On November 12, 2020 CNS Pharmaceuticals, Inc. (the "Company") Presented the Corporate Presentation (Presentation, CNS Pharmaceuticals, NOV 12, 2020, View Source [SID1234570788]).

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On November 12, 2020 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the "Company") reported that members of the senior management team will participate in a fireside chat during the 2020 Jefferies Virtual London Healthcare Conference on November 19, 2020 at 11:25 a.m. ET (Press release, Aurinia Pharmaceuticals, NOV 12, 2020, View Source [SID1234570787]).

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In order to participate in the audio webcast, interested parties can register and access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

On November 12, 2020 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune / inflammatory diseases, reported financial results for the third quarter ended September 30, 2020 (Press release, Alpine Immune Sciences, NOV 12, 2020, View Source [SID1234570786]).

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"Over the last quarter, we built upon the strong momentum created from our option and license agreement with AbbVie for worldwide rights to ALPN-101, by completing an additional private financing with top-tier biotech investors led by Omega Funds, among others," said Mitch Gold, executive chair and chief executive officer. "These transformative deals have provided us the capital to continue progressing our multiple product candidates through clinical trials."

Third Quarter 2020 and Subsequent Updates

Raised $60 Million in a Private Placement. In July, Alpine raised $60 million in gross proceeds through a private placement led by Omega Funds with participation from Avidity Partners, EcoR1 Capital, LLC, Invus Public Equities, L.P., and Samsara BioCapital, among others. Alpine intends to use the net proceeds to fund the development of its clinical and preclinical pipeline as well as for general corporate purposes.
Preparation for a Phase 2 study of ALPN-101 in systemic lupus erythematosus (SLE). Alpine and AbbVie have agreed on the design of an international Phase 2 study of ALPN-101 in adults with active lupus, anticipated to commence enrollment in the first half of 2021. SLE is a potentially life-threatening, multi-system, chronic autoimmune disease with few approved treatment options. As previously announced, ALPN-101 is the subject of an option and licensing agreement with AbbVie.
Continued enrollment in NEON-1, a Phase 1 study of ALPN-202 in advanced malignancies. Enrollment is ongoing in the dose escalation portion of NEON-1, a Phase 1, first-in-human monotherapy study of ALPN-202, a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor.
Financial Highlights

As of September 30, 2020, Alpine had cash, cash equivalents, restricted cash, and short-term investments totaling $141.3 million.
Revenue was $1.9 million for the quarter ended September 30, 2020 compared to $0.3 million in the quarter ended September 30, 2019.
Research and development expenses for the third quarter ended September 30, 2020 were $6.2 million compared to $9.5 million for the third quarter ended September 30, 2019.
General and administrative expenses for the third quarter ended September 30, 2020 were $2.7 million compared to $2.5 million for the third quarter ended September 30, 2019.
Alpine recorded a net loss of $6.1 million and $11.5 million for the third quarters ended September 30, 2020 and 2019, respectively.
As of September 30, 2020, Alpine had $141.3 million in cash, cash equivalents, restricted cash, and short-term investments. Alpine expects that its current cash resources, combined with the potential $75 million in pre-option exercise milestones payable under its option and license agreement with AbbVie, for the development and commercialization of ALPN-101, are sufficient to fund Alpine’s planned operations into 2024, including a planned Phase 2 study of ALPN-101 in systemic lupus erythematosus and the further development of ALPN-202 and ALPN-303.

For additional information regarding Alpine’s planned operations, please refer to "Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operation – Liquidity and Capital Resources" in Alpine’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which Alpine anticipates filing with the Securities and Exchange Commission on or about November 12, 2020.

Conference Call

Individuals interested in listening to the conference call may do so by dialing (800) 816-3005 for domestic callers, or (857) 770-0069 for international callers, and using the conference ID: 4382628; or from the webcast link in the investor relations section of the company’s website at: www.alpineimmunesciences.com. The recorded webcast will be available for replay for approximately 30 days following the call.

On November 12, 2020 Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported financial results for the third quarter of 2020 and provided a corporate update, including updates on its oral COVID-19 vaccine pre-clinical studies and clinical trials (Press release, Aviragen Therapeutics, NOV 12, 2020, View Source [SID1234570785]).

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"To defeat the COVID-19 epidemic, we need not only effective vaccines, but effective vaccines that are easy to administer, store, and distribute. We need a practical global solution," said Andrei Floroiu, chief executive officer of Vaxart. "The strong pre-clinical data we generated and the clinical progress we have made strengthen our belief that our oral tablet COVID-19 vaccine will emerge as a global solution against the COVID-19 pandemic."

