On February 24, 2022 Calliditas Therapeutics reported that Year-End Report, 2021 (Press release, Calliditas Therapeutics, FEB 24, 2022, View Source [SID1234608923])

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"The accelerated approval of TARPEYO was for the indication of reduction of proteinuria, which was the endpoint of Part A of the trial, in adult patients with IgA nephropathy with risk of rapid progression, which is characterized as generally UPCR ≥ 1.5 g/g. It is well established that patients with higher levels of proteinuria have a worse outlook and prognosis as they tend to experience a more rapid decline of their kidney function, as measured by eGFR. These patients are therefore at considerable risk of progressing to ESRD, resulting in the need for dialysis or transplantation. We are obviously thrilled to be able to bring a medication to all these patients, who before now did not have any approved treatment options that addressed their illness.

This undertaking has taken well over a decade to reach patients and is the result of the incredibly hard work and dedication of a diverse and extraordinary group of people, working as a team towards a common goal. It has been a privilege to help guide and participate in this amazing journey over the last 4 years, and I am confident that this is just the beginning of our evolution into a broad-based biopharma business with the requisite talent, resources and science to continue to deliver enduring value to all of our stakeholders."

Renée Aguiar-Lucander, CEO

Summary of Q4 2021
October 1 – December 31, 2021

Net sales amounted to SEK 31.2 million and SEK 0.4 million for the three months ended December 31, 2021 and 2020, respectively.
Operating loss amounted to SEK 222.1 million and SEK 135.9 million for the three months ended December 31, 2021 and 2020, respectively.
Loss per share before and after dilution amounted to SEK 4.19 and SEK 3.41 for the three months ended December 31, 2021 and 2020, respectively.
Cash amounted to SEK 955.5 million and SEK 996.3 million as of December 31, 2021 and 2020, respectively.
Significant events during Q4 2021, in summary
In December 2021, Calliditas announced that the US Food and Drug Administration (FDA) had granted accelerated approval for TARPEYO (budesonide) delayed release capsules indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. TARPEYO is the first and only FDA-approved treatment for this disease and was designed specifically to target the origin of IgA nephropathy. This approval marked the successful transition for Calliditas to a commercial-stage biopharmaceutical company.

On February 23, 2022 Blue Water Vaccines Inc. ("BWV" or "Blue Water Vaccines" or the "Company"), a biopharmaceutical company developing vaccines, reported the closing of its initial public offering of 2,222,222 shares of its common stock at a public offering price of $9.00 per share (Press release, Onconetix, FEB 23, 2022, View Source [SID1234641105]). The shares began trading on the Nasdaq Capital Market under the ticker symbol "BWV" on February 18, 2022.

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The aggregate gross proceeds to BWV from the initial public offering were approximately $20 million, prior to deducting underwriting discounts, commissions, and other estimated offering expenses.

Boustead Securities, LLC acted as the sole book-running manager for the offering.

The Securities and Exchange Commission ("SEC") declared effective a registration statement on Form S-1 relating to these securities on February 11, 2022. A final prospectus relating to this offering was filed with the Securities and Exchange Commission on February 22, 2022. The offering was made only by means of a prospectus, copies of which may be obtained from; Boustead Securities, LLC, Attention: Prospectus Department, 6 Venture, Suite 325, Irvine, CA 92618, or by telephone at 949-502-4408 or by email at [email protected]. Investors may also obtain these documents at no cost by visiting the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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On February 23, 2022 Photocure ASA reported Hexvix/Cysview revenues of NOK 94.2 million in the fourth quarter of 2021 (Q4 2020: NOK 97.7 million) (Press release, , FEB 23, 2022, View Source,million%20(NOK%2015.2%20million). [SID1234611427]). Unit sales in the U.S. and Europe rose 11% and 12%, respectively, while the revenue comparison was impacted by a one-time reversal of an accrual in the prior-year period and foreign exchange. Photocure has a solid pipeline of anticipated Blue Light Cystoscopy (BLC) tower installations in the U.S. and expects placements to accelerate during the second half of 2022.

