Bellerophon: Commercialization Pact for INOpulse® in Greater China with Baylor BioSciences

 Bellerophon to receive a license payment of $6 million, as well as royalties on net sales in Greater China

 Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced that it has entered into a license agreement for the development and commercialization of INOpulse® with Baylor BioSciences, a life sciences company dedicated to the development and commercialization of innovative medical products for Greater China.

Under the terms of the license agreement, Bellerophon will receive a license payment of $6 million, payable within 90 days subject to certain closing conditions set forth in the agreement. Additionally, Bellerophon is entitled to royalties of 5% on net sales resulting from all of the licensed INOpulse indications within Greater China. Baylor BioSciences will receive exclusive rights to develop and commercialize INOpulse within Greater China for diseases associated with pulmonary hypertension, including the lead indication of fibrotic interstitial lung disease (fILD), as well as PH-Sarcoidosis and PH-COPD.

https://finance.yahoo.com/news/bellerophon-therapeutics-announces-license-agreement-133000392.html

Tax Havens Obscured at Least $1.4 Trillion of Foreign Investment in China

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Tax Havens Obscured at Least $1.4 Trillion of Foreign Investment in China

US and European investment into mainland China has largely been channeled through offshore vehicles set up by Chinese companies in tax havens, according to newly-published research, suggesting that foreign exposure to Chinese assets is much larger than recorded by official statistics.

US and European investors’ holdings of equities and bonds issued by offshore vehicles controlled by Chinese companies such as Alibaba Group Holding and Tencent Holdings reached $1.4 trillion at the end of 2020, according to new estimates from the Global Capital Allocation Project based at Columbia and Stanford universities.

That was almost three times the amount investors from those countries held directly in companies registered in China.

The data shows the depth of the financial links between the world’s second-largest economy and the major developed economies, making any decoupling a challenging prospect. Those links also mean that foreign companies are more exposed to China than previously thought, and US and European governments will need to pay greater attention to potential risks from investment in Chinese companies routed through these offshore entities, the researchers suggested.

“The sums involved, the involvement of retail investors and mutual funds, and the shaky shareholder rights these structures imply, clearly point to a need for regulation,” the researchers said.

The data also mean efforts to regulate global tax havens will need to take into account the interests of Chinese companies. The amount Chinese-controlled offshore entities raised from US and European investors almost tripled from 2016 to 2020, according to the Project.

“There has been a lot of attention and policy effort on regulating tax havens’ activities. Our work points to the growing importance of China in these jurisdictions, and this is likely to make global coordination on policy efforts more important but also more difficult to achieve,” the researchers said.

Chinese companies tend to use tax havens less as a tax avoidance mechanism and more as a means to circumvent Chinese government restrictions on foreign ownership in some sectors, and because foreign investors often see foreign courts as more reliable than China’s, the researchers said.

The data is the only publicly available resource which “looks through” investment in companies registered in tax havens to where the invested capital is ultimately used. Most official statistics look at investment by residency, counting an investment in a Chinese-controlled Cayman Islands company as an investment in the Cayman Islands.

The Project’s researchers found that US ownership of stocks and bonds issued by Chinese companies was $922 billion higher at the end of 2020 than the US Treasury figures for investment in China. “Under this more comprehensive view, US residents’ portfolios were much more exposed to China up to 2020, leaving them exposed to the subsequent tumble in Chinese tech stocks,” the researchers said.

The research also has implications for global financial balances. China is recorded in official statistics as a large net creditor to the rest of world in part because its companies have relatively few liabilities to overseas investors. China’s creditor position is “much smaller” when the liabilities of Chinese-controlled companies registered outside China are included, the researchers said.

The project’s data covers investment from residents in the US, the euro area, the UK, Canada, Switzerland, Norway, Denmark and Sweden. It is lagging due to the time required to work out the ultimate controllers of companies registered in tax havens.

The value of foreign investors’ holdings of Chinese stocks and bonds has almost certainly fallen since the end of 2020, as increased regulation and crackdowns on tech companies, strict pandemic controls and a property sector slump led many foreign buyers to sell their holdings. The value of all foreign holdings of mainland stocks and bonds is down almost 20% from the peak at the end of 2021, according to the latest data from the People’s Bank of China.

