On June 24, 2021, Athersys, Inc. (the "Company," "we," "us" or "our") reported that it entered into a common stock purchase agreement (the "Purchase Agreement") with Aspire Capital Fund, LLC ("Aspire Capital"), which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $100 million of shares of the Company’s common stock over the 36-month term of the Purchase Agreement (Filing, 8-K, Athersys, JUN 24, 2021, View Source [SID1234584361]).

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Concurrently with entering into the Purchase Agreement, the Company also entered into a registration rights agreement with Aspire Capital (the "Registration Rights Agreement"), pursuant to which the Company agreed to file one or more registration statements, as permissible and necessary to register under the Securities Act of 1933, as amended (the "Securities Act"), the sale of the shares of the Company’s common stock that may be issued to Aspire Capital under the Purchase Agreement.

The Purchase Agreement provides that the number of shares of our common stock that may be sold pursuant to the Purchase Agreement shall be limited to 40,000,000 shares.

Pursuant to the Purchase Agreement and the Registration Rights Agreement, we intend to register under the Securities Act the sale of 40,000,000 shares of our common stock that we may issue to Aspire Capital after the registration statement referred to above (the "Registration Statement") is declared effective under the Securities Act.

After the U.S. Securities and Exchange Commission (the "SEC") has declared the Registration Statement effective, on any business day on which the closing sale price of the Company’s common stock equals or exceeds $1.00 per share, we have the right, in our sole discretion, to present Aspire Capital with a purchase notice (each, a "Purchase Notice"), directing Aspire Capital (as principal) to purchase up to 200,000 shares of our common stock per trading day, provided that the aggregate price of such purchase shall not exceed $500,000 per trading day, up to $100 million of our common stock in the aggregate. The purchase price per share pursuant to such Purchase Notice (the "Purchase Price") is the lower of (i) the lowest sale price for the Company’s common stock on the date of sale or (ii) the arithmetic average of the three lowest closing sale prices for the Company’s common stock during the ten consecutive business days ending on the business day immediately preceding the purchase date of those securities. The applicable Purchase Price will be determined prior to delivery of any Purchase Notice.

In addition, on any date on which we submit a Purchase Notice to Aspire Capital in an amount of at least 100,000 shares, we also have the right, in our sole discretion, to present Aspire Capital with a volume-weighted average price purchase notice (each, a "VWAP Purchase Notice") directing Aspire Capital to purchase an amount of the Company’s common stock equal to a percentage (not to exceed 30%) of the aggregate shares of common stock traded on the NASDAQ Capital Market on the next business day (the "VWAP Purchase Date"), subject to a maximum number of shares determined by the Company (the "VWAP Purchase Share Volume Maximum"). The purchase price per share pursuant to such VWAP Purchase Notice (the "VWAP Purchase Price") shall be the lower of (i) the closing sale price on the date of sale and (ii) 95% of the volume weighted average price for the Company’s common stock traded on the NASDAQ Capital Market on (a) the VWAP Purchase Date if the aggregate shares to be purchased on that date does not exceeded the VWAP Purchase Share Volume Maximum and the sale price of our common stock has not fallen below the price set by us in the VWAP Purchase Notice (the "VWAP Minimum Price Threshold") (to be appropriately adjusted for any reorganization, recapitalization, non-cash dividend stock split, reverse stock split or other similar transaction) or (b) the portion of such business day until such time as the aggregate shares to be purchased will equal the VWAP Purchase Share Volume Maximum. Further, if the sale price of our common stock falls on the VWAP Purchase Date below the greater of (i) 90% of the closing price of our common stock on the business day immediately preceding the VWAP Purchase Date or (ii) the VWAP Minimum Price Threshold, the VWAP Purchase Price will be determined using the percentage in the VWAP Purchase Notice of the total shares traded for such portion of the VWAP Purchase Date prior to the time that the sale price of our common stock fell below the VWAP Minimum Price Threshold and the volume weighted average price of our common stock sold during such portion of the VWAP Purchase Date prior to the time that the sale price of our common stock fell below the VWAP Minimum Price Threshold.

The floor price and the respective prices and share numbers in the preceding paragraphs shall be appropriately adjusted for any reorganization, recapitalization, stock dividend, stock split, reverse stock split or other similar transaction. Additionally, the Purchase Agreement provides that the Company and Aspire Capital shall not effect any sales under the Purchase Agreement if such shares proposed to be issued and sold, when aggregated with all other shares of the Company’s common stock that Aspire Capital and its affiliates beneficially own, would result in Aspire Capital and its affiliates beneficially owning more than 19.99% of the Company’s then issued and outstanding common stock.

