On March 8, 2019 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported fourth quarter and full-year 2018 financial results for the periods ended December 31, 2018 (Press release, Allogene, MAR 8, 2019, View Source [SID1234534130]).

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"We are very proud of what Allogene has accomplished in just ten months. Every move we have made has been toward achieving one goal, making allogeneic CAR T therapy available to patients," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "We are excited to soon embark upon our first company sponsored trial for ALLO-501 in relapsed/refractory non-Hodgkin lymphoma (NHL) and progress the buildout of our planned state-of-the-art manufacturing facility in Newark, California. With our focus and drive to progress our pipeline of cell therapy candidates, which includes the planned IND submission of ALLO-715 in multiple myeloma (MM) later this year, we feel confident in Allogene’s ability to be a leader in the development of AlloCAR T therapies."

2018 and Recent Highlights

Corporate

In September 2018, the company completed a $120.2 million private financing and in October 2018, Allogene’s Initial Public Offering (IPO) raised $372.6 million in gross proceeds.

In February 2019, Allogene entered into a lease agreement to develop a 118,000 square foot state-of-the-art cell therapy manufacturing facility in Newark, California. World class manufacturing is core to the Allogene strategy to deliver readily available cell therapy faster, more reliably and at greater scale. The manufacturing facility is being designed for both clinical and commercial supply, upon potential regulatory approval, of AlloCAR T therapy.

ALLO-501 (Allogene-Sponsored Program in Collaboration with Servier)

In January, the U.S. Food & Drug Administration (FDA) cleared Allogene’s first Investigational New Drug (IND) application for ALLO-501 in patients with relapsed/refractory NHL.

The planned Phase 1 study will utilize ALLO-647, Allogene’s proprietary anti-CD52 monoclonal antibody (mAb) as a part of the lymphodepletion regimen.

Site qualification is underway, and the trial is on-track to initiate in the 1H of 2019.

The Phase 1 portion will enroll approximately 24 patients with relapsed/refractory large B-cell lymphoma or follicular lymphoma.

The primary objective of the study is to evaluate the safety and tolerability of ALLO-501 and ALLO-647.

The Phase 1 portion of the trial is designed to determine the optimal dose of ALLO-501 for the Phase 2 portion of the trial.

ALLO-715

On track to file an IND application in 2019 for ALLO-715, a wholly-owned CAR T product candidate targeting B cell maturation antigen (BCMA) for multiple myeloma.

UCART19 (Servier-Sponsored Program in Collaboration with Allogene)

Servier and Allogene presented pooled data from the Phase 1 trials of UCART19 in relapsed/refractory acute lymphoblastic leukemia (ALL) at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) meeting. The analysis suggested that an anti-CD52 mAb may be an important contributor for AlloCAR T cell expansion, and the use of anti-CD52 mAb will now be mandated in the UCART19 trials.

Fourth Quarter and Full Year 2018 Financial Results

Research and development expenses were $18.5 million for the fourth quarter of 2018, which includes $1.3 million of non-cash stock-based compensation expense. For the full year of 2018, research and development expenses were $151.9 million which includes $109.4 million related to the asset acquisition from Pfizer. The total research and development expense for the year includes $1.7 million of non-cash stock-based compensation expense.

General and administrative expenses were $14.5 million for the fourth quarter of 2018, which includes $4.6 million of non-cash stock-based compensation expense. For the full year of 2018, general and administrative expenses were $41.0 million, which includes $16.9 million of non-cash stock-based compensation expense.

Net loss for the fourth quarter of 2018 was $30.5 million, or $0.37 per share, including non-cash stock-based compensation expense of $5.9 million. For the full year of 2018, net loss was $211.5 million, or $7.31 per share, including non-cash stock-based compensation expense of $18.6 million.

As of December 31, 2018, Allogene had $721.4 million in cash, cash equivalents, and investments.

2019 Financial Guidance

Allogene expects full year 2019 net losses to be between $200 million and $210 million including estimated non-cash stock-based compensation expense of $45 million to $50 million and excluding any impact from potential business development activities.

Conference Call and Webcast Details

Allogene will host a live conference call and webcast today at 5:30 AM Pacific Time/8:30 AM Eastern Time to discuss financial results and provide a business update. To access the live

conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 3589112. The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On March 8, 2019 Aptorum Group Limited (NASDAQ:APM), a Hong Kong based pharmaceutical company currently in the preclinical stage, dedicated to developing and commercializing therapeutic projects and diagnostic technologies to tackle unmet medical needs, reported that the start time for the Company’s scheduled presentation at the Barclays Global Healthcare Conference 2019 has been updated to an earlier time slot (Press release, Aptorum, MAR 8, 2019, View Source [SID1234534146]).

