Altimmune To Announce Third Quarter 2020 Financial Results On November 10

On November 3, 2020 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that it will release its third quarter 2020 financial results on Tuesday, November 10, 2020 (Press release, Altimmune, NOV 3, 2020, View Source [SID1234569777]).

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Altimmune management will host a conference call for investors beginning at 8:30 a.m. ET on Tuesday, November 10, 2020 to discuss the financial results and provide a business update.

Affimed to Report 3rd Quarter 2020 Financial Results & Corporate Update November 10, 2020

On November 3, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that it will release third quarter 2020 results on Tuesday, November 10, 2020 and host a conference call at 8:30 a.m. ET to discuss financial results and corporate developments (Press release, Affimed, NOV 3, 2020, View Source [SID1234569776]).

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The conference call will be available via phone and webcast. To access the call, please dial +1-646-741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference conference ID 9847055 approximately 15 minutes prior to the call.

To access the live audio webcast of the conference call please visit the "Investors" section of the company’s website at View Source A replay of the call will be archived on the Affimed website for 30 days after the call.

Massive Bio Secures Additional $2.6 Million Financing Round Led by Revo Capital and Tops its Total Raise to $6.6 Million

On November 3, 2020 Massive Bio, Inc., a leader in precision medicine and artificial intelligence (AI) enabled patient centric clinical trial enrollment, reported a $2.6 million round of funding led by Revo Capital with additional participation from Cavendish Impact Foundation (CIF), through their donor advised fund at ImpactAssets (Press release, Massive Bio, NOV 3, 2020, View Source [SID1234569774]). The investment brings Massive Bio’s total funding since launch to $6.6 million and will enable the biotechnology company to scale to meet the demand in the U.S. and overseas for its oncology clinical trial recruitment platform solutions. The financing round builds on an exceptional year for Massive Bio which saw a rapidly growing roster of clients across the pharmaceutical company and contract research organization (CRO) industry globally, and exponential demand which was further accelerated by COVID-19.

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Massive Bio Co-founder and CEO Selin Kurnaz stated, "Since our foundation in 2015, Massive Bio has experienced impressive growth, relying mostly on revenue generated by customer demand to fuel its growth. However, due to an additional layer of growth at rapid pace that we have been experiencing in 2020, we have partnered with very hard working and passionate investors, Revo Capital and CIF, to execute our vision even more rapidly and broadly. I could not be prouder of our team and success, and this is our time to expand globally." Massive Bio has focused on improving patient enrollment for oncology clinical trials since the company was founded in 2015. Approximately 3%-5% of cancer patients participate in clinical trials and enrollment rates have decreased further since the COVID-19 pandemic. Dr. Kurnaz added, "As an industry we are just scratching the surface of how powerful digital health technology and value-added services can be when combined with the massive scale offered by the global research portfolio ecosystem".

"Amid the COVID-19 pandemic and beyond, the clinical trial industry needs a digital health technology solution to assist in study enrollment now more than ever," said Cenk Bayrakdar, Revo Capital’s Managing Director. "Massive Bio has a unique solution that was purpose-built to address the challenges associated with clinical trial recruitment challenges, which aligned with their patient-centric approach makes it a powerful solution for the industry, and we are excited to collaborate with and support them as they work to transform their ideas into a world-changing company."

"At CIF, we are committed to being long-term partners and supporters of the companies in which we invest. We have been impressed with Massive Bio because of their innovative approach to a significant problem in cancer care equality – helping to enroll as many patients as possible in clinical trials, which can potentially be life saving for patients who may have few other options," said Rachel Butler, President and Board Co-Chair of the Cavendish Impact Foundation. "Selin and the Massive Bio team have built an impressive business and expansive list of clients, and we look forward to supporting the team as they build the company into the premier global oncology trial recruitment platform."

Supernus Announces Third Quarter 2020 Financial Results

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.

Corcept Therapeutics Announces Third Quarter 2020 Financial Results and Provides Corporate Update

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.