Neon Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update

On March 2, 2020 Neon Therapeutics, Inc. (Nasdaq: NTGN) reported financial results for the fourth quarter and full-year ended December 31, 2019 and provided a business update (Press release, Neon Therapeutics, MAR 2, 2020, View Source [SID1234555024]).

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"Earlier this year, we were delighted to announce our entry into a definitive merger agreement with BioNTech. Once closed, the transaction will combine two organizations with a common culture of pioneering translational science and a shared vision for the future of cancer immunotherapy," said Hugh O’Dowd, Chief Executive Officer of Neon. "We continue to be encouraged by the potential of our novel neoantigen-targeted T cell therapies and are confident that this merger with BioNTech will provide the foundation from which to ensure that potential will be realized."

BioNTech Transaction Details

Under the terms of the definitive merger agreement, Neon will, following consummation of the acquisition, merge with Endor Lights, Inc., a Delaware corporation and a direct, wholly-owned subsidiary of BioNTech SE (Nasdaq: BNTX) and become a wholly-owned subsidiary of BioNTech. At closing, BioNTech will issue, and Neon shareholders will receive, 0.063 American Depositary Shares (ADS) (each ADS representing one ordinary share of BioNTech) in exchange for each of their shares of Neon. The exchange ratio implies a deal value of approximately $67 million, or $2.18 per share of Neon, based on the closing price of BioNTech’s ADSs of $34.55 on Wednesday, January 15, 2020, the date of the definitive merger agreement.

The transaction was unanimously approved by both BioNTech’s and Neon’s boards of directors. The transaction, which is expected to close during the second quarter of 2020, is subject to approval by Neon’s shareholders and the satisfaction of customary closing conditions. Certain stockholders of Neon owning approximately 36% of the outstanding Neon shares have entered into voting agreements, pursuant to which they have agreed, among other things, and subject to the terms and conditions of the agreements, to vote in favor of the Neon acquisition.

Fourth Quarter and Full Year 2019 Financial Results:

Cash Position: As of December 31, 2019, cash and cash equivalents were $29.4 million, as compared to cash, cash equivalents and marketable securities of $103.3 million as of December 31, 2018.

R&D Expenses: R&D expenses were $12.7 million for the fourth quarter of 2019 and $59.7 million for the year ended December 31, 2019, as compared to $18.0 million for the fourth quarter of 2018 and $60.4 million for the year ended December 31, 2018. The decrease for both fourth quarter and full year 2019 was primarily driven by decreased costs supporting NEO-PV-01, including clinical development and manufacturing costs, as Neon shifted its strategic focus towards personal and precision neoantigen-targeted T cell therapy candidates. The decreases were partially offset by an increase in costs related to Neon’s investment in NEO-PTC-01 and other pre-clinical candidates that are aligned with Neon’s refined strategic focus, as well as an increase in personnel-related costs, including one-time restructuring charges in connection with our November 2019 workforce reduction.

G&A Expenses: G&A expenses were $5.3 million for the fourth quarter of 2019 and $21.4 million for the year ended December 31, 2019, as compared to $5.8 million for the fourth quarter of 2018 and $18.3 million for the year ended December 31, 2018. The decrease for the fourth quarter was primarily due to the timing of expenditures associated with protecting Neon’s owned and in-licensed intellectual property. The increase for

the full year was primarily due to increased personnel-related costs and costs associated with being a public company.

Net Loss Attributable to Common Stockholders: Net loss was $17.8 million for the fourth quarter of 2019 and $79.8 million for the year ended December 31, 2019, or a net loss per basic and diluted share of $(0.63) and $(2.86), respectively, as compared to a net loss of $23.1 million for the fourth quarter of 2018 and $83.3 million for the year ended December 31, 2018, or a net loss per basic and diluted share of $(0.84) and $(5.54), respectively.

Karyopharm Therapeutics Announces Proposed Public Offering of Common Stock

On March 2, 2020 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an oncology-focused pharmaceutical company, reported the commencement of a registered underwritten public offering of $150 million in shares of its common stock (Press release, Karyopharm, MAR 2, 2020, View Source [SID1234555052]). In addition, Karyopharm also intends to grant the underwriters a 30-day option to purchase up to $22.5 million in shares of its common stock.

