Form 6-K AC Immune SA For: Apr 28

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April 28, 2021 7:12 AM EDT

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16
OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of April, 2021

Commission File Number: 001-37891

AC IMMUNE SA

(Exact name of registrant as specified in its charter)

EPFL Innovation Park

Building B

1015 Lausanne, Switzerland

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

Form 20-F

☒

Form 40-F

☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Yes

☐

☒

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

Yes

☐

☒

Signature

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

		AC IMMUNE SA

		By:	/s/ Andrea Pfeifer
			Name:	Andrea Pfeifer
			Title:	Chief Executive Officer


		By:	/s/ Joerg Hornstein
			Name:	Joerg Hornstein
			Title:	Chief Financial Officer
Date:	April 28, 2021

Exhibit Index

Exhibit Number	Description
99.1	Interim Condensed Financial Statements (Unaudited) (IFRS) as of and for the three months ended March 31, 2021

99.2	Management’s Discussion and Analysis of Financial Condition and Results of Operations

99.3	Press Release dated April 28, 2021

Exhibit 99.1

AC Immune SA

Balance Sheets

(in CHF thousands)

	Notes	As of March 31, 2021			As of December 31, 2020
ASSETS
Non-current assets
Property, plant and equipment	5		4,896			4,416
Right-of-use assets	6		2,147			2,223
Long-term accrued income	3		93			—
Long-term financial assets	8		334			334
Total non-current assets			7,470			6,973

Current assets
Prepaid expenses	7		3,330			3,954
Short-term accrued income	3		688			1,591
Other current receivables			379			329
Short-term financial assets	8		65,000			65,000
Cash and cash equivalents	8		151,092			160,893
Total current assets			220,489			231,767
Total assets			227,959			238,740

SHAREHOLDERS’ EQUITY AND LIABILITIES

Shareholders’ equity
Share capital			1,539			1,538
Share premium			354,736			346,890
Treasury shares	9		(85	)		(100	)
Accumulated losses			(148,774	)		(132,850	)
Total shareholders’ equity			207,416			215,478

Non-current liabilities
Long-term deferred income	3		93			—
Long-term lease liabilities	6		1,706			1,780
Net employee defined-benefit liabilities			7,619			7,464
Total non-current liabilities			9,418			9,244

Current liabilities
Trade and other payables			370			2,184
Accrued expenses			9,734			11,085
Short-term deferred income	3		580			306
Short-term lease liabilities	6		441			443
Total current liabilities			11,125			14,018
Total liabilities			20,543			23,262
Total shareholders’ equity and liabilities			227,959			238,740

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

AC Immune SA

Statements of Income/(Loss)

(in CHF thousands except for per share data)

		For the Three Months Ended March 31,
	Notes	2021			2020
Revenue
Contract revenue	3		—			12,281
Total revenue			—			12,281

Operating expenses
Research & development expenses			(13,329	)		(15,209	)
General & administrative expenses			(4,338	)		(4,504	)
Other operating income/(expense)			416			130
Total operating expenses			(17,251	)		(19,583	)
Operating loss			(17,251	)		(7,302	)

Financial income			—			59
Financial expense			(26	)		(57	)
Exchange differences			543			(389	)
Finance result, net	10		517			(387	)

Loss before tax			(16,734	)		(7,689	)
Income tax expense			—			—
Loss for the period			(16,734	)		(7,689	)

Loss per share:	4
Basic and diluted loss for the period attributable to equity holders			(0.23	)		(0.11	)

Statements of Comprehensive Income/(Loss)	For the Three Months Ended March 31,
(in CHF thousands)	2021			2020

Loss for the period		(16,734	)		(7,689	)
Other comprehensive loss not to be reclassified to income or loss in subsequent periods (net of tax):
Re-measurement losses on defined-benefit plans (net of tax)		—			—
Total comprehensive loss, net of tax		(16,734	)		(7,689	)

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

AC Immune SA

Statements of Changes in Equity

(in CHF thousands)

	Notes	Share capital		Share premium			Treasury shares		Accumulated losses			Total
Balance as of January 1, 2020			1,437		346,526			—		(75,521	)		272,442
Net loss for the period			—		—			—		(7,689	)		(7,689	)
Other comprehensive income/(loss)			—		—			—		—			—
Total comprehensive income			—		—			—		(7,689	)		(7,689	)
								—
Share-based payments			—		—			—		852			852
Issuance of shares, net of transaction costs:
restricted share awards			—		46			—		(46	)		—
exercise of options					(4	)		—		—			(4	)
Balance as of March 31, 2020			1,437		346,568			—		(82,404	)		265,601

	Notes	Share capital		Share premium			Treasury shares			Accumulated losses			Total
Balance as of January 1, 2021			1,538		346,890			(100	)		(132,850	)		215,478
Net loss for the period			—		—			—			(16,734	)		(16,734	)
Other comprehensive income/(loss)			—		—			—			—			—
Total comprehensive income			—		—			—			(16,734	)		(16,734	)
								—
Share-based payments			—		—			—			857			857
Proceeds from sale of treasury shares in public offerings, net of underwriting fees	9		—		7,937			15			—			7,952
Transaction offering costs			—		(125	)		—			—			(125	)
Issuance of shares, net of transaction costs:
restricted share awards			1		39			—			(47	)		(7	)
exercise of options			—		(5	)		—			—			(5	)
Balance as of March 31, 2021			1,539		354,736			(85	)		(148,774	)		207,416

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

AC Immune SA

Statements of Cash Flows

(in CHF thousands)

		For the Three Months Ended March 31,
	Notes	2021			2020
Operating activities
Loss for the period			(16,734	)		(7,689	)
Adjustments to reconcile net loss for the period to net cash flows
Depreciation of property, plant and equipment	5		441			368
Depreciation of right-of-use assets	6		107			108
Finance expense, net	10		(638	)		433
Share-based compensation expense			857			852
Change in net employee defined-benefit liability			155			181
Interest expense	10		23			54
Changes in working capital
Decrease/(increase) in prepaid expenses	7		586			(632	)
Decrease in accrued income	3		810			881
(Increase) in other current receivables			(50	)		(247	)
(Decrease) in accrued expenses			(1,449	)		(2,587	)
Increase)/(decrease) in deferred income	3		368			(2,025	)
Increase/(decrease) in trade and other payables			(1,798	)		640
Cash used in operating activities			(17,322	)		(9,663	)
Interest income			—			60
Interest paid			(15	)		(80	)
Finance costs			(2	)		(4	)
Net cash flows used in operating activities			(17,339	)		(9,687	)

Investing activities
Purchases of property, plant and equipment	5		(790	)		(212	)
Net cash flows used in investing activities			(790	)		(212	)

Financing activities
Repayment of short-term financing obligation			—			(263	)
Principal payments of lease obligations	6		(108	)		(107	)
Proceeds from sale of treasury shares in public offerings, net of underwriting fees	9		7,952			—
Transaction costs on public offerings			(125	)		—
Proceeds from issuance of common shares			(12	)		(4	)
Net cash flows provided by/(used in) financing activities			7,707			(374	)

Net decrease in cash and cash equivalents			(10,422	)		(10,273	)

Cash and cash equivalents at January 1			160,893			193,587
Exchange gain/(loss) on cash and cash equivalents			621			(454	)
Cash and cash equivalents at March 31			151,092			182,860
Net decrease in cash and cash equivalents			(10,422	)		(10,273	)

Additional Information

For the three months ended March 31, 2021, the acquisition CHF 0.1 million of property, plant and equipment was non-paid and recorded within accrued expenses.

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

AC Immune SA

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

Corporate information

AC Immune SA (the “Company,” “AC Immune,” “ACIU,” “we,” “our,” “ours,” or “us”) 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 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 Financial Statements of AC Immune SA as of and for the three months ended March 31, 2021 were authorized for issuance by the Company’s Audit and Finance Committee on April 27, 2021.

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

Statement of compliance

These Interim Condensed Financial Statements as of and for the three months ended March 31, 2021, have been prepared in accordance with International Accounting Standard 34 (IAS 34), Interim Financial Reporting, and such financial information should be read in conjunction with the audited financial statements in AC Immune’s Annual Report on Form 20-F for the year ended December 31, 2020, and any public announcements made by the Company during the interim reporting period.

Basis of measurement

The financial statements have been prepared under the historical cost convention.

Revenue recognition

The Company has adopted IFRS 15 (Revenue from Contracts with Customers). This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under IFRS 15, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of IFRS 15, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company applies the five-step model to contracts only when it is probable that the entity will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of IFRS 15, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

The Company enters into licensing and collaboration agreements (LCAs), which are within the scope of IFRS 15, under which it licenses certain rights to its product candidates and intellectual property (IP) to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, upfront license fees; development, regulatory and/or commercial milestone payments; payments for research and clinical services the Company provides through either its full-time employees or third-party vendors; and royalties on net sales of licensed products commercialized from the Company’s IP. Each of these payments results in license, collaboration and other revenues, which are classified as contract revenue on the statements of income/(loss).

Licenses of intellectual property

If the license to the Company’s intellectual property (IP) is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are sold in conjunction with a related service, the Company uses its judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. If the performance obligation is settled over time, the Company determines the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

Milestone payments

At the inception of each arrangement that includes development, regulatory and/or commercial milestone payments, the Company evaluates whether the milestones are considered highly probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is highly probable that a significant revenue reversal would not occur in future periods, the associated milestone value is included in the transaction price. These amounts for the performance obligations under the contract are recognized at the time they are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments recorded would affect contract revenues and earnings in the period of adjustment.

