On May 27, 2021 Scientia Vascular may focus largely on producing medical devices of tiny proportions, reported that certainly doesn’t carry over to its latest wave of financing (Press release, Scientia Vascular, MAY 27, 2021, View Source [SID1234583261]).

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The Salt Lake City-based company, which develops not only a suite of microcatheters and guidewires but also the manufacturing technology it takes to produce them, has received $50 million in growth equity to support and expand that development.

The funding came solely from Vivo Capital, a global healthcare investment firm that has backed biotech and medtech companies through its multiple nine-figure venture funds, including, most recently, Esco Lifesciences’ $200 million series A.

The $50 million in growth capital will help speed up global sales and marketing efforts for Scientia’s existing products while also supporting new product development in the neurovascular stroke, peripheral vascular and interventional oncology markets.

RELATED: Surmodics gets FDA nod for Telemark microcatheter

Currently, Scientia’s product portfolio includes a handful of guidewires and microcatheters that, since their 2018 commercial launch, have been used primarily in neurovascular surgeries and specifically in stroke treatment.

Among these are the Plato line of microcatheters—including the Plato 17 model, which was cleared (PDF) by the FDA just last month—and the trio of Aristotle flexible guidewires. Additionally, last August, the company received FDA clearance for and began rolling out its Zoom Wire collection of guidewires, which are designed to lead catheters into the body during intensive, time-critical vascular operations, such as during ischemic or hemorrhagic stroke.

At the time of the Zoom Wire’s launch, John Lippert, Scientia’s founder and CEO, said in a statement that the company had plans to introduce an even wider line of guidewires and microcatheters under the Zoom umbrella in 2021.

Beyond designing and developing its range of neurovascular devices, Scientia also does all of its own manufacturing. To that end, the company has invented patented micromachining and microfabrication technologies to achieve high levels of stability and flexibility in its guidewires and catheters. Scientia has also automated much of this proprietary manufacturing process to ensure consistency in the quality of its products.

RELATED: FDA approves wireless brace that uses brainwaves to improve hand function in stroke patients

The realm of microcatheters and guidewires has long been dominated by medtech giants like Stryker and Boston Scientific, both of which boast a broad range of products for interventional vascular operations.

More recently, smaller startups have begun to challenge these behemoths with innovative takes on the products, whether through new manufacturing processes like Scientia’s or entirely new technology. In the latter category are companies like Sensome, which is developing sensor-equipped guidewires that use machine learning algorithms to analyze the tissue they come in contact with during stroke treatment.

On May 27, 2021 AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio," the "Company" or "we") (NASDAQ: ANPC), a biotechnology company with operations in China and the United States, reported its unaudited financial results for the first quarter ended March 31, 2021 (Press release, Anpac Bio, MAY 27, 2021, View Source [SID1234580678]). The Company’s financial statements and related financial information for the quarter ended March 31, 2021 are unaudited or have not been reviewed by the Company’s independent registered accountant. These financial results could differ materially if they were reviewed by the Company’s independent registered accountant.

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Financial highlights for the First Quarter 2021

Total revenue was RMB2.2 million (US$0.3 million) for the first quarter of 2021, an increase of 137.2% from RMB0.9 million for the first quarter of 2020.

Gross profit margin was 58.4% for the first quarter of 2021, representing an increase of 25.7 % from 32.7% for the first quarter of 2020, primarily due to higher selling prices charged for CDA-based tests and improved operational efficiency as well as higher volume of CDA-based tests performed during the first quarter of 2021.

The average selling price ("ASP") of CDA-based tests was RMB401.0(US$61.2) for the first quarter of 2021, an increase of RMB20.0, or 5.0% from RMB381.0 in the same period of 2020, primarily due to a broader product offering of more comprehensive multi-cancer detection tests at higher price points.

Net loss was RMB29.3 million (US$4.5 million) for the first quarter of 2021, compared to a net loss of RMB21.2 million for the first quarter of 2020. The net loss for the first quarter of 2021 was mainly attributable to RMB3.2 million (US$0.5 million) changes in the fair value of the convertible debts, RMB3.9 million (US$0.6 million) of selling and marketing expenses, RMB3.4 million (US$0.5 million) of research and development expenses and RMB 19.2 million (US$2.9 million) of general and administrative expenses.

Short-term debt was RMB22.4 million (US$3.4 million) as of March 31, 2021, an increase of 171.9% from RMB8.2 million at the end of last fiscal year (December 31, 2020). The increase in short-term debt was mainly due to issuance of additional convertible debentures with a fair value of USD$2.5 million.
As of March 31, 2021, the Company had cash and cash equivalents of RMB9.0 million (US$1.4 million), compared to RMB3.0 million as of December 31, 2020.
Business Highlights for the First Quarter of 2021

The Company reached a record high number of commercial CDA tests for the 1st Quarter versus any previous Q1 in the Company’s history.

