AC Immune Reports Second Quarter 2024 Financial Results and Provides a Corporate Update

Rhea-AI Summary

AC Immune reported Q2 2024 financial results and provided a corporate update. Key highlights include:

- Exclusive option and license agreement with Takeda for ACI-24.060, with $100 million upfront and potential milestones up to $2.1 billion
- ACI-24.060 ABATE Phase 2 trial in Alzheimer's disease progressing as planned
- ACI-7104.056 VacSYn Phase 2 trial in Parkinson's disease on track for interim data in H2 2024
- Promising preclinical results for ACI-19764, an NLRP3 inhibitor
- Cash balance of CHF 175.2 million, providing a three-year runway

Financial results: Contract revenues of CHF 0.7 million, R&D expenses of CHF 17.1 million, G&A expenses of CHF 4.6 million, and a net loss of CHF 22.8 million for Q2 2024.

Positive

• Secured $100 million upfront payment from Takeda partnership with potential for $2.1 billion in milestones
• Cash balance increased to CHF 175.2 million, providing a three-year runway
• ACI-24.060 ABATE Phase 2 trial enrollment progressing as planned
• Promising preclinical results for ACI-19764 NLRP3 inhibitor

Negative

• Net loss increased to CHF 22.8 million in Q2 2024 from CHF 16.8 million in Q2 2023
• R&D expenses increased to CHF 17.1 million from CHF 13.7 million in the comparable period
• G&A expenses increased by CHF 0.9 million to CHF 4.6 million

Insights

Financial Analyst

AC Immune's Q2 2024 results showcase a significant financial boost from the Takeda partnership, with an upfront payment of $100 million and potential future milestones of up to $2.1 billion. This deal has substantially improved the company's cash position to CHF 175.2 million, providing a three-year runway. However, the company's net loss widened to CHF 22.8 million from CHF 16.8 million year-over-year, primarily due to increased R&D expenses. The 24.8% rise in R&D costs to CHF 17.1 million reflects intensified clinical activities, particularly in Parkinson's and Alzheimer's studies. While the Takeda deal provides financial stability, investors should monitor the company's burn rate and progress in clinical trials to assess long-term value creation.

Medical Research Analyst

AC Immune's pipeline progress is promising, particularly the advancement of ACI-24.060 for Alzheimer's disease. The ABATE Phase 2 trial is progressing as planned, which is important given the recent Takeda partnership. The company's diversified approach, including the VacSYn Phase 2 trial for Parkinson's disease and the development of NLRP3 inhibitors, demonstrates a comprehensive strategy in addressing neurodegenerative diseases. The morADC platform, combining SupraAntigen® and Morphomer® technologies, shows potential for enhanced targeted interventions. However, investors should note that while preclinical results are encouraging, especially for ACI-19764 in neuroinflammation, clinical success remains uncertain. The upcoming interim data from the VacSYn trial in H2 2024 will be a critical milestone to watch.

Market Research Analyst

The Takeda partnership significantly enhances AC Immune's market position in the competitive neurodegenerative disease space. This validation from a major pharmaceutical company could attract investor attention and potentially lead to increased valuation. The deal structure, with tiered double-digit royalties on future sales, provides a favorable long-term revenue model. However, the neurodegenerative disease market is highly competitive and risky, with many high-profile failures in recent years. AC Immune's diverse pipeline mitigates some risk, but investors should be aware that the company's success heavily depends on clinical trial outcomes. The upcoming R&D day could be a catalyst for stock movement, potentially providing deeper insights into the company's technology platforms and development strategy.

