Cryoport Announces Pricing of Public Offering of Common Stock

On June 19, 2019 Cryoport, Inc. (Nasdaq: CYRX) (Nasdaq: CYRXW) ("Cryoport" or the "Company") reported the pricing of its underwritten public offering of an aggregate of 3,750,000 newly issued shares of common stock at a price of $17.00 per share (Press release, Cryoport, JUN 19, 2019, View Source [SID1234537176]). In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 562,500 shares of common stock. The net proceeds to the Company from the offering of the shares are expected to be approximately $59.8 million after deducting underwriting discounts and commissions and estimated offering expenses, and assuming no exercise of the underwriters’ option to purchase additional shares. Subject to customary conditions, the offering is expected to close on June 24, 2019.

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The Company expects to use the net proceeds from the offering of the shares for working capital, inventory development, global infrastructure buildout and facilities expansion, sales and marketing and, potentially, acquisitions with strategic impact.

Jefferies and SVB Leerink are acting as joint book-running managers for the offering. Needham & Company, Janney Montgomery Scott, B. Riley FBR, and Roth Capital Partners are acting as co-managers for the offering.

The public offering was made pursuant to a registration statement on Form S-3 that was previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A final prospectus supplement and accompanying base prospectus relating to and describing the final terms of the offering will be available on the SEC’s website located at View Source or may be obtained from Jefferies, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-821-7388 or by email at [email protected]; or SVB Leerink, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at 800-808-7525, ext. 6132 or by email at [email protected].

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

Seven and Eight Biopharmaceuticals Inc. Announces Clinical Collaboration

On June 19, 2019 Seven and Eight Biopharmaceuticals Inc. reported that it has signed a clinical research collaboration agreement with Roche to explore the combination of Seven and Eight’s BDB001, an immune modulator targeting toll-like receptors (TLR) 7 and 8, and atezolizumab, a monoclonal antibody against the checkpoint target of PD-L1, in treating solid tumors (Press release, Seven and Eight Biopharmaceuticals, JUN 19, 2019, View Source [SID1234537175]).

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"We are pleased to enter into clinical collaboration with Roche," says Dr. Walter Lau, CEO of Seven and Eight. "Toll-like receptors 7 and 8 are amongst the most promising targets for immuno-oncology, and our dual agonists have demonstrated the ability to stimulate specific types of innate immune responses, generating enhanced adaptive anti-tumor immunity. We hope through our joint efforts with Roche, we can better delineate how to use BDB001 and atezolizumab together in the treatment of cancer patients."

Under the terms of the agreement, Seven and Eight will sponsor and be responsible for the conduct of the clinical study, in which the combined regimen of BDB001 and atezolizumab is studied for safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activities in solid tumor patients.

Zymeworks Announces Pricing of $175.0 Million Public Offering

On June 19, 2019 Zymeworks Inc. (NYSE/TSX:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics (the "Company"), reported the pricing of its previously-announced underwritten public offering (the "Offering") of 5,555,556 common shares and, to a certain investor, pre-funded warrants to purchase up to 4,166,690 common shares (Press release, Zymeworks, JUN 19, 2019, View Source [SID1234537174]). The common shares are being offered at a price to the public of US$18.00 per common share and the pre-funded warrants are being offered at a price of US$17.9999 per pre-funded warrant, for aggregate gross proceeds to the Company of approximately US$175.0 million, before deducting the underwriting discounts and commissions and estimated Offering expenses. In addition, the Company has also granted the underwriters of the Offering a 30-day over-allotment option to purchase up to an additional 1,458,336 common shares on the same terms and conditions.

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The Company intends to use the net proceeds of the Offering to accelerate and expand the global development of ZW25 both as a single agent and in combination with other anti-cancer agents in a variety of HER2-expressing tumors, including gastroesophageal, breast and other underserved cancers; to accelerate and expand the clinical development of ZW49 through its ongoing adaptive Phase 1 clinical trial and follow-on global studies; to advance other novel preclinical programs, including those involving non-HER2-expressing tumors; and for general corporate purposes.

J.P. Morgan Securities, LLC is acting as active book-running manager for the Offering. Wells Fargo Securities, LLC and Stifel, Nicolaus & Company, Incorporated are acting as passive book-running managers, Raymond James Ltd. is acting as co-lead manager and Ladenburg Thalmann & Co. Inc. is acting as co-manager.

The securities described above are being offered in Canada pursuant to Zymeworks’ final prospectus supplement, dated June 19, 2019 (the "Canadian Supplement"), to its Canadian final base shelf prospectus, dated March 6, 2019 (the "Base Prospectus"), and in the United States pursuant to Zymeworks’ final prospectus supplement, dated June 19, 2019 (the "U.S. Supplement", together with the Canadian Supplement, the "Supplements"), to its U.S. shelf registration statement on Form S-3, as amended, including a prospectus dated January 31, 2019 (the "Registration Statement"). The Supplements will be filed in Canada and the United States on June 20, 2019.

The Offering is expected to close on or about June 24, 2019, subject to the satisfaction of customary closing conditions, including the listing of the common shares to be issued and that are issuable under the Offering on the TSX and NYSE and any required approvals of each exchange.

The Supplements and the Registration Statement contain important detailed information about the Offering. A copy of the Canadian Supplement will be filed and can be found on SEDAR at www.sedar.com, and a copy of the U.S. Supplement and the related Registration Statement can be found on EDGAR at www.sec.gov. Copies of the Supplements may also be obtained from J.P. Morgan Securities, LLC, Attention; Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204; Wells Fargo Securities, LLC, Attention; Equity Syndicate Department, 375 Park Avenue, New York, NY 10152, by telephone at (800) 326-5897, or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at [email protected]. Prospective investors should read the Supplements and the Registration Statement before making an investment decision.

