  
Number Exercisable, shares 646,000
Exercise Price | $ / shares $ 5.00
Weighted Average Remaining Contractual Life (years) 2 years 5 months 26 days
Proceeds to Company if Exercised | $ $ 3,230,000
Number Outstanding, shares 646,000
Options One [Member]  
Number Exercisable, shares 585,000
Exercise Price | $ / shares $ 3.25
Weighted Average Remaining Contractual Life (years) 4 months 9 days
Proceeds to Company if Exercised | $ $ 1,901,250
Number Outstanding, shares 585,000
Option Two [Member]  
Number Exercisable, shares 944,748
Exercise Price | $ / shares $ 3.40
Weighted Average Remaining Contractual Life (years) 6 years 10 months 2 days
Proceeds to Company if Exercised | $ $ 3,212,143
Number Outstanding, shares 944,748
Option Three [Member]  
Number Exercisable, shares 740,000
Exercise Price | $ / shares $ 3.60
Weighted Average Remaining Contractual Life (years) 5 years 7 months 9 days
Proceeds to Company if Exercised | $ $ 2,664,000
Number Outstanding, shares 740,000
Option Four [Member]  
Number Exercisable, shares 1,607,837
Exercise Price | $ / shares $ 4.00
Weighted Average Remaining Contractual Life (years) 1 year 11 months 23 days
Proceeds to Company if Exercised | $ $ 6,431,348
Number Outstanding, shares 1,607,837
Option Five [Member]  
Number Exercisable, shares 89,163
Exercise Price | $ / shares $ 4.38
Weighted Average Remaining Contractual Life (years) 3 years 3 months 25 days
Proceeds to Company if Exercised | $ $ 390,534
Number Outstanding, shares 89,163
Total Option [Member]  
Number Exercisable, shares 4,662,748
Proceeds to Company if Exercised | $ $ 18,069,275
Number Outstanding, shares 4,662,748
v3.24.3
StockBased Compensation (Details 6) - Stock Options [Member]
9 Months Ended
Sep. 30, 2024
$ / shares
shares
Number Of Rsus Outstanding Begining Balance shares | shares 3,634,952
Granted | shares 844,313
Vested/Settled | shares (573,203)
Cancelled / Forfeited | shares (677,213)
Number Of Rsus Outstanding ending Balance | shares 3,228,849
Share Price Beginning Balance shares | $ / shares $ 1.01
Share Price Granted | $ / shares 0.71
Share Price Vested/Settled | $ / shares 1.40
Share Price Cancelled / Forfeited | $ / shares 0.83
Share Price ending Balance | $ / shares $ 0.90
v3.24.3
StockBased Compensation (Details 7)
9 Months Ended
Sep. 30, 2024
USD ($)
shares
RSU Expense | $ $ 601,777
Compensation Expense RSUs | shares 844,313
Compensation Expense One [Member]  
RSU Expense | $ $ 13,589
Compensation Expense RSUs | shares 14,000
Equity Incentive Plan 2015
Compensation Expense grant date Feb. 22, 2024
Compensation Expense Vesting Period 36 Months
First Vesting date Feb. 22, 2025
Second vesting date Feb. 22, 2026
Third vesting date Feb. 22, 2027
Compensation Expense Two [Member]  
RSU Expense | $ $ 85,389
Compensation Expense RSUs | shares 115,000
Equity Incentive Plan 2015
Compensation Expense grant date May 23, 2024
Compensation Expense Vesting Period 36 Months
First Vesting date May 23, 2025
Second vesting date May 23, 2026
Third vesting date May 23, 2027
Compensation Expense Three [Member]  
RSU Expense | $ $ 209,832
Compensation Expense RSUs | shares 297,340
Equity Incentive Plan 2015
Compensation Expense grant date Jun. 01, 2024
Compensation Expense Vesting Period 11 Months
First Vesting date May 01, 2025
Compensation Expense Four [Member]  
RSU Expense | $ $ 23,645
Compensation Expense RSUs | shares 38,198
Equity Incentive Plan 2015
Compensation Expense grant date Jul. 01, 2024
Compensation Expense Vesting Period 11 Months
First Vesting date Jun. 01, 2025
Compensation Expense Five [Member]  
