On July 28, 2022 Novocure (NASDAQ: NVCR) reported financial results for the quarter ended June 30, 2022 (Press release, NovoCure, JUL 28, 2022, View Source [SID1234617105]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields) .

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"The second quarter was a period of solid progress, further solidifying the fundamentals of our business," said William Doyle, Novocure’s Executive Chairman. "We generated $141 million in net revenues in the quarter, released promising data from our gastric cancer pilot study, announced a new pivotal trial collaboration with Merck, and advanced our late-stage clinical studies. The future is bright for Novocure, and we are hopeful our progress will enable us to treat many more cancer patients in the near future."

"Novocure is entering a transformational period," said Asaf Danziger, Novocure’s Chief Executive Officer. "In the next 18 months, we expect to reach a number of clinical and product development milestones, including data releases from multiple pivotal trials and the limited release of our new flex arrays. We are eager to continue exploring the potential of our platform therapy, and I would like to thank my Novocure colleagues for their passion and determination in advancing the science and adoption of Tumor Treating Fields."

Financial updates for the second quarter ended June 30, 2022:

Total net revenues for the quarter were $140.9 million, an increase of 6% compared to the same period in 2021.
The United States, EMEA and Japan contributed $108.2 million, $18.5 million, and $8.3 million in quarterly net revenues, respectively.
German revenue was impacted by a reduction in German active patient numbers and approval rates as a result of updated coverage criteria.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $5.9 million.
Gross margin for the quarter was 80%.
Research, development and clinical studies expenses for the quarter were $57.1 million, an increase of 13% from the same period in 2021.
Sales and marketing expenses for the quarter were $44.7 million, an increase of 31% compared to the same period in 2021. This reflects increased investments in early commercial and market access capabilities.
General and administrative expenses for the quarter were $31.7 million, a decrease of 3% compared to the same period in 2021.
Net loss for the quarter was $24.0 million with loss per share of $0.23.
Adjusted EBITDA* for the quarter was $7.3 million.
Cash, cash equivalents and short-term investments were $948.5 million as of June 30, 2022.
Operational updates for the second quarter ended June 30, 2022:

As of June 30, 2022, there were 3,454 active patients on therapy. Active patients from North America, EMEA and Japan contributed 2,229, 879 and 346 active patients, respectively.
1,383 prescriptions were received in the quarter. Prescriptions from North America, EMEA and Japan contributed 954, 334 and 95 prescriptions, respectively.
Quarterly updates and achievements:

Today, we are announcing that top-line data from the LUNAR pivotal study will be distributed in early Q1 2023 versus the final week of 2022 to ensure optimal visibility and timing for all audiences. Our clinical operations and data collection efforts remain on track.
In May 2022, we entered into a clinical trial collaboration agreement with MSD, a tradename of Merck & Co., Inc., ("MSD") to conduct a double-blind, placebo-controlled study of TTFields concomitant with pembrolizumab and maintenance temozolomide for the treatment of newly diagnosed GBM. We intend to engage the FDA in pre-submission discussions in the near-term regarding the parameters of the KEYNOTE D58 trial protocol design.
In June 2022, we announced results of the phase 2 pilot EF-31 study evaluating the use of TTFields together with standard-of-care (chemotherapy alone or in combination with trastuzumab for HER2-positive patients) as first-line treatment for gastric cancer. Initial analysis was conducted with a median follow-up period of 8.6 months. The primary endpoint, confirmed objective response rate, was 50%. Median progression-free survival was 7.8 months. Duration of response was 10.3 months. Median overall survival had not yet been reached with a one-year survival rate of 72%. We look forward to further exploration of these potential benefits as we look ahead to a randomized phase 3 clinical study.
In June 2022, we announced the first patient has been enrolled in the phase 2 pilot KEYNOTE B36 study, conducted in collaboration with MSD. KEYNOTE B36 is designed to evaluate the safety and effectiveness of TTFields together with pembrolizumab for the treatment of locally advanced or metastatic intrathoracic NSCLC that expresses PD-L1.
Anticipated clinical milestones:

Data from phase 2 pilot EF-33 study with high-intensity arrays in recurrent GBM (2022)
Last patient enrollment in phase 3 pivotal METIS study in brain metastases (2022)
Data from phase 3 pivotal LUNAR study in NSCLC (early Q1 2023)
Last patient enrollment in phase 3 pivotal PANOVA-3 study in locally advanced pancreatic cancer (2023)
Data from phase 3 pivotal INNOVATE-3 study in recurrent ovarian cancer (2023)
Data from phase 3 pivotal METIS study in brain metastases (2023)
Data from phase 3 pivotal PANOVA-3 study in locally advanced pancreatic cancer (2024)
Conference call details
Novocure will host a conference call and webcast to discuss second quarter 2022 financial results at 8 a.m. EDT today, Thursday, July 28, 2022. Analysts and investors can participate in the conference call by using the following registration link, and dial-in details will be provided.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On July 28, 2022 Takeda (TOKYO:4502/NYSE:TAK) reported that strong financial results for the first quarter of fiscal year 2022 (period ended June 30, 2022) and is on track to meet its full-year management guidance (Press release, Takeda, JUL 28, 2022, View Source [SID1234617104]).

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The gain on the sale of Takeda’s Japan diabetes portfolio in the first quarter of the previous fiscal year has impacted reported financial results on a year-over-year basis, as expected. The sale contributed a one-off 133 billion yen to revenue and 131.4 billion yen to operating profit in Q1 FY2021. This impact is excluded from core financial results; the Company delivered +8.3% core revenue growth and +17% core operating profit growth at CER this quarter, with a core operating profit margin of 32.8%.

Takeda chief financial officer, Costa Saroukos, commented: "Takeda has delivered strong first quarter performance with Growth and Launch Products continuing to drive robust core revenue growth. Our results reflect continued momentum and solid commercial execution across key business areas."

"First quarter results also reflect the impact of the last of our major non-core divestitures in the prior year. The sale of the Japan diabetes portfolio in FY2021 is the main factor behind the year-over-year decline in reported operating profit and is the only difference between reported and core revenue growth in our Q1 FY2022 results."

"Foreign exchange has been a tailwind for our performance in the first quarter, while our portfolio momentum and prudent cost management have allowed us to improve our core operating profit margin despite rising inflation and other emerging macro challenges. We also remain resilient amid the outlook for increasing interest rates as approx. 98% of our debt is now secured at fixed interest rates averaging approx. 2%."

(a) Further information regarding certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source
(b) We define Free Cash Flow as cash flows from operating activities, subtracting acquisition of property, plant and equipment ("PP&E"), intangible assets and investments as well as removing any other cash that is not available to Takeda’s immediate or general business use, and adding proceeds from sales of PP&E, as well as from sales of investments and businesses, net of cash and cash equivalents divested.
(c) Core results adjust our reported results calculated and presented pursuant to IFRS to exclude the effect of items unrelated to Takeda’s core operations, such as, to the extent applicable for each line item, amortization and impairment of intangible assets, other operating income and expenses, certain JV-related accounting adjustments, non-recurring items, purchase accounting effects and transaction related costs.
(d) CER (Constant Exchange Rate) change eliminates the effect of foreign exchange rates from year-over-year comparisons by translating Reported or Core results for the current period using corresponding exchange rates in the same period of the previous fiscal year.

COMMERCIAL UPDATES ACROSS FIVE KEY BUSINESS AREAS

Growth in key business areas in Q1 FY2022 was driven mainly by Growth & Launch Products, which delivered revenue of 363.6 billion yen and +26% growth at CER.

Gastroenterology (GI), with 270.4 billion yen in reported revenue, grew +15% on a CER basis driven by gut-selective ENTYVIO and TAKECAB/VOCINTI. The strong launch in China of VOCINTI was a key contributor to growth. Global revenue for ENTYVIO is forecast to grow +20% on a CER basis in FY2022.
Rare Diseases, with 181.6 billion yen in reported revenue, grew +7% on a CER basis driven by continued strong performance of TAKHZYRO and promising LIVTENCITY sales following a U.S. launch in December 2021. Geographical expansion is expected to continue with additional TAKHZYRO launches and LIVTENCITY approvals planned for FY2022.
Plasma-Derived Therapies (PDT) Immunology, with 141.9 billion yen in reported revenue, delivered outstanding growth of +18% on a CER basis driven by continued strong global demand for Immunoglobulin and higher sales of Albumin. Our global plasma donation footprint grew to 212 centers as of June 30, 2022. With plans for >25 centers to be opened this fiscal year, the Company is targeting to increase plasma collection volume by 10-20% in FY2022 compared to FY2021.
Oncology, with 117.5 billion yen in reported revenue, declined -10% on a CER basis mainly due to the impact of generic competition to VELCADE. ALUNBRIG delivered growth of +34.7% on a CER basis. EXKIVITY market data showed early signs of commercial success with a U.S. launch in September 2021 and global expansion continues with approvals in UK, Switzerland, Australia and South Korea. Additional approval decisions are expected in FY2022, including in China. Following discussions with the EMA, Takeda has decided to withdraw the EU Marketing Authorization Application (MAA) for EXKIVITY in second-line treatment of EGFR Exon20 insertion+ non-small cell lung cancer (NSCLC).
Neuroscience, with 142.4 billion yen in reported revenue, grew +11% on a CER basis signaling a continued rebound from COVID-19. TRINTELLIX grew +5.2% at CER driven by continued market share gains, notably in Japan. We expect VYVANSE growth in FY2022 to be driven by the expanding adult market in the U.S.
PIPELINE UPDATE

