On September 7, 2021 Natera, Inc. (NASDAQ: NTRA) a leader in transforming care through genetic and cell-free DNA testing, reported an agreement with NRG Oncology, a National Cancer Institute (NCI)-funded group, to use the Signatera personalized molecular residual disease (MRD) test in NRG-GI008: Colon Adjuvant Chemotherapy based on Evaluation of Residual Disease (CIRCULATE-US), a prospective, multi-center, randomized clinical trial to investigate MRD-guided treatment strategies for patients with early stage colon cancer (Press release, NRG Oncology, SEP 7, 2021, View Source [SID1234587356]).

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The study will enroll approximately 2,000 patients with stage II or III colon cancer after resection. Patients identified as MRD-negative by Signatera will be randomized to receive either standard-of-care (SOC) adjuvant chemotherapy or observation unless circulating tumor DNA (ctDNA) is subsequently detected during surveillance. Patients identified as MRD-positive will be randomized to receive SOC chemotherapy or an intensified regimen with mFOLFIRINOX. The study’s primary endpoint is to compare disease-free survival in (1) MRD-negative patients between immediate vs. delayed adjuvant chemotherapy, and (2) MRD-positive patients between SOC vs. intensified adjuvant chemotherapy.

The CIRCULATE-US study is part of an international collaboration announced at the ESMO (Free ESMO Whitepaper) 2019 conference to tailor adjuvant chemotherapy using emerging ctDNA technologies. CIRCULATE-Japan, which also uses Signatera to drive adjuvant treatment escalation and de-escalation in patients with resected colon cancer, has already reported promising data1,2 at the ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) GI conferences this year.

"Current standard-of-care guidelines recommend adjuvant chemotherapy for all stage III and high-risk stage II patients, when in reality, only 20%-25%3 of these patients receive any benefit, while everyone is at risk of having side effects,” said Arvind Dasari, M.D., M.S., principal study investigator and associate professor, MD Anderson Cancer Center. "We are pleased to have selected Natera for this study based on the strength and quality of their evidence. We believe Signatera will help us expand the role of ctDNA in identifying patients who are likely to benefit from chemotherapy and those who can be spared."

"We are proud to partner with NRG Oncology on this innovative study that is unlikely to be repeated in the U.S.," said Alexey Aleshin, M.D., Natera’s VP of medical affairs, oncology. "We believe the CIRCULATE-US study could provide definitive evidence to further strengthen Signatera as a potentially predictive biomarker for the management of early stage colon cancer and, in the process, improve outcomes for tens of thousands of patients in this country."

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions.

Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

On September 7, 2021 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer and other senior executives, will participate in two upcoming virtual investor conferences (Press release, ALX Oncology, SEP 7, 2021, View Source [SID1234591863]).

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H.C. Wainwright 23rd Annual Global Investment Conference
Format: Fireside chat with analyst, Swayampakula Ramakanth
Date: Monday, September 13
Time: 7:00 AM Eastern Time
Webcast link: Available here

Cantor Virtual Global Healthcare Conference
Format: Fireside chat with analyst, Alethia Young
Date: Tuesday, September 28
Time: 11:50 AM Eastern Time
Webcast link: Available here

A live webcast of the fireside chats can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com and selecting Events under the News and Events tab. A replay of the webcasts will be archived for up to 90 days following the fireside chat dates.

On September 7, 2021 Provectus Biopharmaceuticals, Inc. (the "Company") reported to disclose the composition of its fully diluted shares of common stock, par value $.001 per share ("Common Stock"), outstanding as of the date hereof in comparison to its fully diluted shares of Common Stock outstanding in 2017 (Press release, 8-K, Provectus Biopharmaceuticals, SEP 7, 2021, View Source [SID1234587292]). The number of authorized shares of preferred stock and Common Stock of the Company are 25,000,000 and 1,000,000,000, respectively.

