On March 2, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that Snehal Patel, CEO of Greenwich LifeSciences, will participate in multiple virtual investor conferences in March 2021 (Press release, Greenwich LifeSciences, MAR 2, 2021, View Source [SID1234575940]).

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A previously recorded webcast of the Company’s presentation is available on the Company’s website here.

H.C. Wainwright Global Life Sciences Conference 2021:

The Company will be participating in the H.C. Wainwright Global Life Sciences Conference with a virtual presentation that will be available on demand beginning on March 9th. In addition, the Company will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website at: View Source

Landmark Health Innovations 2021:

The Company will be participating in the Landmark Health Innovations Conference with a live virtual presentation on March 11th at approximately 3:40 pm EST to High Net Worth and Family Office conference participants in this by-invitation event. Landmark’s Health Innovations 2021, a two-day virtual event, will feature virtual presentations from a roster of select companies, an expert keynote address, and an "Investor Roundtable" session to introduce Landmark’s investors. For more information, please visit the conference website at: View Source

BIO-Europe Spring 2021:

The Company will be participating in the BIO-Europe Spring partnering event from March 22-25 with an on-demand presentation available to conference participants. The BIO-Europe Spring 2021 program content includes business development, therapeutic areas, startup innovations, digital health, and scheduled one-on-one meetings. For more information, please visit the conference website at: https://informaconnect.com/bioeurope-spring/

Benzinga Biotech Small-Cap Conference 2021:

The Company will be participating in the Benzinga Biotech Small-Cap Conference with a live 15 minute virtual presentation on March 25th to Benzinga’s small-cap investors followed by Q&A. The Company may also participate in a 30 minute oncology panel on March 25th and on Benzinga’s YouTube "PowerHour" show scheduled for March 11th. In addition, Benzinga may also publish an article on the Company. For more information, please visit the conference website at: View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On March 2, 2021 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, will present at the H.C. Wainwright Global Life Sciences Conference which will be available on demand starting on March 9, 2021 at 7:00 am (ET) (Press release, Mannkind, MAR 2, 2021, View Source [SID1234575939]). Interested parties can access a link to the on demand webcast of the presentation from the Events & Presentations section of the Company’s website at View Source The webcast replay will remain available for 14 days following the live presentation.

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On March 2, 2021 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the fourth quarter and 12 months ended December 31, 2020 (Press release, Quanterix, MAR 2, 2021, View Source [SID1234575937]).

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"Responding to the pandemic crisis as well as advances in therapies to treat Alzheimer’s has accelerated our leadership of precision health and the proteomics revolution," said Chairman, Chief Executive Officer and President, Quanterix, Kevin Hrusovsky. "There is a strong demand for ultra-sensitive protein analytical tools to support disease studies, diagnostics and drug development as the COVID focus shifts from battling the acute virus to the long-hauler impact of the virus on organ and overall human health (CNS, Cardiac, Respiratory, Immunology, etc). We enter 2021 on strong footing as we scale Quanterix to support this unprecedented opportunity."

Fourth Quarter 2020 Financial Highlights

Key financial results for the four quarter of 2020 are shown below:

Q4 GAAP total revenue, which includes Grant Revenue, was $26.1M versus prior year Q4 of $15.9M;
Q4 non-GAAP total revenue was $21.6M versus prior year Q4 of $15.9M, an increase of 36%;
Q4 GAAP product revenue was $15.7M versus prior year Q4 of $11.4M, an increase of 38%;
Q4 GAAP service and other revenue was $5.5M versus prior year Q4 of $4.3M, an increase of 28%
Full Year 2020 Financial Highlights

Key financial results for FY 2020 are shown below:

FY GAAP total revenue, which includes one-time License Revenue and Grant Revenue, was $86.4M versus prior year FY of $56.7M;
FY non-GAAP total revenue was $68.8M versus prior year FY of $56.7M, an increase of 21%;
FY GAAP product revenue was $44.0M versus prior year FY of $40.5M, an increase of 9%;
FY GAAP service and other revenue was $24.1M versus prior year FY of $16.1M, an increase of 50%
For additional information on the non-GAAP financial measures included in this press release, please see "Use of Non-GAAP Financial Measures" and "Reconciliation of Non-GAAP Financials" below.

