On November 9, 2020 ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the third quarter ended September 30, 2020 and provided an update on its clinical activities (Press release, ASLAN Pharmaceuticals, NOV 9, 2020, View Source [SID1234570358]).

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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "The third quarter saw great progress being made on multiple fronts for ASLAN. We resumed our multiple ascending dose (MAD) study of ASLAN004 following the lifting of COVID-19 restrictions and quickly completed recruitment of the second cohort, which we believe is an indicator of the scale of the unmet need we aim to address in atopic dermatitis. Recruitment of the third cohort is underway from sites in the US, Australia and Singapore, and we expect to announce new, unblinded data in early 2021. The move of our primary listing to the US is now complete and aligned with our plans to initiate a global Phase 2b study in atopic dermatitis in 2021 and new clinical studies of ASLAN003 in autoimmune disease."

Third quarter 2020 and recent business highlights

Clinical development

ASLAN004

Investigational New Drug application submitted to the US Food and Drug Administration became effective and Clinical Trial Notification cleared by the Therapeutics Goods Administration in Australia.
Seven new clinical sites opened in the US and Australia designed to support recruitment of patients into the ongoing MAD study.
Initiated recruitment of patients into third dose cohort in October at sites in the US, Australia and Singapore following successful safety review of second cohort that resumed recruitment in August. ASLAN004 was found to be well tolerated at 400mg and the Data Monitoring Committee (DMC) recommend that the MAD study continue as planned.
ASLAN003

Announced plans to develop ASLAN003, ASLAN’s next generation inhibitor of dihydroorotate dehydrogenase (DHODH), in autoimmune conditions, such as multiple sclerosis, following review of the data generated on ASLAN003 and discussions with experts in the field. ASLAN believes that ASLAN003 has a potential best in class profile as a potent oral DHODH inhibitor targeting autoimmune indications.
Appointed renowned neurologist Professor Gavin Giovannoni, Chair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry, as a scientific advisor to the Company. ASLAN will work with Professor Giovannoni on the clinical development plan of ASLAN003.
Based on previous observations of anti-viral activity against Dengue and Zika viruses, ASLAN recently determined that ASLAN003 has nanomolar potency against SARS-CoV-2 in Vero E6 cells (EC50 = 1.4 nM) and is assessing the potential of ASLAN003 as a treatment for COVID-19 and other viral infections.
Corporate updates

Appointed Dr Kenneth Kobayashi as Chief Medical Officer. Dr Kobayashi most recently worked at Dermira, where he was responsible for the development of lebrikizumab, and previously held roles at Novartis and LEO Pharma. Dr Kobayashi brings more than 25 years of experience in drug development, clinical practice and regulatory affairs as a Dermatology expert.
Movement of primary listing to the Nasdaq Global Market and delisting from the Taipei Exchange completed in August. ASLAN has retained its listing of American Depositary Shares (ADS) on Nasdaq in the United States.
Anticipated upcoming milestones

Interim, unblinded data on ASLAN004 from the 3 dose cohorts (up to 24 patients) and initiation of the expansion cohort (an additional 18 patients) expected in early 2021.
Completion of MAD clinical study of ASLAN004 in moderate-to-severe atopic dermatitis (AD) patients expected in 1H 2021.
Initiation of Phase 2b study of ASLAN004 for AD expected in 2021.
Third quarter 2020 financial highlights

Cash used in operations for the third quarter of 2020 was US$2.6 million compared to US$7.0 million in the same period in 2019.
Research and development expenses were US$2.2 million in the third quarter of 2020 compared to US$4.1 million in the third quarter of 2019. The decrease was driven by the completion of clinical studies related to varlitinib.
General and administrative expenses were US$1.3 million in the third quarter of 2020 compared to US$1.1 million in the third quarter of 2019.
Net loss for the third quarter of 2020 was US$3.5 million compared to a net loss of US$5.2 million for the third quarter of 2019.
Cash, cash equivalents and short-term investments totaled US$12.1 million as of September 30, 2020 (this includes US$0.9 million of cash received in connection with the ADS scheme that will be paid to our depository agent in 4Q 2020) compared to US$22.2 million as of 31 December 2019. Weighted average ADS outstanding for the third quarter of 2020 was 38.0 million (or equivalent) compared to 32.0 million (or equivalent) for the third quarter of 2019. One ADS is the equivalent of five ordinary shares.

