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

On July 13, 2020 Helix BioPharma Corp. (TSX: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that, further to its news release dated June 11, 2020, it intends to file its interim consolidated financial statements for the three and nine month periods ended April 30, 2020, related management’s discussion and analysis ("MD&A") and related management certifications (the "Interim Disclosure Documents") by July 30, 2020 (Press release, Helix BioPharma, JUL 13, 2020, View Source [SID1234561824]).

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On July 13, 2020 Celsion Corporation (NASDAQ: CLSN), an oncology focused drug-development company, reported that it has received a recommendation from the independent Data Monitoring Committee (DMC) to consider stopping the global Phase III OPTIMA Study of ThermoDox in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer (Press release, Celsion, JUL 13, 2020, View Source [SID1234561822]).

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The recommendation was made following the second pre-planned interim safety and efficacy analysis by the DMC on July 9, 2020. The DMC analysis found that the pre-specified boundary for stopping the trial for futility of 0.900 was crossed with an actual value of 0.903. However, the 2-sided p-value of 0.524 for this analysis provides uncertainty, subsequently, the DMC has left the final decision of whether or not to stop the OPTIMA Study to Celsion. There were no safety concerns noted during the interim analysis.

"We are surprised and disappointed that the OPTIMA Study results were not found to be more robust at this analysis. Nonetheless, we intend to follow the advice of the DMC and will consider our options either to stop the study or continue to follow patients after a thorough review of the data, and an evaluation of our probability of success. Timing for this decision is made less urgent by the fact that the OPTIMA Study has been fully enrolled since August 2018 and that the vast majority of the trial expenses have already been incurred," stated Michael H. Tardugno, Celsion’s chairman, president and chief executive officer.

"This, of course, is inconclusive and difficult news for the medical community, HCC patients and our shareholders, and confirms the complexity and challenge of treating primary liver cancer," he added. "The present development had never been anticipated by the Company or our advisors based on both the first pre-planned efficacy analysis and on tracking against the sub-group analysis of the Company’s earlier HEAT Study upon which the OPTIMA Study is based. We will conduct additional analyses of the unblinded data from the trial to better understand the results and to develop our plan going forward. As always, we wish to acknowledge and thank all the patients and investigators for their participation in the trial."

The OPTIMA Study is a global, randomized, double-blind, placebo-controlled clinical trial assessing the efficacy of ThermoDox in combination with RFA, which was standardized to a minimum of 45 minutes for treating patients with a lesion 3-7 cm in size, versus standardized RFA alone. The OPTIMA Study enrolled 554 patients at 65 clinical sites in North America, Europe, China and Asia Pacific. In addition to the primary overall survival endpoint, progression-free survival, time to disease progression, and safety are key secondary endpoints.

The statistical plan for the OPTIMA Study included two interim efficacy analyses by the DMC. The first interim analysis was announced in November 2019 following data lock in August 2019 after the prescribed minimum number of 128 patient events (deaths) was reached, and the second interim analysis was conducted in July 2020 following data lock in April 2020 after the prescribed minimum number of 158 events was reached.

Conference Call and Webcast

Celsion will be holding a conference call and webcast on Wednesday, July 15 to discuss its current observations about the results of the OPTIMA Study, the DMC’s recommendations and the Company’s next steps. Further information regarding the time of the call and dial-in instructions will be provided separately.

About ThermoDox

Celsion’s most advanced program is a heat-mediated drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox, a lyso-thermosensitive liposomal doxorubicin (LTLD) whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. ThermoDox is positioned for use with multiple heating technologies and has the potential to treat of a broad range of cancers including metastatic liver, recurrent chest wall breast cancer and non-muscle invading bladder cancers.

Celsion’s LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. In the first mechanism, rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, ThermoDox is engineered with a half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream.

In the second mechanism, when an external heating device heats tumor tissue to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that can release a chemotherapeutic agent directly into the tumor and the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method damages only the tumor and the area subject to tumor invasion, supporting more precise drug targeting.