AC Immune (ACIU) 6-K Current report (foreign)

Exhibit 99.1

Condensed Consolidated Balance Sheets (Unaudited)

(in CHF thousands)

Balance Sheets	Notes	As of June 30, 2022			As of December 31, 2021
ASSETS
Non-current assets
Property, plant and equipment	5		4,997			5,116
Right-of-use assets	6		2,632			2,914
Intangible asset	9		50,416			50,416
Long-term financial assets	6		361			363
Total non-current assets			58,406			58,809
Current assets
Prepaid expenses	10		3,465			3,015
Accrued income	3		433			975
Other current receivables			335			428
Short-term financial assets	11		91,000			116,000
Cash and cash equivalents	11		63,147			82,216
Total current assets			158,380			202,634
Total assets			216,786			261,443
SHAREHOLDERS’ EQUITY AND LIABILITIES
Shareholders’ equity
Share capital			1,796			1,794
Share premium			431,260			431,251
Treasury shares	12		(124	)		(124	)
Currency translation differences			49			—
Accumulated losses			(230,169	)		(200,942	)
Total shareholders’ equity			202,812			231,979
Non-current liabilities
Long-term lease liabilities	6		2,050			2,340
Net employee defined benefit liabilities	7		—			7,098
Total non-current liabilities			2,050			9,438
Current liabilities
Trade and other payables			337			2,003
Accrued expenses	8		10,585			16,736
Deferred income	3		425			717
Short-term lease liabilities	6		577			570
Total current liabilities			11,924			20,026
Total liabilities			13,974			29,464
Total shareholders’ equity and liabilities			216,786			261,443

The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).

Condensed Consolidated Statements of Income/(Loss) (Unaudited)

(in CHF thousands except for per share data)

		For the Three Months Ended June 30,						For the Six Months Ended June 30,
	Notes	2022			2021			2022			2021
Revenue
Contract revenue	3		—			—			—			—
Total revenue			—			—			—			—
Operating expenses
Research & development expenses			(15,692	)		(13,710	)		(30,815	)		(27,040	)
General & administrative expenses			(4,374	)		(5,235	)		(8,550	)		(9,573	)
Other operating income/(expense)	3		207			256			677			673
Total operating expenses			(19,859	)		(18,689	)		(38,688	)		(35,940	)
Operating loss			(19,859	)		(18,689	)		(38,688	)		(35,940	)
Financial income			—			—			—			—
Financial expense			(126	)		(202	)		(279	)		(228	)
Exchange differences			345			(178	)		485			365
Finance result, net	13		219			(380	)		206			137
Loss before tax			(19,640	)		(19,069	)		(38,482	)		(35,803	)
Income tax expense			(3	)		—			(7	)		—
Loss for the period			(19,643	)		(19,069	)		(38,489	)		(35,803	)
Loss per share:	4
Basic and diluted loss for the period attributable to equity holders			(0.23	)		(0.26	)		(0.46	)		(0.50	)

Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)		For the Three Months ended June 30,						For the Six Months ended June 30,
(in CHF thousands)	Notes	2022			2021			2022			2021
Loss for the period			(19,643	)		(19,069	)		(38,489	)		(35,803	)
Items that will be reclassified to income or loss in subsequent periods (net of tax):
Currency translation differences			39			—			49			—
Items that will not to be reclassified to income or loss in subsequent periods (net of tax):
Remeasurement gains on defined-benefit plans (net of tax)	7		7,381			—			7,381			—
Total comprehensive loss, net of tax			(12,223	)		(19,069	)		(31,059	)		(35,803	)

The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).

