Cell analysis instruments provider Cytek BioSciences sets terms for $248 million IPO

Cytek BioSciences, which provides cell analysis instruments for life science applications, announced terms for its IPO on Monday.

The Fremont, CA-based company plans to raise $248 million by offering 14.6 million shares (19% insider) at a price range of $16 to $18. At the midpoint of the proposed range, Cytek BioSciences would command a fully diluted market value of $2.3 billion.

Cytek Biosciences' core products are the Aurora and Northern Lights systems, which are full spectrum flow cytometers that deliver high-resolution cell analysis by using the full spectrum of fluorescence signatures from multiple lasers to distinguish fluorescent tags on single cells, also known as full spectrum profiling. As of March 31, 2021, the company has placed over 750 instruments to over 620 companies around the world, including pharmaceutical companies, over 125 biopharma companies, academic research centers, and clinical research organizations. 

Cytek BioSciences was founded in 2014 and booked $99 million in sales for the 12 months ended March 31, 2021. It plans to list on the Nasdaq under the symbol CTKB. Morgan Stanley, Goldman Sachs, Piper Sandler, and Cowen are the joint bookrunners on the deal. It is expected to price during the week of July 19, 2021.

Relevant Profile: CTKB

https://www.renaissancecapital.com/IPO-Center/News/84302/Cell-analysis-instruments-provider-Cytek-BioSciences-sets-terms-for-$248-mi

BlueRock Gets FDA Fast Track for Treatment of Advanced Parkinson's Disease

 BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly owned subsidiary of Bayer AG, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for DA01 for advanced Parkinson's disease (PD). DA01, BlueRock's pluripotent stem cell-derived dopaminergic neuron therapy, is under evaluation in a Phase 1 study.

The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. A drug candidate that receives Fast Track designation may be eligible for more frequent interaction with the FDA to discuss the drug candidate's development plan as well as eligibility for accelerated approval and priority review.

"Receiving Fast Track Designation from the FDA is an important step, which will help us further accelerate clinical development of our DA01 cell therapy approach for Parkinson's disease," says Joachim Fruebis, Ph.D., BlueRock's Chief Development Officer. "This is another critical step in the BlueRock mission to create authentic cellular medicines to reverse devastating diseases, with the vision of improving the human condition."

About the Trial
The trial will enroll ten patients in the United States and Canada. The primary objective of the Ph1 study is to assess the safety and tolerability of DA01 cell transplantation at one-year post-transplant. The secondary objectives of the study are to assess the evidence of transplanted cell survival and motor effects at one- and two-years post-transplant, to evaluate continued safety and tolerability at two years, and to assess feasibility of transplantation.

More information about this trial is available at clinicaltrials.gov (NCT#04802733).

https://finance.yahoo.com/news/bluerock-therapeutics-receives-fda-fast-120000123.html

Spruce Biosciences started at Buy by Wainwright

 Target $30

https://www.marketscreener.com/quote/stock/SPRUCE-BIOSCIENCES-INC-113534514/news/Spruce-Biosciences-HC-Wainwright-Starts-Spruce-Biosciences-at-Buy-With-30-Price-Target-35889085/

Taiwan approves Medigen's COVID-19 vaccine candidate

 Taiwan's government on Monday approved the emergency use and production of Medigen Vaccine Biologics Corp's COVID-19 vaccine candidate, a major step in the island's plans to develop its own vaccines to protect against the coronavirus.

The vaccine candidate has yet to finish clinical trials and no efficacy data is available, but Taiwan's health ministry said studies so far have shown that antibodies created by the shot have been "no worse than" those created by AstraZeneca's vaccine.

Taiwan-based Medigen said last month it was seeking a speedy emergency use authorisation, or EUA, from the government for its vaccine candidate after safely completing Phase II trials.

Developing its own vaccine has been a major goal of Taiwan's government, though it also has ordered some 20 million shots from Moderna Inc, AstraZeneca and the COVAX global sharing scheme.

The health ministry said there were no major safety concerns during clinical trials in Taiwan of Medigen's vaccine candidate.

It added that Medigen had to present a monthly report on safety for the vaccine candidate, MVC-COV1901, which is designed for people aged over 20, who will get two shots 28 days apart.

Health Minister Chen Shih-chung told reporters that with the EUA approved, it would now take some time for the company to ramp up its production.

"There should be a small amount of supply available in August," he added.

Chen said the government "encourages" manufacturers to submit efficacy reports from further clinic trials within one year, referring to trials akin to Phase III trials.

Medigen's shares closed down 1.35% on Monday before the announcement, compared to a 0.6% fall in the broader market .

The recombinant protein vaccine has been developed in collaboration with the National Institutes of Health in the United States.

Taiwan's government in May signed deals with Medigen, and another firm developing a domestic vaccine, UBI Pharma , for five million doses each, and has agreements for another five million each, for a total of 20 million shots.

The EUA for UBI's vaccine candidate is still pending.

