On March 22, 2021, Anixa Biosciences, Inc. (the "Company") reported that it entered into an amended and restated underwriting agreement (the "Underwriting Agreement") with H.C. Wainwright & Co., LLC, as representative (the "Representative") of the underwriters (the "Underwriters"), to issue and sell 4,285,715 shares of common stock of the Company, par value $0.01 per share ("Common Stock"), in an underwritten, firm-commitment public offering pursuant to an effective registration statement on Form S-3 (File No. 333-232067) and a related prospectus and prospectus supplement, in each case filed with the Securities and Exchange Commission (the "Offering") (Filing, 8-K, Anixa Biosciences, MAR 24, 2021, View Source [SID1234577075]). The public offering price to the public is $5.25 per share of Common Stock, less underwriting discounts and commissions. In addition, the Company granted the Underwriters an option to purchase, for a period of 30 days from the date of the Underwriting Agreement, up to an additional 642,857 shares of Common Stock at the same public offering price.

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In connection with the Offering, the Company agreed to pay the Representative an underwriting discount equal to 7.0% of the gross proceeds of the Offering and a management fee equal to 1.0% of the gross proceeds of the Offering. The Company also agreed to pay the Representative $50,000 for non-accountable expenses, an expense allowance of up to.$100,000 for legal fees and other out-of-pocket expenses and $15,950 for closing expenses. The Company agreed to issue to the Representative, or its designees, warrants to purchase up to 300,000 shares of Common Stock (up to 345,000 shares of Common Stock if the over-allotment option is exercised in full) at an exercise price of $6.5625 per share (the "Underwriter Warrants"). The Underwriter Warrants will have a term of five years from the commencement of the sales in the Offering.

The Company estimates that the net proceeds from the Offering will be approximately $20.3 million, or approximately $23.4 million if the Underwriters exercise in full their option to purchase additional shares of Common Stock, in each case after deducting underwriting discounts and commissions and estimated offering expenses. The Offering is expected to close on or about March 25, 2021, subject to customary closing conditions.

The Underwriting Agreement contains customary representations, warranties, covenants and agreements by the Company, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended (the "Securities Act"), other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. Copies of the Underwriting Agreement and form of Underwriter Warrant are filed as Exhibit 1.1 and 4.1 to this Current Report on Form 8-K, respectively, and are incorporated herein by reference. The foregoing description of the Underwriting Agreement and Underwriter Warrants are qualified in their entirety by reference to such exhibits. A copy of the opinion of Ellenoff Grossman & Schole LLP as to the legality of the shares of Common Stock, Underwriter Warrants and shares of Common Stock issuable upon exercise of the Underwriter Warrants to be issued in the Offering and related consent is filed as Exhibit 5.1 to this Current Report on Form 8-K.

On March 24, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the fourth quarter and full year for the period ended December 31, 2020 (Press release, Navidea Biopharmaceuticals, MAR 24, 2021, View Source [SID1234577074]).

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"We are very excited about the progress we have made, completing all the patients in the Phase 2B NAV3-31 trial and submitting our briefing book to the FDA were milestone accomplishments this past year," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "We are looking forward to hearing back from the FDA and continuing our due diligence discussions with Jubilant over the near term."

