On November 14, 2018 Agendia, Inc., a world leader in precision oncology, reported new data from the I-SPY 2 study, presented at the European Organization for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Symposium (Press release, Agendia, NOV 14, 2018, View Source [SID1234531318]). The two presentations demonstrate both the prognostic, and the predictive role of the MammaPrint 70-Gene Breast Cancer Risk of Recurrence and BluePrint 80-Gene Molecular Subtyping tests in determining which patients are likely to respond to therapies. Dr. Laura van’t Veer, chief research officer and co-founder at Agendia, and Professor of Laboratory Medicine at the University California San Francisco, will present the results at the 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium at 15:00 GMT on Wednesday, Nov. 14, 2018.

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MammaPrint High1/High2 risk class as a pre-specified biomarker of response to nine different targeted agents plus standard neoadjuvant therapy for ~1000 breast cancer patients in the I-SPY 2 TRIAL (Abstract 2)1

A new analysis from the I-SPY 2 trial showed that a subgroup of "Ultra-High Risk" patients identified by MammaPrint respond better to certain targeted therapies and treatment combinations. Patients were classified as either MammaPrint High Risk (MP1), indicating less aggressive disease, or MammaPrint Ultra-High Risk (MP2), indicating more aggressive disease. Nearly 50 percent of patients were classified as MP2 and had higher rates of pathological complete response (pCR) compared to MP1 patients.

In addition, MP2 patients had a higher chance of achieving pCR if they received veliparib/carboplatin, neratinib, ganitumab, TDM1/pertuzumab or pembrolizumab in addition to the standard paclitaxel treatment alone or in combination with trastuzumab. Together, these findings support the use of the MammaPrint High Risk or Ultra-High Risk result as a predictive biomarker of treatment response.

BluePrint basal subtype predicts neoadjuvant therapy response in ~400 HR+HER2- patients across 8 arms in the I-SPY 2 TRIAL (Abstract 3)2

A second analysis of the I-SPY 2 trial evaluated neoadjuvant chemotherapy response in different subgroups of patients with HR+/HER2- disease. Using the BluePrint Molecular Subtyping test, patients were classified as having either basal, luminal or HER2 subtypes. Patients with the basal subtype were four times more likely to achieve pCR with neoadjuvant therapy than patients with the luminal subtype, and this association was independent of the type of treatment they received. Additionally, more than three-quarters of patients with the HR+/HER2- basal subtype of cancer were classified as having MP2 Ultra-High Risk disease, suggesting that genetic and molecular risk signatures can be used to predict treatment response in similar subgroups of patients.

Dr. Laura van ‘t Veer, Chief Research Officer and Co-founder at Agendia said:

"The results presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium demonstrate that MammaPrint is not just a prognostic test, it is also a predictive test. When used in conjunction with BluePrint, it can stratify patients into different subgroups to help identify which are more likely to respond to new treatments or to neoadjuvant chemotherapy and which are not likely to respond and should be given an alternative treatment. We need to further investigate the clinical implications, but this is an important milestone with significant value for women with breast cancer."

Dr. William Audeh, Chief Medical Officer at Agendia said:

"The new studies stemming from the I-SPY 2 trial are very encouraging and highlight the continuing and constantly expanding utility of MammaPrint and BluePrint to identify which patients will respond to specific treatments based on the genomic signatures of their tumors. In discovering the MammaPrint signature with her colleague Dr. Rene Bernards, Dr. van ‘t Veer harnessed the power of genomics to provide a platform capable of yielding continuous new discoveries to further understand and personalize the treatment of breast cancer. As the landmark I-SPY 2 trial further evolves, we anticipate future findings that will continue to bolster the value of precision oncology."

MammaPrint High1/High2 risk class as a pre-specified biomarker of response to nine different targeted agents plus standard neoadjuvant therapy for ~ 1000 breast cancer patients in the I-SPY 2 TRIAL. Poster presented at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper). November 2018; Dublin, Ireland.
BluePrint basal subtype predicts neoadjuvant therapy response in ~400 HR+HER2- patients across 8 arms in the I-SPY 2 TRIAL. Poster presented at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper). November 2018; Dublin, Ireland.
About MammaPrint

MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-gene expression profile of breast cancer tissue samples to assess a patient’s risk for distant metastasis. The device is FDA-cleared and CE-marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy. MammaPrint is the only test of its kind recommended for lymph node-negative and lymph node-positive patients by both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and National Comprehensive Cancer Network (NCCN). The test is also recommended by many other national and international clinical practice guidelines.

