On January 30, 2020 THERADIAG (ISIN: FR0004197747, Mnemonic: ALTER), a company specializing in in vitro diagnostics of autoimmune diseases and Theranostics reported its consolidated annual sales and its cash level at December 31, 2019, data under audit (Press release, Theradiag, JAN 30, 2020, View Source [SID1234553704]).

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2019 consolidated revenue of € 9.6 million

As of December 31, 2019, Theradiag generated revenue of 9.6 million euros compared to 8.9 million in 2018, an increase of + 8.3% in line with the strategic axes set by the company.

The Theranostics activity recorded strong growth of + 10.5%, driven by sales of routine LISA TRACKER kits which now represent the company’s recurring activity in this segment. These kit sales exceeded a threshold with 4.3 million euros on the 2019 annual global (vs. 3.9 million at December 31, 2018). In the future, the Theranostics activity may be assimilated to this recurring activity of kit sales, now well in place, and the company will communicate on this one element of global Theranostics.

In France, where the model is now established, sales in Theranostics were particularly satisfactory with growth of 19%.

In the United States, Theradiag has concluded a year of transition reflecting the exit of its former partner in this territory. The transfer to its new partner Halio DX is gradual and will be finalized at the end of the first quarter of 2020.

In export, the company maintains a very satisfactory level of sustained activity, particularly in Spain and the United Kingdom, two strategic countries.

The In Vitro Diagnostics (IVD) activity posted overall growth in sales of + 6.0% with 5.2 million euros at the end of December 2019. It should be noted that this growth includes 1 st semester non-recurring instrumentation sales . Aside from this exceptional element, sales in this historic business segment are, as expected, slightly down. Theradiag pursues in this historical segment, in addition to its primary activity of autoimmunity, a strategy of niche specialization, such as genetics or male fertility.

Cash position

At December 31, 2019, Theradiag’s free cash flow stood at 2.9 million euros compared to 3.4 million euros at December 31, 2018 and 3.2 million euros at June 30, 2019.

Bertrand de Castelnau, CEO of Theradiag commented, "Theradiag and all the teams have made good progress in 2019: new products, new partners, new markets. We followed our roadmap with the objective of developing growth in our strategic priority markets, without compromising the investments necessary for the future of Theradiag. Priority has been given to restructuring the mix of our activities and setting milestones for internationalization, in market segments with higher profitability potential. We are staying the course to gradually improve our financial performance indicators. "

"This year is indeed a pivotal year. The overall sales growth is positive and points in the right direction. The development of the strategy around partnerships centered on Theranostics is gradually unfolding, we have recorded great successes this year and keep our commitment to innovation which is one of our key success factors. " Added Pierre Morgon, Chairman of the Board of Directors of Theradiag.

Reminder of the main events of 2019

Partnership with three new strategic distributors in Asia, December 2019
CE marking of the new i-Track 10 automated system for monitoring biotherapies, November 2019
Strategic agreement with PredictImmune for the marketing of PredictSURE IBD in French-speaking European countries, October 2019
Signing of an agreement with Halio DX as part of its development in the United States, May 2019
Signature of a development and distribution agreement with Immunodiagnostic Systems (IDS) regarding access to the latest generation IDS-i10 controller , April 2019
End of legal dispute with HOB Biotech, April 2019

Financial calendar:

2019 annual results , March 18, 2020, after market close
Annual General Meeting , May 14, 2020

Next congresses in which Theradiag participates:

12-15 February 2020 15 th congress ECCO (European Crohn’s and Colitis Organization), Vienna, Austria
5-6 March 2020: Days of the Syndicate of Young Medical Biologists – Biomed-J 2020, Paris
March 6-7, 2020: Seminar Therapeutic Study of Inflammatory Conditions of the Digestive Tube (GETAID), Paris
March 26-29, 2020: Francophone Days of Hepato-gastroenterology and Digestive Oncology 2020 (JFHOD), Paris.

On January 30, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Science magazine has published a preclinical report supporting the potential role of MLL1-Menin inhibition in the management of nucleophosmin (NPM1) mutant acute myeloid leukemia (AML) (Press release, Syndax, JAN 30, 2020, View Source [SID1234553703]). The article, "Therapeutic targeting of preleukemia cells in a mouse model of NPM1 mutant acute myeloid leukemia," will be published in the journal’s January 31, 2020 issue and is currently available online.

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This study examined the activity of VTP-50469, an orally-available inhibitor of MLL1-Menin interaction and close analog of the Company’s lead Menin inhibitor, SNDX-5613, for the treatment of established NPM1 AML and the possible prevention of the disease in high-risk populations. Using preclinical models of NPM1 AML, the authors established that the presence of an NPM1 mutation is a clear indicator of pre-leukemic activity and represents a critical step in the development of AML. VTP-50469 was shown to eradicate NPM1 mutant cells at various stages of disease development, suggesting that Menin-MLL inhibition could potentially serve either as a targeted preventive therapy or as a treatment of established disease.