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J.P. Morgan, Morgan Stanley and Jefferies are acting as joint book-running managers for the offering.

An automatically effective shelf registration statement relating to the shares of common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on February 26, 2020. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at [email protected], or by phone at (877) 821-7388.

This press release does 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 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.

Sangamo Therapeutics Announces Participation at Upcoming Investor Conferences

On March 2, 2020 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that management will present at the following investor conferences (Press release, Sangamo Therapeutics, MAR 2, 2020, View Source [SID1234555068]):

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Cowen 40th Annual Health Care Conference
Presentation Date: Wednesday, March 4th at 10:00 a.m. Eastern Time
Location: Boston, MA
Barclays Global Healthcare Conference
Presentation Date: Wednesday, March 11th at 8:30 a.m. Eastern Time
Location: Miami, FL
Presentations will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentation will also be available on the Sangamo website after the event.

Vizient Shares Insights into CAR-T Data for Cytokine Release Syndrome, Large B-cell Cancer and Pediatric Leukemia at 2020 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR

On March 2, 2020 Vizient, Inc. reported that shared insights on chimeric antigen receptor T-cell (CAR-T) data and its implications for patients with cytokine release syndrome, large B-cell cancer, and pediatric and young adult patients with leukemia (Press release, Vizient, MAR 2, 2020, View Source [SID1234555089]). Analyses were derived using Vizient’s Clinical Data Base/Resource Manager (CDB/RM) and presented as posters at the 2020 Transplantation & Cellular Therapy Meeting of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) held Feb. 19-23 in Orlando.

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The meeting included clinicians, administrators, clinical research professionals, laboratory technicians and pharmacists and focused on issues in hematopoietic cell transplantation and cellular therapy. Vizient‘s Alyssa Hartsell Harris, presented three posters at the event:

Real-World Quality and Cost Burden of Cytokine Release Syndrome (CRS) Requiring Tocilizumab or Steroids during CAR-T Infusion Encounter. The poster covered a retrospective cohort of 1,570 CAR-T infusion encounters for patients 18 years and older undergoing CAR-T procedures for diffuse large B-cell lymphoma from October 2017 to July 2019. It described the length of stay, costs and hospital mortality rates across patients who received tocilizumab and dexamethasone or prednisolone to treat CRS, a serious adverse event after CAR-T infusion.

Quality and Cost Outcomes in Chimeric Antigen Receptor T-Cell Immunotherapy in Adult Large B-Cell Cancer Patients from the Vizient Clinical Database. The poster covered a retrospective cohort of 1,570 patients 18 years and older undergoing CAR-T procedures from October 2017 to July 2019. It described unplanned readmission rates, adverse events due to the immunotherapy as well as provided a cost analysis.

Quality and Cost Outcomes in Chimeric Antigen Receptor T-cell Immunotherapy in Pediatric and Young Adult Patients with Acute Lymphoblastic Leukemia from the Vizient Clinical Database. The poster covered a retrospective cohort of 139 patients 25 years and under undergoing CAR-T procedures between October 2017 and October 2019. It described inpatient and outpatient mortality, length of stay, readmissions and provided a cost analysis.

"The collection of CAR-T data within our clinical data base continues to improve and is beginning to offer interesting insights into this new therapy," said Gladys J. Epting, Ph.D., associate vice president, analytics, at Vizient. "It is exciting to see how the data is demonstrating the clinical response by patients as well as cost and outcomes. These insights will help shape next steps for both clinicians and payers."

Vertex Announces Cancellation of its March 3 Presentation at the Cowen Health Care Conference

On March 2, 2020 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported the cancellation of its planned March 3 presentation and webcast at the Cowen Health Care Conference (Press release, Vertex Pharmaceuticals, MAR 2, 2020, View Source [SID1234555132]). Following implementation of a companywide travel and meetings policy that is designed to reduce potential disruption from coronavirus, the Vertex senior management team will, as a precautionary measure, no longer attend the conference.

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