On May 18, 2022 Calliditas reported that launched its first commercial product, TARPEYO, in the US, supported by 40 experienced specialty sales executives who were trained and in the field in late January (Press release, Calliditas Therapeutics, MAY 18, 2022, View Source [SID1234614779]). Our commercial product was already available to ship to patients at the end of January, reflecting the great collaboration between our CMC group and our commercial team in the US.

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Our transformation from a primarily R&D based company to a commercial stage, fully integrated business has been a journey, which first started 3 years ago when we brought onboard our first employee in the US. Under the guidance of a small but highly experienced senior team, we started to build our medical affairs and market access teams in preparation for a future regulatory approval.

With a fully integrated operation and a streamlined supply and distribution chain in place, the US organization had grown significantly and was by mid-2021 ready for the final step, onboarding of the sales force. When accelerated approval of TARPEYO was granted by the FDA, the entire organization was well prepared and ready. TARPEYO TouchpointsTM was available within hours and prescribers were able to access details regarding the product, the indication and could write prescriptions for appropriate patients. There was hope at last for IgAN patients in the US, as an approved product became available for the first time.

This is obviously just the very beginning of the journey, but we are very encouraged by the strong interest and early successes we have experienced, which have resulted in net product revenues of $1.9M (SEK 18.0M) for the first couple of months of commercial availability, and we remain fully committed to continuing to build the TARPEYO franchise."

CEO Renée Aguiar-Lucander

Summary of Q1 2022
January 1 – March 31, 2022
Net sales amounted to SEK 49.7 million, whereof TARPEYO net sales amounted to SEK 18.0 million, for the three months ended March 31, 2022. No net sales were recorded for the three months ended March 31, 2021.
Operating loss amounted to SEK 208.4 million and SEK 150.8 million for the three months ended March 31, 2022 and 2021, respectively.
Loss per share before and after dilution amounted to SEK 3.95 and SEK 2.62 for the three months ended March 31, 2022 and 2021, respectively.
Cash amounted to SEK 825.4 million and SEK 867.3 million as of March 31, 2022 and 2021, respectively.
Significant events during Q1 2022, in summary
In January 2022, Calliditas announced commercial availability and initial sales of TARPEYO (budesonide) delayed release capsules, the first and only FDA approved treatment for IgA nephropathy, indicated for reduction of proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression, generally considered a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g.
In February 2022, Calliditas announced that the first patient had been randomized in the company’s pivotal phase 2b/3 TRANSFORM study in patients with primary biliary cholangitis (PBC).
In March 2022, Calliditas expanded its licensing agreement with Everest to extend the territory covered to include South Korea.
Significant events after the reporting period
In May 2022, Calliditas announced that the first patient had been randomized in the company’s proof-of-concept Phase 2 study in patients with squamous cell carcinoma of the head and neck (SCCHN) with the NOX 1 and 4 inhibitor setanaxib.
Investor Presentation May 18, 2022 14:30 CET

The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on May 18, 2022 at 7:00 a.m. CET.

On May 17, 2022 LifeArc reported that RQ Biotechnology Ltd (RQ Bio), a company it co-founded, reported that has signed a licensing agreement with AstraZeneca PLC (AZN) (Press release, LifeArc, MAY 17, 2022, View Source [SID1234615989]). Under the terms of the agreement, RQ Bio has granted AstraZeneca an exclusive worldwide licence to develop, manufacture and commercialise RQ Bio’s existing early-stage mAbs against SARS-CoV-2 and a right of first refusal to take an exclusive licence in respect of any additional mAbs against SARS-CoV-2 .

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RQ Bio will receive upfront and milestone payments of up to $157 million and will be eligible to receive single digit royalties on sales. The successful licensing deal was supported by Oxford University Innovation, a wholly-owned subsidiary of the University of Oxford that manages the University’s technology transfer and consulting activities, who worked efficiently and creatively with all parties on the corresponding technology licences and the filing of intellectual properties.

RQ Bio today emerges from stealth mode announcing its launch as a new UK-based biotechnology company. The company, which is headquartered in London, is dedicated to developing treatments and preventative therapies based on potent broad spectrum mAbs to provide instant and long-lasting immunity for vulnerable people at risk of severe disease or death from existing, emerging and new viral infections.

"LifeArc is committed to backing leading UK academics and scientists, and we were inspired to fund RQ Bio because of the exceptional group of founders who are so passionately dedicated to finding new treatments and preventative therapies for viral infections in areas of high unmet patient need," said Clare Terlouw, Head of LifeArc Ventures. "LifeArc provided a wide range of support to help RQ Bio execute on its business plan, including financial backing from our venture team, scientific expertise and access to its world-class laboratory facilities. We look forward to further supporting RQ Bio as it becomes a world-leading infectious disease company."

The RQ Bio executive team is composed of biotech and pharmaceutical industry leaders with proven expertise in end-to-end antibody generation. Key appointments include:

Hugo Fry, CCO at Imbria and former Sanofi Executive, appointed Chief Executive Officer
Mike Westby, co-founder of RQ Bio, CSO of Centauri Therapeutics and former Pfizer R&D Executive, remains a key Scientific Advisor
Paul Kellam, co-founder of RQ Bio, Professor of Virus Genomics at Imperial College London and Vice President of Infectious Diseases & Vaccines at Kymab UK, remains a key Scientific Advisor
Jane Osbourn OBE, co-founder of RQ Bio, CSO of Alchemab and previous Chair of the UK Bioindustry Association (BIA), remains a key Scientific Adviser.
To maximise and accelerate patient impact, the company will continue to be supported by its collaborations with its scientific co-founders, the University of Oxford and leading UK medical research charity LifeArc. Professor Gavin Screaton, Head of the Medical Sciences Division at the University of Oxford, will continue to advise in his capacity as scientific and medical co-founder, as will Clare Terlouw, Head of LifeArc Ventures and UK BIA board member, as a member of the Board of Directors.

