Orion Group Interim Report 1–3/2022

On April 28, 2022 Orion Group reported that Interim Report 1–3/2022 (Press release, Orion , APR 28, 2022, View Source [SID1234613161])

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This is a summary or Orion’s Interim Report 1–3/2022. The complete report is attached to this stock exchange release and is available at View Source

Net sales totalled EUR 271 million (EUR 269 million in 2021).
Operating profit was EUR 71 (75) million.
Profit before taxes was EUR 72 (75) million.
Equity ratio was 53% (54%).
Return on capital employed before taxes (ROCE) was 36% (38%).
Return on equity after taxes (ROE) was 33% (35%).
Basic earnings per share were EUR 0.41 (0.42).
Cash flow per share before financial items was EUR 0.23 (0.19).
The outlook for 2022 remains unchanged. Orion estimates that net sales in 2022 will be at a similar level as in 2021 (net sales in 2021 were EUR 1,041 million). Operating profit is estimated to be at a similar level as in 2021 (operating profit in 2021 was EUR 243 million).
Nubeqa spearheads Orion’s growth – war and ever more stressed supply chains causing concerns

"The year 2022 for Orion has started with mixed feelings. On the one hand, we have had positive news flow from darolutamide and the overall business has developed well. At the same time, however, the war in Ukraine has caused a great deal of concern and our thoughts are with our employees in Ukraine and everyone suffering from this situation. Also, the effects of the COVID-19 pandemic are not over yet. Global supply chains remain under high stress and cost inflation has accelerated faster than anticipated. For Orion, the increase in costs is particularly challenging, as raising the prices of prescription medicines for human use in Orion’s markets is often not an option. We remain committed to looking after the health and safety of our employees, ensuring production continuity and product availability, and safeguarding patient safety in ongoing clinical trials.

Orion’s net sales in January-March 2022 grew by one per cent from the comparative period and the operating profit was slightly lower than in the comparative period. The sales of Dexdor and Simdax declined clearly as expected but, thanks to the strong sales development of Nubeqa and Easyhaler portfolio, net sales of the Proprietary Products unit increased slightly. Nubeqa sales were further boosted by large product deliveries to our partner Bayer. These shipments can and will cause quarterly volatility to total Nubeqa revenues booked by Orion. Net sales of the Specialty Products unit also increased slightly, due to for example strong sales of self-care products in Finland. Sales of the Animal Health unit declined due to the timing of deliveries to partners and also because of the termination of one distribution agreement in Finland. Fermion and Contract Manufacturing performed according to expectations in the first three months of the year.

In February 2022, detailed positive results from the Phase III ARASENS study with darolutamide were reported in the New England Journal of Medicine and at the 2022 ASCO (Free ASCO Whitepaper) GU Cancers Symposium. Orion’s collaboration partner Bayer also upgraded its estimate on darolutamide’s peak sales potential. In March, we published our plans to change and refocus the strategy of Orion’s R&D function and started negotiations in accordance with the Act on Co-operation within Undertakings. Orion plans for R&D to focus on cancer and pain in future. The search continues for partners for the ODM-208 molecule and the digital therapy software solution for treating chronic pain.

We remain dedicated to our 2025 growth target and as part of that journey continue our efforts to find new cooperation opportunities and product and business acquisition targets.

Finally, I would like to express my warmest congratulations to Liisa Hurme, who was appointed as Orion’s President and CEO as of 1 November 2022. I am convinced that Liisa, with her broad expertise and experience, is well placed to continue the work on Orion’s growth strategy that we have developed together as colleagues. Collaborating together, we will ensure that the upcoming CEO transition goes smoothly."

Outlook for 2022 (provided on 10 February 2022)

Orion estimates that net sales in 2022 will be at a similar level as in 2021
(net sales in 2021 were EUR 1,041 million).

Operating profit is estimated to be at a similar level as in 2021
(operating profit in 2021 was EUR 243 million).

