Day One Announces Pricing of Upsized Public Offering of Common Stock

On June 14, 2022 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN), a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported the pricing of its upsized underwritten public offering of 10,000,000 shares of its common stock at a public offering price of $15.00 per share (Press release, Day One, JUN 14, 2022, View Source [SID1234616030]). All shares of common stock are being offered by Day One. The gross proceeds to Day One from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $150.0 million. In addition, Day One has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about June 17, 2022, subject to the satisfaction of customary closing conditions.

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J.P. Morgan, Cowen and Piper Sandler are acting as the joint book-running managers for the offering. Wedbush PacGrow is acting as the lead manager for the offering.

The securities are being offered by Day One pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying base prospectus may also be obtained, when available, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or via email at [email protected]]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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.

Proscia Raises $37M Series C To Fulfill The Promise Of Precision Medicine With AI-Enabled Pathology

On June 14, 2022 Proscia, a leader in digital and computational pathology solutions, reported that it has raised $37 million to advance the way we understand and treat diseases like cancer (Press release, Proscia, JUN 14, 2022, View Source [SID1234616029]). The round includes participation from Highline Capital Management, Triangle Peak Partners, and Alpha Intelligence Capital as well as existing investors including Scale Venture Partners, Hitachi Ventures, ROBO Global, Emerald Development Managers, and Razor’s Edge Ventures. This investment brings Proscia’s total funding to $72 million.

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Demand for digital pathology, which shifts the standard of cancer research and diagnosis from microscope to digital image, is rising to tap into the full potential of pathology data. Proscia has established itself as the sole player driving this complete modernization across both life sciences organizations and diagnostic laboratories. Its Concentriq platform combines enterprise scalability with a broad portfolio of AI applications to accelerate breakthroughs and unlock clinical insights that advance precision medicine.

"Proscia is uniquely positioned to enable a new frontier of patient care," said Jacob Doft, CEO of Highline Capital Management. "Digital pathology is a critical catalyst in the acceleration of precision medicine, creating a wealth of new data that is driving novel therapies and optimizing diagnosis so that each patient receives the most individualized treatment. We are excited to be a part of Proscia’s journey as it expands its leadership position with its AI-enabled platform."

Proscia’s user base includes 10 of the top 20 pharmaceutical companies as well as the Joint Pathology Center, which selected Concentriq to digitize the world’s largest human tissue repository of over 55 million slides. Leading reference laboratories and health systems, including LabPON, the first laboratory to reach 100% digital diagnosis, also rely on Concentriq.

"Pathology deserves the same revolutionary technology that has transformed the rest of medicine and our lives," said David West, Proscia’s CEO. "Our Series C will enable us to continue delivering this innovation to the scientists and pathologists who are using it to improve patient outcomes. We are thrilled to partner with incredible investors who believe deeply in our mission as we take the next step in our journey."

The financing will enable Proscia to accelerate adoption of computational pathology, strengthening its market and product leadership. It will use the infusion of capital to scale its commercial operations. This includes expanding its sales, marketing, and support teams as well as growing distribution partnerships following its recent OEM agreement with Siemens Healthineers. Proscia will also increasingly focus on its regulatory strategy on the heels of its CE IVDR certification.

To continue offering the widest variety of AI applications on a single pathology platform, Proscia will invest in broadening its own portfolio of computational solutions and introduce a growing number of third-party applications onto Concentriq. It will build on the success of its DermAI and AI breakthrough in melanoma detection as well as extend digital pathology’s first suite of process automation solutions beyond Automated QC.

"Pathology is a multi-billion dollar market transitioning to digital," said Steve Holloway, Executive Director at Signify Research. "Adoption has moved beyond the largest life sciences organizations and medical centers as the benefits have become increasingly clear, much like we saw when the digitization of radiology crossed an inflection point."

Today’s announcement comes as demand for AI-enabled pathology continues to grow. By breaking free from the limitations of glass slides, research organizations and diagnostic laboratories are overcoming a range of systemic challenges intensified by the rising cancer burden; drug development timelines average 12 years before patients gain access to new therapies, and the number of cancer cases is expected to rise 47% by 2040, putting added burden on a shrinking pathologist population. It is estimated that one billion slides will be digitized each year, fundamentally transforming the way we diagnose and treat patients in fulfilling the promise of precision care.

Beyond Air® Announces Fiscal Year End 2022 Financial Results Conference Call and Webcast Moved to Tuesday, June 28th

On June 14, 2022 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported that it has rescheduled the reporting of the financial results for its fiscal fourth quarter and year ended March 31, 2022 to Tuesday, June 28, 2022 (Press release, Beyond Air, JUN 14, 2022, View Source [SID1234616006]). The Company’s management team will also host its quarterly conference call and webcast at 4:30 pm Eastern Time on June 28th.