Research and development services

The Company has certain arrangements with our collaboration partners that include contracting our employees for research and development (R&D) programs. The Company assesses if these services are considered distinct in the context of each contract and, if so, they are accounted for as separate performance obligations. These revenues are recorded in contract revenue as the services are performed.

Sublicense revenues

The Company has certain arrangements with our collaboration partners that include provisions for sublicensing. The Company recognizes any sublicense revenues at the time point at which it is highly probable they will be obtained and will not be subject to reversal in the future.

Contract balances

The Company receives payments and determines credit terms from its customers for its various performance obligations based on billing schedules established in each contract. The timing of revenue recognition, billings and cash collections results in billed other current receivables, accrued income (contract assets) and deferred income (contract liabilities) on the balance sheets. Amounts are recorded as other current receivables when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be 1 year or less.

Critical judgments and accounting estimates

The preparation of the Company’s Interim Condensed Financial Statements in conformity with IAS 34 requires management to make judgments, estimates and assumptions that affect the amounts reported in the Interim Condensed 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 in which the Company has had to make judgments, estimates and assumptions relate to (i) revenue recognition on LCAs, (ii) clinical development accruals, (iii) net employee defined-benefit liability, (iv) income taxes, (v) share-based compensation, and (vi) right-of-use assets and lease liabilities. 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.

Fair value of financial assets and liabilities

The Company’s financial assets and liabilities are comprised of receivables, short-term financial assets, cash and cash equivalents, trade payables and lease liabilities. The fair value of these financial instruments approximate 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.

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

The accounting policies adopted in the preparation of the Interim Condensed Financial Statements are consistent with those followed in the preparation of the Company’s annual financial statements for the year ended December 31, 2020.

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 March 31, 2021, after considering the Company’s cash position of CHF 151.1 million and short-term financial assets of CHF 65 million as of March 31, 2021. Hence, the unaudited Interim Condensed 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.

Contract revenues

AC Immune generated no contract revenues in the three months ended March 31, 2021, a decrease of CHF 12.3 million over the comparable period in 2020. The Company reclassified CHF 0.1 million for the comparable period in 2020 from contract revenues to other operating income/(expense) for prior grants from the Michael J. Fox Foundation for Parkinson’s Research (“MJFF”).

The following table provides contract revenue amounts from its LCAs for the three months ended March 31, 2021:

	For the Three Months Ended March 31,
in CHF thousands	2021		2020
Eli Lilly and Company		—		12,091
Genentech		—		—
Janssen		—		190
Life Molecular Imaging		—		—
Other		—		—
Total contract revenue		—		12,281

The following table presents changes in the Company’s contract assets and liabilities during the three months ended March 31, 2021 and 2020:

in CHF thousands	Balance at the beginning of the reporting period		Additions		Deductions			Balance at the end of the reporting period
Three months ended March 31, 2021
Accrued income		1,591		781		(1,591	)		781
Deferred income		306		781		(414	)		673
Three months ended March 31, 2020
Accrued income		1,095		190		(1,095	)		190
Deferred income		4,477		195		(2,221	)		2,452

During the three months ended March 31, 2021 and 2020, the Company recognized the following contract revenues as a result of changes in the contract asset and the contract liability balances in the respective periods:

	For the Three Months Ended March 31,
in CHF thousands	2021		2020
Revenue recognized in the period from:
Amounts included in the contract liability at the beginning of the period		—		2,221
Performance obligations satisfied in previous periods		—		10,000

3.1

Licensing and collaboration agreements

Morphomer Tau small molecule – 2018 license agreement with Eli Lilly and Company

In December 2018, we entered into an exclusive, worldwide licensing agreement with Eli Lilly and Company (Lilly) to research and develop Morphomer Tau small molecules for the treatment of AD and other neurodegenerative diseases. More specifically, this is an exclusive license with the right to Lilly to grant sublicenses under the ACIU Patents, the ACIU know-how, and ACIU’s interests in the Joint Patents and the joint know-how to Exploit the Licensed Compounds and Licensed Products. The agreement became effective on January 23, 2019 (the “effective date”) when the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, expired. In Q3 2019, the Company and Lilly entered into the first amendment to divide the first discretionary milestone payment under the agreement of CHF 60 million into two installments, with the first CHF 30 million paid in Q3 2019 and the second CHF 30 million to be paid on or before March 31, 2020 unless Lilly terminated the agreement earlier. In Q1 2020, the Company and Lilly entered into a second amendment to replace the second CHF 30 million to be paid on or before March 31, 2020 with two milestone payments, one of CHF 10 million to be paid on or before March 31, 2020 and the other of CHF 60 million following the first patient dosed in a Phase 2 clinical study of a licensed product in the US or EU.

Per the terms of the agreement, the Company received an initial upfront payment of CHF 80 million in Q1 2019 for the rights granted by the Company to Lilly. To date, the Company has completed a Phase 1 clinical study with ACI-3024. The program will be expanded to NeuroOrphan indications and ACI-3024 will be further evaluated for efficacy in models of rare Tauopathies.

Additionally, the Company and Lilly have continued candidate characterization across the research program, identifying new and highly differentiated candidates with desired cerebrospinal fluid exposure and selectivity for pathological aggregated Tau. These will be broadly developed in Tau-dependent neurodegenerative diseases by Lilly.

Lilly is responsible for leading and funding further clinical development and will retain global commercialization rights for all indications.

Per the terms of the agreement, the Company may become eligible to receive additional milestone payments totaling up to approximately CHF 880 million for clinical and regulatory milestones and CHF 900 million upon achievement of certain commercial milestones. In addition to milestones, we will be eligible to receive royalties on sales at a percentage rate ranging from the low double-digits to the mid-teens. The agreement will terminate by the date of expiration of the last royalty term for the last licensed product. However, under the terms of the agreement, Lilly may terminate the agreement at any time by providing 3 months’ prior notice to us.

AC Immune assessed this arrangement in accordance with IFRS 15 and concluded that Lilly is a customer. The Company identified the following significant performance obligations under the contract: (i) a right-of-use license and (ii) research and development activities outlined in the development plan. Per the agreement, the Company was responsible for the preclinical and Phase 1 activities for the first clinical candidate, ACI-3024, which the Company determined was distinct and capable of being completed by Lilly or a third party. Preclinical activities for which AC Immune was responsible prior to their completion in Q2 2019 included final manufacturing of materials for use in the regulatory submission of the protocol and in the Phase 1 study. For the completed Phase 1, AC Immune was responsible for leading the study design, obtaining relevant regulatory agency approvals, arranging necessary third-party contracts, completing patient selection, ensuring patient treatment, following up with patients, drafting the clinical study report development and other relevant clinical activities to ensure that the primary objective of the study was completed. The Company used CMOs for certain of its preclinical activities and CROs to complete certain Phase 1 activities and to issue the final clinical study report.

The Company’s preclinical and Phase 1 activities did not represent integrated services with the licensed IP for which Lilly contracted. Lilly purchased a license to the Company’s Tau therapeutic small-molecule program, which was delivered at commencement of the agreement, and AC Immune’s preclinical and Phase 1 activities did not affect the form or functionality of this license. The Company’s objective for the Phase 1 activity was to assess safety and tolerability and did not modify or customize ACI-3024. The completion of these preclinical and Phase 1 activities does not affect the licensed IP.

Finally, per the agreement, each party has three representatives on a joint steering committee (JSC); depending upon the agenda, additional field experts can attend the JSC to provide the technical and scientific contribution required. The JSC meets on a regular basis depending on agreements between the representatives. The JSC is responsible for serving as the forum to (i) discuss, review and approve certain activities by reviewing and discussing the development progress with updates on back-up candidates, (ii) discuss, review and approve all amendments to the global development plan, (iii) periodically discuss and review commercialization of licensed products and (iv) review and approve reports related to development costs among other activities. The JSC is intended to ensure that communication between the parties remains consistent and that the development plan is progressing as intended.

The valuation of each performance obligation involves estimates and assumptions with revenue recognition timing to be determined by either delivery or the provision of services.

The Company used the residual approach to estimate the selling price for the right-of-use license and an expected cost plus margin approach for estimating the research and development activities. The right-of-use license was delivered on the effective date. The research and development activities were delivered over time as the services were performed. For these services, revenue was recognized over time using the input method, based on costs incurred to perform the services, as the level of costs incurred over time is thought to best reflect the transfer of services to Lilly. The Company determined the value of the research and development activities to be CHF 6.9 million and deferred this balance from the effective date. To date, the Company has cumulatively recognized CHF 6.9 million in contract revenue, resulting in no deferred income (contract liability) on the balance sheets. The remaining CHF 73.1 million from the upfront payment was allocated to the right-of-use license and recognized on the effective date.

At inception of the agreement, none of the clinical, regulatory or commercial milestones had been included in the transaction price, as all milestone amounts were fully constrained. To date, the Company has recognized CHF 40 million from milestone payments triggered in Q3 2019 and Q1 2020 related to the right-of-use license for IP as there were no further constraints related to these milestones. In assessing that future clinical, regulatory or commercial milestones are fully constrained, the Company considered numerous factors to determine that these milestones are not highly probable to obtain, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to Lilly and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

For the three months ended March 31, 2021 and 2020, we have recognized nil and CHF 12.1 million, respectively.

