Company Announcements

Ondine Biomedical Reports Robust Growth in H1 2024

Source: RNS
RNS Number : 1970G
Ondine Biomedical Inc.
30 September 2024
 

ONDINE BIOMEDICAL INC.

("Ondine Biomedical", "Ondine" or the "Company")

 

Ondine Biomedical Reports Robust Growth in H1 2024

 

Unaudited results for the six months to 30 June 2024

 

Ondine Biomedical Inc. (AIM:OBI), a leading provider of light-activated antimicrobial technology to prevent and treat hospital infections, is pleased to announce strong operational results for the first half of 2024, highlighting significant progress and expansion in its commercial and clinical endeavors.

 

Financial figures throughout this interim report are in Canadian dollars unless otherwise specified.

 

Operational Highlights

 

·      Commercial growth: Adoption of the Company's novel light-activated antimicrobial, Steriwave®, increased by 190% to 29 hospitals by the end of H1 2024 (H1 2023: 10 Hospitals). Commenced commercial roll-out of the 2nd generation Nasal Illuminator in Canada post-period.

 

·      Strategic partnership: Following the end of H1 2024, the Company announced a strategic partnership with Mölnlycke Health Care, a world-leading MedTech company that specializes in innovative solutions for wound care and surgical procedures, to bring Ondine's Steriwave nasal decolonization technology to the UK, EU, and Middle Eastern markets.

 

·      Clinical trial progress: In June, the Clinical trial agreement for the US Phase 3 trial was signed with HCA Healthcare (HCA). Ondine, HCA and the contract research organization are collaboratively finalizing the details and site selection for the trial.  

 

·      Advancing into ICU: As previously announced, the Company accelerated plans to pursue the large and critical ICU market, and has partnered with the Royal Columbian Hospital Foundation's Advancing Innovation in Medicine (AIM) division to study Steriwave in intensive care units (ICU).

 

Financial Highlights

 

·      Revenue of $0.9 million, reflecting a 101% increase compared to $0.4 million in H1 2023.

·      Gross margin at 62%, up 300 basis points from 59% in H1 2023.

·      Loss from operations of $7.8 million (H1 2023: $8.0 million).

·      Cash, cash equivalents and restricted cash of $1.4 million as at 30 June 2024 (31 December 2023: $3.1 million).

·      Secured c.$11 million of capital in support of commercial growth and general operations comprised of $6 million in May 2024 and a post-period private placement of $5 million to be delivered on or before 8 November 2024.

·      Financial support of $0.7 million from Founder and CEO Carolyn Cross was received on an interest free, unsecured basis along with commitment for continued working capital support on similar terms while the Company secures additional long-term finance.

 

Carolyn Cross, CEO:

 

"Our significant revenue growth and expanded hospital adoption of Steriwave are testaments to the technology's efficacy as well as the need for simple solutions to prevent complex hospital infections. The Mölnlycke partnership underscores the value we bring to healthcare systems and marks a new era of accelerated growth for Ondine as we pursue approval for the large US market and expansion into critical care settings. We are excited about the road ahead and continued momentum in the second half of 2024."

 

Live Presentation

 

Ondine will be hosting a presentation to all existing and potential shareholders at 16:30 BST (08:30 Pacific time) held via the Investor Meet Company platform. Questions can be submitted at any time during the live presentation.

 

Investors can sign up to Investor Meet Company for free and add to meet ONDINE BIOMEDICAL INC. via: https://www.investormeetcompany.com/ondine-biomedical-inc/register-investor

 

Investors who already follow ONDINE BIOMEDICAL INC. on the Investor Meet Company platform will automatically be invited.

 

Related Party Transaction

 

On 30 September Carolyn Cross provided a loan (the "Loan") of C$400,000 to the Company for additional working capital ahead of securing longer term financing. This is in addition to the C$285,000 loan provided on 11 September 2024. The Loan is deemed to constitute a related party transaction for the purpose of AIM Rule 13. The Company's Independent Directors, having consulted with Singer Capital Markets, the Company's nominated adviser, consider that the terms of the Loan are fair and reasonable insofar as Shareholders are concerned.

 

As previously announced, Carolyn and Robert Cross, who jointly own 49.5% of the Company, have indicated they will continue to support the Company with short term financing on similar favourable terms to extend the runway while the Company secures longer term financing.

 

Enquiries:

 

Ondine Biomedical Inc.       

 

Carolyn Cross, CEO 

+1 (604) 665 0555

 

 

Singer Capital Markets (Nominated Adviser and Joint Broker)

 

Phil Davies, Sam Butcher

 

+44 (0)20 7496 3000

 

 

RBC Capital Markets (Joint Broker)

 

Rupert Walford, Kathryn Deegan

+44 (0)20 7653 4000


 

Vane Percy & Roberts (Media Contact)


Simon Vane Percy, Amanda Bernard

+44 (0)77 1000 5910

 

 

About Ondine Biomedical Inc.

 

Ondine Biomedical Inc. is a clinical Canadian life sciences company and leader in light-activated antimicrobial therapies (also known as 'photodisinfection'). Ondine has a pipeline of investigational products, based on its proprietary photodisinfection technology, in various stages of development.

