Quarterly Report • Sep 27, 2022
Quarterly Report
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2022 Half Year Report
ONWARD Half Year Report 3

In this Half Year Report 'ONWARD', 'the Company', 'the Group', 'we', 'us' and 'our' are sometimes used for convenience in contexts where reference is made to ONWARD Medical N.V. and/or any of its subsidiaries in general or where no useful purpose is served by identifying the particular company.

Board's Statements 56 Overview of Risks 58 Forward-Looking Information / Statements 60 Definitions & Abbreviations 62

Dear Shareholders, Colleagues, Partners, and Collaborators,
It is a privilege to lead this company, working to make a difference in the lives of the nearly 7 million people worldwide with spinal cord injury (SCI). In the first half of 2022, we continued to execute against our strategy – advancing development of our technology, enlarging our IP portfolio, validating our therapies through clinical milestones, and strengthening our organizational capabilities.
I would like to highlight two key achievements from the first half of this year:
In the second half of 2022, more important milestones are en route:
By year-end, we expect to therefore have demonstrated clinical validation for both of our major technology platforms.
In addition to the above milestones, we will continue to drive clinical trial enrollment, add operational capabilities, advance our technology, and recruit outstanding people to our determined and committed team.
Thank you for your continued support as we work passionately to help the SCI community.
Warm regards,

In the first half of 2022, we continued to execute on our strategy to research, develop and commercialize novel therapies that help people with SCI enjoy life in every way that matters to them. Our key operational highlights for the first half of 2022 include the following:
Our research partners at EPFL and Lausanne University Hospital (CHUV) made dramatic new discoveries that have the promise to help people with SCI and other movement disabilities such as Parkinson's disease.
The Company added 24 patents to its IP portfolio, now totaling over 330 issued and pending patents. We also obtained option rights to license intellectual
property from EPFL and CHUV that will allow the Company to develop and commercialize a novel Brain-Spine Interface (BSI), which captures brain signals recorded by a brain implant to trigger spinal cord stimulation, restoring voluntary control over paralyzed limbs; and develop and commercialize therapies to alleviate gait disorders (freezing of gait, etc.) in people with Parkinson's disease by stimulating the spinal cord.
We are pursuing de novo clearance from FDA and CE mark for ARCEX, with the intent to commercialize the therapy for the restoration of upper limb function in 2023. The first half of 2022 marked two key milestones on our ARCEX roadmap:
We also made important progress with our implantable ARCIM platform. Its initial target indication is restoration of blood pressure and trunk control in people with SCI, many of whom struggle with problematic low blood pressure called orthostatic hypotension (OH):
• In May, the Company's ARCIM implantable pulse generator (IPG) was used in a human for the first time. The ARCIM IPG is a purpose-built IPG that delivers targeted electrical

stimulation to the spinal cord in the precise areas responsible for triggering or controlling movement and autonomic functions that may be affected by a spinal cord injury or neurodegenerative disorder.
• In May, the first patient was enrolled in the HemON feasibility study, a precursor to our upcoming pivotal trial for blood pressure and trunk control.
We continued to enhance our organizational capabilities and augment our leadership team in preparation for commercialization of our initial therapy, expected in 2023. The Company also enhanced our visibility in the financial markets:

| EUR' Million | 2022 | 2021 |
|---|---|---|
| For the six-month period ended, 30 June | Unaudited | Unaudited |
| Total Revenues & Other Incomes | 1,0 | 0,6 |
| Research & Development Expenses | (6,2) | (3,3) |
| Clinical & Regulatory Expenses | (3,0) | (1,9) |
| Marketing & Market Access Expenses | (0,9) | (0,4) |
| Patent Fees & Related Expenses | (0,7) | (0,8) |
| Quality Assurance Expenses | (0,5) | (0,3) |
| General & Administrative Expenses | (4,8) | (3,2) |
| Total Operating Expenses | (16,1) | (9,8) |
| Operating Loss for the Period | (15,1) | (9,3) |
| Net Finance Expenses | (0,9) | (2,9) |
| Income Tax Expense | (0,0) | (0,0) |
| Net loss for the Period | (16,0) | (12,2) |
| At | 30 June 2022* | 31 December 2021 |
| Cash positions at end of period | 76,8 | 89,4 |
| Interest-bearing loans | (12,0) | (11,5) |
| Equity | 68,9 | 82,7 |
Other Income during the first six months of 2022 increased to EUR 1,0 million (H1 2021: EUR 0,6 million), following a new grant from the European Innovation Council and SMEs Executive Agency (EISMEA) focusing on brain-spine interfaces to reverse upper and lowerlimb paralysis.
Total Operating Expenses increased during H1 2022 by EUR 6,3 million to EUR 16,1 million. The increase in operating expenses included EUR 2,9 million of additional Research & Development expenses, driven by increased staff and outsourced development expenses associated with the Company's ARC Therapies. It also included clinical expenses of EUR 3,0 million, an increase of EUR 1,1 million compared to the same period in the prior year, as a result of the Up-LIFT and LIFT Home studies. Lastly, General & Administrative Expenses showed an increase of EUR 1,6 million compared to the same period in the prior year due to the costs associated with being a public company following the Euronext listing in October 2021.
Net Finance Expense decreased during the first six months of 2022 by EUR 2 million compared to H1 2021. The costs in H1 2021 included interest on the Company's innovation loan from RVO NL (Dutch government), the convertible loan (CLA), and the accrued dividend for the preference A shares. Both the CLA and preference A shares converted in October 2021. The expense for the first half of 2022 relates to the innovation loan from RVO NL and bank interest paid on the positive cash balance.
*30 June 2022 values are unaudited


