On August 3 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for medical imaging and therapeutic applications, and GE Healthcare reported the signing of an exclusive agreement for the manufacturing and distribution of iodine-123 (I-123) capsules in the United States (Press release, NorthStar Medical Radiostopes, AUG 3, 2021, View Source [SID1234585641]). Under the contract terms, GE Healthcare’s Pharmaceutical Diagnostics unit will manufacture and supply NorthStar with I-123 capsules under the NorthStar label using a new, state-of-the-art production system at its facility in Arlington Heights, Ill. Upon receipt of the required regulatory approvals, NorthStar will retain exclusive U.S. marketing and distribution rights for these I-123 capsules, which will be available in 100µCi and 200µCi formulations.

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Iodide I-123 (as sodium iodide I-123) is a radioisotope of iodine, a staple product in radiopharmacies that is used routinely in nuclear medicine as the proven standard for the diagnosis of physiological abnormalities in the thyroid, including thyroid cancer. The American Cancer Society estimates that approximately 44,280 Americans will be diagnosed with thyroid cancer in 2021.

"This exclusive sales and manufacturing agreement marks NorthStar’s strong and growing relationship with GE Healthcare, and we look forward to working with the company in meeting the needs of radiopharmacy customers and the patients we all serve," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "NorthStar is strongly committed to the future of nuclear medicine. The ability to provide I-123 further expands our diagnostic imaging portfolio, which includes domestically produced, non-uranium Mo-99/technetium-99m and FibroScint, a novel fibrin-specific diagnostic imaging agent with potential clinical utility in cardiovascular care."

"We are pleased to sign this agreement and look forward to working with NorthStar in providing patients across the United States with I-123 capsules," said Chris Vessell, U.S. Nuclear Medicine Supply Chain Leader, GE Healthcare Pharmaceutical Diagnostics. "NorthStar has proven itself a leader in successfully driving technology development to produce innovative, real-world solutions for radioisotope production to meet healthcare needs, and we anticipate a productive relationship with the company."

GE Healthcare Pharmaceutical Diagnostics imaging agents support three patient procedures every second worldwide across MRI, X-ray/CT, ultrasound and nuclear medicine imaging.

On August 3, 2021 Nordic Nanovector ASA (OSE: NANOV) reported an update on the timeline for PARADIGME, its ongoing pivotal Phase 2b trial of Betalutin (177Lu lilotomab satetraxetan) in 3rd-line relapsed rituximab/anti-CD20 refractory follicular lymphoma (3L R/R FL) (Press release, Nordic Nanovector, AUG 3, 2021, View Source [SID1234585658]). The Company, having reviewed the recent rate of patient recruitment in discussion with its clinical advisors and in light of the continuing impact from the COVID pandemic, now anticipates the preliminary three-month data readout from PARADIGME during the first half of 2022.

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The Company will host a live webcast and Q&A on Thursday, 5 August 2021, at 08.30 CEST. A link to the webcast will be available in the afternoon on Wednesday, 4 August on www.nordicnanovector.com.

The Company reports that 92 patients have been enrolled into PARADIGME as of 3 August, compared with 83 patients enrolled as of 25 May 2021 and 73 as of 17 February 2021.

While the changes to the PARADIGME protocol and initiatives implemented to improve execution of the trial have positively impacted recruitment, the ongoing COVID pandemic situation, exacerbated by the spread of the more infectious SARS-CoV-2 delta variant, continues to affect the Company’s ability to screen, enrol and treat new patients. This is because the physical condition of the patient population targeted for this study means they are at the greatest risk from COVID-19 infection. As a result, the rate of patient recruitment has been slower than anticipated.

Nordic Nanovector continues to prioritise and commit all necessary resources to the completion of PARADIGME. As part of this prioritisation, Nordic Nanovector has decided to close clinical sites at which enrolment has been particularly challenging and refocus resources on other initiatives; the trial remains open for enrolment at 85 sites. The Company’s current cash position will support its operations into H2 2022.

In addition, the Company confirms it will invest no further funds in its Archer-1 Phase 1b trial investigating Betalutin in combination with rituximab in 2nd-line FL. The findings from this study, announced on 25 May 2021, will be important to inform the future development strategy for Betalutin in 2L FL.

