Titan Pharmaceuticals Announces Pricing Of $2.1 Million Registered Direct Offering

On August 7, 2019 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) reported it has entered into a securities purchase agreement with a single accredited institutional investor to purchase approximately $2.1 million of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) in a registered direct offering and warrants to purchase shares of common stock in a concurrent private placement (Press release, Titan Pharmaceuticals, AUG 7, 2019, View Source [SID1234538347]). The combined purchase price for one share of common stock and each warrant will be $0.75.

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Under the terms of the purchase agreement, Titan has agreed to sell 2,852,314 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof). In a concurrent private placement, Titan has agreed to issue warrants to purchase up to an aggregate of 2,852,314 shares of common stock. The warrants will be exercisable for a period of five years commencing six months from the date of issuance and have an exercise price of $1.07 per share.

The Company expects the net proceeds from the registered direct offering and concurrent private placement to be approximately $1.83 million after deducting the placement agent’s fees and other estimated offering expenses. The registered direct offering and concurrent private placement is expected to close on or about August 9, 2019, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the sole placement agent in connection with the offering.

The shares of common stock and pre-funded warrants are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-230742), which was declared effective by the United States Securities and Exchange Commission ("SEC") on April 24, 2019. The warrants issued in the concurrent private placement and shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales 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. A prospectus supplement relating to the shares of common stock will be filed by Titan with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

TG Therapeutics to Host Conference Call on Second Quarter 2019 Financial Results and Business Update

On August 7, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that a conference call will be held, Friday, August 9, 2019 at 8:30 AM ET to discuss results for the second quarter of 2019 and provide a business outlook for the remainder of the year (Press release, TG Therapeutics, AUG 7, 2019, http://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-host-conference-call-second-quarter-2019 [SID1234538297]). Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer will host the call.

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In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Second Quarter 2019 Business Update Call. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for replay on the Company’s website, for a period of 30 days after the call.

TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.

Allogene Therapeutics Reports Second Quarter 2019 Financial Results

On August 7, 2019 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported financial results for the quarter ended June 30, 2019 (Press release, Allogene, AUG 7, 2019, View Source [SID1234538313]).

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"The second quarter was an important one on many fronts, from advancing our pipeline with the clearance of our second investigational new drug application, to designing our state-of-the-art manufacturing facility and the continued onboarding of highly-skilled employees who are passionate about bringing allogeneic cell therapy to patients," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Our teams are focused on advancing our allogeneic platform, which includes our first company-sponsored clinical trial with ALLO-501 for patients with relapsed/refractory non-Hodgkin lymphoma. We are pleased with how this dose escalation study is progressing, which includes the use of our selective lymphodepletion strategy anchored around our proprietary anti-CD52 antibody, ALLO-647."
Recent Highlights
ALLO-501 (anti-CD19 AlloCAR T)

The ALLO-501 Phase 1 portion of the ALPHA trial for patients with relapsed/refractory non-Hodgkin lymphoma (NHL) was initiated in Q2 2019. The trial is designed to assess the safety and tolerability at increasing dose levels of ALLO-501 in the most common NHL subtypes of relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Five sites with expertise in CAR T are open for enrollment. The company remains on track to release topline data from the ongoing Phase 1 ALPHA trial in the first half of 2020.

The Company continues to progress the planned second generation of ALLO-501, which is devoid of the rituximab off-switch, through preclinical development and plans to introduce this next generation prior to the start of the Phase 2 registrational study.
ALLO-715 (anti-BCMA AlloCAR T)

An Investigational New Drug (IND) application for ALLO-715, a wholly-owned CAR T product candidate targeting B cell maturation antigen (BCMA) for relapsed/refractory multiple myeloma, was cleared by the U.S. Food & Drug Administration (FDA) in May 2019. The Company remains on track to initiate a Phase 1 trial in the second half of 2019.