RSU Expense | $ $ 13,209
Compensation Expense RSUs | shares 21,583
Equity Incentive Plan 2015
Compensation Expense grant date Jul. 08, 2024
Compensation Expense Vesting Period 6 Months
First Vesting date Jan. 01, 2025
Compensation Expense Six [Member]  
RSU Expense | $ $ 247,098
Compensation Expense RSUs | shares 343,192
Equity Incentive Plan 2015
Compensation Expense grant date Sep. 01, 2024
Compensation Expense Vesting Period 9 Months
First Vesting date Jun. 01, 2025
Compensation Expense Seven [Member]  
RSU Expense | $ $ 9,015
Compensation Expense RSUs | shares 15,000
Equity Incentive Plan 2015
Compensation Expense grant date Sep. 30, 2024
Compensation Expense Vesting Period 36 Months
First Vesting date Sep. 30, 2025
Second vesting date Sep. 30, 2026
Third vesting date Sep. 30, 2027
v3.24.3
StockBased Compensation (Details 8)
9 Months Ended
Sep. 30, 2024
USD ($)
shares
Equity Incentive RSU 573,203
Incentive RSU Issued 447,612
RSUs Held for Taxes | $ $ 125,591
Equity Incentive Plan Eight [Member]  
Incentive Plan 2015
Equity Incentive RSU 4,667
Incentive Vest Date Jul. 13, 2024
Incentive RSU Issued 3,165
RSUs Held for Taxes | $ $ 1,502
Equity Incentive Plan Nine [Member]  
Incentive Plan 2015
Equity Incentive RSU 29,000
Incentive Vest Date Aug. 15, 2024
Incentive RSU Issued 21,291
RSUs Held for Taxes | $ $ 7,709
Equity Incentive Plan One [Member]  
Incentive Plan 2015
Equity Incentive RSU 21,582
Incentive Vest Date Feb. 08, 2024
Incentive RSU Issued 21,582
RSUs Held for Taxes | $ $ 0
Equity Incentive Plan Two [Member]  
Incentive Plan 2015
Equity Incentive RSU 9,000
Incentive Vest Date Mar. 01, 2024
Incentive RSU Issued 6,057
RSUs Held for Taxes | $ $ 2,943
Equity Incentive Plan Three [Member]  
Incentive Plan 2015
Equity Incentive RSU 44,217
Incentive Vest Date Mar. 27, 2024
Incentive RSU Issued 40,530
RSUs Held for Taxes | $ $ 3,687
Equity Incentive Plan Ten [Member]  
Incentive Plan 2015
Equity Incentive RSU 2,000
Incentive Vest Date Sep. 11, 2024
Incentive RSU Issued 2,000
RSUs Held for Taxes | $ $ 0
Equity Incentive Plan Eleven [Member]  
Incentive Plan 2015
Equity Incentive RSU 2,500
Incentive Vest Date Sep. 21, 2024
Incentive RSU Issued 2,500
RSUs Held for Taxes | $ $ 0
Equity Incentive Plan Four [Member]  
Incentive Plan 2015
Equity Incentive RSU 51,000
Incentive Vest Date Apr. 04, 2024
Incentive RSU Issued 32,337
RSUs Held for Taxes | $ $ 18,663
Equity Incentive Plan Five [Member]  
Incentive Plan 2015
Equity Incentive RSU 50,000
Incentive Vest Date May 01, 2024
Incentive RSU Issued 34,496
RSUs Held for Taxes | $ $ 15,504
Equity Incentive Plan Six [Member]  
Incentive Plan 2015
Equity Incentive RSU 11,500
Incentive Vest Date Jun. 01, 2024
Incentive RSU Issued 6,670
RSUs Held for Taxes | $ $ 4,830
Equity Incentive Plan Seven [Member]  
Incentive Plan 2015
Equity Incentive RSU 14,962
Incentive Vest Date Jun. 15, 2024
Incentive RSU Issued 11,684
RSUs Held for Taxes | $ $ 3,278
Equity Incentive Plan Twelve [Member]  
Incentive Plan 2015
Equity Incentive RSU 332,775
Incentive Vest Date Sep. 28, 2024
Incentive RSU Issued 265,300
RSUs Held for Taxes | $ $ 67,475
v3.24.3
StockBased Compensation (Details 9)
9 Months Ended
Sep. 30, 2024
shares
Incentive RSUs Cancelled 677,213
Equity Incentive RSU 573,203
Equity Incentive RSU 677,213
RSUs Cancelled Plan One [Member]  
Incentive RSUs Cancelled 8,000
Equity Incentive Plan 2015
Equity Incentive RSU 8,000
Incentive Cancellation Date Jan. 16, 2024
Incentive Vest Date Sep. 28, 2024
RSUs Cancelled Plan Two [Member]  
Incentive RSUs Cancelled 6,000