In Q1 FY2022, Takeda further demonstrated pipeline momentum and its ability to bring new therapies to patients. Pipeline updates in Q1 FY2022 include:

TAK-003, Takeda’s dengue vaccine candidate, prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases with no important safety risks identified in the overall population, including both seropositive and seronegative individuals through 54 months. These data from the Phase 3 TIDES trial were presented at the 8th Northern European Conference on Travel Medicine (NECTM8). TAK-003 is currently undergoing regulatory review in the European Union and select dengue-endemic countries, with decisions expected in FY2022.
Additional information related to this announcement is available here.
The New England Journal of Medicine published results from a Phase 2 clinical study of investigational fazirsiran (TAK-999/ARO-AAT) for the treatment of liver disease associated with alpha-1 antitrypsin deficiency (AATD). Co-developed with Arrowhead Pharmaceuticals, fazirsiran was granted Breakthrough Therapy Designation in July 2021 and Orphan Drug Designation in February 2018 by the U.S. FDA for the treatment of AATD.
Additional information related to this announcement is available here.
ADCETRIS Phase 3 data was presented at the 59th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrating statistically significant improvement in overall survival in adult patients with previously untreated Stage III or IV classical Hodgkin Lymphoma.
Additional information related to this announcement is available here.
Takeda and Moderna announced plans to transfer marketing authorization for Spikevax COVID-19 vaccine in Japan to Moderna.
Additional information related to this announcement is available here.
TAKHZYRO demonstrated positive results in the prevention of hereditary angioedema (HAE) attacks in patients 2 to <12 years of age. These results, which were consistent with earlier studies in adult and adolescent patients, were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2022. There are currently no long-term prophylactic treatments approved for HAE patients younger than 6 years and global regulatory filings are scheduled to begin in FY2022.
Additional information related to this announcement is available here.
HYQVIA met its primary endpoint in a pivotal Phase 3 clinical trial evaluating its efficacy and safety as a maintenance therapy for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). Preparations are now underway for regulatory filings in the U.S. and EU.
Additional information related to this announcement is available here.
In June 2022, Takeda signed a licensing agreement with Momenta Pharmaceuticals, Inc., which was acquired by Johnson & Johnson, for an investigational hypersialylated immunoglobulin (HsIG) candidate. HsIG has the potential to have similar efficacy as IGs but at a lower dose due to its increased potency. If proven safe and effective, it has the potential to help address patient needs for significantly lower administration volume with better tolerability and convenience, while simultaneously helping to address existing supply constraints.
FY2022 OUTLOOK
On track towards full-year FY2022 guidance (Unchanged from May 2022)

Company outlook for FY2022 reflects management’s expectations for continued business momentum across Takeda’s five key business areas, discipline in operating expenses, and FX favorability.
For more details on Takeda’s Q1 FY2022 results and other financial information including key assumptions in FY2022 forecast and management guidance, please visit: View Source

On July 28, 2022 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that Chief Scientific Officer and Co-Founder, Dr Julian Kenyon, MD, MB, ChB, reflects on the unique anti-cancer effects of PRP discovered as a result of the significant and diligent research invested by the Company and its joint research team over the past decade (Press release, Propanc, JUL 28, 2022, View Source [SID1234617103]). PRP is a proenzyme therapy for the treatment and prevention of metastatic cancer from solid tumors. This unique approach could become an effective tool in the fight against metastatic cancer, which is the main cause of patient death for sufferers. PRP is considered unique because rather than kill cancer cells like most standard therapies, proenzymes induce cancer cells to differentiate so they are no longer malignant and die off naturally, "thus preventing these dangerous cells to spread and metastasize," according to Dr Kenyon.

