On August 6, 2020 GW Pharmaceuticals plc (Nasdaq: GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, reported financial results and operating progress for the second quarter ended June 30, 2020 (Press release, GW Pharmaceuticals, AUG 6, 2020, View Source [SID1234568621]).

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"We were pleased with the strength of U.S. Epidiolex sales in the second quarter in spite of the COVID-19 pandemic. Further, the recent approval and imminent launch of Epidiolex for the treatment of seizures associated with TSC provides a meaningful new opportunity to accelerate momentum through the second half of 2020 and beyond," stated Justin Gover, GW’s CEO. "We also continue to be excited about the potential of our product pipeline, in particular nabiximols, for which we recently outlined our accelerated US development strategy in the treatment of spasticity in patients with MS and other conditions. We look forward to commencing the nabiximols Phase 3 program as well as multiple other pipeline clinical trials in the second half of the year."

FINANCIAL RESULTS

Total revenue for the quarter ended June 30, 2020 was $121.3 million compared to $72.0 million for the quarter ended June 30, 2019
Net loss for the quarter ended June 30, 2020 was $8.8 million compared to net income of $79.7 million for the quarter ended June 30, 2019. The prior year quarter included net proceeds of $104.1 million from the sale of a Rare Pediatric Priority Review Voucher.
Cash and cash equivalents at June 30, 2020 were $477.6 million
OPERATIONAL HIGHLIGHTS

Epidiolex (cannabidiol) progress:
Total Q2 net product sales of Epidiolex of $117.7 million
U.S. commercial update
U.S. Epidiolex Q2 net product sales of $111.1 million
TSC indication approved by FDA, August commercial launch planned
TSC payer reimbursement anticipated quickly following launch
European commercial update
Ex-U.S. Epidyolex Q2 net product sales of $6.6 million
Pricing & reimbursement progress in Germany, France and Italy
TSC EMA submission under review
Clinical progress with additional indications
Phase 3 trial in Rett Syndrome expected to re-commence in H2 2020
Strengthening commercial exclusivity
Orphan exclusivity in both the U.S. and EU
3 new patents granted and listed in Orange Book, bringing total of 13 patents listed in Orange Book, 12 of which expire in 2035
One recent patent listed is a non-use patent directed to the oral formulation
Epidiolex composition patent application in process
TSC patent applications under review
Nabiximols
MS Spasticity Clinical program
Three positive Phase 3 MS spasticity trials already completed outside of the U.S.
Five new MS Spasticity Phase 3 trials expected to commence in H2 2020 (2) and H1 2021 (3), any one of which could enable a NDA submission
Phase 3 muscle tone studies – placebo-controlled cross-over design
N=52; Expected start: Q4 2020
N=190; Expected start: Q1 2021
N=36 (nabiximols responders); Expected start: Q1 2021
Phase 3 spasm frequency studies – placebo-controlled parallel group
N=450; Expected start: Q4 2020
N=~200 (nabiximols responders); Expected start: Q2 2021
Spinal Cord Injury (SCI) spasticity clinical program
Three SCI trials expected to be initiated in 2020 and 2021
N=~100 (observational clinical discovery study); Expected start: Q4 2020
N=~100 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: Q2 2021
N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: H2 2021
Post-Traumatic Stress Disorder (PTSD) clinical program
Phase 2/3 study in PTSD (N=~ 325); Expected start: H1 2021
Additional pipeline programs
Schizophrenia (GWP42003)
Phase 2b trial expected to commence H2 2020
CBDV in autism trials expected to recommence in H2 2020
30-patient open label study in autism
Investigator-led 100 patient placebo-controlled trial in autism
Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
Phase 1b safety study in patients continues to recruit
Orphan Drug and Fast Track Designations granted from FDA and EMA
Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast today at 4:30 pm EDT. To participate in the conference call, please dial 833-937-1050 (toll free from the U.S. and Canada) or 845-403-8302 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company’s website at View Source A replay of the call will also be available through the GW website shortly after the call and will remain available for 90 days. Replay Numbers: (toll free):1-877-481-4010 or 919-882-2331 (international). For both dial-in numbers please use conference Replay ID: 35770.

