On February 16, 2021 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") reported that due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 46,875,000 shares of common stock of the Company at a price to the public of $1.60 per share, less underwriting discounts and commissions (Press release, AIkido Pharma, FEB 16, 2021, View Source;bought-deal-offering-of-common-stock-to-75-million-301229527.html [SID1234575146]). The closing of the offering is expected to occur on or about February 19, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 7,031,250 shares of common stock at the public offering price, less underwriting discounts and commission.

The gross proceeds are expected to be approximately $75 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The offering is being conducted pursuant to the registration statement on Form S-3 (File No. 333-238172), as amended, previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC") on June 18, 2020. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source Electronic copies of the final prospectus relating to this offering, when available, may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by email at [email protected] or by telephone at 646-975-6996. Before investing in this offering, interested parties should read in their entirety the registration statement that the Company has filed with the SEC, which provides additional information about the Company and this offering.

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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On February 16, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will present at the following upcoming investor conferences (Press release, Personalis, FEB 16, 2021, View Source [SID1234575145]):

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Cowen 41st Annual Healthcare Conference
Presenting on Tuesday, March 2, 2021 at 1:30 p.m. Eastern Time
Barclays Global Healthcare Conference
Presenting on Wednesday, March 10, 2021 at 11:30 a.m. Eastern Time

On February 16, 2021 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended December 31, 2020, as well as key clinical and corporate developments (Press release, Cel-Sci, FEB 16, 2021, View Source [SID1234575143]).

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Clinical and Corporate Developments include:

In December 2020, CEL-SCI updated the status of its pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Injection). Data lock has been completed, and the study entered its final stage of statistical analysis. CEL-SCI remains blinded to the study data and is not involved in this process which is conducted by independent contractors. The statistical analysis plan follows the protocol stated objectives and is designed to meet FDA requirements to define the clinical benefits that Multikine might provide for patients newly diagnosed with advanced primary (not yet treated) squamous cell carcinoma of the head and neck. The analysis looks at multiple parameters to gain the most information on the possible benefits of using Multikine immunotherapy as a first line treatment before standard of care for these patients.
CEL-SCI continued expanding and upgrading its dedicated cGMP facility in which it manufactures Multikine. The construction, which began in 2020, is expected to be completed in the coming months and will double the facility’s capacity to accommodate two shifts for increased production of Multikine.
In December 2020, CEL-SCI announced that its LEAPS COV-19 peptides, delivered as a therapeutic treatment following SARS-CoV-2 virus challenge, achieved a 40% survival rate in human ACE2 transgenic mouse model as compared to 0% survival in the two control groups. These studies were conducted at the University of Georgia Center for Vaccines and Immunology. As COVID-19 mutations increase, LEAPS COV-19’s mechanism of action which targets the non-mutating part of the SARS-CoV-2 virus is becoming more important.
In December 2020, CEL-SCI sold 1,000,000 shares of common stock at a public offering price of $14.65 per share and received aggregate proceeds of approximately $13.6 million. On December 31, 2020, CEL-SCI’s cash position was approximately $21.9 million. After December 31, 2020, CEL-SCI has received approximately $3.9 million through the exercise of warrants and stock options.
"As the data analysis for our Phase 3 trial is being conducted, we are focused on expanding manufacturing of Multikine so that we will be ready to produce significant commercial quantities for this unmet medical need. We believe that Multikine may add substantial clinical benefit and help these patients." stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported a net loss of approximately $7.9 million for the quarter ended December 31, 2020 versus net loss of approximately $5.5 million for the quarter ended December 31, 2019.

During the three months ended December 31, 2020, CEL-SCI incurred approximately $3.6 million in costs to upgrade its manufacturing facility to prepare for the potential commercial production of Multikine. Total estimated costs of this upgrade are approximately $10.5 million, of which approximately $6.7 million has been incurred through December 31, 2020.