Anti-Abeta antibody in AD – 2006 agreement with Genentech, a member of the Roche Group

In November 2006, we signed an exclusive, worldwide licensing agreement for crenezumab, our humanized monoclonal therapeutic antibody targeting misfolded Abeta. The agreement was amended March 2009, January 2013, May 2014 and May 2015. The agreement also provides for the development of a second therapeutic product for a non-AD indication based on the same intellectual property and anti-Abeta antibody compound. The value of this partnership is potentially greater than USD 340 (CHF 324) million.

The term of the agreement commenced on the effective date and, unless sooner terminated by mutual agreement or pursuant to any other provision of the agreement, terminates on the date on which all obligations between the parties with respect to the payment of milestones or royalties with respect to licensed products have passed or expired. Either party may terminate the agreement for any material breach by the other party, provided a cure period of 90 days from the date when that notice is given.

Genentech commenced a first Phase 3 clinical study in March 2016 for crenezumab (CREAD). In March 2017, Genentech started a second Phase 3 clinical trial (CREAD 2). Since 2013, crenezumab has also been studied in a Phase 2 trial in individuals who carry the PSEN1 E280A autosomal-dominant mutation and do not meet the criteria for mild cognitive impairment due to AD or dementia due to AD, and are thus in a preclinical phase of AD (autosomal dominant AD (ADAD)). In 2019, Genentech initiated a Tau Positron Emission Tomography (PET) substudy of the ongoing Phase 2 trial in ADAD to evaluate the effect of crenezumab on Tau burden, which may also increase understanding of disease progression in the preclinical stage of ADAD.

If crenezumab receives regulatory approval, we will be entitled to receive royalties that are tied to annual sales volumes with different royalty rates applicable in the US and Europe ranging from the mid-single digits to mid-teens. To date, we have received total milestone payments of USD 65 million (CHF 70.1 million) comprised of an upfront payment of USD 25 (CHF 31.6) million and of USD 40 (CHF 38.2) million for clinical development milestones achieved all-in prior to January 1, 2017. Genentech may terminate the agreement at any time by providing 3 months’ notice to us. In such event all costs incurred are still refundable.

AC Immune assessed this arrangement in accordance with IFRS 15 and concluded that Genentech is a customer. The Company identified the following performance obligations under the contract: (i) a right-of-use license and (ii) conducting of research under a research plan. The Company considered the research and development capabilities of Genentech and Genentech’s right to sublicense to conclude that the license has stand-alone functionality and is distinct. The Company’s obligation to perform research does not significantly impact or modify the licenses’ granted functionality.

At execution of the agreement, the transaction price included the upfront consideration received of USD 25 (CHF 31.6) million. At inception, none of the clinical or regulatory milestones had been included in the transaction price, as all milestone amounts were fully constrained. The Company has received three milestone payments since inception, totaling USD 40 (CHF 38.2) million. The Company could receive USD 275 (CHF 262) million or more for further regulatory milestones for this exclusive worldwide alliance. In assessing that future regulatory milestones are fully constrained, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and is contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to royalties will be recognized when the related sales occur, as they were determined to relate predominantly to the license granted to Genentech and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

On January 30, 2019, we announced that Roche, the parent of Genentech, is discontinuing the CREAD and CREAD 2 (BN29552 and BN29553) Phase 3 studies of crenezumab in people with prodromal-to-mild sporadic AD. The decision came after an interim analysis conducted by the Independent Data Monitoring Center (IDMC) indicated that crenezumab was unlikely to meet its primary endpoint of change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score. This decision was not related to the safety of the investigational product. No safety signals for crenezumab were observed in this analysis and the overall safety profile was similar to that seen in previous trials.

Crenezumab continues to be studied in the Phase 2 preventive trial, which began in 2013 in Columbia, of cognitively healthy individuals who carry the PSEN1 E280A autosomal-dominant mutation and are in a preclinical phase of ADAD. This study will determine if treating people carrying this mutation with crenezumab prior to the onset of AD symptoms will slow or prevent the decline of cognitive and functional abilities.

For the three months ended March 31, 2021 and 2020, we have recognized no revenues from this arrangement.

Anti-Tau antibody in AD – 2012 agreement with Genentech, a member of the Roche Group

In June 2012, we entered into a second agreement with Genentech to research, develop and commercialize our anti-Tau antibodies for use as immunotherapeutics and diagnostics. The agreement was amended in December 2015. The value of this exclusive, worldwide alliance is potentially greater than CHF 400 million and includes upfront and clinical, regulatory and commercial milestone payments. In addition to milestones, we will be eligible to receive royalties on sales at a percentage rate ranging from the mid-single digits to low-double digits. The agreement also provides for collaboration on at least one additional therapeutic indication outside of AD built on the same anti-Tau antibody program as well an anti-Tau diagnostic product for AD.

To date, we have received payments totaling CHF 59 million, including a milestone payment of CHF 14 million received and recognized in Q4 2017 associated with the first patient dosing in a Phase 2 clinical trial for AD with an anti-Tau monoclonal body known as semorinemab, a milestone payment of CHF 14 million recognized in Q2 2016 and received in July 2016, associated with the announcement of the commencement of the Phase 1 clinical study of semorinemab, and a milestone payment of CHF 14 million received in 2015 in connection with the ED-GO decision. As we met all performance obligations on reaching these milestones, we have recognized revenue in the respective periods. Genentech may terminate the agreement at any time by providing 3 months’ notice to us.

AC Immune assessed this arrangement in accordance with IFRS 15 and concluded that Genentech is a customer. The Company identified the following performance obligations under the contract: (i) a right-of-use license and (ii) conduct of research under a research plan. The Company considered the research and development capabilities of Genentech and Genentech’s right to sublicense to conclude that the license has stand-alone functionality and is distinct. The Company’s obligation to perform research does not significantly impact or modify the licenses’ granted functionality.

At execution of the agreement, the transaction price included an upfront consideration received of CHF 17 million. At inception, none of the clinical or regulatory milestones had been included in the transaction price, as all milestone amounts were fully constrained. The Company has received three milestones since inception totaling CHF 42 million. The Company could also receive up to an additional CHF 368.5 million in clinical, regulatory and commercial milestones. In assessing that future clinical, regulatory or commercial milestones are fully constrained, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as they were determined to relate predominantly to the license granted to Genentech and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

On September 23, 2020, the Company reported that Genentech informed us of top line results from a Phase 2 trial of the anti-Tau antibody, semorinemab, in early (prodromal to mild) Alzheimer’s disease (AD) which show that semorinemab did not meet its primary efficacy endpoint of reducing decline on Clinical Dementia Rating-Sum of Boxes (CDR-SB) compared to placebo. The primary safety endpoint was however met. Two secondary endpoints, Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) and Alzheimer’s Disease Cooperative Study Group – Activities of Daily Living Inventory (ADCS-ADL), were not met. A second Phase 2 study of semorinemab in patients with moderate AD remains ongoing.

For the three months ended March 31, 2021 and 2020, we have recognized no revenues from this arrangement.

Tau vaccine in AD – 2014 agreement with Janssen Pharmaceuticals, Inc.

In December 2014, we entered into an agreement with Janssen Pharmaceuticals, Inc. (“Janssen”) one of The Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize therapeutic anti-Tau vaccines for the treatment of AD and potentially other Tauopathies. The value of this strategic partnership is potentially up to CHF 500 million and includes upfront and clinical, regulatory and commercial milestones. In addition to milestones, we will be eligible to receive royalties on sales at a percentage rate ranging from the low-double digits to the mid-teens. In April 2016, July 2017, January 2019 and November 2019, the companies entered into the first, second, third and fourth amendments, respectively. These amendments allow for the alignment of certain payment and activity provisions with the Development plan and Research plan activities. We and Janssen are co-developing second-generation therapeutic vaccines, ACI-35.030 and JACI-35.054, through Phase 1b/2a completion. AC Immune and Janssen will jointly share research and development costs until the completion of the first Phase 2b (AC Immune’s contribution to the first Phase 2b trial is capped). From Phase 2b and onwards, Janssen will assume responsibility for the clinical development, manufacturing and commercialization of the vaccines.

Under the terms of the agreement, Janssen may terminate the agreement at any time after completion of the first Phase 1b clinical study in 2016 by providing 90 days’ notice to us. If not otherwise terminated, the agreement shall continue until the expiration of all royalty obligations as outlined in the contract.

The agreement also allows for the expansion to a second indication based on the same anti-Tau vaccine program and based on intellectual property related to this program.

The Company received an upfront, non-refundable license fee of CHF 25.9 million, which we recognized as revenue in 2014. In May 2016, we received a payment of CHF 4.9 million for reaching a clinical milestone in the first Phase 1b study. As we met all performance obligations on reaching the milestone, we have recognized this income as revenue.