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Condensed Consolidated Statements of Changes in Equity (Unaudited)

(in CHF thousands)

	Notes	Share capital		Share premium		Treasury shares			Accumulated losses			Currency Translation Differences		Total
Balance as of January 1, 2021			1,538		346,890		(100	)		(132,850	)		—		215,478
Net loss for the period			—		—		—			(35,803	)		—		(35,803	)
Other comprehensive income/(loss)			—		—		—			—			—		—
Total comprehensive loss			—		—		—			(35,803	)		—		(35,803	)
							—						—
Share-based payments			—		—		—			1,694			—		1,694
Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs			—		7,825		15			—			—		7,840
Issuance of shares, net of transaction costs:
restricted share awards			1		104		—			(112	)		—		(7	)
exercise of options			—		80		—			—			—		80
Balance as of June 30, 2021			1,539		354,899		(85	)		(167,071	)		—		189,282

	Notes	Share capital		Share premium		Treasury shares			Accumulated losses			Currency Translation Differences		Total
Balance as of January 1, 2022			1,794		431,251		(124	)		(200,942	)		—		231,979
Net loss for the period			—		—		—			(38,489	)		—		(38,489	)
Other comprehensive income/(loss)	7		—		—		—			7,381			49		7,430
Total comprehensive loss			—		—		—			(31,108	)		49		(31,059	)
							—						—
Share-based payments			—		—		—			1,886			—		1,886
Transaction offering costs			—		—		—			—			—		—
Issuance of shares, net of transaction costs:
restricted share awards			—		5		—			(5	)		—		—
exercise of options			2		4		—			—			—		6
Balance as of June 30, 2022			1,796		431,260		(124	)		(230,169	)		49		202,812

The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).

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Condensed Consolidated Statements of Cash Flows (Unaudited)

(in CHF thousands)

		For the Six Months Ended June 30,
	Notes	2022			2021
Operating activities
Loss for the period			(38,489	)		(35,803	)
Adjustments to reconcile net loss for the period to net cash flows:
Depreciation of property, plant and equipment	5		893			916
Depreciation of right-of-use assets	6		282			225
Finance (income)/expense, net	13		(598	)		(395	)
Share-based compensation expense			1,886			1,694
Change in net employee defined benefit liability			283			310
Interest expense	13		274			224
Changes in working capital:
(Increase)/decrease in prepaid expenses	10		(601	)		1,131
Decrease in accrued income	3		552			870
Decrease in other current receivables			93			48
(Decrease) in accrued expenses	8		(4,982	)		(677	)
(Decrease)/increase in deferred income	3		(306	)		113
Decrease in trade and other payables			(1,584	)		(1,824	)
Cash used in operating activities			(42,297	)		(33,168	)
Interest income			—			—
Interest paid			(322	)		(190	)
Finance costs			(5	)		(4	)
Net cash flows used in operating activities			(42,624	)		(33,362	)
Investing activities
Short-term financial assets, net	11		25,000			(30,000	)
Purchases of property, plant and equipment	5		(1,077	)		(1,418	)
Rental deposits	6		2			(29	)
Net cash flows provided by/(used in) investing activities			23,925			(31,447	)
Financing activities
Principal payments of lease obligations	6		(283	)		(225	)
Proceeds from sale of treasury shares in public offerings, net of underwriting fees and transaction costs	12		—			7,840
Transaction costs associated with issuance of shares in relation to asset acquisition previously recorded in Accrued expenses			(776	)		—
Proceeds from issuance of common shares			6			73
Net cash flows (used in)/provided by financing activities			(1,053	)		7,688
Net decrease in cash and cash equivalents			(19,752	)		(57,121	)
Cash and cash equivalents at January 1			82,216			160,893
Exchange gain on cash and cash equivalents			683			363
Cash and cash equivalents at June 30			63,147			104,135
Net decrease in cash and cash equivalents			(19,752	)		(57,121	)
Supplemental non-cash activity
Capital expenditures in Trade and other payables or Accrued expenses	5		1			247

The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited).

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Notes to the Interim Condensed Consolidated Financial Statements (Unaudited)
(in CHF thousands, except share and per share amounts)

1. Corporate information

AC Immune SA was founded in 2003. The Company controls a fully-owned subsidiary, AC Immune USA, Inc. (“AC Immune USA” or “Subsidiary” and, together with AC Immune SA, “AC Immune,” “ACIU,” “Company,” “we,” “our,” “ours,” “us”), which was registered and is organized under the laws of Delaware, USA in June 2021. The Company and its Subsidiary form the Group (See “Note 2. Basis of preparation and changes to the Company’s accounting policies”).

