On June 1, 2020 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported that the company has entered into a debt financing agreement with Hercules Capital, Inc. (NYSE: HTGC) for up to $100 million (Press release, G1 Therapeutics, JUN 1, 2020, View Source [SID1234560748]). G1 plans to use the proceeds to fund commercialization and further development of trilaciclib, its first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy.

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!

"We expect to file a New Drug Application for trilaciclib later this month for myelopreservation in small cell lung cancer. This financing strengthens our balance sheet as we prepare for commercial launch in our first indication and to execute a robust development plan to evaluate trilaciclib in additional tumor types," said Mark Velleca, M.D., Ph.D., Chief Executive Officer.

The $100 million credit facility from Hercules is available in four tranches: the first tranche of $30 million is available at loan closing, of which the company plans to utilize $20 million immediately, with the remaining $10 million available through March 31, 2021; the second tranche of $20 million will be available upon achievement of U.S. Food and Drug Administration approval of trilaciclib in small cell lung cancer and initiation of a registrational trial in metastatic colorectal cancer, to be available from January 1, 2021 through December 15, 2021; an additional tranche of $30 million will be available from April 1, 2021 through December 31, 2022, subject to certain terms and conditions, including in connection with net product revenues for trilaciclib; and a final tranche of $20 million will be available prior to December 31, 2022 to support strategic initiatives, subject to future approvals by Hercules.

The term loan has a 24-month interest only period from date of closing, extendible up to 42 months upon achievement of certain conditions. Maturity of the loan is 48 months from date of closing, extendible up to 60 months upon achievement of certain milestones.

"This structured investment represents a significant commitment from Hercules and provides an example of the breadth of our platform and our ability to finance life sciences companies through all stages of development. We are excited to begin our partnership with the G1 management team as they advance the New Drug Application for trilaciclib and prepare for a commercial launch," said Bryan Jadot, Senior Managing Director and Life Sciences Group Head for Hercules.

Armentum Partners acted as the company’s sole financial adviser in connection with the loan facility.

On June 1, 2020 Nanjing Legend Biotech reported that it has set a proposed range of $18-$20 per ADS for the offering, which would raise $350 million and value Legend at $2.6 billion (Press release, Legend Biotech, JUN 1, 2020, View Source [SID1234560746]). In 2017, Legend surprised the world when its anti-BCMA CAR-T therapy produced a 94% overall response rate in pretreated multiple myeloma patients. Six months later, Janssen Pharma paid $350 million upfront to partner the candidate. Janssen has added another $110 million in milestones so far, and it could make up to $1.3 billion in remaining payments.

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!

On June 1, 2020 Cancer Research UK reported that Around 2.4 million people in the UK are waiting for cancer screening, further tests or cancer treatment (Press release, Cancer Research UK, JUN 1, 2020, View Source [SID1234560745]).*

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!

"Delays to diagnosis and treatment could mean that some cancers will become inoperable. Patients shouldn’t need to wait for this to be over before getting the treatment they need." – Professor Charles Swanton
COVID-19 has caused enormous disruption to cancer services across the UK, including delays to cancer treatment, screening and diagnosis, and huge decreases in patients being urgently referred to hospital with suspected cancer symptoms.**

Delays to cancer screening have had the biggest impact on the total number, with a backlog of around 2.1 million people left waiting for breast, bowel or cervical screening. During this time, 3,800 cancers would normally be diagnosed through screening.

Urgent cancer referrals, often known as the two week wait, have been severely impacted with up to 290,000 people missing out on further testing, which would normally catch up to 20,300 cancers in the same time period.

There will also be a backlog of treatment to catch up on, with up to 12,750 fewer patients receiving surgery, 6,000 fewer for chemotherapy and 2,800 fewer receiving radiotherapy since lockdown began.***

‘COVID-protected’ safe spaces will be a crucial part of addressing the growing backlog and ensuring more people can safely receive treatment or be diagnosed quickly.

But this will only be possible if all cancer patients and healthcare staff – whether symptomatic or asymptomatic – are tested regularly for COVID-19.

Cancer Research UK has estimated that to test patients ahead of hospital appointments and cancer staff weekly, between 21,000 and 37,000 COVID-19 tests must be done each day across the UK. This means that doctors and nurses can care for their patients in a safe, ‘COVID-protected’ environment.****

A clear national plan for testing is needed to support the effective recovery and restoration of cancer services.

Michelle Mitchell, Cancer Research UK’s chief executive, said: "The enormous strain COVID-19 has placed on cancer services is of great concern to us. The NHS has had to make very hard decisions to balance risk, and there have been some difficult discussions with patients about their safety and ability to continue treatment during this time. But we’re over the peak of the pandemic now, and cancer care is starting to get up and running again as ‘COVID-protected’ spaces are being set up.