AC Immune assessed this arrangement in accordance with IFRS 15 and concluded that Janssen is a customer. The Company identified the following performance obligations under the contract: (i) a right-of-use license and (ii) research and development services including a development and chemistry, manufacturing and controls work plan. The Company considered the research and development capabilities of Janssen, their right to sublicense, and the fact that the research and development services are not proprietary and can be provided by other vendors, to conclude that the license has stand-alone functionality and is distinct. The Company’s obligation to perform research and development services does not significantly impact or modify the licenses’ granted functionality. Based on these assessments, the Company identified the license and the research and development services as the performance obligations at the inception of the arrangement, which were deemed to be distinct in the context of the contract.

At execution of the agreement, the transaction price included only the upfront consideration received of CHF 25.9 million. At inception, none of the clinical, regulatory or commercial milestones has been included in the transaction price, as all milestone amounts were fully constrained. The Company did receive a payment of CHF 4.9 million for reaching a clinical milestone in the first Phase 1b study in May 2016. The Company could also receive up to more than CHF 458 million in clinical, regulatory and commercial milestones as well as tiered, low-double digit to mid-teen royalties on aggregate net sales of products. In assessing that future clinical, regulatory or commercial milestones are fully constrained, the Company considered numerous factors to determine that these milestones are not highly probable to obtain, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur, as they were determined to relate predominantly to the license granted to Janssen and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

For the three months ended March 31, 2021 and 2020, we have recognized nil and CHF 0.2 million, respectively.

Tau-PET imaging agent in AD – 2014 agreement with Life Molecular Imaging (LMI) (formerly Piramal Imaging SA)

In May 2014, we entered into an agreement, our first diagnostic partnership, with LMI, the former Piramal Imaging SA. The partnership with LMI is an exclusive, worldwide licensing agreement for the research, development and commercialization of the Company’s Tau protein PET tracers supporting the early diagnosis and clinical management of AD and other Tau-related disorders and includes upfront and sales milestone payments totaling up to EUR 159 (CHF 178) million, plus royalties on sales at a percentage rate ranging from mid-single digits to low-teens. LMI may terminate the LCA at any time by providing 3 months’ notice to us.

In connection with this agreement, AC Immune received a payment of EUR 500 (CHF 664) thousand, which was fully recognized in 2015. In Q1 2017, we recorded a milestone payment of EUR 1 (CHF 1.1) million related to the initiation of “Part B” of the first-in-man Phase 1 study. In Q3 2019, the Company recognized EUR 2 (CHF 2.2) million in connection with the initiation of a Phase 2 trial of Tau-PET tracer in patients with mild cognitive impairment and mild–to-moderate AD in comparison with non-demented control participants. The Company is eligible to receive variable consideration related to the achievement of certain clinical milestones totaling EUR 8 (CHF 9) million should the compound make it through Phase 3 clinical studies. We are also eligible to receive potential regulatory and sales-based milestones totaling EUR 148 (CHF 165) million. Finally, the Company is eligible for royalties from the mid-single digits to low-double digits.

AC Immune assessed this arrangement in accordance with IFRS 15 and concluded that LMI is a customer. The Company has identified that the right-of-use license as the only performance obligation. The Company determined that transaction price based on the defined terms allocated to each performance obligation specified in the contract.

The upfront payment constitutes the amount of consideration to be included in the transaction price and has been allocated to the license. None of the clinical, regulatory or commercial milestones has been included in the transaction price as these variable consideration elements are considered fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts.

Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur as these amounts have been determined to relate predominantly to the license granted to LMI and therefore are recognized at the later of when the performance obligation is satisfied or the related sales occur. The Company considered LMI’s right to sublicense and develop the Tau protein PET tracers, and the fact that LMI could perform the research and development work themselves within the license term without AC Immune, to conclude that the license has stand-alone functionality and is distinct. The Company believes that the contracted amount represents the fair value. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

For the three months ended March 31, 2021 and 2020, we have recognized no revenues from this arrangement.

3.2

Grant income

Grants from the Michael J Fox Foundation

In Q3 2017, AC Immune formally signed a grant continuation with the MJFF. This grant provides funds for the development of PET tracers for pathological forms of the protein a-syn, to support the early diagnosis and clinical management of PD. We subsequently signed two additional grants that facilitated the execution of a first-in-human study for a potential a-syn-PET tracer (“PET tracer”) with the current lead compound and to further develop the PET tracer. The Company retains its IP rights for these a-syn-PET tracers. These grants concluded in Q2 2020.

In May 2020, the Company, as part of a joint arrangement with Skåne University Hospital (“Skåne”) in Sweden, was awarded a USD 3.2 (CHF 3.1) million grant from the MJFF’s Ken Griffin Alpha-synuclein Imaging Competition. As part of this grant, the Company is eligible to receive USD 2.5 (CHF 2.4) million directly from the MJFF. Skåne will receive USD 0.7 (CHF 0.7) million of the total grant directly from the MJFF over two years to conduct and support the clinical arm of the project.

The MJFF expects that the Company and Skåne will complete tasks according to the agreed timelines. The Company’s funding is variable depending on the satisfactory achievement of these specific tasks within a specific period of time.

For the three months ended March 31, 2021 and 2020, the Company has recognized CHF 0.4 million and CHF 0.1 million in grant income, respectively. As of March 31, 2021, the Company has recorded CHF 0.5 million as short-term deferred income.

Grant from the Target ALS Foundation

In Q1 2021, AC Immune was awarded a USD 0.3 (CHF 0.2) million grant from the Target ALS Foundation (“Target ALS”). This grant funds a collaboration between the Company and the Investigators at the Healey Center for ALS at Massachusetts General Hospital (“MGH”) to accelerate the development of the Company’s proprietary immunoassays to detect disease-associated forms of TDP-43 in CSF and blood samples.

For the three months ended March 31, 2021 and 2020, the Company recognized less than CHF 0.1 million and nil in grant income, respectively. As of March 31, 2021, the Company recorded CHF 0.2 million and CHF 0.1 million in short-term and long-term accrued income, respectively, and CHF 0.1 million as short-term and long-term deferred income, respectively.

Loss per share

	For the Three Months Ended March 31,
in CHF thousands except for share and per share data	2021			2020
Basic loss per share (EPS)
Numerator
Net loss attributable to equity holders of the Company		(16,734	)		(7,689	)
Denominator
Weighted-average number of shares outstanding used to compute EPS basic attributable to equity holders		72,305,949			71,864,213
Basic loss per share for the period attributable to equity holders		(0.23	)		(0.11	)

Diluted loss per share (EPS)
Numerator
Net loss attributable to equity holders of the Company		(16,734	)		(7,689	)
Denominator
Weighted-average number of shares outstanding to equity holders		72,305,949			71,864,213
Effect of dilutive securities from equity incentive plans		—			18,394
Weighted-average number of shares outstanding used to compute EPS diluted attributable to equity holders		72,305,949			71,882,607
Diluted loss per share for the period attributable to equity holders		(0.23	)		(0.11	)

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 March 31,
	2021		2020
Share options issued and outstanding		1,180,778		331,896
Restricted share awards subject to future vesting		14,711		154,195

Property, plant and equipment

The following table shows the movement in the net book values of property, plant and equipment for the three months ended March 31, 2021:

	As of March 31, 2021
in CHF thousands	Furniture			IT Equipment			Lab Equipment			Leasehold Improvements			Total
Acquisition Cost
Balance at December 31, 2020		214			1,497			7,958			464			10,133
Acquisitions		13			134			747			27			921
Disposals		—			—			(10	)		—			(10	)
Balance at March 31, 2021		227			1,631			8,695			491			11,044

Accumulated depreciation
Balance at December 31, 2020		(61	)		(970	)		(4,405	)		(281	)		(5,717	)
Depreciation expense		(11	)		(89	)		(322	)		(19	)		(441	)
Disposals		—			—			10			—			10
Balance at March 31, 2021		(72	)		(1,059	)		(4,717	)		(300	)		(6,148	)

Carrying Amount
December 31, 2020		153			527			3,553			183			4,416
March 31, 2021		155			572			3,978			191			4,896

AC Immune continues to enhance its laboratory equipment to support its R&D functions. This effort has continued since the year ended December 31, 2020, with CHF 0.9 million invested in lab and IT equipment, representing an increase of 9.3%. This is consistent with the Company’s long-term strategic plan.

Right-of-use assets and lease liabilities

AC Immune recognized additions of less than CHF 0.1 million for right-of-use of leased assets for the three months ended March 31, 2021.

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, 4.6% 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 three months ended March 31, 2021:

in CHF thousands	Buildings			Office Equipment			IT Equipment			Total
Balance as of December 31, 2020		2,106			63			54			2,223
Additions		—			42			—			42
Disposals		—			(11	)		—			(11	)
Depreciation		(99	)		(4	)		(4	)		(107	)
Balance as of March 31, 2021		2,007			90			50			2,147

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

For the three months ended March 31, 2021 and 2020, the impact on the Company’s statements of income/(loss) and statements of cash flows is detailed in the table below:

	For the Three Months Ended March 31,
in CHF thousands	2021		2020
Statements of income/(loss)
Depreciation of right-of-use assets		107		108
Interest expense on lease liabilities		14		14
Expense for short-term leases and leases of low value		187		141
Total		308		263

Statements of cash flows
Total cash outflow for leases		308		263

The Company’s statements of cash flow were impacted by a shift from cash generated from operations of CHF 0.1 million to the net cash used in financing activities for the three months ended March 31, 2021 and 2020, respectively.

