On October 7, 2020 Guardant Health, Inc. (Nasdaq: GH) ("Guardant Health"), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported the pricing of an underwritten public offering of 7,000,000 shares of its common stock at a public offering price of $102.00 per share, before deducting underwriting discounts and commissions, all of which are being sold by SoftBank Investment Advisers (Press release, Guardant Health, OCT 7, 2020, View Source [SID1234568203]). In addition, SoftBank Investment Advisers has granted the underwriter a 30-day option to purchase up to 700,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions. Guardant Health is not selling any of its shares in the offering and will not receive any of the proceeds from the sale of shares in the offering by SoftBank Investment Advisers. The offering is expected to close on October 9, 2020, subject to the satisfaction of customary closing conditions.

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J.P. Morgan Securities LLC is acting as sole book-running manager of the offering.

The public offering is being made pursuant to an automatic shelf registration statement on Form S-3 that was filed by Guardant Health with the U.S. Securities and Exchange Commission (the "SEC") and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus, when available, may be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected].

On October 7, 2020 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported that highlighted the use of its licensed drug – aldoxorubicin – in the combination immunotherapy used by ImmunityBio, Inc. and NantKwest, Inc. to treat former Senate Majority Leader Harry Reid’s stage IV pancreatic cancer (Press release, CytRx, OCT 7, 2020, View Source [SID1234568202]). It was widely reported in June 2020 that former Senator Reid described himself as being in "complete remission" after receiving experimental treatment pioneered by the Chief Executive Officer of ImmunityBio and NantKwest.1

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Earlier this year, CytRx highlighted that ImmunityBio and NantKwest announced the initiation of a Phase 2 randomized, two-cohort, open-label study for first and second-line treatment of locally advanced or metastatic pancreatic cancer (QUILT-88). The study received Food and Drug Administration ("FDA") authorization and was slated to initially enroll 268 subjects across both cohorts. It has been indicated that enrollment was expected to begin in June 2020.

"We wish former Senator Reid the best now that he is reportedly in complete remission and hope that his combination immunotherapy treatment can become the basis for treating other individuals with pancreatic cancer," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "Although former Senator Reid is only one person and other comprehensive studies and trials are necessary and required, we continue to be encouraged with the progress and results of this promising pancreatic cancer treatment that includes aldoxorubicin."

CytRx out-licensed global development, manufacturing and commercialization rights for aldoxorubicin to ImmunityBio in 2017. The Company has an agreement with ImmunityBio that can yield up to $343 million in potential milestone payments as well as prospective royalties on sales of aldoxorubicin.

On October 7, 2020 OncoNano Medicine, Inc. reported positive results from its ongoing Phase 2a study of ONM-100, an innovative imaging agent used in intraoperative surgical resection of solid tumors (Press release, OncoNano Medicine, OCT 7, 2020, View Source [SID1234568201]). The data, presented today at the World Molecular Imaging Congress (WMIC) Virtual 2020, demonstrate successful imaging of various solid tumors.

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"As low pH is a hallmark of all solid tumors, our novel imaging agent ONM-100 has the potential to become a useful tool for successful tumor resection surgeries," said Ravi Srinivasan, Ph.D., President of OncoNano Medicine. "These data indicate that ONM-100 was well-tolerated and was able to visualize various solid tumor types. We are encouraged by these findings and are excited to continue developing ONM-100 to address this persistent and challenging unmet need in detection of cancer."

OncoNano is currently enrolling patients in the Phase 2a trial to further evaluate the safety and pharmacokinetic/pharmacodynamic (PK/PD) profile of ONM-100. More information can be found at ClinicalTrials.gov

Presentation Overview

TITLE: Image Guided Robotic Prostatectomy Using the pH-Activated Micellar Imaging Agent ONM-100 – A Phase 2 Study of Tumor and Camera Agnostic Detection of Solid Cancers

PRESENTER: Aditya Bagrodia, M.D., Assistant Professor, Department of Urology, University of Texas Southwestern Medical Center

Results announced today are based on 16 patients with various cancers (4 breast, 5 head and neck, 6 prostate and 1 ovarian), all of whom received a single intravenous dose of ONM-100 the same day as, or previous to the day of surgery. The findings indicate that ONM-100:

Is well tolerated at doses 3X higher than doses administered in Phase 1
Detects pathologically confirmed tumor regions through the prostatic capsule, indicating imaging feasibility during robotic prostatectomy
Demonstrates ability to provide fluorescence signals even within a few hours after dosing, which combined with a half-life > 55 hours enables a wide imaging window
Can feasibly image breast, head and neck, prostate, and ovarian cancers.
About ONM-100

ONM-100 is OncoNano’s lead product candidate under development. ONM-100 utilizes a proprietary pH-sensitive micelle platform to encapsulate a fluorescent tag and exploit a universal biomarker of all solid cancers – the relatively acidic pH of the tumor microenvironment – to intraoperatively image tumors. ONM‑100 micelles remain inactive at normal physiological pH until exposure to the acidic tumor microenvironment triggers micelle dissociation and fluorescent tag activation. This has the potential to make tumors visible during surgery with standard surgical imaging equipment. ONM-100 is currently in Phase 2 clinical trials. ONM-100 was partially funded for clinical research by the Cancer Prevention and Research Institute of Texas (CPRIT).

On October 7, 2020 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 it was selected to present at the 2020 BIO Investor Forum conference to be held virtually from October 13-15, 2020 and will be participating at the BIO-Europe partnering conference to be held virtually from October 26-29, 2020 (Press release, Greenwich LifeSciences, OCT 7, 2020, View Source [SID1234568200]).

