27th Sep 2022 07:00
27 September 2022
Ondine Biomedical Inc.
("Ondine" or the "Company")
Interim results for the six months to 30 June 2022
Significant strategic and operational progress
Ondine Biomedical Inc (AIM: OBI), the Canadian life sciences company addressing the critical need for solutions to a broad spectrum of healthcare-associated and drug-resistant infections, announces its unaudited results for the six months ended 30 June 2022.
Unless otherwise specified, all financial figures throughout this interim report are in Canadian dollars.
Corporate and operational highlights (including post-period)
· Completion of FDA approval Phase 2 clinical trial at HCA's Memorial Health, Savannah (USA) - top line results met the primary endpoint showing nasal photodisinfection eliminated or significantly decreased Staphylococcus aureus (S. aureus) in 92% of carriers treated per protocol (P
· Substantially advanced readiness for the nasal photodisinfection US Phase 3 clinical trial.
· Completion of SARS-CoV-2 infectivity clinical trial at University of Navarra (Spain) - top line results met the primary endpoint demonstrating suppression of SARS-CoV-2 replication and infectivity - manuscript submitted for peer review and publication.
· Peer reviewed new research presentation at World AMR Congress 2022 (USA) demonstrating photodisinfection efficacy against ESKAPE bacteria.
· Sunnybrook Hospital/UHN (Canada) results published in Nature/ Scientific Reports "Translational feasibility and efficacy of nasal photodynamic disinfection of SARS-CoV-2" demonstrating 90% of patient samples showing decrease in viral infectivity, with 70% showing no detectable viruses after a single 5-minute treatment session.
· Peer reviewed new research presentation at the Swiss Society of Microbiology Annual Congress 2022 by University Hospital Zurich (Switzerland) of in vitro results demonstrating >99.99% eradication by photodisinfection of pathogens associated with replacement joint infections with no reported regrowth.
· Significant addition to key personnel in Ondine's senior management and operating teams to strengthen clinical trial, operating scale-up, and commercial capabilities.
· Progression of key relationships including with several UK NHS trusts.
· Initiation of discussions with distribution partners in Europe, the UK and North America.
Financial highlights
· Loss from operations in H1 2022 of $8.4 million (H1 2021: $4.6 million), driven by accelerating clinical and regulatory efforts for the US market, operating scale-up, public company-related costs, and adding key personnel to support future growth.
· Total revenues in H1 2022 were $0.26 million (H1 2021: $1.98 million), reflecting the cessation of COVID pandemic-related sales as of Q3 2021.
· Cash and cash equivalents of $20.9 million as of 30 June 2022 (31 December 2021: $30.4 million).
Carolyn Cross, Ondine Biomedical Chief Executive Officer, said:
"The progress made this year has been, and continues to be, foundational. We have built on and expanded our talented team, adding bench-strength in key positions and increasing our personnel by almost 50%. We have improved our infrastructure and are strategically enhancing our processes to scale with our business. Our vision, mission and purpose remain steadfast and clear: to bring photodisinfection to hospitals around the world to better respond to the growing antimicrobial resistance threat. With significant progress through recent and ongoing data delivery, I am excited for the months ahead and confident that we will be successful in the upcoming FDA-related milestones."
Chief Executive Officer's Statement
The 2022 first half outcomes came in line with our expectations. The increase in expenditure resulted primarily from executing on our IPO related commitments of completing the Phase 2 study for the FDA and making substantial progress in Phase 3 clinical trial preparations. Year over year, there was greater spending on clinical trials, regulatory planning, product development, and operations scale up of personnel and equipment to enable us to achieve our future FDA related milestones. The company also expanded its marketing and commercial activities to track alongside progress through the FDA. The increase in the property costs reflects lease renewal of the Bothell WA facilities.
During the first half of 2022, we made significant progress towards our IPO use-of-proceeds commitments. We have completed the US Phase 2 clinical trial demonstrating microbiological efficacy of nasal photodisinfection achieving the primary endpoint: HCA's Memorial Health (Georgia, USA) clinical trial showed nasal photodisinfection eliminated or significantly decreased Staphylococcus aureus (S. aureus) in 92% of carriers treated per protocol (P
Alongside our focus on achieving our US regulatory milestone targets, we have started to invest in a scientific awareness programme in North America, as well as creating wider awareness of photodisinfection in Canada, the UK and Europe where we already have approval. Key connections via members of our Board of Directors and our leadership team have already started opening doors with the NHS and some hospital groups in Europe. In addition, we have commenced negotiations with distribution partners across North America, the UK and Europe.
