On April 22, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, reported financial results for the first quarter ended March 31, 2021, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, APR 22, 2021, View Source [SID1234578354]).

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The Company’s lead investigational drug is Rhenium NanoLiposome (RNL), a radiotherapy in development for several rare cancer targets, including recurrent glioblastoma (GBM). RNL, currently being evaluated in the U.S. multi-center ReSPECT Phase 1 dose-finding clinical trial, is designed to safely, effectively, and conveniently deliver a very high dose of radiation directly to brain tumors.

"In the first quarter of 2021, we made meaningful progress in critical areas including advancing our drug development and manufacturing activities, refining our clinical understanding of RNL behavior in the glioblastoma patients and in seeking FDA feedback on potential new clinical indications for RNL," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics.

First Quarter 2021 Clinical Highlights

Company highlights during the first quarter of 2021 included:

Entering into a master services agreement (MSA) with Piramal Pharma Solutions for the development, manufacture, and supply of RNL intermediate drug product.
Completing the 6th dose escalation cohort, with 18 patients treated in ReSPECT, with concomitant increases in both RNL drug volume and radiation dose.
Beginning treatment in an expansion cohort at the 6th dose with higher drug flow rates and faster drug infusion times.
Submitting 2 RNL pre-IND meeting briefing packages to the U.S. Food and Drug Administration (FDA) for treatment of leptomeningeal metastases and pediatric brain cancers, specifically ependymoma, high-grade glioma, and diffuse intrinsic pontine glioma.
Expected Upcoming Clinical Milestones and Events for 2021

In upcoming quarters in 2021, the Company intends to focus on a number of additional business objectives and potential milestones:

Complete enrollment of the ReSPECT Phase 1 trial for RNL in recurrent glioblastoma.
Complete pivotal trial planning in conjunction with FDA feedback for RNL in recurrent glioblastoma.
Complete a pre-IND meeting with the FDA, execute IND-enabling studies, if needed, and move into clinical trials for new RNL indications.
Continue development and evaluation of additional external and internal drug development candidates to expand the drug development pipeline.
Continue to explore partnership opportunities for three clinical-stage investigational drugs: RNL, DocePLUS and generic DoxoPLUS.
First Quarter 2021 Financial Results

As of March 31, 2021, the Company’s cash balance was $14.4 million, compared to $8.3 million as of December 31, 2020.
Total operating expenses for the first quarter of 2021 was $2.5 million, compared to total operating expenses of $2.56 million for the same quarter in 2020.
Net loss for the first quarter of 2021 was $2.7 million, or $(0.33) per share, compared to a net loss of $1.1 million, or $(0.28) per share, for the same quarter in 2020. The net loss was consistent year on year when excluding the book gains on the warrants reported in Q1 2020. Remeasurement of warrant liabilities was no longer required for Series U warrants that were amended in Q2 and Q3 2020 and reclassified to equity.
First Quarter 2021 Results Conference Call

The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.

Event: Plus Therapeutics First Quarter 2021 Results Conference Call
Date: Thursday, April 22, 2021
Time: 5:00 p.m. Eastern Time
Live Call: 877-402-3914 (toll free); 631-865-5294 (Intl.); Conference ID: 3084418
The webcast can be accessed live via the investor section of the Plus Therapeutics website at ir.plustherapeutics.com/events and will be available for replay beginning two hours after the conclusion of the conference call.

On April 22, 2021 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that it will report financial results for the three months ended March 31, 2021 after the close of the U.S. financial markets on Monday, May 3, 2021 and will hold a conference call that same day beginning at 4:30 p.m. Eastern time (Press release, Ligand, APR 22, 2021, View Source [SID1234578353]). Speakers on the call will include Ligand’s CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg.

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On April 22, 2021 Amgen (NASDAQ:AMGN) reported that it will report its first quarter financial results on Tuesday, April 27, 2021, after the close of the U.S. financial markets (Press release, Amgen, APR 22, 2021, View Source [SID1234578352]). The announcement will be followed by a conference call with the investment community at 2:00 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public. The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On April 22, 2021 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 fourth quarter and full year ended December 31, 2020 and provided an update on its clinical development activities (Press release, ASLAN Pharmaceuticals, APR 22, 2021, View Source [SID1234578351]).

