On November 3, 2020 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the third quarter of 2020 and associated Company developments (Press release, Supernus, NOV 3, 2020, View Source [SID1234569769]).

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"During the first nine months of 2020, we delivered strong product sales growth, diversified our revenue base and enhanced our long term growth with two corporate transactions" said Jack Khattar, President and CEO of Supernus. "Our employees have been hard at work in anticipation of the launch of SPN-812. Based on the efficacy and safety demonstrated in its clinical program, SPN-812 can potentially offer an important new option in the treatment of ADHD."

Commercial Update

Third quarter 2020 net product sales were $152.1 million, 52% higher than the same period in 2019, driven by the addition of $40.9 million of net product sales from the acquired commercial products and $11.2 million in net product sales growth from Trokendi XR and Oxtellar XR.

Product Pipeline Update

SPN-812 – Novel non-stimulant for the treatment of ADHD in children and adults

The Company continues to prepare for the commercial launch of SPN-812, which is expected in January 2021, if approved by the FDA. The New Drug Application (NDA) Prescription Drug User Fee Act (PDUFA) target action date is November 8, 2020.
The Company completed enrollment in the SPN-812 Phase III trial in adult patients with ADHD. Topline data from the trial is expected in the first quarter of 2021.
SPN-830 (Apomorphine infusion pump) – Continuous treatment of motor fluctuations ("on-off" episodes) in PD

NDA was submitted to the U.S. Food and Drug Administration (FDA) in September 2020 for the continuous treatment of "on-off" episodes in adults with Parkinson’s disease (PD) whose motor control is unsatisfactory with oral levodopa and at least one other noninvasive PD therapy.
The Company expects to launch SPN-830 in the fourth quarter of 2021, if approved by the FDA.
SPN-820 – Novel first-in-class activator of mTORC1

Preclinical and development activities are ongoing, with the goal of initiating a Phase II clinical program in treatment-resistant depression by the end of 2021.
Operating Expenses

Research and development (R&D) expenses in the third quarter of 2020 were $16.8 million, essentially unchanged from $16.9 million in the same quarter last year.

Selling, general and administrative (SG&A) expenses in the third quarter of 2020 were $54.7 million, compared to $39.3 million in the same quarter last year. This increase was primarily due to costs associated with the new CNS portfolio of commercial products acquired from US WorldMeds (USWM Acquisition) in the second quarter of 2020 and our ongoing preparations for the potential launch of SPN-812.

Amortization expense of intangible assets in the third quarter of 2020 were $6.1 million, compared to $1.3 million in the same quarter last year. This increase results from the USWM Acquisition.

Operating Earnings and Earnings Per Share

Operating earnings (GAAP) in the third quarter of 2020 were $56.1 million, compared to $39.7 million in the third quarter of 2019. Net earnings (GAAP) in the third quarter of 2020 were $40.0 million, or $0.74 per diluted share, as compared to $28.9 million, or $0.54 per diluted share, in the same period last year.

Balance Sheet Highlights

As of September 30, 2020, the Company had $740.1 million in cash, cash equivalents, marketable securities and long term marketable securities, compared to $938.8 million at December 31, 2019. During the first nine months of 2020, the Company generated $107.5 million of cash from operations, inclusive of net changes in working capital. The Company made cash payments of approximately $300 million for acquisition of the CNS portfolio of US WorldMeds and $25 million paid to Navitor upon executing the development and option agreement for SPN-820.

Financial Guidance

The Company is revising full year 2020 financial guidance, which consists of the following components, inclusive of the impact of acquiring the CNS portfolio of US WorldMeds as of June 9, 2020:

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer and the executive management team to discuss these results at 9:00 a.m. Eastern Time, on Wednesday, November 4, 2020.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

On November 3, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported its results for the quarter ended September 30, 2020 (Press release, Corcept Therapeutics, NOV 3, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-third-quarter-2020-financial [SID1234569766]).