The rise of antimicrobial resistance ("AMR") is driving governments and research institutes to seek new solutions to combat antimicrobial-resistant pathogens and help prevent millions of deaths. We are pursuing several non-dilutive funding opportunities, primarily to advance our flagship product Steriwave, to commercialisation following the completion of US Phase III trials. If funding allows we will also expand our wider product pipeline as we believe that photodisinfection has a substantial role to play in not only providing a solution, but also in sparing antibiotic use. New research has suggested that photodisinfection can also help antibiotics to fight resistant pathogens more effectively.[i]
Beyond our initial focus on nasal decolonisation, the possible application areas for photodisinfection are vast - anywhere our proprietary photosensitive compound can be applied and activated with our specifically dosed light. Ondine has a pipeline of products that we believe will address a number of substantial infection concerns, including sinusitis, ventilator-associated pneumonia, burns, wounds Catheter-associated Urinary Tract Infections (CA-UTI) and others. These additional pipeline products will leverage the current clinical and regulatory efforts and will be taken forward as resourcing permits.
The progress made this year has been, and continues to be, foundational. We have built on and expanded our talented team, adding bench-strength in key positions and increasing our personnel by almost 50%. We have improved our infrastructure and are strategically enhancing our processes to scale with our business. Our vision, mission and purpose remain steadfast and clear: to bring photodisinfection to hospitals around the world to better respond to the growing antimicrobial resistance threat. With significant progress through recent and ongoing data delivery, I am excited for the months ahead and confident that we will be successful in the upcoming FDA-related milestones.
Carolyn Cross
Chief Executive Officer
Unaudited condensed consolidated interim financial statements for Ondine Biomedical Inc. For the six months ended June 30, 2022 and 2021
Unaudited condensed consolidated interim statements of financial position
(In thousands of Canadian dollars)
Note | June 30, 2022 | December 31, 2021 | |
Assets |
| ||
Current assets |
| ||
Cash | $ 20,926 | $ 30,365 | |
Accounts and other receivables | 4 | 193 | 248 |
Inventory | 5 | 1,200 | 1,061 |
Prepaid expenses and deposits | 6 | 1,640 | 1,830 |
23,959 | 33,504 | ||
Non-current assets |
| ||
Property and equipment | 7 | 1,316 | 601 |
Other assets | 6 | 35 | 35 |
| 1,351 | 636 | |
| $ 25,310 | $ 34,140 | |
Liabilities |
| ||
Current liabilities |
| ||
Cheques issued in excess of funds on deposit | $ - | $ 497 | |
Accounts payable and other liabilities | 8 | 2,298 | 3,277 |
Current portion of lease liability | 9 | 259 | 148 |
2,557 | 3,922 | ||
Non-current liabilities |
| ||
Lease liability | 9 | 461 | 94 |
Other long-term liabilities | 10 | 474 | 467 |
3,492 | 4,483 | ||
Equity |
| ||
Share capital | 11 | 235,037 | 235,037 |
Contributed surplus | 13 | 10,528 | 10,528 |
Reserves | 17,367 | 16,636 | |
Deficit | (241,114) | (232,544) | |
Equity attributable to owners of the Company | 21,818 | 29,657 | |
Equity attributable to non-controlling interest | - | - | |
21,818 | 29,657 | ||
$ 25,310 | $ 34,140 |
Commitments and contingencies - Note 14; Subsequent events - Note 21
Approved on behalf of the Board:
| |||
"Carolyn Cross" | "Jean Charest" |
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, | |||||
|
| Note | 2022 | 2021 | |
|
|
| |||
Revenue | 13,15 | $ 262 | $ 1,975 | ||
Cost of sales | 17 | (118) | (970) | ||
Gross margin | 144 | 1,005 | |||
Expenses | 18 |
| |||
General and administration | 5,082 | 3,225 | |||
Research and development | 2,642 | 2,138 | |||
Marketing and sales | 603 | (106) | |||
Depreciation and amortization | 7 | 223 | 315 | ||
8,550 | 5,572 | ||||
Loss from operations | (8,406) | (4,567) | |||
|
| ||||
Other income (expense) |
| ||||
Government loan forgiveness | 10 | - | 518 | ||
Accretion and interest expense | (9) | (344) | |||
Change in fair value of embedded derivative | - | (423) | |||
Other income (expense) | 21 | (9) | |||
Foreign exchange gain (loss) | (176) | 224 | |||
(164) | (34) | ||||
Net loss for the period | (8,570) | (4,601) | |||
Other comprehensive loss |
| ||||
Exchange differences on translation of foreign operations(1) | 45 | 22 | |||
Total comprehensive loss | (8,525) | (4,579) | |||
Total comprehensive loss attributable to: |
| ||||
Equity holders of the Company | (8,525) | (4,579) | |||
Non-controlling interest | - | - | |||
Total comprehensive loss for the period | $ (8,525) | $ (4,579) | |||
Net loss per share
Basic and diluted |
|
| $ (0.04) | $ (0.06) |
Weighted average number of shares outstanding
Basic and diluted |
|
| 194,584,524 | 70,671,262 |
(1) May be reclassified to profit or loss in subsequent periods.
