On May 10, 2022 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported financial results for the three months ended March 31, 2022 (Press release, Quanterix, MAY 10, 2022, View Source [SID1234614106]).

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"This is a pivotal time for growth in neurology and therapeutics, marked by breakthroughs in some of the world’s biggest health threats, including Alzheimer’s disease and multiple sclerosis (MS)," said Masoud Toloue, Chief Executive Officer, Quanterix. "I’m excited for the opportunity to lead Quanterix through this next chapter, and looking ahead, we’ll focus on several transformational changes around scaling with quality, innovation, and our ability to translate ultra-sensitive biomarker detection to help researchers and pharmaceutical companies drive earlier disease detection, better prognoses, and enhanced treatment methods."

Toloue continued, "Q1 revenue was in line with our expectations and full-year goals; however, gross margin fell well short of our expectations. As part of our larger goal of scaling with quality, we are implementing specific changes to our inventory management and quality processes, which we expect will improve our gross margins going forward."

First Quarter 2022 Financial Highlights

Key financial results for the first quarter of 2022 are shown below:

•Q1 total revenue was $29.6M versus prior year Q1 of $27.2M(1), an increase of 9%;
•Q1 product revenue was $20.7M versus prior year Q1 of $18.2M, an increase of 13%;
•Q1 service and other revenue was $8.8M versus prior year Q1 of $6.4M, an increase of 37%; and
Q1 gross margin was 49.3% versus prior year Q1 gross margin of 60.1%.

(1)Q1 2021 total revenue includes $2.3M in RADx-related grant revenue.

First Quarter Business Highlights

§Quanterix announced new agreements with Lilly to advance Alzheimer’s disease diagnosis and treatment; the agreements provide Quanterix access to Lilly’s P-tau217 antibody technology to create pathways for plasma-based biomarkers for use in Alzheimer’s disease and establishes framework for future collaboration and supports development of Quanterix tests to advance diagnosing and treating life-threatening diseases. Quanterix recognized $2.7M in service revenue during the first quarter of 2022 under these agreements.
§Quanterix received funding from the Alzheimer’s Drug Discovery Foundation (ADDF) to accelerate Alzheimer’s disease diagnostic plasma test development; the funding will power a series of prospective clinical trials to validate Quanterix’ multi-analyte test in collaboration with Amsterdam University Medical Centers (Amsterdam UMC).
§Quanterix’ Simoa technology powered a major breakthrough in Epstein-Barr Virus and MS, which was featured in the Journal of Science.

•Academic publication pull-through performance continued to be strong; Quanterix’ Simoa technology was highlighted in a record 151 new publications in the first quarter 2022, bringing total Simoa-specific inclusions to over 1,735.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on May 10, 2022 at 8:30 a.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: 4589034.

A live webcast will also be available at: View Source You may also access the live webcast by visiting the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. The webcast will be available on the Company’s website for one year following completion of the call.

On May 10, 2022 Agilent Technologies Inc. (NYSE: A) reported that its PD-L1 IHC 22C3 pharmDx, Code SK006, is now EU CE-IVD–marked for use in cervical cancer. PD-L1 IHC 22C3 pharmDx can be used as an aid in identifying cervical cancer patients for whom treatment with KEYTRUDA (pembrolizumab) may be appropriate (Press release, Agilent Technologies, MAY 10, 2022, View Source [SID1234614137]).1 KEYTRUDA is an anti-PD-1 therapy developed by Merck (known as MSD outside the U.S. and Canada). In Europe, KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 1].2

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PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as KEYTRUDA whose therapeutic value is being demonstrated across a growing list of cancer types. Globally, cervical cancer is the fourth most common cancer among women,3 with approximately 30,447 new cases diagnosed in Europe in 2020.4

Sam Raha, president of Agilent’s Diagnostics and Genomics Group, discussed the impact of the updated labeling. "PD-1/PD-L1-targeted immunotherapies such as KEYTRUDA have become important cancer treatment options for a growing number of patients. With this European indication expansion of PD-L1 IHC 22C3 pharmDx into cervical cancer, pathologists have access to reliable diagnostic results, supporting even more cancer patients who could benefit from targeted therapies."