On November 9, 2020 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that Neurocrine Biosciences management will present at the following investor conferences (Press release, Neurocrine Biosciences, NOV 9, 2020, View Source [SID1234570357]):

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Kevin Gorman, Chief Executive Officer, and Kyle Gano, Chief Business Development and Strategy Officer, will present at the Stifel 2020 Virtual Healthcare Conference at 11:20 a.m. Eastern Time on Monday, November 16, 2020.
Kevin Gorman, Chief Executive Officer, and Matt Abernethy, Chief Financial Officer, will present at the Jefferies Virtual London Healthcare Conference at 2:40 p.m. Greenwich Mean Time (9:40 a.m. Eastern Time) on Tuesday, November 17, 2020.
The live presentations will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentations will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

On November 9, 2020 Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported financial, clinical and operational updates for the third quarter ended September 30, 2020 (Press release, Heat Biologics, NOV 9, 2020, View Source [SID1234570339]).

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Jeff Wolf, Chief Executive Officer of Heat, commented, "We continue to make progress on both our oncology and COVID-19 vaccine programs. We presented data for HS-110 in combination with Nivolumab in our Phase 2 lung cancer trial at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating a strong survival benefit in a cohort of previously treated checkpoint inhibitor naïve patients with advanced non-small cell lung cancer (NSCLC). We are actively pursuing a variety of strategies to maximize value for the program."

"At the same time, we continue to advance PTX-35, our potential first-in-class T-cell co-stimulatory antibody, through clinical development. Earlier this year, we initiated the first clinical trial site for PTX-35 in multiple solid tumors and began dosing patients in the Phase 1 clinical trial. PTX-35 is designed to harness the body’s natural antigen specific immune activation and tolerance mechanisms to reprogram immunity and provide a long-term, durable clinical effect. This study is expected to enroll up to 30 patients with advanced solid tumors refractory to standard of care."

"Importantly, we announced preclinical data for our gp96-based COVID-19 vaccine. The data, generated at the University of Miami Miller School of Medicine and published in bioRxiv, shows robust T-cell mediated immune response directed against the spike protein of SARS-CoV-2. Our gp96-based COVID-19 vaccine induced the expansion of both "killer" CD8+ T-cells that destroy virus infected cells, as well as "helper" CD4+ T-cells that assist in producing highly specific antibodies. As a result, we believe our vaccine has the potential to be used as either a standalone vaccine, or in combination with other antibody-focused vaccine approaches to enhance prophylactic protection. These results highlight the potential utility and versatility of our vaccine platform to address SARS-CoV-2, relevant mutations and other pathogens of interest."

"We continue to strengthen our IP portfolio and were recently awarded an additional U.S. patent covering Heat’s gp96 platform in combination with a T cell costimulatory agonist in a single therapy. We believe the combination of our gp96 platform in a single therapy holds enormous promise in the prevention and treatment of cancer and infectious diseases, such as COVID-19."

"Finally, we have maintained a solid balance sheet with over $117 million of cash and short-term investments as of September 30, 2020. We believe this capital will provide us significant runway to achieve a number of important clinical milestones that we believe will drive value for shareholders in the months and years ahead," concluded Mr. Wolf.

Third Quarter 2020 Financial Results

Recognized $0.8 million of grant revenue for qualified expenditures under the CPRIT and NIH grant. No grant revenue was recognized under the respective grants for the three months ended September 30, 2019. The increase in grant revenue in the current-year period primarily reflects the expected timing of completion of deliveries under the current phase of the contracts. As of September 30, 2020, we had deferred revenue of $1.2 million for CPRIT proceeds received but for which the costs had not been incurred or the conditions of the award had not been met.
Research and development expenses was $3.2 million and $3.1 million for the three months ended September 30, 2020 and 2019, respectively.
General and administrative expense was $6.6 million and $2.0 million for the three months ended September 30, 2020 and 2019. General and administrative expenses primarily consist of personnel costs, including stock-based compensation expense, and consulting expenses to manage the business.
Net loss attributable to Heat Biologics was approximately $8.9 million, or ($0.06) per basic and diluted share for the quarter ended September 30, 2020 compared to a net loss of approximately of $6.2 million, or ($0.18) per basic and diluted share for the quarter ended September 30, 2019.
As of September 30, 2020, the Company had approximately $117.3 million in cash, cash equivalents and short investments.