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) | Number of preferred shares (Note 11) | Share capital | Contributed surplus | Share-based payment reserve | Currency translation reserve | Deficit | Non-controlling interest | Equity | |
Balance, January 1, 2021 | 70,671,262 | 3,000,000 | $ 119,529 | $ 10,378 | $ 18,801 | $ (386) | (182,136) | $ (14) |
$ (33,828) |
Services received at no charge - Note 14 | - | - | - | 150 | - | - | - | - | 150 |
Share-based payments - Note 12 | - | - | - | - | 1,538 | - | - | - | 1,538 |
Total comprehensive loss for the period | - | - | - | - | - | 22 | (4,601) | - | (4,579) |
Balance, June 30, 2021 | 70,671,262 | 3,000,000 | 119,529 | 10,528 | 20,339 | (364) | (186,737) | (14) | (36,719) |
Balance, January 1, 2022 | 194,584,524 | - | 235,037 | 10,528 | 17,034 | (398) | (232,544) | - | 29,657 |
Share-based payments - Note 12 | - | - | - | - | 686 | - | - | - | 686 |
Total comprehensive loss for the period | - | - | - | - | - | 45 | (8,570) | - | (8,525) |
Balance, June 30, 2022 | 194,584,524 | - | $ 235,037 | $ 10,528 | $ 17,720 | $ (353) | $ (241,114) | $ - | $ 21,818 |
Ondine Biomedical Inc.
Unaudited condensed consolidated interim statements of cash flows
(In thousands of Canadian dollars)
For the six months ended June 30, | |||
Note | 2022 | 2021 | |
Cash flows from (used in) operating activities | |||
Net loss for the period | $ (8,570) | $ (4,601) | |
Adjustments for non-cash items: |
| ||
Depreciation of right-of-use assets | 7 | 122 | 115 |
Depreciation and amortization of other property and equipment and intangible assets | 7 | 116 | 229 |
Accretion and interest expense | 9 | 344 | |
Non-cash salary compensation | 13 | - | 150 |
Share-based payments | 12 | 686 | 1,538 |
Unrealized foreign exchange gain (loss) | 171 | (2) | |
Change in fair value of financial instruments | - | 423 | |
Government loan forgiveness | - | (518) | |
Other | (28) | ||
Changes in non-cash working capital | 19 | (900) | 212 |
Non-cash change in other long-term liabilities | - | 186 | |
Net cash used in operating activities | (8,394) | (1,924) | |
Cash flows from (used in) financing activities |
| ||
Loan proceeds from related parties | 13 | - | 1,418 |
Convertible loan notes repayments | - | (23) | |
Interest paid | (23) | (7) | |
Draw on line of credit | - | 300 | |
Payment of lease obligations | 9 | (138) | (124) |
Government loans proceeds | 10 | - | 414 |
Net cash from financing activities | (161) | 1,978 | |
Cash flows used in investing activities | |||
Purchase of property and equipment | 7 | (269) | (63) |
Net cash used in investing activities | (269) | (63) | |
Effect of foreign exchange rate change on cash and cash equivalents |
(118) | (42) | |
Net decrease in cash | $ (8,942) | $ (51) | |
Cash, beginning of period | 29,868 | 626 | |
Cash, end of period | $ 20,926 | $ 575 | |
|
| ||
Supplemental cash flow information | 19 |
1. Nature of operations and liquidity risk
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" (Note 13).
In March 2020, the World Health Organization declared a global pandemic related to the coronavirus known as COVID-19. The expected impacts on global commerce are anticipated to be far reaching. To date the movement of people and goods has become restricted. Management is actively monitoring the situation and is taking appropriate steps as needed to ensure minimal disruption to the Company's operations. As a consequence, the Company has experienced delays in its Steriwave U.S. Food and Drug Administration ("FDA") Phase 2 clinical trials.
