On July 28, 2023 Biogen Inc. (Nasdaq: BIIB) ("Biogen") and Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata") reported that the companies have entered into a definitive agreement under which Biogen has agreed to acquire Reata for $172.50 per share in cash, reflecting an enterprise value of approximately $7.3 billion (Filing, 8-K, Biogen, JUL 28, 2023, View Source [SID1234633478]).

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Reata has made significant advancements developing therapeutics that regulate cellular metabolism and inflammation in serious neurologic diseases. Reata’s FDA-approved SKYCLARYS (omaveloxolone) is the first and only approved treatment for Friedreich’s ataxia (FA) in the United States, with a commercial launch underway, and European regulatory review ongoing. In addition, Reata is developing a portfolio of innovative products for a range of neurological diseases.

"With extensive expertise in rare disease product development and global commercialization, as demonstrated by SPINRAZA and the recent launch of QALSODY, we believe Biogen has the foundation in place to accelerate the delivery of SKYCLARYS to patients around the world," said Christopher Viehbacher, Biogen’s President and Chief Executive Officer. "This is a unique opportunity for Biogen to bolster our near-term growth trajectory, and SKYCLARYS is an excellent complement to our global portfolio of treatments for neuromuscular and rare disease."

"Biogen’s expertise and commercial footprint make it the optimal choice to help SKYCLARYS realize its full potential," said Warren Huff, Chairman and Chief Executive Officer of Reata. "With its clear understanding of the rare disease patient journey and existing commercial infrastructure, we believe Biogen will establish SKYCLARYS as the standard of care in the treatment of this devastating genetic disease."

Financial Details and Terms of the Transaction

The transaction, which was approved by the boards of directors of both companies, is currently anticipated to close in the fourth quarter of 2023. Biogen expects this acquisition to be accounted for as a business combination. The acquisition of Reata is expected to be slightly dilutive to Biogen’s Non-GAAP diluted Earnings Per Share (EPS) in 2023, roughly neutral in 2024, and significantly accretive beginning in 2025, inclusive of associated transaction costs. Biogen plans to update its Full Year 2023 Financial Guidance in conjunction with its third quarter 2023 earnings release.

Biogen expects to finance the acquisition with cash on hand, supplemented by the issuance of term debt. The transaction is subject to customary closing conditions, including approval by Reata stockholders and the receipt of necessary regulatory approvals. Biogen has entered into voting and support agreements with certain stockholders of Reata representing approximately 36% of the voting power of Reata’s common stock.

Conference Call Details

Biogen will host an investor call on July 28, 2023, at 9:00 a.m. ET. The conference call will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation will also be accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

Advisors

Lazard acted as financial advisor to Biogen in this transaction and Cravath, Swaine & Moore acted as its legal advisor. Goldman Sachs acted as financial advisor to Reata and Vinson & Elkins acted as its legal advisor.

On July 28, 2023 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported the acceptance of two abstracts for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, being held October 20-24, 2023 in Madrid, Spain (Press release, Aravive, JUL 28, 2023, View Source [SID1234633477]). Posters will feature clinical data from the Company’s ongoing Phase 1b/2 trials of batiraxcept in clear cell renal cell carcinoma (ccRCC) and pancreatic adenocarcinoma (PDAC).

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Presentation Details:

Title: Phase 1b/2 Study of Batiraxcept (BT, AVB-S6-500, an AXL pathway inhibitor) in Combination with Cabozantinib (Cabo) in Patients with Advanced Clear Cell Renal Cell Carcinoma (ccRCC) who Failed First Line (1L) Therapy
Presenter: Neil Shah, MBBS
Abstract Number: 2294

Title: Phase 1b/2 Study of Batiraxcept (AVB-S6-500, BT) plus Nab-paclitaxel (NP) and Gemcitabine (G) as first-line treatment (1L) for metastatic pancreatic adenocarcinoma (PDAC)
Presenter: Vaibhav Sahai, MBBS, MS
Abstract Number: 3218
Posters will be available on the "Publications" section of the Aravive website at the start of the meeting.

On July 28, 2023 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported the first patient has been enrolled and safely dosed in EFTISARC-NEO, the Phase II investigator-initiated trial of eftilagimod alpha (efti), a soluble LAG-3 protein and MHC Class II agonist, in combination with radiotherapy and the anti-PD-1 therapy KEYTRUDA (pembrolizumab) for patients with soft tissue sarcoma (Press release, Immutep, JUL 28, 2023, View Source [SID1234633468]). This chemo-free trial is the first to evaluate efti in a neoadjuvant setting.

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Soft tissue sarcoma (STS), an orphan disease, represents a high unmet medical need with a poor prognosis. The incidence of STS varies in different regions, with approximately 23,400 cases annually and a crude incidence of 4.7 per 100,000 in Europe, according to the RARECARE project. In the United States, the number of new cases is estimated to be 13,400 annually with 5,140 deaths, according to the American Cancer Society.

The open-label EFTISARC-NEO Phase II study, which will treat up to 40 patients, is being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) and is primarily funded with an approved grant from the Polish government awarded by the Polish Medical Research Agency program. The trial’s Principal Investigators are Dr. Katarzyna Kozak, M.D., Ph.D., and Paweł Sobczuk, M.D., Ph.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at MSCNRIO.