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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "ASLAN made significant progress in the fourth quarter of 2020 and that momentum has carried over into 2021. After completing recruitment of the third cohort in our multiple ascending dose trial for ASLAN004 in the fourth quarter, we announced positive interim data supportive of its potential as a novel, first-in-class antibody targeting IL-13R with a differentiated efficacy and safety profile in atopic dermatitis. We are on track to complete enrolment of the expansion cohort with an additional 27 patients by mid-2021 and anticipate reporting topline data in the third quarter of 2021. At the same time, we are continuing to prepare for our Phase 2b study, which we expect to initiate in the second half of 2021. ASLAN is in a strong financial position with the necessary resources to fund its development activities to achieve important value creating milestones for shareholders."

Fourth quarter 2020 and recent business highlights

Clinical development

ASLAN004

In March 2021, ASLAN announced positive interim unblinded data from the three dose cohorts of the ongoing Phase 1 randomised, double-blind placebo controlled multiple ascending dose (MAD) study of ASLAN004 for the treatment of moderate to severe atopic dermatitis (AD). ASLAN004, a novel, first-in-class antibody, was well tolerated across all doses and showed improvements compared to placebo in all efficacy endpoints, supporting its potential as a differentiated treatment for AD.
ASLAN003

New data from a study conducted by the University of Liverpool, UK, published in the Toxicology in Vitro Journal, demonstrated that, out of a panel of six dihydroorotate dehydrogenase (DHODH) inhibitors tested, ASLAN003 has the lowest potential for hepatotoxicity despite being one of the most potent inhibitors of DHODH.
Corporate updates

In March 2021, raised gross proceeds of approximately US$69 million, including the full exercise of an over-allotment option, through an underwritten public offering of 17,250,000 American Depositary Shares (ADSs) representing 86,250,000 ordinary shares at a price to the public of US$4.00 per ADS.
In February 2021, raised gross proceeds of approximately US$18 million resulting from the sale of its ordinary shares through a private placement to new institutional investors, Vivo Capital and Surveyor Capital (a Citadel company).
Between October 2020 and February 2021, raised gross proceeds of approximately US$21.5 million through at-the-market offerings.
Appointed Neil Graham, MBBS, MD, MPH and Kathleen M. Metters, PhD as independent directors. Dr Graham is an expert in immunology and inflammation with more than 30 years’ experience in global drug development and commercialisation, including 10 years at Regeneron Pharmaceuticals, Inc., where he was instrumental in the development of dupilumab. Dr Metters has more than 30 years’ experience in the discovery and development of novel therapies for the treatment of chronic diseases, including autoimmune diseases. She held a number of senior positions at Merck & Co., previously leading work on External Discovery and Preclinical Sciences and was Senior Vice President and Head of Worldwide Basic Research.
Anticipated upcoming milestones

Completion of MAD clinical study of ASLAN004 in moderate-to-severe AD patients and topline clinical results expected in the third quarter of 2021.
Initiation of Phase 2b study of ASLAN004 for AD expected in the second half of 2021.
Fourth quarter 2020 financial highlights

Cash used in operations for the fourth quarter of 2020 was US$5.1 million compared to US$5.1 million in the same period in 2019.
Research and development expenses were US$2.9 million in the fourth quarter of 2020 compared to US$2.7 million in the fourth quarter of 2019.
General and administrative expenses were US$3.0 million in the fourth quarter of 2020 compared to US$3.3 million in the fourth quarter of 2019.
Net loss for the fourth quarter of 2020 was US$5.7 million compared to a net loss of US$29.6 million for the fourth quarter of 2019, which included a one-time impairment charge of US$23 million related to the write-down of varlitinib in the fourth quarter of 2019.
Full year 2020 financial highlights

Cash used in operations for the year ended 31 December 2020 was US$15.1 million compared to US$25.8 million in 2019.
Research and development expenses were US$9.3 million for the full year 2020 compared to US$16.6 million in 2019. The decrease was driven by the completion of clinical studies related to varlitinib.
General and administrative expenses were US$7.2 million for the full year 2020 compared to US$8.5 million in 2019.
Net loss attributable to stockholders for the full year 2020 was US$16.2 million compared to a loss of US$47.0 million in 2019, which included a one-time impairment charge of US$23 million related to the write-down of varlitinib in the fourth quarter of 2019. Excluding the non-cash impairment charge, net loss for the full year 2019 was US$23.9 million.
Cash and cash equivalents totaled US$14.3 million as of 31 December 2020, including US$7.4 million raised from at-the-market offerings in 2020, compared to US$22.2 million as of 31 December 2019. The cash balance as of year-end 2020 excludes proceeds from the additional financing activities completed in the first quarter of 2021 which raised combined gross proceeds of approximately US$101 million. With the additional financing activities in the first quarter of 2021, management believes that its cash and cash equivalents will be sufficient to fund operations into 2023.The weighted average number of ADSs outstanding for the year 2020 was 38.4 million compared to 32.5 million for 2019. One ADS is the equivalent of five ordinary shares.