“We’d expect losses to have occurred and the positions to have shrunk due to lower stock prices for many Chinese tech companies, like Alibaba and Tencent. Even at these lower valuation levels, positions including Chinese companies’ offshore affiliates are going to be higher than positions that only include investments in China-resident entities,” said the researchers.

Despite the market volatility, China has continued to make efforts to further open its onshore bond market to foreign investors and passed a new derivatives law which makes it easier to hedge investments. “It remains to be seen whether foreign investors will trust these policies and renter the market,” the researchers said.

https://finance.yahoo.com/news/tax-havens-obscured-least-1-104036986.html

Biogen separates research and development into two functions

 Biogen Inc. (BIIB) said Thursday that it separated research and development into two functions that report directly to new CEO Christopher Viehbacher. Priya Singhal, currently the head of global safety and regulatory sciences, was promoted to EVP and head of development. There is a search underway for an EVP and head of research, the company said. Biogen's stock is up 13.2% over the past 12 months, while the S&P 500 is down 19.6%.

https://www.morningstar.com/news/marketwatch/20230105354/biogen-separates-research-and-development-into-two-functions

AngioDynamics Reports Fiscal 2023 Second Quarter; Reaffirms Guidance

 Fiscal Year 2023 Second Quarter Highlights

• Net sales of $85.4 million increased 9.1% compared to the prior-year quarter
  • Med Tech net sales of $24.5 million increased 29.7%
  • Med Device net sales of $60.9 million increased 2.6%
• Gross margin of 52.8% increased 100 basis points year over year
• GAAP loss per share of $0.21 and adjusted earnings per share of $0.01

Management is reaffirming its previously issued fiscal year 2023 guidance. Management expects net sales to be in the range of $342 to $348 million, gross margin to be approximately 52.5% to 54.5% and adjusted earnings per share in the range of $0.01 to $0.06 as it continues to invest in new product launches to drive future growth.

Conference Call

The Company's management will host a conference call today at 8:00 a.m. ET to discuss its second quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13734978.

This conference call will also be webcast and can be accessed from the “Investors” section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, January 5, 2023, until 11:59 p.m. ET on Thursday, January 12, 2023. To listen to this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13734978.

https://www.biospace.com/article/releases/angiodynamics-reports-fiscal-2023-second-quarter-financial-results-reaffirms-guidance/

NovoCure Phase 3 Lung Cancer Study Meets Primary Endpoint

 The LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival

The full LUNAR data will be presented at a future medical congress

https://www.biospace.com/article/releases/novocure-announces-pivotal-lunar-study-in-non-small-cell-lung-cancer-met-primary-overall-survival-endpoint/

InflaRx Updates on Planned Phase III Study Design

 

• Multi-national, randomized, controlled adaptive Phase III design for vilobelimab in ulcerative pyoderma gangrenosum (PG)
• Trial size to be adapted upon interim analysis with planned total patient number between approximately 50 and 100 patients
• FDA review of application for emergency use authorization (EUA) of vilobelimab for the treatment of critically ill COVID-19 patients ongoing
• InflaRx’s management team to host investor and business meetings during JPM Week, January 9 – 12, 2023

https://www.biospace.com/article/releases/inflarx-provides-update-on-planned-phase-iii-study-design-in-pyoderma-gangrenosum-with-vilobelimab-and-status-of-its-eua-application-in-critically-ill-covid-19-patients/

Surface Starts Phase 1/2 Study of Antibody, in Advanced Solid Tumors

 SRF114 is designed to preferentially deplete CCR8⁺ Treg cells within the tumor microenvironment and has demonstrated highly specific CCR8-exclusive binding and reduced tumor growth in pre-clinical studies

Initial clinical data anticipated in 2024

https://www.biospace.com/article/releases/surface-oncology-announces-first-patient-dosed-in-a-phase-1-2-study-evaluating-srf114-a-potential-best-in-class-anti-ccr8-antibody-in-patients-with-advanced-solid-tumors/