AC Immune SA is a clinical-stage biopharmaceutical company leveraging our two proprietary technology platforms to discover, design and develop novel proprietary medicines and diagnostics for prevention and treatment of neurodegenerative diseases (NDD) associated with protein misfolding. Misfolded proteins are generally recognized as the leading cause of NDD, such as Alzheimer’s disease (AD) and Parkinson’s disease (PD), with common mechanisms and drug targets, such as amyloid beta (Abeta), Tau, alpha-synuclein (a-syn) and TDP-43. Our corporate strategy is founded upon a three-pillar approach that targets (i) AD, (ii) focused non-AD NDD including Parkinson’s disease, ALS and NeuroOrphan indications and (iii) diagnostics. We use our two unique proprietary platform technologies, SupraAntigen (conformation-specific biologics) and Morphomer (conformation-specific small molecules), to discover, design and develop novel medicines and diagnostics to target misfolded proteins.

The Interim Condensed Consolidated Financial Statements of AC Immune SA as of and for the three and six months ended June 30, 2022 were authorized for issuance by the Company’s Audit and Finance Committee on July 27, 2022. 

2. Basis of preparation and changes to the Company’s accounting policies

Statement of compliance

These Interim Condensed Consolidated Financial Statements as of June 30, 2022 and for the three and six months ended June 30, 2022 and 2021, have been prepared in accordance with International Accounting Standard 34 (IAS 34), Interim Financial Reporting, as issued by the International Accounting Standards Board (IASB), and such financial information should be read in conjunction with the audited consolidated financial statements in AC Immune’s Annual Report on Form 20-F for the year ended December 31, 2021.

Basis of measurement

These Interim Condensed Consolidated Financial Statements have been prepared under the historical cost convention.

Functional and reporting currency

These Interim Condensed Consolidated Financial Statements and accompanying notes are presented in Swiss Francs (CHF), which is AC Immune SA’s functional currency and the Group’s reporting currency. The Company’s subsidiary has a functional currency of the US Dollar (USD). The following exchange rates have been used for the translation of the financial statements of AC Immune USA:

	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2022		2021		2022		2021
CHF/USD
Closing rate, USD 1		0.9650		—		0.9650		—
Weighted average exchange rate, USD 1		0.9871		—		0.9913		—

Critical judgments and accounting estimates

The preparation of the Company’s Interim Condensed Consolidated Financial Statements in conformity with IAS 34 requires management to make judgments, estimates and assumptions that affect the amounts reported in

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the Interim Condensed Consolidated Financial Statements and accompanying notes, and the related application of accounting policies as it relates to the reported amounts of assets, liabilities, income and expenses.

The areas where AC Immune has had to make judgments, estimates and assumptions relate to (i) revenue recognition on Licensing and Collaboration Agreements, (ii) clinical development accruals, (iii) net employee defined benefit liability, (iv) income taxes, (v) share-based compensation, (vi) right-of-use assets and lease liabilities and (vii) our IPR&D asset. Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.

Fair value of financial assets and liabilities

The Company’s financial assets and liabilities are composed of receivables, short-term and long-term financial assets, cash and cash equivalents, trade and other payables, accrued expenses and lease liabilities. The fair value of these financial instruments approximates their respective carrying values due to the short-term maturity of these instruments, and are held at their amortized cost in accordance with IFRS 9, unless otherwise explicitly noted.

Accounting policies, new standards, interpretations and amendments adopted by the Company

The accounting policies adopted 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 for the year ended December 31, 2021.

The Company has not adopted any other standard, interpretation or amendment that has been issued but is not yet effective. Such standards are not currently expected to have a material impact on the entity in the current or future reporting periods, and on foreseeable future transactions.

Going concern

The Company believes that it will be able to meet all of its obligations as they fall due for at least 12 months from June 30, 2022, after considering the Company’s cash position of CHF 63.1 million and short-term financial assets of CHF 91.0 million as of June 30, 2022. Hence, the unaudited Interim Condensed Consolidated Financial Statements have been prepared on a going-concern basis.