Equity Incentive Plan 2015
Equity Incentive RSU 6,000
Incentive Cancellation Date Jan. 16, 2024
Incentive Vest Date Oct. 04, 2024
RSUs Cancelled Plan Three [Member]  
Incentive RSUs Cancelled 8,000
Equity Incentive Plan 2015
Equity Incentive RSU 8,000
Incentive Cancellation Date Jan. 16, 2024
Incentive Vest Date Sep. 28, 2025
RSUs Cancelled Plan Four [Member]  
Incentive RSUs Cancelled 6,000
Equity Incentive Plan 2015
Equity Incentive RSU 6,000
Incentive Cancellation Date Jan. 16, 2024
Incentive Vest Date Oct. 04, 2025
RSUs Cancelled Plan Five [Member]  
Incentive RSUs Cancelled 8,000
Equity Incentive Plan 2015
Equity Incentive RSU 8,000
Incentive Cancellation Date Jan. 16, 2024
Incentive Vest Date Sep. 28, 2026
RSUs Cancelled Plan Six [Member]  
Incentive RSUs Cancelled 667
Equity Incentive Plan 2015
Equity Incentive RSU 667
Incentive Cancellation Date Feb. 09, 2024
Incentive Vest Date Jun. 15, 2024
RSUs Cancelled Plan Seven [Member]  
Incentive RSUs Cancelled 667
Equity Incentive Plan 2015
Equity Incentive RSU 667
Incentive Cancellation Date Feb. 09, 2024
Incentive Vest Date Jun. 15, 2025
RSUs Cancelled Plan Eight [Member]  
Incentive RSUs Cancelled 666
Equity Incentive Plan 2015
Equity Incentive RSU 666
Incentive Cancellation Date Feb. 09, 2024
Incentive Vest Date Jun. 15, 2026
RSUs Cancelled Plan Nine [Member]  
Incentive RSUs Cancelled 1,775
Equity Incentive Plan 2015
Equity Incentive RSU 1,775
Incentive Cancellation Date Mar. 25, 2024
Incentive Vest Date Mar. 27, 2024
RSUs Cancelled Plan Ten [Member]  
Incentive RSUs Cancelled 2,098
Equity Incentive Plan 2015
Equity Incentive RSU 2,098
Incentive Cancellation Date Mar. 25, 2024
Incentive Vest Date Jun. 15, 2024
RSUs Cancelled Plan Twenty Nine [Member]  
Incentive RSUs Cancelled 8,000
Equity Incentive Plan 2015
Equity Incentive RSU 8,000
Incentive Cancellation Date Aug. 31, 2024
Incentive Vest Date Mar. 27, 2025
RSUs Cancelled Plan Thirty [Member]  
Incentive RSUs Cancelled 8,000
Equity Incentive Plan 2015
Equity Incentive RSU 8,000
Incentive Cancellation Date Aug. 31, 2024
Incentive Vest Date Mar. 27, 2026
RSUs Cancelled Plan Thirty One [Member]  
Incentive RSUs Cancelled 4,667
Equity Incentive Plan 2015
Equity Incentive RSU 4,667
Incentive Cancellation Date Aug. 31, 2024
Incentive Vest Date Oct. 04, 2024
RSUs Cancelled Plan Thirty Two [Member]  
Incentive RSUs Cancelled 4,666
Equity Incentive Plan 2015
Equity Incentive RSU 4,666
Incentive Cancellation Date Aug. 31, 2024
Incentive Vest Date Oct. 04, 2025
RSUs Cancelled Plan Eleven [Member]  
Incentive RSUs Cancelled 2,667
Equity Incentive Plan 2015
Equity Incentive RSU 2,667
Incentive Cancellation Date May 17, 2024
Incentive Vest Date Oct. 04, 2024
RSUs Cancelled Plan Twelve [Member]  
Incentive RSUs Cancelled 2,666
Equity Incentive Plan 2015
Equity Incentive RSU 2,666
Incentive Cancellation Date May 17, 2024
Incentive Vest Date Oct. 04, 2025
RSUs Cancelled Plan Thirteen [Member]  
Incentive RSUs Cancelled 1,000
Equity Incentive Plan 2015
Equity Incentive RSU 1,000
Incentive Cancellation Date May 17, 2024
Incentive Vest Date Mar. 27, 2025
RSUs Cancelled Plan Fourteen [Member]  
Incentive RSUs Cancelled 1,000
Equity Incentive Plan 2015
Equity Incentive RSU 1,000
Incentive Cancellation Date May 17, 2024
Incentive Vest Date Mar. 27, 2026
RSUs Cancelled Plan Fifteen [Member]  
Incentive RSUs Cancelled 3,334
Equity Incentive Plan 2015
Equity Incentive RSU 3,334
Incentive Cancellation Date May 17, 2024
Incentive Vest Date Sep. 28, 2024
RSUs Cancelled Plan Sixteen [Member]  
Incentive RSUs Cancelled 3,333
