On May 27, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its participation at three upcoming virtual investor conferences (Press release, TG Therapeutics, MAY 27, 2021, View Source [SID1234580694]). Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, is scheduled to participate in the following:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Jefferies Virtual Healthcare Conference: Fireside chat scheduled to take place on Tuesday, June 1, 2021, at 2:00 PM ET
Goldman Sachs 42nd Annual Global Healthcare Conference: Fireside chat scheduled to take place on Tuesday, June 8, 2021, at 1:20 PM ET
Raymond James Human Health Innovation Conference: Presentation scheduled to take place on Tuesday, June 22, 2021, at 10:00 AM ET
A live webcast of each presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source Following each event, an archive file will be available for thirty days.

On May 27, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported that Chris Martin, Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021, at 8:30 a.m. ET (Press release, ADC Therapeutics, MAY 27, 2021, View Source [SID1234580711]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days.

On May 27, 2021 enGene Inc., a clinical-stage biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, reported the dosing of the first patient in the LEGEND study, a first-in-human Phase 1/2 clinical trial of EG-70 in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) (Press release, enGene, MAY 27, 2021, View Source [SID1234583245]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Based on enGene’s DDX platform, EG-70 is a non-viral gene therapy encoding two RIG-I agonists to stimulate the innate immune system, and IL-12 to stimulate the adaptive immune system. By stimulating both arms of the immune system, intravesically administered EG-70 yields remarkable tumor regression in preclinical models of bladder cancer, with induction of effective immunological memory and minimal signs of toxicity.

"Initiating our first clinical study of EG-70 is an important milestone for enGene, validating the potential of our platform to develop novel therapeutics towards clinically meaningful outcomes," said Jason Hanson, Chief Executive Officer at enGene. "This is the first time a non-viral gene therapy directly activating both innate and adaptive immunity is being evaluated as an anti-tumor agent in humans, and we are excited about the outcome of this trial towards positively impacting the lives of patients battling difficult-to-treat cancers."

"Patients with BCG-unresponsive high risk NMIBC have limited treatment options other than radical cystectomy which is associated with significant morbidity and quality of life alterations. Based on our understanding of high grade bladder cancer, the mechanism of BCG resistance/relapse, and the EG-70 mechanism of action, I strongly believe that this novel intravesical therapy has the potential, with few side effects, to make a meaningful difference for patients," said Dr. Gary Steinberg, Professor and Director at the Perlmutter Cancer Center Goldstein Urology Bladder Cancer Program of NYU Langone Health, and lead Principal Investigator for the EG-70 Phase 1/2 study.

The LEGEND study, both first-in-human and first-in-class, is an open-label, monotherapy, multi-center, dose-escalation trial evaluating safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of EG-70 administered by intravesical instillation. To learn more about the first-in-human clinical trial of EG-70 in BCG-unresponsive NMIBC, please visit ClinicalTrials.gov.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."