The Company has a history of incurring significant losses and as at June 30, 2022, had an accumulated deficit of $241,114 (December 31, 2021 - $232,544). Cash and cash equivalents are comprised of cash and cheques issued in excess of funds on deposit. As at June 30, 2022, the Company had a cash and cash equivalents balance of $20,926 (December 31, 2021 - $29,868) and a working capital of $21,402 (December 31, 2021 - $29,582). For the six months ended June 30, 2022, cash used in operations totaled $8,394 (June 30, 2021 - $1,924).
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. Management believes the Company's cash and cash equivalents will provide sufficient liquidity to meet its working capital requirements for at least twelve months from June 30, 2022. The Company will need to raise funds through public or private equity and/or debt financing in 2023 and beyond to advance its operations. Although the Company has been successful in obtaining financing in the past, there can be no assurance that it will be able to obtain such financing in the future, or that such financing will be on terms advantageous to the Company, and it may be dilutive to shareholder interests.
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 ("IFRS") as issued by the International Accounting Standards Board ("IASB') 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, 2021.
The unaudited condensed consolidated interim financial statements were approved and authorized for issue by the Board of Directors on September 26, 2022.
(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, 2021.
3. Significant accounting policies
The accounting policies in these unaudited condensed consolidated interim financial statements are as described under "Significant accounting policies" in the Company's consolidated financial statements for the year ended December 31, 2021.
4. Accounts and other receivables
June 30, 2022 | December 31, 2021 | ||
Trade receivables | $ 95 | $ 158 | |
Other receivables | 98 | 90 | |
$ 193 | $ 248 |
The following table reflects the loss allowance for trade receivables balance:
June 30, 2022 | December 31, 2021 | ||
Gross carrying value |
| $ 959 | $ 1,022 |
Expected credit loss allowance |
| (864) | (864) |
Trade receivables - net |
| $ 95 | $ 158 |
5. Inventory
|
| June 30, 2022 | December 31, 2021 |
Raw materials |
| $ 601 | $ 561 |
Finished goods |
| 599 | 500 |
|
| $ 1,200 | $ 1,061 |
During the six months ended June 30, 2022, raw materials and finished goods included in cost of sales amounted to $90 (June 30, 2021 - $940). During the six months ended June 30, 2022 and 2021, inventory valued at $13 and $2, respectively, was written off and reflected within cost of sales.
6. Prepaids and deposits, and non-current assets
| June 30, 2022 | December 31, 2021 |
Prepaid insurance | $ 243 | $ 391 |
Deposits | 35 | 35 |
Other prepaid costs | 1,397 | 1439 |
| $ 1,675 | $ 1,865 |
Less: Current portion of prepaid expenses and deposits | $ 1,640 | $ 1,830 |
Other non-current assets | $ 35 | $ 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, 2021 | $ 193 | $ 225 | $ 382 | $ 279 | $ 513 | $ 378 | $ 762 | $ 2,732 |
Additions | 21 | - | - | - | 57 | 20 | 178 | 276 |
Disposals | - | - | - | - | - | (20) | (139) | (159) |
Exchange adjustment | - | (1) | - | (1) | 1 | - | (4) | (5) |
Balance, December 31, 2021 | $ 214 | $ 224 | $ 382 | $ 278 | $ 571 | $ 378 | $ 797 | $ 2,844 |
Additions | 81 | 16 | 29 | - | 143 | - | 608 | 877 |
Transfers and other | - | - | 34 | - | - | 63 | - | 97 |
Disposals and derecognition | (38) | - | - | - | - | (21) | (630) | (689) |
Exchange adjustment | 3 | 2 | 5 | 3 | 7 | (9) | 11 | 22 |
Balance, June 30, 2022 | $ 260 | $ 242 | $ 450 | $ 281 | $ 721 | $ 411 | $ 786 | $ 3,151 |
Accumulated depreciation |
|
|
|
|
|
|
|
|
Balance, January 1, 2021 | $ 151 | $ 219 | $ 350 | $ 279 | $ 433 | $ 160 | $ 469 | $ 2,061 |
Additions | 19 | 1 | 10 | - | 22 | 57 | 234 | 343 |
Disposals and derecognition | - | - | - | - | - | (20) | (139) | (159) |
Exchange adjustment | 1 | - | - | (1) | 2 | (4) | - | (2) |
Balance, December 31, 2021 | $ 171 | $ 220 | $ 360 | $ 278 | $ 457 | $ 193 | $ 564 | $ 2,243 |
Additions | 32 | 5 | 10 | - | 23 | 30 | 122 | 222 |
Transfers and other | - | - | 24 | - | - | (8) | - | 16 |
Disposals and derecognition | (38) | - | - | - | - | (6) | (630) | (674) |
Exchange adjustment | 3 | 1 | 4 | 3 | 5 | 2 | 10 | 28 |
Balance, June 30, 2022 | $ 168 | $ 226 | $ 398 | $ 281 | $ 485 | $ 211 | $ 66 | $ 1,835 |
Net book value |
|
|
|
|
|
|
|
|
December 31, 2021 | $ 43 | $ 4 | $ 22 | $ - | $ 114 | $ 185 | $ 233 | $ 601 |
June 30, 2022 | $ 92 | $ 16 | $ 52 | $ - | $ 236 | $ 200 | $ 720 | $ 1,316 |
During the six months ended June 30, 2022, depreciation of $15 (June 30, 2021 - $28) was allocated to cost of sales and $223 to operating expenses (June 30, 2021 - $140).