Fourth Quarter and Full Year Business Highlights

Awarded an $18.2M contract with the NIH through its RADx initiative to accelerate the continued development and scale-up of a novel SARS-CoV-2 antigen test.
Received FDA Emergency Use Authorizations for novel SARS-CoV-2 antigen test (after year-end) and for semi-quantitative antibody test, underscoring our longstanding science-first mentality and deep dedication to the highest standards of quality and scientific rigor across our business.
Leveraging the unparalleled ultra-sensitivity of Simoa, enabled several leading researchers globally, including at the NIH, to begin tackling leading-edge COVID challenges, such as establishing potential for blood based anti-viral endpoints for new drug therapies and understanding the long-term complications of COVID-19.
Expanded our differentiated Neurology menu to include tau phosphorylated at threonine 181 (pTau-181), a highly specific biomarker for the study of Alzheimer’s disease pathology, in cerebral spinal fluid (CSF), serum and plasma as well as launched Neuro Multiplex assays associated with many neurodegenerative diseases. Our biomarker portfolio is now supporting leading Alzheimer’s programs globally and a growing body of research, including work published recently in The Lancet Neurology. This work suggests that blood pTau-181 levels could prove critical to predicting Alzheimer’s disease progression and differentiating the disease from other neurodegenerative disorders, marking a critical step toward AD early detection, clinical trial advancements, improved patient triaging and asymptomatic screening.
Novartis’ multiple sclerosis (MS) drug KESIMPTA (ofatumumab), which utilized Nf-L as secondary endpoint, was approved by the FDA.
Quanterix’ Simoa technology was highlighted in a record 443 new publications in 2020, bringing total Simoa-specific inclusions to over 1,120. Also, was invited to present at several marquis symposiums showcasing our Precision Health vision and potential to catalyze asymptomatic medicine.
Instrument installed base increased by 34% in 2020 to 535, despite access challenges posed by COVID-19. This includes 93 HD-X placements with over 50% new installations and 84 new SR-X and SP-X placements.
Solidified Simoa’s technological leadership by achieving a 100x sensitivity improvement in a pilot of the digital enzyme-linked immunosorbent assay (ELISA) that powers the Company’s HD-X and SR-X Ultra-Sensitive Biomarker Detection Systems.
Entered into a non-exclusive royalty-bearing license agreement with Abbott Laboratories, to grant Abbott access to Quanterix’ portfolio of bead-based technology patents for use in in-vitro diagnostic (IVD) applications.
Realized multi-category revenue opportunities with one of the largest multi-national, healthcare payor groups, with execution of multiple population surveillance studies, creating beachhead for our vision for the future of precision medicine, where early and non-invasive disease detection has the potential to transform life and healthcare costs.
Successfully raised ~$385 million in gross proceeds across 2020 and early-2021 through our follow-on offerings, further strengthening our balance sheet with growth capital.
William Geist joined Quanterix as Chief Operating Officer to help us sustain and grown our strong momentum across numerous digital biomarker platforms.
Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on March 2 at 4:30 p.m., EST. Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 4438067. A live webcast will also be available at: View Source The webcast will be available on the Company’s website, View Source, for one year following completion of the call.

On March 2, 2021 NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a clinical-stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported positive new preclinical data investigating first-in-class radioenhancer NBTXR3, which is being evaluated as a tumor-agnostic, combo-agnostic product candidate across several tumor types (Press release, Nanobiotix, MAR 2, 2021, View Source [SID1234575936]). The data is being shared via poster presentation at the first American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Special Conference on Radiation Science and Medicine, held March 2-3, 2021, by researchers from the University of Texas MD Anderson Cancer Center (MD Anderson).

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PRECLINICAL DATA ON NBTXR3 COMBO

NBTXR3 is composed of sterile, functionalized, crystalline hafnium oxide nanoparticles that are delivered by intratumoral injection one time prior to radiotherapy (XRT). After activation by XRT, the product candidate has a physical primary mechanism of action through which a higher dose of radiation is delivered within the tumor, enhancing the tumor-killing effect of XRT without increasing the dose in surrounding healthy tissues. The subsequent biological secondary mechanism of action that we are evaluating is the potential activation of several immune pathways upon tumor cell destruction, generating adaptive immune response within the body.

NBTXR3 is being evaluated in an expansive global development plan both as a single agent activated by XRT and in combination with other anti-cancer therapies including chemotherapy and immune checkpoint inhibitors. This study examined NBTXR3 activated by XRT in combination with anti-PD-1 along with TIGIT and LAG3 inhibitors in an in vivo anti-PD-1 resistant mouse model (344SQR).

Key Findings Include:

The combination therapy of NBTXR3 + XRT + anti-PD-1 + anti-LAG3 + anti-TIGIT (Combo therapy) significantly promoted the proliferation activity of CD8+ T cells, improved local and distant tumor control, and increased survival rate
The anti-tumor efficacy of the Combo therapy was heavily dependent on CD4+ and CD8+ Tcells
The survivor mice from the groups treated with the Combo therapy were immune to re-injections of tumor cells
The survivor mice maintained significantly higher percentages of memory CD4+ and CD8+ T cells, as well as stronger anti-tumor immune activities than control
The Combo therapy augmented anti-tumor response in both irradiated and unirradiated (abscopal) tumors
POSTER PRESENTATION