 

Ondine's nasal photodisinfection system has a CE mark in Europe and the UK and is approved in Canada and several other countries under the name Steriwave®. In the US, it has been granted Qualified Infectious Disease Product designation and Fast Track status by the FDA and is currently undergoing clinical trials for regulatory approval. Products beyond nasal photodisinfection include therapies for a variety of medical indications such as chronic sinusitis, ventilator-associated pneumonia, burns and other indications.

 

 

Chief Executive Officer's Statement

 

The first half of 2024 has been productive for Ondine, marked by robust growth and significant commercial advancements. Our continued progress is a direct reflection of the dedication and hard work of our team, our supporters and shareholders, as well as the trust placed in us by the healthcare professionals we serve.

 

Commercial Traction

 

Our recent commercial traction and rapid new hospital adoption rate have led to our strategic partnership with Mölnlycke Health Care, a global leader in the wound care and infection control industry, announced on 23 September 2024. This partnership will help to accelerate adoption of Steriwave in key markets, starting initially with the United Kingdom, which has a total addressable market of over 3 million major surgeries annually[1] and over 200,000 annual intensive care unit (ICU) admissions.[2] 

 

Successful outcomes in initial hospital deployments continue to fuel adoption growth in our target markets of Canada and the UK. We grew the number of hospitals which are using, or have approved use of, Steriwave to 29 (190% increase year-over-year) and doubled our revenues compared to the same period last year. We are now deployed in five of Canada's 10 largest hospitals and aim to be in 9 of 10 of Canada's largest hospitals by the end of next year.

 

This year Ondine made significant inroads into the UK's National Health Service (NHS), in addition to our existing sales into the HCA UK network. In June, Steriwave became the first light-activated antimicrobial therapy to be listed on the NHS Supply Chain, the online procurement system which simplifies the purchasing process for NHS hospitals and clinics across England and Wales.

 

Following a successful initial pilot program, Ondine signed its first commercial contract with Mid Yorkshire Teaching NHS Trust - the first of the NHS Trusts to officially adopt universal nasal decolonization for presurgical patients. Mid Yorkshire Teaching NHS Trust accelerated its adoption of Steriwave into 2 hospitals, Pinderfields and Pontefract Hospitals, as standard of care. In a collaboration with Health Innovation Yorkshire & Humber and the York Health Economics Consortium (YHEC), data from the Mid Yorkshire hospitals is being used to conduct a health economic analysis of Steriwave. The findings, expected in the fourth quarter, should help to support further adoption into hospitals across the NHS Trusts in light of the NHS long term goals of innovative solutions to address antimicrobial resistance, reduced costs and improved patient outcomes.

 

Clinical Advancements

 

With the clinical trial and CRO agreements signed, and work progressing on site selections and finalizing details with principal investigators, we are poised to initiate our US Phase 3 trial with HCA Healthcare once the necessary funding is obtained, a key steppingstone to access the large US market. This trial, to be conducted at 14 HCA hospitals, will compare standard-of-care infection prevention practices with, and without, Steriwave nasal decolonization. The primary endpoint of this 5,000-patient trial is the reduction of surgical site infections, one of the most prevalent healthcare-associated infections (HAI) that costs US healthcare billions of dollars annually. We are very pleased to have esteemed Dr. Ed Septimus - Professor of Internal Medicine, Texas A&M College of Medicine and Senior Lecturer at Harvard Medical School - as Co-Medical Monitor for this large US clinical study.

 

Another major application for Steriwave is in intensive care units (ICU), where 12-13% of patients suffer from hospital-acquired infections, significantly increasing length of stay, mortality, and costly burden to overstretched healthcare resources. Preventing these infections is a priority for hospitals and nasal decolonization for these high-risk patients is recommended in multiple guidelines, including from the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), the Society for Healthcare Epidemiology of America (SHEA) and Infectious Diseases Society of America (IDSA), and the European Guidelines (ESCMID). We are, therefore, very pleased with our recently announced research collaboration with the Royal Columbian Hospital Foundation & Advancing Innovation in Medicine (AIM) division led by Dr Steven Reynolds in support of Steriwave's intensive care unit application. This collaboration sets the stage to unlock the expansive global ICU market, where nasal decolonization (using topical antibiotic ointments over 5 days) is already recognized as a key infection prevention strategy.

 

The purpose of this strategic initiative is to integrate Ondine's Steriwave into ICU infection control and workflow protocols to determine the impact of rapid broad spectrum nasal decolonization on ICU infection rates, length of stay and mortality rates. Commencing with a four-month feasibility phase with a minimum of 320 ICU patients at Royal Columbian Hospital (RCH), the initial research is aimed at optimizing workflow protocols and collecting vital data on enrolment rates and baseline infection metrics. Results from this initial phase will inform a larger multicenter study involving up to 2,000 ICU patients to assess pharmacoeconomics, infection prevention, and patient outcomes in critical care settings. The $855,000 pilot study, supported by the RCH Foundation, will be funded by Ondine through the issuance of equity, over four milestones.

 

Financial Performance

 

On the financial front, we are pleased that revenues more than doubled year-on-year while holding operating costs steady, offsetting increased costs related to Phase 3 clinical trial preparations with strategic cost-saving measures. Cost of goods sold continued to fall, further increasing gross margins to 62%, up 300 basis points from 59% in H1 2023.

 

We raised circa $11 million, including a successful financing of over $6 million in May and $5 million post-period in a private placement financing. Furthermore, Ondine has the working capital support of founders and substantial shareholders while currently exploring longer term funding options with our advisors, and we are confident in the ability to secure longer-term growth capital.

