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Neurocrine Biosciences to Present at Upcoming Healthcare Conferences

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.

Heat Biologics Provides Third Quarter 2020 Business Update

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]).

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.

Alligator Bioscience presents at the SITC 35th Annual Meeting

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]).

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.

Sunesis Pharmaceuticals to Host Conference Call on November 16th to Discuss Third Quarter 2020 Financial Results and Recent Highlights

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]).

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.

Spectrum Pharmaceuticals to Present at Two Upcoming Investor Conferences in November

On November 6, 2020 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that management will present an overview of the company’s business strategy and development-stage programs at two upcoming virtual investor conferences (Press release, Spectrum Pharmaceuticals, NOV 9, 2020, View Source [SID1234570336]):

Stifel Virtual Healthcare Conference, Monday, November 16th, 2020 at 2:40 p.m. ET.
Jefferies London Healthcare Conference, Wednesday, November 18th, 2020 at 2:20 p.m. ET.
A live webcast of the presentations will be available from the Investor Relations section of the company’s website at View Source with a replay available shortly after each event.