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AC Immune Progress Update on Phase 2 Active Immunotherapy Clinical Pipeline for Alzheimer's and Parkinson diseases
Newsfilter· 2024-01-03 13:10
AC Immune Progress Update on Phase 2 Active Immunotherapy Clinical Pipeline for Alzheimer's and Parkinson diseases ABATE Phase 1b/2 AD trial of ACI-24.060 completed enrollment of cohorts 1 and 2 and is expected to complete cohort 3 in January; 6-month and 12-month amyloid PET data expected in H1 & H2 2024, respectivelyReTain Phase 2b clinical trial of ACI-35.030 in preclinical AD being launched now by partner VacSYn Phase 2 PD trial of ACI-7104.056 completed enrollment of cohort 1 and commenced cohort 2; sa ...
AC Immune(ACIU) - 2023 Q3 - Quarterly Report
2023-11-02 16:00
Exhibit 99.1 Condensed Consolidated Balance Sheets (Unaudited) (In CHF thousands) As of September 30, December 31, Note 2023 2022 Assets Non-current assets Property, plant and equipment 5 3,627 4,259 Right-of-use assets 6 2,403 2,808 Intangible asset 9 50,416 50,416 Long-term financial assets 6 361 361 Total non-current assets 56,807 57,844 Current assets Prepaid expenses 10 5,534 4,708 Accrued income 3 312 408 Other current receivables 406 392 Short-term financial assets 11 48,000 91,000 Cash and cash equi ...
AC Immune(ACIU) - 2023 Q2 - Quarterly Report
2023-08-03 16:00
Exhibit 99.1 Condensed Consolidated Balance Sheets (Unaudited) (In CHF thousands) As of June 30, December 31, Note 2023 2022 Assets Non-current assets Property, plant and equipment 5 3,760 4,259 Right-of-use assets 6 2,539 2,808 Intangible asset 9 50,416 50,416 Long-term financial assets 6 361 361 Total non-current assets 57,076 57,844 Current assets Prepaid expenses 10 5,167 4,708 Accrued income 3 675 408 Other current receivables 303 392 Short-term financial assets 11 53,000 91,000 Cash and cash equivalen ...
AC Immune(ACIU) - 2023 Q1 - Quarterly Report
2023-04-27 16:00
Exhibit 99.1 Condensed Consolidated Balance Sheets (Unaudited) (In CHF thousands) As of March 31, December 31, Note 2023 2022 Assets Non-current assets Property, plant and equipment 5 4,011 4,259 Right-of-use assets 6 2,674 2,808 Intangible asset 8 50,416 50,416 Long-term financial assets 6 361 361 Total non-current assets 57,462 57,844 Current assets Prepaid expenses 9 5,438 4,708 Accrued income 3 218 408 Other current receivables 598 392 Short-term financial assets 10 48,000 91,000 Cash and cash equivalen ...
AC Immune(ACIU) - 2022 Q4 - Annual Report
2023-03-15 16:00
, UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ...
AC Immune(ACIU) - 2022 Q3 - Quarterly Report
2022-10-27 16:00
Financial Performance - Total revenue for the nine months ended September 30, 2022, was CHF 3,934,000, compared to CHF 0 for the same period in 2021[4] - Operating loss for the three months ended September 30, 2022, was CHF 13,463,000, a decrease from CHF 20,283,000 in the same period of 2021, representing a 33.5% improvement[4] - The company reported a loss for the period of CHF 52,004,000 for the nine months ended September 30, 2022, compared to a loss of CHF 51,720,000 for the same period in 2021[5] - The basic and diluted loss per share for the nine months ended September 30, 2022, was CHF 0.62, compared to CHF 0.71 for the same period in 2021[4] - The company recorded a total comprehensive loss of CHF 44,373,000 for the nine months ended September 30, 2022, compared to CHF 51,720,000 for the same period in 2021, showing an improvement of approximately 14.3%[5] - The net loss attributable to equity holders for the three months ended September 30, 2022, was CHF 13.5 million, compared to CHF 15.9 million for the same period in 2021, resulting in a basic and diluted loss per share of CHF 0.16[37] - The net loss attributable to equity holders for the nine months ended September 30, 2022, was CHF 52 million, slightly higher than CHF 51.7 million for the same period in 2021, with a basic and diluted loss per share of CHF 0.62[37] Assets and Liabilities - Total shareholders' equity decreased to CHF 190,054,000 as of September 30, 2022, down from CHF 231,979,000 at