TG Therapeutics, Inc. to Present at the 37th Annual J.P. Morgan Healthcare Conference

On January 7, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX) reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will present at the 37th Annual J.P. Morgan Healthcare Conference, being held at the Westin St. Francis, in San Francisco, CA (Press release, TG Therapeutics, JAN 7, 2019, View Source [SID1234532525]). The presentation is scheduled to take place on Thursday, January 10, 2019 at 10:00 AM PT.

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A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

bluebird bio and Inhibrx Announce Collaboration to Research, Develop and Commercialize CAR T Cell Immunotherapies

On January 7, 2019 bluebird bio, Inc. (Nasdaq: BLUE) and Inhibrx, Inc. (Inhibrx) reported that they have entered into an exclusive license agreement to research, develop and commercialize chimeric antigen receptor (CAR) T cell therapies using Inhibrx’s proprietary single domain antibody (sdAb) platform to multiple cancer targets (Press release, bluebird bio, JAN 7, 2019, View Source [SID1234532541]). The small size of sdAbs may enable the generation of more complex CAR T cell products such as those designed to combine additional functions into a single CAR molecule or recognize multiple tumor antigens simultaneously.

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"Access to the Inhibrx sdAb binder technology will allow us to combine the advancements we’ve made with our T cell therapy platform with their sdAb binder technology to generate novel cellular therapies with the potential to help patients in their fight against cancer," said Philip Gregory, D. Phil., chief scientific officer, bluebird bio. "The technology from Inhibrx adds to our growing portfolio of tools and technologies that we can combine with our internal lentiviral vector, CAR and T cell expertise to discover potential new product candidates designed to recognize tumor-specific proteins expressed by cancer cells and kill them upon engagement."

"We are pleased to have formalized our relationship with bluebird bio, allowing us to couple our proprietary sdAb platform with a leading cell therapy platform," said Brendan Eckelman, Chief Scientific Officer and Executive Vice President of Corporate Strategy of Inhibrx. "Together with bluebird bio, we have generated compelling proof of concept preclinical data on the utility of incorporating our sdAbs into bluebird bio’s constructs for CAR-T cell generation."

Under the terms of the license agreement, Inhibrx will provide bluebird bio the exclusive worldwide rights to develop, manufacture and commercialize certain cell therapy products containing sdAbs directed to various cancer targets. bluebird bio will be responsible for the clinical development and commercialization of the cancer-targeting CAR-T products. Inhibrx received a $7.0 million upfront payment and is also entitled to receive specified developmental milestone payments as well as percentage tiered royalties on future product sales.

IMMUTEP ENTERS INTO CLINICAL TRIAL COLLABORATION, SERVICE AND SUPPLY AGREEMENT WITH CYTLIMIC

On January 7, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), is reported that it has entered into a clinical trial collaboration agreement, a supply agreement and a service agreement with CYTLIMIC Inc. (the "Agreements") for its lead product candidate eftilagimod alpha as part of a cancer vaccine (Press release, Immutep, JAN 7, 2019, View Source [SID1234532573]).

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The agreements enable the two parties to collaborate on clinical trials to evaluate efti as part of a therapeutic cancer vaccine (a therapy containing cancer antigens to boost a patient’s own immune cells to recognize and kill cancer cells related to the antigens) containing CYTLIMIC’s innovative cancer peptide vaccine, called CYT001.

The trials will be conducted by and are under the control of CYTLIMIC who will fully fund all development costs.

Under the collaboration agreement, Immutep will receive an upfront payment of US$500,000 and is eligible to receive up to US$4.5M in milestone payments upon the achievement of milestones by CYTLIMIC.

This therapeutic cancer vaccine with efti is the third example wherein efti is being evaluated in clinical studies in a combination.

Immutep retains complete exclusivity over its patent rights specifically covering its own clinical development programs and those it is conducting in conjunction with its other collaboration partners evaluating IMP321 in combination with either chemotherapy (AIPAC trial) or PD-1 / PD-L1 immunotherapy (INSIGHT and TACTI trials).

In addition to the collaboration agreement, Immutep has entered into a supply agreement to provide efti to CYTLIMIC for the manufacture of CYT001 for use in the clinical development and commercialisation of the vaccine. The Parties have also entered into a service agreement where Immutep will provide technical support services to CYTLIMIC during the development and commercialisation of CYT001.