VXA-CoV2-1 is a single-dose COVID-19 tablet vaccine candidate that we believe can be conveniently distributed and administered without the need for cold-chain storage and distribution.

Unlike injectable vaccines, animal data indicate that VXA-CoV2-1 activates both systemic and mucosal immunity, a broader immune response that has the potential to offer superior protection against SARS-CoV-2. By leveraging over a decade’s worth of work building Vaxart’s platform technology, VXA-CoV2-1 is under investigation to assess its ability to provide durable immunity following a single dose with favorable tolerability.

Recent Business Highlights:

Pre-Clinical and Clinical Developments:

Completed enrollment in the Company’s Phase 1 study of VXA-CoV2-1, its oral tablet COVID-19 vaccine candidate.
Reported COVID-19 Hamster Challenge Study data showing protection against COVID-19 in hamsters receiving two oral doses of Vaxart’s oral vaccine. Animals were protected against systemic weight loss, lung weight gain, showed a 4-5 log reduction in lung viral load, and developed IgG titers above 10,000. Both oral and intranasal delivery of VXA-CoV2-1 (rAd-S-N) conferred similar protection against intranasal viral challenge on all these metrics.
Posted Preclinical studies of a recombinant adenoviral mucosal vaccine to prevent SARS-CoV-2 infection to Biorxiv, which noted immunization with the vaccine candidate induced strong IgA response in the lungs of animals, indicative of a mucosal immune response.
Restarted its Norovirus vaccine program with a booster study in subjects that were primed in the previously conducted Phase 1b Norovirus trial.
Manufacturing:

Expanded collaboration with Kindred Biosciences for the manufacturing of our COVID-19 oral vaccine. Kindred’s California plant will be responsible for scaling the COVID-19 clinical trial material into mid-size bioreactors and the Kansas plant will be responsible for manufacturing at 2000L scale in its single use bioreactors.
Entered into a master services agreement with Attwill Vascular Technologies, LP for processing, lyophilizing, and tableting compounds for the Company’s oral COVID-19 vaccine.
Corporate Developments:

Addition to the Board of Directors: In August, Vaxart appointed Karen J. Wilson to its Board of Directors. Ms. Wilson is a biopharmaceutical finance executive and board member with more than 30 years of industry and leadership experience in life sciences companies with relevant knowledge in finance, strategy, and risk management. She is a certified public accountant and holds a bachelor’s degree in business from the University of California, Berkeley.

Financial Results for the Fiscal Period Ended September 30, 2020

Vaxart reported a net loss of $8.1 million for the third quarter of 2020 compared to $5.3 million for the third quarter of 2019. The increase was mainly due to an increase in operating expenses. Net loss per share for the third quarter was $0.08 in 2020 compared to $0.32 in 2019, in part due to an increase in the number of shares outstanding.
Vaxart ended the quarter with cash and cash equivalents of $133.4 million compared to $44.4 million as of June 30, 2020. The increase was primarily due to net proceeds of $97.0 million for the issuance of common stock, partially offset by $9.3 million of cash used in operations.
Revenue for the third quarter was $265,000 compared to $454,000 in the third quarter of 2019. The decrease was principally due to a reduction in revenue from our contract with Janssen, for which activities were mostly completed between July 2019 and June 2020.
Research and development expenses were $4.6 million for the third quarter compared to $3.7 million for the third quarter of 2019. The increase was mainly due to manufacturing expenses related to the COVID-19 vaccine candidate and higher stock-based compensation costs, partially offset by reductions in the cost of clinical trials for our norovirus vaccine candidate and in personnel costs after we ceased internal manufacturing as part of our December 2019 restructuring.
General and administrative expenses were $4.2 million for the third quarter compared to $1.5 million for the third quarter of 2019. The increase was mainly due to higher legal fees and an increase in headcount, with higher stock-based compensation costs.

On November 12, 2020 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported its participation in the following upcoming investor conferences (Press release, Fate Therapeutics, NOV 12, 2020, View Source [SID1234570784]):

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Stifel Healthcare Virtual Conference on Tuesday, November 17, 2020 from 4:00-4:30PM ET
Jefferies Global Healthcare Virtual Conference on Thursday, November 19, 2020 from 9:05-9:35AM ET
Evercore ISI HealthCONx Virtual Conference on Tuesday, December 1, 2020 from 3:30-3:50PM ET
A live webcast, if recorded, of each presentation will be available through the investor relations section of the Company’s website at www.fatetherapeutics.com. Following each live webcast, an archived replay will be available on the Company’s website for 30 days.