the end of 2021, reflecting a decline of approximately 17.9%[1] - Cash and cash equivalents decreased to CHF 44,503,000 as of September 30, 2022, from CHF 82,216,000 at the end of 2021, indicating a reduction of 45.1%[2] - Total current liabilities decreased to CHF 13,600,000 as of September 30, 2022, from CHF 20,026,000 at the end of 2021, a reduction of 32.1%[3] - Total non-current assets decreased to CHF 57,955,000 as of September 30, 2022, from CHF 58,809,000 at the end of 2021, a decline of 1.4%[2] - As of September 30, 2022, accrued expenses totaled CHF 10.976 million, down from CHF 16.736 million as of December 31, 2021[48] - Prepaid expenses totaled CHF 2.9 million as of September 30, 2022, slightly down from CHF 3.0 million as of December 31, 2021[50] - Short-term financial assets due in one year or less amounted to CHF 96.0 million as of September 30, 2022, compared to CHF 116.0 million as of December 31, 2021[51] Cash Flow and Operating Activities - Cash used in operating activities for the nine months ended September 30, 2022, was CHF 55.8 million, an increase from CHF 47.5 million in the same period of 2021[8] - Net cash flows used in operating activities for the nine months ended September 30, 2022, amounted to CHF 56.2 million, compared to CHF 47.9 million in the prior year[8] - The net decrease in cash and cash equivalents for the nine months ended September 30, 2022, was CHF 38.6 million, compared to CHF 67.8 million in the same period of 2021[8] - Cash and cash equivalents at September 30, 2022, were CHF 44.5 million, down from CHF 93.6 million at the same time in 2021[8] - The company believes it can meet all obligations for at least 12 months from September 30, 2022, with a cash position of CHF 44.5 million and short-term financial assets of CHF 96.0 million[22] Research and Development - Research and development expenses for the nine months ended September 30, 2022, were CHF 45,200,000, an increase from CHF 42,158,000 in the same period of 2021[4] - The company recognized EUR 4 million (CHF 3.9 million) in contract revenue for the milestone achievement related to the Tau PET Tracer PI-2620 in Alzheimer's disease development[31] - The company received follow-on grant funding totaling USD 0.5 million (CHF 0.5 million) for the development of its alpha-synuclein PET imaging diagnostic agent, with USD 0.4 million (CHF 0.4 million) coming directly from the Michael J. Fox Foundation[33] - For the nine months ended September 30, 2022, the company recognized CHF 0.8 million in grant income, consistent with the previous year[34] Investments and Financial Gains - The company invested CHF 0.8 million in laboratory and IT equipment, representing a 7.0% increase from the beginning of the year[40] - The company recorded net financial losses of less than CHF 0.1 million for the three months ended September 30, 2022, compared to net financial gains of CHF 4.4 million in the same period of 2021[53] - For the nine months ended September 30, 2022, net financial gains were CHF 0.2 million, significantly lower than CHF 4.5 million recorded in the prior year[54] Other Information - The company had short-term financial assets of CHF 20.0 million as of September 30, 2022, compared to a net decrease of CHF 30.0 million in the prior year[8] - The company has 6,221,617 treasury shares remaining as of September 30, 2022[52] - There were no subsequent events after the balance sheet date that warrant disclosure or recognition in the Interim Condensed Consolidated Financial Statements[55]
AC Immune(ACIU) - 2022 Q2 - Quarterly Report
2022-07-27 16:00
Exhibit 99.1 The accompanying notes are an integral part of these Interim Condensed Consolidated Financial Statements (Unaudited). Condensed Consolidated Balance Sheets (Unaudited) (in CHF thousands) Balance Sheets Notes As of June 30, 2022 | --- | --- | --- | --- | |----------------------------------------------------|-------|-----------|-----------| | | | | 2021 | | ASSETS | | | | | Non-current assets | | | | | Property, plant and equipment | 5 | 4,997 | 5,116 | | Right-of-use assets | 6 | 2,632 | 2,914 | ...