Currently, PD-L1 IHC 22C3 pharmDx is the only CE-IVD marked companion diagnostic indicated as an aid in identifying cervical cancer patients with PD-L1 CPS ≥ 1 for treatment with KEYTRUDA. This indication expansion extends the scope of patients who can be tested to determine eligibility for KEYTRUDA, and further strengthens Agilent’s leadership position as a partner in the development of IHC-based diagnostics for targeted cancer therapies.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

1. PD-L1 IHC 22C3 pharmDx [Instructions for Use]. Santa Clara, CA: Agilent Technologies, Inc. (2022).
2. Keytruda [Summary of Product Characteristics]. European Medicines Agency (2022).
3. WHO. Cervical cancer, Key facts. www.who.int/news-room/fact-sheets/detail/cervical-cancer (accessed May 09, 2022).
4. European Cancer Information System (ECIS), European Commission. Cervical cancer burden in EU-27. View Source (accessed May 09, 2022).

On May 10, 2022 Bio-Path Holdings, Inc., (NASDAQ: BPTH) a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it will host a live conference call and audio webcast on Tuesday, May 17, 2022 at 8:30 a.m. ET to report financial results for the first quarter ended March 31, 2022 and to provide a business overview (Press release, Bio-Path Holdings, MAY 10, 2022, View Source [SID1234614170]).

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To access the live conference call, please call (844) 815-4963 (domestic) or (210) 229-8838 (international) at least five minutes prior to the start time and refer to conference ID 9488426. A live audio webcast of the call will also be available on the Presentations section of the Company’s website, www.biopathholdings.com. An archived webcast will be available on the Bio-Path website approximately two hours after the event.

On May 10, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company’s senior management team will participate in a fireside chat at the 2022 RBC Capital Markets Global Healthcare Conference on Tuesday, May 17, 2022 at 4:35 p.m. ET in New York, NY (Press release, Karyopharm, MAY 10, 2022, View Source [SID1234614025]).

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A live webcast of the fireside chat can be accessed under "Events & Presentations" in the Investor section of the Company’s website, View Source, and will be available for replay for 90 days following the event.

On May 10, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported an update on the progress made in the Company’s two lead development programs (Press release, Celsion, MAY 10, 2022, View Source [SID1234614059]).

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"We continue to make important progress in both of our lead development programs, and I am very pleased by the encouraging results to date," said Michael H. Tardugno, chairman, president and chief executive officer of Celsion. "Our PLACCINE DNA-based vaccine platform was recently highlighted at the 2022 World Vaccine Congress and is demonstrating its potential for rapid design and capability for targeting two or more different COVID variants in one vaccine. We have demonstrated a proof-of-concept utilizing a standard mouse model showing that PLACCINE can target two variants and produce robust levels of IgG, neutralizing antibodies, and t-cell responses. This proof-of-concept data is comparing favorably to commercial vaccines in mouse models with this data recently reported at the World Vaccine Congress. A vaccine that targets multiple strains at once and designed to provide long lasting immunity, is important in a future COVID-19 vaccination strategy. We are moving this program forward quickly and anticipate confirming our proof-of-concept in non-human primates over the next several months, with durability results later this year."

Mr. Tardugno continued, "OVATION 2, the Phase II study of our GEN-1 immunotherapy in ovarian cancer is 85% enrolled. In spite of all of the challenges presented by COVID 19, we are hopeful to complete enrollment in the third quarter of this year. Preclinical and clinical data gives us every reason to believe in GEN-1’s promise for ovarian cancer patients along with the support from leading medical researchers of the Gynecological Oncology Group (GOG). The GOG’s interest in forging a partnership to develop GEN-1 in ovarian cancer will assist Celsion in its plans for an accelerated registrational program. Meanwhile, FDA has approved our protocol for a second Phase II clinical trial to evaluate GEN-1 in combination with Avastin (bevacizumab) in patients with advanced ovarian cancer. Our preclinical tumor inhibition data provides a convincing basis for this study. We look forward to initiating this study at major comprehensive cancer hospitals later this year."

About PLACCINE

PLACCINE is a first in class DNA vaccine platform that can target multiple antigens and be administered with a standard intramuscular injection. PLACCINE was derived from the Company’s proprietary TheraPlas platform.

About GEN-1

GEN-1, an IL-12 DNA plasmid vector formulated into nanoparticles with a lipopolymeric delivery system, is the first product designed via the TheraPlas platform technology. GEN-1 may prove to be a safe and effective immunotherapy for treating various types of tumors by producing high levels of interleukin-12 (IL-12) at the site of tumors. IL-12 is one of the most active cytokines for stimulating an immune response against cancer. However, when administered as a recombinant protein requiring systemic administration, the pharmacokinetics of IL-12 requires that it be given by frequent, large bolus injections, resulting in serious toxicities that limit its use. GEN-1 addresses the toxicity issues associated with systemic IL-12. GEN-1’s nanoparticle design enables local administration (into the abdominal cavity) and cell transfection followed by persistent, local secretion of IL-12 at therapeutic levels, while avoiding the toxicities associated with recombinant IL-12.