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"Photocure showed strong execution and resilience in 2021 as we continued to grow our U.S. business and successfully completed our first full year of operations in continental Europe despite several surges of Covid-19. While product revenue declined 4% in the fourth quarter of 2021 due to a one-time accrual reversal in Q4 2020 and the impact of foreign exchange, fourth quarter unit sales in the U.S. and Europe rose 11% and 12%, respectively year-over-year. We are particularly pleased with the progress that we made during the 2-year pandemic period, given the challenging conditions. Procedure volumes for bladder cancer resection surgeries in the U.S. declined 11%, while we grew Cysview unit volume by 24% from 2019 to 2021, resulting in an increase in our market penetration," says Daniel Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 94.5 million in the fourth quarter of 2021 (NOK 97.9 million), and an EBITDA* of NOK -5.5 million (NOK 15.2 million). Adjusted for the one-time reversal of an accrual in the fourth quarter of 2020, Hexvix/Cysview revenues increased 5% in the fourth quarter 2021 and were up 10% in constant currencies. The EBIT ended at NOK -11.5 million (-6.2) and the cash balance at the end of the fourth quarter 2021 was NOK 322.9 million. The installed base of rigid cystoscopes in the U.S. was 311 at the end of the fourth quarter, an increase of 43 units or 16% since the same period in 2020, including a total base of 48 flexible cystoscopes.

"Demand for BLC equipment remains very strong, and while some customers are awaiting the launch of the new Karl Storz system, we placed 9 towers in the fourth quarter. Our backlog for new capital equipment continues to grow, and we are extremely pleased that Karl Storz’s new blue light system was approved by the FDA earlier this month. As a result, both Photocure and Karl Storz are energized and preparing to launch this new system in the coming months," Schneider adds.

The Company’s pipeline of anticipated BLC tower installations in the U.S. remains robust given the demand by physicians and facilities to offer the benefits of BLC with Cysview in their practices. With the new Karl Storz blue light system anticipated to launch throughout the U.S. in the second quarter of 2022, Photocure expects that the placements of new blue light rigid towers will accelerate in the back half of the year. Meanwhile, the Company will continue to focus on increasing the use of Cysview in existing accounts as well as placing flexible BLC equipment, for which installation momentum is increasing.

"While the worldwide pandemic required us to take measures to manage through a period of great uncertainty, we used that time and deployed the necessary resources to position our global commercial organization to drive significant Hexvix/Cysview growth once healthcare access returns to normal. With our European operations fully integrated, a new high-definition BLC system launching in the U.S. market, and Covid-19 becoming better managed, we believe that 2022 will be an exciting year for Photocure as we help more bladder cancer patients realize the benefits of Hexvix/Cysview," 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 2021 financial report on page 24.

Photocure will present its fourth quarter 2021 report on Wednesday 23 February 2022 at 14:00 CET. The investor presentation will be streamed live and be hosted by Daniel 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/20220223_10/

On February 23, 2022 Race Oncology Limited ("Race") reported a researcher team, led by Professor Borje Andersson and Associate Professor Ben Valdez of the MD Anderson Cancer Center (Texas, USA), have identified a number of additional clinically translatable drug combinations that showed synergy with Zantrene when tested in Acute Myeloid Leukaemia (AML) cells (Press release, Race Oncology, FEB 23, 2022, View Source [SID1234610001]).

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This study1, sponsored by Race Oncology, has been published in the Journal Leukemia & Lymphoma and is entitled "Enhanced cytotoxicity of bisantrene when combined with venetoclax, panobinostat, decitabine and olaparib in acute myeloid leukemia cells."

The MD Anderson team identified synergism of Zantrene and venetoclax in combination with panobinostat, decitabine, or olaparib, known inhibitors of BCL2, histone deacetylase, DNA methyltransferase, and poly (ADP-ribose) polymerase, respectively, in AML cells.

These combinations were found to enhance DNA damage, cleavage of Caspase 3 and PARP1, DNA fragmentation, increased ROS, and potent apoptosis activation in AML cells. Similar results were observed using mononuclear cells isolated from leukaemia patients, but not from healthy donors. The SAPK/JNK signalling pathway was strongly activated by the combination treatments, whereas the PI3K/mTOR and Wnt/b-catenin pro-survival pathways were inhibited.

Chief Scientific Officer, Dr Daniel Tillett said: "This work provides further preclinical data to support our upcoming Phase 1b/2 extramedullary AML trial in Australian and Europe, where patients will be treated with Zantrene in combination with decitabine or cytarabine. We are extremely excited about being able to quickly translate this work from the lab into the clinic, where it has the potential to help AML patients in need."