There are no trading volume requirements or restrictions under the Purchase Agreement, and we will control the timing and amount of any sales of our common stock to Aspire Capital. Aspire Capital has no right to require any sales by us, but is obligated to make purchases from us as we direct in accordance with the Purchase Agreement. The Company may deliver multiple Purchase Notices and VWAP Purchase Notices to Aspire Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has been completed. There are no limitations on use of proceeds, financial or business covenants, restrictions on future fundings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement. The Purchase Agreement may be terminated by us at any time, at our discretion, without any penalty or cost to us. Also, Aspire Capital has agreed that neither it nor any of its agents, representatives and affiliates shall engage in any direct or indirect short-selling or hedging, which establishes a net short position with respect to our common stock during any time prior to the termination of the Purchase Agreement.

The Purchase Agreement provides for customary events of default, upon the occurrence of which Aspire Capital may terminate the Purchase Agreement. Such events of default include, without limitation:

the lapse, or unavailability to Aspire Capital for the sale of shares of the Company’s common stock, of any registration statement that is required to be maintained effective pursuant to the terms of the Registration Rights Agreement, subject to specified cure periods;

the suspension from trading or failure of the Company’s common stock to be listed on a Principal Market (as defined in the Purchase Agreement) for a period of three consecutive business days;

the delisting of the Company’s common stock from the Principal Market, provided the Company’s common stock is not immediately thereafter trading on the New York Stock Exchange, the NYSE American, the NASDAQ Global Select Market, the NASDAQ Global Market or the NASDAQ Capital Market;

the failure for any reason by the Company’s transfer agent to issue shares to Aspire Capital within five business days after the applicable purchase date that Aspire Capital is entitled to receive such shares;

if any proceeding against the Company is commenced pursuant to or within the meaning of any bankruptcy law;

if at any time the number of shares sold pursuant to the Purchase Agreement exceeds 40,000,000 shares, if applicable, unless and until stockholder approval is obtained; and

any breach by the Company of the representations, warranties, covenants or other term or condition contained in the Purchase Agreement or any related agreements that would reasonably be expected to have a material adverse effect, except, in the case of a breach of a covenant which is reasonably curable, only if such breach continues for a period of at least five business days.

The foregoing is a summary description of certain terms of the Purchase Agreement and the Registration Rights Agreement. For a full description of all terms, please refer to copies of the Purchase Agreement and the Registration Rights Agreement that are filed herewith as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference. All readers are encouraged to read the entire text of the Purchase Agreement and the Registration Rights Agreement.

The issuance of all shares of common stock that may be issued from time to time to Aspire Capital under the Purchase Agreement is exempt from registration under the Securities Act, pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D promulgated thereunder.

On June 24, 2021 ATCC, the world’s premier biological materials management and standards organization, reported that it’s expanding their collection of next-generation 2-D and 3-D patient tissue-derived in vitro cancer models, including three-dimensional organoids, as part of its renewed partnership with the National Cancer Institute (NCI), of the National Institutes of Health, to support the Human Cancer Models Initiative (HCMI) (Press release, American Type Culture Collection (ATCC), JUN 24, 2021, View Source [SID1234584356]). ATCC has been collaborating with the NCI and the HCMI since 2016 to offer scientists a wide variety of novel and physiologically relevant models to study cancer, identify and target novel therapies, and facilitate translational cancer research. The ATCC collection is the first collection of novel cancer models that is derived from the biopsy of patients, and it’s the leading commercially available patient-derived collection that contains rare and pediatric cancers.

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The HCMI is an international consortium dedicated to generating novel human tumor-derived models annotated with genomic, clinical, and biospecimen data. The consortium comprises of funding agencies and cancer model development and sequencing centers, including the NCI, Cancer Research UK (CRUK), Hubrecht Organoid Technology (HUB), and Wellcome Sanger Institute (WSI). NCI funds cancer model development centers including Broad Institute, Cold Spring Harbor Laboratories, Stanford University, and Weill Cornell Medical College. ATCC is the distributor for the HCMI models. The cancer model generating institutions deposit the models into ATCC, where they are authenticated, expanded, preserved, and made available for global distribution.

