On October 28, 2020 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the third quarter ended September 30, 2020 (Press release, Vanda Pharmaceuticals, OCT 28, 2020, View Source [SID1234569263]).

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"Vanda continued to deliver strong commercial performance in the third quarter, despite the ongoing COVID-19 pandemic, while at the same time we advanced our robust clinical development pipeline," said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO.

Key Financial and Corporate Highlights

Third Quarter of 2020

Total net product sales from HETLIOZ and Fanapt were $60.3 million in the third quarter of 2020, a 1% increase compared to $59.5 million in the third quarter of 2019.
HETLIOZ net product sales were $39.6 million in the third quarter of 2020, a 5% increase compared to $37.6 million in the third quarter of 2019.
Fanapt net product sales were $20.7 million in the third quarter of 2020, a 6% decrease compared to $21.9 million in the third quarter of 2019.
Income before taxes was $8.4 million in the third quarter of 2020 compared to $12.3 million in the third quarter of 2019.
First Nine Months of 2020

Total net product sales from HETLIOZ and Fanapt were $180.5 million in the first nine months of 2020, a 9% increase compared to $166.3 million in the same period in 2019.
HETLIOZ net product sales were $116.5 million in the first nine months of 2020, a 12% increase compared to $104.4 million in the same period in 2019.
Fanapt net product sales were $64.0 million in the first nine months of 2020, a 3% increase compared to $61.9 million in the same period in 2019.
Income before taxes was $20.7 million in the first nine months of 2020 compared to $23.2 million in the same period in 2019.
Cash, cash equivalents and marketable securities (Cash) were $348.5 million as of September 30, 2020, representing an increase to Cash of $48.9 million compared to September 30, 2019.
Key Product and Pipeline Highlights

Products

Vanda is encouraged by the strength of its commercial performance during the third quarter of 2020 despite the COVID-19 pandemic. Vanda continues to implement marketing and sales strategies aimed at supporting continued growth and minimizing the impact of disruptions caused by the COVID-19 pandemic, including the Fanapt for schizophrenia direct-to-consumer campaign, which was launched at the end of the second quarter of 2020.

Pipeline

The COVID-19 pandemic has impacted clinical research globally, including some of Vanda’s previously reported clinical trials. The tradipitant gastroparesis program has resumed patient enrollment, while randomization for the tradipitant motion sickness and atopic dermatitis programs, as well as the Fanapt bipolar disorder and long acting injectable studies, is currently on hold.

Tradipitant

The gastroparesis Phase III clinical study (VP-VLY-686-3301) is ongoing. The study reached 50% enrollment towards a target of 200 randomized patients and is expected to complete enrollment in the first half of 2021 with a New Drug Application (NDA) filing projected for later that year.
Interim analysis from the Phase III clinical study (ODYSSEY VLY-686-3501) shows that tradipitant may accelerate clinical improvement in patients with COVID-19 pneumonia.1 Vanda continues to recruit patients for this study.
HETLIOZ (tasimelteon)

The Smith-Magenis Syndrome (SMS) marketing authorization applications were accepted by the U.S. Food and Drug Administration (FDA) for priority review with a Prescription Drug User Fee Act (PDUFA-VI) target action date of December 1, 2020.2
VSJ-110 (previously known as CFTRact-K267)

The Investigational New Drug (IND) application to evaluate Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activator VSJ-110 for the treatment of allergic conjunctivitis was approved by the FDA.3
Key Publications

The article "Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study" was published in the September 2020 issue of Frontiers in Neurology.4
GAAP Financial Results

Income before taxes was $8.4 million in the third quarter of 2020 compared to $12.3 million in the third quarter of 2019. Net income was $5.9 million in the third quarter of 2020, compared to net income of $100.4 million in the third quarter of 2019. Diluted net income per share was $0.11 in the third quarter of 2020, compared to diluted net income per share of $1.84 in the third quarter of 2019.

Income before taxes was $20.7 million in the first nine months of 2020 compared to $23.2 million in the same period in 2019. Net income was $15.1 million in the first nine months of 2020, compared to net income of $111.3 million in the same period in 2019. Diluted net income per share was $0.28 in the first nine months of 2020, compared to diluted net income per share of $2.03 in the same period in 2019.

