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.

On July 13, 2020 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported additional information on preliminary results for the second quarter and first half of 2020, along with an outlook for continued strong growth trends in the third and fourth quarters of 2020 (Press release, Qiagen, JUL 13, 2020, View Source [SID1234561826]). QIAGEN also provided initial perspectives that business trends are expected to continue at a solid pace during 2021 and an update on the potential future impact of the coronavirus pandemic.

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Second quarter and first half 2020 results
As an update to the announcement on July 9, 2020, net sales for the second quarter of 2020 were $443 million, an increase of 19% at constant exchange rates (or CER) (previously 18-19% CER) and 16% at actual rates from $382 million in the same period of 2019. Instrument sales increased 48% CER and 45% at actual rates in the second quarter of 2020 to $68 million from $47 million in the same period of 2019, while sales of consumables and related revenues rose 14% CER and 12% at actual rates to $375 million from $335 million in the year-ago period. Among the customer classes, Life Sciences sales advanced 25% CER and 23% at actual rates to $239 million from $194 million in the second quarter of 2019, while Molecular Diagnostics sales grew 12% CER and 9% at actual rates to $204 million from $188 million in the year-ago period. The QuantiFERON-TB test for tuberculosis detection ($33 million, -46% CER, -46% at actual rates) faced significant headwinds in the U.S. and Europe due to reduced demand, but experienced accelerating trends in regions where quarantines and lockdown measures have been eased.
Adjusted earnings per share (EPS) for the second quarter of 2020 are now expected to be $0.56 CER (previously $0.55-0.56 CER) based on preliminary results, an increase of about 70% from $0.33 in the second quarter of 2019. Results were also well above the outlook announced on May 5, 2020, for at least $0.40 CER.

For the first half of 2020, net sales were $815 million, an increase of 14% CER and 12% at actual rates from $730 million in the first six months of 2019. Adjusted EPS are expected to be $0.90 CER based on preliminary results, an increase of 50% CER from $0.60 in the first half of 2019.

