On February 12, 2021, CNS Pharmaceuticals, Inc. (the "Company") reported that it entered into a Capital on Demand Sales Agreement (the "Agreement") with JonesTrading Institutional Services LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC (collectively, the "Agents") (Filing, 8-K, CNS Pharmaceuticals, FEB 12, 2021, View Source [SID1234575032]). Pursuant to the terms of the Agreement, the Company may sell from time to time through the Agents shares of the Company’s common stock, par value $0.001 per share ("Common Stock") with an aggregate sales price of up to $20.0 million (the "Shares").

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Any sales of Shares pursuant to the Agreement will be made under the Company’s effective "shelf" registration statement (the "Registration Statement") on Form S-3 (File No. 333-252471), which became effective on February 3, 2021 and the related prospectus supplement and the accompanying prospectus, as filed with the Securities and Exchange Commission (the "SEC") on February 12, 2021.

Under the Agreement, the Company may sell Shares through the Agents by any method that is deemed an "at the market offering" as defined in Rule 415 under the Securities Act of 1933, as amended (the "Securities Act").

Sales of the Shares, if any, may be made at market prices prevailing at the time of sale, subject to such other terms as may be agreed upon at the time of sale, including a minimum sales price that may be stipulated by the Company’s Board of Directors or a duly authorized committee thereof. The Company or the Agents, under certain circumstances and upon notice to the other, may suspend the offering of the Shares under the Agreement. The offering of the Shares pursuant to the Agreement will terminate upon the sale of Shares in an aggregate offering amount equal to $20.0 million, or sooner if either the Company or the Agents terminate the Agreement pursuant to its terms.

The Company will pay a commission to the Agents of 3.0% of the gross proceeds of the sale of the Shares sold under the Agreement and reimburse the Agents for certain expenses. The Company has also provided the Agents with customary indemnification rights. The Company is not obligated to make any sales of Common Stock under the Agreement.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Agreement is also incorporated by reference into the Registration Statement.

A copy of the opinion of Schiff Hardin LLP relating to the legality of the shares of Common Stock issuable under the Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K and is also incorporated by reference into the Registration Statement.

The above disclosure shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On February 12, 2021 Enlivex Therapeutics Ltd. (NASDAQ: ENLV), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, reported the closing of its previously announced offering of 2,296,107 ordinary shares, par value NIS 0.40 per share, of the Company at a price to the public of $20.00 per ordinary share, less underwriting discounts and commissions (Press release, Enlivex Therapeutics, FEB 12, 2021, View Source [SID1234575033]).

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H.C. Wainwright & Co. acted 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 344,416 additional ordinary shares at the public offering price, less underwriting discounts and commissions.

The gross proceeds to Enlivex, before deducting underwriting discounts and commissions and offering expenses, are approximately $45.92 million. The Company intends to use the net proceeds from this offering for (i) clinical, regulatory, manufacturing and research and development activities; (ii) potential acquisitions and in-licensing; and (iii) other general corporate purposes.

The securities described above were offered by Enlivex pursuant to a "shelf" registration statement on Form F-3 (File No. 333-232009) previously filed with the Securities and Exchange Commission (the "SEC") on June 7, 2019 and declared effective by the SEC on June 21, 2019 and the Form F-3MEF filed on February 9, 2021 (File No. 333-252926). The offering of the securities described above was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities offered have been filed with the SEC and are available on the SEC’s website at View Source or 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 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 11, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, reported financial results for its fiscal quarter ended December 31, 2020 (Press release, Anavex Life Sciences, FEB 11, 2021, View Source [SID1234574897]).

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"We are thrilled to begin the new year with this business outlook, which adds to the breadth of strong clinical data we’ve reported across our precision medicine pipeline using orally once daily ANAVEX2-73 (blarcamesine) for Rett syndrome, Parkinson’s disease dementia and Alzheimer’s disease," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "We look forward to providing on a timely basis in 2021 multiple clinical data read-outs from these clinical programs. The converging biomarker-driven clinical data is giving us added confidence in our efforts to meet our goal of potentially bringing new therapeutic interventions to patients."

Anavex Life Sciences’ product portfolio includes small molecule drug lead candidate ANAVEX2-73 for the treatment of Alzheimer’s disease, Parkinson’s disease and Rett syndrome.

ANAVEX2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.[1]

Anavex Life Sciences’ 2021 Business and Clinical Outlook:

Underlying cause of Alzheimer’s disease and therapeutic intervention:

Researchers at the University of California San Diego have identified the underlying cause of Alzheimer’s disease in neurons. They discovered that changes in the structure of chromatin are responsible.[2] Sigma-1 Receptor (SIGMAR1), the direct target which gets activated with ANAVEX2-73 demonstrated to restore chromatin structures.[3]
ANAVEX2-73 linked to the prevention and treatment of age-associated diseases through induction of the autophagy "cellular recycling" process and enhanced protein clearance in cells.[4]
ANAVEX2-73 is currently in a Phase 2b/3 Alzheimer’s disease clinical trial utilizing differentiated patient selection criteria and study is presently over 86% recruited.[5]
ANAVEX2-73 program for Rett syndrome and other pipeline updates:

Potential accelerated approval strategy planning underway as Phase 2 U.S. Rett syndrome trial clinical data showed positive clinical activity and safety data with progress within ongoing Phase 2/3 AVATAR adult Rett syndrome and Phase 2/3 EXCELLENCE pediatric Rett syndrome studies.
U.S. Food and Drug Administration (FDA) approved extension of ANAVEX2-73 U.S. Rett syndrome Phase 2 open-label extension study from 12 weeks to 36 weeks.
Anavex received compassionate use Special Access Scheme (SAS) approval in Australia for Rett syndrome patients to continue treatment with ANAVEX2-73 after completing the Phase 2/3 AVATAR adult Rett syndrome clinical extension study.
Anavex has sufficient ANAVEX2-73 available to support all ongoing and planned clinical trials and first-year commercial launch needs for the Rett syndrome program.
ANAVEX2-73 drug substance and oral solution exhibit excellent chemical stability based upon 3 years of stability data in both cases.
New clinical pipeline compound ANAVEX3-71 Phase 1 study is on track: Independent Data Safety Monitoring Board (DSMB) for the Company’s Phase 1 study of its new investigational compound ANAVEX3-71, also a small molecule activating SIGMAR1, has completed its recent pre-planned review of the preliminary Phase 1 safety data. The DSMB recommendation is to continue the study without modification.[6]
Anavex is pioneering the approach of big data in clinical trials to leverage the relevance of phenotypic and genotypic precision medicine analyses of Whole Exome Sequencing (WES) and gene expression (RNAseq) data in drug development and in particular the potential to identify patients’ genetic variants and gene expression changes that may predict increased chances of success of Alzheimer’s disease, Parkinson’s disease and Rett syndrome treatments.
Further clinical milestones are provided in Anavex Life Sciences’ latest corporate presentation, available on anavex.com.
Recent Business Highlights:

In January 2021, Anavex announced that it has been awarded a research grant of $995,862.51 from the Michael J. Fox Foundation for Parkinson’s Research (MJFF) to develop ANAVEX2-73 (blarcamesine) for the treatment of Parkinson’s disease. The award will explore utilization of PET imaging biomarkers to enable measurement of target engagement and pathway activation of the sigma-1 receptor (SIGMAR1) with clinically relevant doses in people with Parkinson’s disease.
Financial Highlights:

On February 11, 2021, cash and cash equivalents of approximately $75 million, sufficient cash runway for up to three (3) years.
Cash and cash equivalents of $47.4 million as of December 31, 2020, compared to $29.2 million at September 30, 2020.
Net loss of $7.9 million, or $0.12 per share for the quarter, compared to net loss of $6.6 million, or $0.12 per share in comparative quarter of fiscal 2020.
Research and development expenses of $7.9 million for the quarter, compared to $6.3 million for comparable quarter of fiscal 2020.
The financial information for the fiscal quarter ended December 31, 2020 should be read in conjunction with the Company’s interim condensed consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.

Conference Call / Webcast Information:

The live webcast of the conference call can be accessed online at View Source

To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 451-7964 and international callers should dial 1 (847) 944-7134. Please use confirmation number 50097999, followed by the pound sign (#).

A replay of the conference call will also be available on www.anavex.com.

On February 11, 2021 Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) ("Infinity" or the "Company"), a clinical-stage biotechnology company developing eganelisib, an oral, immuno-oncology macrophage reprogramming therapeutic candidate, which is designed to address a fundamental biologic mechanism of immune suppression in cancer, reported that it has commenced an underwritten public offering of its common stock (Press release, Infinity Pharmaceuticals, FEB 11, 2021, View Source [SID1234574918]). In addition, the Company intends to grant the underwriters a 30-day option to purchase an additional 15% of the shares of its common stock offered in the public offering on the same terms and conditions. The offering is subject to market and other conditions and there can be no assurances as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the shares in the offering will be sold by the Company.

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Piper Sandler & Co. is acting as sole book-running manager for the offering.

Infinity intends to use net proceeds from the offering for the continued clinical development of eganelisib, for general corporate purposes and for working capital.

The offering will be made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-230258) that became effective with the Securities and Exchange Commission (the "SEC") on April 29, 2019, the base prospectus contained therein and a prospectus supplement. A preliminary prospectus supplement and accompanying base prospectus relating to the offering and the shares of common stock being offered will be filed with the SEC. Before you invest, you should read the prospectus in the registration statement, the preliminary prospectus supplement, and other documents the Company has filed with the SEC for more complete information about the Company and this offering. Copies of the registration statement, the preliminary prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at View Source or, when available, by contacting: Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].

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

On February 11, 2021 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and genetically defined diseases, reported that the company will host a conference call and live webcast on Thursday, February 25, 2021 at 8:00 a.m. ET to report its fourth quarter and year end 2020 financial results and other business highlights (Press release, Agios Pharmaceuticals, FEB 11, 2021, https://investor.agios.com/news-releases/news-release-details/agios-webcast-conference-call-fourth-quarter-and-year-end-2020 [SID1234574934]).

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A live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The conference call can be accessed by dialing 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 8442238. The webcast will be archived and made available for replay on the company’s website beginning approximately two hours after the event.