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HALO Diagnostics and Genomic Testing Cooperative Partner to Advance Early Cancer Detection and Precision Diagnostics

On June 14, 2022 HALO Diagnostics, a precision diagnostics leader, reported that it has joined forces with the Genomic Testing Cooperative (GTC) to offer innovative, personalized testing to its physician network and 1M+ patients served (Press release, Genomic Testing Cooperative, JUN 14, 2022, View Source [SID1234615999]). This solution combines HALO Diagnostics’ clinical ensemble and image-guided therapies with GTC’s genomic profiling of a patient’s DNA / RNA using liquid biopsy and tissue samples. Together, the companies will help patients on every step of their unique healthcare journey – from detection and diagnosis to prognosis and treatment.

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For decades, patients have faced a one-size-fits-all approach to their health. They are now calling for more prompt, personalized care. With this partnership, HALO Diagnostics and GTC are ready to answer this call.

Recent therapeutic approvals in HALO Diagnostics’ core clinical areas such as prostate, breast, and lung cancers have focused on targeted therapies and immunotherapies. Before treatment can begin, patients undergo biomarker testing. This is where GTC comes in: The company’s comprehensive test panels simultaneously query key DNA / RNA alterations, guiding decision making for patients’ treatment plans.

"By bringing together advanced imaging and molecular biomarkers, HALO Diagnostics and GTC will have a unique impact on driving early detection in healthcare," says Dr. John Feller, Chief Medical Officer at HALO Diagnostics. "We will reduce oversights common in individual diagnostic tests, making early detection, minimally invasive therapies, and precision-focused healthcare possible."

Dr. Maher Albitar, GTC’s Founder, CEO, and Chief Medical Officer, agrees. "Combining imaging with molecular profiling is not only a natural expansion in medical diagnostics, but also provides a unique opportunity for innovation in the era of artificial intelligence." He adds, "We are very excited to be working with HALO Diagnostics. This collaboration will save patient lives and accelerate the development of key radiogenomic biomarkers."

With this partnership, the innovation is just beginning.

GTC recently showcased Liquid Trace, its latest liquid biopsy test that combines cell-free DNA and cell-free RNA to improve the test’s sensitivity for diagnosing solid tumours and blood-related cancers, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s annual meeting from June 3-7, 2022. The Liquid Trace test is now available to HALO Diagnostics’ patients indicated for this precision-focused approach.

KBI Biopharma SA and Selexis SA Expand in Europe by Opening an Integrated Biologics Manufacturing Facility in Geneva, Switzerland

On June 14, 2022 KBI Biopharma SA (KBI) and Selexis SA, both JSR Life Sciences companies, reported that an expanded, fully-integrated mammalian contract development and manufacturing services facility is now open and operational in Geneva, Switzerland (Press release, JSR, JUN 14, 2022, View Source [SID1234615992]).

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The ~94,000 square-foot integrated KBI/Selexis state-of-the-art facility builds upon the companies’ existing market foothold by combining best-in-class cell line development (CLD) and expert mammalian cell manufacturing in a single location. KBI and Selexis leverage their expertise and efficient end-to-end services for biomanufacturing clients.

This expansion enables industry-leading delivery of client programs through increased quality, efficiency, and time savings across a diverse portfolio of molecule formats. Under one roof, KBI and Selexis provide cell line transfection through cGMP drug manufacturing with Selexis’ specialized high-titer mammalian cell line development technologies and services and KBI’s cGMP bulk drug manufacturing for clinical and commercial requirements.

"This expansion in Geneva will provide our global clients with streamlined capabilities to support mammalian-based therapies," said Mark W. Womack, Chief Executive Officer for KBI Biopharma and Selexis SA. "With a single touchpoint for best-in-class cell line development, process development, and manufacturing, clients experience heightened access to our process and product-based expertise."

He added, "This facility expansion, together with our track record in the space, strengthens our commitment to deliver a seamless experience to the European biopharmaceutical community and clients around the globe."

The fully integrated Selexis and KBI development platform has supported more than 60 clinical development programs with high productivity and robust product quality. The two companies have developed a seamless approach, to optimize the client experience.

"We have always been a science-driven, customer-centric company. This expansion in Geneva helps our clients optimize their complex biomanufacturing processes under accelerated timelines," said Ulrich Valley, Senior Vice President, Operations & Site Head, KBI Biopharma, Geneva.

The KBI Biopharma facility will create more than 200 technical positions in development, operations, and quality assurance. The facility includes a suite of analytical testing laboratories and dual 2,000L single-use cGMP manufacturing trains with downstream processes capable of producing 8-10 kg yields per batch.

With the expanded Geneva facility now operational, KBI and Selexis will celebrate with ribbon-cutting activities and facility tours starting in July 2022.