 

Outlook

 

2024 is proving to be a pivotal year for the Company with significant progress made on the commercial and clinical development fronts. Looking ahead, we have an exciting and challenging chapter before us, one that will very much define us in the years to come. We are ready.  

 

On behalf of the Board and all the Ondine employees, we would like to thank our numerous supporters and shareholders for the many contributions that pave the way for our continued success.

 

Carolyn Cross

Chief Executive Officer

30 September 2024

 

 

 



 

Ondine Biomedical Inc.

Unaudited condensed consolidated interim statements of financial position

(In thousands of Canadian dollars)


Notes

June 30, 2024

 $

December 31, 2023

$

Assets


 


Current assets


 


Cash


1,218

2,981

Restricted cash


152

 157

Accounts and other receivables

4, 16

 238

326

Inventory

5

 1,288

1,066

Prepaid expenses and deposits

6

  326 

 220



  3,222

 4,750

Non-current assets




Property and equipment

7

767

 949

Other assets

6

 36

 35

 


 803

 984

Total Assets


 4,025

 5,734

Liabilities


 


Current liabilities


 


Accounts payable and other liabilities

8, 16

 3,440

3,108

Current portion of lease liability

9

351

382

Current portion of warrant liability

10

215

-



 4,006

3,490

Non-current liabilities


 


Lease liability

9

 -

159

 


-

159

Total Liabilities


4,006

3,649

Equity


 


Share capital

11

 244,829

239,647

Contributed surplus


10,528

10,258

Reserves


 18,758

18,244

Deficit


 (274,096)

 (266,334)

Total Shareholders' Equity


 19

2,085

Total Liabilities and Shareholders' Equity


4,025

5,734

Going concern - Note 1; Commitments and contingencies - Note 14; Subsequent events - Note 22

Approved on behalf of the Board:

 




"Carolyn Cross"


                   "Jean Charest"


 

 

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

 

 



 

Ondine Biomedical Inc.

Unaudited condensed consolidated interim statements of loss and comprehensive loss  

(In thousands of Canadian dollars, except share and per share amounts)

For the six months ended June 30,


Notes

2024

$

2023

$

Revenue

13, 15

 859

428

Cost of goods sold

17

(330)

(177)

Gross margin


529

251

Expenses

18

 


General and administration


 4,272

4,747

Research and development


3,301

2,185

Marketing and sales


514

1,055

Depreciation and amortization

7

272

294



8,359

8,281

Loss from operations


(7,830)

(8,030)



 


Other income (expense)


 


Government loan forgiveness


-

 151  

Accretion and interest expense 


 (22)

 (20)

Interest income


-

204

Loss on disposal of property and equipment


-

(95)

Change in fair value of warrant liability


112

-

Other income (expense)


(2)

(5)

Foreign exchange gain (loss)


(20)

(105)



68

130

Net loss for the period


(7,762)

(7,900)

Other comprehensive loss


 


Exchange differences on translation of foreign operations (1)


28

(16)

Total comprehensive loss


(7,734)

(7,916)



 


Net loss per share


 


Basic and diluted


 (0.03)

 (0.04))



 


Weighted average number of shares outstanding


 


Basic and diluted


 241,469,143

194,715,848

 

(1)  May be reclassified to profit or loss in subsequent periods.

 

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

 

 


Ondine Biomedical Inc.

Unaudited condensed consolidated interim statements of changes in equity

(In thousands of Canadian dollars, except share amounts)


Number of common shares
(Note 11)

Share capital

$

Contributed surplus

$

Share-based payment reserve

$

Currency translation reserve

$

Accumulated Deficit

$

Equity

$

Balance, January 1, 2023

 194,592,857

 235,042

 10,528

 18,479

 (483)

 (251,922)

 

 11,644

Issuance of share capital - Note 11

390,550

370

-

(370)

-

 -

-

Share-based payments - Note 12

 -  

 -  

-

417

-

-

417

Total comprehensive loss for the period

 -  

 -  

-

 -  

(16)

(7,900)

(7,916)

 Balance, June 30, 2023

 194,983,407

 235,412

 10,528

18,526

(499)

(259,822)

4,145

Balance, January 1, 2024

226,753,789

239,647

 10,528

18,726

(482)

 (266,334)

2,085

Issuance of share capital upon financing - Note 10

50,531,970

5,732

-

-

-

-

5,732

Share issuance costs - Note 11

-

(550)

-

-

-

-

(550)

Share-based payments - Note 12

 -  

-

-

486

-

-

486

Total comprehensive loss for the period

 -  

-

-

-

28

(7,762)

(7,734)

Balance, June 30, 2024

277,285,759

244,829

 10,528

19,212

(454)

(274,096)

19

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

 

 


Ondine Biomedical Inc.