The Company has developed and completed testing at the end of February 2021 of a new generation of multi-cancer detection sensor named CDA Pro Sensor (CDAPS) which is a technology breakthrough with improved performance over the previous generation cancer detection sensors in a number of areas, including detection signal stability, sensor device yield, and detection sensitivity and specificity. The Company expects that CDAPS will extend the competitiveness for AnPac in the space of cancer screening.

On January 25, 2021, the National Medical Products Administration (NMPA), the regulatory agent for medical products in China, approved the Company to start registration testing of AnPac Bio’s class III lung cancer auxiliary diagnosis medical device at its designated medical device testing laboratory, which is a major progress and step towards obtaining a Class III medical device registration certificate.

The Company continued to receive validation on the efficacy of CDA testing through follow-up studies. As of March 31, 2021, AnPac Bio had contacted 23,857 individuals tested using CDA packages in China and received substantive feedback regarding health conditions and disease development from 14,127 individuals.

As of March 31, 2021, the Company filed 237 patent applications globally, among which 142 patents had been granted, including 20 patents granted in the United States, 65 in greater China (including eight in Taiwan), and 57 in other countries and regions.

The Company continued to build a cancer risk assessment database, which totaled approximately 222,200 samples as of March 31, 2021, including approximately 178,300 samples from commercial CDA-based tests and approximately 43,900 samples from research studies.
Dr. Chris Yu, AnPac Bio’s Chairman and CEO commented: "We are very pleased with our strong Q1 performance results, including (1) a 137.2% in revenue increase over the same period last year, (2) development and final evaluations of our next generation of multi-cancer detection sensor technology which includes significant performance improvements, and (3) receiving approval from the National Medical Products Administration (NMPA) to start registration test of AnPac Bio’s class III lung cancer auxiliary diagnosis medical device. We are going into Q2 with strong momentum. Our continued focus in completing our Class III medical device registration and our new product development pipeline is showing great progress. We have also worked closely with our customers and commercial partners to achieve accelerated revenue growth."

On May 27, 2021 eFFECTOR Therapeutics, Inc. (eFFECTOR), a biopharmaceutical company focused on pioneering the development of selective translation regulation inhibitors (STRIs) for the treatment of cancer, and Locust Walk Acquisition Corp. (NASDAQ: LWAC), a blank-check company formed for the purpose of acquiring or merging with one or more businesses, reported they have entered into a definitive merger agreement (Press release, eFFECTOR Therapeutics, MAY 27, 2021, View Source [SID1234580695]). Upon closing of the transaction, anticipated to occur in the third quarter of 2021, the combined company will be named eFFECTOR Therapeutics, Inc. and will be led by Steve Worland, Ph.D., president and CEO. The combined company’s common stock is expected to be listed on the Nasdaq Capital Market under the ticker symbol "EFTR".

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"This milestone is the beginning of a significant new chapter in eFFECTOR’s history, as we build on our strong scientific foundation as leaders in the development of selective translation regulator inhibitors as a new class of therapies for cancer," said Dr. Worland. "We’re entering into this transaction to accelerate eFFECTOR’s growth with the goal of delivering a new class of medicines to help drive improved health outcomes for people with cancer. We are excited to be selected by the management and board of LWAC, whose members have vast experience as investors and operating executives in the biotechnology industry."

"After evaluating more than 90 biotech companies, eFFECTOR emerged as the best choice for our business combination," stated Chris Ehrlich, CEO and director of LWAC. "eFFECTOR is at the cutting-edge of targeting translation regulation, which has the potential to simultaneously address multiple drivers of cancer. We are confident that the highly experienced management team with a track record of pipeline advancement and business accomplishments are prepared to lead eFFECTOR as a publicly listed company. This transaction positions eFFECTOR to reach important value inflection points for our impressive list of stakeholders."

The transaction includes up to $175 million in trust at LWAC (less any redemptions by existing LWAC stockholders) and a concurrent, fully committed $60 million PIPE financing of common stock issued at $10.00 per share from new and existing leading healthcare investors including founding Series A investors Abingworth, SR One, The Column Group and U.S. Venture Partners, as well as Altitude Life Science Ventures, Sectoral Asset Management, Pfizer Ventures, Alexandria Venture Investments, BioMed Ventures and Osage University Partners.

Proceeds from the transaction are expected to provide eFFECTOR with the capital to further develop its pipeline, advancing it through multiple clinical milestones, including the following:

Report topline data from the randomized Phase 2b KICKSTART clinical trial of eFFECTOR’s lead product candidate, tomivorsertib, an oral small-molecule inhibitor of mitogen-activated protein kinases 1 and 2 (MNK) 1/2, in combination with pembrolizumab in metastatic non-small cell lung cancer (NSCLC), both in the frontline extension and frontline settings; this study is open for enrollment.
Initiate multiple Phase 2a expansion cohorts for zotatifin, a small-molecule inhibitor of eIF4A, in patients with breast cancer and NSCLC in the second half of 2021.
Support expansion of both tomivosertib and zotatifin into additional indications.
Key Transaction Terms

Upon the closing of the business combination, and assuming no redemptions of shares of LWAC by its public stockholders, eFFECTOR would be expected to have cash resources of approximately $210 million (less any redemptions), and a total enterprise valuation of $419 million.

