On November 13, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that company management will present and participate in the following conferences in November (Press release, Iovance Biotherapeutics, NOV 13, 2018, View Source;p=irol-newsArticle&ID=2376890 [SID1234531249]):

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Credit Suisse 27th Annual Healthcare Conference in Scottsdale, AZ on Tuesday, November 13, 2018.

Jefferies Global Healthcare Conference in London, United Kingdom on Thursday, November 15, 2018 at 4:00 p.m. GMT.

Evercore ISI HealthCONx Conference in Boston, MA on Tuesday, November 27, 2018 at 11:20 a.m. ET.
A live audio webcast of the Jefferies and Evercore ISI conference presentations will be available by visiting the Investors section of Iovance Biotherapeutics’ website at View Source A replay of the webcasts will be archived on Iovance Biotherapeutics’ website for 30 days following the presentations.

On November 13, 2018 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a company focused on the
development of novel immunotherapies based on proprietary chimeric antigen receptor engineered T cell ("CAR T")
technology and gene therapies for rare diseases, reported financial results and recent corporate highlights for the third quarter ended September 30, 2018 (Press release, Mustang Bio, NOV 13, 2018, View Source [SID1234531346]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "The third quarter of 2018 and recent months have been marked by clinical progress and a key addition to our management team with the appointment of Martina A. Sersch, M.D., Ph.D., as Chief Medical Officer. Notably, we expanded our pipeline into gene therapy by securing an exclusive worldwide license agreement with St. Jude Children’s Research Hospital ("St. Jude") for the development of a first-in-class, ex vivo, clinical-stage lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency ("X-SCID"). Data from a multicenter Phase 1/2 trial led by St. Jude in infants under the age of two years old are extremely encouraging. Eight patients under the age of two with X-SCID have been treated to date, with results presented at the 21st Annual Meeting of the American Society of Gene & Cell Therapy in May 2018. The therapy was well tolerated. In addition, six patients achieved reconstituted immune systems within three to four months following treatment, with the remaining two patients continuing to progress favorably in earlier stages of recovery. Four of these six patients have discontinued monthly infusions of intravenous immunoglobulin, and the remaining patients, at earlier stages of recovery, continue to progress favorably. In three patients who had disseminated infections prior to therapy, all infections resolved completely. In addition, the therapy is being investigated in patients over the age of two in a second Phase 1/2 trial at the National Institutes of Health ("NIH"), with equally encouraging data and an excellent safety profile to date. The two patients with the longest follow-up have seen sustained restoration of antibody production after immunization, and all five patients treated experienced a decrease in viral infections and overall clinical improvement."

Dr. Litchman continued, "We also recently announced updates on two Phase 1 clinical trials at City of Hope using our
HER2-specific CAR T cell therapy, including a first-of-its-kind trial using intraventricular delivery of CAR T cells to brains of patients with HER2-positive breast cancer with brain metastases. As we look ahead to the fourth quarter of 2018, we look forward to filing our first Investigational New Drug (IND) application to support a Phase 1/2 trial of MB-102 in acute myeloid leukemia ("AML"), blastic plasmacytoid dendritic cell neoplasm and high-risk myelodysplastic syndrome."

Recent Corporate Highlights:
• In July 2018, Mustang completed a pre-IND meeting with the U.S. Food and Drug Administration ("FDA") for MB102 (CD123 CAR T). Based on the meeting, Mustang expects to file an IND in the fourth quarter of 2018 to support a Phase 1/2 trial of MB-102 in AML, blastic plasmacytoid dendritic cell neoplasm and high-risk myelodysplastic
syndrome.
• In August 2018, Mustang announced that it entered into an exclusive worldwide license agreement with St. Jude
for the development of a first-in-class ex vivo lentiviral gene therapy for the treatment of X-SCID, also known as
bubble boy disease. The therapy is currently being evaluated in a Phase 1/2 multicenter trial in infants under the
age of two. This study is the world’s first lentiviral gene therapy trial for infants with X-SCID. The therapy is also
being investigated in patients over the age of two in a second Phase 1/2 trial at the National Institutes of Health
("NIH").
• In October 2018, Mustang appointed Martina A. Sersch, M.D., Ph.D., as Chief Medical Officer.
• Also in October 2018, Mustang announced that a first-of-its-kind Phase 1 clinical trial evaluating the safety and
effectiveness of intraventricular delivery of CAR T cells to the brains of patients with HER2-positive breast cancer
with brain metastases has been initiated at City of Hope. In addition, Mustang announced that City of Hope dosed
the first patient in a Phase 1 clinical trial of HER2-specific CAR T cells in treating recurrent or refractory grade IIIIV
glioma. The trial will evaluate the side effects and best dose of HER2-specific CAR T cells in treating patients
with grade III-IV glioma that has come back or does not respond to treatment.
Financial Results:
• As of September 30, 2018, Mustang’s consolidated cash, cash equivalents, short-term investments (certificates of
deposit) and restricted cash totaled $41.3 million, compared to $47.2 million as of June 30, 2018, and $61.5 million
as of December 31, 2017, a decrease of $5.9 million for the quarter and a decrease of $20.2 million year-to-date.
• Research and development expenses were $5.3 million for the third quarter of 2018, compared to $2.2 million for
the third quarter of 2017. Non-cash, stock-based compensation expenses included in research and development
were $0.7 million for third quarter of 2018, compared to $0.3 million for the third quarter of 2017.
• Research and development expenses from license acquisitions were $1.0 million for the third quarter of 2018,
compared to $0.3 million for the third quarter of 2017.
• General and administrative expenses were $1.3 million for the third quarter of 2018, compared to $4.6 million for
the third quarter of 2017. Non-cash, stock-based compensation expenses included in general and administrative
expenses were $0.2 million for the third quarter of 2018, compared to $0.5 million for the third quarter of 2017.
• Net loss attributable to common stockholders was $7.5 million, or $0.28 per share, for the third quarter of 2018,
compared to $6.9 million, or $0.27 per share, for the third quarter of 2017. Net loss attributable to common
stockholders was $18.9 million, or $0.70 per share, for the first nine months of 2018, compared to $15.7 million,
or $0.63 per share, for the first nine months of 2017.

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.