On November 9, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that it will present data from three immuno-oncology projects at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Virtual Annual Meeting, November 9-14, 2020 (Press release, Alligator Bioscience, NOV 9, 2020, View Source [SID1234570338]).

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The presentations will include the Phase I study of ATOR-1015, the Phase I-ready ALG.APV-527 developed in partnership with Aptevo Therapeutics, as well as the novel bispecific concept Neo-X-Prime.

"The fact that three of our immuno-oncology projects have been selected for presentation at this year’s SITC (Free SITC Whitepaper) is a clear confirmation of Alligator’s strong presence in the field. The presentations span from advanced clinical patient data to thrilling early data from our next generation drug concept Neo-X-Prime", said Per Norlén, CEO at Alligator Bioscience.

Abstracts are available on the SITC (Free SITC Whitepaper) website and the accompanying posters will be available in the Virtual Poster Hall open from 8:00 am ET on Monday, Nov. 9, until the Virtual Poster Hall closes on Dec. 31, 2020. The posters are also posted on the Alligator Bioscience website.

Title: Safety and pharmacodynamic activity of ATOR-1015, a CTLA-4 x OX40 bispecific antibody, in a Phase I dose escalation study of patients with advanced solid malignancies

Poster summary: ATOR-1015 is currently evaluated in clinical Phase I at a flat dose of 750 mg, which is the highest dose to be evaluated in the ongoing study. One dose limiting toxicity (infusion related reaction) has been observed at 750 mg. No severe immune-related adverse events have been reported. Best clinical response is stable disease.

Details of the presentation: Live question and answer sessions will occur for the ATOR-1015 poster (Number 369) on Wednesday, Nov. 11, from 5:15 to 5:45 p.m. ET and Friday, Nov. 13, from 4:20 to 4:50 p.m. ET.

Title: ALG.APV-527: Potent tumor-directed T cell activation and in vivo tumor inhibition induced by a 4-1BB x 5T4 ADAPTIR bispecific antibody

Poster summary: The presentation covers preclinical data demonstrating that ALG.APV-527 has a favorable safety profile with no indications of systemic immune activation or liver toxicity. In experimental disease models, ALG.APV-527 increased anti-tumor responses and promoted tumor-specific memory. Clinical development is planned for ALG.APV-527 and CTA documents are prepared for filing of a Phase I clinical trial in the EU.

Details of the presentation: Live question and answer sessions will occur for the ALG.APV-527 poster (Number 851) on Wednesday, Nov. 11, from 5:15–5:45 p.m. ET and Friday, Nov. 13, from 4:40–5:10 p.m. ET.

Title: A bispecific antibody targeting CD40 and EpCAM induces superior anti-tumor effects compared to the combination of monospecific antibodies

Poster summary: The presentation will cover the Neo-X-Prime bispecific prototype antibody targeting CD40 and EpCAM. Neo-X-Prime induces superior anti-tumor effects compared to a combination of monotargeting compounds. Furthermore, Neo-X-Prime induces a broad immunological memory against tumor antigens.

Details of the presentation: Live question and answer sessions will occur for the Neo-X-Prime poster (Number 858) on Thursday, Nov. 12, from 4:50–5:20 p.m. ET and Saturday, Nov. 14, from 1–1:30 p.m. ET.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 2:00 p.m. CET on November 9, 2020.

On November 9, 2020 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported that it will host a conference call on Monday, November 16th, 2020 at 4:30pm Eastern Time to discuss corporate updates and financial results for the third quarter ended September 30, 2020 (Press release, Sunesis, NOV 9, 2020, https://ir.sunesis.com/news-releases/news-release-details/sunesis-pharmaceuticals-host-conference-call-november-16th [SID1234570337]).

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The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 1776248.

To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.