Equity Incentive Plan 2015
Equity Incentive RSU 3,333
Incentive Cancellation Date May 17, 2024
Incentive Vest Date Sep. 28, 2025
RSUs Cancelled Plan Seventeen [Member]  
Incentive RSUs Cancelled 3,333
Equity Incentive Plan 2015
Equity Incentive RSU 3,333
Incentive Cancellation Date May 17, 2024
Incentive Vest Date Sep. 28, 2026
RSUs Cancelled Plan Eighteen [Member]  
Incentive RSUs Cancelled 9,334
Equity Incentive Plan 2015
Equity Incentive RSU 9,334
Incentive Cancellation Date May 31, 2024
Incentive Vest Date Sep. 11, 2024
RSUs Cancelled Plan Nineteen [Member]  
Incentive RSUs Cancelled 9,333
Equity Incentive Plan 2015
Equity Incentive RSU 9,333
Incentive Cancellation Date May 31, 2024
Incentive Vest Date Sep. 11, 2025
RSUs Cancelled Plan Twenty [Member]  
Incentive RSUs Cancelled 9,333
Equity Incentive Plan 2015
Equity Incentive RSU 9,333
Incentive Cancellation Date May 31, 2024
Incentive Vest Date Sep. 11, 2026
RSUs Cancelled Plan Twenty One [Member]  
Incentive RSUs Cancelled 3,333
Equity Incentive Plan 2015
Equity Incentive RSU 3,333
Incentive Cancellation Date Jul. 12, 2024
Incentive Vest Date Oct. 04, 2024
RSUs Cancelled Plan Twenty Two [Member]  
Incentive RSUs Cancelled 3,333
Equity Incentive Plan 2015
Equity Incentive RSU 3,333
Incentive Cancellation Date Jul. 12, 2024
Incentive Vest Date Oct. 04, 2025
RSUs Cancelled Plan Twenty Three [Member]  
Incentive RSUs Cancelled 5,666
Equity Incentive Plan 2015
Equity Incentive RSU 5,666
Incentive Cancellation Date Aug. 04, 2024
Incentive Vest Date Oct. 04, 2025
RSUs Cancelled Plan Twenty Four [Member]  
Incentive RSUs Cancelled 10,000
Equity Incentive Plan 2015
Equity Incentive RSU 10,000
Incentive Cancellation Date Aug. 04, 2024
Incentive Vest Date Sep. 21, 2024
RSUs Cancelled Plan Twenty Five [Member]  
Incentive RSUs Cancelled 5,667
Equity Incentive Plan 2015
Equity Incentive RSU 5,667
Incentive Cancellation Date Aug. 04, 2024
Incentive Vest Date Oct. 04, 2024
RSUs Cancelled Plan Twenty Six [Member]  
Incentive RSUs Cancelled 178,909
Equity Incentive Plan 2015
Equity Incentive RSU 178,909
Incentive Cancellation Date Aug. 15, 2024
Incentive Vest Date Sep. 28, 2024
RSUs Cancelled Plan Twenty Seven [Member]  
Incentive RSUs Cancelled 178,894
Equity Incentive Plan 2015
Equity Incentive RSU 178,894
Incentive Cancellation Date Aug. 15, 2024
Incentive Vest Date Sep. 28, 2025
RSUs Cancelled Plan Twenty Eight [Member]  
Incentive RSUs Cancelled 178,872
Equity Incentive Plan 2015
Equity Incentive RSU 178,872
Incentive Cancellation Date Aug. 15, 2024
Incentive Vest Date Sep. 28, 2026
v3.24.3
StockBased Compensation (Details 10)
9 Months Ended
Sep. 30, 2024
$ / shares
shares
Option Ten [Member]  
Number Of Stock Outstanding Balance 115,000
Share Price | $ / shares $ 0.74
Weighted Average Remaining Contractual Life (years) 1 year 7 months 20 days
Options One [Member]  
Number Of Stock Outstanding Balance 40,000
Share Price | $ / shares $ 0.58
Weighted Average Remaining Contractual Life (years) 1 year 1 month 13 days
Option Two [Member]  
Number Of Stock Outstanding Balance 15,000
Share Price | $ / shares $ 0.60
Weighted Average Remaining Contractual Life (years) 2 years
Option Three [Member]  
Number Of Stock Outstanding Balance 21,583
Share Price | $ / shares $ 0.61
Weighted Average Remaining Contractual Life (years) 3 months
Option Four [Member]  
Number Of Stock Outstanding Balance 38,198
Share Price | $ / shares $ 0.62
Weighted Average Remaining Contractual Life (years) 8 months 1 day
Option Five [Member]  
Number Of Stock Outstanding Balance 450,000
