On July 31, 2024 Creatv Bio, a Division of Creatv MicroTech, Inc. (Creatv) reported that its Cancer Associated Macrophage-Like (CAML) liquid biopsy biomarker has been included as part of the pivotal Phase 3 trial of BriaCell Therapeutics Corporation’s lead clinical candidate, Bria-IMT in combination with an immune checkpoint inhibitor in metastatic breast cancer (Press release, CREATV MICROTECH, JUL 31, 2024, View Source [SID1234645217]).

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This study is expected to enroll a total of 404 patients in two arms – Bria-IMT in combination with an immune checkpoint inhibitor versus treatment of physicians’ choice in late-stage metastatic breast cancer patients, with no approved alternative therapies available (listed on ClinicalTrials.gov as NCT06072612). Bria-IMT was awarded Fast Track status by the U.S. Food and Drug Administration (FDA).

Blood samples are being provided to Creatv to analyze for the presence of circulating tumor cells (CTCs), CAML subtyping, and to monitor PD-L1 upregulation in patients. The samples are being taken at baseline and at a designated time following the initial patient treatment.

Creatv previously demonstrated that CAMLs can accurately (i) predict a cancer’s aggressiveness as well as multi-organ metastasis, (ii) provide a universal companion diagnostics tool using blood instead of tissue from patients, (iii) predict treatment response within approximately 30 days of receiving a new therapy in any solid tumor type, (iv) detect minimal residual disease, and (v) cancer recurrence.

"The use of biomarkers like CAMLs holds great promise in helping clinicians determine whether a patient is responding to a specific therapy in a timely manner," remarked Dr. Cha-Mei Tang, President and CEO of Creatv Bio. "We are looking forward to participating in this important trial with BriaCell and are confident that as a result, this biomarker will provide clinicians with a valuable tool to guide their treatment choices for cancer patients."

On July 31, 2024 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical-stage immunology company advancing RNA therapeutics to conquer cancer, reported to have dosed the first patient with MT-303 in a Phase 1 study for hepatocellular carcinoma (HCC) (Press release, Myeloid Therapeutics, JUL 31, 2024, View Source [SID1234645216]). MT-303 is Myeloid’s second in vivo mRNA CAR program to enter the clinic from its pipeline of in vivo immune cell programming therapies. Dosing with MT-303 represents a significant milestone to bring advanced novel therapies to people with liver cancer.

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Dr. Matthew Maurer, Chief Medical Officer of Myeloid, commented, "We are thrilled to have swiftly advanced MT-303 into the clinic as the first in vivo CAR therapy applicable to the majority of liver cancers, and other cancers expressing GPC3. MT-303 can be administered like any other off-the-shelf intravenous therapy, without the need for pretreatment conditioning, and offers the potential to trigger a coordinated immune response against the cancer, reinforced and maintained with ongoing repeat dosing."

GPC3 is a target of significant global interest given its high expression in HCC and limited expression in normal tissues. Unlike autologous cell therapies, Myeloid’s approach focuses on in vivo programming of immune cells with off-the-shelf mRNA-encoded CAR technology that expresses selectively within myeloid cells. MT-303 arms myeloid cells with a proprietary chimeric antigen receptor that enables these cells to kill hepatocellular carcinoma and to engage an adaptive immune response against the tumor. This coordinated immune response is essential to foster a sustained immune surveillance and defense against tumor recurrence.

Dr. Timothy Humphries, Linear Clinical Research, lead principal investigator on the MT-303 trial added, "Hepatocellular carcinoma is a highly lethal cancer with limited effective therapies. I am elated to bring the option and potential of MT-303, the first in vivo CAR therapy for this disease, to my patients with the hope of providing tolerable and durable clinical benefit."

"The Myeloid team continues to push forward and revolutionize cancer treatment with the world’s first clinical-stage in vivo mRNA CAR therapies," said Daniel Getts, Ph.D., CEO of Myeloid. "With multiple clinical trials ongoing that evaluate our therapeutic candidates, including MT-302, our novel TROP2-targeting mRNA CAR in dose escalation studies, and adding MT-303, we have a proven ability to translate cutting-edge mRNA CAR technology into clinical candidates. We are excited by the transformative potential of our in vivo immune cell programming for liver cancer patients."

