On January 8, 2018 Pieris Pharmaceuticals, Inc. presented Investor Presentation of dated January 2018 (Press release, Pieris Pharmaceuticals, JAN 8, 2018, View Source [SID1234522946]).

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On January 8, 2018 Foundation Medicine (NASDAQ:FMI) reported preliminary unaudited total revenue of approximately $48.9 million for the fourth quarter of 2017 and approximately $152.9 million for the full year ended December 31, 2017, representing a 70% and 31% increase from the $28.8 million and $116.9 million recorded in the fourth quarter and full year ended December 31, 2016, respectively (Press release, Foundation Medicine, JAN 8, 2018, View Source [SID1234522944]).

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"2017 was a year of significant milestones for Foundation Medicine, including posting record revenue and achieving our largest annual increase in recorded clinical volume," stated Troy Cox, chief executive officer of Foundation Medicine. "Our most notable achievement was the successful completion of the parallel review process during the fourth quarter which culminated with FDA approval and a preliminary National Coverage Determination (NCD) for FoundationOne CDx from CMS. This approval and preliminary NCD are transformational for our company, clinicians, biopharma partners and most importantly, for patients with advanced cancer, as we continue to meaningfully improve access to personalized cancer care."

Revenue from biopharmaceutical companies is expected to be approximately $33.4 million in the fourth quarter of 2017 and approximately $99.7 million for the full year ended December 31, 2017, compared to $19.0 million and $78.8 million in the fourth quarter and full year ended December 31, 2016, respectively. The company reported 6,206 tests to biopharmaceutical customers in this year’s fourth quarter.

Revenue from clinical testing is expected to be approximately $15.5 million in the fourth quarter of 2017 and approximately $53.1 million for the full year ended December 31, 2017, compared to $9.8 million and $38.1 million in the fourth quarter and full year ended December 31, 2016, respectively. The company reported 20,044 clinical tests to ordering physicians in the fourth quarter of 2017, compared to a total of 12,788 tests reported during the fourth quarter of 2016, an increase of 57%. A total of 67,375 clinical tests were reported to ordering physicians for the full year ended December 31, 2017, compared to 43,686 clinical tests reported in 2016, an increase of 54%.

Based on the new revenue reporting the company initiated during 2017, Molecular Information Services revenue is expected to be approximately $37.4 million in the fourth quarter of 2017 and approximately $117.1 million for the full year ended December 31, 2017, compared to $20.4 million and $81.8 million in the fourth quarter and full year ended December 31, 2016, respectively. Pharma Research and Development Services revenue is expected to be approximately $11.5 million in the fourth quarter of 2017 and approximately $35.8 million for the full year ended December 31, 2017, compared to $8.4 million and $35.1 million in the fourth quarter and full year ended December 31, 2016, respectively.

Cash and cash equivalents at December 31, 2017 was approximately $71.4 million, including $30 million in new borrowings received during the fourth quarter under the company’s Credit Facility Agreement with Roche Finance.

2017 Enterprise Highlights:

Received approval from the U.S. Food & Drug Administration (FDA) under the parallel review process for FoundationOne CDx, the first broad genomic profiling test incorporating multiple companion diagnostics.

Simultaneously, the Centers for Medicare and Medicaid Services (CMS) issued a preliminary NCD for FoundationOne CDx, which is expected to improve access to molecular information for personalized healthcare. The NCD is expected to be finalized during the first quarter of 2018.

Grew the biopharma business with new and expanded collaborations for molecular information solutions including companion diagnostics, molecular profiling, data insights, and biomarker discovery.

Presented validation data for a novel assay measuring tumor mutational burden in blood (bTMB) providing evidence that response to immunotherapy can be predicted using a blood sample. Based on these findings, Foundation Medicine’s bTMB assay is being integrated as part of Roche/Genentech’s prospective, randomized Phase III Blood First Assay Screening Trial (BFAST) as a companion diagnostic assay investigating the use of bTMB as a non-invasive biomarker of response to first-line atezolizumab in advanced NSCLC patients.

Received approval from the State of New York Department of Health for FoundationACT, the company’s liquid biopsy assay.

Announced a collaboration with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) to identify patients for its Targeted Agent and Profiling Utilization Registry (TAPUR) study.