On February 16, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the availability of Guardant Reveal, the first blood-only liquid biopsy test for the detection of residual and recurrent disease from a simple blood draw (Press release, Guardant Health, FEB 16, 2021, View Source [SID1234575142]). The first-of-its-kind commercial test improves the management of early-stage colorectal cancer (CRC) patients by detecting circulating tumor DNA (ctDNA) in blood after surgery to identify patients with residual disease who may benefit most from adjuvant therapy, and by detecting recurrence months earlier than current standard-of-care methods like carcinoembryonic antigen (CEA) tests or imaging.1-6

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The Guardant Reveal test achieves industry-leading sensitivity (91 percent)7 for detecting ctDNA by simultaneously interrogating both genomic alterations and methylation. The test accurately reports genomic alterations down to allele frequencies of 0.01 percent, and effectively filters out biological noise sources such as mutations caused by clonal hematopoiesis of indeterminate potential. The incorporation of biologically relevant epigenomic signatures has been essential to increasing the sensitivity of the test to detect early-stage cancers including CRC. Results are obtained from a simple blood draw and returned in as little as 7 days without the need for a tissue biopsy.

"For the more than 1.5 million colorectal cancer survivors today in the U.S.8, the risk of recurrence is a serious one. Colorectal cancer is the second leading cause of cancer death in the U.S. and an estimated 10-30 percent of early-stage patients recur8—so it’s vital that oncologists have better tools to manage these patients by quickly identifying those high-risk patients who may benefit from adjuvant therapy after surgery, and by detecting recurrence earlier as part of regular surveillance," said Helmy Eltoukhy, Guardant Health CEO. "At Guardant Health our goal is to help cancer patients across the care continuum, and with the Guardant Reveal test, we are now able to serve an earlier patient group, early-stage colorectal cancer patients, where an unmet medical need exists given the limitations of current tools."

"The use of liquid biopsies in clinical practice represents a new frontier in improving cancer care for patients at all stages of their disease," said Aparna Parikh, MD, MPH, Gastrointestinal Oncologist at Massachusetts General Hospital and Assistant Professor of Medicine, Harvard Medical School. "It’s exciting to see that Guardant Health’s liquid biopsy tests not only inform targeted therapies for advanced cancer patients, but can now detect signs of cancer in the blood after curative intent surgeries. With this test, clinicians now have an additional tool to evaluate whether a patient with early-stage colorectal cancer is at high risk for recurrence, helping to inform adjuvant treatment after surgery in certain settings, and to detect microscopic recurrence of cancer months earlier than today’s standard of care."

The Guardant Reveal test is Guardant Health’s first commercially available liquid biopsy test for clinical use in the management of early-stage cancer. The test will focus first on one indication where the unmet medical need exists, early-stage CRC, with additional cancer types to follow.

On February 16, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported that Laura Shawver, Ph.D., Silverback’s chief executive officer, will present at the following upcoming investor conferences (Press release, Silverback Therapeutics, FEB 16, 2021, View Source [SID1234575141]):

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Event: Goldman Sachs West Coast Biotech Bus Tour
Location: Virtual
Date: Tuesday, February 23, 2021
Time: 2:00 PM ET / 11:00 AM PT

Event: SVB Leerink 10th Annual Global Healthcare Conference
Location: Virtual
Date: Wednesday, February 24, 2021
Time: 4:20 PM ET / 1:20 PM PT

Event: Cowen 41st Annual Healthcare Conference
Location: Virtual
Date: Wednesday, March 3, 2021
Time: 3:20 PM ET / 12:20 PM PT

Event: H.C. Wainwright Global Life Sciences Conference
Location: Virtual
Date: Tuesday, March 9, 2021
Time: 7:00 AM ET / 4:00 AM PT
The webcast and archived replay of the SVB Leerink, Cowen, and H.C. Wainwright presentations will be available on the Silverback website, www.silverbacktx.com, for 30 days.