Dr. Getts continued, "Strategically, these clinical programs provide insights as we continue to expand our development portfolio to other targets, to other immune cell types, and to novel receptor combinations for our in vivo CAR approaches."

Myeloid’s in vivo programming candidates are designed with proprietary insights to deliver personalized therapy, providing benefits to patients while reducing time and costs through the elimination of ex vivo handling of patient cells and complex neoantigen sequencing. The Myeloid platform integrates validated antibody/antigen binding with novel combinations of myeloid signaling domains, coded within a simple mRNA that can be delivered repeatedly using lipid nanoparticles (LNPs). The platform’s versatility provides a range of signaling domains and immune cell types useful for combination approaches.

About Liver Cancer

With limited treatment options, and over 850,000 new cases diagnosed globally each year, liver cancer has become the third leading cause of cancer death. After initial treatment success with small molecule therapies, the development of new treatment approaches in the field of liver cancer has been limited. Today, patients with liver cancer who are refractory to first line treatment are left with few treatment options, creating a substantial unmet medical need. Myeloid sees an opportunity to make a significant contribution to address this need, by providing a new CAR for these patients who are living with liver cancer. The CARs are capable of providing a coordinated and durable immune response to counter advanced disease. The CARs are combinable and will expand the treatment options for physicians.

About the Phase 1 Study of MT-303

The MT-303 Phase 1 study (NCT06478693) is an open-label dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-303 in adults with advanced or metastatic hepatocellular carcinoma that overexpresses GPC3. This study will also define the recommended Phase 2 dose (RP2D) of MT-303.

About MT-303

MT-303 represents the first candidate in a new therapeutic modality targeting hepatocellular carcinoma (HCC). This clinical candidate is a first-in-class, GPC3-FcA-LNP, with a strong preclinical profile supporting its advance into this first-in-human trial. GPC3 is overexpressed in most human hepatocellular carcinomas, with limited expression in corresponding normal tissues. Increased GPC3 expression has been linked to tumor growth.

Treatment with MT-303 as a monotherapy demonstrates activity in a GPC3/HCC preclinical model, confirming the tumor-fighting potency of programmed myeloid cells even in the model’s absence of T cells. MT-303 has demonstrated strong expression in myeloid cells and a favorable safety profile in rodents and non-human primates. Unlike other therapies, MT-303 brings the potential advantages of eliciting a full immune response by also presenting tumor neoantigen to stimulate T cells.

MT-303 represents Myeloid’s second in vivo CAR clinical program, building on the company’s innovative approach to cancer treatment through immune cell programming.

On July 31, 2024 Prestige Biopharma, a pioneer in biopharmaceuticals, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for Tuznue, a Herceptin (trastuzumab) biosimilar (Press release, Prestige BioPharma, JUL 31, 2024, View Source [SID1234645215]). This milestone positions Prestige Biopharma to become the first Singaporean firm to commercialize its biosimilar in the European Union.

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The CHMP’s positive opinion is based on clinical evidence from Phase 1 and Phase 3 clinical studies that tested the biosimilarity of Tuznue to Herceptin. The Phase 1 clinical PK study in healthy volunteers demonstrated PK equivalence, as well as similarity in safety and immunogenicity. Finally, the global Phase 3 confirmatory efficacy and similarity study met its primary endpoint and demonstrated similarity in efficacy, PK, safety, and immunogenicity in HER2-positive patients with early breast cancer. This favourable decision is a crucial step toward final approval from the European Commission (EC). Once approved, Tuznue will be commercialized across Europe.

Prestige Biopharma has already established licensing agreements with major pharmaceutical partners for global marketing and sales. These agreements are set to generate immediate milestone payments and provide early revenue for the company. Negotiations are also underway to ensure a strong market entry for Tuznue in Europe.

"Receiving a positive CHMP opinion for Tuznue marks a major milestone for Prestige Biopharma, significantly advancing our revenue generation strategy and accelerating future pipeline approvals," said Lisa Park, the CEO of Prestige Biopharma. "This recognition solidifies our position as a leading biosimilar developer. We are committed to leveraging this achievement to enhance our market presence and drive continued success."

About TUZNUE (HD201, Herceptin biosimilar)

Tuznue is a biosimilar of Herceptin (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC).