Announced a collaboration with the National Cancer Institute (NCI) and ECOG-ACRIN Cancer Research Group to identify patients for the NCI-Match (Molecular Analysis for Therapy Choice) study.
Increased FoundationCORE, the company’s molecular information database, to nearly 180,000 clinical cases.
Expanded the company’s global footprint and patient access to personalized healthcare by commencing operations at the company’s laboratory in Penzberg, Germany. The Penzberg location is supporting continued growth and expansion in Europe through the company’s commercial collaboration with Roche.

Published 95 peer-reviewed manuscripts in top medical and scientific journals and presented 141 podium talks and posters at scientific and medical meetings.

Complete 2017 fourth quarter and full year financial results will be announced during the company’s fourth quarter and fiscal year 2017 financial results conference call. The company also anticipates providing 2018 financial guidance at that time. This press release contains certain unaudited financial results for the company. These unaudited results could change as a result of further review by the company’s management and its independent auditors.

Mr. Cox is scheduled to present at the 36th Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2017, at 3:30 p.m. PST, in San Francisco. Additionally, Mr. Cox will participate in a panel discussion focused on the FDA and CMS parallel review process on Monday, January 8, 2018 at 5:15 p.m. PST. Live, listen-only webcasts of these presentations and the breakout session may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of these webcasts will be available shortly after the conclusion of the presentations and will be archived on the company’s website for two weeks.

On January 8, 2018 Adaptimmune Therapeutics plc presented corporate presentation – January 2018 (Presentation, Adaptimmune, JAN 8, 2018, View Source [SID1234522942]).

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On January 9, 2018 H3 Biomedicine Inc., a clinical stage biopharmaceutical company specializing in the discovery and development of next generation cancer medicines using its data science and precision chemistry product engine, reported that it will outline its key 2018 strategies and goals that build upon its success in advancing three differentiated, internally generated cancer therapies into clinical trials (Press release, H3 Biomedicine, JAN 8, 2018, View Source [SID1234522971]). Markus Warmuth, M.D., President and CEO of H3 Biomedicine, will provide an overview of the company and further details on its 2018 goals during its presentation at the 36th Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2017, at 9:00 a.m. PST in the Elizabethan D conference room at the Westin St. Francis Hotel in San Francisco.

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"Over the past six years, we built a leading oncology product engine at the interface of data science and precision chemistry with the goal of discovering cancer therapies that address molecular traits driving cancer in select patient segments. Last year, we continued to see the successful translation of this innovation as we advanced our third internally generated therapy into clinical trials and garnered significant interest from the scientific and medical community as evidenced by a large number of key publications, papers and presentations on our product engine and clinical pipeline," said Dr. Warmuth. "With initial clinical data expected from at least two of our three therapies and our product engine continuing to drive forward new programs to achieve additional investigational new drug (IND) filings in the future, 2018 will be a pivotal year for H3 as we continue to advance toward our vision — as embodied in our name — of improving Health and providing Hope for Humans."

2017 Accomplishments

Received FDA acceptance for our IND application and dosed first patients with H3B-6545, an oral, first-in-class ESR1 covalent antagonist targeting wild-type and mutant estrogen receptor α in endocrine-therapy resistant metastatic breast cancer patients. H3 has two additional therapies in Phase I clinical trials including:
– H3B-6527, an oral, potent and highly selective small molecule covalent inhibitor of FGFR4 for treatment of hepatocellular carcinoma (HCC) patients with overexpression of FGF19; and
– H3B-8800, an oral, first-in-class, selective SF3b modulator treating hematological malignancies with spliceosome mutations;
Achieved orphan drug designation in the U.S. from the Food and Drug Administration for H3B-8800
in acute myelogenous leukemia and chronic myelomonocytic leukemia and H3B-6527 in HCC;
Garnered significant interest from the medical and scientific community with numerous publications
accepted in leading scientific and medical journals, with highlights as follows:
– Publication in Cancer Research highlighting an oral dosing of H3B-6527 in mice led to dose-dependent pharmacodynamic modulation of FGFR4 signaling and tumor regression in FGF19 altered HCC xenograft models;
– Publication in Nature Communications highlighting preclinical data describing a novel immune evasion mechanism in bladder cancer;
– Publication in Nature Communications reporting preclinical data from novel discovery research around RNA splicing modulators;
– Oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s (AACR) (Free AACR Whitepaper) New Drugs on the Horizon session on data from H3B-6545;
– Four poster presentations at AACR (Free AACR Whitepaper) on preclinical programs highlighting splicing platform and lead position in drugging RNA splicing defects in cancer;
– Oral presentation at the International Liver Cancer Association (ILCA) annual meeting demonstrating FGFR4 inhibition with H3B-6527;
– Poster presentation at the San Antonio Breast Cancer Symposium (SABCS) demonstrating potent inhibition of ERα with H3B-6545;