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At the BIO Investor Forum, Snehal Patel, CEO of Greenwich LifeSciences will present and will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. The presentation will highlight the Company’s GP2 program and its plans to commence a Phase III clinical trial, will include a pre-recorded audio track available to conference attendees on demand, and will be simultaneously made available on the investor section of the Company’s website at: View Source

At the BIO-Europe partnering conference, the Company will seek to meet with international pharmaceutical companies seeking to license marketing rights for promising therapeutics for their respective regions. The Company previously initiated a global and regional out-licensing process with industry leading advisor, Torreya Partners, which is expected to continue as the upcoming GP2 Phase III trial commences.

About BIO Investor Forum

The 19th annual BIO Investor Forum is an international biotech investor conference focused on early and established private companies as well as emerging public companies. The event features plenary sessions, business roundtables and therapeutic workshops, company presentations, and scheduled one-to-one meetings. For more information, please visit the conference website at: View Source

About BIO-Europe

The 26th annual BIO-Europe global life sciences partnering conference includes access to company pitches, program sessions, and sponsor and showcase company content. The event is expected to bring together over 4,000 executives from more than 2,000 life sciences companies spanning an estimated 60+ countries. Program content includes business development, therapeutic areas, startup innovations, digital health, and scheduled one-to-one meetings. For more information, please visit the conference website at: https://informaconnect.com/bioeurope/

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 October 7, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) a novel bioelectric medicine company progressing Nano-Pulse Stimulation (NPS) technology, reported that clinical results from studies spanning the Company’s dermatologic application portfolio will be presented at the American Society for Dermatologic Surgery (ASDS) virtual annual meeting on October 9-11, 2020 (Press release, Pulse Biosciences, OCT 7, 2020, View Source [SID1234568199]). Positive study results generated using the Company’s innovative cellular-specific Nano-Pulse Stimulation mechanism performed with its CellFX System for the treatment of sebaceous hyperplasia lesions, cutaneous non-genital warts, plantar warts, and basal cell carcinoma will be presented in two oral presentations and two e-posters.

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These newest published results from NPS clinical studies provide further evidence of the unique CellFX cellular mechanism of action for multiple applications across the lesion treatment spectrum. These recent findings were also the basis for the recently initiated multicenter clinical study to compare NPS technology to RF electrodessication in clearing sebaceous hyperplasia lesions. Treatment of the first study patient was previously announced by the Company on October 1, 2020.

"The positive results being shared at this year’s ASDS meeting add to the growing body of evidence in support of using Nano-Pulse Stimulation technology delivered by the CellFX System to treat a broad range of dermatology applications for which targeted clearance of cellular lesions or structures is medically or cosmetically desirable," said Darrin Uecker, President and CEO of Pulse Biosciences. "These data underscore our persistent dedication to providing dermatologists a highly differentiated non-thermal solution with vast opportunity."

Highlights from this meeting of leading dermatologic surgeons demonstrate:

Successful use of lower NPS energy levels to maintain high levels of effectiveness in clearing sebaceous hyperplasia lesions with greatly improved cosmesis and high subject satisfaction
Favorable clearance rate for warts on the hands, leg, knee, neck; no plume detected in a subset of NPS procedures
Encouraging findings of biopsy-confirmed elimination of residual BCC in the known NPS treatment zone for 8 nodular BCCs and 21 superficial BCCs, indicating promising potential for NPS treatment of both BCC-subtypes
Strong clearance rate of difficult-to-treat, recalcitrant plantar warts in a single treatment session
Dr. Ted Lain, author of the non-genital cutaneous wart study, said: "We are pleased to present conclusive evidence of consistently high rates of clearance across a variety of anatomical areas in one to two NPS treatments. Compared to today’s standard wart treatments, which typically require two to four visits to clear common cutaneous warts, these NPS results represent a much more convenient approach for the patient and the physician." Dr. Lain is Chief Medical Officer of Sanova Dermatology in Austin, TX.

Members of the dermatologic surgery community who have registered for the virtual meeting can gain access to accepted video presentations and posters at the ASDS meeting portal. The listed dates and times below are subject to change.

Title

Lead Author Session Information
A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation (NPS) for Treatment of Cutaneous Non-Genital Warts

Edward (Ted) Lain, MD,
Chief Medical Officer of Sanova Dermatology, Austin, TX

Oral Presentation
(narrated video slide set)

Friday, October 9th at

11:15am ET

General Derm Track

Nano-Pulse Stimulation (NPS) Procedure to Treat Sebaceous Hyperplasia – A Dose-Ranging, Multi-Center, Pivotal Study

Girish (Gilly) Munavalli, MD,
Medical Director of Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC.

Oral Presentation
(narrated video slide set)

Saturday, October 10th at

11:00 to 11:45am ET

Cosmetic Track

A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation (NPS) Technology for Cutaneous Warts on the Feet

Brenda LaTowsky, MD,
Clear Dermatology& Aesthetics Center, Scottsdale, AZ

Poster Presentation
A first human feasibility study of Nano-Pulse Stimulation (NPS) to evaluate the potential elimination of a biopsy-confirmed nodular or superficial BCC in a short-term treat and resect study design

Christopher B. Harmon, MD,
Mohs surgeon and founder of Surgical Dermatology Group, Birmingham, AL

Poster Presentation
"We are thrilled to showcase our latest research and congratulate the American Society for Dermatology Surgery for hosting this important scientific exchange with aesthetic and surgical dermatology professionals as we work toward commercial introduction of our CellFX System powered by Nano-Pulse Stimulation technology," said Ed Ebbers, Pulse’s Executive Vice President and General Manager, Dermatology.