To date, the Company has financed its cash requirements primarily from its public offerings, share issuances, contract revenues from license and collaboration agreements and grants. The Company is a clinical-stage company and is exposed to all the risks inherent to establishing a business. Inherent to the Company’s business are various risks and uncertainties, including the substantial uncertainty as to whether current projects will succeed. The Company’s success may depend in part upon its ability to (i) establish and maintain a strong patent position and protection, (ii) enter into collaborations with partners in the pharmaceutical and biopharmaceutical industries, (iii) successfully move its product candidates through clinical development, (iv) attract and retain key personnel and (v) acquire capital to support its operations.

In addition to the foregoing, based on the Company’s current assessment, the Company does not expect any material impact on its long-term development timeline, its liquidity or ability to remain a going concern due to the worldwide spread of the Covid-19 virus. The Company continues to assess the effect on its operations by carefully monitoring the spread of Covid-19 and taking appropriate steps intended to offset any negative impacts from the Covid-19 virus.

3. Contract revenues and other operating income

For the three and six months ended June 30, 2022 and 2021, AC Immune generated no contract revenues.

The following table presents changes in the Company’s contract assets and liabilities during the six months ended June 30, 2022 and 2021:

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in CHF thousands	Balance at the beginning of the reporting period		Additions		Deductions			Balance at the end of the reporting period
Six months ended June 30, 2022:
Accrued income		975		602		(1,144	)		433
Deferred income		717		359		(651	)		425
Six months ended June 30, 2021:
Accrued income		1,591		781		(1,652	)		720
Deferred income		306		781		(678	)		409

During the three and six months ended June 30, 2022 and 2021, the Company did not recognize contract revenues as a result of changes in the contract asset and the contract liability balances in the respective periods nor from performance obligations satisfied in previous periods.

3.1 Licensing and collaboration agreements

For a discussion of our licensing and collaboration agreements for the fiscal year ended December 31, 2021, please refer to Note 13.1 “Licensing and Collaboration agreements” of our Annual Report on Form 20-F for the year ended December 31, 2021 filed on March 22, 2022.

As it relates to revenue recognition, there have been no significant events or transactions associated with our license and collaboration agreements that have occurred for the three and six months ended June 30, 2022.

3.2 Grant income

Grants from the Michael J. Fox Foundation

For a discussion of our Grants from the Michael J. Fox Foundation (MJFF) for the fiscal year ended December 31, 2021, please refer to Note 13.2 “Grant Income” of our Annual Report on Form 20-F for the year ended December 31, 2021 filed on March 22, 2022.

For the three and six months ended June 30, 2022 and 2021, the Company has recognized CHF 0.2 million and CHF 0.6 million in grant income, respectively. As of June 30, 2022, the Company has recorded CHF 0.4 million in both accrued income and deferred income, respectively.

Grant from the Target ALS Foundation

For a discussion of our Grants from the Target ALS Foundation (Target ALS) for the fiscal year ended December 31, 2021, please refer to Note 13.2 “Grant Income” of our Annual Report on Form 20-F for the year ended December 31, 2021 filed on March 22, 2022.

For the three and six months ended June 30, 2022 and 2021, the Company recognized less than CHF 0.1 million and CHF 0.1 million, respectively. As of June 30, 2022, the Company has recorded CHF 0.1 million in in deferred income.

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4. Loss per share

	For the Three Months Ended June 30,
in CHF thousands except for share and per share data	2022			2021
Loss per share (EPS)
Numerator
Net loss attributable to equity holders of the Company		(19,643	)		(19,069	)
Denominator
Weighted-average number of shares outstanding used to compute EPS basic and diluted attributable to equity holders		84,462,675			72,715,783
Basic and diluted loss per share for the period attributable to equity holders		(0.23	)		(0.26	)

	For the Six Months Ended June 30,
in CHF thousands except for share and per share data	2022			2021
Loss per share (EPS)
Numerator
Net loss attributable to equity holders of the Company		(38,489	)		(35,803	)
Denominator
Weighted-average number of shares outstanding used to compute EPS basic and diluted attributable to equity holders		83,510,567			72,113,581
Basic and diluted loss per share for the period attributable to equity holders		(0.46	)		(0.50	)