Fourth Quarter 2020 Highlights and Subsequent Events

Announced positive results from continued analysis of subjects who have completed Arm 3 of the Company’s NAV3-31 Phase 2B study. These data further corroborated Navidea’s hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in patients with active rheumatoid arthritis ("RA") and that this imaging can provide an early indicator of treatment efficacy.
Submitted a formal Type B Meeting Request to the U.S. Food and Drug Administration ("FDA"). The FDA granted the Type B meeting and the Company has submitted the Briefing Book. The FDA is currently reviewing these formal briefing documents containing results from the NAV3-31 Phase 2B study and the proposed Phase 3 design and protocol.
Achieved last patient, last visit in the Company’s NAV3-31 Phase 2B study. Study closeout and data analysis are ongoing.
Opened the first US site, Northwestern University, for enrollment in the Company’s NAV3-32 Phase 2B trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA.
Continued enrollment in the Investigator Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
Received notice of patent grant from the USPTO for US 10,806,803: "Compositions for targeting macrophages and other CD206 high expressing cells and methods of treating and diagnosis."
Received a notice of allowance from the USPTO for the patent application: "Compounds and methods for diagnosis and treatment of viral infections" (US Patent Application 15/729,635).
Performed preclinical studies that demonstrate macrophage phenotype change from an immunosuppressive to a pro-inflammatory state and a synergistic effect on tumor growth reduction using the Company’s doxorubicin-containing construct with an approved checkpoint inhibitor therapy.
Appointed Malcolm G. Witter to the Company’s Board of Directors. Mr. Witter brings decades of financial and corporate governance experience to the board.
Entered into a Stock Purchase Agreement and Letter of Investment Intent with an existing investor, pursuant to which the Company issued to the investor 50,000 shares of newly-designated Series E Redeemable Convertible Preferred Stock (the "Series E Preferred Stock") for an aggregate purchase price of $5.0 million. The Series E Preferred Stock is convertible into a maximum of 2,173,913 shares of Common Stock.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team is working diligently to advance the technology in key disease areas, with an emphasis on our RA program. We have completed all patients and all visits in our NAV3-31 Phase 2B trial and we are eagerly anticipating feedback from the FDA on our briefing package and design of the Phase 3 trial. We continue to prepare for initiation of this trial and have also opened up enrollment for the NAV3-32 Phase 2B trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients. Concurrent with all of this, we have made exciting progress in our therapeutics pipeline and will continue to advance these towards the clinic."

Financial Results

Total net revenues for the fourth quarter 2020 were $219,000, compared to $119,000 for the same period in 2019. Total net revenues for the full year of 2020 were $914,000, compared to $651,000 for 2019. The increases were primarily due to increased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development coupled with increased license revenue from net transitional sales in Europe.
Research and development ("R&D") expenses for the fourth quarter of 2020 were $1.3 million, compared to $1.7 million in the same period in 2019. R&D expenses for the full year of 2020 were $4.9 million, compared to $5.3 million in the same period in 2019. The decreases were primarily due to net decreases in drug project expenses, including decreased Manocept therapeutic development costs, decreased Manocept diagnostic development costs, and decreased Tc99m development costs, offset by increased NAV4694 development costs. The net decreases also included decreased regulatory consulting and travel expenses offset by increased employee compensation.
Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2020 were $1.7 million, compared to $1.2 million in the same period in 2019. SG&A expenses for the full year of 2020 were $6.7 million, compared to $6.3 million in 2019. The net increases were primarily due to increased legal and professional services, employee compensation, European Medicines Agency annual fees for Lymphoseek, and franchise taxes, offset by decreased travel, depreciation and amortization, losses on disposal of assets, insurance, and investor relations services.
Navidea’s net loss attributable to common stockholders for the fourth quarter of 2020 was $3.0 million, or $0.11 per share, compared to $2.8 million, or $0.15 per share, for the same period in 2019. Navidea’s net loss attributable to common stockholders for the full year of 2020 was $11.4 million, or $0.48 per share, compared to $10.9 million, or $0.76 per share, for 2019.
Navidea ended the fourth quarter of 2020 with $2.7 million in cash and cash equivalents. Since December 31, 2020, the Company has received $7.9 million of cash related to the Series D and Series E Preferred Stock funding transactions. To date, the Company has received over $14 million of proceeds from the issuance of Series C, Series D and Series E Preferred stock.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On March 24, 2021 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, reported financial results for the fourth quarter and full year 2020, and provided an update on its clinical development programs (Press release, Equillium, MAR 24, 2021, View Source [SID1234577073]).

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"It was an exciting year of clinical advancement for Equillium and our lead asset, itolizumab, a first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway," said Bruce Steel, chief executive officer at Equillium. "As the pathway plays a central role in a number of immuno-inflammatory diseases, we think of itolizumab as a pipeline in a product and are currently evaluating the therapeutic in acute graft-versus-host disease, lupus and lupus nephritis, and uncontrolled asthma. While the pandemic caused delays in our clinical studies last year, we look forward to our forthcoming data from all three studies in 2021. We anticipate the data this year will be important for all stakeholders, but none more so than the patients with these severe and life-threatening diseases."

