On March 3, 2021 Bio-Techne Corporation (NASDAQ: TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities, reported it has reached an agreement to acquire Asuragen, Inc. for initial consideration of $215 million in cash plus contingent consideration of up to $105 million upon the achievement of certain future milestones (Press release, Bio-Techne, MAR 3, 2021, View Source [SID1234576105]). The transaction will be financed through a combination of cash on hand and an existing revolving line of credit. Bio-Techne anticipates the acquisition to close in the fourth quarter of its fiscal 2021.

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Founded in 2006, Asuragen is headquartered in Austin, Texas and is a leader in the development, manufacturing and commercialization of genetic carrier screening and oncology testing kits. Asuragen’s products leverage proprietary chemistries which can be used on widely available platforms including, PCR, qPCR, capillary electrophoresis, and next-generation sequencing instruments. This platform agnostic approach enables its clinical laboratory customers to solve complex molecular diagnostic challenges and empowers hospital and regional labs to expand in-house testing capabilities, furthering the decentralization of the molecular diagnostics market, enabling quicker turn-around times and ultimately delivering better patient care. Asuragen’s headquarters includes a scalable, Good Manufacturing Practice (GMP)-compliant 50,000 square foot manufacturing facility as well as a CLIA-certified laboratory. In 2020, Asuragen generated greater than $30 million in revenue globally and its Chief Executive Officer, Matt McManus, will join the Bio-Techne team to continue to lead the legacy Asuragen business as well as the integration process.

Asuragen brings a leading portfolio of best-in-class molecular diagnostic and research products, including its FDA-cleared AmplideX Fragile X Diagnostic and Carrier Screening kit for the screening of prospective parents as potential carriers of Fragile X chromosomal abnormalities as well as its Quantitidex qPCR IS BCR-ABL kit to enable the monitoring of leukemia patients for minimal residual disease. In addition to its existing portfolio of innovative and enabling technologies, Asuragen’s pipeline includes expanded carrier screening panels for various pathologies recognized by The American College of Obstetricians and Gynecologists (ACOG) as areas of concern for prospective new parents. Bio-Techne sees multiple growth synergies following the closing of the transaction, including Asuragen’s capabilities and proven track record in productizing lab-developed tests and commercializing innovative molecular products for broader market adoption.

"Asuragen is very complimentary with Bio-Techne’s existing diagnostics franchise and the addition of this business is expected to drive growth synergies throughout the expanded portfolio," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "We are not only acquiring a financially strong and scalable business, building our diagnostic portfolio and expanding our bandwidth with an additional CLIA-certified and GMP compliant laboratory, but are also adding a team with deep expertise in the intricacies of the global regulatory environment and a proven track record of opening new market channels. This critical mass will be very beneficial to the Genomics and Diagnostics Segment as we commercialize our pipeline of liquid biopsy tests through our Exosome Diagnostics business and also opens the possibility of approaching the market with kitted versions of these products. We anticipate continued traction with Asuragen’s leading portfolio of molecular diagnostic kits for both clinical and research uses and see significant potential in its pipeline of expanded carrier screening panels. Asuragen is a great addition to the Bio-Techne team."

"The Asuragen team is extremely excited to be joining Bio-Techne at this point in our growth trajectory," said Matt McManus, Chief Executive Officer of Asuragen. "Bio-Techne’s global presence, reputation and relationships within the clinical diagnostic and research communities will enable Asuragen to broaden our reach and accelerate penetration into the high-growth molecular diagnostic markets addressed by our portfolio. I am honored to continue to lead the Asuragen team as a part of Bio-Techne. I would like to thank all of the great people of Asuragen for their committed efforts growing our company to this point and am looking forward to the next stage of growth under the Bio-Techne umbrella."

Fredrickson & Byron, P.A. is serving as Bio-Techne’s legal counsel. Perella Weinberg Partners LP is the financial advisor and Vinson & Elkins LLP is serving as legal counsel to Asuragen.

