On May 19, 2021 Blueprint Medicines Corporation (NASDAQ: BPMC) reported the presentation of updated Phase 1/2 ARROW trial data demonstrating durable clinical benefits of GAVRETO (pralsetinib) in metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and other advanced solid tumors (Press release, Blueprint Medicines, MAY 19, 2021, View Source [SID1234580330]). GAVRETO showed high response rates in treatment-naïve patients with RET fusion-positive NSCLC, clinical activity across a number of RET fusion-positive tumor types and a safety profile consistent with previously reported results. These data will be presented during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 4-8.

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"Precision therapies have significantly improved outcomes in non-small cell lung cancer driven by actionable biomarkers, and these pralsetinib data show the transformative impact of targeting RET alterations in the front-line treatment setting," said Giuseppe Curigliano, M.D., Ph.D., Associate Professor of Medical Oncology at the University of Milano and the Head of the Division of Early Drug Development at the European Institute of Oncology, IRCCS, Italy. "In treatment-naïve metastatic NSCLC, these results are particularly encouraging, with many patients remaining in response. The data highlight the critical importance of identifying RET alterations before initiating treatment, so that more patients have the opportunity to benefit from targeted therapy."

"Updated data in metastatic RET fusion-positive non-small cell lung cancer underscore how GAVRETO may transform the standard of care, including in the first-line treatment setting," said Becker Hewes, M.D., Chief Medical Officer at Blueprint Medicines. "The results in treatment-naïve patients with RET fusion-positive NSCLC reflect the compelling clinical profile of GAVRETO, with high response rates and durability of response that have strengthened over time. In other RET-altered cancers, target lesions were reduced across a diverse range of tumor types, with the majority of patients responding to treatment. In collaboration with Genentech, we look forward to engaging with the FDA based on the strength of these data in metastatic RET fusion-positive solid tumors."

Clinical Activity Data

The ASCO (Free ASCO Whitepaper) data included response-evaluable populations comprising 216 patients with RET fusion-positive NSCLC who had measurable disease at baseline and received a starting GAVRETO dose of 400 mg once daily, and 19 patients with other RET fusion-positive solid tumors, as of a date cutoff date of November 6, 2020. Tumor response was assessed by blinded independent central review using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and all responses were confirmed.

RET Fusion-Positive NSCLC

With a median follow-up of 17.1 months, GAVRETO showed durable clinical benefits in patients with RET fusion-positive NSCLC with or without prior therapy. In 68 treatment-naïve patients, the overall response rate (ORR) was 79 percent (95% CI: 68%, 88%). The complete response (CR) rate was 6 percent, 10 percent of patients had complete regression of target tumors, and 74 percent of patients had a partial response (PR). The median duration of response (DOR) was not reached (95% CI: 9.0 months, not reached).

For treatment-naïve patients, the initial study protocol limited enrollment to those determined by the investigator to be ineligible for standard platinum-based chemotherapy, which may be due to age, comorbidities or other poor prognostic factors. This eligibility restriction was removed in July 2019, with the goal of including a population more reflective of real-world practice. In an exploratory analysis of treatment-naïve patients enrolled after this expansion of inclusion criteria (n=25), the ORR was 88 percent (95% CI: 69%, 98%), and all responses were PRs.

In 126 patients who previously received platinum-based chemotherapy, the ORR was 62 percent (95% CI: 53%, 70%). The CR rate was 4 percent, 12 percent of patients had complete regression of target tumors, and 58 percent of patients had a PR. The median DOR was 22.3 months (95% CI: 15.1 months, not reached).

Other RET Fusion-Positive Solid Tumors

In a heavily pre-treated patient population who had a median follow-up of 12.1 months, GAVRETO showed clinical activity across multiple additional RET-driven tumor types. In 19 patients with a variety of RET fusion-positive solid tumors beyond NSCLC and thyroid cancer, the ORR was 53 percent (95% CI: 29%, 76%) and the median DOR was 19.0 months (95% CI: 5.5 months, not estimable). Tumor reductions were shown in patients with the following cancers – pancreatic, cholangiocarcinoma, colon, lung (except NSCLC), mesenchymal, salivary duct, sweat gland and thymus – as well as patients diagnosed with cancers of unknown primary origin. In the three patients with pancreatic cancer, a particularly difficult-to-treat tumor type, there was one CR and two PRs.