8. Accounts payable and other liabilities
|
| June 30, 2022 | December 31, 2021 |
Accounts payable |
| $ 598 | $ 1,202 |
Accrued liabilities |
| 714 | 556 |
Employee related payables |
| 912 | 1,424 |
Accrued interest |
| 74 | 95 |
|
| $ 2,298 | $ 3,277 |
9. Lease liability
| June 30, 2022 | December 31, 2021 | |
Current portion | $ 259 | $ 148 | |
Non-current | 461 | 94 | |
Total lease liability |
| $ 720 | $ 242 |
The Company's leases are for office space and a laboratory property. Interest expense on lease obligations for the six months ended June 30, 2022 was $7 (June 30, 2021 - $7). The expense relating to variable lease payments not included in the measurement of lease obligations was $62 (June 30, 2021 - $55). This consists of variable lease payments for operating costs and property taxes. Total cash outflow for leases was $200 (June 30, 2021- $186), including $131 (June 30, 2021- $124) of principal payments on lease obligations.
As at June 30, 2022, the minimum annual payments under these leases, including an estimate of operational costs for its office premises based on current costs, is provided below.
2022 | $ 200 |
2023 | 409 |
Thereafter | 503 |
$ 1,112 |
10. Other long-term liabilities
Other long-term liabilities represent government guaranteed loans received. The balances of the government loans are as follows:
| June 30, 2022 | December 31, 2021 | |
Paycheck Protection Program | a | $ 401 | $ 394 |
Other | 73 | 73 | |
Total other long-term liabilities |
| $ 474 | $ 467 |
(a) Paycheck Protection Program
In 2020 and 2021, Ondine Research Laboratories, Inc. and Ondine Biomedical U.S., Inc., subsidiaries of the Company received an unsecured advance of US$735 ($919) under the Paycheck Protection Program ("PPP"), which is guaranteed by the Small Business Administration ("US SBA"), pursuant to the Coronavirus Aid, Relief and Economic Security Act. The loan bears interest at 1% per annum and is repayable, in blended payments, over a two year term. In 2021, the Company filed a loan forgiveness application for the advance received in 2020, and the Company was granted full loan forgiveness by the US SBA in 2021 of US$424 ($518) and this portion of the loan balance was released to the consolidated statement of comprehensive income. Subject to the satisfaction of certain conditions, the loan may be forgiven if the proceeds are used to fund qualifying expenditures such as payroll and benefits costs, rent, and utilities costs over an elected coverage period. As at June 30, 2022, the loan of US$311 ($401) (December 31, 2021 - US$311 ($394)) was recorded as part of "other long-term liabilities' in the consolidated statement of financial position.
11. Share capital
(a) Common Stock
Authorized
An unlimited number of common shares without par value.
Issued
As at June 30, 2022, the Company's issued share capital comprised of 194,584,524 common shares (December 31, 2021 - 194,584,524).
(b) Preferred Stock
Authorized
An unlimited number of fixed-value, voting, preferred shares, entitled to a non-cumulative dividend of 6% per annum, redeemable and retractable at $1/share.
Issued
As at June 30, 2022, the Company's issued preferred share capital comprised of nil preferred shares (December 31, 2021 - nil).
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, 2022, the maximum number of total options that can be outstanding are 19,458,452 (December 31, 2021- 19,458,452).
