OncoSec Appoints Brian Leuthner as Interim Chief Executive Officer

On June 24, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") reported that Daniel O’Connor has resigned and that Brian Leuthner, formerly Chief Operating Officer, has been appointed Interim Chief Executive Officer, effective June 25, 2021 (Press release, OncoSec Medical, JUN 24, 2021, View Source [SID1234584371]). Mr. O’ Connor is also stepping down from his seat on the Board of Directors.

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"Under Dan’s leadership over the past four years, OncoSec has transformed itself into the leading intra-tumoral cancer immunotherapy Company," said Margaret Dalesandro, Ph.D., Chair of the Board of Directors at OncoSec. "Dan operationally drove several value-creating clinical programs with the Company’s lead product candidate, TAVO, including the now fully enrolled pivotal study in anti-PD-1 checkpoint refractory metastatic melanoma patients, KEYNOTE-695, as well as a phase 2 program in metastatic triple negative breast cancer. Under his leadership, OncoSec is well-capitalized to meet important inflection points and has established a string of strategic partnerships with large pharma companies and top research institutions. On behalf of the Board, I want to thank Dan for his tireless work ethic and leadership in delivering to our shareholders a Company that is now extremely well-positioned for success."

Dr. Dalesandro continued, "Brian Leuthner, a former public company CEO with decades of experience, will now step into the CEO role bringing fresh energy and his own brand of leadership, which we are confident will enhance the Company’s upward trajectory and further exploit the potential of our platform for the benefit of both cancer patients and our shareholders. In parallel, I, along with the Board, will evaluate and potentially identify a new CEO candidate who will work to ensure that we reach the next evolution as the leading intra-tumoral cancer immunotherapy company."

Mr. Leuthner joined OncoSec in February 2021. Over the course of his 32-year career in biotech and pharmaceuticals, Mr. Leuthner has held several leadership positions, including several public and private CEO positions. For a decade, Mr. Leuthner was co-founder, President, and CEO of Edge Therapeutics, Inc., an orphan disease-focused company.

Mr. Leuthner added, "I came to OncoSec because I saw it as a well-established company with valuable technology that I believed I could further enhance. As OncoSec’s Interim Chief Executive Officer, I look forward to adding to the momentum Dan built as we strive to improve the long-term outcomes to patients living with cancer"

About TAVO
OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.

HUYABIO Announces HBI-8000 Brand Name of Hiyasta™

On June 24, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported that HBI-8000 will be marketed under the brand name Hiyasta in Japan (Press release, HUYA Bioscience, JUN 24, 2021, View Source [SID1234584367]). Hiyasta was recently approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adult T-cell leukemia/lymphoma (ATLL) as monotherapy.

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Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "Today’s approval of Hiyasta for ATLL came in just 9 months. Our commercial partnership with Meiji will now bring Hiyasta to patients and provide much needed public health benefit for this devastating, life threatening disease."

Hiyasta was also submitted to the PMDA in March for approval as monotherapy to treat peripheral T-cell lymphoma (PTCL). In addition, the ODD designation for Hiyasta in Japan has been formally approved for both ATLL and PTCL.

About HBI-8000
HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylases (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATLL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATLL cells more sensitive to immune cytotoxicity targeting.

About HUYABIO International

HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development

Entry into a Material Definitive Agreement

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.

ATCC Expands Commercially Available Collection of Rare Cancer Culture Models Derived From Patient Samples in Collaboration with HCMI

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."

Anavex Life Sciences Announces Closing of $50 Million Registered Direct Offering

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.