On June 15, 2022 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, reported financial results and the corporate update for the first quarter of 2022, ending March 31, 2022 (Press release, Vivoryon Therapeutics, JUN 15, 2022, View Source [SID1234615990]). The report is available on the Company’s website at View Source

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"In the first quarter of 2022, we continued to make meaningful progress, further advancing our unique QPCT/L inhibitor varoglutamstat to treat patients with Alzheimer’s disease through clinical development in Europe and the U.S., with both our European Phase 2b VIVIAD study and our U.S. Phase 2a/b study VIVA-MIND on track," said Dr. Ulrich Dauer, CEO of Vivoryon. "There still is an extremely high unmet medical need for safe, effective and widely available treatments against this devastating disease, and we at Vivoryon remain fully committed to playing an important role in making a real difference to patients and their families. We look forward to providing an update on varoglutamstat in the context of the VIVIAD interim safety analysis planned for mid-2022, where we anticipate to obtain important safety and tolerability data which will be key to our lead candidate’s further development."

Corporate Updates and Post-period Events

U.S. Phase 2a/b VIVA-MIND study (NCT03919162) for varoglutamstat in patients with early AD: actively enrolling patients, with currently eleven sites open and on track for an interim futility analysis planned for the first half of 2023.
European Phase 2b VIVIAD study (NCT04498650) for varoglutamstat in patients with mild cognitive impairment (MCI) and mild AD: actively enrolling patients, on track for an interim safety readout in mid-22, Vivoryon continues to anticipate final data in the second half of 2023.
Preparations for clinical development in Greater China, led by partner Simcere, ongoing with Clinical Trail Application for varoglutamstat approved by China’s Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA); preparations for Phase 1 and subsequent Phase 2 studies ongoing
Successful completion of a private placement in April 2022, raising gross proceeds of EUR 21 million, with net proceeds from the offering intended to be used to support the ongoing clinical development of lead candidate varoglutamstat, as well as for general corporate purposes; capital raise supported by a number of high-quality institutional investors from Europe and the U.S. as well as members of Vivoryon’s Executive and Non-Executive Boards.
Financial Results for Q1 of 2022

In the first quarter of 2022, research and development expenses amounted to EUR 5.8 million and increased compared to the first quarter of 2021 (EUR 4.3 million). This increase was mainly driven by costs associated with production cost for our compound varoglutamstat/PQ912 which is used in the VIVIAD trial as well as in the US trial VIVA-MIND which started in the fourth quarter of 2021.

General and administrative expenses decreased to EUR 0.8 million (Q1 2021: EUR 1.2 million). This decrease is largely attributable to consulting (Q1-2022: EUR 0.3 million, Q1-2021: EUR 0.6 million) and share based payment expense (Q1-2022: EUR 0.1 million, Q1-2021: EUR 0.2 million). The Company did not generate any licensing revenue in the reporting period.

Net loss of the period was EUR 6.4 million compared to EUR 5.4 million in the first quarter of 2021.

The Company held EUR 7.7 million in cash and cash equivalents as of March 31, 2022, respectively EUR 14.7 million as of December 31, 2021.

On April 1, 2022 the Company completed a private placement by way of accelerated book building. The gross proceeds of the offering amounted to approximately EUR 21.0 million.

All results are in line with management expectations.

Financial Guidance

Vivoryon updated its financial guidance following the capital raise completed in April 2022. According to current planning and estimates, Vivoryon expects that its existing cash and cash equivalents will be sufficient to fund its research and development expenses as well as the general and administrative expenses and cash flows from investing and financing activities at least through end of May 2023. This guidance does not include potential milestone payments from development partnerships, potential payments from licensing agreements and/or additional financing measures, as far as such payments have not yet been recognized in revenues. The financial guidance takes into account all costs to ensure sustainable study drug supply with varoglutamstat for the VIVA-MIND U.S. study.

Additional information regarding other relevant information is included in the financial statements as of December 31, 2021, which is included in the Company’s Annual Report 2021.