The Company ended the six-month period with a positive cash balance of EUR 76,8 million on 30 June 2022 (30 December 2021: EUR 89,4 million). The decrease in cash of EUR 12,6 million compared to 31 December 2021 is due to cash outflows mainly for operating activities.
Interest-bearing Loans increased from 31 December 2021 by EUR 0,5 million to EUR 12 million, due to the interest that accumulated on the innovation loan from RVO NL (Dutch government).
The Company's positive Equity position of EUR 82,7 million at year-end 2021 decreased to EUR 68,9 million on 30 June, 2022. The decrease related to the operating loss for the period of EUR 16 million and is mitigated by positive reserve items related to the sharebased payment expense of EUR 0,8 million, the revaluation of defined benefit obligation through comprehensive income of EUR 0,7 million, and the foreign currency translation impact of US operations of EUR 0,6 million.

We expect to continue the steady and consistent execution of our strategy in the second half of 2022.
This month, we released positive top-line data from our first pivotal study, UP-LIFT, which demonstrated the effectiveness of our transcutaneous ARCEX Therapy to restore strength and function in the hands and arms of people with spinal cord injury. Late this year or in early 2023, we plan to file a regulatory submission for de novo clearance, allowing the Company to commercialize ARCEX for this indication in the US. We also plan to pursue a CE mark authorizing the Company to commercialize ARCEX Therapy in Europe. These authorizations are expected in the second half of 2023.
We expect top-line data from our LIFT Home study in the second half of 2022. The Company plans to discuss findings from LIFT Home with regulatory authorities to determine the requirements to gain clearance to market ARCEX for home use, including the design and scope of a pivotal study for the home setting should this be necessary.
Also in the second half of 2022, we expect to release combined top-line data from the STIMO-HEMO and HemON studies. Both studies are exploring the use of ARCIM Therapy to normalize low blood pressure and provide enhanced trunk control in people with SCI, which is the first planned indication for ARCIM. By year-end, we expect to therefore have demonstrated clinical validation for both of our major technology platforms.
We expect to continue building our team and capabilities in preparation for launch of its ARCEX Therapy in the second half of 2023, both operationally and commercially. In late 2022 or early 2023, we plan to place even greater focus on recruiting for sales, marketing, and field service roles to cover the US and select European markets. We will also continue to strengthen our Board of Directors. Already in September, we announced the addition of Vivian Riefberg to our Board. In 2020, Ms. Riefberg retired as a senior partner with McKinsey & Company, where she held a variety of senior positions, including leader of the Public Sector Practice for the Americas and co-leader of the U.S. Healthcare practice. She served on McKinsey & Company's global board of directors and on the committee evaluating and developing global partners. Ms. Riefberg is currently Professor of Practice at the University of Virginia Darden School of Business where she holds the David C. Walentas Jefferson Scholars Chair.
With a strong balance sheet, we expect our current cash to propel operations through the end of 2024 and support investments in product development, clinical trials, operational capabilities, and commercial launch. We will continue to consider opportunities to further strengthen our cash position as equity capital markets improve in the US and across the globe.


| For the six-month period ended, 30 June | |||||
|---|---|---|---|---|---|
| All amounts in EUR '000 Notes |
2022 | 2021 | |||
| Unaudited | Unaudited | ||||
| Grants & Other Income | 963 | 586 | |||
| Total Revenues & Other Income | 963 | 586 | |||
| Research & Development Expenses | (6,215) | (3,849) | |||
| Clinical & Regulatory Expenses | (3,034) | (1,944) | |||
| Marketing & Market Access Expenses | (867) | (353) | |||
| Patent Fees & Related Expenses | (689) | (786) | |||
| Quality Assurance Expenses | (466) | (322) | |||
| General & Administrative Expenses | (4,796) | (3,156) | |||
| Total Operating Expenses | (16,068) | (10,410) | |||
| Operating Loss for the Period | (15,105) | (9,824) | |||
| Financial Expense | (855) | (2,931) | |||
| Net Finance Cost | (855) | (2,931) |
| 1 2 3 4 6 7 8 9 10 5 Condensed Consolidated Interim Financial Statements |
|
|---|---|
| -------------------------------------------------------------------------------------------------------- | -- |