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Since 2013, Dr Kenyon and his joint research team have published five scientific papers highlighting the effects of proenzymes against a range of solid tumors, by inducing cell differentiation (reversing cancerous cells so they are no longer malignant), impairing angiogenesis (blood vessel formation) of solid tumors, and inhibiting cancer stem cell (CSC) formation by blocking the epithelial to mesenchymal (EMT) process. The EMT is a normal biological process normally associated with embryogenesis and wound healing. When CSCs undergo the EMT process, they become motile and invasive, with an ability to spread into surrounding tissues. Furthermore, they become immortal and are resistant to standard treatment approaches, which can often cause a patient to relapse post treatment.

"Since our first peer reviewed scientific publication in 2013, which highlights how proenzymes suppresses the EMT program and promotes cell differentiation, I continue to be amazed at the compelling results achieved by our research team which demonstrates that we have a unique approach to treat and prevent metastatic cancer by targeting and eradicating cancer stem cells, whilst leaving healthy cells alone. This confirms what I observed clinically, when I first treated 46 late-stage cancer patients in a compassionate use study, which extended the survival of a number of patients, free from the serious side effects normally associated with standard treatment approaches. Since then, we have achieved proof of concept, in vivo (in a living organism), and completed translational development activities so that we can reproduce these scientific results in a randomized and controlled clinical study in advanced cancer patients."

The joint scientific papers have been published in journals such as Cellular Oncology, Scientific Reports (an online Nature journal) and Expert Opinion on Biological Therapy. One paper, which explores in vivo pharmacokinetic (activity of drugs in an organism over time) studies and the anti-tumour efficacy of PRP against orthotopic (grafted) pancreatic and ovarian cancer tumours, as well as clinical observations from the compassionate use study conducted by Dr Kenyon, achieved over 2,000 reads, thus indicating strong interest among the scientific community.

Further research is in progress with the Company’s joint research partners focusing on the effects of PRP on the tumor microenvironment. Results shows that PRP causes reversal of the malignant tumor phenotype (observable characteristics) towards a normal, or benign state, which was, "most unexpected, very exciting and powerfully conclusive," according to Ms. Belen Toledo MSc, from the laboratory of Professor Macarena Perán PhD, University of Jaén, Spain.

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine and skin cancers.

On July 28, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that management will participate virtually in the following investor conferences during August 2022 (Press release, Sapience Therapeutics, JUL 28, 2022, View Source [SID1234617102]):

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2022 BTIG Biotechnology Conference, August 8-9, 2022

Sapience management will participate virtually in one-on-one meetings with investors on August 9.
2022 Wedbush PacGrow Healthcare Conference, August 9-10, 2022

Sapience management will participate virtually in a fireside chat with Robert Driscoll, Research Analyst at Wedbush, on August 10 at 8:35 am ET. Company management will also participate in virtual one-on-one meetings with investors on the same day.

On July 28, 2022 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported results for the quarter ended June 30, 2022, and provided a corporate update (Press release, AC Immune, JUL 28, 2022, View Source [SID1234617101]).

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Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: "With world-class collaborators, including three major pharma companies, and cash for operations until Q1 2024, we believe we are well positioned to execute on multiple value-creating milestones. Our experienced team is working to deliver in H2 2022 four further clinical readouts from our precision medicine pipeline, adding to the three already reported.

"We continue to make real progress towards our goal of earlier diagnosis and prevention," Dr. Pfeifer continued, "We recently treated the first prodromal Alzheimer’s disease patient in our innovative adaptive design Phase 1b/2 trial of ACI-24.060, a highly differentiated best-in-class vaccine-candidate that has demonstrated strong immunogenicity against the two most toxic forms of Abeta, pyroGlu-Abeta and oligomeric Abeta. We expect interim data later this year from the Phase 1b, enabling us to advance into Phase 2 in individuals with Down syndrome, virtually all of whom develop Alzheimer’s."