2020 and 2021 Year-to-Date Corporate Highlights:

Raised a total of $83.7 million in financing net proceeds in 2020 and through the registered direct offering completed in February 2021, strengthening Equillium’s balance sheet and extending its expected cash runway into the second half of 2023
Announced positive interim data from EQUATE study in acute graft-versus-host disease (aGVHD)
Presented translational data in aGVHD demonstrating the impact of itolizumab on effector T cell function at the:
Transplantation & Cellular Therapy Meetings of ASTCT & CIBMTR
Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper)
2021 Transplantation and Cellular Therapy Meetings Digital Experience
Presented data at the 2020 American College of Rheumatology Meeting, demonstrating that CD6 modulation improves kidney and skin pathology in preclinical models of systemic lupus erythematosus (SLE)
Presented data at the European Respiratory Society International Congress 2020 demonstrating that the CD6-ALCAM pathway may contribute in multiple ways to asthma pathology
Strengthened leadership and positioned Equillium for organizational growth, including the following additions since the beginning of this year:
Dolca Thomas, M.D., appointed as executive vice president of research and development and chief medical officer
Y. Katherine Xu, Ph.D., partner at Decheng Capital, appointed to Equillium’s board of directors
Upcoming Catalysts:

EQUALISE Phase 1b study: topline data from Type A patients (SLE), 1Q 2021
EQUATE Phase 1b study: topline data in first-line aGVHD, 1H 2021
Regulatory feedback on proposed pivotal study in first-line aGVHD, Mid-2021
Initiate pivotal study in first-line aGVHD, 2H 2021*
EQUALISE Phase 1b study: interim data from Type B patients (lupus nephritis), 2H 2021
EQUIP Phase 1b study: topline data in uncontrolled asthma, 2H 2021
*Proposed protocol & timeline for site initiation contingent on regulatory review

Fourth Quarter and Full Year 2020 Financial Results

Research and development (R&D) expenses for the fourth quarter of 2020 were $6.6 million, compared with $5.4 million for the same period in 2019. The increase in the fourth quarter of 2020 compared to the same period in 2019 was due to greater headcount expenses, greater research and translational science expenses, and an increase in clinical development expenses driven by approximately $0.9 million in expenses incurred in the fourth quarter of 2020 associated with preparing to launch a registrational study in COVID-19 patients, which was discontinued. Those increases were partially offset by a reduction in overhead costs, especially travel, and lower consulting expenses. For the full year of 2020, R&D expenses were $19.4 million, compared with $17.6 million for the same period in 2019. The year-over-year increase in R&D expenses was primarily driven by greater headcount expenses and research expenses, offset by lower overhead costs, especially related to travel and recruiting, and lower total clinical development expenses related to the EQUIP study and the Australian R&D tax incentive credit, partially offset by increases in expenses associated with the EQUALISE study and preparing to initiate a study in COVID-19 patients.

General and administrative (G&A) expenses for the fourth quarter of 2020 were $2.4 million, compared with $2.2 million for the same period in 2019. The increase in the fourth quarter of 2020 compared to the same period in 2019 was due to greater headcount expenses, driven by higher stock-based compensation, and greater consulting expenses, partially offset by a reduction in overhead expenses driven by lower insurance costs. For the full year of 2020, G&A expenses were $10.2 million, compared with $9.1 million for the same period in 2019. The year-over-year increase was primarily due to increased headcount expenses, driven by greater stock-based-compensation but partially offset by lower salary expense, and greater consulting expenses, offset by lower legal costs and overhead expenses, especially related to travel.

Net loss for the fourth quarter of 2020 was $8.9 million, or $(0.36) per basic and diluted share, compared with a net loss of $7.6 million, or $(0.44) per basic and diluted share for the same period in 2019. Net loss for the full year of 2020 was $29.8 million, or $(1.46) per basic and diluted share, compared with a net loss of $25.6 million, or $(1.47) per basic and diluted share for the same period in 2019. The increase in net loss for the full year of 2020 compared to the same period in 2019 was driven primarily by greater operating expenses and to a lesser extent by lower interest income and higher interest expense.

Cash used in operations for the fourth quarter of 2020 was $8.3 million compared to $4.9 million in the third quarter of 2020. Key drivers of the quarter-over-quarter increase in cash used in operations include the resumption in enrollment in the EQUIP and EQUALISE studies following a pause earlier in the year due to COVID-19, payment of directors and officers annual insurance premiums in the fourth quarter, spending in the fourth quarter associated with preparing to launch a registrational study in COVID-19 patients that was discontinued, and a reimbursement from the Australian Taxation Office associated with our 2019 R&D tax incentive claim that was received in the third quarter.

Cash, cash equivalents and short-term investments totaled $82.2 million as of December 31, 2020, compared to $53.1 million as of December 31, 2019. Subsequent to 2020, Equillium further strengthened its balance sheet through the completion of a registered direct offering with Decheng Capital, which raised $29.9 million in net proceeds. Equillium believes that its cash and investments will be sufficient to fund its currently planned operations into the second half of 2023.