On August 6, 2020 ChromaDex Corp. (NASDAQ:CDXC) reported second quarter 2020 financial results (Press release, ChromaDex, AUG 6, 2020, View Source [SID1234568251]).

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"We achieved record net sales of $15.3 million in the second quarter while maintaining our focus on the science, announcing our 200th research agreement and tenth published human trial on Niagen," says ChromaDex CEO Rob Fried. "Business adjustments at the onset of the pandemic and continued marketing efficiencies allowed us to reach a financial goal of positive Adjusted EBITDA excluding total legal expenses."

Results of operations for the three months ended June 30, 2020

For the three months ended June 30, 2020 ("Q2 2020"), ChromaDex reported net sales of $15.3 million, up 38% compared to $11.1 million in the second quarter of 2019 ("Q2 2019"). The increase in Q2 2020 revenues was driven by growth in sales of Tru Niagen and Niagen ingredient revenues.

Gross margin increased by 310 basis points to 59.4% in Q2 2020 compared to 56.3% in Q2 2019. The increase in gross margin was largely driven by the positive impact of increased Tru Niagen consumer product sales and product cost saving initiatives, including a benefit of approximately 110 basis points related to savings from prior year initiatives that were recognized in Q2 2020.

Operating expenses decreased by $0.7 million to $12.8 million in Q2 2020, compared to $13.4 million in Q2 2019. The decrease in operating expenses was driven by a decrease of $1.1 million in general and administrative expense, and a decrease of $0.1 million of research and development expense, partially offset by $0.7 million of higher selling and marketing expense. The decrease in general and administrative expense was driven by $1.1 million of lower legal expenses.

The net loss for Q2 2020 was ($3.7) million or ($0.06) per share compared to a net loss of ($7.8) million or ($0.14) per share for Q2 2019.

Adjusted EBITDA excluding total legal expense, a non-GAAP measure, was a profit of $0.5 million for Q2 2020, compared to a loss of ($2.1) million for Q2 2020, a $2.6 million improvement.

ChromaDex defines Adjusted EBITDA excluding total legal expense as net income or (loss) which is adjusted for interest, income tax, depreciation, amortization, non-cash stock compensation costs, severance and restructuring expense, bad debt expense related to Elysium Health and total legal expense.

For Q2 2020, the net cash used in operating activities was ($1.6) million versus ($9.0) million in Q2 2019.

2020 Outlook

Looking forward, the impact of COVID-19 on revenues is difficult to predict and the Company is managing expenses to mitigate the bottom-line impact. The Company does not expect any supply chain disruption at this time and, based on trends-to-date, expects continued revenue growth this year. Based on the Company’s current financial outlook, revenue growth will be driven by its U.S. ecommerce business, new international market launches with its partners and distributors, such as in the U.K. and Australia, new online platforms, including Persona Nutrition, a Nestlé Health Science company, and the Company’s new product, Tru Niagen Beauty. The Company expects continued gross margin improvement driven by a higher mix of Tru Niagen sales, product design changes implemented in late 2019, and additional supply chain cost savings initiatives in 2020. The Company expects lower selling, marketing and advertising as well as general and administrative expenses as a percentage of net sales driven by strong growth from returning customers and scale on our fixed overhead costs driven by organizational realignment initiatives, as well as new systems and processes.

Investor Conference Call

ChromaDex management will host an investor conference call to discuss the first quarter results and provide a general business update on Thursday, August 6, at 4:30pm ET.

Participants should call in at least 10 minutes prior to the call. The dial-in information is as follows:

Date: Thurs., August 6, 2020
Time: 4:30 p.m. Eastern time (1:30 p.m. Pacific time)
Toll-free dial-in number: (833) 979-2703

International dial-in number: (236) 714-2223
Conference ID: 1563949
Webcast link: ChromaDex Second Quarter 2020 Earnings Conference Call

The conference call will be broadcast live and available for replay here and via the investor relations section of the Company’s website at www.chromadex.com.