About BluePrint

BluePrint is an 80-gene complementary test provided with MammaPrint which allows functional molecular subtyping of a breast cancer sample into three distinct subtypes: Luminal-type, HER2-type and Basal-type, each with marked differences in long-term outcome and response to neoadjuvant chemotherapy.

About I-SPY 2

I-SPY 2 is an interventional, randomized neoadjuvant Phase II clinical trial that is evaluating the efficacy of new targeted drug agents in combination with standard chemotherapy compared to standard therapy alone. The goal of the trial is to identify more treatment regimens for different subsets of breast cancer patients based on the molecular characteristics of their tumors and by learning about which early indicators of response are predictors of treatment success. A MammaPrint High Risk result is a prerequisite for patients included in the trial.

On November 14, 2018 Cytori Therapeutics (NASDAQ: CYTX) ("Cytori" or the "Company") reported Q3 2018 financial results and provided updates on corporate activities (Press release, Cytori Therapeutics, NOV 14, 2018, View Source [SID1234531481]).

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Q3 2018 net loss was $2.3 million, or $0.27 per share. Operating cash burn for Q3 was approximately $2.6 million. Cytori ended Q3 with approximately $6.8 million of cash and cash equivalents.

Cytori is developing its lead chemotherapy drug, ATI-0918, a generic version of pegylated liposomal doxorubicin hydrochloride, with the goal of submitting a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) next year. We previously completed a bioequivalence study against the European reference drug and are in the process of completing manufacturing-related activities to support the MAA. The Company also continues to evaluate potential commercial partnering opportunities for ATI-0918 with a focus on Europe, which has a current estimated market size of over $120 million.

Cytori is also developing another chemotherapy drug, ATI-1123, a patented, albumin-stabilized pegylated liposomal docetaxel. The Company recently received an orphan drug designation from the U.S. FDA for small cell lung cancer and intends to pursue FDA’s 505(b)(2) new drug application (NDA) pathway in the U.S. which may offer accelerated and lower cost development.

In the first half of 2019, Cytori expects a 1-year data readout from the 45 patient, multi-center, potential pivotal clinical trial in stress urinary incontinence conducted in Japan called ADRESU.

Later in 2018, Cytori expects a 6-month data readout from the 40 patient, French SCLERADEC II clinical trial in scleroderma patients.

Cytori is actively conducting the U.S. Phase I RELIEF trial in thermal burn injury trial sponsored by BARDA. Cytori completed a successful In-Process Review meeting with BARDA this past June.

Commercially, Cytori is focusing its efforts in Japan and continues to see favorable growth trends in the use of its cell therapy products approved under the Regenerative Medicine Law in the aesthetic and orthopedic markets. The Company remains on track to see continued double digit year-over-year growth in Celution System consumable utilization.

Finally, Cytori recently received the first $1.0 million royalty milestone from Bimini Technologies, LLC (Bimini). In 2013, Cytori divested the Puregraft product line that includes periodic royalty payments of up to $10.0 million and certain other economic benefits based on Bimini achieving gross profits milestones.

"A key corporate objective is to complete manufacturing support activities and seek European marketing authorization for ATI-0918, our lead oncology drug product. Furthermore, we have recently expanded development activities for the ATI-1123 phase II oncology program and its potential 505(b)(2) acceptability," said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. "In cell therapy, we are focused on continued revenue growth based on positive quarter-over-quarter and year-over-year consumable utilization trends. In the meantime, we are awaiting pivotal clinical data from our Japanese stress urinary incontinence trial."