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Financial Highlights

Revenue of $86.3 million, a 6 percent increase from third quarter 2019
GAAP diluted net income of $0.17 per share, compared to $0.22 per share in third quarter 2019
Non-GAAP diluted net income of $0.24 per share, compared to $0.31 per share in third quarter 2019
Cash and investments of $444.2 million, compared to $409.6 million at June 30, 2020
Announcement of $200 million stock repurchase program
2020 revenue guidance narrowed to $355 – 365 million
Revenue was $86.3 million in the third quarter, compared to $81.5 million in the third quarter of 2019. Third quarter GAAP net income was $21.6 million, compared to $26.3 million in the same period last year. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the third quarter was $30.0 million, compared to $37.8 million in the third quarter of 2019. A reconciliation of GAAP to non-GAAP net income is included below.

Corcept narrowed its 2020 revenue guidance range to $355 – 365 million. The company’s initial guidance, announced in January 2020, was $355 – 375 million.

Third quarter operating expenses were $61.6 million, compared to $48.5 million in the third quarter of 2019, primarily due to increased spending on clinical trials in Cushing’s syndrome, antipsychotic-induced weight gain and solid tumors, and on the formulation and manufacture the company’s proprietary selective cortisol modulators.

Cash and investments were $444.2 million at September 30, 2020, an increase of $34.7 million from June 30, 2020.

The company announced a program to repurchase up to $200 million of its common stock, funded using cash and investments. Details of the program are provided below.

"While pandemic-related public health restrictions and related changes in physician and patient practices dampened our third quarter commercial results," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer, "we have built a remarkably stable and profitable business. After Covid-19 is brought under control, we expect our growth to resume.

"Meanwhile, the breadth of our clinical development program continues to increase. We are now evaluating our proprietary, selective cortisol modulators in patients with Cushing’s syndrome, four different types of solid tumors, antipsychotic-induced weight gain (APIWG) and – starting this month – nonalcoholic steatohepatitis (NASH). The pandemic’s effect on these trials has varied," added Dr. Belanoff. "Studies of illnesses which are acutely life-threatening, including advanced ovarian and pancreatic cancer have recruited briskly. Studies of illnesses that are not perceived as immediately dire – such as antipsychotic-induced weight gain – have lagged."

Cushing’s Syndrome

Phase 3 GRACE trial of relacorilant in patients with any etiology of Cushing’s syndrome continues at sites in the United States, Canada, Europe and Israel; NDA submission planned for second quarter 2022
Enrollment begun in Phase 3 GRADIENT trial of relacorilant in patients with Cushing’s syndrome of adrenal origin continues, with sites planned in the United States, Europe and Israel
"We are evaluating our proprietary selective cortisol modulator relacorilant as a treatment for Cushing’s syndrome in two double-blind, placebo-controlled Phase 3 trials," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "GRACE has a planned enrollment of 130 patients with any type of Cushing’s syndrome. GRADIENT has a planned enrollment of 130 patients with Cushing’s syndrome caused by adrenal adenomas – an etiology of hypercortisolism where medical treatment has not been rigorously studied. While recruitment in both trials has slowed due to the pandemic, our investigators are enthusiastic. We plan to submit an NDA based on results from the GRACE trial in the second quarter of 2022."

Solid Tumors

Enrollment complete in 178-patient, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with metastatic ovarian cancer; results expected in first half 2021
Enrollment continues in 80-patient, open-label Phase 3 RELIANT trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer; results in first 40 patients expected in first half 2021
Selection of optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer expected in first quarter 2021
Initiation of 20-patient, open-label, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess
"Our oncology program is evaluating three mechanisms by which cortisol modulators may benefit patients with solid tumors," said Dr. Grauer. "Our Phase 2 trial in patients with metastatic ovarian cancer and our Phase 3 trial in patients with metastatic pancreatic cancer are evaluating whether relacorilant can enhance the efficacy of nab-paclitaxel by reducing cortisol’s suppression of apoptosis – the programmed cell death chemotherapy is meant to promote. We expect results from both of these trials in the first half of next year.