The following table presents the contractual undiscounted cash flows for lease obligations as of March 31, 2021:

in CHF thousands	As of March 31, 2021
Less than one year		491
1-3 years		979
3-5 years		811
Total		2,281

Prepaid expenses

Prepaid expenses include predominantly prepaid R&D costs, administrative costs and net employee defined-benefit liability expenses totaling CHF 3.3 million and CHF 4.0 million as of March 31, 2021 and December 31, 2020, respectively.

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 March 31, 2021 and December 31, 2020:

	As of
in CHF thousands	March 31, 2021		December 31, 2020
Cash and cash equivalents		151,092		160,893
Total		151,092		160,893

	As of
in CHF thousands	March 31, 2021		December 31, 2020
Short-term financial assets due in one year or less		65,000		65,000
Total		65,000		65,000

For the three months ended March 31, 2021, no short-term financial assets matured. The Company also has two deposits in escrow accounts totaling CHF 0.3 million for the lease of the Company’s premises as of March 31, 2021 and December 31, 2020, respectively.

Share capital and public offerings

In September 2020, AC Immune established an “at the market offering program” for the sale of up to USD 80 (CHF 76) million worth of our common shares issued from time to time by entering into an Open Market Sales Agreement (“Sales Agreement”) with Jefferies LLC (“Jefferies”) as the sales agent.

In Q3 2020, the Company also issued 5,000,000 common shares with a par value of CHF 0.02, which were

held as treasury shares.

For the three months ended March 31, 2021, the Company sold 764,977 common shares previously held as treasury shares pursuant to the Sales Agreement, raising USD 8.8 (CHF 8.0) million, net of underwriting fees. We paid commissions to Jefferies totaling USD 0.3 (CHF 0.2) million. As a result of the sales, the Company has 4,235,023 treasury shares remaining.

10.

Finance result, net

For the three months ended March 31, 2021 and 2020, AC Immune recorded CHF 0.5 million in net financial gains and CHF 0.4 million in net financial losses, respectively. The Company recorded CHF 0.5 million in foreign currency gains compared to CHF 0.4 million in foreign currency losses in the prior period.

11.

Subsequent events

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

Exhibit 99.2

Management’s Discussion and Analysis of Financial Condition
and Results of Operations

This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited interim condensed financial information as of and for the three months ended March 31, 2021, included as Exhibit 99.1 to this Report on Form 6-K. We also recommend that you read our management’s discussion and analysis and our audited financial statements and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2020 on file with the US Securities and Exchange Commission (the “SEC”).

Unless otherwise indicated or the context otherwise requires, all references to “AC Immune” or the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to AC Immune SA.

We prepare and report our financial statements and financial information in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (the “IASB”). None of our financial statements were prepared in accordance with generally accepted accounting principles in the United States. We maintain our books and records in Swiss Francs (CHF). We have made rounding adjustments to some of the figures included in this management’s discussion and analysis. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that precede them. Unless otherwise indicated, all references to currency amounts in this discussion and analysis are in Swiss Francs.

This discussion and analysis is dated as of April 28, 2021.

Results of Operations

The Covid-19 global pandemic has impacted various countries in which AC Immune currently operates clinical trials and business operations. The extent to which Covid-19 may impact us will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the outbreak, the severity of Covid-19, or the effectiveness of actions to contain and treat Covid-19.

The Company continued to effect its business continuity plan during the interim period ended March 31, 2021. The Company implemented its plan quickly and continues to adapt as the situation evolves. Currently, we have mostly resumed normal operations at full capacity, with minimal disruption to our business. We are continuously assessing and adapting our working practices and business operations to ensure compliance with official guidance and orders related to the pandemic, and are working proactively with our partners and other stakeholders to take steps intended to mitigate and minimize any negative impact to our research, clinical programs and other business operations.

Many of our key trials are already fully enrolled and patient follow-up can continue remotely in most cases. However, the current pandemic may impact certain clinical trials as long as the pandemic is ongoing. Most notably:

ACI-35.030 for AD: The Company continues to collect data from the Phase 1b/2a study. The interim analysis of ACI-35.030 at the lowest dose (safety, tolerability and immunogenicity) was obtained in Q2 2020 and led to the initiation of the second highest dosing group in the Phase 1b/2a clinical trial. The interim analysis of this second highest dosing group (safety, tolerability and immunogenicity) was obtained in Q4 2020 and led to the initiation of the highest dosing group in the Phase 1b/2a clinical trial in Q1 2021. The initiation of these dosing groups of ACI-35.030 commenced in accordance with the underlying development plans.

ACI-3024: Our Phase 1 study for ACI-3024 in healthy young, elderly non-Japanese and Japanese volunteers was completed in 2020.

ACI-24 for Down syndrome (DS): The Company’s ACI-24 Phase 1b trial has been completed and the final analysis is ongoing.

The Regulatory submission of the ACI-24-DS Phase 2 trial was initiated as planned. The start of the clinical trial will be dependent on the evolving Covid-19 situation.

ACI-24 for AD: The Company continues to collect safety, immunogenicity and biomarker data from patients in the ongoing Phase 2 study of ACI-24. The 18-month interim data analysis is anticipated for the ongoing study in Q2 2021.

Crenezumab: In response to the government-imposed stay at home order in Colombia related to the Covid-19 pandemic, the dosing of participants in the Colombian API study was temporarily interrupted in H1 2020. The dosing restarted on May 18, 2020. Participants are receiving crenezumab or placebo for at least five years as part of the long-term prevention study, and despite the interruption, we continue to expect data from the study in Q1 2022.

PI-2620: The longitudinal Phase 2 study in AD and the Phase 1 test/re-test study in PSP enrolling patients in the UK were impacted by Covid-19 and Brexit and have been suspended. An investigator-initiated Phase 2 study in AD in Korea continues with a potential data analysis in Q2 2021. The Phase 1 PSP study may resume in Q2 2021 in the UK, depending on the ongoing Covid-19 pandemic, but a backup study is being also prepared in Germany which could begin in H2 2021.

The Company has drug supplies that are expected to be sufficient to complete ongoing trials as well as additional drug substance supplies expected to be sufficient to support ongoing cohorts of clinical trials for a period of at least three to six months. The Company will refrain from starting new clinical trials if a minimum of a six-month supply on hand cannot be secured. Finally, the Company currently does not expect delays to its clinical trials due to manufacturing or supply-chain issues.

Comparison of the three months ended March 31, 2021 and 2020

Contract revenues

AC Immune generated no contract revenues in the three months ended March 31, 2021, a decrease of CHF 12.3 million over the comparable period in 2020. The following table summarizes our revenues during the three months ended March 31, 2021 and 2020:

	For the Three Months Ended March 31,
in CHF thousands, unaudited	2021		2020		Change
Contract revenue		—		12,281		(12,281	)
Total revenues		—		12,281		(12,281	)

For the three months ended March 31, 2021, the Company recorded no contract revenues. The decrease compared with the prior period is predominantly related to:

a decrease of CHF 12.1 million in our agreement with Lilly. The Company recognized a CHF 10 million milestone as well as CHF 2.1 million for R&D activities in 2020.

Research and Development Expenses

Research and development (R&D) activities are essential to our business and represent the majority of our costs incurred. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using information from the clinical sites and our vendors. Our collaboration arrangements have different arrangements to share costs for the development of our product candidates. We have completed our R&D spending in both of our Genentech collaborations. We and Janssen are co-developing second-generation therapeutic vaccines, ACI-35.030 and JACI-35.054, through Phase 1b/2a completion. AC Immune and Janssen will jointly share research and development costs until the completion of the first Phase 2b (AC Immune’s contribution to the first Phase 2b trial is capped). From Phase 2b and onwards, Janssen will assume responsibility for the clinical development, manufacturing and commercialization of the vaccines. We expect to incur additional R&D expenditures associated with the expansion of our Morphomer Tau program into NeuroOrphan indications as well as an expansion of ACI-3024 to be evaluated in other rare Tauopathies. In addition to these arrangements, we expect that our total future R&D costs will continue to increase over current levels, in line with our three-pillar strategy that focuses on (i) AD, (ii) focused non-AD NDD including NeuroOrphan indications and (iii) diagnostics.

The table below provides a breakdown of our R&D costs, including direct R&D costs, manufacturing costs related to R&D and other R&D costs not allocated directly to programs. The R&D costs not allocated to specific programs include employment costs, regulatory, quality assurance and intellectual property (IP) costs. We do not assign our internal costs, such as salary and benefits, share-based compensation expenses, laboratory supplies, and other direct expenses and infrastructure costs to individual R&D projects, because the employees within our R&D groups are typically deployed across multiple research and development programs.

