On September 15, 2020 CNS Pharmaceuticals, Inc. (the "Company") reported that it entered into a purchase agreement (the "Purchase Agreement"), and a registration rights agreement (the "Registration Rights Agreement"), with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which Lincoln Park has committed to purchase up to $15.0 million worth of the Company’s common stock, $0.001 par value per share (the "Common Stock") (Filing, 8-K, CNS Pharmaceuticals, SEP 15, 2020, View Source [SID1234565417]).

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Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $15.0 million worth of shares of the Company’s Common Stock. Such sales of Common Stock by the Company, if any, will be subject to certain limitations, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on the date that a registration statement covering the resale of shares of Common Stock that have been and may be issued under the Purchase Agreement, which the Company agreed to file with the Securities and Exchange Commission (the "SEC") pursuant to the Registration Rights Agreement, is declared effective by the SEC and a final prospectus in connection therewith is filed and the other conditions set forth in the purchase agreement are satisfied, all of which are outside the control of Lincoln Park (such date on which all of such conditions are satisfied, the "Commencement Date").

Thereafter, under the Purchase Agreement, on any business day selected by the Company that the closing sale price of the Common Stock equals or exceeds the threshold price set forth in the Purchase Agreement, the Company may direct LPC to purchase up to 30,000 shares of Company Common Stock on such business day (each, a "Regular Purchase"), provided, however, that (i) the Regular Purchase may be increased to up to 50,000 shares, provided that the closing sale price of the Common Stock is not below $2.00 on the purchase date; (ii) the Regular Purchase may be increased to up to 75,000 shares, provided that the closing sale price of the Common Stock is not below $2.50 on the purchase date; (iii) the Regular Purchase may be increased to up to 100,000 shares, provided that the closing sale price of the Common Stock is not below $3.00 on the purchase date; and (iv) the Regular Purchase may be increased to up to 150,000 shares, provided that the closing sale price of the Common Stock is not below $4.00 on the purchase date. In each case, Lincoln Park’s maximum commitment in any single Regular Purchase may not exceed $1,000,000. In addition, after the Commencement Date, the Company may direct Lincoln Park to purchase, on two separate occasions that must be at least 30 business days apart, $1,000,000 worth of Common Stock per such purchase (each, a "Tranche Purchase"). The purchase price per share for each Regular Purchase and each Tranche Purchase will be based on prevailing market prices of the Common Stock immediately preceding the time of sale. There are no upper limits on the price per share that Lincoln Park must pay for shares of Common Stock under the Purchase Agreement. In addition to Regular Purchases and Tranche Purchases, the Company may also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional accelerated purchases if the closing sale price of the Common Stock equals or exceeds the threshold price at the times set forth in the Purchase Agreement. The above-referenced share amount limitations and closing sale price thresholds are subject to adjustment for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction as provided in the Purchase Agreement.

Lincoln Park has no right to require the Company to sell any shares of Common Stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to satisfaction of the conditions set forth in the Purchase Agreement. Actual sales of shares of Common Stock to Lincoln Park will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the Common Stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations.

The net proceeds under the purchase agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to Lincoln Park. The Company expects that any proceeds received by the Company from such sales to Lincoln Park will be used for working capital and general corporate purposes.

The aggregate number of shares that the Company can sell to Lincoln Park under the Purchase Agreement may in no case exceed 19.99% of the shares of the Common Stock outstanding immediately prior to the execution of the Purchase Agreement) (the "Exchange Cap"), unless (i) stockholder approval is obtained to issue shares above the Exchange Cap, in which case the Exchange Cap will no longer apply, or (ii) the average price of all applicable sales of our Common Stock to Lincoln Park under the Purchase Agreement equals or exceeds the lower of (A) the official closing price of the Company’s Common Stock on Nasdaq on the trading day immediately preceding the date of the Purchase Agreement and (B) the average official closing price of our Common Stock on Nasdaq for the five consecutive trading days ending on the trading day immediately preceding the date of the Purchase Agreement, adjusted such that the transactions contemplated by the Purchase Agreement are exempt from the Exchange Cap limitation under applicable Nasdaq rules.

