Cleveland BioLabs, Inc. Announces $14 Million Registered Direct Offering of Common Stock

On February 23, 2021 Cleveland BioLabs, Inc. (NASDAQ:CBLI), reported that it has entered into definitive agreements with certain healthcare-focused and institutional investors for the issuance and sale of 2,000,000 shares of its common stock at a purchase price of $7.00 per share in a registered direct offering (Press release, Cleveland BioLabs, FEB 23, 2021, View Source [SID1234575469]). The closing of the offering is expected to occur on or about February 23, 2021, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be approximately $14 million. The Company currently intends to use the net proceeds from the offering for general corporate purposes.

The shares described above are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-238578), including an accompanying prospectus previously filed with, and declared effective by the Securities and Exchange Commission (the "SEC") on May 29, 2020. The offering will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

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

Biocept and Protean BioDiagnostics Establish Research Collaboration to Demonstrate Advantages of Biocept’s Target Selector™ Assay Kit for Non-Small Cell Lung Cancer Patients

On February 23, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that it will collaborate with Protean BioDiagnostics Inc. to research the ability of Biocept’s Target Selector molecular assay to determine EGFR status in non-small cell lung cancer (NSCLC) patients (Press release, Biocept, FEB 23, 2021, View Source [SID1234575485]). The research will be conducted in an independent pathology laboratory setting.

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Protean BioDiagnostics also expects to validate the analytical performance of a laboratory developed test (LDT) based on Biocept’s EGFR assay test kit in accordance with the requirements of the College of American Pathologists (CAP) validation process.

Biocept’s novel molecular assay kit, available for research-use-only and with CE-IVD mark, enables molecular laboratories around the world to utilize its Target Selector platform to analyze both formalin-fixed paraffin-embedded (FFPE) tissue samples and circulating tumor DNA (ctDNA) from biological fluids. Target Selector leverages patented Switch-Blocker technology to enrich specimens for mutations of interest and block DNA amplification from normal cells, requiring less tumor sample and resulting in higher assay sensitivity than most commercial assays. Biocept’s molecular assays have been validated for the detection of frequent oncogenic mutations EGFR, KRAS and BRAF, which are among the most frequently evaluated biomarkers for lung cancer and melanoma.

"We are pleased to collaborate with Biocept to demonstrate the potential of its assay in determining EGFR status," said Anthony M. Magliocco, MD, President and CEO of Protean BioDiagnostics. "Obtaining adequate tissue sample for genomic profiling continues to be a challenge in first-line therapy selection for patients with NSCLC. Target Selector EGFR assays require 50% less tumor input sample than most commercial assays, making it a potentially powerful tool in helping qualify more patients for targeted tyrosine kinase inhibitor, or TKI, therapy. This potential advantage is coupled with previous studies demonstrating Target Selector assays’ best-in-class low-end limit of detection of mutations in both FFPE and liquid biopsy samples."

"Protean BioDiagnostics is the ideal partner for this collaboration, as we share a joint commitment to advancing the best possible care for patients with cancer," said Michael Nall, Biocept President and CEO. "Protean has extensive experience working with some of the world’s leading biotechnology companies. Together, our goal is to demonstrate how Target Selector assays can help physicians create more personalized, responsive treatment plans for their patients."

About Target Selector Molecular Assay Kits
Target Selector molecular assay kits are marketed for research-use-only (RUO) in the U.S. and CE-IVD in the European Union and other CE Mark geographies, offering industry-leading sensitivity for the detection of mutations/variants of interest in both FFPE and ctDNA. Target Selector assays with Switch-Blocker technology can also provide results with smaller DNA inputs (minimum 4.6 ng) than most tissue-based assays, allowing laboratories to get results even with small amounts of tissue. These capabilities should allow laboratories to eliminate macro-dissection of tumor blocks, potentially resulting in major workflow improvements and cost savings.

Target Selector assays can be used in combination with a variety of low-cost analytical platforms including qPCR, Sanger sequencing, microarrays, and mass-spectrometry, in addition to next generation sequencing. Target Selector kits (RUO and CE-IVD) offer high content per assay, which can reduce costs by selectively amplifying multiple mutations/variants in hot-spot regions of interest in a single reaction. All Target Selector assays are quantitative.

Target Selector molecular assay kits (RUO and CE-IVD) are currently available for EGFR and BRAF mutations. Additional test kits for other oncogene mutations are planned for launch in the future. For more information on Biocept’s Target Selector molecular assay kits, contact Biocept Customer Service at (888) 332-7729 or [email protected].

Abeona Therapeutics to Present at the 10th Annual SVB Leerink Global Healthcare Conference

On February 22, 2021 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported that the company will present at the 10th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 24, 2021 at 11:20 am EST (Press release, Abeona Therapeutics, FEB 22, 2021, View Source [SID1234575361]).

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A live webcast of the presentation will be available on the investor section of the Abeona Therapeutics website, www.abeonatherapeutics.com, and an archived replay will be accessible for up to 30 days.

Invitae to Present at The Cowen 41st Annual Healthcare Conference

On February 22, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that members of its management team will present at The Cowen 41st Annual Healthcare Conference on Tuesday, March 2, 2021 at 2:50 p.m. Eastern /11:50 a.m. Pacific (Press release, Invitae, FEB 22, 2021, View Source [SID1234575377]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

The live webcast of the fireside chat may be accessed by visiting the investors section of the company website at ir.invitae.com. A replay of the webcast will be available shortly after the conclusion of the fireside chat.

Castle Biosciences to Release Fourth Quarter and Full Year 2020 Financial Results and Host Conference Call on Monday, March 8, 2021

On February 22, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that it will release its financial results for the fourth quarter and year-ended December 31, 2020, after the close of market on Monday, March 8, 2021 (Press release, Castle Biosciences, FEB 22, 2021, View Source [SID1234575393]).

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Company management will host a conference call and webcast to discuss its financial results and provide a corporate update at 4:30 p.m. Eastern time on the same day.

Conference Call and Webcast Details

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website (View Source). Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until March 29, 2021.

To access the live conference call via phone, please dial 877-282-2581 from the United States and Canada, or +1 470-495-9479 internationally, at least 10 minutes prior to the start of the call, using the conference ID 3834669.

There will be a brief Question & Answer session following management commentary.