On September 29, 2020 Greenwich LifeSciences, Inc. (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 the closing of its initial public offering of 1,260,870 shares of its common stock at a public offering price of $5.75 per share for gross proceeds of $7,250,002, before deducting offering expenses (Press release, Greenwich LifeSciences, SEP 29, 2020, View Source [SID1234567756]). In addition, the Company has granted the underwriter a 45-day option to purchase up to 189,130 additional shares of common stock at the public offering price, less the underwriting discount, to cover over-allotments, if any. The shares began trading on The Nasdaq Capital Market on September 25, 2020, under the symbol "GLSI."

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Aegis Capital Corp. acted as the sole book running manager.

A registration statement relating to the shares of common stock being sold in this offering was declared effective by the Securities and Exchange Commission (the "SEC") on September 24, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained on the SEC’s website, www.sec.gov, or by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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 September 29, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the company’s participation at the Digital World CB & CDx meeting which will be held online, September 29-October 1, 2020 (Press release, Personalis, SEP 29, 2020, View Source [SID1234567755]).

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Personalis will present "Enabling the Expansive Interrogation of a Tumor & Its Microenvironment from a Single Sample for Translational Research and Precision Medicine," featuring the Personalis universal cancer immunogenomics platform, ImmunoID NeXT. Kedar Hastak, PhD, will present for Personalis.

Dr. Hastak will discuss challenges facing immuno-oncology translational and clinical researchers and review the importance of insights into the complex and dynamic interactions between the tumor and immune cells of the cancer microenvironment. He will present the company’s solution to these barriers, ImmunoID NeXT, that consolidates multiple biomarker assays into one, providing a multidimensional view of the tumor and its microenvironment. He will also talk about the Personalis diagnostic initiatives, NeXT Dx, which supports patient management and biomarker-driven clinical trials, and NeXT CDx, a comprehensive companion diagnostic platform.

On September 29, 2020 US Oncology Research, one of the largest community-based oncology research site management organizations in the U.S., reported that it is celebrating the significant milestone of contributing to the FDA approval of over 100 cancer therapies (Press release, US Oncology, SEP 29, 2020, View Source [SID1234567753]). This achievement is a result of the hard work and dedication to research from more than 165 research locations conducting over 1,600 clinical trials for cancer therapy. More than 80,000 participants have enrolled in clinical trials since 1999.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"US Oncology Research’s core mission is to bring potentially life-saving and life-improving treatments to the community where patients seek care," said Robert L. Coleman, MD, FACOG, FACS, chief scientific officer, US Oncology Research. "These new interventions come from expert stewardship and execution of clinical research protocols positioned to better understand cancer biology and challenge the status quo. We are, therefore, incredibly proud of this milestone, which reflects the dedication and collective spirit of investigators across The US Oncology Network, committed to defining the next treatment standard. Research is a team sport dedicated to the individual patient."

With each approved therapy, real patient stories reflect the hope and potential that new science brings. One such patient is Henry "Ray" Picagli, who consulted with his oncologist, James H. Essell, MD, at Cincinnati-based OHC (Oncology Hematology Care), after his lymphoma returned after chemotherapy. "Dr. Essell told us about the CAR-T clinical trial OHC was offering for patients in my exact situation and that he thought I would be a good candidate for the investigational treatment," said Picagli. "I was immediately all-in for two reasons. Obviously, I want to live, but I also want others to benefit from what I’m doing, even if it helps only one person."

Today, Ray’s scans are clear, and he is in remission. "I spoke with friends in the medical field," added Picagli. "Everyone said the same thing: ‘You have no idea how lucky you are to be able to get this investigational treatment and that it’s available at OHC. And they were right.’"i

OHC is one of 68 community-based practices in The US Oncology Network, including about 482 sites of care and more than 1,350 physicians, many of which offer their patients a chance to participate in advanced clinical trials. "Usually available only in major academic medical centers or hospital systems, these novel cancer trials are accessible to patients close to home, right in their own communities," said Michael Seiden, MD, PhD, president of The US Oncology Network. "With about 400 active trials at any given time, US Oncology Research is making a tangible difference in the lives of patients."

Having access to a state-of-the-art clinical trial has made all the difference for Laura Reith, who was diagnosed with stage IV triple negative breast cancer just months after delivering a baby. "I wanted to stay closer to home so I could continue with my life," said Reith, who enrolled in a trial under the guidance of her physicians at Illinois Cancer Specialists (ICS), a practice in The US Oncology Network. "I work full-time. I have small kids. It would be difficult to spend a full day in a hospital hours away." Now in her 39th round of treatment in the trial, which she started in 2018, she shows no signs of disease.ii

"It’s all about having the right advocate in your corner. I’m so thankful to have a team of physicians that cares about more than just the dollars – they care about not only my journey but about the future," said Reith. "Being on a clinical trial has provided me hope above all. Hope for more time with my kids. Hope for a future without cancer."

On September 29, 2020 Sema4, a patient-centered health intelligence company, reported that it has entered into a research agreement with Janssen Research & Development, LLC (Janssen) to optimize oncology clinical trials (Press release, Sema4, SEP 29, 2020, View Source [SID1234567751]). Together, Sema4 and Janssen will utilize genomic testing and advanced data analytics to more efficiently and accurately identify patients diagnosed with cancer who may be candidates for oncology clinical trials.