For the three months ended March 31, 2021, our R&D expenses totaled CHF 13.3 million, a decrease of CHF 1.9 million from CHF 15.2 million incurred during the comparable period. The following tables summarize our R&D expenses during the three months ended March 31, 2021 and 2020:

	For the Three Months Ended March 31,
In CHF thousands	2021		2020		Change
Discovery and preclinical expenses		4,940		3,769		1,171
Clinical expenses		2,143		6,245		(4,102	)
Group function expenses		285		111		174
Total Direct R&D		7,368		10,125		(2,757	)
Payroll expenses		4,500		3,763		737
Share-based compensation		316		303		13
Other non-allocated		1,145		1,018		127
Total R&D		13,329		15,209		(1,880	)

	For the Three Months Ended March 31,
in CHF thousands, unaudited	2021		2020		Change
Operating expenses¹		8,513		11,446		(2,933	)
Salaries and related costs²		4,816		3,763		1,053
Total R&D expenses		13,329		15,209		(1,880	)

	¹	Includes depreciation expense
	²	Includes share-based compensation expense

Discovery and preclinical expenses increased by CHF 1.2 million, primarily due to:

an increase in ACI-24 for DS of CHF 0.5 million for development costs associated with the optimized vaccine formulation, CHF 0.4 million for the expansion of our Morphomer Tau program into NeuroOrphan indications, CHF 0.3 million for the development of our anti-TDP-43 antibody with the initiation of investigational new drug-enabling studies, CHF 0.2 million for certain neuroinflammation investments and CHF 0.5 million for other discovery programs,

This was partially offset by:

a decrease of CHF 0.4 million in ACI-24 for AD based on completion of manufacturing process development and CHF 0.2 million for certain a-syn projects.

Clinical expenses decreased by CHF 4.1 million, primarily due to:

a decrease of CHF 1.8 million for Phase 1 activities for our Morphomer Tau compound which completed in 2020, CHF 1.0 million for ACI-24 for DS as a result of prior period scaling up activities for a Phase 2 clinical trial which were not repeated in the current period, CHF 0.9 million for ACI-35.030 related to reduced costs in accordance with our R&D costs sharing arrangement with Janssen as well as the non-repetition of certain clinical activities for the current Phase 1b/2a, and CHF 0.6 million for ACI-24 for AD as the six-month safety period completes.

The variances in Group function expenses relate to regulatory and quality assurance, IP and other non-allocated costs. The variances in Other non-allocated expenses relate to administrative R&D and certain non-allocated functional expenses.

Total salaries and related costs increased by CHF 1.1 million, primarily due to:

an increase in salary- and benefit-related costs of CHF 1.0 million primarily related to the internal reallocation of certain employees’ salaries and annualization of 2020 hires; and

higher share-based compensation expense of less than CHF 0.1 million related predominantly to an increase of stock options issued to employees.

General and administrative expenses

General and administrative expenses consist primarily of salaries and related costs, including share-based compensation, professional fees such as legal and accounting related services, infrastructure expenses, and other operating expenses.

For the three months ended March 31, 2021, our general and administrative expenses totaled CHF 4.3 million, a decrease of CHF 0.2 million from CHF 4.5 million incurred during the comparable period. The following table summarizes our general and administrative expenses for the three months ended March 31, 2021 and 2020:

	For the Three Months Ended March 31,
in CHF thousands, unaudited	2021	2020	Change
Operating expenses¹	1,945	1,737	208
Salaries and related costs²	2,393	2,767	(374	)
Total general and administrative expenses	4,338	4,504	(166	)

	¹	Includes depreciation expense
	²	Includes share-based compensation expense

This decrease is primarily due to:

a decrease in salary- and benefit-related costs of CHF 0.4 million primarily related to the internal reallocation of certain employees’ salaries; and

a decrease of CHF 0.1 million in travel expenditures.

This was partially offset by;

an increase in our directors and officers insurance of CHF 0.3 million for the period.

Finance result, net

The following table presents the net financial result during the three months ended March 31, 2021 and 2020:

	For the Three Months Ended March 31,
in CHF thousands, unaudited	2021		2020	Change
Financial income	—		59	(59)
Financial expense	(26	)	(57)	31
Exchange differences	543		(389)	932
Finance result, net	517		(387)	904

Net finance result was a gain, primarily related to:

a CHF 0.9 million increase in exchange difference, primarily related to a favorable movement in the USD-CHF exchange rate during the period as well as the non-repetition of a CHF 0.1 million loss on a forward contract.

Liquidity and Capital Resources

To date, AC Immune has financed its cash requirements primarily from its public offerings, share issuances, contract revenues from licensing 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. As of March 31, 2021, we had cash and cash equivalents of CHF 151.1 million and short-term financial assets of CHF 65 million for a total liquidity balance of CHF 216.1 million.

Our primary uses of capital are, and we expect will continue to be, R&D expenses, compensation and related expenses, and other operating expenses including rent. Cash and cash equivalents used to fund operating expenses are impacted by the timing of when we pay expenses, as reflected in the change in our outstanding accounts payable and accrued expenses. We expect to incur substantial expenses in connection with a number of our product candidates in various stages of clinical development. We and Janssen are co-developing second-generation therapeutic vaccines, ACI-35.030 and JACI-35.054, through Phase 1b/2a completion. AC Immune and Janssen will jointly share research and development costs until the completion of the first Phase 2b (AC Immune’s contribution to the first Phase 2b trial is capped). From Phase 2b and onwards, Janssen will assume responsibility for the clinical development, manufacturing and commercialization of the vaccines. We expect to incur additional R&D expenditures associated with the expansion of our Morphomer Tau program into NeuroOrphan indications as well as an expansion of ACI-3024 to be evaluated in other rare Tauopathies.

We plan to continue to fund our operating and capital funding needs through proceeds received from licensing and collaboration agreements (LCAs) and through equity or other forms of financing. For example, in September 2020 we entered into the Open Market Sales Agreement (“Sales Agreement”) with Jefferies LLC (“Jefferies”), which provides that, upon the terms and subject to the conditions and limitations set forth in the Sales Agreement, we may elect to issue and sell, from time to time, shares of our common shares having an aggregate offering price of up to USD 80 (CHF 76) million through Jefferies acting as our sales agent. Under the Sales Agreement, Jefferies may sell the shares of common shares by any method permitted by law deemed to be an “at the market offering” as defined under the Securities Act of 1933, as amended, in privately negotiated transactions with our consent or in block transactions. Jefferies will use commercially reasonable efforts to sell the shares of common shares subject to the Sales Agreement from time to time, consistent with its normal sales and trading practices, on mutually agreed terms. We will pay Jefferies a commission of up to 3.0% of the gross sales proceeds of any common shares sold through Jefferies under the Sales Agreement. We are not obligated to make any sales of common shares under the Sales Agreement, and we have not yet sold any common shares pursuant to the Sales Agreement.

We may also consider entering into additional LCAs and selectively partnering for clinical development and commercialization.

Cash Flows

The following table summarizes AC Immune’s cash flows for the periods indicated:

	For the Three Months Ended March 31,
in CHF thousands, unaudited	2021		2020		Change
Net cash provided by/(used in):
Operating activities	(17,339	)	(9,687	)	(7,652	)
Investing activities	(790	)	(212	)	(578	)
Financing activities	7,707		(374	)	8,081
Net decrease in cash and cash equivalents	(10,422	)	(10,273	)	(149)

Operating activities

Net cash used in operating activities was CHF 17.3 million for the three months ended March 31, 2021, compared with net cash used in operating activities of CHF 9.7 million for the three months ended March 31, 2020. The change in cash used in operating activities for the three months ended March 31, 2021 was due to the Company’s reporting a net loss of CHF 16.7 million for the three months ended March 31, 2021, compared with a net loss of CHF 7.7 million for the same period in 2020, driven by (i) a decrease of CHF 12.3 million in contract revenues, principally due to the recognition of a CHF 10 million milestone payment and CHF 2.1 million for R&D activities associated with our agreement with Lilly in the prior period, which did not repeat in the current period, partially offset by (ii) a CHF 1.9 million decrease in R&D costs for the three months ended March 31, 2021.

Investing activities

Net cash used in investing activities was CHF 0.7 million for the three months ended March 31, 2021, compared with net cash used in investing activities of CHF 0.2 million for the three months ended March 31, 2020. The variance relates to an increase in fixed asset purchases.

Financing activities

Net cash provided by financing activities was CHF 7.7 million for the three months ended March 31, 2021, compared with net cash used in financing activities of CHF 0.4 million for the three months ended March 31, 2020. The increase of CHF 8.1 million was predominantly related to CHF 8.0 million received from the sale of common shares that were previously held as treasury shares in accordance with our at the market offering (“ATM”) program, net of underwriting fees.

Operating Capital Requirements and Plan of Operations

We do not expect to generate revenues from royalties based on product sales unless and until our partners obtain regulatory approval of, and successfully commercialize, our current or any future product candidates. As of March 31, 2021, we had cash and cash equivalents of CHF 151.1 million and short-term financial assets of CHF 65 million, resulting in CHF 216.1 million of liquidity. The decrease relative to December 31, 2020 was predominantly related to R&D spending on our major discovery and R&D programs, and the strengthening of the Company’s infrastructure, systems and organization. This was offset by the receipt of CHF 8.0 million, net of underwriting fees, for the sale of 764,977 of our common shares that were previously held as treasury shares in accordance with our ATM program. There can be no certainty as to the exact timing of future milestone payments, or in fact, whether any of these will ever be made, given that they are contingent on clear milestones being reached. Accordingly, assuming that we do not receive potential milestone payments and based upon our currently contemplated R&D strategy, we believe that our existing capital resources will be sufficient to meet our projected operating requirements through Q1 2024.