Share Price | $ / shares $ 0.68
Weighted Average Remaining Contractual Life (years) 2 years 6 months 18 days
Total Option [Member]  
Number Of Stock Outstanding Balance 3,228,849
Option Six [Member]  
Number Of Stock Outstanding Balance 450,000
Share Price | $ / shares $ 0.69
Weighted Average Remaining Contractual Life (years) 1 year 6 months 3 days
Option Seven [Member]  
Number Of Stock Outstanding Balance 665,550
Share Price | $ / shares $ 0.70
Weighted Average Remaining Contractual Life (years) 1 year
Option Eight [Member]  
Number Of Stock Outstanding Balance 297,340
Share Price | $ / shares $ 0.71
Weighted Average Remaining Contractual Life (years) 6 months 29 days
Option Nine [Member]  
Number Of Stock Outstanding Balance 343,192
Share Price | $ / shares $ 0.72
Weighted Average Remaining Contractual Life (years) 8 months 1 day
Option Eleven [Member]  
Number Of Stock Outstanding Balance 14,000
Share Price | $ / shares $ 0.97
Weighted Average Remaining Contractual Life (years) 1 year 4 months 24 days
Option Twelve [Member]  
Number Of Stock Outstanding Balance 4,000
Share Price | $ / shares $ 1.31
Weighted Average Remaining Contractual Life (years) 11 months 19 days
Option Thirteen [Member]  
Number Of Stock Outstanding Balance 9,333
Share Price | $ / shares $ 1.32
Weighted Average Remaining Contractual Life (years) 10 months 9 days
Option Fourteen [Member]  
Number Of Stock Outstanding Balance 675,322
Share Price | $ / shares $ 1.46
Weighted Average Remaining Contractual Life (years) 5 months 26 days
Option Fifteen [Member]  
Number Of Stock Outstanding Balance 17,332
Share Price | $ / shares $ 1.58
Weighted Average Remaining Contractual Life (years) 7 months 6 days
Option Sixteen [Member]  
Number Of Stock Outstanding Balance 38,333
Share Price | $ / shares $ 1.72
Weighted Average Remaining Contractual Life (years) 11 months 1 day
Option Seventeen [Member]  
Number Of Stock Outstanding Balance 666
Share Price | $ / shares $ 2.15
Weighted Average Remaining Contractual Life (years) 7 months 28 days
Option Eighteen [Member]  
Number Of Stock Outstanding Balance 34,000
Share Price | $ / shares $ 2.95
Weighted Average Remaining Contractual Life (years) 1 month 17 days
v3.24.3
StockBased Compensation (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended
Sep. 02, 2024
Jul. 08, 2024
Jul. 02, 2024
Sep. 30, 2024
Sep. 30, 2024
Jun. 30, 2024
Mar. 31, 2024
Sep. 30, 2023
Jun. 30, 2023
Mar. 31, 2023
Sep. 30, 2024
Sep. 30, 2023
Share-based Payment Arrangement, Noncash Expense         $ 323,539 $ 208,046 $ 411,220 $ 537,980 $ 592,174 $ 693,657    
Restricted Stock Units (RSUs) [Member]                        
Weighted Average Remaining Contractual Life                     1 year 2 months 23 days  
Granted shares 343,192                   297,340  
Number of shares granted to employee     38,198                  
Number of shares granted to consultant   21,583                    
Number of shares granted to third party       15,000                
Share-based Payment Arrangement, Noncash Expense                     $ 937,567 $ 1,511,351
Remaining unrecognized compensation cost related to non-vested RSUs       $ 1,031,071 $ 1,031,071           1,031,071  
Option [Member]                        
Share-based Payment Arrangement, Noncash Expense                     $ 287,013 287,013
Option [Member] | 2015 Equity Incentive Plan [Member]                        
Weighted Average Remaining Contractual Life                     3 years 5 months 15 days  
Common Stock, Shares Authorized       9,700,000 9,700,000           9,700,000  