About Itolizumab
Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

On March 24, 2021 Onxeo S.A. (Euronext Growth: ALONX; Nasdaq First North: ONXEO), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), in particular against rare or resistant cancers, reported its new dates for the publication of its 2020 annual results and the holding of its annual general meeting (Press release, Onxeo, MAR 24, 2021, View Source [SID1234577072]).

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Due to the rights issue that is ongoing until March 31, 2021, the publication of the 2020 annual results will take place on April 21, 2021 after market close and the annual general meeting will be held on June 10, 2021. The date for the publication of the 2021 half-year results, scheduled for July 28 after market close, remains unchanged.

On March 24, 2021 Enveric Biosciences reported that it is one of the sponsors for the Benzinga Biotech Global Small Cap Conference taking place on March 24-25, 2021 (Press release, Enveric Biosciences, MAR 24, 2021, View Source [SID1234577071]). The information contained in this article in no way represents investment advice or opinion on the part of Benzinga or its writers and is intended for informational purposes only.

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Chemotherapy is considered one of the most effective ways to battle cancer. However, it comes with side effects that can significantly affect the quality of life of a patient. Although there have been developments to tackle these side effects, today, the many needs of these patients remain unmet.

Enveric Biosciences is targeting these unmet medical needs by using naturally occurring compounds to provide supportive care for cancer patients suffering from the side effects of treatment, such as radiation dermatitis.

Enveric is also developing a product that can target indications such as chemotherapy-induced peripheral neuropathy, with future areas of focus targeting CNS indications such as depression, pain and anxiety.

The company also seeks to advance novel combinations of cannabidiol (CBD) with chemotherapeutic agents. Its preclinical data suggests combination therapies may improve the activity of certain chemotherapies, potentially enabling more potent or longer-lasting therapeutic effects in diseases such as Glioblastoma. These combination therapies may allow greater therapeutic effect with a lower dose of the chemotherapeutic agent, which could minimize the severity of side effects.

Adoption of a Patient-Centric Model
In the world of biotech, most companies have a molecule or a drug delivery platform that they find promising. After they observe the potential of the molecule, they look for a patient population where it can be used.

At Enveric, the model is reversed.

The company looks at patients first and then both internally and through targeted business development look for the most efficacious therapeutics solutions to deal with these challenging indications.

Enveric’s mission is to enhance the quality of life of patients who live with the side effects of cancer treatment using novel therapeutic drugs to create a new standard of care.

Recent News
Raise in Capital

Enveric raised $22.8 million in gross proceeds during the first quarter of 2021. This growth capital — along with zero debt and strong liquidity — creates a well-rounded balance sheet and capitalization structure that allows the company to accelerate its business plans and opportunistically evaluate M&A opportunities such as PureForm and Diverse.

Supply Agreement

On Feb 25, 2021, Enveric announced an exclusive agreement with PureForm Global, a biosciences company focused on the discovery and production of pure cannabinoids for use in treating diseases and promoting wellness. With this agreement, PureForm will supply Enveric with synthetic cannabidiol (CBD) and cannabigerol (CBG) in current good manufacturing practice (cGMP) facilities in the U.S. to look after its supply needs for its clinical trial as well as the potential to collaborate on development opportunities.

License Agreement

Earlier in March, the company acquired an exclusive perpetual license from Diverse Biotech for five molecules, four of which are dermatology-focused and one focuses on pain. The agreement will allow Enveric to expand its development candidates pipeline through CBD conjugation with existing standard-of-care drugs through Diverse Biotech’s advanced chemistry drug delivery platform.

Upcoming Global Small Cap Conference
At Benzinga’s Biotech Small Cap Conference on March 25, David Johnson, Enveric Chairman and CEO will participate on the panel, "The Natural Solutions: Cannabis & Cannabinoids" at 11:40 a.m. EST followed by a corporate presentation at 12:30 p.m. EST.

"Enveric Biosciences is poised for growth with a strong financial base," said Mr. Johnson. "Its key clinical programs are already making progress, aiming to be in the clinic for two indications by the end of 2021. Enveric is focused on advancing its robust pipeline of new-generation, naturally occurring and synthetic compounds that will provide the company with an opportunity to change the standard of care for cancer patients by extending and enhancing patient quality of life."

To catch the latest information from Enveric Biosciences at the upcoming Biotech Small Cap Conference, sign up to participate here.