Neurocrine Biosciences Announces Repurchase of Convertible Notes

On May 24, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) (the "Company" or "Neurocrine Biosciences") reported that it has entered into separate, privately negotiated transactions (the "Agreements") with certain holders of its existing 2.25% Convertible Senior Notes due 2024 (the "2024 Notes") to repurchase approximately $179.4 million aggregate principal amount of the 2024 Notes for an aggregate repurchase price of an amount of cash estimated to be the sum of (i) approximately $224.0 million, (ii) an amount based in part on the trading price of the Company’s common stock and (iii) accrued and unpaid interest (Press release, Neurocrine Biosciences, MAY 24, 2022, View Source [SID1234615004]). The 2024 Notes repurchases are expected to close over a period ending on June 14, 2022, subject to customary closing conditions. Such repurchases of the 2024 Notes could affect the market price of the Company’s common stock.

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Following these repurchases, approximately $201.8 million aggregate principal of the Company’s 2024 Notes will remain outstanding, from an initial principal balance of $517.5 million. "Given our balance sheet flexibility, we have now reduced our convertible debt levels by approximately 60% over the past two years in an effort to minimize dilution for our shareholders," said Matt Abernethy, Chief Financial Officer of Neurocrine Biosciences. "Our capital allocation priorities remain focused on growing INGREZZA and advancing our mid-to-late-stage clinical programs."

This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which the offer, solicitation, or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

BERGENBIO ASA: RESULTS FOR THE FIRST QUARTER 2022

On May 24, 2022 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported its results for the first quarter 2022 (Press release, BerGenBio, MAY 24, 2022, View Source [SID1234614968]).

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A briefing by BerGenBio’s senior management team will take place at 10:00am CEST today via a webcast presentation, followed by a Q&A session. Please see below for details.

Operational Highlights – first quarter 2022 (including post-period end)

Post-period end, business strategy update announced, focusing on two key indications; 1st line STK11m non-small cell lung cancer (NSCLC) and COVID-19. ​
Primary endpoint met in hospitalized COVID-19 patients in complete data analysis of ACCORD2 (BGBIL019), a randomized Phase II study of bemcentinib in combination with standard of care therapy.
Presented clinical trial data from Phase IIa bemcentinib COVID-19 clinical trial (BCBC020) at 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).​
Cristina Oliva, MD appointed as Chief Medical Officer, bringing over 20 years of senior clinical development experience across large pharmaceutical, biotechnology and Clinical Research Organizations.
Publication of a peer-reviewed article entitled "AXL targeting restores PD-1 blockade sensitivity of STK11/LKB1 mutant NSCLC through expansion of TCF1+ CD8+ T cells" in the journal Cell Reports Medicine.
Announced inclusion of bemcentinib, in the EUSolidAct platform study of hospitalized COVID-19 patients designed to enroll up to 500 patients across European centers participating in the EUSolidAct platform.
Financial Highlights – first quarter 2022

(Figures in brackets = same period 2021 unless otherwise stated)

Revenue amounted to NOK 0.0 million (NOK 0.0 million) for the first quarter 2022
Total operating expenses for the first quarter were NOK 78.6 million (NOK 83.4 million)
The operating loss for the first quarter came to NOK 78.6 million (NOK 83.4 million)
Cash and cash equivalents amounted to NOK 367.8 million at the end of the first quarter 2022 (NOK 436.6 million by end of December 2021)
Martin Olin, Chief Executive Officer of BerGenBio, commented: "Earlier this month, we provided an update on the Company’s strategy. BerGenBio’s mission remains unchanged, and we believe that the announced focus provides an optimal path to unlock the potential of AXL inhibition as a transformative treatment modality for severe diseases.​

By focusing the development of our lead asset bemcentinib to two key areas, STK11 mutated (STK11m) 1st line non-small cell lung cancer (NSCLC) and COVID-19, we believe we have defined the path to efficiently advance BerGenBio’s clinical and commercial potential. Both indications represent significant unmet medical needs and our defined plans for each of these indications provides a strong foundation for bringing new drug to market with the aim of achieving better outcomes for patients and the generation of significant value for our shareholders.​

With a focused strategy and rightsized organization, I believe we are well positioned to unlock significant potential value related to the two indications selected and define the path to market."