Common Stock Shares Reserved For Future Issuance       603,502 603,502           603,502  
Option [Member] | 2024 Stock Incentive Plan [Member]                        
Common Stock, Shares Authorized       7,500,000 7,500,000           7,500,000  
Warrants [Member]                        
Weighted Average Remaining Contractual Life                     7 months 6 days  
Share-based Payment Arrangement, Noncash Expense                     $ 5,238 $ 25,447
Warrants Series A and Series B [Member]                        
Weighted Average Remaining Contractual Life                     3 years 10 months 17 days  
v3.24.3
Commitments and Contingencies (Details) - Finance Lease Obligations [Member]
Sep. 30, 2024
USD ($)
2024 - remaining $ 14,983
2025 59,934
2026 59,934
2027 59,934
2028 59,933
Greater than 5 years 202,259
Total 456,977
Less: Amount representing interest (40,812)
Present value of minimum lease payments $ 416,165
v3.24.3
Commitments and Contingencies (Details 1) - USD ($)
9 Months Ended 12 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Operating right-of-use assets $ 635,857 $ 549,504
Operating lease liabilities, current portion 219,060 199,323
Operating lease liabilities, long term 448,045 378,054
Operating Lease Right of Use Obligations [Member]    
Operating right-of-use assets $ 635,857 $ 549,504
Weighted average remaining lease (months) 47 months 33 months
Weighted average discount rate 3.70% 3.02%
Operating lease liabilities, current portion $ 190,099 $ 199,323
Operating lease liabilities, long term 350,810 378,054
Total operating lease liabilities $ 540,909 $ 577,377
v3.24.3
Commitments and Contingencies (Details 2)
Sep. 30, 2024
USD ($)
Less: imputed interest $ (1,080,126)
Operating Lease Right of Use Obligations [Member]  
2024 - Remaining 61,552
2025 241,924
2026 225,368
2027 144,593
2028 44,059
Total 717,496
Less: imputed interest (50,391)
Total Operating Lease Liabilities $ 667,105
v3.24.3
Commitments and Contingencies (Details 3)
Sep. 30, 2024
USD ($)
Commitments and Contingencies  
2024 - Remaining $ 27,481
2025 12,373
Total Operating Lease Liabilities $ 39,854
v3.24.3
Commitments and Contingencies (Details 4)
Sep. 30, 2024
USD ($)
Total Grants Repayable $ 454,544
Grants Repayable [Member]  
2024 - Remaining 27,857
2025 37,789
2026 45,545
2027 50,564
2028 54,073
Greater than 5 years 238,716
Total Grants Repayable $ 454,544
v3.24.3
Commitments and Contingencies (Details 5)
Sep. 30, 2024
USD ($)
Commitments and Contingencies  
2024 - Remaining $ 551,774
2025 1,046,366
2026 813,844
2027 607,484
2028 2,536,778
Greater than 5 years 326,851
Total 5,883,097
Less: imputed interest (1,080,126)
Total Long-Term Debt $ 4,802,971
v3.24.3
Commitments and Contingencies (Details 6)
Sep. 30, 2024
USD ($)
Total Amount Remaining $ 1,232,263
2025 419,278
2024 - Remaining 812,985
National Universty of Taiwan  
Total Amount Remaining 510,000
2025 0
2024 - Remaining 510,000
MD Anderson Cancer Center  
Total Amount Remaining 327,092
2025 163,546
2024 - Remaining 163,546
Guys and St Thomas  
Total Amount Remaining 217,464
2025 152,225
2024 - Remaining 65,239
Xentic Bioscience  
Total Amount Remaining 81,447
2025 55,305
2024 - Remaining 26,142
UMC  
Total Amount Remaining 96,260
2025 48,202
2024 - Remaining $ 48,058
v3.24.3
Commitments and Contingencies (Details 7) - Restricted stock option
9 Months Ended
Sep. 30, 2024
USD ($)
Outstanding Award 3  
Outstanding award $ 527,940
Amortized of outstanding award 2024 0
Amortized of outstanding award 2023 393,853
Amortized of outstanding award 2022 $ 134,087