"We understand how important reliable cancer models are to overcoming the roadblocks that hinder cancer research and pre-clinical drug discovery," said Raymond Cypess, DVM, Ph.D., Chairman and CEO of ATCC. "ATCC brings nearly 100 years of cell culture experience to this effort. It’s that tried and tested expertise that enables us to ensure the highest quality models — which are essential if we’re to support meaningful breakthroughs in cancer research that will benefit all patients, today and tomorrow."

ATCC is committed to making available a growing collection of patient-derived next-generation cancer models (NGCMs) generated by the HCMI that includes common as well as rare and understudied examples of cancer from numerous tissues. For this latest expansion, over the coming months, ATCC will add to the collection nearly 100 human-patient derived models from primary, metastatic, and recurrent cancers — in addition to models from diverse genetic backgrounds. The expanded collection will include rare and pediatric cancers — along with organoids and other advanced models — for cancers of the colon, pancreas, breast, stomach, and esophagus. ATCC also will be releasing its first gallbladder model.

"What differentiates these models from historical cancer cell lines is the accompanying bioinformation; the breadth and depth of the patient, tumor and model bioinformation is unique and will enable insights and advances in cancer research that were not previously possible," explained Mindy Goldsborough, Ph.D., Chief Scientific Officer of ATCC. "The production and distribution of these models is now happening at scale. And it’s contributing to research that’s more valuable and reproducible than ever before."

Members of the HCMI Consortium are acutely aware of just how significant organoids and other advanced-technology cancer models are to speeding up the pace of life-saving discovery. The crucial role that ATCC plays in supplying them is evident:

"By enabling broad dissemination, the partnership between HCMI and ATCC is democratizing the use of these new cancer models," said Olivier Elemento, Director of the Englander Institute for Precision Medicine at Weill Cornell Medicine. "And that can only lead to life-changing breakthroughs."

"The world is currently witnessing an unprecedented, transformative shift in cancer models that will serve as the foundation for the future of cancer research," echoed Jesse Boehm, Principal Investigator at the Broad Institute and the Director of the Broad Cancer Model Development Center. "Our collaboration with ATCC empowers us to drive the kind of research that will directly benefit human health — with the ultimate goal of saving people’s lives."

On June 24, 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) disorders, reported the closing of its previously announced registered direct offering to Deep Track Capital for the issuance and sale of an aggregate of 2,380,953 shares of its common stock at a purchase price of $21.00 per share of common stock. H.C. Wainwright & Co. acted as the exclusive placement agent for the offering (Press release, Anavex Life Sciences, JUN 24, 2021, View Source [SID1234584350]).

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The gross proceeds from the offering were approximately $50 million before deducting placement agent fees and other offering expenses. Anavex intends to use the net proceeds from the offering for advancing its pipeline and for working capital and general corporate purposes.

The shares of common stock described above were offered pursuant to Anavex’s shelf registration statement on Form S-3 (File No. 333-232550) filed with the Securities and Exchange Commission (the "SEC") on July 3, 2019 and declared effective on July 15, 2019. Such shares of common stock have been offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered in the registered direct offering were filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail: [email protected] or by telephone: (212) 856-5711.

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

On June 24, 2021 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company focused on developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, reported the publication of an original scientific paper in Nature Chemical Biology describing anti-tumor effects of bi-steric mTORC1-selective inhibitors that potently suppress phosphorylation of 4EBP1, a key translational regulator of oncogene expression (Press release, Revolution Medicines, JUN 24, 2021, View Source [SID1234584348]). In preclinical models of cancers with mutations that drive mTORC1 hyperactivation, a series of bi-steric inhibitors demonstrated the favorable anti-tumor effects and tolerability of deeply and selectively inhibiting mTORC1 compared to earlier generations of mTOR inhibitors. Mutations that cause hyperactive mTORC1 signaling are found in tumors with and without co-existent RAS mutations. This original research was led by scientists at Revolution Medicines and conducted in collaboration with the Neal Rosen Lab at the Memorial Sloan Kettering Cancer Center, as well as researchers from McGill University and The Karolinska Institute.

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Revolution Medicines recently advanced RMC-5552, the company’s investigational first-in-class bi-steric mTORC1 inhibitor, into clinical development. RMC-5552 is a potent and selective inhibitor of mTORC1 that is being developed as an anti-cancer therapeutic for patients with solid tumors that exhibit hyperactivation of the mTOR pathway, including certain RAS-addicted cancers. The compound is designed to inhibit mTORC1 and thereby protect the natural tumor suppressor activity of 4EBP1, without the undesirable inhibition of mTORC2. RMC-5552 has demonstrated anti-tumor activity in a wide variety of preclinical models. Revolution Medicines has also reported in vivo data demonstrating that RMC-5552 may increase anti-tumor activity in combination with KRASG12C inhibitors in lung and colon cancers harboring both KRAS mutations and co-mutations in the mTOR signaling pathway that can cause resistance to single agent RAS inhibition.