AC Immune(ACIU) - 2022 Q1 - Quarterly Report
2022-04-27 16:00
Interim Condensed Consolidated Financial Statements (Unaudited) [Condensed Consolidated Balance Sheets (Unaudited)](index=1&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) As of March 31, 2022, the company's total assets were CHF 235.5 million, a decrease from CHF 261.4 million at the end of 2021, primarily driven by a reduction in cash and cash equivalents, while total shareholders' equity also decreased to CHF 214.1 million from CHF 232.0 million, mainly due to accumulated losses during the period Condensed Consolidated Balance Sheet Summary (in CHF thousands) | Balance Sheet Items | As of March 31, 2022 | As of December 31, 2021 | | :--- | :--- | :--- | | **Total Assets** | **235,519** | **261,443** | | Total non-current assets | 58,461 | 58,809 | | Total current assets | 177,058 | 202,634 | | *Cash and cash equivalents* | *57,835* | *82,216* | | **Total Shareholders' Equity and Liabilities** | **235,519** | **261,443** | | **Total Shareholders' Equity** | **214,131** | **231,979** | | *Accumulated losses* | *(218,793)* | *(200,942)* | | **Total Liabilities** | **21,388** | **29,464** | | Total non-current liabilities | 9,477 | 9,438 | | Total current liabilities | 11,911 | 20,026 | [Condensed Consolidated Statements of Income/(Loss) (Unaudited)](index=2&type=section&id=Condensed%20Consolidated%20Statements%20of%20Income%2F%28Loss%29%20(Unaudited)) For the three months ended March 31, 2022, the company reported zero contract revenue, consistent with the same period in 2021, with the operating loss increasing to CHF 18.8 million from CHF 17.3 million year-over-year due to higher research and development expenses, resulting in a net loss of CHF 18.8 million and a loss per share of CHF (0.23), unchanged from the prior year Statement of Income/(Loss) Summary (in CHF thousands) | Metric | For the Three Months Ended March 31, 2022 | For the Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Total Revenue | — | — | | Research & development expenses | (15,123) | (13,329) | | General & administrative expenses | (4,166) | (4,338) | | **Operating loss** | **(18,830)** | **(17,251)** | | **Loss for the period** | **(18,848)** | **(16,734)** | | **Basic and diluted loss per share** | **(0.23)** | **(0.23)** | [Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)](index=2&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income%2F%28Loss%29%20(Unaudited)) For the first quarter of 2022, the total comprehensive loss was CHF 18.8 million, composed of the net loss for the period of CHF 18.8 million, slightly offset by a CHF 10 thousand positive currency translation difference, while in the same period of 2021, the total comprehensive loss equaled the net loss of CHF 16.7 million Statement of Comprehensive Income/(Loss) (in CHF thousands) | Item | For the Three Months Ended March 31, 2022 | For the Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Loss for the period | (18,848) | (16,734) | | Other comprehensive income/(loss) | 10 | — | | **Total comprehensive loss, net of tax** | **(18,838)** | **(16,734)** | [Condensed Consolidated Statements of Changes in Equity (Unaudited)](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity%20(Unaudited)) Shareholders' equity decreased from CHF 232.0 million at the start of 2022 to CHF 214.1 million as of March 31, 2022, primarily driven by the total comprehensive loss of CHF 18.8 million for the period, which was slightly offset by share-based payments of CHF 1.0 million Changes in Equity for Q1 2022 (in CHF thousands) | Description | Amount | | :--- | :--- | | Balance as of January 1, 2022 | 231,979 | | Total comprehensive loss | (18,838) | | Share-based payments | 989 | | Issuance of shares, net | 1 | | **Balance as of March 31, 2022** | **214,131** | [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) In the first quarter of 2022, the company used CHF 23.1 million in cash for operating activities, an increase from CHF 17.3 million in the prior-year period, while investing activities used CHF 0.5 million and financing activities used CHF 0.9 million, resulting in a net decrease in cash and cash equivalents of CHF 24.6 million, with the balance falling to CHF 57.8 million at the end of the period Cash Flow Summary (in CHF thousands) | Cash Flow Activity | For the Three Months Ended March 31, 2022 | For the Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash flows used in operating activities | (23,143) | (17,339) | | Net cash flows used in investing activities | (540) | (790) | | Net cash flows (used in)/provided by financing activities | (916) | 7,707 | | **Net decrease in cash and cash equivalents** | **(24,599)** | **(10,422)** | | Cash and cash equivalents at end of period | 57,835 | 151,092 | Notes to the Interim Condensed Consolidated Financial Statements (Unaudited) [Corporate Information](index=5&type=section&id=1.