"These unprecedented findings highlight the potential for single agent Menin-MLL inhibition to rapidly eradicate fully developed NPM1 mutant leukemia, even in the case of aggressive relapsed AML," said Scott A. Armstrong, M.D., Ph.D., President, Dana-Farber/Boston Children’s Cancer and Blood Disorders Center, and Chairman, Department of Pediatric Oncology, Dana-Farber Cancer Institute, and senior author of the study. "In addition, these results provide support for a Menin-MLL inhibitor to serve as a novel strategy to prevent AML development in high-risk patient populations, as NPM1 mutations are acquired in pre-leukemic clones."

"NPM1 mutant AML represents the most common type of cytogenetically normal AML," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "On the heels of our recent Cancer Cell publication, these findings add to the growing body of compelling preclinical data supporting the potential for SNDX-5613 to serve as an effective intervention for both NPM1 mutant AML and MLL-r acute leukemias. We are committed to providing patients with more targeted therapeutic options and are hopeful that these findings will translate into the clinic in our ongoing Phase 1/2 AUGMENT-101 trial."

About SNDX-5613

SNDX-5613 is a potent, selective, small molecule inhibitor of the Menin-MLL binding interaction that is being developed for the treatment of MLL-rearranged (MLL-r) acute leukemias, including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML); VTP-50469 is a close analog of SNDX-5613. MLL rearrangements occur in approximately 80% of acute leukemia cases in infants and up to 10% of all leukemias. In preclinical models of MLL-r acute leukemias, SNDX-5613 demonstrated robust, dose-dependent inhibition of tumor growth, resulting in a marked survival benefit. Menin-MLL interaction inhibitors have also demonstrated robust treatment benefit in multiple preclinical models of NPM1 mutant AML, which represents the most frequent genetic abnormality in adult AML. SNDX-5613 is currently being evaluated in the Company’s AUGMENT-101 Phase 1/2 open-label clinical trial for the treatment of relapsed/refractory (R/R) acute leukemias.

About AUGMENT-101

AUGMENT-101 is a Phase 1/2 open-label trial designed to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered SNDX-5613. The Phase 1 dose escalation portion of AUGMENT-101 will enroll adults with R/R acute leukemias and establish a recommended Phase 2 dose. The Phase 2 portion will evaluate efficacy, as defined by Complete Response rate (per International Working Group response criteria), across three expansion cohorts: MLL-r ALL, MLL-r AML and NPM1 mutant AML. The Company expects to report initial clinical data from the trial in 2020. Additional information about the AUGMENT-101 trial is available via Clinicaltrials.gov (NCT 04065399).

About NPM1 Mutant Acute Myeloid Leukemia

NPM1 mutant AML, which is distinguished by point mutations in the NPM1 gene that drive the leukemic phenotype, is the most common type of cytogenetically normal adult AML and represents approximately 30% of all adult AML cases. This subtype of AML has a 5-year overall survival rate of approximately 50%. Similar to MLL-r leukemias, NPM1 mutant AML is highly dependent on the expression of specific developmental genes, shown to be negatively impacted by inhibitors of the Menin-MLL interaction. NPM1 mutant AML is routinely diagnosed through currently available screening techniques. There are currently no approved therapies indicated for NPM1 mutant AML.

On January 30, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Quest Diagnostics, JAN 30, 2020, View Source [SID1234553702]).

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"We had a solid fourth quarter and ended the year by delivering record revenues, earnings and cash from operations," said Steve Rusckowski, Chairman, CEO and President. "Strong volume growth from expanded health plan network access, combined with outstanding execution of our Operational Excellence strategy, helped us offset significant reimbursement pressure.

"Quest is well positioned once again in 2020 to deliver on our commitment to grow revenues and earnings. We have a strong value proposition that supports health care’s triple aim of improving medical quality and the patient experience while reducing the cost of care. Our guidance for 2020 reflects our continued momentum, partially offset by yet another year of meaningful reimbursement pressure."

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage
of net revenues, income from continuing operations attributable to Quest Diagnostics, and diluted EPS from continuing
operations, see note 2 of the financial tables attached below.

Beginning in 2019, the company has changed how it presents adjusted income measures to additionally exclude amortization
expense for all periods presented. We believe this presentation provides investors with additional insight to evaluate our
performance period over period and relative to competitors, as well as to analyze the underlying trends in our business.

Dividend and Share Repurchase Authority Increased

Quest Diagnostics’ Board of Directors authorized a 5.7% increase in its quarterly dividend from $0.53 to $0.56 per share, or $2.24 per share annually, payable on April 21, 2020 to shareholders of record of Quest Diagnostics common stock on April 7, 2020. This dividend increase is the company’s ninth since 2011.

The Board also increased the company’s share repurchase authorization by $1 billion, bringing the total authorization available to $1.2 billion as of December 31, 2019.

