First Quarter 2022

On April 28, 2022 Merck & Co reported its first quarter 2022 results (Presentation, Merck & Co, APR 28, 2022, View Source [SID1234613162]).

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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.