Potentially dilutive securities that were not included in the diluted per share calculations because they would be anti-dilutive were as follows: 

	For the Three Months Ended June 30,
	2022		2021
Share options issued and outstanding		149,457		1,174,014
Restricted share awards subject to future vesting		16,039		8,511

	For the Six Months Ended June 30,
	2022		2021
Share options issued and outstanding		174,408		1,179,992
Restricted share awards subject to future vesting		8,328		11,594

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5. Property, plant and equipment

The following table shows the movement in the net book values of property, plant and equipment for the six months ended June 30, 2022:

	As of June 30, 2022
in CHF thousands	Furniture			IT Equipment			Lab Equipment			Leasehold Improvements			Assets Under Construction			Total
Acquisition Cost
Balance at December 31, 2021		263			1,756			9,142			810			695			12,666
Additions		17			81			528			38			110			774
Transfers		—			4			18			7			(29	)		—
Balance at June 30, 2022		280			1,841			9,688			855			776			13,440
Accumulated depreciation
Balance at December 31, 2021		(106	)		(1,316	)		(5,739	)		(389	)		—			(7,550	)
Depreciation expense		(25	)		(143	)		(657	)		(68	)		—			(893	)
Balance at June 30, 2022		(131	)		(1,459	)		(6,396	)		(457	)		—			(8,443	)
Carrying Amount
December 31, 2021		157			440			3,403			421			695			5,116
June 30, 2022		149			382			3,292			398			776			4,997

AC Immune continues to enhance its laboratory equipment to support its R&D functions and IT equipment. This effort has continued since the year ended December 31, 2021, with CHF 0.6 million invested in lab equipment, including the expansion of our leased lab space, and IT equipment, representing an increase of 5.8% from the beginning of the year in these categories.

6. Right-of-use assets and lease liabilities

AC Immune recognized no additions for its right-of-use of leased assets for the six months ended June 30, 2022.

Regarding lease liabilities, the amortization depends on the rate implicit in the contract or the incremental borrowing rate for the respective lease component. The weighted averages of the incremental borrowing rates are 2.5% for buildings, 5.3% for office equipment and 2.6% for IT equipment, respectively.

The following table shows the movements in the net book values of right-of-use of leased assets for the six months ended June 30, 2022:

in CHF thousands	Buildings			Office Equipment			IT Equipment			Total
Balance as of December 31, 2021		2,776			98			40			2,914
Depreciation		(262	)		(12	)		(8	)		(282	)
Balance as of June 30, 2022		2,514			86			32			2,632

There are no variable lease payments that are not included in the measurement of lease obligations. All extension options have been included in the measurement of lease obligations.

For the three and six months ended June 30, 2022, and 2021, the impact on the Company’s condensed consolidated statements of income/(loss) and consolidated statements of cash flows is as follows:

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	For the Three Months Ended June 30,
in CHF thousands	2022	2021
Statements of income/(loss)
Depreciation of right-of-use assets	141	119
Interest expense on lease liabilities	18	15
Expense for short-term leases and leases of low value	173	169
Total	332	303
Statements of cash flows
Total cash outflow for leases	333	303

	For the Six Months Ended June 30,
in CHF thousands	2022		2021
Statements of income/(loss)
Depreciation of right-of-use assets		282		225
Interest expense on lease liabilities		36		30
Expense for short-term leases and leases of low value		347		356
Total		665		611
Statements of cash flows
Total cash outflow for leases		666		611

The following table presents the contractual undiscounted cash flows for lease obligations as of June 30, 2022:

in CHF thousands	As of June 30, 2022
Less than one year		638
1-3 years		1,245
3-5 years		900
Total		2,783

The Company also has deposits in escrow accounts totaling CHF 0.4 million for leases of the Company’s premises as of both June 30, 2022 and December 31, 2021, respectively. These deposits are presented in Long-term financial assets on the Company’s condensed consolidated balance sheets.