The income tax benefit of $88.1 million reflected in the financial results for both the third quarter of 2019 and the first nine months of 2019 includes the favorable impact of the release of Vanda’s deferred tax asset valuation allowance.

2020 Financial Guidance

Vanda will continue to assess the impact of the evolving pandemic on its business and operations and will provide future updates to its financial guidance as necessary. The financial guidance previously communicated by Vanda is shown below.

Conference Call

Vanda has scheduled a conference call for today, Wednesday, October 28, 2020, at 4:30 PM ET. During the call, Vanda’s management will discuss the third quarter 2020 financial results and other corporate activities. Investors can call 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode number 8971955. A replay of the call will be available on Wednesday, October 28, 2020, beginning at 7:30 PM ET and will be accessible until Wednesday, November 4, 2020 at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 8971955.

The conference call will be broadcast simultaneously on Vanda’s website, www.vandapharma.com. Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.

On October 28, 2020 Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, reported financial results for the third quarter ended September 30, 2020 (Press release, Penumbra, OCT 28, 2020, View Source [SID1234569262]).

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Revenue of $151.1 million in the third quarter of 2020, an increase of 8.3%, or 7.7% in constant currency1, compared to the third quarter of 2019. US revenue of $109.7 million was approximately 22% above the same period a year ago.
Third Quarter 2020 Financial Results
Total revenue increased to $151.1 million for the third quarter of 2020 compared to $139.5 million for the third quarter of 2019, an increase of 8.3%, or 7.7% on a constant currency basis. The United States represented 73% of total revenue and international represented 27% of total revenue for the third quarter of 2020. Revenue from sales of vascular products grew to $75.2 million for the third quarter of 2020, an increase of 33.6%. US vascular revenue increased 43.5%, while international vascular revenue declined 8.6% compared to the third quarter of 2019. Revenue from sales of neuro products declined to $75.9 million for the third quarter of 2020, a decrease of 8.8%. US neuro revenue and international neuro revenue declined 1.0% and 17.9%, respectively, compared to the third quarter of 2019.

Gross profit was $90.9 million, or 60.2% of total revenue, for the third quarter of 2020, compared to $96.0 million, or 68.8% of total revenue, for the third quarter of 2019.

Total operating expenses for the third quarter of 2020 were $111.1 million, or 73.5% of total revenue. In the third quarter of 2020, total operating expenses include $20.7 million of one-time, non-recurring personnel-related expenses associated with the launch of our Lightning product. Excluding the one-time, non-recurring personnel-related expenses associated with the launch of our Lightning product, total adjusted operating expenses1 (a non-GAAP measure) were $90.4 million, or 59.9% of total revenue, for the third quarter of 2020. This compares to total operating expenses of $83.0 million, or 59.5% of total revenue, for the third quarter of 2019. R&D expenses were $34.9 million for the third quarter of 2020, compared to $13.7 million for the third quarter of 2019. SG&A expenses were $76.2 million for the third quarter of 2020, compared to $69.3 million for the third quarter of 2019.

Operating loss for the third quarter of 2020 was $20.2 million. Excluding the one-time, non-recurring personnel-related expenses associated with the launch of our Lightning product, total adjusted operating income1 (a non-GAAP measure) was $0.5 million for the third quarter of 2020. This compares to an operating income of $13.0 million for the third quarter of 2019.

Impact of COVID-19 Pandemic
While we have continued to see some positive trends in certain areas of our business beginning in May, we remain mindful of the negative impacts on business trends we experienced in April due to the COVID-19 outbreak. The Company has experienced and believes that the impact of the COVID-19 pandemic on the Company’s business differs by geography and procedure type. Due to the uncertain scope and duration of the pandemic, the global resurgence of cases, and uncertain timing of global recovery and economic normalization, we still cannot reliably estimate the future impact of the pandemic. Further, we think the on-going impact of the pandemic in the United States and other parts of the world could cause periodic disruption in our revenue until the pandemic is contained.

