TG Therapeutics Provides Business Update and Reports First Quarter 2020 Financial Results

On May 11, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the first quarter ended March 31, 2020 and recent company developments (Press release, TG Therapeutics, MAY 11, 2020, View Source [SID1234557486]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "The first few months of 2020 have undoubtedly been the most impactful and exciting in our Company’s history. We kicked off the year with the initiation of our first rolling regulatory submission for umbralisib in both MZL and FL and most recently reported positive topline results from our UNITY-CLL Phase 3 trial evaluating our proprietary U2 combination in patients with CLL. This positive outcome marks a major step forward in our mission of developing the best possible combination treatment options for patients with B-cell diseases." Mr. Weiss continued, "We now have three successful pivotal data sets which we believe have the potential to support regulatory approvals across MZL, FL and CLL. With more than $150 million proforma in cash on our balance sheet, we are well funded through and beyond our next set of key milestones, including the release of topline data from the ULTIMATE MS Phase 3 program, submission of an NDA/BLA for U2 in CLL, and hopefully, our first approval for umbralisib in MZL and FL, all of which are targeted to occur over approximately the next 9 months."

Recent Developments and Highlights

Chronic Lymphocytic Leukemia:

In May 2020, reported positive topline results from the Company’s UNITY-CLL Phase 3 trial evaluating U2 (the combination of umbralisib and ublituximab) in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL). The trial met its primary endpoint of improved progression-free survival (PFS) (p<.0001), as determined by an Independent Review Committee (IRC) and will be stopped early for superior efficacy. Regulatory submission and full data presentation targeted by year-end 2020.
Marginal Zone Lymphoma & Follicular Lymphoma:

In January 2020, received guidance from the U.S. Food and Drug Administration (FDA) allowing submission of a single New Drug Application (NDA) for marginal zone lymphoma (MZL) and follicular lymphoma (FL) indications. A rolling NDA submission for umbralisib to treat adult patients with previously treated MZL and FL was initiated, with completion of submission targeted in the first half of 2020.
In March 2020, received orphan drug designation for umbralisib from the FDA for the treatment of FL.
Multiple Sclerosis:

In May 2020, announced the publication of results from the multicenter Phase 2 trial evaluating ublituximab in patients with relapsing forms of multiple sclerosis (RMS) in the Multiple Sclerosis Journal.
Awaiting topline data from the Company’s Phase 3 ULTIMATE I & II trials evaluating ublituximab in patients with RMS, targeted in second half 2020.
Board of Directors & Management:

In May 2020, appointed Sagar Lonial, MD, FACP, Professor and Chair of the Department of Hematology and Medical Oncology at the Emory University School of Medicine, as well as the Chief Medical Officer at Winship Cancer Institute of Emory University, to the Company’s Board of Directors.
In May 2020, strengthened executive team with the addition of Owen A. O’Connor, MD, PhD as Chief Scientific Officer. Dr. O’Connor most recently served as a Professor of Medicine and Experimental Therapeutics, the Director of the Center for Lymphoid Malignancies, and Co-Program Director of the Lymphoid Development and Malignancy Program in the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center.
Bolstered Balance Sheet:

In May 2020, strengthened balance sheet with more than $75 million in gross proceeds through the Company’s At-the-Market (ATM) facility, $40 million of which came from a longtime shareholder.

Key Objectives for 2020

Complete rolling NDA submission for umbralisib in patients with previously treated MZL and FL, in the first half of 2020.
Report topline results from the Phase 3 ULTIMATE I & II trials in RMS, in the second half of 2020.
Present full data from the UNITY-CLL Phase 3 trial and present full data from the FL and MZL umbralisib monotherapy cohorts of the UNITY-NHL trial at a major medical meeting, by year-end 2020.
Target an NDA/Biologics Licensing Application (BLA) submission of U2 for the treatment of patients with CLL (including both previously untreated and relapsed/refractory patients), by year end 2020.
Continue to advance our early pipeline candidates including our anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), our covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, and our anti-CD47/CD19 bispecific antibody, TG-1801.