In all instances, the Company may not sell shares of its Common Stock to Lincoln Park under the purchase agreement if it would result in Lincoln Park beneficially owning more than 4.99% of its Common Stock.

The Company has agreed with Lincoln Park that it will not enter into any "variable rate" transactions as defined in the Purchase Agreement with any third party for a period set forth in the Purchase Agreement. Lincoln Park has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Common Stock.

As consideration for Lincoln Park’s irrevocable commitment to purchase Common Stock upon the terms of and subject to satisfaction of the conditions set forth in the Purchase Agreement, upon execution of the Purchase Agreement, the Company issued 201,991 shares of Common Stock to Lincoln Park as commitment shares.

Lincoln Park has represented to the Company, among other things, that it is an "accredited investor" (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended (the "Securities Act")). The securities referred to in this current report on Form 8-K are being issued and sold by the Company to Lincoln Park in reliance upon the exemptions from the registration requirements of the Securities Act afforded by Section 4(a)(2) of the Securities Act and Rule 506(b) of Regulation D promulgated thereunder.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, agreements and conditions to completing future sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time, at no cost or penalty. During any "event of default" under the Purchase Agreement, all of which are outside of Lincoln Park’s control. The Company may not initiate any regular or other purchase of shares by Lincoln Park, until an event of default is cured. In addition, in the event of bankruptcy proceedings by or against the Company, the purchase agreement will automatically terminate.

This current report on Form 8-K shall not constitute an offer to sell or a solicitation of an offer to buy any shares of Common Stock, nor shall there be any sale of shares of Common Stock in any state or 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.

The foregoing descriptions of the Purchase Agreement and the Registration Rights Agreement are qualified in their entirety by reference to the full text of such agreements, copies of which are attached hereto as Exhibit 10.1 and 10.2, respectively, and each of which is incorporated herein in its entirety by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements, and may be subject to limitations agreed upon by the contracting parties.

On September 15, 2020 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported the expansion of its cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston, Massachusetts (Press release, Takeda, SEP 15, 2020, View Source [SID1234565253]). The facility provides end-to-end research and development capabilities and will accelerate Takeda’s efforts to develop next-generation cell therapies, initially focused on oncology with potential to expand into other therapeutic areas.

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"We are collaborating with some of the best scientists and innovators around the world establishing a highly differentiated immuno-oncology pipeline leapfrogging into new modalities and mechanisms with curative potential," said Chris Arendt, Ph.D., Head of Takeda’s Oncology Therapeutic Area Unit. "With three oncology cell therapy programs in the clinic and two more targeted to enter the clinic in fiscal year 2021, we are working with urgency and purpose for patients. This new facility helps us rapidly scale our manufacturing capabilities so we can simultaneously advance multiple highly differentiated cell therapy programs."

Oncology cell therapy is a type of immunotherapy that uses genetically modified immune cells to find and kill cancer cells. Because cell therapies are engineered from living cells, they need to be manufactured in a highly regulated environment to maintain cleanliness, consistency and contamination control. Each oncology cell therapy platform has unique process requirements for how they are formulated, manufactured, transported and ultimately administered to patients. Next-generation cell therapy is one of the multiple investigational platforms that Takeda is researching in oncology as part of its focus on redirected immunity. Takeda’s pipeline of diverse immuno-oncology programs harnesses innate immunity, including through innovative cell therapies, immune engager platforms, innate immuno-modulation, novel-scaffold immune check point platforms and oncolytic viruses.

