AbbVie Announces Extension of Expiration Date for Exchange Offers for Allergan Notes and Expects No Further Extensions of Expiration Date

On May 6, 2020 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported the extension of the expiration date of the offers to exchange (each, an "Exchange Offer" and, collectively, the "Exchange Offers") any and all outstanding notes of certain series issued by Allergan Finance, LLC ("Allergan Finance"), Allergan, Inc. ("Allergan Inc"), Allergan Sales, LLC ("Allergan Sales") and Allergan Funding SCS ("Allergan Funding" and, together with Allergan Finance, Allergan Inc and Allergan Sales, "Allergan") (the "Allergan Notes") for new notes to be issued by AbbVie (the "AbbVie Notes") and the related consent solicitations (each, a "Consent Solicitation" and, collectively, the "Consent Solicitations") being made by AbbVie on behalf of Allergan to adopt certain amendments to each of the indentures (each, an "Allergan Indenture") governing the Allergan Notes (Press release, AbbVie, MAY 6, 2020, View Source [SID1234557072]). AbbVie hereby extends such expiration date from 5:00 p.m., New York City time, on May 8, 2020 to 5:00 p.m., New York City time, on May 12, 2020 (the "Expiration Date"). AbbVie currently expects that there will be no further extensions of the Expiration Date.

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On the early participation date of November 7, 2019, requisite consents were received and supplemental indentures were executed eliminating substantially all of the covenants, restrictive provisions, events of default and any guarantees of the related Allergan Notes in each Allergan Indenture. Such supplemental indentures will become operative only upon settlement of the Exchange Offers, which is expected to occur on May 14, 2020.

The Exchange Offers and Consent Solicitations were commenced in connection with AbbVie’s previously announced proposed acquisition of Allergan plc (the "Acquisition") and are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement, dated October 25, 2019, and the related letter of transmittal, each as amended by the press releases dated November 18, 2019, December 20, 2019, January 27, 2020, February 24, 2020, March 9, 2020, March 23, 2020, April 6, 2020, April 20, 2020 and April 27, 2020 and as amended hereby (collectively, the "Offering Documents"), and are conditioned upon the closing of the Acquisition, which condition may not be waived by AbbVie, and certain other conditions that may be waived by AbbVie.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

Durham startup targeting pancreatitis raises $2.7M from 19 investors

On May 5, 2020 Lamassu Pharma, a biotech startup that is developing small molecule therapeutics to treat acute pancreatitis, reported the company has found plenty of investors despite the ongoing COVID-19 pandemic (Press release, Lamassu Pharma, MAY 5, 2020, View Source [SID1234646264]).

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The Durham firm says in an SEC filing that it has raised nearly $2.7 million.

And 19 investors are backing the company with a minimum investment of $50,000.

Lamassu is looking to raise another $200,000 in a round of equity with a near-$3 million target.

"We capitalizing on our expertise in early translational research to bring products to phase I/II, then partner with clinical and commercial development specialists. Our innovative model ensures that early development efforts bring product to definitive clinical testing as efficiently as possible to benefit patients and ensure early investment will lead to clinical results," the company says.

"Our lead candidate is a novel small molecule therapy for acute pancreatitis. This was developed at Mayo Clinic by leading scientists, and has profound preclinical efficacy to completely mitigate mortality and morbidity associated with severe acute pancreatitis. We are currently focused on continued development of this compound through safety testing in preparation for definitive clinical trials. Our ultimate goal is saving the lives of patients afflicted with this disease."

Lamassu launched in 2018.

Founders include:

GABI HANNA, MD, CEO and Co-Founder
Physician, and co-founder of Lamassu Pharma. Research focus on translational medicine and commercialization, bringing innovations to clinical trial and patient benefit.

GREG PALMER, PHD, CSO and Co-Founder
Biomedical engineer with expertise in imaging, medical devices, and translational science.

RABI HANNA, MD, CMO and Co-Founder
Chair of Pediatric Oncology at Cleveland Clinical, brings translational and clinical expertise.

PRESS RELEASE – CLINICAL TRIAL COLLABORATION AGREEMENT WITH MSD (MERCK US)

On May 5, 2020 NETRIS Pharma SAS, a private clinical-stage biopharmaceutical company developing therapeutics based on dependence receptor biology, reported that it has entered into a clinical collaboration agreement with MSD to investigate the safety, clinical and biological activity of NP137 with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with locally advanced/metastatic uterine tumors. NP137 targets netrin-1, which is overexpressed in over two-thirds of uterine tumors (Press release, Netris Pharma, MAY 5, 2020, View Source [SID1234611183]).

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The companies have entered this collaboration based on promising clinical data obtained from a phase 1 trial investigating NP137 monotherapy in patients with advanced solid tumors and the growing evidence that resistance to an anti-PD-1 therapy, such as KEYTRUDA, can be alleviated when combined with blocking netrin-1.

Under the terms of the agreement, NETRIS will sponsor a large phase 1b/2 study, which will be conducted in collaboration with the Centre Léon Bérard and with support of the specialist French oncology group of clinicians, GINECO (Groupe d’Investigateurs National des Etudes des Cancers Ovariens). The study will investigate the safety and efficacy of NP137 combined with KEYTRUDA in patients with advanced/metastatic endometrial carcinoma or cervix carcinoma.