AC Immune Reports Second Quarter 2024 Financial Results and Provides a Corporate Update

• Announced exclusive option and license agreement with Takeda for ACI-24.060 on May 13 for $100 million upfront and total potential milestones of up to approximately $2.1 billion
• ACI-24.060 ABATE Phase 2 trial in Alzheimer’s disease (AD) on track with enrolment expectations
• ACI-7104.056 VacSYn Phase 2 trial of anti-a-syn active immunotherapy in Parkinson’s disease (PD) on track for safety and immunogenicity interim data in H2 2024
• Potent inhibitor of the inflammatory NLRP3 pathway, ACI-19764, demonstrates promising preclinical results and may be broadly applicable to treat CNS and non-CNS diseases
• Cash balance of CHF 175.2 million at quarter end, including CHF 92.3 million from Takeda, provides sufficient runway for three years
  
  

Lausanne, Switzerland, August 6, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision therapeutics for neurodegenerative diseases, today reported results for the quarter ended June 30, 2024, and provided a corporate update.

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented, “AC Immune is entering the second half of 2024 with tremendous momentum. We are excited about the recently announced partnership with Takeda for ACI-24.060 as a potential best-in-class Abeta-targeted active immunotherapy. Enrollment in the ABATE Phase 2 trial of ACI-24.060 in AD continues to progress as planned.”

“We are also excited to be advancing our preclinical programs, some of which were recently featured in multiple presentations at the AAIC 2024 conference. Our novel morADC platform, a synergistic combination of our SupraAntigen® and Morphomer® platforms, has significant potential for enhanced targeted interventions for a variety of neurodegenerative diseases and also offers opportunities for simultaneous combination approaches. These morADCs are already showing promise in multiple preclinical models, and we look forward to sharing more details on this and on other preclinical development programs in an upcoming R&D day. Our solid financial position, enhanced by the Takeda partnership, enables us to drive clinical and preclinical development, leveraging the core competency of AC Immune that is anchored by our foundational expertise in neurodegenerative disease drug discovery.”

Q2 2024 and Subsequent Highlights

• AC Immune and Takeda signed an exclusive option and license agreement for AC Immune’s active immunotherapies targeting Abeta, including ACI-24.060 for AD. Under the terms of the agreement, AC Immune received an upfront payment of $100 million from Takeda and, if all related milestones are achieved over the course of the agreement, is eligible to receive payments of up to approximately $2.1 billion including an option exercise fee and additional potential development, commercial and sales-based milestones. Upon commercialization, AC Immune will be entitled to receive tiered double-digit royalties on worldwide net sales.
• Enrolment in the ACI-24.060 ABATE Phase 2 AD trial continues.
• We also completed the regulatory toxicology studies for the anti-TDP-43 monoclonal antibody candidate in Q2 which will enable us to proceed with IND filing.
• Our targeted NLRP3 inhibitor candidates continue to show excellent promise in preclinical results featured at the AD/PD™ 2024 conference:
  • ACI-19764 is a brain penetrant small molecule in preclinical development that directly binds and inhibits NLRP3. Its activity in vitro and in vivo was demonstrated in two models of neuroinflammation. In addition, ACI-19764 demonstrated an excellent safety profile and optimal exposure for sustained NLRP3 inhibition in the brain.
  • AC Immune intends to file an IND from the NLRP3 program in the near future.
• AC Immune’s preclinical programs were featured in multiple presentations at the Alzheimer’s Association International Conference (AAIC) 2024:
  • A new class of neurodegenerative disease-fighting drugs: morADC (Morphomer®- antibody drug conjugates), presented by Madiha Derouazi (Chief Scientific Officer, AC Immune), featured data from AC Immune’s proprietary morADC platform. Results demonstrated the ability of morADCs to penetrate the blood brain barrier in vivo and produce potent catalytic activity in vitro compared to the parental monoclonal antibody or small molecule alone.
  • Active immunotherapy, ACI-24.060, induces anti-Abeta antibodies with binding profiles mirroring clinically validated monoclonal antibodies, presented by Emma Fiorini (AC Immune), featured results from non-human primates demonstrating that ACI-24.060 induced antibody responses in a similar range of levels of donanemab and lecanemab and with preferential oligomeric Abeta binding as compared to monomeric Abeta.
  • Discovery and preclinical development of [¹⁸F]ACI-19626, a first-in-class TDP-43 PET tracer, presented by Tamara Seredenina (AC Immune), described the selection of [¹⁸F]ACI-19626 for evaluation as a potential PET tracer for detection and monitoring progression of TDP-43 aggregates based on its favorable affinity, selectivity and pharmacokinetic properties.
• Board and Management Share Purchases: Members of the Board of Directors and certain members of executive management purchased shares in AC Immune SA during Q2 2024, following the announcement of the exclusive option and license agreement with Takeda for ACI-24.060. As a foreign private issuer (FPI), individual shareholdings will be disclosed in the Annual Report on Form 20-F.
  