Presentation and Webcast Details

The live webcast link is available at www.bergenbio.com in the Investors/Financial Reports section. A recording will be available shortly after the webcast has finished.

Webcast link: https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20220524_3

The first quarter report and presentation are available on the Company’s website in the Investors/Financial Reports section and a recording of the webcast will be made available shortly after the webcast has finished.

AFFIMED TO REPORT FIRST QUARTER 2022 FINANCIAL RESULTS & CORPORATE UPDATE ON JUNE 1, 2022

On May 24, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will release first quarter 2022 results and corporate update on Wednesday, June 1, 2022 (Press release, Affimed, MAY 24, 2022, View Source [SID1234614989]). The Company will host a conference call at 8:30 a.m. Eastern Daylight Time. The conference call will be available via phone and webcast. To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference conference ID 4440407 approximately 15 minutes prior to the call. To access the live audio webcast of the conference call please visit the "Investors" section of the Company’s website at View Source A replay of the call will be archived on Affimed’s website for 30 days after the call.

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Myeloid Therapeutics to Participate at Investor Conferences in June 2022

On May 24, 2022 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage mRNA-immunotherapy company developing novel therapies for cancer and autoimmune diseases, reported that it will participate in the following investor conferences during June 2022 (Press release, Myeloid Therapeutics, MAY 24, 2022, View Source [SID1234615006]):

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Wells Fargo Private Biotech Symposium, taking place virtually on June 1, 2022
Jefferies Healthcare Conference, taking place in New York, NY, June 8-10th, 2022. Daniel Getts, Ph.D., CEO of Myeloid, will present a company overview on Friday, June 10th, at 12:15 pm ET.

OncoSec Receives Triple Negative Breast Cancer Foundation’s Vanguard Award for Excellence in Oncology Research

On May 23, 2022 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec") reported that it is the recipient of the 2022 Vanguard Award presented by the Triple Negative Breast Cancer (TNBC) Foundation (Press release, OncoSec Medical, MAY 23, 2022, View Source [SID1234614949]). OncoSec’s Head of Patient Advocacy, Kimberly Irvine, will accept the award on behalf of the Company at the Foundation’s gala titled, "No One Fights Alone," on May 25, 2022.

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"On behalf of OncoSec, I want to thank the TNBC Foundation for this distinguished honor and recognition," said Kimberly Irvine, Head of Patient Advocacy. "Our efforts aiming to provide much needed therapies to patients with metastatic TNBC (mTNBC) is one key pillar of our mission to help patients with cancer who don’t respond to currently available treatments. As a two-time breast cancer survivor, myself, I understand the unmet need. We look forward to continuing our research and working with the TNBC patient community to learn about their experiences and how we can better meet their needs."

Hayley Dinerman, Executive Director at TNBC Foundation, added, "Triple negative breast cancer accounts for up to 15% of breast cancers in the U.S., but many patients have never heard of TNBC. As the leading advocacy group for the TNBC community, it’s our goal to educate and support patients battling this disease, and to recognize academic, pharmaceutical and biotech industry partners who work to improve patient outcomes. The TNBC Foundation is thrilled to recognize OncoSec as the 2022 Vanguard Award recipient for its unrelenting dedication to cancer research and to patients struggling with TNBC. We are excited to see new developments from the company as it progresses its TNBC program."

The Triple Negative Breast Cancer Foundation’s Vanguard Award for Excellence in Oncology Research was previously awarded to Immunomedics (acquired by Gilead Sciences, Inc.) in 2019, Eisai Co., Ltd. in 2018, and Hackensack University Medical Center in 2017.

To learn more about the Vanguard Award and the TNBC Foundation visit, tnbcfoundation.org.

About TAVO
OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.