On June 14, 2022 CivicaScript,TM which is dedicated to bringing lower-cost generic medicines to U.S. consumers, and EmsanaRx, PBC, the only pharmacy benefit manager built by employers, for employers, reported that EmsanaRx is joining CivicaScript as a partnering member (Press release, CivicaScript, JUN 14, 2022, https://civicascript.com/2022/05/22/emsana-announcement-to-come/ [SID1234617442]). The partnership will make CivicaScript medicines available to EmsanaRx’s self-funded employer members.

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"We welcome the partnership of EmsanaRx as we work to provide quality generic medicines that are affordable and available to everyone," said CivicaScript President Gina Guinasso. "Everyone deserves access to the medicines they need to stay healthy. CivicaScript partners with organizations that share our belief that the needs of families and patients come first."

While many generic medicines cost less than brand-name drugs, some high-cost generics are more expensive than they need to be due to lack of market competition. Numerous studies confirm that medication costs can dictate whether patients ration their prescriptions or even fill them in the first place. CivicaScript and its members are intent on addressing that problem.

Created in 2020 to bring affordable versions of common but high-priced generic medicines to market, CivicaScript’s model is to develop quality generic medicines with its trusted manufacturing partners, then work with like-minded payors, pharmacy benefit managers (PBMs) and pharmacies across the country that pass along the cost savings to their customers.

CivicaScript will initially develop and manufacture six to 10 medicines for which there is currently not enough market competition to drive down price. Its first medication is expected to be available in the U.S. late this summer.

EmsanaRx joins Health Care Service Corporation (HCSC), the Blue Cross Blue Shield Association (BCBSA) and 18 independent and locally operated Blue Cross and Blue Shield (BCBS) companies and Anthem, Inc. as CivicaScript members. The PBM was launched last year by the Purchaser Business Group on Health (PBGH) to tackle the challenges large, self-funded employers face in providing high-quality, cost-effective medications to millions of Americans and their families.

"High drug costs are a big problem for self-funded employers. They spend more than $140 billion each year for prescription drugs on behalf of employees and their families. They are looking for ways to curb the costs of prescription drugs, which are rising by 20% each year and eating away at jobs, wages and other business costs," said Greg Baker, EmsanaRx founder and CEO. "Our partnership with CivicaScript has the potential to expand the availability of needed medications at lower cost to millions of Americans."

On June 14, 2022 Prestige BioPharma Group, comprising Singapore-based biopharmaceutical company Prestige BioPharma Limited. and biopharmaceutical CDMO company Prestige Biologics Co., Ltd., reported that the Group is participating in the BIO International Convention 2022, taking place in San Diego from June 13 to 16, 2022 (Press release, Prestige BioPharma, JUN 14, 2022, View Source [SID1234616226]).

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The Group aims to partner with global players for its core pipelines and secure clients for its CDEMO business at the world’s largest event for the biotechnology and pharmaceutical industries. After 2 years of online conventions, this year’s event is back in-person, thus expected to gather a high number of participants including around 3,000 companies from all over the world.

At booth #1421 in Bioprocess Zone, Hall B2, Prestige BioPharma Group showcases its technological platform for bioprocessing value chain, ranging from drug discovery to commercialization, which enhances productivity and cost-effectiveness. In particular, Prestige BioPharma introduces its biosimilar and antibody portfolio and share current progress on each pipeline to discusses partnership in development or commercialization. Prestige Biologics concentrates on securing clients and business contracts of its CDEMO services that provide customized manufacturing suites as well as development and engineering solutions.

Michael Ruppert, Director of International Business Development at Prestige BioPharma, said: "Our goal here is to build global network and partnership to enter the global market. In addition to biosimilars and first-in-class antibody drugs, we also look forward to discussing collaborations in research and development of vaccines against next-generation infectious diseases."

Jae-young Yang, CEO of Prestige Biologics, said: "In the competitive CDMO market, we have armed ourselves with state-of-the-art biomanufacturing facilities and patent technologies that ensures high quality and productivity. We will seize this opportunity to raise Prestige Biologics’ profile worldwide and secure new clients for CDEMO business."

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.

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.