"In the first quarter of 2021, we expect to select a dosing regimen for our selective cortisol modulator exicorilant to advance as a treatment for castration-resistant prostate cancer. Androgen deprivation therapy is the standard treatment for this disease. However, with time, many tumors treated with androgen deprivation therapy switch to cortisol stimulation as the pathway to growth. Our hypothesis, which is well-supported in pre-clinical models, is that a regimen that combines an androgen receptor antagonist such as enzalutamide with a cortisol modulator will close off this tumor escape route.

"Finally, our recently initiated Phase 1b trial of relacorilant combined with pembrolizumab is testing whether co-administrating a cortisol modulator can help immunotherapy achieve its intended effect by reducing cortisol-activated immune suppression."

Metabolic Diseases

Enrollment begun in GRATITUDE II, a 150-patient, double-blind, placebo-controlled Phase 2 trial of miricorilant to reverse long-standing APIWG
Enrollment continues in GRATITUDE, a double-blind, placebo-controlled, Phase 2 trial of miricorilant to reverse recent APIWG
Double-blind, placebo-controlled Phase 2 trial of miricorilant in patients with NASH starting this month
"In the third quarter, we opened GRATITUDE II, the second Phase 2 trial of our selective cortisol modulator miricorilant in patients with antipsychotic-induced weight gain – a life-threatening disorder experienced by many of the millions of patients who take antipsychotic medications," said Dr. Grauer. "GRATITUDE II is enrolling patients with long-standing weight gain. Its sister trial, GRATITUDE is enrolling patients with recent weight gain.

"These trials follow promising pre-clinical and clinical data. For example, in the Phase 1b trial we completed earlier this year, healthy volunteers given miricorilant plus olanzapine gained less weight and had lower triglycerides and less sharply elevated liver enzymes than those who received olanzapine plus placebo after only two weeks of dosing.

"Finally, we plan to begin evaluating miricorilant as a potential treatment for liver disease. Extensive pre-clinical data suggests miricorilant may benefit patients with NASH, a serious liver disorder that affects millions of patients," added Dr. Grauer. "We are on-track to open a double-blind, placebo-controlled trial of miricorilant in patients with NASH by year-end."

Conference Call

We will hold a conference call on November 3, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, click this link 15 minutes prior to the scheduled start time or dial 1-888-204-4368 from the United States or 1-313-209-4906 internationally (passcode 9018217). A replay will be available through November 17, 2020 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally
(passcode 9018217).

About Corcept’s Stock Repurchase Program

Our Board of Directors has approved a program authorizing the repurchase of up to $200 million of the company’s common stock through September 30, 2021. Purchases under this program may be made in the open market, in privately negotiated transactions or otherwise. The timing and amount of any repurchases will be determined based on market conditions, stock price and other factors. The program does not require the company to repurchase any specific number of shares of its common stock and may be modified, suspended or discontinued at any time without notice.

On November 3, 2020 Acorda Therapeutics, Inc. (NASDAQ:ACOR) reported its financial results for the third quarter ended September 30, 2020 (Press release, Acorda Therapeutics, NOV 3, 2020, View Source [SID1234569765]).

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"We are encouraged by the 24% increase in INBRIJA net sales over the second quarter, even with the challenges posed by the second wave of COVID-19. We are also pleased that coverage for INBRIJA continued to increase during the quarter, with over 96% of commercially-insured patients now having access to it," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "In addition, AMPYRA’s performance and the milestone payment we received for FAMPYRA have further strengthened our financial position. We are also continuing our work to reduce operating costs and monetize excess capacity at our Chelsea facility, to help drive long-term value for all shareholders."

Third Quarter 2020 Financial Results
For the quarter ended September 30, 2020, the Company reported INBRIJA net revenue of $5.8 million, compared to $4.9 million for the same quarter in 2019.