Guidance for Full Year 2020

The company estimates full year 2020 results as follows:

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, the gain associated with the sale and leaseback of a property, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: Investor; or via live webcast on the company’s website at www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-357-4210 for domestic callers or 203-369-0125 for international callers. No passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on January 30, 2020 until midnight Eastern Time on February 13, 2020. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On January 30, 2020 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Duke University investigators have dosed the first patient in a proof-of-concept Phase 1b study to evaluate GlycoMimetics’ novel GMI-1359 drug candidate in patients with advanced breast cancer (Press release, GlycoMimetics, JAN 30, 2020, View Source [SID1234553700]). The dose-escalating study will enroll up to 12 individuals with metastatic, hormone receptor positive breast cancer with stable or minimally progressive disease, including bone metastasis. GMI-1359 is a dual inhibitor of both E-selectin and CXCR4. The trial is designed to evaluate safety, pharmacokinetics and pharmacodynamic measures of biologic activity, such as increases in circulating tumor cells and mobilization of CD34+ and immune T-cell subsets. GlycoMimetics expects the trial results to be available in late 2020, the conclusions of which the Company will use to inform future development of GMI-1359.

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Kelly Marcom, M.D., and Dorothy Sipkins, M.D., Ph.D., both of the Duke Cancer Institute, are the trial’s co-principal investigators.This clinical trial builds on published findings from Dr. Sipkins on the key roles of both E-selectin and CXCR4 in the trafficking of metastatic cancer cells and of their establishment as micro-metastases in bone. Dr. Sipkins’ research suggests that both E-selectin and CXCR4 mediate key mechanisms that promote progression and migration of cancer cells to protective niches in the bone marrow micro-environment, and reveals the potential for an E-selectin and CXCR4 inhibitor like GMI-1359 to molecularly excise disseminated breast cancer cells.1

"The initiation of enrollment is an important milestone in our exploration of GMI-1359 and its potential as a novel approach to treating metastatic cancer," said GlycoMimetics Senior Vice President of Clinical Development and Chief Medical Officer Helen Thackray, M.D., FAAP. "We’re pleased to have such distinguished researchers at Duke University begin to explore the use of this investigational therapy and look forward to learning more about its potential impact as clinical study advances."

More information on this clinical trial can be found at www.clinicaltrials.gov.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as acute myeloid leukemia and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The newly initiated Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug’s activity.

On January 30, 2020 University of Pennsylvania reported a scientific team is developing a new CAR T-cell gene therapy treatment for advanced metastatic prostate cancer with a $500,000 grant from Alliance for Cancer Gene Therapy (ACGT) (Press release, University of Pennsylvania, JAN 30, 2020, View Source [SID1234553699]).

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The ACGT grant was awarded to Joseph Fraietta, PhD, assistant professor of microbiology and a T-cell biologist with expertise in tumor immunology and translational medicine, and Naomi Haas, MD, director of the Prostate and Kidney Cancer Program, associate professor of medicine, and nationally renowned expert in the field of prostate and kidney cancer. The goal of the ACGT-funded study is to overcome prostate cancer’s stubborn resistance to CAR T-cell therapy, a therapy that has been successful in treating blood cancers. Drs. Fraietta and Haas are exploring approaches for re-engineering T-cells to enable them to induce safe, long-term remission for advanced, metastatic prostate cancer patients.

"The grant from ACGT will help us advance our clinical work in a very novel way," said Dr. Fraietta. "If we can unlock the epigenetic code that controls the fate and function of T-cells, it could be a game changer."

"The ACGT Scientific Advisory Council is impressed with the potential of this research team and their successful innovations in the use of T-cell therapy," noted Kevin Honeycutt, CEO and president of ACGT. "Because Drs. Fraietta and Haas are building on direct results already achieved with patients, there may be less transition time required to get a promising new treatment into the clinic for prostate cancer patients. Plus, we believe this research could provide a tumor-attack roadmap to help fight other cancers, including lung, pancreatic, ovarian and brain."

In the ACGT-funded study, Drs. Fraietta and Haas are going from the bedside back to the benchtop to employ new insight into how to better enable T-cells to battle cancer cells in solid tumors. Drs. Haas and Fraietta will explore the connection between nutrient availability and epigenetic programming, and how these factors influence the viability of T-cells and their anti-tumor functionality. This research builds on durable results being achieved by Dr. Haas in related prostate cancer clinical trials. In these trials, different doses of CAR T-cell gene therapies are being used to treat metastatic patients for whom traditional hormonal therapies, chemotherapies, radiation and surgery have failed.

"For so many years, chemotherapy, radiation and surgery were the traditional treatments for cancer. For prostate cancer, there’s also hormone therapy," said Honeycutt. "Unfortunately, as the cancer progresses, it often stops responding to these traditional treatments. New cell and gene therapy approaches like the ones Drs. Fraietta and Haas are employing offer new hope to all cancer patients. ACGT has been dedicated to funding innovative science that harnesses the power of cell and gene therapy and transforms how cancer is treated. The work of Drs. Fraietta and Haas is a great example of this promise."

ACGT has been instrumental in funding some of the decade’s most transformative research, including breakthroughs in the use of CAR T-cell gene therapy for leukemia by the University of Pennsylvania’s Carl H. June, MD. "Dr. June received his first ACGT grant in 2004 and a second in 2008, back when gene therapy was considered a risky proposition," says Honeycutt. "Fast forward to today and the field has changed dramatically with major pharmaceutical companies and research institutions vying for the next big discovery using gene therapy or immunotherapy."