The Company is planning to host an R&D Day for analysts, investors and press in Q4 2021. At the event, senior management and selected external speakers will discuss the positioning of Betalutin as a potential new treatment for R/R FL and outline the strategy for its future development and commercialisation in this indication pending positive results. In addition, the Company will discuss its multiple opportunities to expand the market for Betalutin and present other projects in its portfolio.

Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, commented: "The positive changes to the trial protocol and the initiatives we have implemented have increased the rate of recruitment into PARADIGME. However, they have not led to the expected acceleration in enrolment rate due to the spread of the emerging delta variant, which has meant that COVID restrictions have continued to impede the progress of PARADIGME, in common with many other clinical trials. Given this situation, we believe it is prudent to reset the anticipated timeline for completing the study, as we continue to focus on delivering preliminary top line data as soon as possible."

On August 3, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that management will participate in a Fireside Chat at the 12th Annual Wedbush PacGrow Healthcare Conference on Wednesday, August 11th at 9:45AM ET (Press release, SpringWorks Therapeutics, AUG 3, 2021, View Source [SID1234591663]).

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To access the live webcast please visit the "Events & Presentations" page within the Investors & Media section of the company’s website at View Source A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

On August 3, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that Janssen Biotech, Inc. (Janssen) dosed the first patient with JNJ-78278343, a bispecific antibody developed using Zymeworks’ Azymetric and EFECT therapeutic platforms (Press release, Zymeworks, AUG 3, 2021, View Source [SID1234585594]).

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"On behalf of everyone at Zymeworks, I’d like to congratulate the team at Janssen for advancing this bispecific candidate into the clinic," said Ali Tehrani Ph.D., Zymeworks’ President & CEO. "This represents our fourth pharmaceutical collaboration with programs reaching clinical development. We look to continue to demonstrate the value and strength of our platform technologies, which are an important part of our business model, complementing the value derived from our two lead clinical assets and preclinical pipeline."

Zymeworks will receive a payment in connection with this milestone under Zymeworks’ 2017 licensing agreement with Janssen. Under the terms of that agreement, Zymeworks provided Janssen with a worldwide, royalty-bearing license to research, develop and commercialize up to six bispecific antibodies directed to Janssen therapeutic targets using Zymeworks’ Azymetric and EFECT platforms. Janssen is responsible for all research, development and commercial activities under the licensing agreement. Zymeworks received an upfront payment of US$50 million and is eligible to potentially receive up to US$282 million in development and up to US$1.12 billion in commercial milestone payments, as well as tiered royalties on potential sales. Janssen also has the option to develop two additional bispecific programs under the agreement subject to a future option payment.

About the Azymetric Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific and multispecific antibodies, allowing simultaneous binding to several different disease targets. This unique technology enables the development of multifunctional therapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering and internalization and increase tumor-specific targeting. These features are designed to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric therapeutics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life and high stability. In addition, they are compatible with standard manufacturing processes that deliver high yields and purity, potentially reducing drug development costs and timelines.

About the EFECT Platform

The EFECT platform is a library of antibody Fc modifications engineered to activate or suppress the antibody-mediated immune response. This platform, which is compatible with traditional monoclonal as well as Azymetric bispecific antibodies, further enables the customization and optimization of therapeutic responses for different diseases.

On August 3, 2021 Cerus Corporation (Nasdaq: CERS) reported financial results for the second quarter ended June 30, 2021 (Press release, Cerus, AUG 3, 2021, View Source [SID1234585610]).

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Recent developments and highlights include:

Second quarter 2021 total revenue of $37.8 million, reflecting a 41% increase over the prior year period. Total revenue was composed of (in thousands, except %):

As of this release, the Company is increasing its 2021 annual product revenue guidance range to $118 million to $122 million (from the prior guidance of $110 million to $114 million), representing an approximately 28% to 33% increase over full year 2020 reported product revenue.
Submitted PMA supplement to U.S. FDA for 7-day storage of INTERCEPT platelets.
Announced collaboration with LifeSouth Community Blood Centers to manufacture INTERCEPT Fibrinogen Complex, expanding the initial launch footprint into the Florida market.
First hospital customer contracts signed in initial launch states for INTERCEPT Fibrinogen Complex.
Announced the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a New Technology Add-On Payment (NTAP) for INTERCEPT Fibrinogen Complex.
Submitted fourth and final module (Manufacturing) of CE Mark application for INTERCEPT red blood cells.
Cash, cash equivalents, and short-term investments of $123 million at June 30, 2021.
"The second quarter of 2021 was exceptional for Cerus on numerous fronts. Our record quarterly product revenue of $31.5 million exceeded our expectations and was led by U.S. platelet adoption," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "This strong momentum gives us confidence in delivering significant top-line growth over the balance of the year, and we are raising our full year product revenue guidance accordingly."