%20Corporate%20information) AC Immune SA is a clinical-stage biopharmaceutical company founded in 2003, focused on developing medicines and diagnostics for neurodegenerative diseases (NDD) like Alzheimer's and Parkinson's, with a strategy built on a three-pillar approach targeting AD, non-AD NDD, and diagnostics, utilizing its two proprietary technology platforms: SupraAntigen (biologics) and Morphomer (small molecules) - The company is a clinical-stage biopharmaceutical firm specializing in neurodegenerative diseases (NDD) associated with protein misfolding[11](index=11&type=chunk) - Corporate strategy is based on three pillars: (i) Alzheimer's Disease (AD), (ii) non-AD NDD (including Parkinson's, ALS, NeuroOrphan indications), and (iii) diagnostics[11](index=11&type=chunk) - Utilizes two proprietary technology platforms: SupraAntigen® for conformation-specific biologics and Morphomer® for conformation-specific small molecules[11](index=11&type=chunk) [Basis of Preparation and Accounting Policies](index=5&type=section&id=2.%20Basis%20of%20preparation%20and%20changes%20to%20the%20Company%27s%20accounting%20policies) The financial statements are prepared in accordance with IAS 34 and are presented in Swiss Francs (CHF), with the company asserting it has sufficient cash (**CHF 57.8 million**) and short-term financial assets (**CHF 116.0 million**) to operate as a going concern for at least 12 months from March 31, 2022, and key accounting estimates involve revenue recognition, clinical accruals, and valuation of its IPR&D asset - The financial statements have been prepared in accordance with International Accounting Standard 34 (IAS 34), Interim Financial Reporting[13](index=13&type=chunk) - The company has been prepared on a going-concern basis, with a cash position of **CHF 57.8 million** and short-term financial assets of **CHF 116.0 million** as of March 31, 2022[23](index=23&type=chunk) - Critical accounting judgments and estimates relate to revenue recognition, clinical development accruals, share-based compensation, and the IPR&D asset[19](index=19&type=chunk) [Contract Revenues](index=6&type=section&id=3.%20Contract%20revenues) The company generated **no contract revenues** for the three months ended March 31, 2022 and 2021, but recognized grant income of **CHF 0.4 million** from the Michael J. Fox Foundation and **less than CHF 0.1 million** from the Target ALS Foundation during the first quarter of 2022 - For the three months ended March 31, 2022 and 2021, AC Immune generated **no contract revenues**[26](index=26&type=chunk) - There were no significant events or transactions related to license and collaboration agreements in Q1 2022[28](index=28&type=chunk) - In Q1 2022, the company recognized **CHF 0.4 million** in grant income from the Michael J. Fox Foundation and **less than CHF 0.1 million** from the Target ALS Foundation[30](index=30&type=chunk)[31](index=31&type=chunk) [Loss Per Share](index=8&type=section&id=4.%20Loss%20per%20share) Basic and diluted loss per share for the first quarter of 2022 was CHF (0.23), identical to the same period in 2021, with the net loss attributable to shareholders being CHF 18.8 million, calculated on a higher weighted-average number of shares (83.5 million) compared to the prior year (72.3 million) Loss Per Share Calculation | Item | For the Three Months Ended March 31, 2022 | For the Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net loss attributable to equity holders (CHF thousands) | (18,848) | (16,734) | | Weighted-average shares outstanding | 83,486,354 | 72,305,949 | | **Basic and diluted loss per share (CHF)** | **(0.23)** | **(0.23)** | - Potentially dilutive securities, including **199,636 share options** and **521 restricted share awards**, were excluded from the calculation as they would be anti-dilutive[33](index=33&type=chunk)[34](index=34&type=chunk) [Property, Plant and Equipment](index=8&type=section&id=5.%20Property%2C%20plant%20and%20equipment) The carrying amount of property, plant, and equipment decreased slightly from CHF 5.1 million to CHF 4.9 million during the first quarter of 2022, with the company investing CHF 0.2 million in lab and IT equipment, while depreciation for the period was CHF 0.5 million Movement in Property, Plant and Equipment (in CHF thousands) | Item | December 31, 2021 | Additions | Depreciation | March 31, 2022 | | :--- | :--- | :--- | :--- | :--- | | **Carrying Amount** | **5,116** | **252** | **(460)** | **4,908** | [Right-of-Use Assets and Lease Liabilities](index=8&type=section&id=6.