The Phase 1 ALLO-715 UNIVERSAL trial is designed to assess the safety and tolerability at increasing dose levels of ALLO-715 to identify an optimal dose of ALLO-715 for the potential Phase 2 study. This trial will utilize ALLO-647, the Company’s proprietary anti-CD52 monoclonal antibody, as a part of the lymphodepletion regimen. The trial also includes the potential for exploratory cohorts that will allow study of additional lymphodepletion regimens, including one that only uses ALLO-647 without fludarabine and cyclophosphamide.

Additional Pipeline Updates

UCART19 (Servier-Sponsored Program in Collaboration with Allogene) – Servier has re-initiated recruitment for the CALM and PALL trials in relapsed/refractory acute lymphoblastic leukemia. UCART19 is expected to be advanced to potential registrational trials in 2020.
Corporate Highlights

The Company recently announced the appointment of Rafael G. Amado, M.D. as Executive Vice President of Research and Development and Chief Medical Officer. In this new position, Dr. Amado will lead the Company’s clinical and research functions with the goal of rapidly advancing our pipeline of allogeneic CAR T therapies for hematologic and solid tumors. This appointment reunites Dr. Amado with many former colleagues, including David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder.
Second Quarter Financial Results

As of June 30, 2019, Allogene had $650.2 million in cash, cash equivalents, and investments, compared to $721.4 million as of December 31, 2018.

Research and development expenses were $31.8 million for the second quarter of 2019, which includes $4.7 million of non-cash stock-based compensation expense, compared to $122.5 million for the second quarter of 2018. The second quarter of 2018 included a non-cash charge of $109.4 million related to in process research and development acquired as a result of the Pfizer asset acquisition.

General and administrative expenses were $14.2 million for the second quarter of 2019, which includes $6.7 million of on-cash stock-based compensation expense, compared to $12.5 million for the second quarter of 2018.

Net loss for the second quarter of 2019 was $41.2 million, or $0.41 per share, including non-cash stock-based compensation expense of $11.5 million, compared to a net loss of $134.9 million, or $43.82 per share for the second quarter of 2018.

The Company continues to expect full-year 2019 net losses to be between $200 million and $210 million dollars, 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 4851687. 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.

Prometic to report its second quarter financial results and hold conference call

On August 7, 2019 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic), a biopharmaceutical company focused on developing novel therapeutics to treat unmet needs in patients with liver, respiratory and kidney disease, reported that it will report its financial results for the second quarter ended June 30th, 2019 on Monday August 12th, 2019 after market close (Press release, ProMetic Life Sciences, AUG 7, 2019, View Source [SID1234538331]).

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Prometic will host a conference call at 11:00 a.m. (EDT) on Tuesday August 13th, 2019. The
telephone numbers to access the conference call are 1-888-231-8191 and 647-427-7450.
An audio replay of the call will be available as of Tuesday August 13th 2019 at 2:00 p.m. (EDT).
The numbers to access the audio replay are 416-849-0833 and 1-855-859-2056 using
the following password: 3058704.

A live audio webcast of the conference call will be available via:

View Source

VolitionRx Limited Schedules Second Quarter 2019 Earnings Conference Call and Business Update

On August 7, 2019 VolitionRx Limited (NYSE American: VNRX) reported it will host a conference call on Tuesday, August 13 at 8:30 a.m. Eastern time to discuss its financial and operating results for the second quarter of 2019 in addition to providing a business update (Press release, VolitionRX, AUG 7, 2019, View Source [SID1234538348]).

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Event:

VolitionRx Limited Second Quarter 2019 Earnings and Business Update Conference Call

Date:

Tuesday, August 13, 2019

Time:

8:30 a.m. Eastern time

U.S. & Canada Dial-in:

1-877 407 9716 (toll free)

U.K. Dial-in:

0 800 756 3429 (toll free)

Toll/International:

1-201 493 6779

Conference ID:

13693585

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on recent developments and Volition’s activities, including details of new and ongoing clinical trials, important events that have taken place in the second quarter of 2019, and milestones for the remainder of 2019 and beyond.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until August 27, 2019. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13693585.