"We are excited to collaborate with MSD, an established leader in cancer immunotherapy, on our proof-of-concept phase1b/2 study as we work to improve the lives of cancer patients," said Patrick Mehlen, Founder and Chief Executive Officer of NETRIS Pharma. "Immunotherapies are revolutionizing the treatment of patients in several cancer indications, but there remain many other tumor types in which existing immunotherapies have not demonstrated sufficient efficacy. Based on our preclinical and clinical data demonstrating the role of netrin-1 in promoting tumor progression and modulating tumor plasticity and microenvironment, we believe NP137’s effect in combination with KEYTRUDA will lead superior patient response to immunotherapy."

"The preliminary safety data and anti-tumor activity observed in the Phase 1a trial, together with the unique mode of action of NP137, are very exciting and clearly support evaluating a combination with KEYTRUDA," said Isabelle Ray Coquard, MD, Ph.D. and Principal Investigator of the trial. "We anticipate starting the study summer 2020."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

The Phase 1b/2 clinical trial will enroll up to 240 patients and be divided into a Ph1b part to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics of the NP137 KEYTRUDA combination and/or chemotherapeutic agents. The Phase 2 part will assess via randomization the clinical activity of the combination in both tumor types.

About NP137
NP137, a humanized monoclonal antibody of isotype IgG1 directed against netrin-1, is the first drug candidate developed by NETRIS Pharma. Most types of tumors produce an abnormal amount of dependence receptors’ ligands, which prevents cells from dying. Netrin-1 is overexpressed in a large percentage of human cancers, including over two thirds of gynecologic cancers.

In preclinical studies, NP137 inhibited tumor growth and had a significant impact on tumoral plasticity, which potentiates the efficacy of chemotherapies and immune checkpoint inhibitors. In the phase 1 dose-escalation study, NP137 was found to be safe and very well tolerated up to 20mg/kg, with no dose limiting toxicity (DLT). In addition, patients with advanced uterine cancers exhibited encouraging signs of anti-tumor activity, including prolonged stable disease and objective responses.

About GINECO
GINECO (Groupe d’Investigateurs National pour l’Etude des Cancers de l’Ovaire et du sein) is the French Cooperative Group in Oncology labelled by INCA (National Cancer Institute in France) developing and conducting gynecological and metastatic breast cancer clinical trials at the national and international level. The network comprises more than 700 specialized investigators representing more than 150 public or private oncology units.

Interim Report – January to March 2020

On May 5, 2020 Affibody Medical AB (publ) ("Affibody" or "the Company"), a Swedish biotechcompany focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod, reported its First Quarter Report for 2020 (Press release, Affibody, MAY 5, 2020, View Source [SID1234575698]).

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Financial Highlights

Revenue for the first Quarter 2020 amounted to SEK 9.6 (30.0) m
Operating result for the quarter amounted to SEK -58.2 (-24.9) m
Net result for the quarter amounted to SEK -58.9 (-24.7) m
Cash flow for the quarter amounted to SEK -78.4 (10.7) m
Cash and cash equivalents at the end of the period amounted to SEK 296.4 (101.6) m.
Significant Events during period

An EGM on February 17, 2020 elected José Suarez as Board member.
Significant Events after the close of the Reporting Period

On May 15, 2020, Affibody and Inmagene Biopharmaceuticals announced a strategic partnership to develop and commercialize ABY-035, a bispecific molecule targeting Interleukin-17A (IL-17), for multiple auto-immune diseases. Inmagene will be responsible for commercialization in mainland China, Hong Kong, Taiwan, and Macau (Greater China), and South Korea, as well as development activities in the Asia Pacific region, excluding Japan. Affibody will retain global commercial rights outside of Greater China and South Korea. The partners will work together to enroll patients into global registrational trials to support Biologics License Applications (BLAs) in multiple indications worldwide. Under the terms of the agreement, Affibody will receive a $10 million upfront payment and is eligible to receive up to $215.5 million in additional regulatory
Affibody is a clinical stage Swedish biotech company with a broad product pipeline focused on developing innovative bi- and multi-specific next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod.

The company operates a focused experimental medicine model and currently has three clinical stage programs. The first two are therapeutic programs that targets psoriasis, and B-cell driven autoimmune diseases respectively. The third program is a diagnostic imaging program that is directed primarily towards metastatic breast cancer.

Anavex Life Sciences to Announce Fiscal 2020 Second Quarter Financial Results on Thursday, May 7th, 2020

On May 5, 2020 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, reported that it will issue financial results for its fiscal quarter ended March 31, 2020 on Thursday, May 7th, 2020 (Press release, Anavex Life Sciences, MAY 5, 2020, View Source [SID1234561601]).

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Management will host a conference call on Thursday, May 7th, 2020 at 4:30pm Eastern Time to review financial results and provide an update on its clinical programs and corporate highlights. Following management’s formal remarks, there will be a question and answer session with equity analysts.

Conference Call / Webcast Information:

The live webcast of the conference call can be accessed online at View Source

To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 939-3921 and international callers should dial 1 (678) 302-3550. Please use confirmation number 49673201, followed by the pound sign (#).

A replay of the conference call will also be available on www.anavex.com.