Safety Data

As of a data cutoff date of November 6, 2020, a total of 471 patients were enrolled with a GAVRETO dose starting at 400 mg once daily. Across tumor types, GAVRETO was well-tolerated with no new safety signals observed. The most common treatment-related adverse events (AEs) reported by investigators (≥20 percent) were neutropenia, increased aspartate aminotransferase (AST), anemia, decreased white blood cell count, increased alanine aminotransferase (ALT), hypertension, constipation and asthenia. Overall, 6 percent of patients discontinued GAVRETO due to treatment-related AEs.

These updated data will be reported in two ASCO (Free ASCO Whitepaper) poster presentations: one on RET fusion-positive NSCLC (Abstract #9089) and one on RET fusion-positive solid tumors (Abstract #3079). Copies of the data presentations will be available starting June 4, 2021 in the "Science―Publications and Presentations" section of Blueprint Medicines’ website.

About GAVRETO (pralsetinib)

GAVRETO (pralsetinib) is a once-daily oral targeted therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of three indications: adult patients with metastatic RET fusion-positive NSCLC as detected by an FDA approved test, adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and adults and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). These indications are approved under accelerated approval based on ORR and DOR. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. In addition, GAVRETO is approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic RET fusion-positive NSCLC after platinum-based chemotherapy.

GAVRETO is not approved for the treatment of any other indication in the U.S. by the FDA or in China by the NMPA, or for any indication in any other jurisdiction by any other health authority.

GAVRETO is designed to selectively and potently target oncogenic RET alterations, including secondary RET mutations predicted to drive resistance to treatment. In preclinical studies, GAVRETO inhibited RET at lower concentrations than other pharmacologically relevant kinases, including VEGFR2, FGFR2 and JAK2. For more information, visit GAVRETO.com.

Blueprint Medicines and Roche are co-developing GAVRETO globally (excluding Greater China) for the treatment of patients with RET-altered NSCLC, various types of thyroid cancer and other solid tumors. The European Medicines Agency validated a marketing authorization application for GAVRETO for the treatment of RET fusion-positive NSCLC. The FDA granted breakthrough therapy designation to GAVRETO for the treatment of RET fusion-positive NSCLC that has progressed following platinum-based chemotherapy and for RET mutation-positive MTC that requires systemic treatment and for which there are no acceptable alternative treatments.

Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of GAVRETO in Greater China, which encompasses Mainland China, Hong Kong, Macau and Taiwan.

Enrollment is ongoing in the Phase 1/2 ARROW trial, including for patients with various RET fusion-positive solid tumors, and in the Phase 3 AcceleRET Lung trial for treatment-naïve patients with RET fusion-positive NSCLC. For more information about GAVRETO clinical trials, visit www.clinicaltrials.gov or www.blueprintclinicaltrials.com.

About RET-Altered Solid Tumors

RET activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and multiple types of thyroid cancer. RET fusions are implicated in approximately 1 to 2 percent of patients with NSCLC and approximately 10 to 20 percent of patients with papillary thyroid cancer, while RET mutations are implicated in approximately 90 percent of patients with advanced MTC. In addition, oncogenic RET fusions are observed at low frequencies in colorectal, breast, pancreatic and other cancers, as well as in patients with treatment-resistant EGFR-mutant NSCLC.

On May 19, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported additional data from the Company’s dose-escalation cohort of the Phase 1 study of STRO-002, a folate receptor alpha (FolRα) targeting antibody-drug conjugate (ADC) for patients with advanced, progressive ovarian cancer; the data will also be presented as a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting to be held on June 4-8, 2021 (Press release, Sutro Biopharma, MAY 19, 2021, View Source [SID1234580329]).

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"We are pleased to share today the maturing dose-escalation data on STRO-002 that will be presented by principal investigator Dr. R. Wendel Naumann during the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting," said Bill Newell, Chief Executive Officer of Sutro Biopharma. "The 39 patients with advanced, progressive ovarian cancer on the study achieved a median progression-free survival of 7.2 months. Median duration of response was 5.8 months in the five confirmed responders. The dose-escalation data positions STRO-002 as a potentially important treatment option providing durable clinical benefit, especially when compared to standard of care and other agents in clinical development."