Financial Results for the Three Months Ended March 31, 2020

R&D Expenses: Other research and development (R&D) expense (not including non-cash compensation) was $34.0 million for the three months ended March 31, 2020, compared to $30.9 million for the three months ended March 31, 2019. The modest increase in R&D expense is primarily attributable to costs associated with the preparation of the Company’s NDA filing for umbralisib in MZL and FL. We expect our R&D expenses to decrease during 2020 as costs associated with our main pivotal clinical trials continue to decline over the remainder of the year, partially offset by expenses associated with the expected NDA/BLA filing for U2 in CLL.

G&A Expenses: Other general and administrative (G&A) expense (not including non-cash compensation) was $5.2 million for the three months ended March 31, 2020, as compared to $1.9 million for the three months ended March 31, 2019. The increase in other G&A expenses is primarily due to the build out of our commercial team and infrastructure in anticipation of the potential commercialization of umbralisib and ublituximab. We expect G&A expenses to increase modestly during the remainder of 2020.

Net Loss: Net loss was $51.1 million for the three months ended March 31, 2020, compared to a net loss of $35.2 million for the three months ended March 31, 2019. Excluding non-cash compensation, the net loss for the three months ended March 31, 2020 was approximately $40.0 million, compared to a net loss of $33.3 million for the three months ended March 31, 2019.

Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $78.3 million as of March 31, 2020. Pro forma cash, cash equivalents and investment securities as of March 31, 2020 are approximately $154.3 million, after giving effect to $76.0 million of net proceeds from the utilization of the Company’s ATM sales facility during the second quarter of 2020 at an average price of $17.07. The Company believes its cash, cash equivalents and investment securities on hand as of March 31, 2020, inclusive of the proceeds raised from the ATM facility, as well as future availability under the Company’s debt and ATM facility, will be sufficient to fund the Company’s planned operations through the end of 2021.

bluebird bio Announces Amended BCMA CAR-T Collaboration Agreement

On May 11, 2020 bluebird bio, Inc. (NASDAQ: BLUE) reported that it has amended its existing co-promotion/co-development agreement with Bristol Myers Squibb (BMS) to enable the companies to focus their efforts on efficient commercialization of idecabtagene vicleucel (ide-cel; bb2121) in the U.S., the companies’ lead investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, currently in review with the FDA (Press release, bluebird bio, MAY 11, 2020, http://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-announces-amended-bcma-car-t-collaboration [SID1234557484]).

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"Under our amended collaboration, we and BMS are redoubling our commitment to ide-cel and optimizing the relationship as we work together to bring this critical treatment to patients in the commercial setting," said Joanne Smith-Farrell, PhD, Chief Business Officer and Oncology Franchise Leader, bluebird bio. "With bluebird exiting the passive participation as supplier outside the U.S., we and BMS are taking steps to ensure an efficient and robust supply chain for this program. This, together with the monetization of our ex-U.S. royalties and milestones will allow bluebird to continue to participate in co-developing and co-commercializing ide-cel within the U.S. and to refocus resources on our internal programs and pipeline."

"Our collaboration with bluebird has resulted in the first CAR T cell therapy submitted for regulatory approval to target the B-cell maturation antigen and for multiple myeloma," said Krishnan Viswanadhan, Pharm.D., Senior Vice President, Global Cell Therapy Franchise Lead for Bristol Myers Squibb. "This amended partnership allows Bristol Myers Squibb to leverage our global manufacturing capabilities and consolidate all responsibilities outside the United States."

The companies will continue to share equally profits and losses in the U.S. Under the terms of the amended agreement, BMS will buy out its obligations to pay bluebird bio future ex-U.S. milestone and royalty payments for ide-cel and bb21217, the companies’ second BCMA-directed CAR T immunotherapy, for a one-time upfront payment of $200 million. bluebird bio is currently in the process of building out and qualifying its wholly-owned manufacturing facility in Durham, North Carolina for the production of lentiviral vector (LVV) to support the U.S. commercial market for ide-cel and for bluebird bio’s pipeline. Over time, BMS will assume responsibility for manufacturing of LVV outside the U.S.

PORTAGE MAKES ADDITIONAL INVESTMENT IN STIMUNITY S.A.S, A PARIS-BASED CANCER IMMUNOTHERAPY COMPANY.

On May 11, 2020 Portage Biotech Inc. ("Portage" or "the Company") (Canadian Securities Exchange: PBT.U, OTC Markets : PTGEF), reported that It has made an additional €900k investment in its associate, Stimunity, the Paris-based cancer immunotherapy company focused on STING (Press release, Portage Biotech, MAY 11, 2020, View Source [SID1234557483]). Stimunity has reached a major milestone in its preclinical development plan and the additional financing will enable it to start the manufacturing of its biologic cGAMP-VLP (STI-001) lead compound.

