On July 13, 2020 Horizon Therapeutics plc (Nasdaq: HZNP) reported that its second-quarter 2020 financial results will be released on Wednesday, Aug. 5, 2020 (Press release, Horizon Therapeutics, JUL 13, 2020, View Source [SID1234561831]). Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

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The live webcast and a replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.

On July 13, 2020 TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that it will host a key opinion leader (KOL) webinar on envafolimab for the treatment of sarcoma on Friday, July 17, 2020, at 11:00 AM Eastern Time (Press release, Tracon Pharmaceuticals, JUL 13, 2020, View Source [SID1234561830]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The KOL webinar will feature a presentation by Robert Maki, M.D., Ph.D., of the University of Pennsylvania School of Medicine, who will discuss the current treatment landscape and unmet medical need in treating patients with sarcoma. Dr. Maki will be available to answer questions at the conclusion of the event.

TRACON’s Chief Executive Officer, Charles Theuer, M.D., Ph.D., will also provide an update on the Company’s lead product candidate, envafolimab, for treating patients with sarcoma. Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently being studied in China in a Phase 2 registration trial as a single agent in MSI-H/dMMR colorectal cancer patients, in combination with gemcitabine and oxaliplatin in a Phase 3 registration trial in biliary tract cancer, as well as in several Phase 1 trials in the U.S. and Japan. Having agreed with the U.S. Food and Drug Administration (FDA) on trial design, TRACON intends to initiate the ENVASARC pivotal study of envafolimab in the sarcoma subtypes of undifferentiated pleomorphic sarcoma and myxofibrosarcoma in the second half of 2020.

You can register for the webinar by clicking here.

Dr. Maki is a graduate of Cornell University Medical College, and has a Ph.D. in Immunology from Cornell University Graduate School of Medical Sciences. He completed his internship and residency at Brigham and Women’s Hospital and fellowship in medical oncology at the Dana Farber Cancer Institute. Dr. Maki’s expertise includes the more than 70 types of bone and soft tissue sarcomas, and he is the co-author of Management of Soft Tissue Sarcoma, from Springer Books. Dr. Maki is Board certified in internal medicine and medical oncology, and treats patients at the Abramson Cancer Center at the University of Pennsylvania.

On July 13, 2020 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported an interim update for the Phase 2 portion of its NC318 monotherapy phase 1/2 trial (Press release, NextCure, JUL 13, 2020, View Source [SID1234561829]).

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Based on the current enrollment criteria and clinical response data, at this time the company does not plan to advance the non-small cell lung cancer (NSCLC) and ovarian cancer cohorts into the stage 2 portion of the Simon 2-stage trial. The analysis of biomarker data for these cohorts has been delayed and is not yet complete. The company will evaluate whether to pursue additional monotherapy studies in NSCLC and ovarian cancer after a review of that information. The company continues to enroll in head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer cohorts. One confirmed partial response has been observed in HNSCC and this indication has been advanced to the stage 2 portion of the Simon 2-stage trial. The company is continuing to assess Siglec-15 (S15) biomarker data as a basis for patient selection.

"While the monotherapy data in the NSCLC and ovarian cancer cohorts are disappointing, we continue to evaluate patient selection criteria for our ongoing NC318 clinical trials," said Michael Richman, NextCure’s president and chief executive officer. "We expect to provide an NC318 clinical data update and additional biomarker data in the fourth quarter of 2020."

NextCure also announced that Kevin N. Heller, M.D., the company’s chief medical officer, has resigned, effective August 4, 2020 to pursue a new opportunity. Dr. Heller will serve as a consultant to the company. The company has initiated a search for a new chief medical officer.

"We thank Kevin for all of his work on behalf of the company and look forward to his continued support as a clinical consultant," said Mr. Richman.

About the Phase 2 Portion of the NC318 Phase 1/2 Clinical Trial

The Phase 2 component of the Phase 1/2 clinical trial is designed as a single-arm trial to evaluate the efficacy of NC318 at a 400 mg dose administered every two weeks. NextCure expects to enroll up to 100 patients with NSCLC, ovarian cancer, head and neck cancer and triple-negative breast cancer. The primary endpoints are safety and tolerability, and secondary endpoints include response rate, progression-free survival, duration of response and overall survival.