The release of full second quarter and first-half 2020 results remains planned for August 4, 2020.
Third quarter and full-year 2020 outlook
For the third quarter of 2020, QIAGEN expects net sales growth of approximately 16-21% CER compared to $383 million in the same period of 2019, and adjusted EPS to grow approximately 45-60% CER to about $0.52-0.58 CER from $0.36 in the year-ago quarter. This outlook is based on expectations for a continuation of trends from the first half of 2020 into the third and fourth quarters of the year. Sustained elevated demand for coronavirus test products is expected to more than offset weaker year-over-year sales trends in other areas of the portfolio, which are being adversely impacted by quarantines and lockdown actions in countries around the world.
For full-year 2020, QIAGEN expects net sales growth of approximately 15-18% CER from the 2019 level of $1.53 billion and adjusted EPS growth of at least 40% CER to at least $2.00 CER from $1.43 per share in 2019. The outlook for adjusted EPS does not include any potential capital gain that could result from the expected divestiture of its minority investment in ArcherDX.
Perspectives for 2021
In terms of business trend perspectives for 2021, QIAGEN currently assumes that the first SARS-CoV-2 vaccine would become progressively available on a large scale during the year, but that coronavirus
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testing products will be required for a longer-term period before demand starts to recede. QIAGEN also expects to see recovery trends continuing in other areas of the portfolio during the course of 2021. Based on these assumptions, QIAGEN currently expects a continuation of net sales growth at a double-digit CER pace for 2021 compared to full-year 2020 results, and for adjusted EPS growth of at least 18% CER from the results in 2020.
Sample to Insight portfolio update
These perspectives take into account the following developments:
•RNA production capacity and instruments: QIAGEN’s production capacity for viral RNA extraction solutions exceeded 12 million patient samples per month as of June 30, 2020, ahead of the previously announced plan for at least 10 million patient samples per month. QIAGEN is on track to reach its goal for more than 20 million patient tests per month during the fourth quarter of 2020.
In addition, QIAGEN is ramping up production capacity for consumables used on automation systems and instruments, with ongoing strong demand for QIAGEN platforms. These include 200 new placements of the QIAsymphony automation system in the first half of 2020, representing a 60% increase from the prior-year period and building on more than 2,500 cumulative placements of this flagship system at the end of 2019. In the QIAcube family of sample processing instruments, more than 415 new placements of QIAcube Connect and 175 new placements of the QIAcube HT high-throughput version were nearly double the placement levels in the same period of 2019, building on over 8,000 cumulative placements of QIAcube platforms at the end of 2019. Additionally, about 250 new placements of the EZ1 instrument were completed in the first half of 2020, an increase of more than 100% from the first half of 2019, adding to over 3,750 cumulative placements at the end of 2019. Given the current demand levels, QIAGEN is also expanding production capacity for viral RNA extraction solutions that can be used on high-throughput third-party instruments.
•QIAstat-Dx: QIAGEN continues to increase cartridge production capacity at two sites in Europe amid high demand for the QIAstat-Dx syndromic system and the QIAstat-Dx Respiratory SARS-CoV-2 Panel, a test available in the U.S., Europe and other countries to differentiate the novel coronavirus from 21 other respiratory pathogens. Cumulative placements of QIAstat-Dx are now approximately 1,500 systems.
•NeuMoDx: QIAGEN has reached an amended agreement to acquire the remaining 80.1% stake in NeuMoDx Molecular, Inc. that it does not currently own. The timing of closing is dependent upon the outcome of Thermo Fisher Scientific Inc.’s announced plans to fully acquire QIAGEN in a voluntary public tender. The acquisition of NeuMoDx requires customary regulatory approvals and clearances. QIAGEN expects NeuMoDx to provide significant sales contributions in the future based on its differentiation as a rapid, integrated PCR-based platform that offers a dedicated COVID-19 test as well as tests for an increasing number of other infectious diseases. Additionally, a new multiplex test combining analysis for influenza, RSV (respiratory syncytial virus) and the SARS-CoV-2 virus is planned to be launched on the NeuMoDx systems in the second half of 2020.
•OEM components for other diagnostic suppliers: QIAGEN continues to scale up production capacity at sites in the U.S. and Europe for reagents purchased by other diagnostic companies for use in their own COVID-19 testing solutions. These products include individualized components such as enzymes and PCR mixes.
•Antibody test in development: QIAGEN plans to launch in the second half of 2020 a serology test (assessing the body’s immune response to the coronavirus via antibodies) and a rapid antigen test (detection of an active coronavirus infection). These two tests are designed to complete QIAGEN’s portfolio of tests for use in coronavirus testing.
•Digital PCR: The first units of the QIAcuity digital PCR platform are scheduled to be installed in August 2020 as QIAGEN begins full commercialization. QIAGEN has a strong pipeline of customer leads, and has increased production capacity in light of higher-than-expected demand.
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QIAcuity is a series of differentiated new platforms designed to make highly versatile digital PCR technology available to Life Sciences laboratories worldwide.

On July 13, 2020 Notable, which is redefining cancer treatment by taking a functional approach to precision oncology in hematological cancers, reported that it is hosting a July 23 webinar titled, "Emerging Treatment Approaches for Higher Risk Myelodysplastic Syndromes (Press release, Notable Labs, JUL 13, 2020, View Source [SID1234561825])." Speakers from the Stanford Cancer Institute and the MDS Foundation will explore current standards of care for MDS as well as emerging treatment options.

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The event will be moderated by Dr. Sandra Kurtin, a member of the MDS Foundation Board of Directors, as well as the Chair of MDS Foundation’s International Nurse Leadership Board. The main speaker will be Dr. Michael Spinner, Instructor in the Division of Oncology at the Stanford Cancer Institute.

Drs. Kurtin and Spinner will discuss:

The current standard treatment approach for higher risk MDS
Treatment options for patients who relapse or do not respond to standard therapies
Novel targeted therapies, immunotherapies, and new technologies being investigated
This free event takes place on July 23 at 10am PT. To register, visit View Source