News conference and conference call

A webcast and a conference call for analysts, investors and media will be held on Thursday, 28 April 2022 at 13.30 EEST. The event will be held only online and by conference call.

A link to the live webcast will be available on Orion’s website at www.orion.fi/en/investors. A recording of the event will be available on the website later the same day.

Anixa Biosciences Announces Presentation on Breast Cancer Vaccine Trial at the American Society of Clinical Oncology (ASCO) Annual Meeting

On April 28, 2022 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported a presentation outlining the design of its breast cancer vaccine trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 3-7, 2022 (Press release, Anixa Biosciences, APR 28, 2022, View Source [SID1234613155]). The presentation, titled "Phase 1 Trial of an alpha-Lactalbumin vaccine in patients with moderate- to high-risk operable triple-negative breast cancer (TNBC)" will be presented by the study’s principal investigator, Dr. George Thomas Budd of Cleveland Clinic, Anixa’s collaboration partner.

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Additional presentation details can be found below:

Abstract #: TPS1125

Date/Time: June 6, 2022, 9:00 AM EDT

About Triple-Negative Breast Cancer

One in eight women in the U.S. will be diagnosed with an invasive breast cancer at some point in their lives. Approximately 10-15% of those diagnoses are TNBC, however TNBC accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of recurrence. This form of breast cancer is twice as likely to occur in African-American women, and approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.

About Anixa Bioscience’s Breast Cancer Vaccine

Anixa’s investigational vaccine, currently in Phase 1 trials, takes advantage of endogenously produced proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in the majority of triple-negative breast cancers. Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing.

AVEO Oncology to Announce First Quarter 2022 Financial Results and Host Conference Call and Webcast on May 5, 2022

On April 28, 2022 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported that it will report first quarter 2022 financial results on Thursday, May 5, 2022 (Press release, AVEO, APR 28, 2022, View Source [SID1234613154]). AVEO’s management team will host a conference call and audio webcast at 8:30 a.m. ET on Thursday, May 5, 2022, to discuss the financial results and provide a business update.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The call can be accessed by dialing (800) 954-1051 (U.S. and Canada) or (303) 223-0117 (international). The passcode for the conference call is 22018215. To access the live webcast, or the subsequent archived recording, please visit the Calendar of Events sub-section within the Investors section of the AVEO website at www.aveooncology.com.

VBI Vaccines Announces Data from VBI-1901 in Recurrent Glioblastoma Patients Selected for Poster Discussion at the 2022 ASCO Annual Meeting

On April 28, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that tumor response and overall survival data from the ongoing Phase 2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), was accepted for presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, VBI Vaccines, APR 28, 2022, View Source [SID1234613153]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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VBI’s data was selected for presentation and discussion in both a poster session and a poster discussion session. The poster discussion will highlight selected abstracts from the poster session, placing the abstracts in context, with a focus on how the findings apply to clinical practice and future research.

Presentation Details

Title: Evaluation of tumor responses and overall survival in patients with recurrent glioblastoma (GBM) from a Phase IIa trial of a CMV vaccine immunotherapeutic candidate (VBI-1901)
Date: Sunday, June 5, 2022
Poster Session/Poster Discussion Session: Central Nervous System Tumors
Poster Session Time: 8:00 AM – 11:00 AM CDT
Poster Discussion Session Time: 11:30 AM – 1:00 PM CDT
About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.

Seagen to Highlight Data from Expanding Oncology Portfolio at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 28, 2022 Seagen Inc. (Nasdaq:SGEN) reported upcoming presentations of new data from its expanding pipeline of marketed and investigational therapies at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 3-7, 2022 in Chicago (Press release, Seagen, APR 28, 2022, View Source [SID1234613152]). The accepted abstracts demonstrate the growth of Seagen’s portfolio and clinical progress across multiple cancer types, including cervical and urothelial cancers and pediatric and adult Hodgkin lymphoma. Groundbreaking overall survival data for Stage III/IV Hodgkin lymphoma patients who were treated with ADCETRIS (brentuximab vedotin) as part of a first-line therapy combination will be detailed in one of three oral presentations for the antibody-drug conjugate medicine.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Other important data include interim results from the dose-expansion cohorts of the innovaTV 205 trial of TIVDAK (tisotumab vedotin-tftv) in combination with other anticancer agents in patients with recurrent metastatic cervical cancer, which will also be featured in an oral presentation. Long-term outcomes from the phase 3 EV-301 trial of PADCEV (enfortumab vedotin-ejfv) in patients with previously treated advanced urothelial carcinoma will be shared in a poster discussion.