Dr. Paweł Sobczuk stated: "Soft tissue sarcoma is a rare, aggressive disease in high need of new therapeutic approaches, and we are pleased to begin treating patients with this novel IO-IO-radiotherapy combination and look forward to evaluating the potential synergistic effects of this chemo-free therapy. In particular, efti’s sustained activation of antigen-presenting cells, leading to proliferation of activated CD8+ T cells and elevated interferon-gamma levels, may transform the immunosuppressed tumour microenvironment of soft tissue sarcomas into one that enables immune checkpoint inhibitors like pembrolizumab to exert their anti-cancer effect. Additionally, we see synergies between efti and radiotherapy to arm, activate, and proliferate cytotoxic T cells with radiotherapy-induced cancer antigens to target this difficult-to-treat tumour."

Immutep CSO, Frédéric Triebel, M.D., Ph.D, said: "We are pleased to see this trial, led by the expert team at the Maria Skłodowska-Curie National Research Institute, begin to enrol and dose patients. EFTISARC-NEO represents the first time efti will be evaluated in the neoadjuvant, non-metastatic cancer setting where patients will receive efti much earlier on in their cancer journey. Also, the neoadjuvant setting gives us the opportunity to assess in the surgical specimen the changes in the tumour microenvironment induced by efti. New information arising from this innovative trial may further broaden the future clinical development of efti and, in the end, bring even greater benefit to patients."

About Eftilagimod Alpha (Efti)

Efti is Immutep’s proprietary soluble LAG-3 clinical stage candidate that is a first-in-class antigen presenting cell (APC) activator that stimulates both innate and adaptive immunity for the treatment of cancer. Efti binds to MHC II molecules on APCs leading to activation/proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

On July 27, 2023 Alexion, AstraZeneca Rare Disease, reported that it has entered a definitive purchase and licence agreement for a portfolio of preclinical gene therapy programmes and enabling technologies from Pfizer Inc. (Pfizer) (Press release, AstraZeneca, JUL 28, 2023, View Source [SID1234633466]). The agreement furthers Alexion and AstraZeneca’s commitment to advancing next-generation genomic medicines with the addition of complementary pipeline assets and innovative technologies.

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As part of the agreement, the transaction will bring to Alexion a number of novel adeno-associated virus (AAV) capsids. AAV capsids have been shown to be an effective mechanism for delivering therapeutic gene cargos for gene therapy and gene editing.1 These new resources build on Alexion and AstraZeneca’s combined capabilities in genomic medicine, recently strengthened with the acquisition of LogicBio, with the objective to develop new genetic therapies with improved safety and efficacy profiles. Additionally, Alexion will seek to welcome talent from Pfizer associated with the portfolio.

Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare Disease, said: "Today’s announcement represents another major step forward in Alexion and AstraZeneca’s ambition to be an industry leader in genomic medicine, which has potential to be transformative and even curative for patients with devastating diseases. We look forward to continuing our work to develop enhanced platforms and technologies with broad therapeutic application while integrating best-in-class expertise to accelerate promising therapeutics into the clinic."

There are more than 7,000 known rare diseases, and around 80% of rare diseases are believed to be caused by a genetic mutation.2,3 Genomic medicines are designed to treat or cure these diseases by addressing the malfunctioning gene. This can be done through addition, alteration or inactivation of the gene to help the body fight the disease.4

Financial considerations
Under the agreement, Alexion will purchase and licence the assets of Pfizer’s early-stage rare disease gene therapy portfolio for a total consideration of up to $1bn, plus tiered royalties on sales.

Alexion plans to close the transaction in Q3 2023, subject to the satisfaction of closing conditions.

On July 28, 2023 Genmab A/S (Nasdaq: GMAB) reported its preliminary first half 2023 financial results and its updated 2023 financial guidance (Press release, Genmab, JUL 28, 2023, View Source [SID1234633454]).

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Preliminary First Half 2023 Financial Results

In the first half of 2023, Genmab’s revenue increased by 34% and operating profit increased by 10%, compared to the first half of 2022 primarily due to higher product royalties. Operating expenses increased by 45%, reflecting continued focused investments in Genmab’s key priorities.

First Half First Half
(DKK million) 2023 2022 % Increase
Revenue 7,052 5,281 34%
Operating expenses (5,118) (3,520) 45%
Operating profit 1,934 1,761 10%

Updated 2023 Financial Guidance

Genmab expects its 2023 revenue to be in the range of DKK 15,500 – 16,500 million, an increase to the previous guidance of DKK 14,600 – 16,100 million, driven by the continued strong growth of DARZALEX net sales and higher total royalty revenues from DARZALEX and other marketed products. DARZALEX royalties are based on Genmab’s revised estimate of DARZALEX 2023 net sales of USD 9.8 – 10.0 billion compared to Genmab’s previous estimate of USD 9.4 – 10.0 billion.

Genmab anticipates its 2023 operating expenses to be in the range of DKK 10,400 – 10,900 million, an increase to the previous guidance of DKK 9,800 – 10,600 million, primarily related to increased and accelerated investment for epcoritamab clinical trials and progression of other pipeline products.

Genmab now expects its 2023 operating profit to be in the range of DKK 4,500 – 6,000 million, compared to the previous guidance of DKK 3,900 – 6,200 million, driven primarily by the items described above.

Revised Previous
(DKK million) Guidance Guidance
Revenue 15,500 – 16,500 14,600 – 16,100
Operating expenses (10,400) – (10,900) (9,800) – (10,600)
Operating profit 4,500 – 6,000* 3,900 – 6,200*
*Operating profit does not sum due to rounding

Genmab’s full financial results for the first half of 2023 will be published on August 3, 2023.