Q3 2018 and year-to-date Financial Performance

Q3 2018 and year-to-date operating cash burn was $2.6 million and $9.5 million, compared to $4.0 million and $13.9 million for the same periods in 2017, respectively.
Q3 2018 and year-to-date product revenues were $0.9 million and $2.2 million, compared to $0.5 million and $2.0 million for the same periods in 2017, respectively.
Q3 2018 and year-to-date contract revenues were $0.5 million and $2.3 million, compared to $1.3 million and $2.9 million for the same periods in 2017, respectively.
Q3 2018 and year-to-date consumable utilization in Japan grew by approximate 90% and 70%, when comparing to the same periods in 2017, respectively.
Cash and debt principal balances at September 30, 2018 were approximately $6.8 million and $13.0 million, respectively.
Q3 2018 adjusted net loss was $4.0 million or $0.45 per share, compared to a net loss of $4.8 million or $1.39 per share for the same period in 2017. The adjusted net loss excludes a non-cash beneficial conversion feature (a non gaap measure) related to the issuance of our Series C convertible preferred shares in the third quarter of 2018 of $2.5 million, as well as a credit of $1.7 million related to a change in fair value of warrant liability (a non gaap measure). Q3 2018 net loss allocable to common stockholders was $4.8 million, or $0.55 per share.
Year-to-date 2018 adjusted net loss was $12.1 million or $1.73 per share, compared to $18.4 million or $6.22 per share for the same period in 2017. The adjusted net loss excludes a non-cash beneficial conversion feature (a non gaap measure) related to the issuance of our Series C convertible preferred shares in the third quarter of 2018 of $2.5 million, as well as a credit of $1.7 million related to a change in fair value of warrant liability (a non gaap measure). Year-to-date 2018 net loss allocable to common stockholders was $12.9 million, or $1.85 per share.
Selected Key Anticipated Milestones:

Complete ATI-0918 development and manufacturing required to prepare and file a MAA with the EMA.
Seek FDA 505(b)(2) pathway applicability for ATI-1123 product.
Obtain Japan MHLW Class III approval for Celution System consumables.
Report 1-year Japanese ADRESU pivotal clinical trial data for post-surgical male stress urinary incontinence.
Enrollment update in the BARDA-funded U.S. RELIEF clinical trial.
Report French investigator initiated SCLERADEC II clinical trial data in scleroderma hand dysfunction.
Management Conference Call Webcast

Cytori will host a management conference call at 5:30 p.m. Eastern Time today to further discuss its progress. The webcast will be available live and by replay two hours after the call and may be accessed under "Webcasts" in the Investor Relations section of Cytori’s website. If you are unable to access the webcast, you may dial in to the call at +1.877.402.3914, Conference ID: 9699923.

On November 13, 2018 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, reported financial results for the quarter ended September 30, 2018, and provided an update on recent clinical and operational developments (Press release, Scynexis, NOV 13, 2018, View Source [SID1234531250]).

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Key Messages:

Women suffering from vaginal yeast infections (vulvovaginal candidiasis or VVC) have only one approved oral treatment option. With SCYNEXIS’s U.S. Food and Drug Administration (FDA)-endorsed Phase 3 registration program for VVC on track to begin by year-end, and with a potential New Drug Application (NDA) filing planned for 2020, ibrexafungerp may become the much-needed oral alternative for the millions of women who are not well-served by fluconazole.

Despite existing therapies, mortality associated with invasive aspergillosis remains as high as 50%. Based on positive pre-clinical data, an ibrexafungerp combination regimen has the potential to show superiority to the current standard of care. SCYNEXIS has initiated a Phase 2 study as a proof of concept in this indication.

Patients with no therapeutic options for invasive fungal infections continue to enroll in SCYNEXIS’s ibrexafungerp programs designed for such refractory infections, including infections caused by Candida auris, a multidrug-resistant pathogen that is the subject of recent warnings by the Centers for Disease Control and Prevention (CDC) and other health authorities.

As of September 30, 2018, SCYNEXIS has $49.5 million in cash and cash equivalents and short-term investments, adequate to fund activities into 2020.
"With our successful End-of-Phase 2 Meeting with the FDA, we continue to advance toward our goal of bringing ibrexafungerp to patients in need," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "Following FDA’s agreement with our proposed overall design of the Phase 3 registration program for VVC, we anticipate that results showing superiority of ibrexafungerp over placebo would lead to filing an NDA in 2020 for the treatment of VVC, followed by a supplemental NDA in 2021 for the prevention of recurrent VVC."