On March 3, 2021 Vaxalto Biotherapeutics, Inc. (www.vaxalto.com), a pre-clinical stage biotechnology company focused on developing and commercializing novel engineered immunotherapeutic oncolytic viruses, and Mount Sinai Innovation Partners (MSIP), part of the Icahn School of Medicine at Mount Sinai, reported that they have partnered to develop novel cancer immunotherapies (Press release, Vaxalto Biotherapeutics, MAR 3, 2021, View Source [SID1234576057]). Mount Sinai has granted an exclusive, worldwide license to Vaxalto covering intellectual property and technology related to an avian paramyxovirus (APMV) oncolytic virus platform and novel immuno-modulator targeting the lymphatic system. This technology forms the core of Vaxalto’s proprietary, multimodal therapeutic approach utilizing direct destruction of cancer cells, vascular and immune system activation.

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"We are delighted to be partnering with Mount Sinai to develop our novel viral immunotherapy, which eliminates tumors following intra-tumoral administration and leads to long-term protection from cancer recurrence based on animal studies," said Dr. Mihaela Skobe, Vaxalto co-founder and Director, Laboratory for Metastasis and Lymphatic Research, Department of Oncological Sciences at Mount Sinai.

Skobe is joined by Dr. Peter Palese and Dr. Adolfo Garcia-Sastre, also from the Icahn School of Medicine at Mount Sinai, to form Vaxalto’s scientific leadership team.

"We look forward to this collaboration between Mount Sinai and Vaxalto, in an effort to advance potential breakthrough therapies using a novel approach to treating a range of cancers," said Dr. Erik Lium, President, Mount Sinai Innovation Partners and Executive Vice President and Chief Commercial Innovation Officer, Mount Sinai Health System

On March 3, 2021 Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd.,reported that the FDA granted Fast Track Designation of OKN-007, the proprietary drug for Diffuse Intrinsic Pontine Glioma (DIPG) (Press release, Oblato, MAR 3, 2021, View Source [SID1234576047]).

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The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

With the Fast Track Designation of OKN-007 for the treatment of DIPG, Oblato is eligible for Accelerated Approval and Priority Review and for Rolling Review that allows the Company to submit completed sections of its New Drug Application (NDA) for review by FDA before the entire application can be reviewed. The Company expects that the period of the regulatory approval process will be reduced.

DIPG is a rare pediatric brainstem cancer with limited treatment options. After a DIPG diagnosis, ninety percent of the patients die within 24 months, and the overall 5-year survival is less than one percent.

In addition to the Fast Track Designation, Oblato has already received Rare Pediatric Disease designation for DIPG. The Company is eligible for a rare pediatric disease priority review voucher from the FDA that can be redeemed for a priority review of a marketing application of a different product and is transferrable, when the Company receives NDA approval.

"We anticipate that the Fast Track Designation for DIPG will shorten the NDA review process. The Company will make every effort to develop this treatment for this rare pediatric disease," stated an official from the Company.

On March 3, 2021 Photocure ASA (OSE: PHO) reported Hexvix/Cysview revenues of NOK 97.7 million in the fourth quarter of 2020 (Q4 2019: NOK 58.8). Product revenues increased 20% in FY2020 representing strong execution in an unprecedented year (Press release, PhotoCure, MAR 3, 2021, View Source [SID1234576046]). Due to the ongoing pandemic, the Company suspends guidance for its 2023 revenue ambition in the range of NOK 1 billion. Photocure plans to re-issue financial guidance once the impact from Covid-19 is significantly diminished and physician practices and patient flow have normalized in both the U.S. and Europe.

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"Photocure grew sales in 2020 despite the significant operational challenges during a major global pandemic," says Dan Schneider, President & Chief Executive Officer of Photocure. "Despite the limited access to hospitals and physicians due to Covid-19, we still achieved positive growth in the U.S. Key accomplishments for the year included: continuing to generate growth in Cysview product sales and installations of BLC equipment in the U.S.; successfully integrating the European Hexvix business and launching commercial operations on 1 October; generating value with our partner, Asieris, who is advancing Cevira through Phase III development, and working with our licensing partners to expand Hexvix use worldwide."

Photocure reported total group revenues of NOK 97.9 million in the fourth quarter of 2020 (NOK 115.6 million) with an EBITDA before restructuring of NOK 15.2 million (NOK 54.8 million), and where the corresponding period in 2019 included sign-on fee and milestone payments of NOK 56.5 million. Hexvix/Cysview revenues were NOK 97.7 million (NOK 58.8 million). Growth in the U.S. market continued, despite limited access to hospitals and physicians due to the Covid-19 pandemic, with in-market unit sales up 11%, while European revenues grew 83.8% following a successful launch of the Company’s commercial organization in markets previously operated by Ipsen Pharma SAS.