Commenting on the Agreements, Immutep CEO Marc Voigt said: "We are very excited to be working alongside CYTLIMIC to help evaluate efti as part of an innovative cancer vaccine that has potential as a new therapy. Efti is generating interest globally. Following the agreements with CYTLIMIC, it is now being evaluated as part of three different combination therapy types: as part of a therapeutic cancer vaccine, as a chemo-immunotherapy and in an IO combination, showing its broad therapeutic potential."

Commenting on the collaboration, CYTLIMIC President and CEO, Shun Doi, Ph.D. said: "We are delighted with the engagement with Immutep, which will strongly help realize an innovative cancer vaccine-immunotherapy. Our own studies have shown that the combination of LAG-3Ig and Poly IC synergistically boost the efficacy of peptide vaccine, and thus I believe the combination of efti in our vaccine CYT001, which is also unique as an application of artificial intelligence, is an important step to add a new solution in cancer immunotherapy world."

Adagene Announces Collaboration for Discovery of Novel CAR-T with the National Heart, Lung, and Blood Institute at the National Institutes of Health (NIH)

On January 7, 2019 Adagene, Inc., an innovative antibody discovery and engineering company, reported a collaboration with Dr. Richard Childs, Chief of the Laboratory of Transplantation Immunotherapy at the National, Heart, Lung, and Blood Institute, part of the National Institutes of Health, to discover antibodies targeting a novel antigen expressed on the surface of tumor cells (Press release, US NIH, JAN 7, 2019, View Source [SID1234553809]). Dr. Childs’s laboratory will convert these antibodies into a CAR-T, as they work to develop a non-major histocompatibility complex (MHC) restricted immunotherapy approach to targeting an endogenous retrovirus with tumor-restricted expression.

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"We are very pleased to be collaborating with such an expert in the field of clinical cancer biology," said Peter Luo, CEO of Adagene. "At Adagene, our goal is to translate innovation and scientific research into life-saving medications. It is incredibly rewarding to have the opportunity to leverage our proprietary Dynamic Precision Library to develop antibodies against a disease with such highly unmet medical need."

"Adagene has gone to great lengths to develop our leading antigen display technology," said Felix Du, Head of Technology Development at Adagene. "With our unique combination of antigen presentation technologies and having a very large, diverse and fully human antibody discovery library we were able to find the first antibodies targeting non-MHC restricted surface-expressed antigens against this class of challenging cancer targets."

Emergent BioSolutions Announces Preliminary 2018 Financial Results and Provides 2019 Financial Forecast

On January 7, 2019 Emergent BioSolutions Inc. (NYSE: EBS) reported selected preliminary unaudited 2018 financial results and its financial forecast for 2019 (Press release, Emergent BioSolutions, JAN 7, 2019, View Source;p=RssLanding&cat=news&id=2382272 [SID1234532526]).

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Daniel J. Abdun-Nabi, chief executive officer of Emergent BioSolutions, said, "Our preliminary results for 2018 reflect another year of strong financial and operational performance as we continue to execute our strategy. As we enter 2019, we anticipate revenues topping $1 billion for the first time in our corporate history driven by solid organic growth in each of our business units together with contributions from the products that we acquired in 2018. Importantly, we also anticipate significant growth in each of our profitability metrics while simultaneously expanding our portfolio of advanced stage product candidates that address serious global public health threats. We remain steadfast in our commitment to enable governments and commercial customers worldwide to address their public health threat preparedness and response needs as we further our mission of protecting and enhancing life."

PRELIMINARY 2018 FINANCIAL RESULTS (Unaudited)

The company is providing the following preliminary, unaudited financial results for full year 2018.

See "Reconciliation of Net Income to Adjusted Net Income, EBITDA and Adjusted EBITDA" for a definition of terms and a reconciliation table.
Total Revenue
For the full year 2018, the company anticipates total revenue of $779 to $784 million, the midpoint of which represents a $221 million or 39% increase from 2017. This annual increase is due primarily to the contribution of sales of ACAM2000, (Smallpox (Vaccinia) Vaccine, Live), raxibacumab and NARCAN (naloxone HCl) Nasal Spray in 2018 as well as higher CMO revenue, offset by lower BioThrax (Anthrax Vaccine Adsorbed) revenue.