A summary of the status of the stock options outstanding is as follows:
June 30, 2022 | June 30, 2021 | |||
Number of options | Weighted average exercise price | Number of options | Weighted average exercise price | |
Outstanding, beginning of period | 6,833,000 | $ 1.73 | 9,203,356 | $ 1.87 |
Options granted | 1,960,000 | 0.93 | - | - |
Options exercised | - | - | - | - |
Options forfeited | (136,750) | 1.75 | (707,500) | 2.64 |
Options canceled | (1,261,250) | 2.59 | (687,500) | 2.70 |
Outstanding, end of period | 7,395,000 | $ 1.37 | 7,808,356 | $ 1.86 |
Exercisable, end of period | 6,000,856 | $ 0.90 | 2,917,106 | $ 2.38 |
Share-based payments expense for the six months ended June 30, 2022, in the amount of $686 (June 30, 2021 - $1,459) was recorded.
The outstanding options for the the six months ended June 30, 2022 is as follows:
Exercise price | Number of options | Remaining life (years) |
$ 0.01 | 200,000 | 4.26 |
$ 0.50 | 140,000 | 1.42 |
$ 0.90 | 4,345,000 | 2.01 |
$ 0.91 | 50,000 | 4.67 |
$ 0.93 | 1,910,000 | 4.60 |
$ 2.70 | 650,000 | 1.42 |
$ 3.00 | 100,000 | 4.05 |
$ 1.06 | 7,395,000 | 2.73 |
The fair value of stock options granted during the six months ended June 30, 2022 were estimated with the Black-Scholes model using the following assumptions at the time of grant:
Dividend yield |
| 0% |
Annualized volatility |
| 70% |
Risk-free interest rate |
| 1.61% - 1.71% |
Expected life of options (years) |
| 5.0 |
Forfeiture rate |
| 16% |
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 six months ended June 30, 2022, was $0.55 per option (June 30, 2021 - $nil). As at June 30, 2022, stock options outstanding had a remaining contractual life of 2.73 years (June 30, 2021 - 2.29 years).
(b) Options issued under separate agreements
On December 15, 2020, the Company granted options entitling the holders to acquire common shares of the Company. A summary of the status of the options outstanding is as follows:
June 30, 2022 | June 30, 2021 | |
Number of options | Number of options | |
Outstanding, beginning of period | - | 13,036,024 |
Options granted | - | 162,225 |
Options expired | - | (13,036,024) |
Outstanding, end of period | - | 162,225 |
Exercisable, end of period | - | - |
The fair value of options granted during the six months ended June 30, 2021 were estimated with the Black-Scholes model with the following assumptions: risk-free weighted-average interest of 0.25%, expected dividend yield of nil, average expected volatility of 70% and expected life term of 6 months.
The expense for the six months ended June 30, 2022 was $nil (June 30, 2021 - $48). The estimation of the assumptions is as described in Note 12(a).
As at June 30, 2022, options outstanding had a remaining contractual life of nil months (June 30, 2021 - 6 months).
(c) Warrants
On May 30, 2020, December 23, 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, 2022 | June 30, 2021 | |||
Number of warrants | Weighted average exercise price | Number of warrants | Weighted average exercise price | |
Outstanding, beginning of period | 2,795,845 | $ 1.42 | 1,350,000 | $ 2.33 |
Warrants granted | - | - | - | - |
Warrants cancelled | - | - | - | - |
Outstanding, end of period | 2,795,845 | $ 1.42 | 1,350,000 | $ 2.33 |
Exercisable, end of period | 2,795,845 | $ 1.42 | 350,000 | $ 2.57 |
The expense for the six months ended June 30, 2022 was $nil (June 30, 2021 - $31). As at June 30, 2022, warrants outstanding had a remaining contractual life of 2.1 years (June 30, 2021 - 2.53 years).
13. Related party transactions
(a) Revenues, product shipments and expenses
For the six months ended June 30, | |||
| 2022 | 2021 | |
Product sales (i) | $ 5 | $ - | |
Consulting fee expense (ii) | $ - | - |
(i) Product sales for the six months ended June 30, 2022 were to a related company. The revenue associated with product shipments was not recognized due to revenue recognition conditions not being met, and the cost of the product shipped to a related company was included in cost of goods sold. The revenue associated with product shipments will be recognized in a subsequent year(s) upon invoice payment. For the six months ended June 30, 2022, there was $8 (June 30, 2021 - $8) of products shipped to a related party company for which revenue was not recognized.
(ii) Expenses incurred for consulting services provided by companies under the control of an officer and a related party to an officer of the Company.