Unaudited condensed consolidated interim statements of cash flows

(In thousands of Canadian dollars)


For the six months ended June 30,


Notes

2024

$

2023

$

Cash flows from (used in) operating activities


 


Net loss for the period


 (7,762)

(7,900)

Adjustments for non-cash items:


 


Depreciation of right-of-use assets

7

189

187

Depreciation and amortization of other property and equipment

7

95

118

Accretion and interest expense


22

20

Share-based payments

12

486

417

Change in fair value of warrant liability

10

(112)

-

Unrealized foreign exchange (gain) loss


(21)

111

Government loan forgiveness


-

(151)

Loss on disposal of property and equipment


-

95

Other


 -

24

Changes in non-cash working capital

19

19

(1,095)

Net cash used in operating activities


(8,174)

Cash flows from (used in) financing activities


 


Repayment of lease obligations


 (224)

(171)

Repayment of government loan


-

(40)

Proceeds from public offering


6,059

-

Share issuance costs


(550)

-

Net cash from financing activities


5,285

(211)

Cash flows used in investing activities


 


Purchase of property and equipment

7

(10)

(174)

Net cash used in investing activities


(10)

(174)

Net decrease in cash and restricted cash


(1,809)

(8,559)

Effect of foreign exchange rate change on cash and restricted cash


41

(127)

Cash and restricted cash, beginning of period


3,138

13,272

Cash and restricted cash, end of period


1,370

4,586

 


 


Supplemental cash flow information

19

 


 

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

 

 



 

Ondine Biomedical Inc.

Unaudited condensed consolidated interim statements of cash flows

 (In thousands of Canadian dollars)

 

Cash and restricted cash are comprised of:                                                               


For the six months ended June 30,



2024

$

2023

$

Cash


 1,218

4,439

Restricted cash


152

147

Cash, cash equivalents and restricted cash, end of period


1,370

4,586

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

 

Ondine Biomedical Inc.

Notes to the Unaudited Condensed Consolidated Interim Financial Statements

Year ended December 31, 2023 and 2022

(In thousands of Canadian dollars, except as otherwise indicated)

 

1.     Nature of operations and going concern

Ondine Biomedical Inc. (the "Company") was incorporated under the British Columbia Business Corporations Act on September 9, 1996. The Company is a biotechnology company engaged in the development and commercialization of innovative anti-infective therapies covering a broad spectrum of bacterial, fungal and viral infections primarily using antimicrobial photodynamic therapy ("aPDT") as a platform technology for its products, which are used as an alternative to the use of antibiotics. The Company's aPDT products employ laser-based activation of proprietary compounds to treat a wide range of medical infections. The address of the Company's corporate office is 888-1100 Melville Street, Vancouver, BC, Canada. The common shares of the Company are listed on the AIM Market of the London Stock Exchange under the symbol "OBI.L".

These unaudited condensed consolidated interim financial statements have been prepared on a going concern basis, which assumes the Company will be able to meet its obligations and continue its operations in the normal course of business for at least twelve months from June 30, 2024.

The Company has a history of incurring significant losses and as at June 30, 2024, had an accumulated deficit of $274,096 (December 31, 2023 - $266,334). As at June 30, 2024, the Company had a cash and cash equivalents balance of $1,218 (December 31, 2023 - $2,981) and a negative working capital balance of $784 (December 31, 2023 - positive $1,260). In the six months ended June 30, 2024, cash used in operating activities totaled $7,084 (June 30, 2023 - $ 8,174).

The Company's ability to continue as a going concern is dependent on its ability to develop profitable operations and/or to continue to obtain the necessary financing to meet its corporate expenditures and discharge its liabilities in the normal course of business. The Company will need to raise funds through public or private equity and/or debt financings. Although the Company has been successful in raising finance in the past there can be no assurance that it will be successful in the future. If the Company is unable to generate positive cash flows or obtain adequate financing, the Company may need to curtail operations. These factors give rise to material uncertainty that may cast significant doubt on the Company's ability to continue as a going concern. The consolidated financial statements do not give effect to adjustments to carrying values and to the classification of assets and liabilities that would be required if the Company were unable to continue as a going concern and such adjustments could be material.

2.    Basis of preparation

(a) Statement of compliance

These unaudited condensed consolidated interim financial statements have been presented in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board ("IFRS Accounting Standards") as applicable to the preparation of consolidated financial statements, as set out in International Accounting Standard ("IAS") 34, Interim Financial Reporting. They do not include all the information required for a complete set of IFRS financial statements. However, selected explanatory notes are included to explain events and transactions that are significant to an understanding of the changes in the Company's financial position and performance since the last annual consolidated financial statements as at and for the year ended December 31, 2023.

The unaudited condensed consolidated interim financial statements were approved and authorized for issue by the Board of Directors on September 27, 2024.

(b) Basis of measurement

The unaudited condensed consolidated interim financial statements have been prepared on a historical cost basis as stated in the accounting policies. The expenses within the consolidated statements of loss and comprehensive loss are presented by function. Refer to Note 18 for details of expenses by nature.

(c) Use of estimates, assumptions and judgments

The preparation of unaudited condensed consolidated interim financial statements in conformity with IFRS requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the amounts reported in the consolidated financial statements and accompanying disclosures. Although these estimates are based on management's knowledge of current events and actions the Company may undertake in the future, actual results may differ from the estimates and the differences may be material.

Estimates and underlying assumptions are reviewed on an ongoing basis.  Revisions to accounting estimates, if any, are recognized in the year in which the estimates are revised and in any future years affected.

Information about the judgments, estimates and assumptions made by management in preparing these condensed consolidated interim financial statements are as described under "Basis of presentation - Judgments and estimates" in the Company's consolidated financial statements for the year ended December 31, 2023.