Vesting period 2023
Unamortized of outstanding award $ 0
Outstanding Award 4  
Outstanding award 516,040
Amortized of outstanding award 2024 188,187
Amortized of outstanding award 2023 260,119
Amortized of outstanding award 2022 65,088
Unamortized of outstanding award $ 2,646
Vesting period 2024
Outstanding Award 5  
Outstanding award $ 521,176
Amortized of outstanding award 2024 131,034
Amortized of outstanding award 2023 177,584
Amortized of outstanding award 2022 46,686
Unamortized of outstanding award $ 165,872
Vesting period 2025
Total Member  
Outstanding award $ 1,565,156
Amortized of outstanding award 2024 319,221
Amortized of outstanding award 2023 831,556
Amortized of outstanding award 2022 245,861
Unamortized of outstanding award $ 168,518
v3.24.3
Commitments and Contingencies (Details 8) - Restricted Stock Options Vested [Member]
9 Months Ended
Sep. 30, 2024
USD ($)
Total Member  
Outstanding award $ 717,112
Amortized of outstanding award 2024 273,022
Amortized of outstanding award 2023 173,986
Unamortized of outstanding award 270,104
Outstanding Award 1  
Outstanding award $ 242,902
Vesting period 2024
Amortized of outstanding award 2024 $ 148,132
Amortized of outstanding award 2023 94,770
Unamortized of outstanding award 0
Outstanding Award 2  
Outstanding award $ 237,936
Vesting period 2025
Amortized of outstanding award 2024 $ 74,906
Amortized of outstanding award 2023 47,513
Unamortized of outstanding award 115,517
Outstanding Award 3  
Outstanding award $ 236,274
Vesting period 2026
Amortized of outstanding award 2024 $ 49,984
Amortized of outstanding award 2023 31,703
Unamortized of outstanding award $ 154,587
v3.24.3
Commitments and Contingencies (Details Narrative) - USD ($)
9 Months Ended
Feb. 05, 2024
Nov. 03, 2020
Sep. 30, 2024
Payments For Future Research And Collobration     $ 1,232,263
Total Grants Repayable     454,544
Principal balance payable     65,467
Aggerate Amount Payable, Description   under this agreement will be completed by the end of the third quarter of 2024 at a total additional cost to the Company of up to $0.7 million  
Loan agreement, Description 9-month loan agreement with First Insurance Funding for a maximum of $294,603 with fixed interest rate of 8.42%, maturing in November 2024    
Total Long-Term Debt     4,802,971
Amount payable for services rendered     138,971
Amount may be payable by Company in future periods for services rendered     0
Accrued compensation expense     536,535
Recognized total compensation expense     447,008
RSU 2023 [Member]      
Unrecognized compensation expense     270,104
RSU 2024 [Member]      
Unrecognized compensation expense     0
RSU 2025 [Member]      
Unrecognized compensation expense     115,517
RSU 2026 [Member]      
Unrecognized compensation expense     154,587
Two Thousand Twenty Two [Member] | Univercity Of Texas MD [Member]      
Collaborative Obligations Amount Due     138,971
Additional Cost Of Company     327,092
Cost     327,092
August Two Thousand Twenty Three [Member] | Guy's and St Thomas' NHS Foundation Trust [Member]      
Collaborative Obligations Amount Due     0
Additional Cost Of Company     217,464
Cost     217,464
July Thirty One Thousand Twenty Three [Member] | Xenetic Biosciences Inc and CLS Therapeutics [Member]      
Collaborative Obligations Amount Due     26,142
Additional Cost Of Company     81,447
Cost     107,589
January TwoThousand Twenty Four [Member] | University Medical Centre Amsterdam[Member]      
Collaborative Obligations Amount Due     48,106
Additional Cost Of Company     96,260