Taiwan has massively ramped up its vaccination programme in the last month following the donation of almost 6 million vaccine doses from Japan and the United States and the gradual arrival of vaccines directly ordered from manufacturers.

Around 20% of Taiwan's 23.5 million people have received at least one of the two-shot vaccine regimen.

Taiwan now has the coronavirus under control after domestic cases spiked in May.

Chen said it was "possible" Taiwan would lower its COVID-19 alert level next week, under which personal gatherings are currently restricted and entertainment venues closed.

https://www.marketscreener.com/quote/stock/MEDIGEN-VACCINE-BIOLOGICS-45428599/news/Taiwan-approves-Medigen-s-COVID-19-vaccine-candidate-35887130/

PureTech Health: Weight management firm Gelesis to list on NYSE via SPAC

 Gelesis, founded by biotech firm PureTech Health, will list on the New York Stock Exchange through a merger with an acquisition vehicle, valuing the weight management firm at about $1.3 billion.

Gelesis will merge with Capstar Special Purpose Acquisition Corp, sponsored by affiliates of Capstar Partners LLC and funds managed by bond giant PIMCO, PureTech said on Monday.

Special purpose acquisition companies, or SPACs, are shell companies that raise funds via an initial public offering to take a private company public through a merger at a later date.

Gelesis, London-listed PureTech's third publicly-traded founded entity, is expected to receive proceeds of up to $376 million from the transaction.

The U.S. Food and Drug Administration approved Gelesis' flagship product Plenity in 2019. The pill, when consumed, becomes a substance that expands in the stomach to reduce space available for food, helping people eat less.

https://www.marketscreener.com/quote/stock/PURETECH-HEALTH-PLC-22619613/news/PureTech-Health-Weight-management-firm-Gelesis-to-list-on-NYSE-via-SPAC-deal-35890092/

BioNTech strengthens cancer therapy expertise with U.S. acquisition

 

BioNTech said it was acquiring a production site and a research and development platform from a subsidiary of U.S. biotech company Gilead to expand its footprint in north America and in novel cancer treatments.

The German biotech firm on Monday said it was buying a solid tumour neoantigen T-cell receptor therapy (TCR-Ts) R&D platform and a manufacturing plant in the city of Gaithersburg in the state of Maryland from Kite Pharma.

T-cell receptors (TCRs) are a class of compounds that make it easier for the body's immune cells to identify and destroy cancer cells, while TCR-Ts detect targets both inside and outside the cancer cells.

The acquisition will expand BioNTech's pipeline in individualized cell therapies for cancer patients and add to its existing manufacturing capacities in Idar-Oberstein, Germany, it said.

Kite Pharma will receive a one-time upfront payment, BioNtech said without giving further details.

The deal is expected to close by the end of July, 2021.

https://www.marketscreener.com/news/latest/BioNTech-strengthens-cancer-therapy-expertise-with-U-S-acquisition--35889887/

Moody's warns Indonesia COVID-19 surge threatens fiscal plans, ratings

 

Indonesia's surge in COVID-19 infections threatens to hamper government plans to reduce its fiscal deficit and could undermine the credit rating of Southeast Asia's biggest economy, Moody's Investors Service said on Monday.

The rating agency's comments came days after S&P Global Ratings said the country's growing coronavirus outbreak was adding downside pressures on its economy and credit conditions.

Moody's rates Indonesia's debt at Baa2, one notch above its lowest investment grade rating, with a stable outlook, similar to Fitch Ratings.

S&P also gives Indonesia the same rating, but it has had a negative outlook on Indonesia's sovereign debt since April 2020.

"Although the effects of recently imposed movement restrictions have yet to show, a resurgence in more infectious mutations of the virus poses significant risks to Indonesia's economic recovery and will challenge government plans to reduce the fiscal deficit to pre-pandemic levels, a credit negative," Moody's said in a statement on Monday.

Indonesia is battling one of the world's worst COVID-19 outbreaks, driven by the more contagious Delta variant, with new infections topping 50,000 in four of the past five days and with around 1,000 deaths each day.

The government has imposed movement restrictions from July 3 and is currently considering whether to extend them beyond Tuesday.

Moody's said it expected Indonesia's economy to grow 4.5% in 2021, following a 2.1% contraction last year.

The government is expected to increase spending on social programmes at a time when revenue growth is unlikely to recover significantly after slumping in 2020, Moody's said.

Moody's forecasts a fiscal deficit of 5.9% of GDP for 2021, slightly larger than the government's 5.7% outlook, and said the government's plan to revert to a deficit cap of 3% in 2023 "is now increasingly under threat because mitigating measures introduced in 2020 are unlikely to be fully unwound."

Moody's praised the government for proposals to overhaul the tax sector, which include raising value added tax rates and introducing a carbon tax, but said "the measures are likely to be placed on the back-burner" due to a fragile economic recovery and political difficulties.

https://www.marketscreener.com/news/latest/Moody-s-warns-Indonesia-COVID-19-surge-threatens-fiscal-plans-ratings--35888079/