"Significant improvements in overall and event-free survival are important new findings in adult and pediatric Hodgkin lymphoma patients, respectively," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "We look forward to the presentations and plan to submit supplemental applications to the Food and Drug Administration to update overall survival in the ADCETRIS prescribing information for Hodgkin lymphoma and expand its indication to include children."

Key data presentations for Seagen include:

Presentations of Company-Sponsored Trials

Abstract Title

Abstract #

Presentation

Lead Author

ADCETRIS (brentuximab vedotin)

First-line brentuximab vedotin plus chemotherapy to improve overall survival in patients with Stage III/IV classical Hodgkin lymphoma: An updated analysis of ECHELON-1

7503

Oral
Friday, June 3
2 p.m. CT

S. M. Ansell

Brentuximab vedotin in combination with lenalidomide and rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma: Safety and efficacy results from the safety run-in period of the phase 3 ECHELON-3 study

7559

Poster
Saturday, June 4
8 a.m. CT

N. L. Bartlett

Updated safety and efficacy data from an open-label, phase 1/2 study of frontline brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (A+AVD) in pediatric patients with advanced-stage classical Hodgkin lymphoma (cHL)

10000

Oral
Monday, June 6
3 p.m. CT

A. R. Franklin

The impact of classic Hodgkin lymphoma (cHL) on informal caregivers: Results from the cHL: Real-world observations from physicians, patients, and caregivers on the disease and its treatment (CONNECT) study

E24004

Online Publication

D. R. Flora

PADCEV (enfortumab vedotin-ejfv)

Long-term outcomes in EV-301: 24-month findings from the phase 3 trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma

4516

Poster Discussion
Saturday, June 4
5:04 p.m. CT

J. E. Rosenberg

Study EV-103 Cohort H: Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients with muscle-invasive bladder cancer who are cisplatin-ineligible

4582

Poster
Saturday, June 4
1:15 p.m. CT

D. P. Petrylak

Benchmarking maintenance therapy survival in first-line advanced urothelial carcinoma using disease modeling

4575

Poster
Saturday, June 4
1:15 p.m. CT

M. D. Galsky

Real world treatment patterns and clinical outcomes with first-line therapy in cisplatin-eligible and ineligible patients with advanced urothelial carcinoma

4565

Poster
Saturday, June 4
1:15 p.m. CT

G. P. Sonpavde

TIVDAK (tisotumab vedotin-tftv)

Factors associated with receipt of second-line recurrent or metastatic cervical cancer treatment in the United States: A retrospective administrative claims analysis

5532

Poster
Saturday, June 4
1:15 p.m. CT

K. Sonawane

Cervical cancer geographical burden analyzer: An interactive, open-access tool for understanding geographical disease burden in patients with recurrent or metastatic cervical cancer

5523

Poster Discussion
Saturday, June 4
4:30 p.m. CT

T. Castellano

Tisotumab vedotin (TV) + pembrolizumab (pembro) in first-line (1L) recurrent or metastatic cervical cancer (r/mCC): Interim results of ENGOT Cx8/GOG 3024/innovaTV 205

5507

Oral
Monday, June 6
10:12 a.m. CT

D. Lorusso

Productivity losses under various second-line recurrent or metastatic cervical cancer treatment scenarios in the United States

E17520

Online Publication

J. Ting

Patterns of care in Medicaid-enrollees with recurrent or metastatic cervical cancer