Summary of STRO-002-GM1 Phase 1 Dose-Escalation Cohort Update
The dose-escalation cohort enrolled patients with advanced, progressive epithelial ovarian cancer, not pre-selected based on FolRα-expression levels. Patient enrolled were heavily pre-treated and had received a median of six prior lines of therapy – including at least one platinum-based regimen in 100% of patients, and at least three prior lines of platinum regimens in 46%, bevacizumab in 82%, PARP inhibitors in 59%, checkpoint inhibitors in 21%, and other investigational agents in 36% of patients.

The cohort enrolled 39 patients and included 34 patients treated with clinically active dose levels at 2.9 mg/kg or higher, of which 31 patients had at least one post-baseline scan and were evaluable for RECIST responses. The cohort completed enrollment in August 2020 and the data in the ASCO (Free ASCO Whitepaper) 2021 abstract was based on an earlier cut-off date of January 30, 2021. The data that will be presented in a poster at ASCO (Free ASCO Whitepaper) 2021 had a cut-off date of April 23, 2021 and is summarized below.

Of the 31 patients evaluable for RECIST, 10 patients met criteria for response. One patient achieved a complete response (CR) and nine patients achieved a partial response (PR). Of the nine PRs, four were confirmed PRs (cPRs) and five were unconfirmed PRs (uPRs).
For the five confirmed responders (1 CR and 4 cPRs), the median duration of response (DOR) was 5.8 months (95% CI: 2.0, not evaluable).
Median study follow-up was 8.4 months and median progression-free survival (PFS) was 7.2 months (95% CI: 4.5, 10.8).
86% of treatment-emergent adverse events (AEs) were Grade 1 or 2. The most common Grade 3 and 4 AEs were neutropenia (64%), arthralgia (13%), fatigue (10%), neuropathy (8%), and abdominal pain (8%), all of which were managed with standard medical treatment, dose reductions, or dose delays.
Dose limiting toxicities (DLTs) were observed at higher dose levels in two patients – at 6.0 mg/kg (Grade 2 neuropathy/Grade 3 arthralgia) and at 6.4 mg/kg (Grade 3 bone pain).
Tissue samples for FolRα-expression analysis were provided by clinical sites retrospectively and were available in 18 patients treated at ≥ 2.9 mg/kg in the dose-escalation cohort. Antitumor activity was observed across a broad range of FolRα-expression levels.

Dr. Arturo Molina, Chief Medical Officer of Sutro commented, "It is encouraging to see the durable clinical benefit in our dose-escalation cohort, including in patients with lower levels of FolRα-expression who are being excluded from other ovarian cancer clinical trials. The need for new treatment options for this community drives our efforts to potentially bring STRO-002 to the broadest patient population that may benefit from the therapy. In consideration of a potential FolRα biomarker enrichment strategy, we plan to take a data-driven approach through balancing an efficient path forward, while serving the high unmet medical needs for ovarian cancer patients."

The Phase 1 dose-escalation data with a data cut-off date of April 23, 2021 will be available today as part of the Company’s Corporate Presentation, which can be accessed through the Company’s website at www.sutrobio.com. Additionally, the data will be presented virtually as a poster at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting from June 4-8, 2021, with details as follows:

Abstract: #5550
Session: Gynecologic Cancer
Time: Friday, June 4, 2021 at 9 a.m. ET
Title: Phase 1 Dose-Escalation Study of STRO-002, an anti-Folate Receptor alpha (FRα) Antibody Drug Conjugate (ADC), in Patients with Advanced, Progressive Platinum-Resistant/Refractory Epithelial Ovarian Cancer (EOC)
Presenter: R. Wendel Naumann, M.D., Professor & Director of Gynecologic Oncology Research at Levine Cancer Institute, Atrium Health

About the STRO-002-GM1 Phase 1 Study
STRO-002-GM1 is an open-label, multi-center, and two-part single-arm monotherapy Phase 1 study for STRO-002 in patients with advanced, progressive epithelial ovarian cancer, not pre-selected based on FolRα-expression levels. The Phase 1 is intended to study the safety, pharmacokinetics and preliminary efficacy of STRO-002, a folate receptor alpha (FolRα)-targeting ADC. The dose-escalation cohort has enrolled 39 patients and completed enrollment as of August 2020. The dose-expansion cohort is open for enrollment and requires tissue from patients for biomarker analysis prior to enrollment.