On July 31, 2024 Theriva Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Drug Designation (RPDD) for VCN-01 for the treatment of retinoblastoma (Press release, Theriva Biologics, JUL 31, 2024, View Source [SID1234645213]). VCN-01, Theriva’s lead product candidate, is a systemic, selective, stroma-degrading oncolytic adenovirus. Previously, the FDA granted orphan drug designation to VCN-01 for treatment of retinoblastoma.

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"The FDA’s decision to grant rare pediatric drug designation to VCN-01 highlights the urgent need for new treatment options for pediatric patients with retinoblastoma," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "We are encouraged by this important step forward and, in parallel, continue to work closely with leading physicians and regulatory agencies to refine our clinical strategy for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma. Most recently, results from the investigator sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma were determined to be positive by the study Monitoring Committee. Data from this study will further inform our clinical development pathway in this area of high unmet need."

The FDA grants RPDD for rare diseases (fewer than 200,000 affected persons in the United States) that are serious and life-threatening and primarily affect children ages 18 years or younger. If a Biologics License Application for VCN-01 for the treatment of retinoblastoma is approved by the FDA, Theriva may be eligible to receive a Priority Review Voucher that can be redeemed to receive a priority review for any subsequent marketing application or may be sold or transferred.

About Retinoblastoma

Retinoblastoma is a tumor that originates in the retina and is the most common type of eye cancer in children. It occurs in approximately 1/14,000 – 1/18,000 live newborns and accounts for 15% of the tumors in the pediatric population < 1 year old. The average age of pediatric patients at diagnosis is 2, and it rarely occurs in children older than 6. In the U.S., retinoblastoma shows an incidence rate of 3.3 per 1,000,000 with only about 200 to 300 children diagnosed per year according to the American Cancer Society. Preserving life and preventing the loss of an eye, blindness and other serious effects of treatment that reduce the patient’s life span or the quality of life, remains a challenge. In addition, children with retinoblastoma have been more likely to lose their eye and die of metastatic disease in low-resource countries.

About VCN-01

VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to over 80 patients in Phase 1 and investigator-sponsored clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.

On July 31, 2024 Merck, a leading science and technology company, reported organic sales growth in the second quarter of 2024 (Press release, Merck KGaA, JUL 31, 2024, View Source [SID1234645212]). EBITDA pre remained around stable organically compared with the year-earlier figure, which had been increased by one-time effects. Excluding these one-time effects in the year-earlier quarter, EBITDA pre would also have grown organically.

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"We announced that we would gradually return to organic growth during the course of 2024. The second quarter shows our progress on this journey," said Belén Garijo, Chair of the Executive Board and CEO of Merck. "Our business dynamics as well as our assumptions point to growth also for the rest of the year. We are therefore raising our forecast for 2024 at Group level and for the Healthcare and Electronics business sectors."

Thanks to the good business performance of Healthcare and Electronics, Group sales in the second quarter of 2024 increased by 1.7% organically. Foreign exchange effects, especially from the U.S. dollar, had a negative impact of 0.7% on sales development. Overall, Group sales increased by 0.9% to € 5,352 million.

EBITDA pre decreased organically by only 0.8% and amounted to € 1,509 million despite the higher comparative base of the year-earlier quarter, which included one-time effects. Moreover, a provision of a mid double-digit million euro amount for the termination of the xevinapant program had a negative impact on EBITDA pre in the second quarter of 2024. In addition, negative foreign exchange effects of 2.1% were incurred. The total decrease compared with the year-earlier quarter was 2.9%. Without the one-time effect from a patent agreement in OLEDs with UDC (Universal Display Corporation) in the year-earlier quarter and the xevinapant termination provision, EBITDA pre would have grown in the mid-single digit percentage range in the second quarter of 2024. The Group EBITDA pre margin was 28.2% and earnings per share pre were stable compared with the year-earlier quarter at € 2.20.

On July 31, 2024, Merck completed the acquisition of Mirus Bio, which had been announced in May 2024. Mirus Bio is a U.S. life science company that specializes in transfection reagents for the manufacture of viral vectors. With this US$ 600 million acquisition, Merck is complementing its portfolio for the development and manufacture of novel modalities such as cell and gene therapies.