(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, | |||
|
| 2022 | 2021 |
Compensation and other short-term benefits |
| $ 896 | $ 258 |
Directors' fees |
| 308 | 77 |
Share-based payments |
| 164 | 545 |
| $ 1,368 | $ 880 |
The CEO and controlling shareholder of the Company provided her services to the Company without salary compensation, thereby waiving her right to receive a monthly salary as set out in her employment contract for the six months ended June 30, 2021. In the same period, a notional expense of $150 has been recorded to 'contributed surplus' in the consolidated statements of loss and comprehensive loss and charged to reserves in the consolidated statements of changes in equity. Subsequent to June 30, 2021, the CEO and controlling shareholder of the Company had her salary compensation reinstated per the employment contract. As at June 30, 2022, the cumulative notional expense is $10,528 (June 30, 2021 - $10,528).
(c) Related party balances
|
| June 30, 2022 | December 31, 2021 |
Included in accounts payable and other liabilities |
| $ 344 | $ 1,015 |
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. No amount payable was in respect of services provided. The $344 in accounts payable and other liabilities consist of bonus payable to the CEO and the current portion of loans payable to related parties.
14. Commitments and contingencies
Open purchase order commitments as at June 30, 2022 were $1,868 (December 31, 2021 - $1,508) for the purchase of inventory and contracted development and clinical services.
The Company has the following contingencies at June 30, 2022:
(i) The Company's Barbadian subsidiary holds intellectual property in Barbados. 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. Any of the foregoing could have a material impact on the financial position and operating results of the Company.
(ii) The Company and certain of its affiliates have also been named as defendants in certain legal actions in the normal course of business, none of which management believes singularly or cumulatively, will have a material impact on the results of operations and financial position of the Company.
15. Segmented information
Management has determined that the Company has one reportable operating segment, aPDT products. This segment accounts for all of the Company's revenue, cost of sales and operating expenses. Determination of the operating segment was based on the level of financial reporting to the Company's chief operating decision makers. Revenues are attributed to the geographic area where the customer is located.
For the six months ended June 30, | |||
|
| 2022 | 2021 |
Product revenue |
| ||
Canada |
| $ 262 | $ 1,965 |
Other |
| - | 10 |
| $ 262 | $ 1,975 |
Revenue from significant customers are as follows:
For the six months ended June 30, | |||
|
| 2022 | 2021 |
Customer 1 |
| $ - | $ 1,101 |
Customer 2 |
| - | 482 |
Customer 3 |
| 204 | 202 |
Customer 4 |
| 33 | - |
Other |
| 25 | 190 |
| $ 262 | $ 1,975 |
A summary of non-current assets (excluding other assets) by geographical area based on the location of the asset is as follows:
| June 30, 2022 | December 31, 2021 | |
Canada |
| $ 343 | $ 353 |
United States |
| 973 | 248 |
| $ 1,316 | $ 601 |
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, 2022, the carrying values of cash, cheques issued in excess of funds in deposit, accounts and other receivables, bank indebtedness, and accounts payable and other liabilities approximate their fair values because of their nature, relatively short maturity dates.
(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, receivables and amounts due from related parties 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. The Company has evaluated accounts receivable and determined an expected credit loss allowance of $864 for the six months ended June 30, 2022 (December 31, 2021 - $864). During the period ended June 30, 2022, the Company recorded a bad debt expense of $nil (June 30, 2021- $nil).
Foreign currency risk
The results of the Company's operations are subject to currency transaction and translation risks. The fair value of future cash flows of a financial instrument will fluctuate because of changes in foreign exchange rates. The Company operates in Canada, the United States and the United Kingdom and is exposed to foreign exchange risk due to fluctuations in the US$ and GBP 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, 2022, including cash, accounts receivables, accounts payable and other liabilities denominated in US$ and GBP, would result in an increase or decrease of approximately $2,066 (June 30, 2021- $43) in the unaudited condensed consolidated interim statements of loss and comprehensive loss for the six months ended June 30, 2022.
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 was not exposed to fluctuations in interest rates during the years presented as the interest rate on the Company's convertible loan notes and preferred shares is fixed. 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 ensures 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, including advance payments from customers, related party loans, debt and equity issuances. The Company projects and monitors its cash requirements to accommodate changes in liquidity needs.