| Loss for the Period Before Taxes | (15,960) | (12,755) | |
|---|---|---|---|
| Income tax expense | 13 | (35) | (16) |
| Net Loss for the Period | (15,995) | (12,771) | |
| Attributable to: | |||
| Equity holders of the parent | (15,995) | (12,771) | |
| (15,995) | (12,771) | ||
| Earnings Per Share (€): | 10 | ||
| Basic earnings per ordinary share attributable to shareholders | (0.53) | (3.14) | |
| Diluted earnings per ordinary share attributable to shareholders | (0.53) | (3.14) |
| 1 2 |
3 | 4 5 |
6 | 7 | 8 | 9 | 10 | Condensed Consolidated Interim Statement of Profit & Loss |
|---|---|---|---|---|---|---|---|---|
| -------- | --- | -------- | --- | --- | --- | --- | ---- | ----------------------------------------------------------- |

| For the six-month period ended, 30 June | |||||
|---|---|---|---|---|---|
| All amounts in EUR '000 | Notes | 2022 Unaudited |
2021 Unaudited |
||
| Net Loss for the Period Other comprehensive income that will not be reclassified to profit or loss in subsequent periods |
(15,995) – |
(12,771) – |
|||
| Other comprehensive income Currency translation differences |
801 587 |
– (61) |
|||
| Other comprehensive income that will be reclassified to profit or loss in subsequent periods |
1,388 | (61) | |||
| Total Comprehensive Result for the Year, Net of Tax |
(14,607) | (12,832) | |||
| Attributable to: Equity holders of the parent |
(14,607) | (12,832) | |||
| (14,607) | (12,832) |
| All amounts in EUR '000 | Notes | 30 June 2022 Unaudited |
31 December 2021 Audited |
|---|---|---|---|
| Assets | |||
| Non-Current Assets | |||
| Intangible fixed assets | 7 | 10,284 | 10,029 |
| Property, plant and equipment | 272 | 190 | |
| Right of use assets | 1,916 | 2,190 | |
| 12,472 | 12,409 | ||
| Current Assets | |||
| Indirect tax receivables | 369 | 339 | |
| Receivable from related parties | 15 | 258 | 60 |
| Other current assets | 2,512 | 2,546 | |
| Cash and cash equivalents | 76,841 | 89,443 | |
| 79,980 | 92,387 | ||
| 92,452 | 104,796 |



The above balance sheet should be read in conjunction with the accompanying notes.
| Equity & Liabilities | |||
|---|---|---|---|
| Equity & Reserves | |||
| Issued capital | 9 | 3,622 | 3,622 |
| Share premium | 9 | 155,248 | 155,248 |
| Other reserves | 9, 11 | 1,152 | (214) |
| Retained earnings | (91,168) | (75,974) | |
| Total Equity Attributable to Shareholders | 68,854 | 82,683 | |
| Non-Current Liabilities | |||
| Interest-bearing loans | 8 | 12,038 | 11,451 |
| Deferred tax liability | 13 | 1,548 | 1,991 |
| Other financial liabilities | – | – | |
| Lease liability | 1,521 | 1,741 | |
| Post-employment benefits | 12 | 747 | 1,388 |
| 15,854 | 16,572 | ||
| Current Liabilities | |||
| Income tax liabilities | 68 | 83 | |
| Lease liability | 421 | 473 | |
| Trade payables | 14 | 2,624 | 952 |
| Other payables | 14 | 4,631 | 4,034 |
| 7,744 | 5,542 | ||
| 92,452 | 104,796 |
| 1 2 3 4 6 7 8 9 10 5 |
Condensed Consolidated Interim Statement of Financial Position |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------- |
For the six-month period ended, June 30
| All amounts in EUR '000 | Notes | Issued Capital | Share Premium | Other Reserves | Retained Earnings | Total Equity |
|---|---|---|---|---|---|---|
| At 1 January 2022 | 3,622 | 155,248 | (214) | (75,976) | 82,683 | |
| Loss for the period | – | – | – | (15,995) | (15,995) | |
| Other comprehensive income | – | – | 587 | 801 | 1,388 | |
| Total comprehensive result | – | – | 587 | (15,194) | (14,607) | |
| Share based payments | – | – | 779 | – | 779 | |
| At June 30, 2022 (Unaudited) | 9 | 3,622 | 155,248 | 1,152 | (91,168) | 68,854 |
For the six-month period ended, June 30

| All amounts in EUR '000 | Notes | Issued Capital* | Share Premium | Other Reserves | Retained Earnings | Total Equity |
|---|---|---|---|---|---|---|
| At 1 January 2021 | – | 3,083 | 17,933 | (53,111) | (32,095) | |
| Loss for the period | – | – | – | (12,771) | (12,771) | |
| Other comprehensive income | – | – | (61) | – | (61) | |
| Total comprehensive result | – | – | (61) | (12,771) | (12,832) | |
| Share based payments | – | – | 2,007 | – | 2,007 | |
| At June 30, 2021 (Unaudited) | 9 | – | 3,083 | 19,879 | (65,882) | (42,920) |
*) share capital amounts to EUR 39.92 at 30 June 2021
| For the six-month period ended 30 June | |||
|---|---|---|---|
| All amounts in EUR '000 | Notes | 2022 Unaudited |
2021 Unaudited |
| Loss for the Period Before Taxes | (15,960) | (12,755) | |
| Adjusted for: | |||
| • Depreciation and impairment of property, plant and equipment and right-of-use assets |
343 | 124 | |
| • Share based payment transaction expense |
779 | 2,007 | |
| • Post-employment benefits |
98 | 169 | |
| • Net finance costs |
844 | 2,931 | |
| • Net foreign exchange differences |
(11) | – | |
| • Other non-cash items |
103 | (14) | |
| Changes in working capital: | |||
| (Increase) / Decrease in Trade and other receivables | (545) | (112) | |
| Increase / (Decrease) in Trade and other payables | 2,493 | (230) | |
| Interest paid | (246) | (23) | |
| Income tax paid | (35) | – | |
| Bank Charges paid | (12) | (6) | |
| Net cash generated /(used) from operating activities | (12,147) | (7,449) |