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

Personalis Prices Initial Public Offering of Common Stock

On June 19, 2019 Personalis, Inc., a leader in advanced genomics for cancer, reported the pricing of its initial public offering of 7,921,500 shares of common stock at a price to the public of $17.00 per share (Press release, Personalis, JUN 19, 2019, View Source [SID1234537173]). All of the shares of common stock are being offered by Personalis. In addition, Personalis has granted the underwriters a 30-day option to purchase up to an additional 1,188,225 shares of common stock from Personalis at the public offering price less underwriting discounts and commissions. The company’s shares are expected to begin trading on The Nasdaq Global Market on Thursday, June 20, 2019 under the trading symbol "PSNL." The offering is expected to close on June 24, 2019, subject to the satisfaction of customary closing conditions.

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Morgan Stanley, BofA Merrill Lynch and Cowen are acting as joint book-running managers for the offering. Oppenheimer & Co. Inc. is acting as co-manager for the offering.

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission and was declared effective on June 19, 2019. A copy of the final prospectus relating to this offering may be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; BofA Securities, Inc., Attention: Prospectus Department, NC1‐004‐03‐43, 200 North College Street, 3rd floor, Charlotte, NC 28255‐0001, or by emailing [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 631‐274‐2806.

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 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 jurisdiction.

Clinical Results of Fully Human BCMA CAR-T for the Treatment of Relapsed/Refractory Multiple Myeloma Co-developed by IASO BIO and Innovent Presented at the 2019 ASCO and EHA Annual Meetings

On June 19, 2019 IASO Biotherapeutics (IASO BIO), one of the top biotechnology innovators, reported their potential best-in-class therapy back-to-back at two of the most prestigious clinical meetings in the worlds of hematology and oncology, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2019 in Chicago, Illinois, May 31-June 4 [Abstract#8013; Monday, June 3], and the 24th Congress of the European Hematological Society (EHA) (Free EHA Whitepaper), June 13-16 [Abstract#S827; Saturday, June 15] (Press release, IASO BioMed, JUN 19, 2019, View Source [SID1234537172]).

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These notable meetings feature the efforts of the brightest minds driving innovation in hematology and cancer research from around the globe. With a combined international attendance of more than 50,000, this year’s meetings focused heavily on the field of immunotherapy, presenting the latest trends and approaches in immuno-oncology, including adaptive cell therapies, immune checkpoint inhibitors, CAR-T therapies and more.

CT103A is an anti-BCMA CAR-T for the treatment of relapsed/refractory multiple myeloma (R/RMM) co-developed by IASO BIO and Innovent Biologics, Inc. (Innovent) (HKEX:01801). The data of CT103A presented at both conferences show impressive efficacy results, persistence and safety profile and an objective response rate (ORR) of 100%.

In an IIT study conducted by Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, IASO BIO presented compelling results for efficacy and persistence of a therapy that may also provide patients, having relapsed from a prior CAR-T, an option for CAR-T retreatment.

Multiple myeloma is a malignant hematologic cancer with abnormal proliferation of clonal plasma cells, which has no medical cure so far. In many countries, myeloma is the second most common blood cancer. The American Cancer Society estimates that in the United States (U.S.), about 32,110 new cases will be diagnosed this year. In Europe, more than 48,200 people were diagnosed with multiple myeloma in 2018. Among them, 40 percent of patients are diagnosed with moderate or high-risk multiple myeloma, and their median survival is less than five years.

As of the data cutoff date of May 22nd, 2019, the objective response rate (ORR) was 100% (CR-64%, VGPR-36%) with strong persistence and high expansion of the CAR-T in vivo. All patients (100%) experienced CRS. The onset of CRS occurred within 2 to 5 days (median – 2.6) and resolved within 14 days. Mostly grade 1 and 2, at the low and medium dosage levels, CRS was routinely managed with Tocilizumab and steroids. Interestingly, the 12-patient study included 4 patients having previously relapsed from a prior CAR-T therapy, a murine anti-BCMA CAR-T.

"Relapsed/refractory multiple myeloma (R/RMM) is associated with a poor prognosis," said Dr. Chunrui Li of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology. "Many who receive CAR-T treatments have had their disease come back, and with a non-human scFv, retreatment may not be an option due to immunogenicity. With a fully human BCMA scFv, CT103A provides an effective option for these patients. This data suggests they should not be excluded from the benefit of future trials."

About Relapsed/Refractory Multiple Myeloma:

For newly treated patients with multiple myeloma, the common first-line treatment drugs include proteasome inhibitors, immunoregulatory drugs and alkane agents. For most patients, the commonly used first-line treatment can stabilize the patient’s condition for 3-5 years, but a small number of patients show primary drug resistance at the time of initial treatment, and the disease cannot be effectively controlled. Relapse patients are patients who have a reoccurrence after complete remission of the disease. Refractory patients are patients with primary drug resistance or the patients who have finished with first-line treatment and do not achieve remission, or the patients whose disease progress within 60 days after achieving minimal response. For the majority of patients with effective treatment, they will inevitably enter the stage of relapse and refractory after 3-5 years of disease stabilization. For these patients, the overall effective rate of existing second-line treatment is about 40% to 70%, with short remission time.

About CT103A:

CT103A is an innovative therapy co-developed by IASO BIO and Innovent. Previous studies indicate patients with relapsed/refractory multiple myeloma (R/RMM) who received high-dose, BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR-T cells is not effective. To solve this dilemma, CT103A has been developed, A lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3z activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the CT103A CAR-T is potent and persistent.