Life Science: Order intake in Process Solutions continues to recover; other business units deliver organic sales growth

In Life Science, sales declined organically by 3.7% and came in at € 2,258 million in the second quarter of 2024. The main reasons for this were the expected continued inventory destocking by customers of Process Solutions and the decrease in Covid-19-related demand. Sales of Process Solutions were down by 11.8% organically, evolving positively compared with the organic decrease of 19.0% in the first quarter of 2024. At the same time, order intake in this business unit improved both sequentially and in comparison with the second quarter of 2023. Merck expects sales of Process Solutions to recover gradually in the second half of 2024 as inventory destocking by customers comes to an end. The two other Life Science business units delivered organic sales growth in the second quarter of 2024: Science & Lab Solutions by 1.4% and Life Science Services by 8.2%.

EBITDA pre of Life Science decreased organically by 6.1% and amounted to € 655 million. This was mainly attributable to the decline in sales of Process Solutions and the lower share of sales from products with a higher contribution to earnings, partly offset by strict cost management. The EBITDA pre margin of the business sector reached 29.0%. Sequentially, i.e. compared with the first quarter of 2024, both EBITDA pre and the EBITDA pre margin of Life Science increased.

Healthcare: Solid organic growth driven by the Oncology and CM&E franchises

The Healthcare business sector delivered sales of € 2,137 million in the second quarter of 2024. Organically, sales grew by 5.3%. The Oncology franchise, with its cancer drugs Erbitux, Bavencio and Tepmetko, achieved organic sales growth. Sales of Mavenclad for the treatment of multiple sclerosis grew organically by 1.3% compared with the particularly high base of the year-earlier quarter. The organic sales growth of the Cardiovascular, Metabolism and Endocrinology (CM&E) franchise was attributable to various factors, including the market recovery in the area of diabetes in mainland China.

EBITDA pre of Healthcare was € 720 million, growing organically by 4.6% compared with a higher year-earlier base, which was supported by portfolio management. The provision for the termination of the xevinapant program had a negative impact on Healthcare earnings. The EBITDA pre margin of the business sector was 33.7% in the second quarter of 2024.

Electronics: Semiconductor Solutions growth based on market recovery in artificial intelligence and advanced nodes

In the second quarter of 2024, sales of the Electronics business sector grew organically by 7.6% and reached € 957 million. This growth was mainly driven by the Semiconductor Solutions business unit, which delivered organic sales growth of 11.4%. Alongside an increase in demand due to the market inflection for semiconductor materials for artificial intelligence applications and advanced nodes, the business with equipment for customer plants within the Delivery Systems & Services (DS&S) business unit also contributed to this. For the second half of 2024, Merck expects the remaining semiconductor materials market to gradually recover. However, the phasing of the DS&S project business will partly offset this effect.

EBITDA pre of Electronics declined organically by 3.1% against an increased comparative base and came in at € 255 million. The year-earlier quarter had recorded a one-time effect from a patent agreement in OLEDs with UDC. The increased sales in the Semiconductor Solutions unit had a positive effect on EBITDA pre. The EBITDA pre margin of Electronics reached 26.7%. Without the one-time effect, the EBITDA pre margin would have increased compared with the year-earlier quarter.

Merck raises guidance for 2024

For fiscal 2024, Merck is raising its guidance for the Group and for the Healthcare and Electronics business sectors – for both sales and EBITDA pre in each case. This is based on the continued strong performance of Healthcare and by the earlier inflection of the AI and advanced nodes semiconductor materials market in Electronics. For Life Science, the company confirms its previous organic guidance. Merck now expects the following development on Group level:

Net sales: in a range of € 20.7 billion to € 22.1 billion with organic growth of +2% to +5% (previously: € 20.6 billion to € 22.1 billion; organic growth of +1% to +5%) and foreign exchange effects of -3% to 0%.
EBITDA pre: in a range of € 5.8 billion to € 6.4 billion with organic growth of +4% to +10% and negative foreign exchange effects (FX) of -5% to -1% (previously: € 5.7 billion to € 6.3 billion; organic growth of +1% to +7%, FX ‑4% to ‑1%).
EPS pre: € 8.20 to € 9.30 (previously: € 8.05 to € 9.10).
Overview of the key figures for Q2 2024