| 1 2 3 4 6 7 8 9 10 5 |
Condensed Consolidated Interim Financial Statements |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------- |

| (154) | (45) |
|---|---|
| (12) | – |
| (166) | (45) |
| – | 27,106 |
| (315) | (68) |
| (315) | 27,038 |
| 6,382 | |
| (32) | |
| (12,629) | 19,544 |
| 76,841 | 25,894 |
| 89,443 26 |

ONWARD Medical B.V. was a Dutch private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid), incorporated on 20 November 2015. On 21 October 2021 (the First Trading Date) the Company completed a corporate conversion, converting into a public limited company under Dutch law (naamloze vennootschap). The legal name changed to Onward Medical N.V. ("ONWARD").
The registered office is located at High Tech Campus 32, Eindhoven, the Netherlands. ONWARD Medical N.V. is registered in the Commercial Register of the Chamber of Commerce under number 64598748.
ONWARD and its subsidiaries (the "Group") are developing both an Implantable Neurostimulation System (INS) and a non-invasive system for electrical stimulation of specific areas of the spinal cord.
These Condensed Consolidated Interim Financial Statements are comprised of ONWARD and its two wholly owned subsidiaries: ONWARD Medical SA (incorporated in Switzerland) and ONWARD Medical Inc. (incorporated in the United Stated of America).
The interim financial statements of ONWARD Medical N.V. and its subsidiaries for the six months ended 30 June 2022 have not been audited or reviewed. The interim consolidated financial statements were authorized for publication in a Board meeting on 26 September 2022.
The Company's Condensed Consolidated Interim Financial Statements ("Interim financial statements" or "Interim Report") for the six month period ended 30 June 2022 have been prepared in accordance with International Accounting Standard 34 – Interim Financial Reporting as endorsed by the European Union ("IFRS") and should be read in conjunction with the Company's last annual consolidated financial statements as at and for the year ended 31 December 2021.
The significant accounting policies used in the preparation of the Interim Financial Statements are consistent with those followed in the preparation of the Company's annual consolidated financial statements as of and for the year ended 31 December 2021.
The Interim Financial Statements are presented in thousands of euros and all values are rounded to the nearest thousand (€000), except when otherwise indicated, and for the number of shares and the per share amount. Due to rounding, amounts may not add up to totals provided.
The preparation of the Interim Financial Statements requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in the process of applying the Company's accounting policies. The areas involving a higher degree of judgment or complexity, are areas where assumptions and estimates are significant to the Consolidated Financial Statements. The critical accounting estimates used in the preparation of the interim condensed consolidated financial statements are consistent with those followed in the preparation of the Company's annual consolidated financial statements as of and for the year ended 31 December 2021.
As at 30 June 2022 the Company had cash and cash equivalents of EUR 77 million. Based on cash flow forecasts for the years 2022 and 2023, which include significant expenses and cash outflows in relation to the ongoing clinical trials and the continuation of research and development projects, the Company believes that this cash position will be sufficient to meet the Company's capital requirements and fund its operations for at least 12 months as from the date of this Interim Report.
Inherent uncertainties in these forecasts may have an impact on the Company's cash position. To continue development and reach commercialization as planned, the Company may need to attract additional funding in future. Please note that the Company's long-term success is contingent on achieving FDA clearance or approval and CE mark of its products.
In view of the above, and notwithstanding a loss brought forward of EUR 91,2 million as of 30 June 2022 the application of the valuation rules in the assumption of a going concern is justified. As a result, the Interim Financial Statements have been prepared on a going concern basis.
The accounting policies adopted in the preparation of the interim condensed consolidated financial statements are consistent with those followed in the preparation of the Group's annual consolidated financial statements for the year ended 31 December 2021, except for the adoption of new standards effective as of 1 January 2022. The Group has not early adopted any standard, interpretation or amendment that has been issued but is not yet effective.
Several amendments apply for the first time in 2022, but do not have an impact on the interim financial statements of the Group.
The Group has reassessed the presentation of line items in the Condensed Consolidated Interim Statement of Profit and Loss and decided to:
5.1. Present the costs of Quality Assurance expenses as a separate line item as opposed to a component of General & Administrative expenses. This presentation aligns with the internal budgeting and monitoring process. Quality Assurance is a key function towards obtaining regulatory approval for commercialization. This presentation is also in line with companies within the industry and will therefore enhance comparability. This change in presentation is consistent with the presentation in the 2021 Annual Report.
| Reported: 2021 |
Restated: 2021 |
Change |
|---|---|---|
| – | 322 | 322 |
| 3,478 | 3,156 | (322) |