%20Right-of-use%20assets%20and%20lease%20liabilities) The net book value of right-of-use assets, primarily for buildings, decreased to CHF 2.8 million from CHF 2.9 million due to depreciation of CHF 0.14 million in Q1 2022, with total cash outflow for leases during the quarter being CHF 0.33 million, and the company having undiscounted lease obligations of CHF 2.9 million Lease Impact on Income Statement (in CHF thousands) | Expense Item | For the Three Months Ended March 31, 2022 | For the Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Depreciation of right-of-use assets | 140 | 107 | | Interest expense on lease liabilities | 18 | 14 | | Expense for short-term/low value leases | 174 | 187 | | **Total** | **332** | **308** | - Total undiscounted cash flows for lease obligations as of March 31, 2022, amount to **CHF 2.94 million**[40](index=40&type=chunk) [Accrued Expenses](index=9&type=section&id=7.%20Accrued%20expenses) Accrued expenses decreased significantly from CHF 16.7 million at year-end 2021 to CHF 10.6 million as of March 31, 2022, with the reduction primarily due to a **CHF 3.7 million** payment related to a cost-sharing arrangement with Janssen and a **CHF 2.3 million** payment for performance-related remuneration Accrued Expenses (in CHF thousands) | Date | Amount | | :--- | :--- | | As of December 31, 2021 | 16,736 | | As of March 31, 2022 | 10,571 | - The decrease is mainly due to payments of **CHF 3.7 million** for a cost sharing arrangement with Janssen and **CHF 2.3 million** for performance-related remuneration[41](index=41&type=chunk) [Intangible Assets](index=9&type=section&id=8.%20Intangible%20assets) The company holds a single intangible asset: an acquired In-Process Research and Development (IPR&D) asset for a Parkinson's disease vaccine candidate, with its carrying value remaining unchanged at **CHF 50.4 million** as of March 31, 2022, and the asset is not yet being amortized as it has not obtained market approval, and no impairment was identified during the period - The company's intangible asset is an acquired IPR&D asset, a clinically-validated active vaccine candidate for Parkinson's disease, with a carrying value of **CHF 50.4 million**[42](index=42&type=chunk) - The asset is not currently being amortized because it is not yet ready for use pending market approval[42](index=42&type=chunk) - The IPR&D asset was reviewed for impairment in accordance with IAS 36 and was not determined to be impaired as of March 31, 2022[42](index=42&type=chunk) [Prepaid Expenses](index=10&type=section&id=9.%20Prepaid%20expenses) Prepaid expenses, consisting of prepaid R&D, administrative, and insurance costs, totaled **CHF 2.8 million** as of March 31, 2022, representing a slight decrease from **CHF 3.0 million** at the end of 2021 - Prepaid expenses totaled **CHF 2.8 million** as of March 31, 2022, compared to **CHF 3.0 million** as of December 31, 2021[43](index=43&type=chunk) [Cash, Cash Equivalents, and Short-Term Financial Assets](index=10&type=section&id=10.%20Cash%20and%20cash%20equivalents%20and%20short-term%20financial%20assets) As of March 31, 2022, the company held CHF 57.8 million in cash and cash equivalents and CHF 116.0 million in short-term financial assets, with the cash balance decreasing from CHF 82.2 million at the end of 2021, while short-term financial assets remained unchanged Cash and Financial Assets (in CHF thousands) | Asset Type | As of March 31, 2022 | As of December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | 57,835 | 82,216 | | Short-term financial assets | 116,000 | 116,000 | [Treasury Shares](index=10&type=section&id=11.%20Treasury%20shares) As of March 31, 2022, AC Immune held **6,221,617 treasury shares** in relation to its at-the-market offering program - As of March 31, 2022, the Company has **6,221,617 treasury shares** remaining[45](index=45&type=chunk) [Finance Result, Net](index=10&type=section&id=12.%20Finance%20result%2C%20net) For the first quarter of 2022, the company recorded a net financial loss of **less than CHF 0.1 million**, a shift from a net financial gain of **CHF 0.5 million** in the same period of 2021, with the change primarily driven by lower foreign currency gains (**CHF 0.1 million** in Q1 2022 vs. **CHF 0.5 million** in Q1 2021) - In Q1 2022, the company recorded a net financial loss of **less than CHF 0.1 million**, compared to a net financial gain of **CHF 0.5 million** in Q1 2021[46](index=46&type=chunk) - The result was driven by foreign currency gains of **CHF 0.1 million** and interest expense of **CHF 0.2 million** in Q1 2022[46](index=46&type=chunk) [Subsequent Events](index=10&type=section&id=13.%20Subsequent%20events) Management evaluated events occurring after the balance sheet date through the issuance of the financial statements and determined there were **no events** that required recognition or disclosure - The company has determined that there were **no subsequent events** that warrant disclosure or recognition in these Interim Condensed Consolidated Financial Statements[48](index=48&type=chunk)
AC Immune(ACIU) - 2021 Q4 - Annual Report
2022-03-21 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...