"To get cancer services back to normal levels while ensuring no one is put at risk, frequent testing of NHS staff and patients, including those without symptoms, is vital. We now need clear national leadership and guidance for the NHS to dramatically increase testing levels. At the moment, we don’t know who is responsible for making cancer services safe and it’s patients who are suffering in the meantime. The Government must work closely with the NHS to ramp up testing provision with rapid results, as quickly as possible once practical.

"Prompt diagnosis and treatment remain crucial to give people with cancer the greatest chances of survival and prevent the pandemic taking even more lives."

Professor Charles Swanton, Cancer Research UK’s chief clinician, said: "My colleagues and I have seen the devastating impact this pandemic has had on both patients and NHS staff. Delays to diagnosis and treatment could mean that some cancers will become inoperable. Patients shouldn’t need to wait for this to be over before getting the treatment they need.

"We can create a safer environment for both staff and cancer patients if testing efforts ramp up quickly with test results delivered back within 24 hours or less. We know that carrying COVID-19 while asymptomatic or pre-symptomatic is a major concern where healthcare worker staff and patients can transmit infection.

"We need at least weekly testing of healthcare workers and elective admissions to protect patients and staff from future spread and hospital-related complications. Staff in hospitals around the country are working extremely hard and with more testing of staff and patients – with and without symptoms – we will have hospitals and centres protected from COVID-19 where patients can be treated safely."

Paul Soderquist, 66 from Enfield, London was diagnosed with both lung and prostate cancer in 2019. He had surgery for lung cancer in February but his radiotherapy for prostate cancer has been put on hold due to COVID-19.

Paul said: "I was in the unusual position of getting two diagnoses within a few weeks and I count my blessings that I had my lung surgery earlier this year. I’m still being treated for prostate cancer, but it’s non-aggressive and I’ve been assured I will recover. I was due to have radiotherapy, but it’s been postponed until September because of the virus, although I’m still having injections to inhibit testosterone.

"I understand the reasons for the delay, and I know I’m in a queue, but things feel uncertain. My CT scan for both cancers in May has been put on hold too. So, I hope that there aren’t any problems because of that delay."

On June 1, 2020 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the first quarter ended March 31, 2020, and provided a business update on recent corporate and clinical developments (Press release, Protalix, JUN 1, 2020, View Source [SID1234560744]). The Company’s management will discuss the financial results and provide a clinical, corporate and financial highlights on a conference call and live webcast scheduled for Monday, June 1, 2020 at 8:30 am Eastern Daylight Time (EDT).

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 first quarter of 2020 has most certainly been transformational for Protalix, despite the COVID-19 pandemic that affected the global markets," said Dror Bashan, Protalix’s President and Chief Executive Officer. "I am proud to say that despite the pandemic, Protalix was able to keep the company running smoothly and adapt quickly to the changing environment."

"During the quarter, we were able to close a $43.7 million private placement," he continued. "Furthermore, the topline results from the completion of our Phase III BRIDGE study and the subsequent BLA submission for PRX–102 announced in May prove that Protalix has actually gained momentum by leaning into this unprecedented challenge. I am convinced now more than ever that our team is positioned for long-term success and look forward to continuing our momentum through the rest of this year and into 2021."

Conference Call and Webcast Information

The Company will host a conference call on Monday, June 1, 2020, at 8:30 am, Eastern Daylight Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

First Quarter 2020 and Recent Business Highlights

Clinical and Regulatory Advancements

On May 28, 2020, the Company and its development and collaboration partner, Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A., or Chiesi, announced the submission on May 27, 2020 of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa, or PRX–102, for the treatment of adult patients with Fabry disease via the FDA’s Accelerated Approval pathway. PRX–102 was granted Fast Track designation by the FDA in January 2018. Upon the BLA approval, if approved, the Company will be eligible to receive a milestone payment from Chiesi.
On May 11, 2020, the Company announced positive topline results following the completion of its Phase III BRIDGE clinical trial of PRX–102 for the treatment of Fabry disease. The Phase III BRIDGE clinical trial, a 12-month open-label, single arm switch-over study evaluating the safety and efficacy of PRX–102, 1 mg/kg infused every two weeks, met its main objectives for safety and efficacy, and topline analysis indicated substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in patients switched from agalsidase alfa to PRX–102.
On February 6, 2020, Protalix and Chiesi announced the receipt of an agreement letter from the FDA for the Initial Pediatric Study Plan (iPSP) for PRX-102 for the treatment of Fabry disease, outlining an agreed-upon approach to address the needs of pediatric Fabry patients.
Corporate & Financial Developments