Quality assurance expenses General and administrative expenses
5.2. Present the Science expenses as a component of Research & Development expenses as opposed to a separate cost category on the face of the Statement of Profit and Loss. Science expenses consist primarily of the costs of sponsored research activities that are undertaken by universities with which it collaborates. Since its inception, ONWARD has had a close working relationship with two of the founders, Grégoire Courtine, Professor at EPFL and Jocelyne Bloch, Neurosurgeon at CHUV, Professor at Université de Lausanne. The activities between the Company and EPFL are formalized in research agreements which govern the activities sponsored by the Company. In addition to these scientific research expenses also the consultancy expenses and related shared-based payment expenses for Grégoire Courtine and Jocelyne Bloch are included. Science expenses therefore directly relates to and supports our ongoing Research & Development efforts. This presentation is also in line with companies within the industry and will therefore enhance comparability.
Based on the organizational structure, as well as the nature of financial information available and reviewed by the Company's chief operating decision makers to assess performance and make decisions about resource allocations, the Company has concluded that its total operations represent one reportable segment.
| Reported: 2021 |
Restated: 2021 |
Change | |
|---|---|---|---|
| Science expenses | 569 | – | (569) |
| Research & Development expenses | 3,280 | 3,849 | 569 |
| 30 June 2022 Unaudited |
31 December 2021 Audited |
|
|---|---|---|
| Goodwill | 1,852 | 1,702 |
| In-Process R&D | 6,013 | 6,109 |
| License fees | 2,419 | 2,218 |
| Closing net book value | 10,284 | 10,029 |
| 30 June 2022 Unaudited |
|
|---|---|
| Cost | 1,702 |
| Accumulated amortization | – |
| Opening net book value | 1,702 |
| Foreign currency translation adjustment | 150 |
| Net change | 150 |
| Cost | 1,852 |
| Accumulated amortization | – |

| Cost |
|---|
| Accumulated amortization |
| Foreign currency translation adjustment Net change |
| Cost Accumulated amortization |
Closing net book value 1,852

| 30 June 2022 Unaudited |
|
|---|---|
| Cost | 6,261 |
| Accumulated changes | (152) |
| Opening net book value | 6,109 |
| Reclassification (refer to Note 13) | (570) |
| Foreign currency translation adjustment | 474 |
| Net change | (96) |
| Cost | 6,165 |
| Accumulated changes | (152) |
| Closing net book value | 6,013 |
| 30 June 2022 Unaudited |
|
|---|---|
| Cost | 2,218 |
| Accumulated changes | - |
| Opening net book value | 2,218 |
| Foreign currency translation adjustment | 189 |
| Additions | 12 |
| Net change | 201 |
| Cost | 2,419 |
| Accumulated changes | – |
| Closing net book value | 2,419 |
In accordance with accounting standards, intangible assets are tested annually for impairment during the development period prior to commencement of amortization. The Company has reviewed whether changes in market conditions require an update to the impairment assessment performed in December 2021 and concluded that no update is required.
| 1 | 2 3 |
4 | 5 | 6 | 7 | 8 | 9 | 10 | Notes to the Condensed Consolidated Interim Financial Statements | |
|---|---|---|---|---|---|---|---|---|---|---|
| -- | --- | -------- | --- | --- | --- | --- | --- | --- | ---- | ------------------------------------------------------------------ |
On 5 February 2016, the Group was granted a loan from RVO NL (Dutch Government) of € 10 million payable according to a set repayment scheme.
The loan carries interest at 10%.
The current repayment plan for the loan is as presented below:
Certain assets, including Intellectual Property and In-process R&D, have been pledged to RVO NL in case of default of repayment of the loan. These patents have not been capitalized as of 30 June 2022.
| Date | % of Loan amount |
|---|---|
| 1 January 2026 | 15.0 |
| 1 April 2026 | 15.0 |
| 1 July 2026 | 17.5 |
| 1 October 2026 | 17.5 |
| 1 January 2027 | 17.5 |
| 1 April 2027 | 17.5 |
| 1 July 2027 | All due interest |
The Group's financial risk management objectives and policies are consistent with those disclosed in the Consolidated Financial Statements for the year ended 31 December 2021.
The valuation techniques and inputs used to develop measurements for financial liabilities are consistent with those disclosed in the Consolidated Financial Statements for the year ended 31 December 2021.
The carrying amounts and fair values of the Group's financial instruments are as follows, including its fair value hierarchy:
| Balance at 30 June 2022 | Carrying Amount | Fair Value |
|---|---|---|
| Financial liabilities Innovation credit loan (Level 2) |
12,038 | 13,712 |
| Total financial liabilities | 12,038 | 13,712 |
| Balance at 31 December 2021 | Carrying Amount | Fair Value |
| Financial liabilities Innovation credit loan (Level 2) |
11,451 | 13,218 |
| Total financial liabilities | 11,451 | 13,218 |