The installed base of cystoscopes in the U.S. was 268 at the end of the fourth quarter, an increase of 45 units or 20% since the end of 2019. Blue Light Cystoscopy (BLC) in the surveillance setting is a key priority for Photocure in the U.S. market. By the end of the fourth quarter, a total base of 38 flexible cystoscopes have been installed representing a 46% increase over the prior year, giving more patients access to blue light cystoscopy procedures with less constraints in the office-based setting.

"I am pleased with how we managed through these unprecedented times and proud of our employees for adapting to changing working conditions and continuing to serve our patients and customers. Our performance in dealing with the business volatility throughout 2020, including the rebound in the third quarter, gives me confidence in the periods ahead," Schneider adds.

The ongoing Covid-19 pandemic adds continued uncertainty to Photocure’s near-term business forecast, which impacts the reliability of financial estimates. However, the Company believes that the benefits of blue light cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care. Procedures are expected to rebound back to pre-Covid-19 growth rates in the U.S. in places where bladder cancer patient care has been disrupted by Covid-19. In the newly acquired European markets, the Company also expects to see significant growth opportunities.

"Given the ongoing pandemic conditions, we have suspended our guidance for 2023 revenues in the range of NOK 1 billion. However, we plan to re-issue financial guidance once the impact of Covid-19 is significantly diminished and physician practices and patient flow have normalized in both the U.S. and Europe. Importantly, we are continuing to execute on our business plan to become a leader in the bladder cancer treatment segment, and we remain well-prepared to return to our prior growth trajectory when the pandemic is resolved," Schneider concludes.

Please find the full financial report and presentation enclosed.

EBITDA and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the fourth quarter 2020 financial report on pages 26-27.

Photocure will present its fourth quarter 2020 report on Wednesday 3 March 2021 at 14:00 CET. The investor presentation will be streamed live and be hosted by Dan Schneider, CEO and Erik Dahl, CFO.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20210303_1. The presentation is scheduled to conclude at 14:45 CET.

On March 3, 2021 Century Therapeutics, a leading cell therapy company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, reported the closing of a $160 million Series C financing (Press release, Century Therapeutics, MAR 3, 2021, View Source [SID1234576045]). The financing was led by Casdin Capital and brought together a syndicate of new investors including Fidelity Management & Research LLC, the Federated Hermes Kauffmann Funds, RA Capital, Logos Capital, OrbiMed, Marshall Wace, Qatar Investment Authority, Avidity Partners, and Octagon Capital. Founding investors Versant Ventures and Leaps by Bayer also participated. Eli Casdin, Founder and Chief Investment Officer of Casdin Capital will be joining the Century Therapeutics Board of Directors.

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"We are fortunate to be surrounded by such a top-tier group of investors, whose support will enable the acceleration of Century’s technology platform into the clinic," said Lalo Flores, Chief Executive Officer, Century Therapeutics. "With this new investor partnership, we are well-positioned to capitalize on the tremendous potential of our integrated iPSC, cell engineering and manufacturing capabilities to develop safer, more effective and more affordable next generation allogeneic cancer therapies."

Funds raised will help advance Century’s rich pre-clinical pipeline, which includes multiple iPSC-derived CAR-iT and CAR-iNK cell products. These products are designed to resist host rejection, enhance cell persistence, and allow repeat dosing to provide durable responses in all patients. The team anticipates beginning clinical testing of its first products in 2022, as well as generating multiple INDs annually in the coming years.

"It’s a remarkable and transformative time in the field, with the ability to engineer cells for therapeutic impact now a commercial reality. At the same time, iPSC technology has matured and is now leading the transition from bespoke autologous products to off-the-shelf allogeneic ones." said Eli Casdin CIO of Casdin Capital. "We could not be more excited to partner with the expert team at Century Therapeutics and do our part to help them leverage and accelerate their deep technical expertise in cellular reprogramming, differentiation, genetic engineering and manufacturing to deliver on this next phase of cellular therapy."