  

Anticipated 2024 Milestones

ACI-24.060 anti-Abeta active immunotherapy	ABATE Phase 2 trial in AD on track with enrolment expectations
ACI-7104.056 anti-a-syn active immunotherapy	Interim safety and immunogenicity update from the Phase 2 VacSYn study in Parkinson’s disease expected in H2 2024
ACI-35.030 anti-pTau active immunotherapy	First patient treated in ReTain Phase 2b clinical trial expected in the coming months
TDP-43-PET tracer	Phase 1 initiation expected in H2 2024
ACI-15916 a-syn-PET tracer	IND-enabling studies in PD expected to be completed in H2 2024

Analysis of Financial Statements for the Quarter Ended June 30, 2024

• Cash Position: The Company had a total cash balance of CHF 175.2 million (CHF 103.1 million as of December 31, 2023), composed of CHF 51.6 million in cash and cash equivalents and CHF 123.6 million in short-term financial assets. The Company’s cash balance provides sufficient capital resources for three years, assuming the potential milestone payment of CHF 24.6 million related to achieving an undisclosed enrolment target for our ACI-35.030, and no other milestones.
• Contract Revenues: The Company recorded CHF 0.7 million in contract revenues for the three months ended June 30, 2024, compared to nil in the comparable prior period. For the three months ended June 30, 2024, our contract revenues of CHF 0.7 million were related to the efforts made under the agreement with Takeda.
• R&D Expenditures: R&D expenses for the three months ended June 30, 2024, were CHF 17.1 million compared to CHF 13.7 million in the comparable period in 2023. The increase was due mainly to higher clinical expenses, driven by the ramp-up activities for our Phase 2 VacSYn study evaluating ACI-7104.056 in early PD and for the expansion of the ABATE study in our ACI-24.060 active immunotherapy.
• G&A Expenditures: G&A increased by CHF 0.9 million to CHF 4.6 million, mostly due to an increase in legal fees related to business development and licensing activities, as well as salaries and related costs, largely attributable to the higher expenses from equity awards granted in 2024, which have a higher fair value based on our share price development.
• Other Operating Income: The Company recognized less than CHF 0.1 million in grant income from Target ALS grants.
• IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 22.8 million for the three months ended June 30, 2024, compared with a net loss of CHF 16.8 million for the comparable period in 2023.

About AC Immune SA
AC Immune SA is a clinical-stage biopharmaceutical company and a global leader in precision prevention 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® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features sixteen therapeutic and diagnostic programs, including five in Phase 2 development and one in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies, resulting in substantial non-dilutive funding to advance its proprietary programs and >$4.5 billion in potential milestone payments plus royalties.

SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, KR, NO and RU.

The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release.

For further information, please contact:

SVP, Investor Relations & Corporate Communications Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com	U.S. Investors Corey Davis, Ph.D. LifeSci Advisors Phone: +1 212 915 2577 Email: cdavis@lifesciadvisors.com
International Media Chris Maggos Cohesion Bureau Phone: +41 79 367 6254 Email: chris.maggos@cohesionbureau.com

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. 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.