"In addition to our strong commercial execution, I am also very proud of several other accomplishments we made as an organization during the second quarter. As planned, we made two important regulatory submissions, with our PMA supplement to the FDA for 7-day storage of INTERCEPT platelets, as well as the fourth and final module of our CE Mark submission for INTERCEPT red blood cells. In addition, for our therapeutics business, we have signed initial customer contracts with hospitals who plan to begin using INTERCEPT Fibrinogen Complex in the second half of 2021, expanded our initial reach into the state of Florida through our collaboration with LifeSouth and received the NTAP from CMS," Greenman continued.

Revenue

Product revenue during the second quarter of 2021 was $31.5 million, compared to $21.5 million during the same period in 2020. Product revenue growth during the quarter benefited from increased demand for INTERCEPT platelet products in the U.S., with broad-based demand from blood centers across the country.

Second quarter government contract revenue was $6.3 million, compared to $5.3 million during the same period in 2020. Second quarter government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for Red Cells as well as sponsored efforts related to the development of next generation pathogen reduction technology to treat whole blood.

Product Gross Profit & Margin

Product gross profit increased $4.4 million over the same period in 2020, however, product gross margins on product revenue during the second quarter of 2021 were 51.3% compared to 54.9% for the second quarter of 2020. The decrease in product gross margin was expected and was tied to increased sales to our U.S. customers, who typically use the Company’s single dose platelet kits, which provide a lower product gross margin percentage compared to our double dose kits that are used more broadly outside of the U.S. Additionally, increased freight costs also contributed to the decrease when compared to the prior year period.

Operating Expenses

Total operating expenses for the second quarter of 2021 were $36.8 million compared to $31.7 million for the same period of the prior year. In general, operating expenses were higher, in part due to the resumption of certain activities that had been suspended due to the effects of the COVID-19 pandemic.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2021 totaled $19.8 million, compared to $16.1 million for the second quarter of 2020. The year-over-year increase in SG&A expenses was tied to incremental expenses associated with the launch of the Company’s INTERCEPT Fibrinogen Complex product, incentive compensation costs, as well as increases in certain vendor fees.

R&D expenses for the second quarter of 2021 were $17.1 million, compared to $15.6 million for the second quarter of 2020. Higher R&D expenses were driven in part by costs associated with the INTERCEPT red blood cell programs in the U.S. and Europe, including the submissions of the third and fourth modules of the Company’s CE Mark application during the quarter. For the most part, U.S. red blood cell efforts are reimbursed and recorded as Government Contract Revenue on the Company’s statement of operations. Additionally, R&D expense during the 2021 period also included elevated costs associated with the development of a next generation, LED-based illuminator.

Net Loss

Net loss for the second quarter of 2021 was $15.4 million, or $0.09 per basic and diluted share, compared to a net loss of $14.9 million, or $0.09 per basic and diluted share, for the second quarter of 2020.

Balance Sheet

At June 30, 2021, the Company had cash, cash equivalents and short-term investments of $122.8 million, compared to $133.6 million at December 31, 2020.

During the quarter, the Company continued its investments in inventory in response to the expected growth of its business. At the same time, the Company continued to manage its accounts receivable, maintaining healthy days sales outstanding and managed cash use from operations down to $8.7 million. The Company continues to have access to additional funds under its loan agreement and, separately, revolving line of credit. During Q2, the Company exercised its option to extend the interest-only duration of its term loans through 2023, in accordance with its loan agreement. At June 30, 2021, the Company had approximately $54.7 million in outstanding term loans and $9.3 million of borrowings under its revolving loan credit agreement, compared to $39.6 and $8.5 million, respectively, at December 31, 2020.

Increasing 2021 Product Revenue Guidance

Based on the strong first half revenue and expectations for the second half of 2021, the Company now expects 2021 product revenue to be in the range of $118 million to $122 million, as compared to the prior range of $110 million to $114 million. The revised guidance range represents approximately 28% to 33% growth compared to 2020 reported product revenue.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 6554004. The replay will be available approximately three hours after the call through August 17, 2021.