3.   Material accounting policies

The accounting policies in these unaudited condensed consolidated interim financial statements are as described under "Material accounting policies" in the Company's consolidated financial statements for the year ended December 31, 2023.

 

4.     Accounts and other receivables



June 30, 2024

$

December 31, 2023

$

Trade receivables


 232  

324

Other receivables


6

2



238

326  

5.     Inventory

 

 

June 30, 2024

$

December 31, 2023

$

Raw materials

 

376

555

Work-in-progress

 

-

118

Finished goods

 

912

393

 

 

1,288

1,066

During the six months ended June 30, 2024, raw materials, work-in-progress and finished goods included in cost of goods sold amounted to $318 (June 30, 2023 - $157). During the six months ended June 30, 2024 and 2023, inventory valued at $nil and $9, respectively, was written off and reflected within cost of goods sold.

6.     Prepaids and deposits, and non-current assets

 

June 30, 2024

$

December 31, 2023

$

Prepaid insurances

139

154

Lease deposits

36

35

Other prepaid costs

187

66

 

362

255

Less: Current portion of prepaid expenses and deposits

326

220

Other non-current assets

36

35

 


7.   Property and equipment

The Company's property and equipment gross carrying amounts and accumulated depreciation were as follows:

 

Computer equipment

$

Furniture and fixtures

$

Lab and office equipment

$

Leasehold improvements

$

Manufacturing equipment and tools

$

Demo equipment

$

Right-of-use

$

Total

$

Cost









Balance, January 1, 2023

291

246

472

292

781

164

1,086

3,332

Additions

25

-

62

25

65

-

-

177

Transfers and other

-

-

-

-

-

69

-

69

Disposals and derecognition

(176)

(193)

(275)

-

(512)

-

-

(1,156)

Exchange adjustment

(6)

(1)

(11)

(6)

(11)

-

(21)

(56)

Balance, December 31, 2023

134

52

248

311

323

233

1,065

2,366

Additions

3

-

7

-

-

67

-

77

Transfers and other

-

-

-

-

-

-

-

-

Disposals and derecognition

-

-

(10)

-

-

-

-

(10)

Exchange adjustment

 (6)

1

8

9

11

2

31

66

Balance, June 30, 2024

141

53

253

320

334

302

1,096

2,499

Accumulated depreciation









Balance, January 1, 2023

193

230

433

292

527

32

221

1,928

Additions

46

3

36

8

72

47

375

587

Transfers and other

-

-

-

-

-

(7)

-

(7)

Disposals and derecognition

(158)

(193)

(271)

-

(435)

(1)

-

(1,058)

Exchange adjustment

(4)

1

(8)

(5)

(7)

-

(10)

(33)

Balance, December 31, 2023

77

41

190

295

157

71

586

1,417

Additions

19

2

15

6

28

25

189

284

Transfers and other

-

-

-

-

-

-

-

-

Disposals and derecognition

-

-

(10)

-

-

-

-

(10)

Exchange adjustment

2

(1)

8

8

6

1

17

41

Balance, June 30, 2024

98

42

203

309

191

97

792

1,732

 

Net book value









December 31, 2023

57

11

58

16

166

162

479

949

June 30, 2024

43

11

50

11

143

205

304

767

During the six months ended June 30, 2024, depreciation of $12 (June 30, 2023 - $11) was allocated to cost of goods sold, and $272 to operating expenses (June 30, 2023 - $294).

 


8.   Accounts payable and other liabilities

 

 

June 30, 2024

$

December 31, 2023

$

Accounts payable

 

 1,884

1,363

Accrued liabilities

 

1,375

1,605

Employee related payables

 

108

69

Accrued interest

 

73

71

 

 

3,440

3,108

 

9.   Lease liability


 

 

Office spaces and facilities

$

As at January 1, 2023



896

Interest accretion



46

Lease payments



(388)

Exchange adjustment



(13)

As at December 31, 2023

 

 

541

As at January 1, 2024


 

541

Interest accretion



18

Lease payments



(224)

Exchange adjustment



16

As at June 30, 2024

 

 

351

 


 

June 30, 20224

$

December 31, 2023

$

Current portion


351

382

Non-current


-

159

Total lease liability


351

541

 

The Company's leases are for office spaces and a laboratory facility. The expense relating to variable lease payments not included in the measurement of lease obligations was $115 (June 30, 2023 - $86). This consists of variable lease payments for operating costs and property taxes. Total cash outflow for leases was $339 (June 30, 2023- $257), including $206 (June 30, 2023 - $150) of principal payments on lease obligations.

As at June 30, 2024, the minimum annual payments under these leases, including an estimate of operational costs for its office and laboratory premises based on current costs, is provided below.


$

2024

293

2025

232


525

 



 

10.   Warrant liability


Units

Amount

$

Balance, December 31, 2023

-

-

Issued

25,265,977

327

Fair value adjustment

-

(112)

Balance, June 30, 2024

25,265,977

215

 

On May 9, 2024, as part of the Company's finance raise, 25,265,977 warrants were granted with an exercise price of GBP0.15 ($0.26) and an expiration date of February 9, 2025.