Condensed Consolidated Balance Sheets (Unaudited)
(In CHF thousands)

		As of
		June 30,		December 31,
		2024		2023
Assets
Non-current assets
Property, plant and equipment		2,926		3,376
Right-of-use assets		3,235		3,508
Intangible asset		50,416		50,416
Long-term financial assets		415		361
Total non-current assets		56,992		57,661
Current assets
Prepaid expenses		3,864		6,437
Accrued income		402		246
Other current receivables		1,153		622
Accounts receivable		—		14,800
Short-term financial assets		123,560		24,554
Cash and cash equivalents		51,564		78,494
Total current assets		180,543		125,153
Total assets		237,535		182,814
Shareholders' equity and liabilities
Shareholders’ equity
Share capital		2,212		2,089
Share premium		476,074		474,907
Treasury shares		(218)		(105)
Currency translation differences		(35)		(51)
Accumulated losses		(354,608)		(316,197)
Total shareholders’ equity		123,425		160,643
Non-current liabilities
Long-term deferred contract revenue		5,170		—
Long-term lease liabilities		2,542		2,825
Net employee defined benefit liabilities		5,868		5,770
Total non-current liabilities		13,580		8,595
Current liabilities
Trade and other payables		1,435		1,679
Accrued expenses		11,895		11,087
Short-term deferred income		45		138
Short-term deferred contract revenue		86,468		—
Short-term lease liabilities		687		672
Total current liabilities		100,530		13,576
Total liabilities		114,110		22,171
Total shareholders’ equity and liabilities		237,535		182,814

Condensed Consolidated Statements of Income/(Loss) (Unaudited)
(In CHF thousands, except for per-share data)

		For the Three Months				For the Six Months
		Ended June 30,				Ended June 30,
		2024		2023		2024		2023
Revenue
Contract revenue		687		—		687		—
Total revenue		687		—		687		—
Operating expenses
Research & development expenses		(17,138)		(13,682)		(32,303)		(27,555)
General & administrative expenses		(4,551)		(3,681)		(9,522)		(7,787)
Other operating income/(expense), net		41		317		109		725
Total operating expenses		(21,648)		(17,046)		(41,716)		(34,617)
Operating loss		(20,961)		(17,046)		(41,029)		(34,617)
Financial income		739		259		1,368		468
Financial expense		(34)		(27)		(70)		(124)
Exchange differences		(2,504)		(16)		(891)		(67)
Finance result, net		(1,799)		216		407		277
Loss before tax		(22,760)		(16,830)		(40,622)		(34,340)
Income tax expense		—		(3)		—		(6)
Loss for the period		(22,760)		(16,833)		(40,622)		(34,346)
Loss per share:		(0.23)		(0.20)		(0.41)		(0.41)

Condensed Consolidated Statements of Comprehensive Income/(Loss) (Unaudited)
(In CHF thousands)

		For the Three Months				For the Six Months
		Ended June 30,				Ended June 30,
		2024		2023		2024		2023
Loss for the period		(22,760)		(16,833)		(40,622)		(34,346)
Items that will be reclassified to income or loss in subsequent periods (net of tax):
Currency translation differences		—		(8)		16		(16)
Items that will not to be reclassified to income or loss in subsequent periods (net of tax):
Remeasurement gains on defined-benefit plans		—		—		—		—
Total comprehensive loss (net of tax)		(22,760)		(16,841)		(40,606)		(34,362)

Attachment

• 20240805_ACIU_Q2_Earnings_Final

FAQ

What was AC Immune's (ACIU) cash balance at the end of Q2 2024?

AC Immune's cash balance at the end of Q2 2024 was CHF 175.2 million, providing sufficient runway for three years.

How much did AC Immune (ACIU) receive from the Takeda partnership for ACI-24.060?

AC Immune received a $100 million upfront payment from Takeda and is eligible for potential milestones up to approximately $2.1 billion.

What is the status of AC Immune's (ACIU) ACI-24.060 ABATE Phase 2 trial in Alzheimer's disease?

The ACI-24.060 ABATE Phase 2 trial in Alzheimer's disease is progressing as planned with enrollment on track with expectations.

When is AC Immune (ACIU) expecting interim data for the ACI-7104.056 VacSYn Phase 2 trial in Parkinson's disease?

AC Immune expects to report interim safety and immunogenicity data from the ACI-7104.056 VacSYn Phase 2 trial in Parkinson's disease in H2 2024.