For the quarter ended September 30, 2020, the Company reported AMPYRA net revenue of $27.3 million compared to $39.3 million for the same quarter in 2019. As previously announced, AMPYRA lost its exclusivity in September 2018.

Research and development (R&D) expenses for the quarter ended September 30, 2020 were $5.7 million, including $0.6 million of share-based compensation compared to $16.1 million, including $0.7 million of share-based compensation for the same quarter in 2019.

Sales, general, and administrative (SG&A) expenses for the quarter ended September 30, 2020 were $39.9 million, including $1.8 million in share-based compensation compared to $48.7 million, including $2.4 million in share-based compensation for the same quarter in 2019.

The Company received a $15 million milestone payment from Biogen International GmbH under its license and collaboration agreement with Biogen, based on Biogen’s ex-U.S. net sales of FAMPYRA exceeding $100 million over the four consecutive quarters ending with the third quarter of 2020. The Company will retain approximately $14 million of the milestone payment net of the Company’s payment obligations to another party.

Change in fair value of derivative liability for the quarter ended September 30, 2020 was $4.9 million.

Provision for income taxes for the quarter ended September 30, 2020 was $1.5 million compared to a provision for income taxes of $0.02 million for the same quarter in 2019.

The Company reported GAAP net income of $7.3 million for the quarter ended September 30, 2020, or $.05 per diluted share. GAAP net loss in the same quarter of 2019 was $263.5 million, or $5.55 per diluted share.

Non-GAAP net loss for the quarter ended September 30, 2020 was $10.9 million, or $0.23 per diluted share. Non-GAAP net loss in the same quarter of 2019 was $21.9 million, or $0.46 per diluted share. This quarterly non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, changes in the fair value of the derivative liability and asset impairment charges. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At September 30, 2020, the Company had cash, cash equivalents, short-term investments and restricted cash of $101 million compared to $253 million at September 30, 2019. Restricted cash includes $37 million in escrow related to the 6% semi-annual interest portion of the convertible note exchange completed in December 2019. If the Company is permitted under the terms of the notes and elects to pay interest due in stock, the restricted cash will be released from escrow.

For full-year 2020, Acorda continues to expect AMPYRA net revenue to be $85 – $110 million, and operating expenses to be $170 – $180 million. The operating expense guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation as more fully described below under "Non-GAAP Financial Measures."

Webcast and Conference Call
The Company will host a conference call today at 4:30 p.m. ET. To participate in the Webcast/Conference call, please note there is a new pre-registration process.

To register for the Webcast, use the link below:
View Source
To register for the Conference Call, use the link below:
View Source
**When registering please type your phone number with no special characters**.
A replay of the call will be available from 8:30 p.m. ET on November 3, 2020 until 11:59 p.m. ET on December 3, 2020. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 4177747. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Non-GAAP Financial Measures
This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net loss, adjusted to exclude the items below, and has provided 2020 operating expense guidance on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes the presentation of non-GAAP net loss, when viewed in conjunction with our GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our outstanding convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the FAMPYRA monetization, and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iv) asset impairment charges that are not routine to the operation of the business, (v) changes in the fair value of the derivative liability which is a non-cash charge and not related to the operation of the business, and (vi) expenses that pertain to a non-routine restructuring event. The Company believes its non-GAAP net loss measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

In addition to non-GAAP net loss, we have provided 2020 operating expense guidance on a non-GAAP basis, as the guidance excludes restructuring costs and share-based compensation charges. Due to the forward-looking nature of this information, the amount of compensation charges needed to reconcile these measures to the most directly comparable GAAP financial measures is dependent on future changes in the market price of our common stock and is not available at this time. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of this non-GAAP financial measure, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because it excludes (i) expenses that pertain to a non-routine restructuring, and (ii) non-cash charges that are substantially dependent on changes in the market price of our common stock. We believe this non-GAAP financial measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding expected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

On November 3, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it is scheduled to speak at the Credit Suisse 29th Annual Virtual Healthcare Conference (Press release, Quest Diagnostics, NOV 3, 2020, View Source [SID1234569764]). Steve Rusckowski, Chairman, President & CEO will discuss the company’s vision, goals and two-point strategy to accelerate growth and drive operational excellence, and the company’s current perspective on the impact of the COVID-19 pandemic. The presentation is scheduled for Tuesday, November 10, 2020 at 11:45 a.m. Eastern Time.