| 30 June 2022 | |
|---|---|
| Unaudited | |
| Loan opening balance | 11,451 |
| Loan amount received | – |
| Interest accrued during the period | 587 |
| Closing net book value | 12,038 |
There were no changes in the Group's valuation processes, valuation techniques, and types of inputs used in the fair value measurements during the period.
Management has assessed that the fair values of cash and cash equivalents, accounts payable, taxes and social securities and other payables approximate to their carrying amounts largely due to the short-term maturities of these instruments.
During the period, there were no transfers of fair value measurements between Level 1 and Level 2 and no transfers into or out of Level 3 for both financial assets and financial liabilities.
The following table details the remaining undiscounted contractual maturity for the Company's financial liabilities with agreed repayment periods, including both interest and principal cash flows:
| Less than 1 Year |
1-3 Years |
3-5 Years |
More than 5 Years |
Total | |
|---|---|---|---|---|---|
| Innovation loan | – | – | 8,452 | 10,846 | 19,298 |
| Lease liability | 421 | 1,521 | – | – | 1,942 |
| Trade & other payables | 7,255 | – | – | – | 7,255 |
| Total (Unaudited) | 7,676 | 1,521 | 8,452 | 10,846 | 28,495 |
| Less than 1 Year |
1-3 Years |
3-5 Years |
More than 5 Years |
Total | |
|---|---|---|---|---|---|
| Innovation loan | – | – | 6,500 | 12,798 | 19,298 |
| Lease liability | 473 | 1,741 | – | – | 2,214 |
| Trade & other payables | 4,459 | – | – | – | 4,459 |
| Total | 4,932 | 1,741 | 6,500 | 12,798 | 25,971 |
The authorized share capital ("maatschappelijk kapitaal") amounts to EUR 12,225 divided into 50,937,500 Ordinary Shares and 50,937,500 Preferred Shares with a nominal value of EUR 0.12 each. At 30 June 2022, 30,184,388 Ordinary Shares were issued (31 December 2021: 30,184,388 shares). All of the issued Ordinary Shares are fully paid-up and represent capital in the Company. No Shareholders have any voting rights different from any other Shareholder.
For further information on the evolution of Share Capital and Share Premium due to the Corporate Conversion and Initial Public Offering in October 2021, reference is made to note 4.0 of our 2021 Annual Report.
| Opening balance 1 January |
|---|
| Issuance of shares, net of closing |
| costs – in cash |
| Issuance of shares, net of closing |
| costs – in kind (business combinations) |
| 30 June 2022 Unaudited |
30 June 2021 Unaudited |
|
|---|---|---|
| Opening balance 1 January | 155,248 | 3,083 |
| Issuance of shares, net of closing | – | – |
| costs – in cash | ||
| Issuance of shares, net of closing | – | – |
| costs – in kind (business combinations) | ||
| Closing balance 30 June | 155,248 | 3,083 |

| 1 2 3 4 5 7 8 9 10 6 |
|---|
| ------------------------------------------------- |
| Currency Translation Differences |
Share-based Payments |
Convertible Preference Shares |
Total | |
|---|---|---|---|---|
| Balance at 1 January 2021 | (532) | 3,671 | (178) | 2,961 |
| Share based payment expense | – | 2,007 | – | 2,007 |
| for the period | ||||
| Currency translation differences | (61) | – | – | (61) |
| Balance at 30 June 2021 (Unaudited) | (593) | 5,678 | (178) | 4,907 |
| Balance at 1 January 2022 | (283) | 69 | – | (214) |
| Share based payment expense | – | 779 | – | 779 |
| for the period | ||||
| Currency translation differences | 587 | – | – | 587 |
| Balance at 30 June 2022 (Unaudited) | 304 | 848 | – | 1,152 |
The objective of determining diluted EPS is to reflect the maximum possible dilutive effect arising from potential ordinary shares outstanding during the period. The Group has stock option plans that may be settled in ordinary shares of the Group, and which are considered anti-dilutive considering the Group is currently loss making. Therefore, diluted EPS is disregarded.
There have been no other transactions involving ordinary shares or potential ordinary shares between the reporting date and the date of authorization of these Interim Condensed Consolidated Financial Statements.
The following tables reflect the income and share data used in the EPS calculation:
| 2022 Unaudited |
2021 Unaudited |
|
|---|---|---|
| Profit (loss) for the year, attributable to equity holders of the parent |
(15,995) | (12,771) |
| Weighted-average Number of Ordinary Shares | ||
| 2022 Thousands |
2021 Thousands |
|
| Weighted average number of ordinary shares for basic EPS |
30,184 | 9,865 |
| Weighted average number of ordinary shares for basic EPS (adjusted*) |
30,184 | 4,063 |