Merck Group

Key figures

€ million

Q2 2024

Q2 2023

Change

Jan.-June 2024

Jan.-June 2023

Change

Net sales

5,352

5,302

0.9%

10,472

10,595

-1.2%

Operating result (EBIT)1

792

969

-18.3%

1,724

2,004

-14.0%

Margin (% of net sales)1

14.8%

18.3%

16.5%

18.9%

EBITDA2

1,472

1,452

1.4%

2,857

2,942

-2.9%

Margin (% of net sales)1

27.5%

27.4%

27.3%

27.8%

EBITDA pre1

1,509

1,553

-2.9%

2,963

3,140

-5.7%

Margin (% of net sales)1

28.2%

29.3%

28.3%

29.6%

Profit after income tax

605

706

-14.3%

1,305

1,506

-13.3%

Earnings per share (€)

1.40

1.62

-13.6%

2.99

3.45

-13.3%

Earnings per share pre (€)1

2.20

2.20

0.0%

4.26

4.57

-6.8%

Operating cash flow

861

622

38.4%

1,896

1,475

28.6%

Net financial debt1, 3

7,950

7,500

6.0%

–

–

–

Number of employees4

62,176

63,701

-2.4%

–

–

–

1 Not defined by International Financial Reporting Standards (IFRS).

2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation,
amortization, impairment losses, and reversals of impairment losses.

3 Figures for the reporting period ending on June 30, 2024, prior-year figures as of December 31, 2023.

4 Figures for the reporting period ending on June 30, 2024, prior-year figures as of June 30, 2023. This figure refers to all employees at sites of fully consolidated entities.

Life Science

Net sales by business unit

€ million

Q2 2024

Share

Organic growth1

Exchange rate effects

Acquisitions/ divestments

Total change

Q2 2023

Share

Science & Lab Solutions

1,192

53%

1.4%

-0.5%

–

0.9%

1,182

50%

Process Solutions

871

39%

-11.8%

-0.5%

–

-12.3%

994

42%

Life Science Services

194

9%

8.2%

1.0%

–

9.2%

178

8%

Life Science

2,258

100%

-3.7%

-0.4%

–

-4.1%

2,354

100%

1 Not defined by International Financial Reporting Standards (IFRS).

Healthcare

Net sales by major product lines/products

€ million

Q2 2024

Share

Organic
growth1

Exchange rate effects

Total change

Q2 2023

Share

Oncology

490

23%

9.2%

-2.1%

7.1%

458

22%

thereof: Erbitux

276

13%

8.2%

-2.1%

6.1%

260

13%

thereof: Bavencio

186

9%

6.4%

-1.9%

4.5%

178

9%

Neurology & Immunology

434

20%

-7.4%

0.2%

-7.2%

467

23%

thereof: Mavenclad

266

12%

1.3%

0.1%

1.4%

262

13%

thereof: Rebif

168

8%

-18.5%

0.3%

-18.2%

205

10%

Fertility

403

19%

-0.5%

-0.9%

-1.5%

409

20%

thereof: Gonal-f

227

11%

5.0%

-1.0%

4.0%

219

11%

Cardiovascular, Metabolism and Endocrinology

746

35%

13.7%

-1.6%

12.1%

665

32%

thereof: Glucophage

238

11%

23.5%

-2.6%

20.9%

197

10%

thereof: Concor

158

7%

13.2%

-1.8%

11.4%

142

7%

thereof: Euthyrox

155

7%

19.2%

-0.8%

18.4%

131

6%

thereof: Saizen

97

5%

23.0%

-0.6%

22.4%

79

4%

Other

64

3%

50

3%

Healthcare

2,137

100%

5.3%

-1.1%

4.3%

2,049

100%

1 Not defined by International Financial Reporting Standards (IFRS).

Electronics

Net sales by business unit

€ million

Q2 2024

Share

Organic growth1

Exchange rate effects

Acquisitions/ divestments

Total change

Q2 2023

Share

Semiconductor Solutions

665

69%

11.4%

-0.6%

-0.4%

10.4%

602

67%

Display Solutions

188

20%

-2.4%

-1.5%

–

-3.9%

196

22%

Surface Solutions

104

11%

4.1%

-1.3%

–

2.8%

101

11%

Electronics

957

100%

7.6%

-0.9%

-0.2%