Q2 2022 and Subsequent Highlights

Dosed the first patient in the placebo-controlled, Phase 1b/2 ABATE study evaluating the anti-Abeta vaccine ACI-24.060 in patients with prodromal Alzheimer’s disease (AD) and individuals with Down syndrome (DS). An interim data readout from the Phase 1b portion of the trial in AD is expected in H2 2022.
Announced a peer-reviewed publication in JAMA Neurology1 featuring data showing that ACI-24, the predecessor of ACI-24.060, was safe and elicited an immune response in a Phase 1b clinical trial in adults with DS. This was the first-ever anti-Abeta vaccine study conducted in people living with DS and the paper also highlighted data providing evidence of target engagement in the trial.
Announced topline results from the Phase 2 Alzheimer’s Prevention Initiative (API) study evaluating the anti-Abeta monoclonal antibody crenezumab in autosomal dominant Alzheimer’s disease (ADAD). Results showed that both co-primary endpoints of the study were not statistically significant but numerical differences favoring crenezumab were observed across the majority of primary, secondary and exploratory endpoints. More detailed results will be presented at the Alzheimer’s Association International Conference (AAIC) on August 2, 2022 by AC Immune’s partner Genentech, a member of the Roche group and the Banner Alzheimer’s Institute.
Announced that AC Immune Co-Founder and CEO Dr. Andrea Pfeifer received the prestigious Aenne Burda Award for Creative Leadership in recognition of her work.
Expanded leadership by appointing Howard Donovan as Chief Human Resources Officer and member of the Executive Committee. Mr. Donovan is an internationally experienced, commercially focused leader. He joins from the World Economic Forum, where he led People Services since 2015.
Joerg Hornstein, Chief Financial Officer (CFO), will leave AC Immune in the second half of 2022 to pursue a new opportunity. AC Immune is well positioned with two members of the Company’s proven Finance Leadership Team who will transition to new roles. Christopher Roberts has been appointed Vice President, Finance and interim CFO. Julian Snow has been appointed Vice President, U.S. Finance & Corporate Development.
Achieved and Anticipated 2022 Clinical Milestones

ACI-12589
a-syn-PET tracer Reported breakthrough results from first-in-human study at AD/PD 2022 conference
ACI-35.030
anti-pTau vaccine Reported Phase 1b/2a interim analysis from highest dose group; Expect to disclose late-stage development plans in H2 2022
ACI-24.060
anti-Abeta vaccine Dosed first patient in Phase 1b/2 trial of ACI-24.060 in patients with AD and individuals with DS
Phase 1b in AD readout and decision to move into DS expected in H2 2022
Crenezumab
anti-Abeta antibody Reported top line Phase 2 results from API study in autosomal dominant AD .
Semorinemab
anti-Tau antibody Additional biomarker data from the Phase 2 Lauriet study in mild-to-moderate AD expected in H2 2022
PI-2620
Tau-PET tracer Phase 2 results in AD to be unveiled at AAIC in San Diego, California (United States) and online, July 31 – August 4, 2022.
Clinical PET study readout in orphan indication expected in H2 2022
ACI-7104
anti-a-syn vaccine Initiation of Phase 2 trial in early PD expected in H2 2022
Analysis of Financial Statements for the Quarter Ended June 30, 2022

Cash Position: The Company had a total cash balance of CHF 154.1 million, composed of CHF 63.1 million in cash and cash equivalents and CHF 91.0 million in short-term financial assets. This compares to a total cash balance of CHF 198.2 million as of December 31, 2021. The Company’s cash balance provides enough capital resources to progress through at least Q1 2024 without consideration of potential incoming milestone payments.

R&D Expenditures: R&D expenses increased by CHF 2.0 million for the three months ended June 30, 2022, to CHF 15.7 million.

Discovery and preclinical expenses (- CHF 0.5 million): The Company decreased expenditures across a variety of its discovery and preclinical programs, led by ACI-24 for DS as this program advances into clinical development.

Clinical expenses (+ CHF 0.4 million): The Company increased expenditures across multiple clinical programs, predominantly for ACI-24 for DS and ACI-7104.

Other non-allocated (+ CHF 1.2 million): The Company’s other non-allocated R&D expenditure increased by CHF 0.9 million mostly related to the reallocation of certain IT and facilities costs, IT investments, as well as CHF 0.3 million across various other cost centers.

G&A Expenditures: For the three months ended June 30, 2022, G&A decreased by CHF 0.9 million to CHF 4.4 million. This decrease is mostly related to the reallocation of certain IT and facilities expenditures made in Q2 2022 that were not reclassified in the prior period.

Other Operating Income: The Company recognized CHF 0.2 million in grant income for R&D activities performed under our Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Target ALS grants, a decrease of less than CHF 0.1 million compared to the prior period.

IFRS Loss for the Period: The Company reported a net loss after taxes of CHF 19.6 million for the three months ended June 30, 2022, compared with a net loss of CHF 19.1 million for the comparable period in 2021.
References

Rafii MS et al, Safety, Tolerability, and Immunogenicity of the ACI-24 Vaccine in Adults With Down Syndrome, A Phase 1b Randomized Clinical Trial, JAMA Neurology, 2022 May 9:79(5).