Extended multi-year collaboration with Foundation Medicine to continue strengthening leadership position in discovering previously unknown molecular traits driving cancers to select cancer patient populations.

Key 2018 Strategies and Goals

Drive forward clinical pipeline of differentiated cancer therapies to achieve proof of concept rapidly

Achieve Phase 2 dose for all three clinical stage programs and initiate expansion cohorts to critical decision points;
Present initial clinical data from the Phase 1/2 dose escalation and/or expansion cohorts for at least two of the three programs; and
Initiate Phase 1B combination studies for H3B-6545 and H3B-6527 as key component of strategy for these therapies.
Continue to advance our big data science and precision chemistry product engine to deliver additional INDs in the future

Advance FGFR4 mutant inhibitor program addressing hot spot mutations leading to resistance to first generation FGFR4 inhibitors to IND-enabling studies to support 2019 IND filing; Initiate lead optimization on one additional program; Achieve preclinical proof-of-concept for splice modulator-loaded antibodies, an expansion of H3’s capabilities in splice modulation and a key area of differentiation for H3; and Continue to expand data science engine to empower initiation of additional exploratory research projects.

On January 8, 2018 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported preliminary operational and financial results for the fourth quarter and fiscal year ended December 31, 2017 (Press release, NanoString Technologies, JAN 8, 2018, View Source [SID1234522939]).

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Financial Highlights:

Product and service revenue for fiscal year 2017 is expected to be approximately $72 million, versus prior guidance of $68 to $71 million

Product and service revenue for the fourth quarter of 2017 is expected to be approximately $21 million

Total revenue for fiscal year 2017 is expected to be in the range of $113 to $115 million, including approximately $41 to $43 million of collaboration revenue, versus prior guidance of $109 to $112 million

Cash, cash equivalents and short-term investments of approximately $82 million at December 31, 2017
Operational Highlights:

Approximately 125 nCounter Analysis Systems sold in 2016, including 54 nCounter SPRINT Profilers

Installed base of approximately 605 nCounter Analysis Systems at December 31, 2017, and increase of approximately 25% since year-end 2016

More than 1,820 cumulative peer-reviewed publications of studies based on nCounter technology as of December 31, 2017, an increase of more than 25% over the prior year
"While 2017 was a challenging year, we believe that actions we have taken helped to stabilize the business in the fourth quarter and put us on the path to improved growth over the course of 2018," said NanoString president and chief executive officer, Brad Gray. "The changes that we’ve made to our commercial channel have had a positive impact, and we achieved both solid SPRINT sales and record consumables revenue during the fourth quarter. In addition, we have taken actions to resource key development programs, extend the runway provided by our existing cash, and expand our access to additional capital."

Cost Management and Financial Resources

During the fourth quarter, the company shifted resources to its high-impact platform-development programs, Digital Spatial Profiling and Hyb & Seq, and eliminated approximately 30 positions in lower-priority areas of the business. The company now expects that its existing cash on-hand will be sufficient to fund its operations through mid-2019. Additionally, during the first week of January 2018, the company increased its access to capital by entering into a $15 million revolving credit facility and a $40 million "at-the-market" facility agreement for potential future equity financing.

NanoString president and chief executive officer, Brad Gray, will give a corporate update at the JP Morgan Healthcare conference at 8:00 a.m. PST on Thursday January 11th, 2018. A live webcast of the presentation will be available online from the investor relations page of the company’s corporate website at www.nanostring.com. After the live webcast, the presentation will remain available on the website for approximately 30 days.

These preliminary results are based on management’s initial analysis of operations for the quarter and year ended December 31, 2017 and are subject to further internal review and review/audit by the company’s external auditors.