A Purpose-Built Facility to Rapidly Advance Cell Therapy Research & Development

The R&D cell therapy manufacturing facility will produce cell therapies for clinical evaluation from discovery through pivotal Phase 2b trials. The current Good Manufacturing Practices (cGMP) facility is designed to meet all U.S., E.U. and Japanese regulatory requirements for cell therapy manufacturing to support Takeda clinical trials around the world. It will be instrumental in building Takeda’s cell therapy capabilities and capacity to advance multiple next-generation oncology cell therapy platforms and programs with world-class collaborators including Nobel Laureate Shinya Yamanaka, M.D., Ph.D., Kyoto University (induced pluripotent stem cells), Adrian Hayday, Ph.D., Gamma Delta Therapeutics (gamma delta T-cells), Koji Tamada, M.D., Ph.D., Noile-Immune Biotech (armored CAR-Ts), Michel Sadelain, M.D., Ph.D., Memorial Sloan Kettering Cancer Center (next-generation CARs), and Katy Rezvani, M.D., Ph.D., The University of Texas MD Anderson Cancer Center (CAR-NK).

Takeda and MD Anderson are developing a potential best-in-class allogeneic cell therapy product (TAK-007), a Phase 1/2 CD19-targeted chimeric antigen receptor-directed natural killer (CAR-NK) cell therapy with potential for off-the-shelf use being studied in patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Two additional Phase 1 studies of Takeda cell therapy programs were also recently initiated: 19(T2)28z1xx CAR T cells (TAK-940), a next-generation CAR-T signaling domain developed in partnership with Memorial Sloan Kettering Cancer Center (MSK) to treat relapsed/refractory B-cell cancers, and a cytokine and chemokine armored CAR-T (TAK-102) developed in partnership with Noile-Immune Biotech to treat GPC3-expressing previously treated solid tumors. Dr. Sadelain and MSK have intellectual property rights and associated interests related to the content of this release by virtue of licensing agreements between MSK and Takeda.

Harnessing the Power of Takeda’s Cell Therapy Translational Engine

Proactive and deep collaboration between research and development and commercial manufacturing is critical to developing and delivering next-generation cell therapies. Takeda’s Cell Therapy Translational Engine (CTTE) connects clinical translational science, product design, development, and manufacturing through each phase of research, development and commercialization. It provides bioengineering, chemistry, manufacturing and control (CMC), data management, analytical and clinical and translational capabilities in a single footprint to overcome many of the manufacturing challenges experienced in cell therapy development.

"The proximity and structure of our cell therapy teams allow us to quickly apply what we learn across a diverse portfolio of next-generation cell therapies including CAR NKs, armored CAR-Ts and gamma delta T cells, among others," said Stefan Wildt, Ph.D., Head of Pharmaceutical Sciences and Translational Engine, Cell Therapies at Takeda. "Insights gained in manufacturing and clinical development can be quickly shared across our global research, manufacturing and quality teams, a critical ability in our effort to deliver potentially transformative treatments to patients as fast as we can."

On September 15, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), reported that it will hold its 2020 Annual Meeting of Stockholders (the "Annual Meeting") solely by means of remote communication (i.e., a virtual-only stockholder meeting) (Press release, Avid Bioservices, SEP 15, 2020, View Source [SID1234565216]). This change is to protect the safety, health and well-being of its stockholders, directors, employees and the public during the COVID-19 pandemic. As previously announced, the Annual Meeting will be held on Tuesday, October 20, 2020 at 10:00 a.m. PDT.

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Stockholders will not be able to attend the Annual Meeting in person at a physical location. However, the virtual Annual Meeting will provide stockholders of record as of the close of business on August 24, 2020, the ability to participate, vote their shares and ask questions during the meeting via audio webcast.

Despite the change to a virtual-only meeting, the proxy card or voting instruction form, as applicable, included with previously-distributed proxy materials will not be updated to reflect the change from an in-person meeting to a virtual-only meeting and may be used to vote shares in connection with the Annual Meeting.