We expect to generate losses for the foreseeable future, and these losses could increase as we continue product development until we successfully achieve regulatory approvals for our product candidates and begin to commercialize any approved products. We are subject to all the risks pertinent to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. We expect to incur additional costs associated with operating a public company and we anticipate that we will need substantial additional funding in connection with our continuing operations. If we need to raise additional capital to fund our operations and complete our ongoing and planned clinical studies, funding may not be available to us on acceptable terms, or at all.

Our future funding requirements will depend on many factors, including, but not limited to, the following:

the scope, rate of progress, results and cost of our preclinical and clinical studies and of other related activities, according to our long-term strategic plan;

the cost of manufacturing clinical supplies and establishing commercial supplies of our product candidates and any other products we may develop;

the cost, timing and outcomes of regulatory approvals;

the cost and timing of establishing sales, marketing and distribution capabilities;

the terms and timing of any collaborative, licensing and other arrangements that we may establish, including any required milestone and royalty payments thereunder;

the emergence of competing technologies or other adverse market developments; and

the potential cost, timing and outcomes of managing, protecting, defending and enforcing our portfolio of IP.

Quantitative and Qualitative Disclosures about Market Risk

During the three months ended March 31, 2021, there were no significant changes to our quantitative and qualitative disclosures about market risk described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Quantitative and Qualitative Disclosures About Market Risk” in the Annual Report on Form 20-F.

Critical Judgments and Accounting Estimates

There have been no material changes to the significant accounting policies and estimates described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Judgments and Accounting Estimates” in the Annual Report on Form 20-F.

Jumpstart our Business Startups Act Exemption

On April 5, 2012, the Jumpstart our Business Startups Act of 2012, (“the JOBS Act”), was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an “emerging growth company.” As an emerging growth company, we are not required to provide an auditor attestation report on our system of internal controls over financial reporting. This exemption will apply for a period of five years following the completion of our initial public offering (through 2021) or until we no longer meet the requirements of being an emerging growth company, whichever is earlier. We would also cease to be an emerging growth company if (i) we have more than USD 1.07 billion in annual revenue; (ii) we are deemed to be a “large accelerated filer” under the rules of the Securities Exchange Commission, which means that the market value of our common shares that are held by non-affiliates exceeds USD 700 million as of the most recently completed second fiscal quarter; or (iii) we have issued more than USD 1.0 billion in non-convertible debt during the prior three-year period.

Non-IFRS Financial Measures

In addition to our operating results, as calculated in accordance with International Financial Reporting Standards, or IFRS, as adopted by the International Accounting Standards Board, we use adjusted loss and adjusted loss per share when monitoring and evaluating our operational performance. Adjusted loss is defined as loss for the relevant period, as adjusted for certain items that we believe are not indicative of our ongoing operating performance. Adjusted loss per share is defined as adjusted loss for the relevant period divided by the weighted-average number of shares for such period.

We believe that these measures assist our shareholders because they enhance comparability of our results each period and provide more useful insight into operational results for the period. The Company’s executive management uses these non-IFRS measures to evaluate our operational performance. These non-IFRS financial measures are not meant to be considered alone or as substitutes for our IFRS financial measures and should be read in conjunction with AC Immune’s financial statements prepared in accordance with IFRS. The most directly comparable IFRS measure to these non-IFRS measures is net loss. The following table reconciles net loss to adjusted loss and adjusted loss per share for the periods presented:

Reconciliation of Loss to Adjusted Loss and
Loss Per Share to Adjusted Loss Per Share

	For the Three Months Ended March 31,
(in CHF thousands except for share and per share data)	2021			2020
Loss		(16,734	)		(7,689	)
Adjustments
Non-cash share-based payments¹		857			852
Foreign currency (gains)/losses²		(621	)		454
Adjusted Loss		(16,498	)		(6,383	)
Loss per share – basic		(0.23	)		(0.11	)
Loss per share – diluted		(0.23	)		(0.11	)
Adjustment to loss per share – basic		0.00			0.02
Adjustment to loss per share – diluted		0.00			0.02
Adjusted loss per share – basic		(0.23	)		(0.09	)
Adjusted loss per share – diluted		(0.23	)		(0.09	)
Weighted-average number of shares outstanding Adjusted loss –basic		72,305,949			71,864,213
Weighted-average number of shares outstanding Adjusted loss –diluted		72,305,949			71,882,607

	¹	Reflects non-cash expenses associated with share-based compensation for equity awards issued to Directors, Management and employees of the Company. This expense reflects the awards’ fair value recognized for the portion of the equity award which is vesting over the period.
	²	Reflects foreign currency re-measurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and Euro with the Swiss Franc.

Adjustments for the three months ended March 31, 2021 and March 31, 2020 decreased net loss by CHF 0.2 million and CHF 1.3 million, respectively. The Company recorded CHF 0.9 million for share-based compensation expenses, respectively. There were foreign currency re-measurement gains of CHF 0.6 million compared to foreign currency re-measurement losses of CHF 0.5 million, respectively, primarily related to a favorable movement in the USD-CHF exchange rate during the period as well as the non-repetition of a CHF 0.1 million loss on a forward contract.

Cautionary Statement Regarding Forward-Looking Statements

This discussion and analysis contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this discussion and analysis, including statements regarding our future results of operations and financial position, business strategy, product candidates, product pipeline, ongoing and planned clinical studies, including those of our collaboration partners, regulatory approvals, R&D costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Many of the forward-looking statements contained in this prospectus can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “will” and “potential,” among others. Forward-looking statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under the section entitled “Risk Factors” in our Annual Report on Form 20-F, including the impact of Covid-19 on our business, suppliers, patients and employees, and any other impact of Covid-19. These forward-looking statements speak only as of the date of this discussion and analysis, and are subject to a number of risks, uncertainties and assumptions as described under the sections in our Annual Report on Form 20-F entitled “Risk Factors” and in this discussion and analysis. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time such as the global pandemic originating with Covid-19, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Exhibit 99.3

Press Release

AC Immune Reports First Quarter 2021 Financial Results
and Provides Corporate Update

Reported potent interim immunogenicity results for anti-pTau Alzheimer’s vaccine in ongoing Phase 1b/2a study, which support further development into Phase 2/3

Initiated first-in-human clinical study for next-generation alpha-synuclein PET diagnostic with results expected in Q3 2021

Advanced multiple candidates targeting the NLRP3 inflammasome pathway for CNS and non-CNS indications

Strong financial position of CHF 216.1 million in cash ensures the Company is fully financed through at least Q1 2024

Lausanne, Switzerland, April 28, 2021 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today reported its financial results for the quarter ended March 31, 2021. The Company also provided an overview of its recent clinical and corporate highlights and anticipated milestones for 2021.

Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “Our clinical and R&D accomplishments over the last quarter serve to strengthen our leadership in precision medicine for neurodegenerative diseases. Encouraging clinical results from both of our Alzheimer’s vaccine programs further reinforce our belief that early intervention, and ultimately prevention, using vaccines represents a key strategy in neurodegenerative diseases. To enable this strategy, we are advancing our suite of novel diagnostics, such as our alpha-synuclein imaging agent, which recently entered the clinic in Parkinson’s disease. Our vision is to address the heterogeneity of neurodegenerative diseases by pairing earlier, more accurate diagnosis with highly selective treatments that address the right proteinopathy, in the right patient, at the right time.”

Prof. Pfeifer continued: “We are poised to achieve four additional clinical readouts in 2021, as we continue progressing our first-in-class preclinical programs addressing alpha-synuclein, TDP-43, and NLRP3-ASC towards the clinic, driving significant future value creation.

Q1 2021 Highlights

Clinical and R&D

▪

Reported encouraging top line results from a first-of-its-kind Phase 1b study of anti-Abeta vaccine candidate ACI-24 in people with Down syndrome (DS). These results support further development in Down syndrome-related Alzheimer’s disease (AD). AC Immune also reported promising preclinical results for an optimized anti-Abeta vaccine formulation, for which it expects to file an investigational new drug application (IND) in Q4 2021.

▪

Reported promising interim Phase 1b/2a results for ACI-35.030, a novel anti-phospho-Tau (pTau) vaccine candidate, showing strong safety and high titers of antigen-specific antibodies in 100% of older patients with early Alzheimer’s disease. The study is currently

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enrolling patients into the highest dose group, with further clinical readouts expected this year.

▪

Advanced next-generation alpha-synuclein positron emission tomography (PET) tracer candidate, ACI-12589, into a first-in-human clinical study, with an expected data readout in Q3 2021

▪

Identified and characterized the first biologically active small molecule Morphomer™ alpha-synuclein aggregation inhibitors, which significantly decreased alpha-synuclein aggregate formation in cellular assays by interfering with the fibrillation process

▪

Reported key advancements for several therapeutic programs targeting the (NOD)-like receptor protein 3 (NLRP3) inflammasome, including small molecule inhibitors, which showed the first evidence of in vivo activity in a model of peripheral inflammation, as well as high-affinity monoclonal antibodies that bind extracellular components of the NLRP3 pathway and inhibit inflammasome-mediated immune response in vitro

Thought leadership

▪

Co-sponsored a virtual Global Down Syndrome Forum that brought together thought leaders on Down syndrome and Down syndrome-related Alzheimer’s disease to discuss the unmet need and underlying causes of this important health challenge, as well as the broader implications for clinical development in other Alzheimer’s disease populations.