Webcast and Conference Call Information
Penumbra, Inc. will host a conference call to discuss the third quarter 2020 financial results after market close on Wednesday, October 28, 2020 at 4:30 PM Eastern Time. The conference call can be accessed live over the phone by dialing (833) 350-1434 for domestic and international callers (conference id: 3538526), or the webcast can be accessed on the "Events" section under the "Investors" tab of the Company’s website at: www.penumbrainc.com. The webcast will be available on the Company’s website for at least two weeks following the completion of the call.

On October 28, 2020 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical device technology company focused on developing products to diagnose and treat life and organ threatening diseases, reported financial results for its second quarter ended September 30, 2020 and provided an update on recent developments (Press release, Aethlon Medical, OCT 28, 2020, View Source [SID1234569261]).

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Company Updates

Aethlon Medical, Inc. (Company or Aethlon) is continuing the development of its proprietary Hemopurifier, which is a first in class therapeutic device designed for the single use depletion of cancer-promoting exosomes and circulating viruses. The Hemopurifier has previously been designated a Breakthrough Device by the FDA for the treatment of glycosylated viruses, including Ebola and other hemorrhagic fever viruses, and in late 2018 was additionally designated as a Breakthrough Device "…for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease….".

Aethlon has initiated its first clinical trial in patients with advanced and metastatic cancers. Under an Investigational Device Exemption (IDE) application approved by FDA in October 2019 this trial, termed an Early Feasibility Study (EFS – the device equivalent of a phase 1 study), in patients with advanced and/or metastatic head and neck cancer is being run at the UPMC Hillman Cancer Center in Pittsburgh, PA and has been approved by the UPMC Institutional Review Board (IRB) and is now open for enrollment. The EFS is designed to enroll 10-12 subjects and will investigate the combination of the Hemopurifier with standard of care pembrolizumab (Keytruda) in the front line setting.

As previously disclosed, the FDA has also approved an amendment to the Company’s open IDE for the Hemopurifier in life threatening viral infections, to allow for the treatment of patients with SARS-CoV-2/COVID-19 infection. This will allow for up to 40 of these patients to be treated under a New Feasibility Study protocol at up to 20 clinical sites in the U.S. The first sites for this trial have received IRB approval and the Company is currently recruiting additional sites. The Company has also recently treated one patient under an emergency use single patient pathway that allows for the use of an investigational product in patients who have essentially failed other treatment options. This patient successfully received eight Hemopurifier treatments of six hours each over nine days.

Financial Results for the Second Quarter Ended September 30, 2020

At September 30, 2020, we had a cash balance of approximately $14.5 million.

Consolidated operating expenses for the three months ended September 30, 2020 were approximately $1.77 million, compared to approximately $1.70 million for the three months ended September 30, 2019. This increase of approximately $70,000, or 4.1%, in the 2020 period was due to a an increase in general and administrative expenses of approximately $212,000, which was partially offset by a decreases in professional fees of approximately $106,000 and in payroll and related expenses of approximately $37,000.

The $212,000 increase in general and administrative expenses was primarily due to a $143,000 increase in lab supplies in connection with our ongoing effort to continue to build an inventory of Hemopurifiers for our clinical trials, and to a $54,000 increase in our clinical trial expenses.

The $106,000 decrease in our professional fees was primarily due to a $94,000 decrease in our legal fees and a $60,000 decrease in our accounting fees, which were partially offset by a $38,000 increase in scientific consulting expenses.

The $37,000 decrease in payroll and related expenses was due to the combination of a $159,000 reduction in stock-based compensation expense and a $122,000 increase in our cash-based compensation expense. The cash-based compensation increase was in turn due to additions to our headcount and to salary increases.

There was no other expense during the three months ended September 30, 2020. In the three months ended September 30, 2019, other expense primarily consisted of approximately $4,000 of losses on share for warrant exchanges.

As a result of the changes in revenues and expenses noted above, our net loss before noncontrolling interests increased to approximately $1.77 million for the three months ended September 30, 2020, from approximately $1.71 million for the three months ended September 30, 2019.