"The paper published in Nature Chemical Biology highlights the therapeutic promise of mTORC1-selective bi-steric inhibitors in the treatment of tumors driven by the genomic activation of the mTORC1 pathway. Specifically, the published research details the manner in which these selective inhibitors of mTORC1 potently inhibit tumor growth while causing less toxicity and receptor reactivation, a potential mechanism of adaptive resistance, as compared to conventional mTOR inhibitors," said Steve Kelsey, M.D., president, research and development at Revolution Medicines. "These study results offer compelling rationale for our recently initiated clinical development program for RMC-5552."

The company recently initiated a multicenter, open-label dose-escalation and dose-expansion Phase 1/1b clinical trial designed to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of RMC-5552 in patients with advanced relapsed/refractory solid tumors. Results from this study will inform identification of the maximum tolerated dose (MTD) and selection of recommended Phase 2 dose and schedule (RP2DS) for further evaluation of the compound.

The paper published in Nature Chemical Biology is titled, "Selective inhibitors of mTORC1 activate 4EBP1 and suppress tumor growth," and can be accessed at: View Source

About mTORC1

The mTOR Complex 1 (mTORC1) is a central node within the mTOR signaling pathway and a critical regulator of metabolism, growth and proliferation in cancer cells. Oncogenic mutations of genes encoding proteins that lie upstream of mTOR, including PI3K, PTEN, and STK11, can drive abnormal activation of mTORC1 and subsequent inactivation of the tumor suppressor 4EBP1. Selective inhibition of mTORC1 to reactivate 4EBP1 is a potential therapeutic strategy for patients with tumors bearing such mutations. These mutations are often co-occurring with RAS mutations in RAS-addicted tumors and combinations of mTORC1 and RAS-targeted inhibitors may be of particular benefit in this context.

On June 24, 2021 Fosun Kite Biotechnology reported its autologous CD19-directed CAR-T cell therapy Axicabtagene Ciloleucel (FKC876) (axicabtagene ciloleucel) has been approved by China National Medical Products Administration (NMPA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma[1] (Press release, Fosun Kite Biotechnology, JUN 24, 2021, View Source [SID1234584347]).

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Axicabtagene Ciloleucel (FKC876) is an autologous CD19-directed CAR-T cell therapy manufactured in China pursuant to a license from Kite, a Gilead Company ("Kite") of Kite’s Yescarta (axicabtagene ciloleucel), which is the world’s first approved CAR-T cell therapy for adult patients with certain types of NHL. This NDA approval is based on results of a single-arm, open label, multi-center bridging trial which has evaluated and proven the efficacy and safety of Axicabtagene Ciloleucel (FKC876) in the treatment of Chinese patients with refractory intermediate invasive DLBCL.

WU Yifang, Chairman and CEO of Fosun Pharma, says, "CAR-T cell therapy is one of the significant cancer treatment breakthroughs in recent years. It is a great pleasure to work with Kite, a world-leading partner, to bring Axicabtagene Ciloleucel (FKC876) in China together, which is also an important milestone for Fosun Pharma’s global innovation and R&D cooperation. Thanks to NMPA for the rigorous review and recognition of China’s first CAR-T cell therapy. Focusing on unmet clinical needs, Fosun Pharma will continue to take innovative R&D as the core driving force and strive to provide patients with more high-quality, accessible and innovative medicines and treatment options."

MEI Jingping, Chairwoman of Fosun Kite, says, "As the first commercialized product of Fosun Kite, the approval of Axicabtagene Ciloleucel (FKC876) brings a revolutionary treatment option to cancer patients in China. We will continue to guard this innovative vein-to-vein treatment circle with high-quality and rigorous service chains to benefit more cancer patients."

Terence O’Sullivan, Vice President, International Region at Kite comments: "As the world’s first approved CAR-T cell therapy for NHL, Kite’s Yescarta (axicabtagene ciloleucel) has been used in thousands of patients around the world. Thank you to the dedicated healthcare professionals, patients and caregivers who worked with the team at Fosun Kite to make this fast and reliably manufactured treatment option, with the potential of survival for patients facing these challenging and aggressive cancers available in China."