"Our vision is to build on our successful debut with neutralising antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral infectious diseases," said Hugo Fry, CEO of RQ Bio. "By combining our expertise and innovative excellence in core areas we have created a smarter approach to antibody generation making us uniquely positioned to deliver fast patient impact."

On May 17, 2022 Diffusion Pharmaceuticals Inc.(NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported that Robert Cobuzzi, Jr., Ph.D., the Company’s President and Chief Executive Officer, will be presenting at the H.C. Wainwright Global Investment Conference being held at the Fontainebleau Miami Beach Hotel from May 23-26, 2022 (Press release, Diffusion Pharmaceuticals, MAY 17, 2022, https://www.diffusionpharma.com/press-release/diffusion-pharmaceuticals-to-present-at-h-c-wainwright-global-investment-conference/ [SID1234615256]).

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The presentation will be virtual and will provide an overview of recent business and corporate achievements at Diffusion, including an update on TSC clinical trials.

Details of the presentation are as follows:

Date & Time: On demand, beginning 7.00 a.m. ET, Tuesday, May 24, 2022

A replay of the presentation will be available under the presentations section of the Company website at www.diffusionpharma.com. In addition, Dr. Cobuzzi will be available for one-on-one meetings during the conference. Registered investors will be able to request a meeting with management via the conference portal.

On May 17, 2022 Alloy reported that has more than 130 partners in the drug discovery ecosystem across academic, biotech, and large biopharma teams (Press release, Alloy Therapeutics, MAY 17, 2022, View Source [SID1234615175]). Early in our history, we connected with Dren Bio, Inc., an emerging biopharmaceutical company headquartered in Northern California that specializes in the discovery of therapeutic antibodies engineered to selectively deplete pathologic cells and other disease-causing agents. Dren Bio’s pipeline encompasses two distinct drug discovery programs. Their initial product candidates are currently in development for the treatment of a variety of oncology and autoimmune diseases.

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At the time we were introduced to the founders of Dren Bio, they were in the process of raising their first round of financing and were looking for an antibody discovery partner that was both affordable and agile. After considering multiple alternative solutions, the Dren Bio team ultimately selected Alloy for what they perceived as an accessible, transparent business model, notably one that did not include undue royalties for products that they discovered under our ATX-Gx license. After initially licensing the ATX-Gx mouse platform for use at one of our certified third-party service providers’ facilities, the team at Dren Bio eventually transitioned the work directly to Alloy, becoming one of the first customers for our Antibody Discovery Services offering that we launched in early 2020. Through close collaboration, our Alloy Discovery Services team was able to generate an antibody candidate that required no further optimization following initial discovery and characterization. From there, we made sure to remain responsive, offering materials and guidance to continue supporting the Dren Bio team’s internal efforts after shipment. Like all of our collaborations, we tried to treat the program like it was our own. Our CEO was never more than a text message away from Dren’s CEO if there were any questions.

"Alloy Discovery Services acted as a trusted partner and extension of our team, collaborating with us to optimize an antibody that has now become the lead product candidate for our Enhanced ADCC Program," said Nenad Tomasevic, PhD, Dren Bio ‘s Founder and CEO.
Dren Bio has had an incredible run, assembling a highly experienced executive leadership team, securing an impressive $1 billion partnership with Pfizer using its Targeted Myeloid Engager and Phagocytosis Platform, and most recently this year clearing its first clinical IND application with the FDA. Alloy’s relationship with Dren Bio is a shining example of our commitment to providing robust antibody discovery services to companies possessing novel insights into disease biology and that are passionate about developing therapeutic antibodies against today’s most exciting targets.

If you are an early stage biotech looking to explore an ATX-Gx license or run a full discovery campaign with our services group, you can connect with our business development team here to learn more.

On May 17, 2022 Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, reported it has entered into an asset purchase agreement with MannKind Corporation (Nasdaq: MNKD) to sell the V-Go insulin delivery device for $10 million and additional sales-based milestones. Certain inventory and employees are also included under the terms of the agreement (Press release, Zealand Pharmaceuticals, MAY 17, 2022, View Source [SID1234614910]).

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V-Go is a once-daily, wearable, insulin delivery device that helps provide blood sugar control for everyday lifestyles. Designed to be patient-friendly, V-Go is worn like a patch and eliminates the need for taking multiple daily shots.

"This transaction is an important step forward in executing on the strategic refocusing we outlined at the end of March, as we find partners for our commercial and late-stage assets and prioritize the research and development of innovative new peptide therapeutics," said Adam Steensberg, MD, Chief Executive Officer of Zealand Pharma. "We believe MannKind is the right partner to fully leverage the value of V-Go and ensure its continued availability for the patients and prescribers who need it."

"MannKind is committed to bringing innovative solutions to the diabetes patient community to potentially ease daily disease management," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "Acquiring V-Go will help us to address an unmet need while strategically leveraging our infrastructure in the diabetes space and positioning MannKind’s endocrine business for additional growth."

The acquisition of V-Go by MannKind is anticipated to close in May 2022, subject to the satisfaction of certain closing conditions.

Today’s news does not impact Zealand Pharma’s Financial Guidance for 2022 as reiterated in the company’s Interim Report for the First Quarter 2022 announced on May 12, 2022.