E17525

Online Publication

C. A. Leath

TIVDAK (tisotumab vedotin-tftv) Trials in Progress

Trial in progress update on ENGOT-cx8/GOG-3024/innovaTV 205: Addition of a new cohort with first-line (1L) tisotumab vedotin (TV) + pembrolizumab (pembro) + carboplatin (carbo) ± bevacizumab (bev) in recurrent/metastatic cervical cancer (r/mCC)

TPS5603

Poster
Saturday, June 4
1:15 p.m. CT

I. Vergote

innovaTV 207: New combination dosing cohorts in the open label phase 2 study of tisotumab vedotin in solid tumors

TPS6100

Poster
Monday, June 6
1:15 p.m. CT

X. Le

TUKYSA (tucatinib) Trials in Progress

Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer (HER2CLIMB-05, trial in progress)

TPS1108

Poster
Monday, June 6
8 a.m. CT

E. P. Hamilton

Phase 2 trial of tucatinib + trastuzumab deruxtecan in patients with HER2+ locally advanced or metastatic breast cancer with and without brain metastases (HER2CLIMB-04, trial in progress)

TPS1111

Poster
Monday, June 6
8 a.m. CT

I. E. Krop

Disitamab vedotin

Preliminary results of a phase Ib/II combination study of RC48-ADC, a novel humanized anti-HER2 antibody-drug conjugate (ADC) with toripalimab, a humanized IgG4 mAb against programmed death-1 (PD-1) in patients with locally advanced or metastatic urothelial carcinoma

4518

Poster Discussion
Saturday, June 4
5:26 p.m. CT

X. Sheng

A phase II study of RC48-ADC in HER2-negative patients with locally advanced or metastatic urothelial carcinoma

4519

Poster Discussion
Saturday, June 4
5:26 p.m. CT

H. Xu

RC48-ADC for metastatic urothelial carcinoma with HER2 -positive: Combined analysis of RC48-C005 and RC48-C009 trials

4520

Poster Discussion
Saturday, June 4
5:26 p.m. CT

X. Sheng

Pipeline Trials in Progress

Phase 1 study of SGN-B7H4V, a novel, investigational vedotin antibody–drug conjugate directed to B7-H4, in patients with advanced solid tumors (SGNB7H4V-001, trial in progress)

TPS3155

Poster
Sunday, June 5
8 a.m. CT

A. Patnaik

Phase 1 study of SGN-PDL1V, a novel, investigational vedotin antibody–drug conjugate directed to PD-L1, in patients with advanced solid tumors (SGNPDL1V-001, trial in progress)

TPS3154

Poster
Sunday, June 5
8 a.m. CT

A. Patnaik

Phase 1 study of SGN-ALPV, a novel, investigational vedotin antibody–drug conjugate directed to ALPP/ALPPL2 in advanced solid tumors (SGNALPV-001, trial in progress)

TPS3159

Poster
Sunday, June 5
8 a.m. CT

N. Lakhani

Phase 1b/2 study of ladiratuzumab vedotin (LV) in combination with pembrolizumab for first-line treatment of triple-negative breast cancer (SGNLVA-002, trial in progress)

TPS1127

Poster
Monday, June 6
8 a.m. CT

J. L. Meisel

Presentations of Investigator-Sponsored or Cooperative Group Trials

Abstract Title

Abstract #

Presentation

Lead Author

Brentuximab vedotin and association with event-free survival (EFS) in children with newly diagnosed high-risk Hodgkin lymphoma (HL): A report from the Children’s Oncology Group phase 3 study AHOD1331 (NCT 02166463)

7504

Oral
Friday, June 3
2:12 p.m. CT

S. M. Castellino

Brentuximab vedotin and nivolumab alone and then combined with rituximab, cyclophosphamide, doxorubicin, and prednisone for frontline therapy of patients with primary mediastinal large B-cell lymphoma

TPS7589

Poster
Saturday, June 4
8 a.m. CT

R. E. Steiner