The fair value of warrants granted were estimated with the Black-Scholes model using the following assumptions at the time of grant on May 9, 2024:

Dividend yield

0%

Expected volatility

92%

Risk-free interest rate

4.28%

Expected life of options (years)

0.8

Forfeiture rate

0%

 

Volatility was estimated by using the historical volatility of the Company's trading history and volatility history. The expected life in years represents the period of time that options granted are expected to be outstanding. The risk-free interest rate is based on Canadian government benchmark bonds with a term equal to or a remaining term that approximates the expected life of the warrants.

Issuance costs for the warrants of $31 were recorded in the Comprehensive Statements of Loss and Comprehensive Loss.

The fair value of the warrants were determined estimated with the Black-Scholes model using the following assumptions as at June 30, 2024:

 

Dividend yield

0%

Expected volatility

78%

Risk-free interest rate

4.02%

Expected life of options (years)

 0.6 

Forfeiture rate

0%

As at June 30, 2024, warrants outstanding had a remaining contractual life of 0.6 years (June 30, 2023- nil).

11.   Share capital

Common Stock

Authorized

An unlimited number of common shares without par value.

 

 

Issued

As at June 30, 2024, the Company's issued share capital consisted of 277,285,759 common shares (December 31, 2023 - 226,753,789).

On May 9, 2024, the Company issued 50,531,970 common shares at a price of GBP0.07 ($0.12). The Company incurred accounting, legal, advisory and disbursement costs of $550 directly related to the completion of the finance raise. The costs incurred were recorded to equity in the consolidated statement of financial position.

12.  Share-based payments

(a)  Stock Option Plan

On November 1, 2021, the Board of Directors approved and adopted an amended stock option plan for the Company which provides for the grant of stock options to directors, officers, employees and consultants from time to time at the discretion of the directors. Under the terms of the amended stock option plan, the maximum number of options authorized for issuance is 10% of the issued and outstanding common shares in any 10-year period for any employee' share scheme and the maximum number of options authorized for issuance is 5% of the issued and outstanding common shares in any 10-year period for any executive share scheme. As at June 30, 2024, the maximum number of total options that can be outstanding are 27,728,576 (December 31, 2023 - 22,675,379).

A summary of the status of the stock options outstanding is as follows:


June 30, 2024

December 31, 2023


Number of options

 

Weighted average exercise price

$

Number of options

 

Weighted average exercise price

$

Outstanding, beginning of period

3,690,000

0.81

8,070,000

1.07

Options granted

8,940,000

0.15

50,000

0.29

Options expired

-

-

-

-

Options forfeited

(86,250)

0.46

-

-

Options cancelled

(28,750)

0.46

(75,000)

0.90

Outstanding, end of period

12,515,000

0.35

8,045,000

1.07

Exercisable, end of period

1,795,000

0.82

4,785,000

1.11

Share-based payments expense for the six months ended June 30, 2024, in the amount of $486 (June 30, 2023 - $417) was recorded.



 

The outstanding options for the six months ended June 30, 2024 is as follows:

Exercise price

Number of options

Remaining life (years)

$     0.01

  200,000

 2.25

$     0.15

8,940,000

4.58

$     0.29

30,000

3.74

$     0.36

310,000

3.44

$     0.49

390,000

3.24

$     0.90

  1,070,000

1.88

$     0.93

  1,475,000

2.60

$     3.00

  100,000

2.05

$     0.35

12,515,000

3.98

 

The fair value of stock options granted during the six months ended June 30, 2024 and 2023 were estimated with the Black-Scholes model using the following assumptions at the time of grant:


For the six months ended June 30,


2024

2023

Dividend yield

0%

0%

Annualized volatility

81%

76%

Risk-free interest rate

3.52%

2.96%

Expected life of options (years)

5

5

Forfeiture rate

11%

14%

 

Volatility was estimated by using the historical volatility of other companies that the Company considers comparable that have trading history and volatility history. The expected life in years represents the period of time that options granted are expected to be outstanding. The risk-free interest rate is based on Canadian government benchmark bonds with a term equal to or a remaining term that approximates the expected life of the options.

The weighted average fair value of stock options granted during the twelve months ended June 30, 2024, was $0.12 per option (June 30, 2023 - $0.18). As at June 30, 2024, stock options outstanding had a remaining contractual life of 3.98 years (June 30, 2023 - 2.11 years).

(b) Warrants

On May 30, 2020 and December 1, 2021, the Company granted warrants entitling the holders to acquire common shares of the Company as consideration for ongoing consulting and advisory services. A summary of the status of the warrants outstanding is as follows:


June 30, 2024

June 30, 2023


Number of warrants

 

Weighted average exercise price

$

Number of warrants

 

Weighted average exercise price

$

Outstanding, beginning of period

 2,295,845

 1.08

2,295,845

1.08

Outstanding, end of year

 2,295,845

 1.08

 2,295,845

1.08

Exercisable, end of year

 2,295,845

 1.08

 2,295,845

1.08

The expense for the six months ended June 30, 2024 was $nil (June 30, 2023 - $nil). As at June 30, 2024, warrants outstanding had a remaining contractual life of 0.5 years (June 30, 2023- 1.5 years).

13.  Related party transactions

(a)  Revenues, product shipments and expenses

For the six months ended June 30,


2024

$

2023

$

Product sales (i)

 20  

-

(i)   .

(b) Compensation of key management personnel

The Company's key management personnel have the authority and responsibility for planning, directing and controlling activities of the Company and consists of the Company's executive officers and directors.