On May 19, 2021 Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, and the University of California, San Francisco (UCSF) reported they have formed a strategic alliance to accelerate the development and manufacturing of cell-based therapies (Press release, Thermo Fisher Scientific, MAY 19, 2021, View Source [SID1234580328]).

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Under the agreement, Thermo Fisher will build and operate a 44,000-square-foot, state-of-the-art cell therapy development, manufacturing and collaboration center in leased space on UCSF’s Mission Bay campus, which includes biomedical research facilities and hospitals. The site will offer clinical and commercial cGMP cell therapy manufacturing services, along with associated technology development support, to UCSF and other partners.

Expected to open in 2022, the facility will also serve as a central location where customers and UCSF researchers will have access to Thermo Fisher’s broad portfolio of Cell Therapy Systems (CTS) reagents, consumables, and fit-for-purpose instrumentation and compliant software. The CTS product portfolio is designed to work together, and seamlessly transition from research to clinical manufacturing to address cell therapy production workflow challenges.

"We are bringing together UCSF’s leadership in the newest forms of cellular immunotherapy and Thermo Fisher’s extensive capabilities in cell therapy instrumentation, manufacturing and distribution," said Mark Stevenson, executive vice president and chief operating officer of Thermo Fisher Scientific. "This powerful combination will provide customers – from emerging biotechs to large pharma companies – with integrated, end-to-end solutions to reduce costs and accelerate adoption of cell therapies, ultimately improving patient access to these transformative treatments."

Sam Hawgood, MBBS, chancellor of UCSF, said, "We expect breakthrough treatments for many different diseases and conditions to come from cell therapies. Establishing cell therapy manufacturing in such close proximity to our scientists, clinicians and patients will enable UCSF to catalyze innovation in living therapeutics and use the resulting discoveries to benefit our patients."

On May 19, 2021 Sosei Group Corporation ("the Company") (TSE: 4565) reported that it has been notified by Pfizer that the first subject in a clinical trial has been dosed with a new drug candidate nominated from the multi-target drug discovery collaboration between the two companies (Press release, Sosei Heptares, MAY 19, 2021, View Source [SID1234580327]). Achievement of this milestone triggers a payment of US$5 million to Sosei Heptares. This candidate was nominated for advancement by Pfizer in December 2019 generating a US$3 million milestone payment at that time.

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Pfizer nominated three distinct clinical candidates from the collaboration with Sosei Heptares during 2019, all of which are now progressing in Phase I clinical trials. These candidates have also now been disclosed by Pfizer as:

PF-07081532 (an oral GLP1 receptor agonist for Type 2 Diabetes Mellitus and Obesity)
PF-07054894 (a CCR6 antagonist targeting Inflammatory Bowel Disease) and
PF-07258669 (an MC4 receptor antagonist for Anorexia)
This candidate is the ninth GPCR-targeted drug candidate overall originating from Sosei Heptares’ StaR technology and structure-based drug design (SBDD) platform to enter clinical trials.

Dr. Rob Cooke, Chief Technology Officer of Sosei Heptares, said: "The start of clinical trials with this new clinical candidate is a further important milestone in our highly productive and longstanding collaboration with Pfizer. It is a clear demonstration of the power of our structure-based design and discovery capabilities when combined with the complementary development expertise of a truly collaborative partner. This productivity is further exemplified by the fact that nine candidates derived from our platform have entered clinical trials across multiple disease areas, with more than 20 active programs underway either with partners or in house. This broad portfolio of exciting new drug candidates has potential to address significant unmet need globally and generate significant future value for shareholders."

About the Agreement with Pfizer

Sosei Heptares and Pfizer entered a multi-target drug discovery collaboration in November 2015 to research and develop potential new medicines directed at GPCR targets across multiple therapeutic areas. Many of these targets have clinical or biological validation as key points for therapeutic intervention potentially targeting a range of diseases but have proven difficult to address with conventional discovery approaches because of inherent technical challenges.

To address these challenges, Sosei Heptares and Pfizer scientists worked closely together to leverage their respective complementary expertise in enabling GPCR-focused structure-based drug design (SBDD) and development directed to the GPCR targets selected by Pfizer. Pfizer is responsible for developing and commercializing any potential therapeutic agents (small molecules or biologics) for each target and will have exclusive global rights to any potential resulting agents.