7. Net employee defined benefit liabilities

The Company used its independent actuaries to update the calculation of the defined benefit obligation and plan assets as of June 30, 2022. As of the June 30, 2022, the Company recognized a remeasurement gain of CHF 7.4 million on the Company’s condensed consolidated statements of comprehensive income/(loss) related to its net employee defined benefit liability. The primary component of the remeasurement gain as of and for the three and six months period ended June 30, 2022 relates to the increase in the discount rate by 195 basis points to 2.25% from 0.3% as of December 31, 2021.

The resulting impact as a result of the asset ceiling test is to record nil for the net employee defined benefit liability on the Company’s condensed consolidated balance sheets as of June 30, 2022 compared to CHF 7.1 million as of December 31, 2021.

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8. Accrued expenses

	As of
in CHF thousands	June 30, 2022		December 31, 2021
Accrued Expenses		10,585		16,736
Total		10,585		16,736

The Company paid CHF 3.7 million in the period for a previous accrual associated with our cost sharing arrangement with Janssen and CHF 2.3 million related to performance-related remuneration for the six months ended June 30, 2022.

9. Intangible assets

AC Immune’s acquired IPR&D asset is a clinically-validated active vaccine candidate for the treatment of Parkinson’s disease. The asset is not yet ready for use until the asset obtains market approval and is therefore not currently being amortized. The carrying amount and net book value are detailed below:

	As of June 30, 2022						As of December 31, 2021
In CHF thousands	Gross Carrying Amount		Accumulated Amortization		Net Book Value		Gross Carrying Amount		Accumulated Amortization		Net Book Value
Acquired IPR&D Asset		50,416		—		50,416		50,416		—		50,416
Total Intangible Assets		50,416		—		50,416		50,416		—		50,416

In accordance with IAS 36 Impairment of Assets, the IPR&D asset is reviewed at least annually for impairment by assessing the fair value less costs to sell (recoverable amount) and comparing this to the carrying value of the asset. The valuation is considered to be Level 3 in the fair value hierarchy in accordance with IFRS 13 Fair Value Measurement due to unobservable inputs used in the valuation. The Company has not determined the IPR&D asset to be impaired as of June 30, 2022.

10. Prepaid expenses

Prepaid expenses include prepaid R&D costs, administrative costs and net employee defined benefit liability expenses totaled CHF 3.5 million and CHF 3.0 million as of June 30, 2022 and December 31, 2021, respectively.

11. Cash and cash equivalents and financial assets

The following table summarizes AC Immune’s cash and cash equivalents and short-term financial assets as of June 30, 2022 and December 31, 2021:

	As of
in CHF thousands	June 30, 2022		December 31, 2021
Cash and cash equivalents		63,147		82,216
Total		63,147		82,216

	As of
in CHF thousands	June 30, 2022		December 31, 2021
Short-term financial assets due in one year or less		91,000		116,000
Total		91,000		116,000

For the six months ended June 30, 2022, the Company purchased a net CHF 25.0 million in short-term financial assets.

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12. Treasury shares

For a discussion of our at the market offering program with Jefferies LLC for the fiscal year ended December 31, 2021, please refer to Note 11 “Share capital” of our Annual Report on Form 20-F for the year ended December 31, 2021 filed on March 22, 2022.

As of June 30, 2022, the Company has 6,221,617 treasury shares remaining.

13. Finance result, net

For the three months ended June 30, 2022 and 2021, AC Immune recorded CHF 0.2 million in net financial gains compared to CHF 0.4 million in net financial losses for the prior period. The Company recorded CHF 0.3 million in foreign currency gains compared to CHF 0.2 million foreign currency losses in the prior period.

For the six months ended June 30, 2022 and 2021, the Company recorded CHF 0.2 million and CHF 0.1 million in net financial gains, respectively. The Company recorded CHF 0.5 million and CHF 0.4 million in foreign currency gains, respectively.

14. Subsequent events

Management has evaluated subsequent events after the balance sheet date, through the issuance of these Interim Condensed Consolidated Financial Statements, for appropriate accounting and disclosures. The Company has determined that there were no other such events that warrant disclosure or recognition in these Interim Condensed Consolidated Financial Statements.

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