On April 22, 2021 Case Western Reserve University reported that The U.S. Food and Drug Administration has approved human clinical trials to test the safety of cancer-detection technology developed at Case Western Reserve University: a tumor-targeting contrast agent that accurately detects aggressive prostate cancer in a magnetic resonance imaging (MRI) scan (Press release, Case Western Reserve University, APR 22, 2021, View Source [SID1234578350]).

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The molecular-targeted imaging agent is licensed to Molecular Theranostics LLC, a Cleveland based startup company, and its partners U.S. Motek LLC and Jiangsu Motek Pharmaceuticals Ltd. of China.

The agent will undergo a clinical trial at Ohio Clinical Trials Inc. in Columbus through a contract with U.S. Motek. Patient recruitment is expected to start in early May and the trial later in the month.

The imaging agent, known as MT218, was invented in the lab of Case Western Reserve researcher Zheng-Rong Lu, who has been developing the tumor-specific MRI contrast agent for nearly 15 years.

Lu, a co-founder of Molecular Theranostics, and his partners believe the agent could someday allow clinicians to non-invasively and accurately diagnose the malignant prostate cancer in a common MRI scan.

A more precise MRI scan of prostate cancer—and possibly other cancers—could benefit patients who are sometimes needlessly treated with aggressive interventions, or conversely, better identifying those who need the treatments, said Lu, the M. Frank Rudy and Margaret Domiter Rudy Professor of Biomedical Engineering at the Case School of Engineering.

Zheng-Rong Lu
"We are very excited about this phase one clinical trial because it means that our research product is now under clinical development to help people," Lu said. "Our agent has the promise to detect the aggressive solid tumors to provide imaging guidance for precision healthcare of cancer patients."

The key to this more precise diagnosis of the tumor is using Lu’s patented gadolinium-based MRI contrast agent that binds to a molecular marker, called extradomain B fibronectin, a cancer-associated subtype of fibronectin.

The gadolinium agent is a paramagnetic substance that can enhance MRI signals of aggressive tumors to improve the accuracy of cancer diagnosis.

The clinical trials at Motek will assess whether the agent can be safely administered to humans—the first step in the clinical development for detecting the tumors in patients as it has done successfully in animal models, Lu said. The trial participants are expected to be 30 healthy Black and white males between age 18 and 55, he said.

A second trial is being pursued to test the agent’s effectiveness in detecting aggressive tumors and differentiating the types of tumors, Lu said.

Lu’s patented technology was jointly developed by Molecular Theranostics and its affiliates (U.S. Motek LLC and Jiangsu Motek Pharmaceuticals Ltd). Jiangsu Motek Pharmaceuticals announced the FDA approval in March.

Current prostate testing

Prostate cancer is the most common non-skin cancer in the United States: one in eight men nationally will be diagnosed with prostate cancer in his lifetime, according to the Prostate Cancer Foundation.

MRI provides high-resolution, three-dimensional tissue images and is widely used to diagnose prostate cancer.

However, the current technologies—especially MRI contrast agents added to tissues to reveal tumors—are limited. An imprecise diagnosis can lead to either over- or under-treating a tumor, Lu said.

Jiangsu Motek Pharmaceuticals officials said "the gold standard" for clinical diagnosis of prostate cancer is a 12-needle puncture biopsy guided by rectal ultrasound. However, sampling errors in the biopsy—and the fact that various levels of tumors may coexist in the prostate—can lead to a false-negative diagnosis rate of up to 30%, according to the company.

On the other hand, extensive blood tests for prostate cancer and a subsequent biopsy can sometimes lead to overdiagnosis and overtreatment. That overtreatment can lead to

serious infections and reproductive and urinary side-effects, Lu said.

"That’s why this is so important," said Lu. "Research shows that only 20% of patients diagnosed will develop aggressive tumors—so we could spare the other 80% from aggressive over treatment."