The unaudited condensed consolidated balance sheet for September 30, 2020 and the unaudited condensed consolidated statements of operations for the three and six month periods ended September 30, 2020 and 2019 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Wednesday, October 28, 2020 at 4:30 p.m. Eastern Time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source

Please note that registered participants will receive their dial in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:
PARTICIPANT DIAL IN (TOLL FREE): 1-844-836-8741
PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through November 4, 2020. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 10149369.

On October 28, 2020 Nektar Therapeutics (Nasdaq: NKTR) reported that it will announce its financial results for the third quarter 2020 on Thursday, November 5, 2020, after the close of U.S.-based financial markets. Howard Robin, President and Chief Executive Officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time (Press release, Nektar Therapeutics, OCT 28, 2020, View Source [SID1234569260]).

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The press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Tuesday, December 1, 2020.

On October 28, 2020 Asieris Pharmaceuticals, a China-based biotech company specializing in the development and commercialization of new drugs for the treatment of genitourinary tumors and related diseases, reported that Australian regulatory authorities have approved its Phase I clinical trial of APL-1501 (Press release, Asieris Pharmaceuticals, OCT 28, 2020, View Source [SID1234569258]). The objective of this Phase I study is to evaluate the safety, tolerability, and pharmacokinetic (PK) characteristics of APL-1501.

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APL-1501, which is independently developed by the Prodrug Accurate Drug Delivery (PADD) platform of Asieris, is an oral sustained-release product based on APL-1202 and will be the second generation product of APL-1202 to support new clinical development globally. APL-1501 inherits the unique oral administration of APL-1202 and the druggability of APL-1501 is improved by the design of prodrug molecules. Based on these, APL-1501 can improve patient compliance by reducing medication frequency, combined with the sustained-release technology which can contribute to controlled drug release and lengthen the drug plasma exposure time. APL-1501 has better pharmacokinetic (PK) characteristics so that this product is expected to not only treat bladder cancer, but also for other diseases such as prostate cancer, urinary tract infection, etc. Since APL-1501 is a product developed by Asieris independently, a comprehensive global intellectual property rights strategy has been developed to provide strong support for product life cycle managment and global expansion.

APL-1202 is being developed as a new drug of Asieris for the treatment of non-muscle invasive bladder cancer (NMIBC). It is the first oral and reversible methionine aminopeptidase II type (MetAP2) inhibitor currently under Phase III clinical development in the world. APL-1202 finished patient enrollment in pivotal registration trial in China in 2019. APL-1202 also completed the Phase I clinical trial in the US. Currently, the standard treatment of NMIBC is a Trans-Urethral Resection of Bladder Tumor (TURBT). Because of a high tumor recurrence rate after TURBT, intravesical chemo- or immune-therapies are required after the procedure. At present, choice of second-line treatment for relapsed patients is very limited. A radical cystectomy is the standard treatment for recurring high-risk NMIBC patients. No oral drugs have been approved for NMIBC to date.

"The approval of APL-1501 clinical trial in Australia is another important milestone on the journey of Asieris’ international clinical development", commented Dr. Kevin Pan, founder and CEO of Asieris. "As the second generation product of APL-1202, APL-1501 will bring better treatment choice to patients and reduce the pain and adverse reactions. Asieris will continue to adhere to the vision of ‘We strive for healthy and dignified lives’. We hope the innovative products will benefit more patients globally soon."

About APL-1501 and APL-1202

APL-1501 is developed by Asieris from its PADD technology platform as the second generation product of APL-1202, which has better pharmacokinetic characteristics. Besides the treatment of NMIBC, the product is expected to enter more therapeutic fields for clinical development, such as prostate cancer, urinary tract infection, etc.

APL-1202 is being developed as a new drug of Asieris for the treatment of non-muscle invasive bladder cancer (NMIBC) and is the first oral and reversible methionine aminopeptidase II type (MetAP2) inhibitor currently under Phase III clinical development in the world. In preclinical studies, APL-1202 has demonstrated both anti-angiogenic and anti-tumor activities as well as a potential synergistic effect with anti-BCG or epirubicin. APL-1202 is currently under clinical investigation for multiple indications. The treatment regimen with APL-1202 is convenient and well-tolerated, without causing pain or injury to the urethra, and may help some high-risk patients avoid radical cystectomy.