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Approximately 1.8 million people are expected to be diagnosed with cancer in the US in 2020, yet only a small percentage of adult patients participate in oncology clinical trials each year, despite clinical trials evaluating promising investigational therapies. Suboptimal patient recruitment is a significant rate-limiting factor in clinical trials that can lead to studies using excessive resources and time, and being underpowered or even abandoned.

To address this problem, Sema4 will provide Janssen access to two of the company’s key assets: industry-leading genomic testing and its proprietary Centrellis health intelligence platform. Centrellis utilizes automated natural language processing capabilities, complemented by PhD oncology curators, to extract critical information regarding patient characteristics from electronic medical record (EMR) data.

Sema4 will deploy its advanced analytics capabilities to apply Janssen’s clinical trial recruitment criteria to Sema4’s large pool of deidentified clinical and genomic patient data to evaluate if a patient may benefit from one of Janssen’s clinical trials.

"Sema4 is passionate about improving patient care through its work with patients, providers, and biopharmaceutical companies," said Eric Schadt, PhD, Founder and Chief Executive Officer of Sema4. "We are delighted to collaborate with Janssen to utilize our technology and digital expertise and market-leading science experience to potentially accelerate trial recruitment times, with the goal of more treatment options becoming available to patients more quickly."

The collaboration with Janssen follows several other significant developments for Sema4 since the beginning of 2020. Earlier in the year, Sema4 released several software solutions to enable biopharmaceutical partners to rapidly find patients matching clinical trial recruitment criteria and effectively and efficiently design new clinical trials. The company also announced an alliance with artificial intelligence informatics company VieCure, provider of an oncology EMR and point-of-care decision support system, to further enable its national clinical trial support capabilities.

Additionally, Sema4 this year launched its Sema4 Signal Whole Exome/Transcriptome Sequencing (WES/WTS) offering, which is available to biopharmaceutical companies, and became the first commercial laboratory to be approved by the New York State Department of Health (NYSDOH) for WES/WTS for solid and hematologic malignancies utilizing tumor-normal analysis. NYSDOH review represents one of the most rigorous levels of validation nationally for such testing.

On September 29, 2020 Genosity Inc., and Olink Proteomics AB reported that they have entered into a strategic services and collaboration agreement within the United States (Press release, Genosity, SEP 29, 2020, View Source [SID1234567749]). This will allow Olink to further expand its innovative protein biomarker discovery services for the U.S. market, while enabling Genosity to add high throughput proteomics to its repertoire of available technologies.

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Genosity is a biotechnology company that currently offers many genomic assays based on DNA and RNA analysis to its pharmaceutical customers for both clinical research and clinical trials applications. Through the collaboration, Genosity will provide wider access to the Olink high-multiplex protein biomarker discovery portfolio by utilizing Genosity’s cutting edge CLIA/GCP/GLP laboratory. Beyond offering the Olink technology within the Genosity laboratory, Genosity will also provide Olink with a path towards further decentralization and commercialization through inclusion of the Olink technology inside the Genosity Integrated Genomics Toolkit (IGT) software solution. The Genosity comprehensive sample to result report system is operational at a number of institutions within the United States that are potential customers for the Olink technology and allows for easier adoption and implementation of innovative and new testing solutions.

"We are excited to introduce another cutting-edge omics platform into our Genomic ecosystem. As we continue to advance precision medicine, we are always looking for new technologies to add to our laboratory service offering. The ability to perform such highly multiplexed, proteomic profiling experiments with the same sequencers we use to sequence Genomes is revolutionary," said Robert Daber, CTO and cofounder of Genosity.

"We are delighted to enter into this strategic partnership with Genosity, which we are confident will broaden the access to our protein biomarker solutions for the wider scientific community in the U.S. We have been greatly impressed during our discussions with Genosity, from their well-established entrepreneurial history in the biotechnology arena, to their clear understanding of precision medicine and Olink’s contribution to this area. Our conversations with Genosity’s existing customers have only strengthened this impression, and they are clearly at the forefront of genomics, bioinformatics and precision oncology. We are genuinely excited about the opportunity to add proteomics to their offering in order to expand and accelerate precision medicine towards clinical applications and patient care," said Erik Pettersson, Head of Business Development, Olink Proteomics.

"Proteomics is becoming an area of increasing interest for research and clinical research applications. Olink’s unique approach has clearly made it the market leader in this innovative area of biomarker discovery. The key to any biomedical innovation is how it will eventually answer a relevant clinical question for patient care. Proteomics and especially Olink have only scratched the surface of their applications, we look forward to working with them as they expand their footprint across this country and beyond," says Marc Grodman MD, cofounder and CEO, Genosity Inc.

About the technology

Olink’s Proximity Extension Assay (PEA) technology utilizes pairs of antibodies linked to complementary oligonucleotides, which are brought into proximity when the antibody binds to the target protein. The proximity results in formation of PCR Target sequence which can be further amplified, detected, and quantified using standard methodologies. The Olink Explore platform currently enables 1536 proteins to measured using less than 3 µL of sample using Next Generation Sequencing (NGS) readout, producing up to 1.3 million protein data measurements per week per Illumina NovaSeq system. Olink’s technology is superior to other immunoassays because using specific DNA oligos prevents any cross-reactivity as a result of unspecific antibody binding, and enables sensitive, rapid, high throughput protein measurements at very high multiplexing levels, consuming minimal sample.