Dr. Taglietti continued: "In parallel, we are advancing the development of ibrexafungerp for severe, invasive indications. We continue to enroll patients in our FURI study for the treatment of refractory infections; we recently dosed the first patient in our CARES study for the treatment of high-mortality Candida auris infections and we initiated our Phase 2 combination study for the treatment of invasive aspergillosis. We remain committed to maximizing the clinical utility of ibrexafungerp, a first-in-class therapy that combines the broad-spectrum antifungal activity and safety profile of the echinocandin class with the oral convenience of the azole class. With a cash runway into 2020, we are well-funded to progress all ongoing programs."

Ibrexafungerp (formerly SCY-078) Update

VVC Phase 3 Registration Program on Track for Initiation by End of 2018, with Potential NDA Filing in 2020.
In October 2018, SCYNEXIS announced the successful completion of an End-of-Phase 2 Meeting with the FDA for VVC. The FDA has agreed with the SCYNEXIS’s proposed design of the Phase 3 registration program to support approval of oral ibrexafungerp for the treatment of VVC and the prevention of recurrent VVC. SCYNEXIS anticipates initiating the program by the end of 2018.
If approved, ibrexafungerp would provide a much-needed oral option for the millions of women who are currently not well-served by existing VVC therapies. Fluconazole, approved over 25 years ago, is the only oral treatment available and fails to adequately address several patient segments: fluconazole-failure patients, management of VVC during pregnancy, moderate-to-severe VVC, recurrent VVC and VVC caused by fluconazole-resistant Candida spp.

Continued Progress on SCYNEXIS’s Strategy to Expand the Use of Ibrexafungerp in Severe Invasive Fungal Infections.
In October 2018, SCYNEXIS dosed the first patient in the CARES study, a Phase 3, multi-center (U.S. and India), open-label, single-arm study evaluating the efficacy, safety and tolerability of oral ibrexafungerp for the treatment of Candida auris infections. C. auris is an emerging life-threatening and multidrug-resistant fungal pathogen, with a mortality rate of up to 60%.
The FURI study, evaluating oral ibrexafungerp for the treatment of fungal infections refractory or resistant to standard of care, is ongoing with a preliminary data review planned by the end of the year.
SCYNEXIS recently initiated a Phase 2 combination study of oral ibrexafungerp in invasive aspergillosis. An animal model of pulmonary aspergillosis showed improved outcomes and survival rates, supporting the potential superiority of ibrexafungerp in combination with azole therapy versus the standard of care.
Ibrexafungerp is well-positioned to address significant unmet needs in patients suffering from severe invasive fungal infections. It is a first-in-class therapy, with broad-spectrum activity (including against multidrug-resistant strains), fungicidal activity versus Candida, high tissue penetration and a favorable safety profile. These features, available in the convenience of an oral formulation, differentiate ibrexafungerp from available alternatives, and, if approved, would make it an attractive option for the treatment of severe invasive fungal infections.

Presentation at the 2018 ESCMID/ASM Conference on Drug Development. In September 2018, SCYNEXIS presented a poster at the 2018 European Society of Clinical Microbiology and Infectious Diseases (ESCMID)/American Society for Microbiology (ASM) Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. The poster, titled "Ibrexafungerp (formerly SCY-078) Displays Potent In Vitro Activity Against C. Glabrata Isolates with Mutations in fks Genes," describes the results of several pre-clinical studies designed to evaluate the in vitro activity of ibrexafungerp in Candida glabrata strains with fks mutations, which are often contributory in the development of echinocandin resistance. C. glabrata is the second-most common fungal species isolated from blood in the US and one of the most common fungal pathogens worldwide.
Third Quarter 2018 Financial Results
Cash, cash equivalents and short-term investments totaled $49.5 million as of September 30, 2018, with net working capital of $39.1 million.

Research and development expenses decreased to $3.9 million in the third quarter of 2018, compared to $4.5 million in the third quarter of 2017. The decrease of $0.5 million, or 12%, for the three months ended September 30, 2018, was primarily driven by a decrease of $0.8 million in preclinical development expense and a decrease of $0.2 million in consulting expense and was offset in part by an increase of $0.5 million in chemistry, manufacturing, and controls.

Selling, general and administrative expenses increased to $2.4 million in the third quarter of 2018, compared with $2.0 million in the third quarter of 2017. The increase of $0.4 million, or 21%, for the three months ended September 30, 2018, was primarily driven by a $0.2 million charge for deferred offering costs recognized during the three months ended September 30, 2018.

Total other income increased to $6.7 million in the third quarter of 2018 due to a $6.9 million non-cash gain recorded on the fair value adjustment of the warrant liabilities.