Cost     96,260
Managing Director's Agreement [Member]      
Payment under the royalty agreement     218
Royalty Payment     122,572
Clinical Study Research Agreement [Member] | In 2018 [Member] | University of Taiwan [Member]      
Collaborative Obligations Amount Due     510,000
Collaborative Obligations Amount     $ 2,550,000
Lease Agreement Expire Period     three-year
Cost     $ 510,000
Restricted Stock Units (RSUs) [Member]      
Recognized total compensation expense     1,396,638
RSU Vested in 2024     513,394
RSU Vested in 2023     527,940
RSU Vested in 2025     355,304
Unrecognized compensation expense     168,518
Operating Lease Right of Use Obligations [Member]      
Payment Of Lease Liabilities     185,692
Operating Lease Expense     167,465
Short Term Lease Costs     $ 45,161
v3.24.3
Subsequent Events (Details Narrative)
1 Months Ended 3 Months Ended
Nov. 06, 2024
USD ($)
$ / shares
shares
Nov. 04, 2024
shares
Oct. 04, 2024
shares
Oct. 01, 2024
shares
Oct. 29, 2024
EUR (€)
Sep. 30, 2024
USD ($)
Jun. 30, 2024
USD ($)
Mar. 31, 2024
USD ($)
Sep. 30, 2023
USD ($)
Jun. 30, 2023
USD ($)
Mar. 31, 2023
USD ($)
Compensation expense | $           $ 323,539 $ 208,046 $ 411,220 $ 537,980 $ 592,174 $ 693,657
Subsequent Event [Member]                      
Vested stock options granted cancelled   25,000                  
Common stock, shares withheld for taxes     65,424                
Warrants issued to purchase     272,242                
RSUs, vested     337,666                
RSUs, granted 1,000,000                    
Subsequent Event [Member] | Minimum [Member]                      
Closing stock price | $ / shares $ 2.50                    
Subsequent Event [Member] | Maximum [Member]                      
Closing stock price | $ / shares $ 5.00                    
Subsequent Event [Member] | Independent Director Agreement [Member]                      
Description of agreement (i) $30,000 per calendar quarter commencing November 6, 2024; (ii) $1,000 per day for any services performed as a member of a committee of the Company, if any, (iii) a grant of RSUs under the Company’s 2015 Stock Incentive Plan to receive an aggregate of four hundred thousand (400,000) shares of the Company’s common stock underlying the RSUs (as described above under the heading “RSUs Granted”). and (iv) a grant of RSUs under the Company’s 2024 Stock Incentive Plan to receive an aggregate of one million (1,000,000) shares of the Company’s common stock underlying the RSUs, (as described above under the heading “RSUs Granted”). The Independent Director Agreement provides that in the event that the Company undergoes a Change of Control (as defined below), the vesting of the RSUs in (iv) above shall be accelerated to fully-vest the rights to such RSUs provided that the purchase price per share of the Company’s common stock in such transaction exceeds $2.50 per share                    
Total voting power 50.00%                    
RSUs awarded of common stock 300,000                    
Subsequent Event [Member] | Loan agreement [Member]                      
Principal amount | €         € 577,975            
Interest rate         7.00%            
Period of agreement         4 years            
Subsequent Event [Member] | July 1, 2024 [Member]                      
RSUs, vested       33,503              
Subsequent Event [Member] | July 8, 2024 [Member]                      
RSUs, granted 400,000                    
Compensation expense | $ $ 240,800                    

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