On March 16, 2020, the Company announced that it has agreed to conduct a feasibility study with Kirin Holdings Company, Limited, or Kirin, to evaluate the production of a novel complex protein utilizing ProCellEx. The Company received a non-refundable payment of $1.0 million and Kirin will provide research funding for the Company’s scientists to conduct cell line engineering and protein expression studies on the target protein.
On March 12, 2020, the Company entered into securities purchase agreements with certain existing and new institutional and other accredited investors in a private placement. Pursuant to such agreements, the Company issued and sold to the purchasers an aggregate of approximately 17.6 million unregistered shares of its common stock at a price per share of $2.485, or aggregate net committed proceeds equal to approximately $41.3 million. Each share of the Company’s common stock issued in the transaction was accompanied by a warrant to purchase an additional share of common stock at an exercise price equal to $2.36.
Financial Results

For the three months ended March 31, 2020, compared to the three months ended March 31, 2019

The Company recorded revenues from selling goods of $5.0 million during the three months ended March 31, 2020, an increase of $1.5 million, or 43%, compared to revenues of $3.5 million for the same period of 2019. The increase resulted primarily from an increase of $0.8 million in sales of drug product to Brazil as well as an increase of $0.7 million in sales of drug substance to Pfizer Inc.
Revenues from license and R&D services for the three months ended March 31, 2020, were $16.6 million, an increase of $9.7 million, or 140%, compared to revenues of $6.9 million for the same period of 2019. Revenues from the license agreements represent the revenues recognized in connection with previously announced agreements with Chiesi. The increase is primarily due to revenues recognized in connection with the progress of the Company’s clinical trial that have been performed, and with revenues recognized in connection with an updated costs estimation throughout the trials until completion in the amount of $6.7 million.
Cost of goods sold was $3.4 million for the three months ended March 31, 2020, an increase of $1.4 million, or 68%, from cost of goods sold of $2.0 million for the same period of 2019. The increase is primarily due to an increase in sales of goods.
Research and development expenses were $10.3 million for the three months ended March 31, 2020, a decrease of $1.4 million, or 12%, compared to $11.7 million of research and development expenses for the same period of 2019. The decrease was primarily due to a decrease in costs related to manufacturing of our drug in development.
Selling, general and administrative expenses were $3.2 million for the three months ended March 31, 2020, an increase of $1.0 million, or 43%, compared to $2.2 million for the same period of 2019. The increase resulted primarily from a $0.6 million increase in compensation related costs and a $0.2 million increase in professional fees.
Net income for the three months ended March 31, 2020 was $1.7 million, or $0.10 per share, basic and diluted, compared to a net loss of $7.3 million, or $0.50 per share, basic and diluted, for the same period of 2019.

On June 1, 2020 Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ( European Medicines Agency, EMA) issued a favorable opinion that recommended the market for the HLX02 biosimilar (trastuzumab injection) for the treatment of early HER-2-positive breast cancer, HER2-positive metastatic breast cancer and previously untreated HER-2-positive metastatic cancer Contains adenocarcinomas of the stomach or the transition area of ​​the esophagus into the stomach (Press release, Shanghai Henlius Biotech, JUN 1, 2020, View Source;816056005.html [SID1234560743]). According to the EMA-CHMP summary of this positive opinion, HLX02 is the reference product Herceptin (Trastuzumab) very similar. Data show that HLX02 is comparable to Herceptin in terms of quality, safety and effectiveness .

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!

HLX02 is a monoclonal biosimilar antibody (mAb) developed and manufactured by Henlius in accordance with biosimilar guidelines and will be marketed and marketed by Accord in Europe. The CHMP’s opinion is now being reviewed by the European Commission. A regulatory decision is expected over the next two to three months. As soon as a license is granted , a centralized marketing authorization is granted for all EU member states, Iceland, Norway and Liechtenstein .

Dr. Scott Liu , co-founder and CEO of Henlius , commented: "We are proud of CHMP’s favorable opinion on Henlius, as is the fact that Henlius’ capabilities in developing and manufacturing biological products are recognized by an international drug agency. We look forward to the launch of HLX02 as an alternative, high quality and affordable treatment option for patients with HER-2 positive breast cancer and gastric cancer. We will continue to work with Accord, make HLX02 more available in Europe and other regions, and continue to strive to support patients around the world. "

Dr. James Burt , Executive Vice President of Accord Europe and MENA added: "We are committed to providing oncology patients with access to safe, inexpensive drugs. The CHMP’s positive opinion is due to our in-depth expertise and our extensive portfolio of oncological therapies. Our agreement with Henlius reflects our longstanding commitment to biopharmaceutical development, research and manufacturing. "