As provided in the company’s proxy materials, an online portal is available to stockholders at www.proxyvote.com where stockholders can view and download the company’s proxy materials and fiscal year 2020 Annual Report and vote their shares in advance of the Annual Meeting. Stockholders may vote their shares during the Annual Meeting (up until the closing of the polls) by following the instructions available at www.virtualshareholdermeeting.com/CDMO2020 during the meeting.

To be admitted to the virtual-only Annual Meeting, stockholders should visit www.virtualshareholdermeeting.com/CDMO2020 and enter the 16-digit control number found on their Important Notice Regarding the Availability of Proxy Materials, their proxy card or the instructions that accompanied their proxy materials.

Below are additional details on how stockholders can participate in the virtual-only Annual Meeting:

Access the meeting platform beginning at 9:45 a.m. PDT on October 20, 2020.

Vote during the Annual Meeting by following the instructions available on the meeting website during the meeting.

Submit a question during the meeting by visiting www.virtualshareholdermeeting.com/CDMO2020 and entering the stockholder’s 16-digit control number and submitting the question in the "Ask a Question" field.

If any difficulties are encountered while accessing the virtual meeting, contact the technical support number that will be posted on the Virtual Shareholder Meeting log-in page. Technical support will be available beginning at 9:45 a.m. PDT on October 20, 2020 and will remain available until the meeting has ended.

A list of stockholders entitled to vote will be available for inspection by stockholders of record for any legally valid purpose related to the Annual Meeting during the Annual Meeting by following the link provided when stockholders login to www.virtualshareholdermeeting.com/CDMO2020 and for a period of ten days prior to the Annual Meeting by sending a request to [email protected].
Whether or not stockholders plan to attend the virtual-only Annual Meeting, the company urges stockholders to vote and submit their proxies in advance of the meeting by one of the methods described in the proxy materials

On September 15, 2020 Hexagon Bio, Inc. ("Hexagon"), a biotechnology company turning nature’s genomes into medicines, reported that it has closed $47 million in Series A financing (Press release, Hexagon Bio, SEP 15, 2020, View Source [SID1234565209]). The round was led by The Column Group, with participation from 8VC and Two Sigma Ventures. Tod Smeal, formerly of Eli Lilly, Pfizer and SUGEN, will join as Chief Scientific Officer as the company adds drug discovery capabilities to complement its interdisciplinary platform for molecule identification.

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Hexagon’s molecule discovery platform uses data science, genomics, and synthetic biology to discover potent, evolutionarily refined secondary metabolites and their protein targets from fungal genomes. Secondary metabolites, which are small molecules produced by bacteria, fungi, and plants (also known as "natural products"), comprise many of the world’s most efficacious therapeutics including the antibiotic penicillin and the cholesterol-lowering drug lovastatin. Among FDA-approved drugs, 49% of all small molecule cancer drugs and 73% of all antibiotics originated from secondary metabolites. While secondary metabolites have proven to be rich sources of potent drugs, their translation has been hindered by the lack of mechanistic understanding of their intended target. Hexagon’s proprietary algorithms identify novel secondary metabolites, along with their cognate proteins (therapeutic targets), from genomic data, allowing Hexagon to bypass traditional screening methods.

"Hexagon has shown that we can build small molecules targeting key proteins in human disease, using our database of microbial genomes. Now it’s time to scale up, and Hexagon is exceptionally well poised to do so using automation and large-scale DNA sequencing of microbes, starting with fungi," said Hexagon CEO, Maureen Hillenmeyer.

Only a few thousand fungal genomes have been studied, but it is estimated that there are five million fungi on earth. Large-scale sequencing of those genomes could yield novel treatments for a vast array of human diseases. Hexagon will use the Series A funding to develop a proprietary genomics database of new secondary metabolites, and to build a drug discovery team to develop these compounds. Hexagon’s initial therapeutic focus areas are oncology and infectious disease. The platform is extendable to other therapeutic areas including immunology, cardiovascular, neurological, and metabolic disorders.

