On November 12, 2020 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported third quarter 2020 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, NOV 12, 2020, View Source [SID1234570790]).

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Recent Events & Highlights

Initiated the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 15 clinical sites in the United States
Promoted John Bencich to Chief Executive Officer and Dr. Cindy Jacobs to President
Presented successful results from the RAUORA, head-to-head non-inferiority clinical trial comparing cytisinicline and Chantix (varenicline), at the Society for Research on Nicotine and Tobacco European (SRNT-E) Annual Meeting
Presented mechanism of action data comparing 5-HT3 receptor activity of cytisinicline vs. Chantix at SRNT-E, providing rationale for differentiated side effect profile of smoking cessation treatments
Announced smoking cessation Key Opinion Leader Virtual Roundtable to be held on November 17, 2020
"With the initiation of the Phase 3 ORCA-2 trial and the breakthrough evidence, both mechanistically and clinically, in support of cytisinicline in comparison to Chantix, the third quarter of 2020 has undeniably been the most pivotal in the history of our company," commented John Bencich, Chief Executive Officer of Achieve. "Our primary focus in the coming months will be enrollment and execution of ORCA-2, while continuing to explore opportunities for commercialization and expansion into new therapeutic indications, digital health technologies, and audiences who may benefit from cytisinicline, specifically, users of vapes or e-cigarettes."

Phase 3 ORCA-2 Trial Initiation
Achieve’s first Phase 3 ORCA-2 trial was initiated in October 2020 and will randomize 750 U.S. smokers to one of three study arms to determine the efficacy and safety of cytisinicline administered for either 6 or 12 weeks, compared to placebo. The primary endpoint is biochemically verified continuous abstinence during the last 4 weeks of treatment in the 6 and 12-week cytisinicline treatment arms compared to placebo. Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo.

Management Team Update
In September, the Company announced the promotion of John Bencich to Chief Executive Officer and Dr. Cindy Jacobs to President. Mr. Bencich has been serving as Achieve’s Chief Financial and Operating Officer since 2017 and will join the Board of Directors in his role. Dr. Jacobs has been serving as the Chief Medical Officer of Achieve since 2017 and will continue in her role leading the regulatory and clinical development efforts for cytisinicline. Rick Stewart will remain with Achieve as the Executive Chairman of the Board of Directors and Dr. Anthony Clark will remain in his role as Chief Scientific Officer.

RAUORA: Significantly Fewer Adverse Events and Higher Quits Rates for Cytisinicline vs Chantix
Final results from the New Zealand RAUORA Phase 3 non-inferiority clinical trial comparing cytisinicline to varenicline (Chantix) in Māori (indigenous New Zealanders) and whānau (family) of Māori were presented at the SRNT-E Annual Meeting in September 2020. Results showed that cytisinicline met the pre-specified non-inferiority endpoint and was trending towards superiority demonstrating a 4.29% improvement in quit rates in favor of cytisinicline. Subjects in the cytisinicline arm were approximately one and a half times more likely to have quit smoking at 6 months compared to subjects who received varenicline. Importantly, significantly fewer overall adverse events (AEs) were reported in cytisinicline-treated subjects. Of the subjects who experienced AEs (111 in the cytisinicline arm compared to 138 in the varenicline arm), there was significantly less nausea and vivid dreams.

MOA Data Explaining Reduced Nausea and Vomiting with Cytisinicline Presented at SRNT-E
Data presented at the SRNT-E Annual Meeting in September 2020 provides a rationale based on detailed receptor pharmacology to explain why the incidence of nausea and vomiting associated with cytisinicline appears to be consistently lower than that seen with Chantix. The preclinical study, conducted at the University of Cambridge Department of Biochemistry, was designed to examine the in vitro binding characteristics of cytisinicline compared to varenicline at the human 5-HT3 receptor. The study reported an IC50 of 0.50 mM for cytisinicline and 0.25 µM for varenicline, representing a 2000-greater fold agonist binding affinity to the 5-HT3 receptor for varenicline compared to cytisinicline.

Virtual Smoking Cessation KOL Roundtable to be Held November 17, 2020
Achieve announced plans to host a virtual roundtable on cytisinicline and smoking cessation on Tuesday, November 17, 2020, at 12:00PM EST. Five esteemed experts in the field of smoking cessation will discuss the ongoing ORCA-2 trial, review recent cytisinicline data, and discuss the importance of smoking cessation in the midst of the COVID-19 pandemic. Visit View Source for additional information and click here to register for the event.

Financial Results
As of September 30, 2020, the company’s cash, cash equivalents, and restricted cash was $22.4 million. Total operating expenses for the three and nine months ended September 30, 2020 were $3.8 million and $10.0 million, respectively. Total net loss for the three and nine months ended September 30, 2020 was $3.8 million and $10.0 million, respectively.

As of November 12, 2020, Achieve had 3,617,664 shares outstanding.

Conference Call Details
Achieve will host a conference call at 4:30pm Eastern time today, Thursday, November 12, 2020. To access the webcast, log on to the investor relations page of the Achieve website at View Source. Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 8047128. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

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.