Net income for the third quarter of 2018 was $0.4 million, or $0.01 per share. This compares with a net loss for the third quarter of 2017 of $8.4 million, or $0.31 per share.

About Ibrexafungerp (formerly SCY-078)
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and IV formulations. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of IC (including candidemia), IA and VVC, and has granted Orphan Drug Designation for the IC and IA indications.

On November 13, 2018 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported the closing of Tilray, Inc.’s strategic investment in IntelGenx by way of private placement (the "Private Placement") (Press release, IntelGenx, NOV 13, 2018, View Source [SID1234531303]). Pursuant to the Private Placement, the Company issued 1,428,571 common shares ("Common Shares") at a subscription price of U.S.$0.70 per Common Share for gross proceeds of U.S.$1,000,000. The Corporation intends to use the proceeds of the Private Placement for cannabis-infused VersaFilm product development under its previously announced definitive license, development and supply agreement (the "Agreement") with Tilray Inc.

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The Common Shares issued to Tilray, Inc. are subject to a four-month statutory hold period which expires March 14, 2019. Additionally, under the Private Placement purchase agreement, Tilray, Inc. agreed that until May 14, 2019 it would not cause or permit any transfer of any Common Shares.

On November 13, 2018 RadioMedix Inc. (a Texas-based clinical stage biotechnology company) and Orano Med (a nuclear biotechnology company) reported that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AlphaMedixTM for the treatment of neuroendocrine tumors (NETs) (Press release, RadioMedix, NOV 13, 2018, View Source [SID1234531347]). AlphaMedixTM is a 212Pb-labeled somatostatin analogue used for the targeted alpha therapy (TAT) of neuroendocrine tumors (NETs).

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"TAT has brought new hope to our patients with cancer, and the range of available therapies in this area will only increase in the near future. We are pleased to conduct the first TAT clinical trial in the U.S. for neuroendocrine cancers, with the aim of registration of the drug," said Dr. Ebrahim S. Delpassand, CEO of RadioMedix and Medical Director of the clinical studies. "We are hoping that AlphaMedixTM will provide a breakthrough therapy that will benefit our patients soon," added Dr. Delpassand. "We are excited about the progress of our dose escalation studies of AlphaMedixTM", echoed Dr. Izabela Tworowska, Ph.D., CSO of RadioMedix.

The mechanism of action of AlphaMedixTM relies on the delivery of a cytotoxic load of alpha-emitters to SSTR-overexpressing neuroendocrine tumors. Alpha- emitters are highly energetic radioactive particles that can cause irreversible damage to the cancer cells. RadioMedix and Orano Med initiated the Phase 1 clinical trial of the safety and preliminary efficacy of AlphaMedixTM in February of 2018 (NCT03466216); the study is currently recruiting patients at the Excel Diagnostics and Nuclear Oncology Center in Houston, TX U.S.

"FDA’s decision to grant Orphan drug Designation is an important regulatory milestone for AlphaMedixTM, a key program in our pipeline of 212Pb-labeled compounds," said Julien Dodet, CEO of Orano Med. "We believe TAT with 212Pb represents a promising new approach and that AlphaMedixTM has the potential to have a meaningful impact on patients".

Orphan designation is granted by the FDA Office of Orphan Products Development to advance the evaluation and development of safe and effective therapies for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. The designation provides certain benefits to drug developers such as seven-year marketing exclusivity upon FDA approval, tax credits for qualified clinical testing or prescription drug user fee exemption.

About Neuroendocrine Tumors

Neuroendocrine tumors (NETs) are a heterogeneous group of rare neoplasms that originate from neuroendocrine cells. These neoplasms occur mostly in the gastrointestinal tract and pancreas, but can also occur in other tissues including thymus, lung, and other uncommon sites such as ovaries, heart, and prostate. Most NETs strongly express somatostatin receptors (SSTRs).

About AlphaMedixTM

AlphaMedixTM is a radiolabeled SSTR-targeting therapeutic investigational drug for the treatment of NETs patients. The product consists of SSTR-targeting peptide complex radiolabeled with 212Pb and serve as an in vivo generator of alpha-emitting particles. 212Pb isotope is particularly suitable for SSTR therapy applications based upon its half-life, energy and decay properties.