For the six months ended June 30,

 

2024

$

2023

$

Compensation and other short-term benefits (i)

721

98

Directors' fees (ii)

271

327

Share-based payments (iii)

195

52

Consulting expenses (iv)

221

74


1,408

551

(i)   During the six months ended June 30, 2023, the Company reassessed the initial estimates of the key managements' performance against the established criteria, leading to a change in estimate of the bonus accrual and reduced compensation and other short-term benefits by $625.

(ii)   On May 9, 2024, as part of the Company's finance raise, directors' fees of $271 were paid in the form of Common Shares.

(iii)  On January 25, 2024, the Company granted 5,815,000 stock options to key management personnel.

(iv)  Expenses incurred for consulting services provided by companies under the control of an officer and a related party of the Company



 

(c)  Related party balances


June 30,

 2024

$

December 31, 2023

$

Included in warrant liability (i)

17

-

Included in accounts payable and other liabilities (ii)

100

45


117

45

(i)         On May 9, 2024, as part of the Company's finance raise, key management personnel received 2,039,989 warrants

(ii)        Loans payable to related parties are due to the personal holding company of the Company's controlling shareholder. The loans payable to related parties are unsecured. The related party balances included in accounts payable and other liabilities consist of payables for services incurred to related parties

14.  Commitments and contingencies

Open purchase order commitments as at June 30, 2024 were $1,521 (December 31, 2023 - $469) for the purchase of inventory and contracted development and clinical services.

The Company and its subsidiaries may, from time to time, be a party to certain legal disputes and claims arising from employment, environmental or commercial issues in the normal course of business. The Company has the following contingency at June 30, 2024:

(i)         The Company's Barbadian subsidiary held intellectual property in Barbados until December 22, 2022. As a result of the Barbados Companies (Economic Substance) Act passed in 2019, the Barbadian subsidiary must comply with economic substance requirements set out in the legislation. If the Barbadian subsidiary cannot establish economic substance in Barbados, the Barbadian subsidiary could be subject to additional financial penalties and/or could be struck from the register of companies.

On December 22, 2022, the Company transferred the intellectual property from the Barbadian subsidiary to a new Swiss subsidiary via an intercompany sale at a fair value which was determined by an independent third party. Challenges from Barbadian, Swiss, Canadian or United States authorities regarding any of the foregoing, which results in an unfavorable outcome, could have a material impact on the financial position and operating results of the Company.

15.  Segmented information

Management has determined that the Company has one reportable operating segment,



 

 

For the six months ended June 30,

 

2024

$

2023

$

Product revenue

 


Canada

824

390

Other

35

38


859

428

For the six months ended June 30,


2024

$

2023

$

Customer 1

316

290

Customer 2

212

11

Other

331

127


859

428


June 30,
2024

$

December 31, 2023

$

Canada

220

210

United States

547

739


767

949

 

16.  Financial risk management and financial instruments

All assets and liabilities for which fair value is measured or disclosed in the unaudited condensed consolidated interim financial statements are categorized within the fair value hierarchy, described as follows, based on the lowest level input that is significant to the fair value measurement as a whole:

Level 1     Unadjusted quoted market prices in active markets for identical assets or liabilities;

Level 2     Valuation techniques for which the lowest level input that is significant to the fair value measurement is directly or indirectly observable; and

Level 3     Valuation techniques for which the lowest level input that is significant to the fair value measurement is not based on observable market data.

As at June 30, 2024, the carrying values of cash, restricted cash, accounts and other receivables, and accounts payable and other liabilities approximate their fair values because of their nature, relatively short maturity dates.

Financial liabilities measured at fair value through profit or loss on a recurring basis include the warrant liabilities (Note 10) which are categorized as Level 2 fair value inputs.

(a)  Management of risks arising from financial instruments

The overall responsibility for the establishment and oversight of the Company's risk management policies resides with the Board of Directors. The Company's risk management policies are established to identify, analyze and manage the risks faced by the Company and to implement appropriate procedures to monitor risks and adherence to established controls. Risk management policies and systems are reviewed periodically in response to the Company's activities and to ensure applicability. The Company, through its financial assets and liabilities, is exposed to certain risks as follows:

Credit risk

The Company is exposed to credit risk arising from the possibility that cash held, and accounts receivable are non-recoverable.  However, the Company believes that its exposure to credit risk in relation to the cash and receivables is low. All of the cash held by the Company and its subsidiaries was held with reputable financial institutions. Since the majority of the Company's customers are considered to have low default risk and its historical default rate and frequency of losses are low, the lifetime expected credit loss allowance as at June 30, 2024 is shown in the table below. The Company's maximum exposure to credit risk is limited to the carrying amount of financial assets recognized as at June 30, 2024 and June 30, 2023 summarized below:

 

June 30,
2024

$

December 31, 2023

$

Classes of financial assets - carrying amounts

 


Cash and cash equivalents

1,218

2,981

Restricted cash

152

157

Accounts receivable, net of credit loss allowance

238

326


1,608

3,464

The aging of the Company's accounts receivable is as follows:

 

June 30,
2024

$

December 31, 2023

$

Trade accounts receivable, net of credit loss allowance                

 


Current

212

231

Past due 1 to 30 days

-

39

Past due 31 to 60 days

20

54


232

324

Other receivables

6

2


238

326

The change in the Company's credit loss allowance for provision is as follows:


June 30,
2024

$

December 31, 2023

$

Balance - beginning of period

903

864

Credit loss expense - net of reversals

-

9

Balance - end of period

903

903

 

Foreign currency risk

The results of the Company's operations are subject to currency transaction and translation risks. The fair value of future cash flows of a financial instrument will fluctuate because of changes in foreign exchange rates. The Company operates in Canada, the United States, the United Kingdom, Barbados, and Switzerland and is exposed to foreign exchange risk due to fluctuations in the US Dollar ("US$"), Great British Pound ("GBP"), Barbadian Dollar, and Swiss Franc against the Canadian dollar. Foreign exchange risk arises from financial assets and liabilities denominated in currencies other than the functional currency of the respective entities. The Company's primary risk is associated with fluctuations between the US$ and Canadian dollar, and the GBP and Canadian dollar.

The Company has determined that the effect of a 10% increase or decrease in the US$ and GBP against the Canadian dollar on net financial assets and liabilities, as at June 30, 2024, including cash, accounts receivables, accounts payable and other liabilities denominated in US$, and GBP would result in an increase or decrease of approximately $151 (June 30, 2023 - $261) in the unaudited condensed consolidated interim statements of loss and comprehensive loss for the six months ended June 30, 2024.

Interest rate risk

Interest rate risk is the risk that the fair values and future cash flows of the Company will fluctuate because of changes in market interest rates. The Company did not incur or have any other interest-bearing assets or liabilities.

Liquidity risk

Liquidity risk is the risk that the Company will not be able to meet its obligations as they fall due.  The Company's objective is to ensure that there is sufficient liquidity to meet its short-term business requirements, taking into account its anticipated cash flows from operations and its holdings of cash. The Company's principal sources of liquidity are cash provided by operations, related party loans, debt and equity issuances. The Company projects and monitors its cash requirements to accommodate changes in liquidity needs (Note 1).

In addition to the commitments in Note 9, Note 10 and Note 14, the Company has the following contractual financial liabilities as at June 30, 2024:


Carrying amount

$

Contractual cash flows

$

Less than one year

$

More than one year

$

Financial liabilities

 




  Accounts payable and other liabilities

3,440

3,440

3,440

-


3,440

3,440

3,440

-

 



 

17.  Cost of goods sold

For the six months ended June 30,


2024

$

2023

$

Inventory - Note 5

318

157

Inventory write-off - Note 5

-

9

Depreciation - Note 7

12

11


330

177

 

18.  Expenses by nature

General and administration, research and development, marketing and sales, and depreciation and amortization expenses are comprised of the following expenses by nature:

For the six months ended June 30,


2024

$

2023

$

Salaries and benefits

3,621

2,909

Professional fees, contractors and consultants

2,333

2,985

Clinical trial costs

833

148

Share based payment

486

417

Office and lab costs

371

676

Depreciation and amortization

272

294

Technology costs

258

352

Travel and entertainment

113

325

Delivery and logistics

39

48

Advertising and promotion

33

127


8,359

8,281

 

19.  Supplementary cash flow information

For the six months ended June 30,


2024

2023

Changes in non-cash working capital items



Accounts and other receivables

90

84

Inventory

(262)

153

Prepaid expenses and deposits

(105)

(60)

Accounts payable and other liabilities 

296

(1,272)


19

(1,095)

20.   Ultimate controlling party

The Company's CEO is the ultimate controlling party of the Company, personally owning and/or controlling through her personal holding company a total of 40.1% of the issued common shares of the Company as at June 30, 2024 (June 30, 2023 - 55.6%).

On May 9, 2024, as part of the Company's finance raise, 1,825,650 Common Shares and 912,825 warrants were issued to the controlling shareholder.

21.   Capital management

The Company's objectives when managing capital are to ensure sufficient liquidity for operations and adequate funding for growth and capital expenditures while maintaining an efficient balance between debt and equity.

The Company's capital consists of items included in shareholders' equity, debt facilities net of cash and restricted cash.

 

In order to facilitate the management of capital, the Company prepares annual expenditure budgets that are updated as necessary and dependent on various factors, including successful deployment of capital and industry conditions. The annual budgets are approved by the Board of Directors. The Company is not subject to any externally imposed capital requirements.

Management believes that existing cash resources, together with cash generated through operations and funds raised through public or private equity and/or debt financings, will generate sufficient liquidity to meet operating cash requirements for at least the next twelve months.

 

22.   Subsequent events

Subsequent to June 30, 2024, the following transactions had occurred:

1.   On September 11, 2024 the Company's controlling shareholder advanced $285 as unsecured, non-interest-bearing with no specific terms of repayment related party loan.

2.   On September 23, 2024, the Company has agreed to sell 22,222,222 common shares for $5,000 at a price of $0.225 (GBP0.125). The closing of the transaction is expected to be on or before November 8, 2024.

3.   As of September 27, 2024, the Company's controlling shareholder has agreed to provide the company $400 as unsecured, non-interest-bearing with no specific terms of repayment related party loan by the end of September.

 



[1] Surgical Procedure Volumes in UK from 2021-2029. Life Science Intelligence; 2023 Jan. Volume 23.

[2] Hospital Admitted Patient Care Activity, 2011-22. Secondary Care Analytical Team, NHS Digital. Health and Social Care Information Centre. 22 Sep 2022. (link)

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