About NC318

NC318 is a first-in-class immunomedicine against S15, a novel immunomodulatory target found on highly immunosuppressive cells called M2 macrophages in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. In preclinical research, it was observed that S15 promoted the survival and differentiation of suppressive myeloid cells and negatively regulated T cell function, allowing cancer to avoid immune destruction. In preclinical studies, NC318 blocked the negative effects of S15. NextCure believes NC318 has the potential to treat multiple cancer types.

On July 13, 2020 Vaxart, Inc. (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, reported that it has raised gross proceeds of approximately $90 million through its At-the-Market (ATM) facility with participation based on interest received from RA Capital Management and Invus (Press release, Aviragen Therapeutics, JUL 13, 2020, View Source [SID1234561828]). The company sold approximately 11.2 million shares at $7.98 per share, the market price at the time of sale. SVB Leerink is acting as lead sales agent and B. Riley FBR is acting as co-sales agent for the ATM facility.

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The additional funds raised through the ATM facility will support the clinical and preclinical development of Vaxart’s product candidates, to conduct clinical trials, to manufacture its products, and for general corporate and working capital purposes.

The shares of common stock described above were sold by the Company pursuant to an automatically effective shelf registration statement on Form S-3 (File No. 333-239751), filed with the Securities and Exchange Commission on July 8, 2020, which included a prospectus relating to the ATM facility. Copies of the prospectus may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, or by telephone at (800) 808-7525, ext. 6218, or by email at [email protected]. Electronic copies of the prospectus are also available on the SEC’s website at View Source

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

On July 13, 2020 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage immunology and oncology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the second quarter ended 30 June 2020 and provided an update on its clinical activities (Press release, ASLAN Pharmaceuticals, JUL 13, 2020, View Source [SID1234561827]).

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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "As COVID-19 restrictions gradually lift in Singapore we expect to resume recruitment into our multiple ascending dose (MAD) study of ASLAN004 in early August. With the continuing impact of COVID-19 causing some delays in patient recruitment, we plan to share further data from the trial during the fourth quarter of 2020. We have been proactive in preparing to open new study sites in Australia and the US to ensure we can accelerate recruitment, as well as support our planned global Phase 2b study in atopic dermatitis in 2021."

Second quarter 2020 and recent business highlights

Clinical development ASLAN004

Recruitment paused into randomised, double-blind, placebo-controlled MAD study of ASLAN004 in moderate to severe atopic dermatitis (AD) in April 2020 in response to government restrictions in Singapore to contain the spread of COVID-19.

To accelerate recruitment, ASLAN has identified several clinical sites in Australia and the US that could join the ongoing MAD study in the third quarter.

Clinical trial application submitted and regulatory process underway in Australia to initiate recruitment of patients into the ongoing MAD study.

Preparations underway to file Investigational New Drug application to the US Food and Drug Administration later this month.

Varlitinib

Two abstracts on varlitinib presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) virtual congress.

Anticipated upcoming milestones for ASLAN004

Interim, unblinded data from the 3 dose cohorts (up to 24 patients) expected in 4Q 2020, and initiation of the expansion cohort (an additional 18 patients).

Completion of MAD clinical trial in moderate-to-severe AD patients in 1H 2021.

Initiation of Phase 2b study of ASLAN004 for AD in 2021.

Second quarter 2020 financial highlights

Cash used in operations for the second quarter of 2020 was US$3.0 million compared to US$6.5 million in the same period in 2019.

Research and development expenses were US$1.9 million in the second quarter of 2020 compared to US$5.3 million in the second quarter of 2019. The decrease was driven by the completion of clinical studies related to varlitinib and lower manufacturing expenses.

General and administrative expenses were US$1.8 million in the second quarter of 2020 compared to US$1.9 million in the second quarter of 2019. The decrease was primarily due to lower headcount and staffing costs.

Net loss for the second quarter of 2020 was US$4.0 million compared to a net loss of US$7.9 million for the second quarter of 2019.

Cash, cash equivalents and short-term investments totaled US$13.8 million as of 30 June 2020 compared to US$22.2 million as of 31 December 2019. Weighted average shares outstanding for the second quarter of 2020 was 190.0 million compared to 160.2 million for the second quarter of 2019. One American Depositary Share is the equivalent of five ordinary shares.