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The presentation will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. In addition, the archived webcast will be available within 48 hours after the conclusion of the live event and will remain available until December 10, 2020.

On November 3, 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 third quarter ended September 30, 2020 (Press release, GW Pharmaceuticals, NOV 3, 2020, View Source [SID1234569763]).

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"We are pleased to report strong revenue growth in the 3rd quarter despite the challenges presented by COVID-19. Epidiolex meets a serious unmet need within the field of epilepsy and we expect the product to demonstrate continued strong growth in the months and years ahead. The recent expanded indication for the treatment of seizures associated with TSC has been very well received by patients, clinicians and payers," stated Justin Gover, GW’s Chief Executive Officer. "We have also now commenced the pivotal Phase 3 program for nabiximols in the treatment of multiple sclerosis spasticity, which provides multiple opportunities for an NDA submission, including as early as next year. Beyond nabiximols, we are advancing several clinical-stage pipeline candidates, including the recent start of a Phase 2 trial in schizophrenia."

FINANCIAL RESULTS

Total revenue for the quarter ended September 30, 2020 was $137.1 million compared to $91.0 million for the quarter ended September 30, 2019
Total revenue for the first nine months of 2020 of $378.6 million compared to $202.3 million in the prior year period
Net loss for the quarter ended September 30, 2020 was $12.2 million compared to net loss of $13.8 million for the quarter ended September 30, 2019
Cash and cash equivalents at September 30, 2020 were $480.3 million
OPERATIONAL HIGHLIGHTS

Epidiolex (cannabidiol) progress:
Total Q3 net product sales of Epidiolex of $132.6 million
U.S. commercial update
U.S. Epidiolex Q3 net product sales of $121.6 million
TSC indication launched with high prescriber awareness and near universal payer coverage
Expanded payer coverage
85 million lives with no/broad prior authorization (+47% year-to-date)
Ex-U.S. commercial update
Ex-U.S. Epidyolex Q3 net product sales of $11.0 million
UK pricing and reimbursement in place. Progress in Germany, France, Italy and Spain
TSC EMA submission under review
Epidyolex approved in Australia
Strengthening commercial exclusivity
Orphan exclusivity in both the U.S. and EU
13 patents listed in Orange Book, 12 of which expire in 2035
Patents include formulation and method of use
Epidiolex composition patent application in process
Two further Orange Book listable patents to be allowed or granted by Q1 2021
Nabiximols development program:
First Phase 3 MS Spasticity trial underway
Phase 3 placebo-controlled spasm frequency study (N=450)
MS Spasticity trials due to commence
Phase 3 placebo-controlled muscle tone studies:
N=52; Expected start Q4 2020 (subject to COVID)
N=190; Expected start: Q1 2021
N=36 (nabiximols responders); Expected start: Q1 2021
Additional Phase 3 placebo-controlled spasm frequency study (N=200) in nabiximols responders expected start Q2 2021
Spinal Cord Injury (SCI) spasticity clinical program
N=~100 (observational clinical discovery study); Expected start: Q1 2021
N=~160 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: 2021
N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: 2021
Additional pipeline programs:
Schizophrenia (GWP42003)
Phase 2b trial now actively recruiting
Autism:
CBD formulation Phase 2 study expected to commence in Q1 2021
CBDV investigator-led 100 patient placebo-controlled trial in autism – recruitment now resumed
New botanical cannabinoid pipeline product (GW541)
Phase 1 trial underway
Potential targets within field of neuropsychiatry
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 8:30 am EST. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada) or 201-689-8040 (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: 38272.