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The Company will now be presenting on Thursday, March 14th, 2019 at 10:15 a.m. ET. The conference will take place at the Loews Miami Beach Hotel in Miami Beach, Florida and will feature CEOs from industries including Biotechnology, Healthcare Facilities, Managed Care, Specialty Pharmaceuticals, U.S. Pharmaceuticals Life Science Enabling Tool and Healthcare Distribution.

On March 8, 2019 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, MAR 8, 2019, View Source [SID1234534147]):

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J.P. Morgan 2019 Spring Biotech Conference Call Series at 1:00 p.m. Eastern Time on Friday, March 15, 2019
The session may be accessed from the "Investors & Media" page of Regeneron’s website at View Source A replay of the webcast will be archived on the Company’s website and will be available for 30 days.

On March 5, 2019 Exact Sciences Corporation (NASDAQ: EXAS) (the "Company") reported an underwritten public offering of $600 million aggregate principal amount of convertible senior notes due 2027 (the "Notes") pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission (the "SEC") on Form S-3 (Press release, Exact Sciences, MAR 8, 2019, View Source [SID1234534174]). The Company has also granted the underwriter a 30-day option to purchase up to an additional $90.0 million aggregate principal amount of the Notes. Concurrently with this offering, in separate transactions, the Company also expects to enter into agreements with certain holders of its 1.0% Convertible Senior Notes due in January 2025 (the "2025 Notes") to exchange an aggregate of approximately 50% of the outstanding principal amount of such notes for consideration consisting of cash, shares of the Company’s common stock or a combination thereof. The terms of such agreements will be individually negotiated and will depend on the market price of the Company’s common stock and the trading price of the 2025 Notes at the time such agreements are entered into. The cash portion of such consideration will be funded from a portion of the net proceeds from this offering. The Company may also exchange or induce conversions of the 2025 Notes following completion of this offering and may fund such exchanges or conversions with the proceeds of this offering. The Company intends to use the remaining net proceeds of this offering for general corporate and working capital purposes. The Notes will be convertible into cash, shares of the Company’s common stock (and, if applicable, cash in lieu of any fractional share), or a combination thereof, at the Company’s election.

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BofA Merrill Lynch is acting as sole book-running manager for the Notes offering.

An automatically effective shelf registration statement relating to the Notes was filed with the SEC on June 6, 2017. The offering of the Notes will be made only by means of the prospectus and related prospectus supplement, which have been or will be filed with the SEC. A copy of the prospectus supplement and prospectus relating to the Notes offering may be obtained free of charge on the SEC’s website at View Source or by sending a request to BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department (or by e-mail at [email protected]).

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

On March 8, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported it has entered into a purchase agreement with two institutional investors for the purchase of common units and pre-funded units for a combined total of 4,361,370 units in a registered direct offering, for expected gross proceeds of approximately $14 million before placement agent fees and other offering expenses payable by Altimmune (Press release, Altimmune, MAR 8, 2019, View Source [SID1234534132]). Today we disclosed in a Form 8-K cash, cash equivalents and restricted cash of approximately $34.4 million as of December 31, 2018,

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Each common unit is being sold at a public offering price of $3.21 and consists of one share of common stock and 0.70 of a warrant to purchase one share of common stock at an exercise price of $3.21. Each pre-funded unit is being sold at a public offering price of $3.20 and consists of a pre-funded warrant to purchase one share of common stock at an exercise price of $0.01 per share and 0.70 of a warrant to purchase one share of common stock at an exercise price of $3.21. The public offering price of each pre-funded unit is equal to the public offering price of each common unit being sold to the public in this offering, minus $0.01. The pre-funded warrants will be immediately exercisable and may be exercised at any time until all of the pre-funded warrants are exercised in full. The other warrants will be exercisable immediately and will expire five years from the date of issuance. The terms of the warrants and the pre-funded warrants will be substantially the same as the terms of the warrants and the pre-funded warrants issued in connection with our registered direct offering completed October 10, 2018. For a summary of the material terms of the warrants and pre-funded warrants, please refer to Exhibit A attached to this press release.

The offering is expected to close on or about March 12, 2019, subject to customary closing conditions. Altimmune intends to use the net proceeds from this offering for the continued advancement of development activities for our product pipeline, strategic growth opportunities (including potential acquisitions and/or licensing transactions), and general working capital purposes.

Roth Capital Partners is acting as sole placement agent for the offering.

The securities described above are being offered by Altimmune pursuant to a registration statement on Form S-3 (File No. 333-217034) that was declared effective by the Securities and Exchange Commission (SEC) on April 6, 2017. A final prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting Roth Capital Partners, LLC, Attention: Equity Capital Markets, 888 San Clemente Drive, Suite 400, Newport Beach, California 92660, by telephone at (800) 678-9147 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a 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.