In addition to the commitments in Note 9 and Note 14, the Company has the following contractual financial liabilities as at June 30, 2022:
| Carrying amount | Contractual cash flows | Less than one year | More than one year |
Financial liabilities |
| |||
Accounts payable and other liabilities | $ 2,298 | $ 2,298 | $ 2,298 | $ - |
Other long-term liabilities | 474 | 474 | - | 474 |
| $ 2,772 | $ 2,772 | $ 2,298 | $ 474 |
17. Cost of sales
For the six months ended June 30, | |||
|
| 2022 | 2021 |
Inventory - Note 5 |
| $ 90 | $ 940 |
Inventory write-off - Note 5 |
| 13 | 2 |
Depreciation - Note 7 |
| 15 | 28 |
| $ 118 | $ 970 |
18. Expenses by nature
General and administration, research and development, and marketing and sales expenses are comprised of the following expenses by nature:
For the six months ended June 30, | |||
|
| 2022 | 2021 |
Salaries and benefits |
| $ 3,958 | $ 2,060 |
Professional fees, contractors and consultants |
| 1,646 | 788 |
Clinical trial costs |
| 766 | 16 |
Office and lab costs |
| 724 | 584 |
Share based payment |
| 686 | 1,538 |
Depreciation and amortization |
| 223 | 315 |
Technology costs |
| 193 | 128 |
Travel and entertainment |
| 160 | 54 |
Advertising and promotion |
| 125 | 6 |
Delivery and logistics |
| 69 | 83 |
|
| $ 8,550 | $ 5,572 |
19. Supplementary cash flow information
For the six months ended June 30, | |||
|
| 2022 | 2021 |
Changes in non-cash working capital items |
| ||
Accounts and other receivables |
| $ 55 | $ 431 |
Inventory |
| (170) | (627) |
Prepaid expenses and deposits |
| 193 | (49) |
Accounts payable and other liabilities |
| (978) | 457 |
| $ (900) | $ 212 |
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 55.7% of the issued common shares of the Company as at June 30, 2022 (June 30, 2021 - 72.6%).
21. Subsequent events
Subsequent to June 30, 2022, the following transactions have occurred:
1. On July 25, 2022, pursuant to a share for share exchange arrangement, the Company acquired 25,000 common shares in Sinuwave Technologies Corporation ("Sinuwave") in return for 8,333 new common shares of the Company ("Consideration Shares"), resulting in an increase of the Company's ownership in Sinuwave from 99.96% to 100%, and an increase in the Company's issued share capital from 194,584,524 common shares to 194,592,857 common shares.
2. On August 16, 2022, the Company has appointed RBC Capital Markets and Singer Capital Markets as the Company's joint broker, and Arden Partners Plc is no longer the Company's broker. The Company has a prepaid balance of $1,201 with Arden Partners plc as at June 30, 2022.
For more information, please visit: www.ondinebio.com or contact:
Ondine Biomedical Inc. |
|
Angelika Vance, Corporate Communications | +001 (1) 604 838 2702 |
|
|
Strand Hanson Limited (Nominated and Financial Adviser) |
|
James Harris, James Dance, Richard Johnson | +44 (0) 20 7409 3494 |
|
|
RBC Capital Markets |
|
Rupert Walford, Kathryn Deegan | +44 (0) 20 7653 4000 |
|
|
Singer Capital Markets |
|
Aubrey Powell, Asha Chotai | +44 (0) 20 7496 3000 |
Vane Percy & Roberts (Media Contact) | |
Simon Vane Percy, Amanda Bernard | +44 (0) 77 1000 5910 |
About Ondine Biomedical Inc.
Ondine Biomedical Inc. is a Canadian headquartered company innovating in the field of photodisinfection therapies. Ondine has a pipeline of investigational products, based on its proprietary photodisinfection platform, in various stages of development. Products include therapies for a variety of medical indications such as nasal disinfection, sinusitis, ventilator-associated pneumonia, burns, and other indications. Ondine's nasal photodisinfection technology is approved in several jurisdictions under the brand name Steriwave™. It has been awarded the CE mark and, in the US, has been granted Qualified Infectious Disease Product designation and Fast Track status in the UD by the FDA.
About Nasal Photodisinfection
Ondine's nasal photodisinfection is a patented technology using a proprietary methylene blue based formulation. The photodisinfection treatment is carried out by a trained healthcare professional, and is an easy to use, painless, two-step process. The light-activated formulation is applied to each nostril using a nasal swab, and then the nostrils are illuminated with a specific wavelength of light using a disposable light radiator for less than five minutes. The light excites the formulation causing an oxidative burst which rapidly destroys all types of pathogens without harming human tissue. A key benefit of this technology is that pathogens do not develop resistance to the treatment.
Ondine's nasal photodisinfection has a CE mark and is approved in Canada and several other countries under the name Steriwave™. It has been used in Canada for over ten years, with no serious adverse events reported. In the US, it is currently undergoing clinical trials for regulatory approval.
[i] https://doi.org/10.1073/pnas.220837811
Related Shares:
Ondine Biomed