* Ordinary shares were subject to a 5:2 reverse stock split as part of the corporate conversion. The comparative weighted average number of ordinary shares (2021) was restated to include the effect of the reverse stock split.
For the six-month period ended 30 June 2021 an expense of EUR 2 million was recognized. The IPO on 21 October 2021 raised EUR 80 million at a share price of EUR 12.75. Taking into account the reversed stock split that was contemplated just prior to the IPO the share price would have been € 5.10 per share on the outstanding shares prior to the reversed stock split. As both conditions of the IPO event were met, all DR's were deemed fully vested at 21 October 2021. The EIP was settled in the second half of 2021.
ONWARD has awarded options over its ordinary shares to participants (referred to as the "Award" or "Grant'), through a second grant on 1 April 2022.
This fair value per option has been applied to the granted awards resulting in a sharebased payment expense of EUR 779 thousand (June 2021: EUR 2 million).
The following parameters were used in the option model for the calculation of the fair value of the options for the second grant on 1 April 2022:
| 30 June 2022 Unaudited |
30 June 2021 Unaudited |
|
|---|---|---|
| Opening balance Addition to the reserve |
69 779 |
3,671 2,007 |
| Closing balance | 848 | 5,678 |
| 1 2 3 4 5 7 8 9 10 6 |
Notes to the Condensed Consolidated Interim Financial Statements |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------ |
| Financial Year |
Grant Date |
Type of Security |
Options Vested / Unvested |
Exercise Price |
Expiration Date |
Fair Value |
|---|---|---|---|---|---|---|
| 2021 | 15/12/2021 | Stock Options |
Vested: 0 Unvested: 612,000 |
EUR 9.70 | 15/12/2031 | EUR 4.89 |
| 2022 | 01/04/2022 | Stock Options |
Vested: 0 Unvested: 169,800 |
EUR 7.64 | 01/04/20 | EUR 4.18 |
| 2022 |
|---|
| 4.18 |
| 7.64 |
| 7.64 |
| 59.20% |
| 4a |
| – |
| 0.55% |
| 10 |

a: Vesting period is 1 – 4 years and depends on the vesting date of the specific tranche.


The plan deficit decreased when compared to 31 December 2021. The increase in plan assets is mainly attributable to additional capital from new members that joined in the six-month period ended 30 June 2022. Market conditions have caused the principal assumptions used in determining the obligation to change significantly, most notably the discount rate, over the last six months as shown below:
| 2022 | ||
|---|---|---|
| Unaudited | ||
| Balance at 1 January | 1,388 | |
| Service costs | 274 | |
| Admin costs | 9 | |
| Past service costs | - | |
| Employee benefit expenses | 283 | |
| Net interest costs / (income) | 2 | |
| Included in statement of profit and loss | 285 | |
| Actuarial gains / (losses) | ||
| – Financial assumptions |
(1,307) | |
| – Demographic assumptions |
– | |
| – Experience adjustment |
456 | |
| – Return on assets excluding interest income |
57 | |
| (794) | ||
| Exchange rate differences | 53 | |
| Included in statement of comprehensive income | (741) | |
| Contributions by employer | (184) | |
| Balance at 30 June | 747 |
| 30 June 2022 Unaudited |
31 December 2021 Audited |
|
|---|---|---|
| Plan assets Obligation |
2,615 (3,362) |
1,756 (3,144) |
| Net liability | 747 | 1,388 |
| 2022 | 2021 | |
|---|---|---|
| Unaudited | Audited | |
| Discount rate | 2,30% | 0,30% |
| Salary increase | 2,50% | 2,50% |
| Interest credit rate | 1,00% | 0,60% |
| Mortality base table | BVG2020 | BVG2020 |
| Longevity improvement | CMI2018; 1,25% | CMI2018; 1,25% |
The impact of the assumptions above on the movement in the net defined benefit liability for the six-month period ended 30 June 2022 is as follows:
Income tax expense is recognized at an amount determined by multiplying the profit (loss) before tax for the interim reporting period by management's best estimate of the weighted-average annual income tax rate expected for the full financial year, adjusted for the tax effect of certain items recognized in full in the interim period. As such, the effective tax rate in the interim financial statements may differ from management's estimate of the effective tax rate for the annual financial statements.
The Group's consolidated effective tax rate in respect of continuing operations for the six months ended 30 June 2022 was (0.2%) (six months ended 30 June 2021: (0.1%)). The change in effective tax rate was minimal.
The deferred tax liability arose on the acquisition of NeuroRecovery Technolgies, Inc ('NRT') (subsequently renamed to ONWARD Medical Inc.). In the current year the deferred tax impact on the acquired intangibles was reclassified. This reclassification has no impact on the result for the period or equity.
| 2022 | ||
|---|---|---|
| Unaudited | ||
| Opening balance at January 1 | (1,991) | |
| Foreign currency translation difference | (127) | |
| Reclassification | 570 | |
| Deferred tax liability at 30 June | 1,548 |
The increase in trade payables is driven by the near completion of the Up-Lift pivotal study, R&D activities on the ARCEX technology in preparation for FDA de novo clearance and commercialization, and costs associated with the HemON feasibility study.
Other payables increased due to the new grant from the European Innovation Council and SMEs Executive Agency (EISMEA) received in advance. This increase is offset by the decrease in the bonus accrual for six months at the end of June 2022 as opposed to a full year at the end of December 2021.
The increase in receivables from related parties is due to the settlement of withholding taxes on behalf of employees related to the EIP.
Except as disclosed, there are no material changes to the Group's related parties, related party transactions (including their terms and conditions) and future obligations towards related parties, compared to 31 December 2021. Transactions between the Company and its subsidiaries have been eliminated on consolidation and are not disclosed in the notes.
| 30 June 2022 | 30 June 2021 | |
|---|---|---|
| Unaudited | Unaudited | |
| Salary, bonuses and other (short-term employee benefits) | 2,054 | 1,397 |
| Pension premiums (post-employment benefits) | 76 | 26 |
| Share based payments | 698 | 1,579 |
| Net liability | 2,827 | 3,002 |