Title: Integration of anti-TIGIT and anti-LAG3 with NBTXR3-mediated Immunoradiation Therapy Improved Abscopal Effect and Induces Long-term Memory Against Cancer
Timing: View on-demand starting at 9:30am EST on March 2, 2021 on Virtual Conference platform
Poster Number: PO-040
***

About NBTXR3

NBTXR3 is a first-in-class radioenhancer composed of sterile, functionalized, crystalline hafnium oxide nanoparticles. The product candidate is designed to increase the radiotherapy energy deposit inside tumor cells through the nanoparticles’ high atomic number core packaged in the space for interaction with ionizing radiation, and subsequently increase of tumor cell death when compared to radiotherapy alone—without adding toxicity to adjacent healthy tissues. NBTXR3 requires a single, intratumoral administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The primary physical mechanism of action of NBTXR3 activated by radiotherapy could be universal, making it potentially applicable across any solid tumor indication where radiotherapy is a part of standard of care including head and neck, lung, prostate, liver, colorectal, and esophageal cancers. The biological secondary mechanism of action of NBTXR3 activated by radiotherapy has been shown in preclinical studies to prime adaptive immune response, which would potentially bring a new dimension to cancer immunotherapies.

On March 2, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported financial results for the year ended December 31, 2020 and provided a corporate update (Press release, Cellectar Biosciences, MAR 2, 2021, View Source [SID1234575935]).

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Fourth Quarter and Recent Corporate Highlights

Received Orphan Drug Designation from the European Commission for CLR 131 in Waldenstrom’s macroglobulinemia (WM) which provides certain benefits including protocol assistance, reduced EU regulatory filing fees and 10 years of European market exclusivity

Initiated pivotal study of CLR 131 in Waldenstrom’s macroglobulinemia (CLOVER-WaM)

Pivotal study is designed as a global, non-comparator, single arm, expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of CLR 131 and is in alignment with feedback received from the U.S. Food and Drug Administration from the September 2020 guidance meeting
The study will enroll 50 WM patients who have failed first-line therapy, have failed to respond to a BTK inhibitor (i.e., ibrutinib) or had a suboptimal response
The primary endpoint of the study is response rate defined as a partial response or better (a minimum of a 50% reduction in the biological marker IgM)
Announced Closing of $45.0 Million Underwritten Public Offering and Concurrent Private Placement

Announced CLR 131 demonstrated preliminary activity in inoperable brain tumors in an international open label, dose escalation Phase 1 safety study of children and adolescents with relapsed or refractory cancers, specifically high-grade gliomas, high risk neuroblastomas and select soft tissue sarcomas

CLR 131 was measured in brain tumors, confirming that systemic administration of CLR 131 crosses the blood brain barrier and is delivered into tumors
Initial activity was expected to occur at doses of 60 mCi/m2 and higher; disease control has been noted at lower dose levels in heavily pretreated patients with ependymomas
"2020 was an important year for Cellectar, having announced key data from our Phase 2a CLOVER-1 study; having gained clarity on our Waldenstrom’s macroglobulinemia regulatory strategy after a positive meeting with the FDA in the Fall; and having completed a successful capital raise to support our WM pivotal study to our anticipated marketing approval date," said James Caruso, president and CEO of Cellectar. "We are fully engaged in the execution our CLR 131 clinical programs, prioritizing the WM pivotal study, enriching our refractory multiple myeloma data sets, and advancing our pediatric study. In parallel, we continue our research to better understand the unique potential of our delivery platform and look forward to sharing additional data."

2020 Financial Highlights

Cash and Cash Equivalents: As of December 31, 2020, the company had cash and cash equivalents of $57.2 million compared to $10.6 million at December 31, 2019. Cash provided by financing activities was $60.5 million, offset by cash used in operating activities of $13.9 million. The company believes its cash on hand is adequate to fund basic budgeted operations for at least 12 months from the filing of these financial statements.

Research and Development Expense: Research and development expense for the year ended December 31, 2020 was $10.1 million, compared to $9.0 million for the year ended December 31, 2019. The overall increase in research and development expense of approximately 13% was primarily attributable to an increase in general research and development costs resulting from increased personnel-related costs. Manufacturing and related costs decreased due to a reduction in materials production processes and related costs. Clinical and pre-clinical project costs were relatively consistent.

General and Administrative Expense: General and administrative expense for the year ended December 31, 2020 was $5.1 million, compared to $5.2 million for the year ended December 31, 2019. The decrease of approximately 1% in general and administrative costs was primarily related to a decrease in personnel and public company expenses offset by an increase in legal fees and business insurance.

Net Loss: The net loss attributable to common stockholders for the year ended December 31, 2020 was ($15.1) million, or ($0.76) per share, compared to ($14.1) million, or ($1.84) per share, in 2019.