On October 28, 2020 Gracell Biotechnologies Inc. ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported it has secured $100 million in Series C funding (Press release, Gracell Biotechnologies, OCT 28, 2020, View Source [SID1234569266]). The round is led by Wellington Management Company, OrbiMed and Morningside Ventures, and joined by new investor Vivo Capital. Existing investors Temasek Holdings, Lilly Asia Ventures, OrbiMed and King Star Med LP are also participating.

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"We are very pleased to expand our investor base with support from a high caliber consortium," said Dr. William Wei Cao, founder, Chairman, and CEO of Gracell, "Our passion is to bring transformative CAR-T cell therapies to a broader group of patients by developing products that are efficacious and can be made widely available."

Gracell was founded in 2017 with the mission to overcome the major industry challenges that persist for both autologous and allogeneic CAR-T cell therapy approaches. Gracell has developed two pioneering platforms—FasTCAR and TruUCAR. With FasTCAR, Gracell is able to deliver younger, less exhausted T cells for autologous cell therapies with greater potency and next-day manufacturing (22 to 36 hours). With TruUCAR, Gracell is able to derive T cells from non-HLA-matched healthy donors to generate allogeneic CAR-T cell therapies that are readily available off-the-shelf at lower cost for a broad patient base.

Leveraging its FasTCAR and TruUCAR platforms, Gracell is developing a pipeline of autologous and allogeneic cell therapy candidates with the potential to treat both hematologic malignancies and solid tumors. Currently, Gracell’s lead FasTCAR autologous product candidate, GC012F, is being studied in an ongoing investigator-initiated Phase 1 trial in China for the treatment of relapsed or refractory multiple myeloma (r/r MM). Its lead TruUCAR allogeneic product candidate, GC027, is being studied in an ongoing investigator-initiated Phase 1 trial in China for the treatment of relapsed or refractory T cell acute lymphoblastic leukemia (r/r T-ALL).

Proceeds from the round will be used to fund internal research and development and further advance current clinical programs. Jefferies and Cooley advised in the transaction.

On October 28, 2020 Safeguard Scientifics, Inc. (NYSE:SFE) reported that it will release its financial results for the third quarter ended September 30, 2020 prior to market open on Thursday, November 5, 2020 (Press release, Safeguard Scientifics, OCT 28, 2020, View Source [SID1234569265]).

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CONFERENCE CALL AND WEBCAST DETAILS
Please call 10-15 minutes prior to the call to register.

Date: Thursday, November 5, 2020

Time: 9:00 am ET

Webcast: www.safeguard.com/events

Live Number: 833-968-2224 // (International) 825-312-2064

Replay Number: 800-585-8367 // (International) 416-621-4642

Access Code: 9581004

Speakers: Executive Chairman of the Board, Dr. Robert J. Rosenthal; Chief Restructuring Officer, Eric C. Salzman; and Senior Vice President and Chief Financial Officer, Mark A. Herndon

Format: Discussion of third quarter 2020 financial results followed by Q&A

Replay will be available through December 5, 2020 at 11:59 pm ET. For more information please contact [email protected].

On October 28, 2020 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) reported the pricing of an underwritten public offering of 80,000,000 units at a price of $0.10 per unit (Press release, Titan Pharmaceuticals, OCT 28, 2020, View Source [SID1234569264]). Each unit issued in the offering consists of one share of common stock and one warrant to purchase one share of common stock. Gross proceeds, before underwriting discounts and commissions and estimated offering expenses, are expected to be $8.0 million.

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The warrants will have an exercise price of $0.10, will be exercisable commencing on the effective date of an increase in our authorized shares of common stock or a reverse split in an amount sufficient to permit the exercise in full of the warrants and will expire on the fifth anniversary of the initial exercise date. The shares of common stock and the accompanying warrants are immediately separable from the units, and can only be purchased together in the offering. The offering is expected to close on or about October 30, 2020.

Maxim Group LLC is acting as the sole book-running manager for the offering.

The Securities and Exchange Commission (the "SEC") declared effective a registration statement on Form S-1 (File No. 333-249550) relating to these securities on October 28, 2020. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source The offering is being made only by means of a prospectus forming part of the effective registration statement. Electronic copies of the prospectus relating to this offering, when available, may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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.