ONWARD Half Year Report 55

At 30 June 2022, the Group had no legal claim contingencies.
The Group has provided a guarantee to High Tech Campus for EUR 41k and to Wincasa for EUR 283k as collateral for the lease of the office spaces.
The Group has entered into three license agreements with EPFL that will pay out royalties in case the Company is able to generate revenues in the future for products directly linked to these licenses. The royalty scheme with EPFL is based on net sales.
On 27 September 2019 Neurorecovery Technologies Inc. (now ONWARD Medical Inc.) entered into a license agreement with the Regents of the University of California acting through Technology Development Group UCLA campus granting an exclusive license on certain patents in certain fields of neuromodulation and spinal cord stimulation and a non-exclusive license on certain other patent rights. Various revenue milestone payments are due under the exclusive license and fixed royalty payments are due under the nonexclusive license. The agreement contains various milestone and diligence obligations ranging from USD 10k to USD 50k payable upon entering a phase III clinical trial, regulatory approval and/or first commercial sale.
On 8 October 2019 Neurorecovery Technologies Inc. (now ONWARD Medical Inc.) entered into a license agreement with the California Institute of Technology ("Caltech"), the latter on behalf of various intellectual property owners, including UCLA, University of Louisville, DEI and USC, granting an exclusive license on certain technology in certain fields of epidural and transcutaneous neuromodulation and a non-exclusive license of certain other intellectual property. Various revenue milestone payments, diligence obligations and fixed royalty payments are due under the license. These payments range from USD 20k to USD 75k payable upon FDA approval, CE Mark and/or first commercial sale.
We published top line data for the Up-LIFT Study on 13 September 2022.

We have prepared the interim condensed consolidated financial statements for the six months ended 30 June 2022 of ONWARD Medical N.V..
To the best of our knowledge:
Lausanne, 26 September 2022 – Board of Directors

In the Directors' Report in our Annual Report 2021 we set out an overview of our primary strategic, operational, legal and compliance and financial risks. Financial risks are also described in more detail in the notes to the Consolidated Financial Statements 2021 (Note 4.3).
Risk management policies of the Group are established to identify and analyze the risks faced by the Group, to set appropriate risk limits and controls, and to monitor risks and adherence to limits.
In the first six months of 2022, our risk assessment policies and the main identified risks as described in the Annual Report 2021 have not changed and we do not have indication this will significantly change the remaining six months of the financial year 2022.

Some statements in this document may be considered 'forward-looking statements'. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that may occur in the future. These forward-looking statements involve known and unknown risks, uncertainties and other factors that are outside of our control and impossible to predict and may cause actual results to differ materially from any future results expressed or implied. These forwardlooking statements are based on current expectations, estimates, forecasts, analyses and projections about the industry in which we operate and management's beliefs and assumptions about possible future events. You are cautioned not to put undue reliance on these forward-looking statements, which only express views as at the date of this document and are neither predictions nor guarantees of possible future events or circumstances. We do not undertake any obligation to release publicly any revisions to these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as may be required under applicable securities law.


Electrical signal produced by the brain is recorded and translated into a signal allowing the stimulation of the spine in a timely manner
Caltech California Institute for Technology
CE Conformité Européene
CHUV Centre Hospitalier Universitaire Vaudois
EPFL École Polytechnique Fédérale de Lausanne
Epidural Placed or administered outside the dura mater
FDA U.S. Food and Drug Administration Hypotension Lower blood pressure than normal range
IPG ONWARD implantable pulse generator
LTIP Long-Term Incentive Plan
Neurodegenerative Characterized by the degeneration of the nervous system
Neuromodulation Field of bioengineering implicating technologies impacting neural interfaces
Orthostatic hypotension Hypotension caused by transition to an upright position
RVO Rijksdienst voor Ondernemend Nederland
Spinal Cord Injury – damage to the nerves in the spine that circulate signals from the brain to and from the body. It can be caused by a trauma or a disease. This damage can lead to temporary or permanent dysfunctions.
Transcutaneous
Penetrating through the skin. For example: transcutaneous stimulation is stimulation delivered through the skin via electrodes placed on the skin
UCLA University of California, Los Angeles
Up-LIFT Title of a pivotal trial using the Company's ARCEX System

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