Tod Smeal, PhD, will join Hexagon as Chief Scientific Officer to lead drug discovery efforts. Dr. Smeal brings 22 years of research and development experience in the biotechnology and pharmaceutical industries, most recently as Chief Scientific Officer of Cancer Biology, Oncology Drug Discovery at Lilly Research Labs. "Tod Smeal’s track record at delivering clinical candidates, combined with his leadership experience in building drug discovery teams, will enable the company to enter its next phase: developing new targeted therapies identified by Hexagon’s platform," said Maureen Hillenmeyer.

"I am excited by Hexagon’s vision of genomics-driven discovery of secondary metabolites that target disease-driving proteins. The molecules that result from Hexagon’s platform have evolved to target specific proteins and are cell-permeable, making them excellent starting points for drug discovery," said David Goeddel, Chairman of the Board of Directors.

The company is led by CEO and founder Maureen Hillenmeyer. Other Hexagon founders are Brian Naughton, Head of Data and formerly founding scientist at 23andme, Colin Harvey, Head of Platform and Yi Tang, Professor of Chemical and Biomolecular Engineering at UCLA.

In conjunction with the Series A financing, David Goeddel, PhD, Managing Partner at The Column Group will join as chairman of Hexagon’s Board of Directors. Dr. Goeddel’s pioneering work at Genentech in the fields of gene cloning and expression of human proteins was the basis for five marketed therapeutics including human insulin, human growth hormone, interferon-alpha, interferon-gamma and tissue plasminogen activator. Juan Jaen, PhD, co-founder, President and Head of Research at Arcus Biosciences, and formerly co-founder and head of R&D at Flexus Biosciences will join Hexagon’s Board as an independent director.

"Drug resistance in human fungal and bacterial infections is a growing threat with the potential to severely limit treatment options for patients," said Dusan Perovic, Principal at Two Sigma Ventures. "We are proud to support the world-class engineers and data scientists at Hexagon as they work to leverage software and automation to build the next wave of targeted therapies and expand treatment options for infectious diseases."

On September 15, 2020 DAVITA INC. (NYSE: DVA) ("DaVita"), a health care provider focused on transforming care delivery to improve quality of life for patients globally and one of the largest providers of kidney care services in the United States, reported the preliminary results of its modified "Dutch auction" tender offer for up to $1.0 billion of its common stock at a price per share of not less than $77.00 and not more than $88.00, which expired at 12:00 midnight, New York City time, at the end of the day on September 14, 2020 (Press release, DaVita, SEP 15, 2020, View Source [SID1234565207]).

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Based on the preliminary count by the depositary for the tender offer, a total of 8,000,679 shares of DaVita’s common stock were validly tendered and not validly withdrawn at or below the price of $88.00 per share, including 3,388,259 shares that were tendered through notice of guaranteed delivery.

In accordance with the terms and conditions of the tender offer and based on the preliminary count by the depositary, DaVita expects to purchase a total of 8,000,679 shares of its common stock through the tender offer at a price of $88.00 per share, for a total cost of $704,059,752, excluding fees and expenses related to the tender offer.

The total of 8,000,679 shares that DaVita expects to accept for purchase represents approximately 6.6% of DaVita’s total outstanding shares of common stock as of September 14, 2020.

The number of shares expected to be purchased in the tender offer is preliminary and subject to change. The preliminary information contained in this press release is subject to confirmation by the depositary and is based on the assumption that all shares tendered through notice of guaranteed delivery will be delivered within the required two business day period. The final number of shares to be purchased in the tender offer will be announced following the expiration of the guaranteed delivery period and the completion by the depositary of the confirmation process. Payment for the shares accepted for purchase pursuant to the tender offer will occur promptly following the completion of the confirmation process.

DaVita expects to finance the share purchases in the tender offer with cash on hand.

The dealer manager for the tender offer is BofA Securities, Inc. Georgeson LLC is serving as information agent for the tender offer and Computershare is serving as the depositary for the tender offer.