▪

Hosted a comprehensive webinar focusing on the Company’s proprietary Morphomer™ platform underlying the generation of therapeutic and diagnostic small molecules, which featured presentations and a Q&A session with members of AC Immune’s Management and R&D Teams.

Strengthening of Board

▪

Welcomed Dr. Alan Colowick, an experienced biotech and investment executive, to the Company’s Board of Directors

Achieved and Anticipated 2021 milestones

Clinical Milestones

▪

ACI-35.030 anti-pTau vaccine: reported Phase 1b/2a in AD interim results in Q1 (second highest dose); further Phase 1b/2a interim analysis in Q4 (highest dose)

▪

JACI-35.054 alternative anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2 (low dose)

▪

Alpha-synuclein PET imaging agent: advanced third-generation candidate to first-in-human clinical study in Q1; readout expected in Q3

▪

ACI-24 anti-Abeta vaccine in DS: reported Phase 1b top line results in Q1; to present further study results at the Alzheimer's Association International Conference^® 2021 in Q3

▪

ACI-24 in AD: reported Phase 2, 12-month interim analysis in Q1; 18-month interim analysis in Q2

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▪

Semorinemab anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in moderate AD in Q2

▪

ACI-3024 small molecule Morphomer^TM Tau aggregation inhibitor: select NeuroOrphan indication for further development in Q2

▪

ACI-24 in DS: submit investigational new drug (IND) application for optimized vaccine formulation in Q4

Preclinical Milestones

▪

Alpha-synuclein small molecule inhibitor: identified first biologically active small molecule in Q1; start in vivo proof-of-concept studies in Q3

▪

TDP-43 imaging agent: initiate investigational new drug (IND)-enabling studies in Q3

▪

Morphomer™ NLRP3-ASC: report in vivo proof-of-concept results in a non-central nervous system (CNS) disease model and begin in vivo proof-of-concept studies with validated candidate in CNS in Q4

▪

Anti-NLRP3-ASC antibody: begin in vivo proof-of-concept studies in Q4

▪

Anti-TDP-43 antibody: initiate IND-enabling toxicology studies in Q4

▪

TDP-43 biofluid diagnostic: establish validation-ready assay in Q4

Therapeutic and Diagnostic Pipeline Overview

On March 23, 2021, the Company provided a comprehensive overview highlighting strong progress across its clinical and preclinical development pipeline. This supplemental material can be viewed and downloaded in the investor section of the Company’s website.

Analysis of Financial Statements for the quarter ended March 31, 2021

▪

Cash Position: The Company had a total cash balance of CHF 216.1 million, composed of CHF 151.1 million in cash and cash equivalents and CHF 65 million in short-term financial assets. This compares to a total cash balance of CHF 225.9 million as of December 31, 2020. The Company’s cash balance provides enough capital resources to progress through at least Q1 2024 without potential incoming milestone payments.

▪

Contract Revenues: The Company did not record contract revenues for the three months ended March 31, 2021, a decrease of CHF 12.3 million from the comparable period. The decrease is predominantly related to a CHF 10 million milestone payment as well as CHF 2.1 million in R&D activities recognized in 2020, which did not repeat.

▪

R&D Expenditures: R&D expenses decreased by CHF 1.9 million for the three months ended March 31, 2021 to CHF 13.3 million.

Discovery and preclinical expenses (+1.2 million): The Company increased expenditures across a variety of its discovery and preclinical programs. These include investments to advance the optimized formulation of our ACI-24 vaccine, the expansion of our Morphomer™ Tau program into NeuroOrphan indications and various other investments across our programs.

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Clinical expenses (-4.1 million): The Company decreased expenditures across multiple clinical programs, as certain clinical activities completed or incurred significant scaling up in the prior period. For example, the Company completed its clinical activities to complete the Phase 1 trial of our Morphomer™ Tau asset in partnership with Lilly. Additionally, the Company incurred less expense for ACI-24 for DS-related AD as a result of prior period scaling up activities for a Phase 2 clinical trial which were not repeated in the current period.

Salary- and benefit-related costs (+1.1 million): The Company’s salary- and benefit-related costs increased primarily due to the internal reallocation of certain employees’ salaries and annualization of 2020 hires and increases in share-based compensation

▪

G&A Expenditures: For the three months ended March 31, 2021, G&A decreased by CHF 0.2 million to 4.3 million. This decrease is predominantly related to the internal reallocation of certain employees’ salaries.

▪

Other Operating Income: The Company recognized CHF 0.4 million in grant income for R&D activities performed under our MJFF and Target ALS grants, an increase of CHF 0.3 million compared to the prior period

▪

IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 16.7 million for the three months ended March 31, 2021, compared with net loss of CHF 7.7 million for the comparable period in 2020

2021 Financial Guidance

For the full year 2021, the Company expects its total cash burn to range between CHF 65 million ‒75 million.

About AC Immune SA

AC Immune SA is clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen^TM and Morphomer^TM, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features nine therapeutic and three diagnostic candidates, six of which are currently in clinical trials. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company, and Janssen Pharmaceuticals, Inc., resulting in substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments.

For further information, please contact:

Head of Investor Relations and
Corporate Communications

Joshua Drumm, Ph.D.

AC Immune

Phone : +1 917 809 0814

Email: [email protected]

U.S. Media

Katie Gallagher

LaVoie Health Science

Phone: +1 617 792 3937

Email: [email protected]

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European Investors & Media

Chris Maggos

LifeSci Advisors

Phone : +41 79 367 6254

Email : [email protected]

Forward-looking statements

This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

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Balance Sheets

(In CHF thousands)

	As of March 31, 2021			As of December 31, 2020
ASSETS
Non-current assets
Property, plant and equipment		4,896			4,416
Right-of-use assets		2,147			2,223
Long-term accrued income		93			—
Long-term financial assets		334			334
Total non-current assets		7,470			6,973
Current assets
Prepaid expenses		3,330			3,954
Short-term accrued income		688			1,591
Other current receivables		379			329
Short-term financial assets		65,000			65,000
Cash and cash equivalents		151,092			160,893
Total current assets		220,489			231,767
Total assets		227,959			238,740

SHAREHOLDERS’ EQUITY AND LIABILITIES
Shareholders’ equity
Share capital		1,539			1,538
Share premium		354,736			346,890
Treasury shares		(85	)		(100	)
Accumulated losses		(148,774	)		(132,850	)
Total shareholders’ equity		207,416			215,478

Non-current liabilities
Long-term deferred income		93			—
Long-term lease liabilities		1,706			1,780
Net employee defined-benefit liabilities		7,619			7,464
Total non-current liabilities		9,418			9,244

Current liabilities
Trade and other payables		370			2,184
Accrued expenses		9,734			11,085
Short-term deferred income		580			306
Short-term lease liabilities		441			443
Total current liabilities		11,125			14,018
Total liabilities		20,543			23,262
Total shareholders’ equity and liabilities		227,959			238,740

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Statements of Income/(Loss)

(In CHF thousands, except for per-share data)

	For the Three Months Ended March 31,
	2021			2020
Revenue
Contract revenue		—			12,281
Total revenue		—			12,281

Operating expenses
Research & development expenses		(13,329	)		(15,209	)
General & administrative expenses		(4,338	)		(4,504	)
Other operating income/(expense)		416			130
Total operating expenses		(17,251	)		(19,583	)
Operating loss		(17,251	)		(7,302	)

Financial income		—			59
Financial expense		(26	)		(57	)
Exchange differences		543			(389	)
Finance result, net		517			(387	)
Loss before tax		(16,734	)		(7,689	)
Income tax expense		—			—
Loss for the period		(16,734	)		(7,689	)
Loss per share:
Basic and diluted loss for the period attributable to equity holders		(0.23	)		(0.11	)

Statements of Comprehensive Income/(Loss)

(In CHF thousands)

	For the Three Months Ended March 31,
	2021			2020
Loss for the period		(16,734	)		(7,689	)
Other comprehensive loss not to be reclassified to income or loss in subsequent periods (net of tax):
Re-measurement losses on defined-benefit plans (net of tax)		—			—
Total comprehensive loss, net of tax		(16,734	)		(7,689	)

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Reconciliation of loss to adjusted loss and
loss per share to adjusted loss per share

	For the Three Months Ended March 31,
In CHF thousands, except for share and per share data	2021			2020
Loss		(16,734	)		(7,689	)
Adjustments
Non-cash share-based payments¹		857			852
Foreign currency (gains)/losses²		(621	)		454
Adjusted Loss		(16,498	)		(6,383	)

Loss per share – basic		(0.23	)		(0.11	)
Loss per share – diluted		(0.23	)		(0.11	)
Adjustment to loss per share – basic		0.00			0.02
Adjustment to loss per share – diluted		0.00			0.02
Adjusted loss per share – basic		(0.23	)		(0.09	)
Adjusted loss per share – diluted		(0.23	)		(0.09	)
Weighted-average number of shares outstanding Adjusted loss –basic		72,305,949			71,864,213
Weighted-average number of shares outstanding Adjusted loss –diluted		72,305,949			71,882,607

	¹	Reflects non-cash expenses associated with share-based compensation for equity awards issued to Directors, Management and employees of the Company. This expense reflects the awards’ fair value recognized for the portion of the equity award which is vesting over the period.
	²	Reflects foreign currency re-measurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and Euro with the Swiss Franc.

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