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2017 Fully Diluted Shares of Common Stock Outstanding

The Company reported on its Form 10-K for the calendar year ending December 31, 2016, filed with the U.S. Securities and Exchange Commission (the "SEC") on March 31, 2017, that certain equity securities were outstanding:

●364,773,297 shares of Common Stock, as of March 10, 2017,
●48,938,841 privately-held warrants to purchase Common Stock with exercise prices ranging from $0.85 to $3.00 ("Private Warrants"). These warrants were issued by the Company in conjunction with historical private placements and to Company consultants and advisors,
●28,482,344 publicly-traded warrants to purchase Common Stock with an exercise price of $0.85 ("Listed Warrants"). These warrants were issued by the Company in conjunction with a public offering that closed on June 24, 2015, and a registered exchange offer that expired on March 28, 2016,
●8,600 shares of the Company’s Series B Convertible Preferred Stock, par value $.001 per share ("Series B Preferred Stock"), and 112,570,356 warrants to purchase Common Stock with an exercise price of $0.0533 ("Ratchet Warrants"), both issued by the Company in conjunction with a public offering of equity securities that closed on August 30, 2016, and
●3,500,000 options to purchase Common Stock with strike prices ranging from $0.67 to $1.50 ("Stock Options"), issued by the Company-to-Company employees.

The warrants, options, and preferred stock described above were approved by the then-board of directors of the Company. The Company’s fully diluted shares of Common Stock outstanding in 2017 was 563,911,848 on an as converted basis.

2021 Fully Diluted Shares of Common Stock Outstanding

All Private Warrants attributed to historical private placements expired by October 31, 2020. All Listed Warrants expired on June 23, 2020.

The Company reported on its Form 10-K for the calendar year ending December 31, 2020, filed with the SEC on March 2, 2021, that certain equity securities were outstanding:

● 403,557,037 shares of Common Stock, as of February 28, 2021,
● 487,500 privately-held warrants with exercise prices ranging from $0.29 to $2.00,
● 100 shares of Series B Preferred Stock and 86,776,664 Ratchet Warrants, and
● 4,800,000 Stock Options with strike prices ranging from $0.12 to $1.04, issued to Company employees and consultants.

On June 20, 2021, all outstanding convertible promissory notes, totaling $30,560,080 of principal and accrued interest, issued as part of the Company’s 2017 and 2020 Financings and described in the Company’s Form 10-Q for the period ending March 31, 2017, filed on May 10, 2017 with the SEC, and in the Company’s Form 8-K, filed with the SEC on January 7, 2020, respectively, automatically converted into 12,373,247 shares of Series D Convertible Preferred Stock, par value $.001 per share (the "Series D Preferred Stock"), and 9,440,594 shares of Series D-1 Convertible Preferred Stock, par value $.001 per share (the "Series D-1 Preferred Stock"), which collectively are convertible into a total of 106,779,187 shares of Common Stock. For a description of the Series D Preferred Stock and Series D-1 Preferred Stock, see the Company’s Form 10-Q for the period ending June 30, 2021, filed with the SEC on August 12, 2021.

All remaining Series B Preferred Stock was converted into Common Stock on August 25, 2021. All Ratchet Warrants were exercised or expired by August 30, 2021; 13,352,966 were exercised between January 1 and August 30, 2021, and 68,723,698 expired on August 30, 2021.

The Company’s fully diluted shares of Common Stock outstanding as of September 7, 2021 is 528,667,356 on an as converted basis, which consists of 416,575,669 shares of Common Stock outstanding, 512,500 shares of Common Stock issuable upon exercise of warrants, 4,800,000 shares of Common Stock issuable upon exercise of options, and 106,779,187 shares of Common Stock issuable upon conversion of the Series D Preferred Stock and Series D-1 Preferred Stock.

On September 7, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Rob Davis, chief executive officer and president, and Dr. Dean Li, president, Merck Research Laboratories, are scheduled to participate in a virtual fireside chat at the Morgan Stanley 19th Annual Conference on Sept. 13, 2021, at 11:00 a.m. EDT (Press release, Merck & Co, SEP 7, 2021, View Source [SID1234587309]).

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Investors, analysts, members of the media and the general public are invited to watch a live video webcast of the presentations at View Source

On September 7, 2021 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that Charles Theuer, M.D., Ph.D., President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright 23rd Annual Global Investment Conference, being held September 13-15, 2021 (Press release, Tracon Pharmaceuticals, SEP 7, 2021, View Source [SID1234587325]).

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The presentation will be available on-demand beginning at 7:00 AM Eastern Time on Monday, September 13, 2021, in the Investors section on the Company’s website at www.traconpharma.com.