Net Income (GAAP and Adjusted)
For the full year 2018, the company anticipates net income of $60 to $64 million and adjusted net income of $117 to $121 million. The midpoint of the adjusted net income range represents a $23 million or 24% increase from 2017 and reflects the impact of higher product sales and CMO services revenue as well as the positive impact of a lower estimated effective tax rate. (See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.)

Note
The preliminary 2018 financial results are subject to revision and will be finalized upon completion of the company’s external audit, which is anticipated in late February 2019. Once the external audit is completed, the company may report financial results that could differ, and the differences could be material.

2019 FINANCIAL FORECAST

See "Reconciliation of Net Income to Adjusted Net Income, EBITDA and Adjusted EBITDA" for a definition of terms and a reconciliation table.
For the full year of 2019, the company’s financial forecast includes the impact of the following items:

continued deliveries of BioThrax to the Strategic National Stockpile (SNS) under the current procurement contract with the Centers for Disease Control and Prevention (CDC), (the contract and the SNS are now managed by the Office of the Assistant Secretary for Preparedness and Response (ASPR));
initial deliveries of NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant) to the SNS following expected Emergency Use Authorization pre-approval by the U.S. Food and Drug Administration (FDA) under the company’s current development and procurement contract with the Biomedical Advanced Research and Development Authority (BARDA);
full year sales of NARCAN Nasal Spray, Vaxchora (Cholera Vaccine, Live, Oral), and Vivotif (Typhoid Vaccine Live Oral Ty21a), all of which were acquired in the fourth quarter of 2018;
deliveries of ACAM2000 to the SNS under the anticipated follow-on procurement contract with the ASPR;
deliveries of raxibacumab to the SNS under the current procurement contract with BARDA;
domestic and international sales of the other medical countermeasures that comprise Other Product sales;
continued CDMO services revenue;
increased Contract & Grant revenue due to anticipated increased work related to development projects funded by third parties; and
continued investment in discretionary development projects funded by the company targeting opportunities in medical countermeasures for emerging infectious diseases and other public health threats.
The outlook for 2019 does not include estimates for potential new corporate development or other M&A transactions.

Q1 2019 REVENUE FORECAST
For the first quarter of 2019, the company anticipates total revenues of $185 to $205 million.

PRESENTATION WEBCAST
The company will provide an update on the current business and discuss preliminary 2018 financial results, the forecast and corporate goals for 2019, and long-term goals for 2020 during its presentation at the 37th Annual J.P. Morgan Healthcare Conference on January 8, 2019 at 11:00 AM Pacific time.

A live webcast of the presentation can be accessed through Emergent’s website. Visit www.emergentbiosolutions.com and select the "Investors" section. An on-demand replay of the webcast can also be accessed in the investors section after the presentation has concluded.

RECONCILIATION OF NET INCOME TO ADJUSTED NET INCOME, EBITDA AND ADJUSTED EBITDA

This press release contains two financial measures (Adjusted Net Income and EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization), and Adjusted EBITDA) that are considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules and regulations. These non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with generally accepted accounting principles. The Company’s definition of these non-GAAP measures may differ from similarly titled measures used by others. Adjusted Net Income adjusts for specified items that can be highly variable or difficult to predict, or reflect the non-cash impact of charges resulting from purchase accounting (which are all tax effected utilizing the statutory tax rate for the US). EBITDA reflects net income excluding the impact of depreciation, amortization, interest expense and provision for income taxes. Adjusted EBITDA also excludes specified items that can be highly variable and the non-cash impact of certain purchase accounting adjustments (which are all tax effected utilizing the statutory tax rate for the US). The Company views these non-GAAP financial measures as a means to facilitate management’s financial and operational decision-making, including evaluation of the Company’s historical operating results and comparison to competitors’ operating results. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results and the reconciliations to the corresponding GAAP financial measure, may provide a more complete understanding of factors and trends affecting the Company’s business.

The determination of the amounts that are excluded from these non-GAAP financial measures are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the Company’s consolidated financial statements and publicly filed reports in their entirety.