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"We knew since the beginning of the company that STING-activating cGAMP Virus-Like Particle (cGAMP-VLP) technology has a unique property enabling its payload to preferentially target immune cells, which is different from other chemical STING approaches. This has an impact on the stimulation of the immune system and the quality of the anti-tumoral response. We have determined that this targeting mechanism is able to deliver the cGAMP via systemic route of administration and that it leads to induction of systemic anti-tumor T-cell response" says Nicolas Manel, co-founder and Scientific Advisor of the company.

"These new data demonstrate that picking the right approach to modulate STING is key. The use of VLP carrier enables a simple systemic approach to deliver STING modulation directly to immune cells. Portage is pleased with the work performed by Stimunity and this new round of financing will support the progress toward clinical trials" says Dr. Ian Walters, Chairman of Stimunity’s Supervisory Board and CEO of Portage.

Navidea Biopharmaceuticals Regains Commercialization and Distributions Rights in Europe for LYMPHOSEEK®

On May 11, 2020 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that the Company has regained the commercialization and distribution rights in Europe for LYMPHOSEEK (technetium Tc99m tilmanocept) injection from Norgine B.V. ("Norgine") (Press release, Navidea Biopharmaceuticals, MAY 11, 2020, View Source [SID1234557481]). Navidea and Norgine have decided, by mutual agreement, to end the existing license agreement ("Agreement") between the two companies.

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The Agreement was originally entered in March 2015, and provided Norgine with the exclusive rights in Europe for LYMPHOSEEK. As a result of today’s transaction, Navidea has regained all the rights, economics, and intellectual property of LYMPHOSEEK in Europe.

Per this new agreement, both companies will cooperate to complete a seamless transfer of regulatory marketing authorizations back to Navidea. Through the transition, Norgine will remain responsible for the continued commercialization and distribution of LYMPHOSEEK in Europe for a period of six months.

Jed Latkin, CEO of Navidea, commented, "We would like to thank Norgine for our legacy partnership and initiating the commercialization and distribution in Europe. I am delighted that LYMPHOSEEK’s European rights and economics are now fully in the hands of Navidea. We are excited about the potential for this asset in Europe and will work to mirror the product’s successful and broad-based commercial adoption in the United States."

Management plans to address the new agreement during the Company’s First Quarter 2020 Earnings Conference Call, scheduled for Thursday, May 14, 2020 at 5:00 p.m. (EDT). Conference call and webcast details can be found below.

Additionally, the Company has finalized the previously announced $4.2 million financing related to the judgement by the Ohio Court of Common Pleas (the "Judgement"). Navidea has agreed to issue Keystone Capital Partners, LLC, an existing shareholder, up to $4.2 million of mandatory redeemable preferred shares. These preferred shares are guaranteed by a portion of the proceeds of the Judgement.

Conference Call Details

Event: Q1 2020 Earnings and Business Update Conference Call

About LYMPHOSEEK

LYMPHOSEEK (technetium Tc 99m tilmanocept) is approved in Europe for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. LYMPHOSEEK is designed to locate the sentinel lymph nodes and map lymph node drainage from these cancers.

Allakos Reports First Quarter 2020 Financial Results

On May 11, 2020 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing antolimab (AK002) for the treatment of eosinophil and mast cell-related diseases, reported financial results for the first quarter ended March 31, 2020 (Press release, Allakos, MAY 11, 2020, View Source [SID1234557458]).

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First Quarter 2020 Financial Results

Research and development expenses were $18.3 million in the first quarter of 2020 as compared to $15.1 million in the same period in 2019, an increase of $3.2 million.

General and administrative expenses were $11.6 million in the first quarter of 2020 as compared to $5.8 million in the same period in 2019, an increase of $5.8 million.

Allakos reported a net loss of $27.8 million in the first quarter of 2020 as compared to $20.0 million in the same period in 2019, an increase of $7.8 million. Net loss per basic and diluted share was $0.57 for the first quarter of 2020 compared to $0.47 in the same period in 2019.

Allakos ended the first quarter of 2020 with $479.8 million in cash, cash equivalents and marketable securities.