Dr. MA Jun, Director of the Harbin Institute of Hematology & Oncology, Chief Supervisor of Supervisory Committee at the Chinese Society of Clinical Oncology, "Thanks to the reform of national medicines review and approval system in recent years, China’s lymphoma diagnosis and treatment level has progressed rapidly, and CAR-T cell therapies have seen even more significant changes. As China’s first CAR-T product approved by NMPA, Axicabtagene Ciloleucel (FKC876)’s approval for marketing. shows China’s innovation to establish new review guidelines and standards for cell therapies, and determination to bring in world-leading technologies and medicines to benefit cancer patients in China."

Dr. WU De-pei, Chair of the Department of Hematology at the First Affiliated Hospital of Soochow University, Co-Lead Investigator of Axicabtagene Ciloleucel (FKC876) clinical trial, "As a type of malignant cancer with heterogeneity in clinical manifestation, prognosis and other aspects, DLBCL is still facing a large number of unmet medical needs in China. As the first regulatory approved and commercially available CAR-T, the approval of Axicabtagene Ciloleucel (FKC876) provides oncologists with one more option and hope of long term survival to a patient population that previously exhausted all viable treatment options."

Dr. ZHAO Wei-li, Vice Chair of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Lead Investigator of Axicabtagene Ciloleucel (FKC876) clinical trial, comments, "The bridging trial results has demonstrated remarkable similarity between Axicabtagene Ciloleucel (FKC876) and Yescarta in terms of efficacy and safety in the treatment of Chinese adult patients with r/r LBCL. In the bridging trial, 79.2% of patients had achieved a response after a single infusion[1]; Zuma-1 data showed the best objective response rate was 83%, with 58% in complete remission[2]. Overall, Axicabtagene Ciloleucel (FKC876) has demonstrated durable response and survival rate with a manageable safety profile."

HUANG Hai, CEO of Fosun Kite, says, "We really appreciate NMPA’s recognition of Axicabtagene Ciloleucel (FKC876) manufacturing process, quality control and clinical efficacy. We will continue to fulfill our mission "focus on cancer cure". A big thanks to Professor ZHAO Wei-li’s team from Ruijin Hospital Affiliated to Shanghai Jiao Tong University as the Lead Investigator, together with Professor WU De-pei’s team from the First Affiliated Hospital of Soochow University, Professor Hu Yu’s team from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and Professor . Zhang Hui-lai’s team from Tianjin Cancer Hospital, their trust and efforts in the registered clinical trials have promoted successful approval of Axicabtagene Ciloleucel (FKC876) in China. With patients at the center of what we do, Fosun Kite is working hard to make this revolutionary cancer treatment accessible to benefit patients in China as soon as possible."

About Large B-cell Lymphoma

Lymphoma refers to a class of heterogeneous cancers that are specific to the lymphatic system. It is divided into two categories based on cell type: Hodgkin’s lymphoma (HL) and non-Hodgkin’s lymphoma (NHL), and the latter is much more common. Epidemiology estimates 88,090 newly diagnosed NHL patients in China in 2018[4]. LBCL is the most common subtype of NHL among adult lymphoma patients, and it is a type of malignant cancer with heterogeneity in clinical manifestation, prognosis and other aspects; DLBCL incidence is approximately one-third of all NHL in China[5]. Studies have shown 40%-50% of DLBCL patients would become relapsed or refractory after first line treatments[6,7], 73% r/r DLBCL patients would not respond to two or more lines of treatments[8]. A study of 603 patients with r/r DLBCL showed median overall survival of only 6.3 months[8] indicating the limitations with current standard of care, associated with poor outcomes and creating a high unmet need.

About Yescarta

Yescarta is an autologous CD19-directed CAR-T cell therapy of Kite, approved for the U.S. market on October 18, 2017 by FDA for the treatment of adult patients with r/r LBCL after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, and high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma. According to an ongoing single-arm, multi-center, open-label clinical study (ZUMA-1) carried out by Kite evaluating efficacy and safety of axicabtagene ciloleucel in 101 adult patients with r/r LBCL, 1-year follow-up results showed the best objective response rate of 82%, with 54% of patients achieved a complete remission[9]; at a median follow-up of 27.1 months post-infusion, the best objective response rate was 83%, with 58% in complete remission and 39% remain in complete remission[2]; at a median follow-up of 51.1 months, 44% of patients were alive and the median overall survival was 25.8 months[3], confirming that axicabtagene ciloleucel can bring long-term survival benefits to patients.