The boards of directors of both eFFECTOR and LWAC have unanimously approved the proposed transaction, which is expected to be completed in the third quarter of 2021. The closing of the transaction is subject to approval of LWAC shareholders and the satisfaction or waiver of certain other customary closing conditions.

Additional information about the transaction will be provided in a Current Report on Form 8-K to be filed by LWAC with the Securities and Exchange Commission (SEC) and will be available on the SEC’s website at www.sec.gov. In addition, LWAC intends to file a registration statement on Form S-4 with the SEC, which will include a proxy statement/prospectus, and will file other documents regarding the proposed transaction with the SEC.

Advisors

Credit Suisse and Stifel are acting as lead PIPE placement agents, and Credit Suisse is also acting as capital markets advisor to eFFECTOR. Locust Walk Securities is also acting as PIPE placement agent. Latham & Watkins LLP is acting as legal counsel to eFFECTOR. Cantor Fitzgerald is acting as the lead capital markets advisor to LWAC. JMP Securities and Mizuho Securities are also acting as capital markets advisors to LWAC. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to LWAC.

Investor Webcast

The management teams of eFFECTOR and LWAC will host a webcast today, Thursday, May 27 at 9:00 a.m. ET to provide a brief overview of eFFECTOR and the proposed transaction. The webcast can be accessed here: View Source

On May 27, 2021 As interest and demand for more accurate prostate cancer imaging grows, and with the approval of the first Ga-68 PSMA based prostate imaging agent late last year1, Cardinal Health Nuclear & Precision Health Solutions (Cardinal Health) and Telix Pharmaceuticals (US) Inc. (Telix) reported that they have developed an in-depth white-paper, entitled: "Moving beyond the Myth: Meeting the growing demand for Ga-68 radiopharmaceuticals (Press release, Cardinal Health, MAY 27, 2021, View Source [SID1234580712])." The paper shines a light on the pathways for radio-isotope production, distribution and clinical application, as well as highlighting the extensive systems already in place to help ensure potential demand for Ga-68 imaging products is met.

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Despite major disruption caused by COVID-19, 2020 saw two new drug applications (NDA) and an approval by the U.S. Food and Drug Administration (FDA) for the first 68Ga- PSMA-11 product for prostate cancer imaging albeit restricted to use in two academic institutions1. Since then, interest has been building in anticipation of other gallium-based imaging options currently under review by the FDA.

"A key to satisfying the demand for this isotope lies in having a robust network of radiopharmacies like Cardinal Health," said Dr. Christian Behrenbruch, Chief Executive Officer of Telix Pharmaceuticals Limited. "There is a perception in the industry that supply chain issues may limit the availability of gallium-based radiopharmaceuticals. Whilst this may have been true historically, this is no longer the case. The strength and power of gallium lies in its flexibility, with production by either cyclotron or generator. This offers greater flexibility and opportunity for scale than other purely cyclotron-based isotopes. Subject to regulator approval, we look forward to offering state-of-the-art diagnostic imaging to U.S. men living with prostate cancer, and Cardinal Health’s radiopharmacy network and infrastructure will be vital in facilitating nationwide access."

Cardinal Health Nuclear & Precision Health Solutions offers an extensive network of over 130 pharmacies, of which more than 110 are licensed to process 68Ga. Besides distribution efficiencies, Cardinal Health’s Accutrac system tracks doses during transit from the pharmacy to the site of care, enabling a greater than 99% on-time delivery record to help ensure doses are delivered where they are needed, when they are needed. "Patient and physician satisfaction is our top priority," says Tiffany Olson, President of the Cardinal Health Nuclear & Precision Health Solutions business. "Telix Pharmaceuticals is developing gallium-based innovations to advance prostate cancer imaging, and Cardinal Health is ready to help meet that demand."

On May 27, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that Dr. Wei-Wu He, Chairman and Chief Executive Officer of CASI Pharmaceuticals, will be presenting at the Jefferies Virtual Healthcare Conference (Press release, CASI Pharmaceuticals, MAY 27, 2021, View Source [SID1234583246]). Details for the virtual conferences are as follows.

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Jefferies Virtual Healthcare Conference
Date: Friday, June 4th
Time: 9:30 AM (EST)

Webcast or external link of the company presentations will be available under "Events & Presentations" in the "Investors Relations" section of CASI’s website. Archived replays will be available for approximately 30 days following the event.