A replay of the conference call will be available after 7:30 p.m. ET.

Toll-free replay number: 800-585-8367
Replay ID: 1563949

The earnings press release, and its accompanying financial exhibits, will be available on the Investor Relations section of the Company website, www.chromadex.com.

On August 6, 2020 ISA reported that it will present at the 6th Solebury Trout Summer 2020 Private Company Showcase, hosted by Piper Sandler and White & Case. You are welcome to tune in (Press release, ISA Pharmaceuticals, AUG 6, 2020, View Source [SID1234565550]).

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Date: Monday, 10 August 2020

Time: 5:00pm CET / 11:00am EDT.

Webcast: View Source

You may access the stream 15 minutes in advance and a replay of the webcast will be available for 60 days.

On August 6, 2020 ImmVira Group Company and Shanghai Pharmaceuticals Holding Co., Ltd reported a clinical collaboration and exclusive license agreement for ImmVira’s MVR-T3011 intratumoral oncolytic virus program for the commercialization of novel immunotherapies to treat solid malignant tumors (Press release, Immvira, AUG 6, 2020, View Source [SID1234563687]).

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ImmVira’s MVR-T3011 oncolytic virus program has innovated with a genetically engineered oncolytic herpes simplex virus-1 (oHSV-1) to enhance the known oncolytic effects of oHSV-1. Through gene recombinant technologies, PD-1 antibody and interleukin-12 immune modulators are expressed within the virus. Oncolysis is achieved with additional immune response stimulation while keeping the boosted immune activity limited to the locality of MVR-T3011 to achieve a potentially favorable safety profile. The MVR-T3011 intratumoral program aims to target most solid malignant tumors with both remission rate improvement and safety improvement over immune modulator monotherapies. As part of the agreement, Shanghai Pharma will receive an exclusive license and gain access to ImmVira’s MVR-T3011 virus for clinical development, manufacturing and commercialization within certain fields of use in mainland China, Hong Kong, Macau and Taiwan (the Greater China region). ImmVira and Shanghai Pharma will collaborate on clinical trials in China with exclusive commercial rights for intratumoral therapies developed under the agreement assigned to Shanghai Pharma for the Greater China region. ImmVira retains full development and commercialization rights for regions outside of Greater China.

Under the terms of the agreement, ImmVira will receive from Shanghai Pharma an upfront payment and contingent milestone payments that would in the aggregate amount to RMB1.15 billion, as well as royalty payments of up to 12% of net revenues should Shanghai Pharma successfully commercialize a therapy from the collaboration.

"As we continue to lead in oncolytic virus research and development, we are delighted to collaborate with Shanghai Pharma on our first product pipeline," said Grace Zhou, chairman and chief executive officer of ImmVira. "This partnership represents an exceptional opportunity to leverage Shanghai Pharma’s leadership in immunotherapy research, clinical stage expertise, manufacture and countrywide distribution network. With a strong partner like Shanghai Pharma, we are more confident in the commercial success of MVR-T3011 and achieve our goal in engineering more effective yet safer remedies for cancer patients."

"ImmVira is a leader in providing best-in-class oncolytic virotherapy treatments for patients in need. We are pleased to collaborate with ImmVira and have MVR-T3011 intratumoral program join our market leading commercial pipeline. The MVR-T3011 design is a breakthrough novel approach to cancer treatment over monotherapies," said Zuo Min, Executive Director and President of Shanghai Pharma. "In-line with our dedication to providing innovative, safe and effective drugs against serious and chronic diseases, MVR-T3011 represents a sound scientific approach to cancer treatment. We are confident in its eventual commercial success not only as a first-in-class product but also a best-in-class product."

CTI BioPharma has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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