To date, Sosei Heptares has delivered multiple stabilized receptors (StaR proteins), X-ray structures and biophysical data on certain programs. These achievements have led to the design and development of novel small molecule candidates, three of which have now entered clinical trials. The progress under this partnership has triggered multiple significant milestone payments from Pfizer, with further payments and potential royalties possible under the agreement, provided the criteria under the agreement are satisfied.

On May 19, 2021 Photocure ASA (OSE:PHO), the Bladder Cancer Company, reported Hexvix/Cysview revenues of NOK 81.6 million in the first quarter of 2021 (Q1 2020: NOK 54.4 million), and EBITDA of NOK 18.1 million (NOK -4.8 million), following the continued successful launch in markets previously operated by Ipsen Pharma SAS (Press release, PhotoCure, MAY 19, 2021, View Source [SID1234580326]). The third Covid-19 wave impacted operations in the quarter, but a strong March performance indicates the environment is improving.

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"For the first quarter of 2021, Photocure delivered a 50% YoY increase in Hexvix/Cysview sales, unit growth in our U.S. segment, and positive EBITDA driven by the added revenue in Europe, cost containment, and the payment from Asieris to license Hexvix in China and Taiwan. I am pleased with this performance, particularly given the negative impact from the third wave of Covid-19 in January and February of this year, foreign currency headwinds during the quarter, and the difficult comparison to the same period last year when pandemic lockdowns and limited access to care did not occur until mid-March. While access is still closed or significantly restricted in many areas, strong performance in the last month of the quarter in both our U.S. and European segments suggests that the environment is improving," says Daniel Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 88.2 million in the first quarter of 2021 (NOK 55.0 million), with an EBITDA* before restructuring of NOK 18.1 million (NOK -4.8 million) including signing fees from Asieris totaling NOK 6.4 million for the commercialization of Hexvix in Mainland China and Taiwan. Hexvix/Cysview revenues were NOK 81.6 million (NOK 54.4 million) following the successful transition of the Ipsen territories, while unit growth in the U.S. increased 4% despite the limited access to hospitals and physicians due to Covid-19. EBIT grew to NOK 12.3 million (-10.5 million) and the cash balance at the end of the first quarter 2021 was NOK 329.5 million (127.6 million).

The installed base of blue light cystoscopes in the U.S. was 280 at the end of the first quarter, an increase of 42 units, or 18%, compared to the same period in 2020. Blue Light Cystoscopy (BLC) in the surveillance setting is a key priority for Photocure in the U.S. market. By the end of the first quarter, a total base of 41 flexible cystoscopes had been installed giving more patients access to the procedure with less constraints.

"Despite the ongoing commercial challenges, we continued to advance several initiatives to grow the installed base of Blue Light Cystoscope towers and to prepare for increasing procedure volumes when full access to care reopens. In the U.S., we installed 12 new towers during the quarter including 3 flexible Blue Light Cystoscope units. Our growing pipeline suggests the potential for acceleration of Blue Light Cystoscope installations during the remainder of the year, and we believe that the benefits of Blue Light Cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care, " Schneider adds.

The ongoing Covid-19 pandemic adds continued uncertainty to Photocure’s near-term business forecast, but the Company believes that in places where procedures have been postponed due to the fear of exposure to Covid-19, the number of procedures is expected to rebound back to pre-Covid-19 growth rates in the U.S. and positive growth in the Company’s newly acquired European markets.

"Our contracting strategies in the U.S. are also gaining traction and expected to lead to new account growth and higher penetration into our existing institutional customers and physician clinics. In Europe, where we are introducing Photocure as the new sponsor of Hexvix, we have had strong buy-in from leading key opinion leaders in target countries. Despite limited access to our new customers, we are seeing early indications of a turn-around in our key growth markets such as the UK, France, and Italy. As access improves, we will continue to staff our European operations and invest in order to generate additional growth in the region. Our performance in dealing with the ongoing business volatility, including the sales rebound that we saw in March, gives me confidence that we are taking the right steps to return to strong growth and to execute on our strategy to become a leader in the diagnosis and treatment of bladder cancer patients around the world" Schneider concludes.

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the first quarter 2021 financial report on page 23.

Photocure will present its first quarter 2021 report on Wednesday 19 May 2021 at 14:00 CET. The investor presentation will be streamed live and be hosted by Daniel Schneider, CEO and Erik Dahl, CFO.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20210519_6/. The presentation is scheduled to conclude at 14:45 CET.