On May 8, 2019 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the first quarter ended March 31, 2019 (Press release, VolitionRX, MAY 8, 2019, View Source [SID1234535967]). Volition management will host a conference call tomorrow, May 9, at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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Cameron Reynolds, President and Chief Executive Officer of Volition, upon releasing these results, commented, "I could not be more proud of our dedicated team at Volition, and the ground-breaking work they are doing. During the first quarter, we, together with our collaborators, have made significant progress, particularly with the work on the basics of our Nu.QTM platform and its expansion into exciting new areas."

Mr. Reynolds further commented "We were very happy to report the initial data from the first of our product grade assays during this first quarter. We aim to strengthen our product pipeline beyond colorectal cancer to cover several cancers, most notably in lung cancer, and so are especially delighted to have executed an agreement with the National Taiwan University to conduct our first large-scale study in lung cancer. I am also delighted to announce that we are in the process of forming a Texas-based subsidiary to focus on the development and commercialization of our Nu.Q Vet products and help drive early revenue."

Additionally, Mr. Reynolds added "During the first quarter 2019, we further strengthened our balance sheet with existing investors exercising $6.7 million in aggregate amount of outstanding warrants to purchase shares of our common stock and end the quarter with cash and cash equivalents of $16.2 million. Subsequent to the ending of the quarter, a further $5 million in warrants were exercised for cash, making a total of $11.7 million in warrants exercised this year."

Company Highlights

Financial

Cash and cash equivalents as of March 31, 2019 totaled $16.2 million compared to $13.4 million as of the end of 2018.
An additional $5 million in aggregate exercise price of warrants (at $3 per share of common stock) were exercised subsequent to the quarter-end, leaving approximately $4.9 million in aggregate exercise price of warrants (at $3 per share of common stock) outstanding with an expiration date of August 10, 2019.
Continue to manage cash carefully with a cash burn of $3.9 million in the first quarter of 2019.
Intellectual Property

Achieved steady growth in worldwide patent portfolio. This is a key differentiator versus many other technologies either under development or available on the market, where the patent position maybe poor and/or narrow.
– 20 patent families related to our diagnostic tests (including both human and veterinary medicine applications).
– 7 patents granted in the United States.
– 7 patents granted in the European Union.
– 25 further patents granted worldwide.
– 106 patents pending worldwide.
Proof of Concept Data

Tested our optimized product grade assays in three separate small-scale proof of concept cohorts and plan to move onto the larger clinical trial cohorts that are either in our freezer or the collection of which is underway. The preliminary results from our initial optimized product grade assays are as follows:
– In a colorectal cancer cohort (123 subjects), a single Nu.Q assay detected colorectal cancer with an Area Under the Curve (AUC) of 72% while a two-assay panel had an AUC of 84%, cancer versus healthy.
– In a lung cancer cohort (76 subjects), a single Nu.Q assay detected lung cancer, including stage I lung cancer. The AUC for this single assay was 85%, cancer versus healthy.
– In a second confirmatory lung cancer cohort (152 subjects), the same single Nu.Q assay also detected lung cancer with an AUC of 79%, cancer versus healthy.
The above proof of concept results give us confidence to move onto potentially dozens of other assays that we have under development and the large range of cohorts and trials we have collected and planned.

Presented encouraging preliminary results using our Nu.Q platform in veterinary medicine. Executed a non-binding Memorandum of Understanding with Texas A&M University’s College of Veterinary Medicine to conduct a study of Nu.Q Vet. Volition is in the process of establishing a Texas-based subsidiary to drive the development and commercialization of Nu.Q Vet products and help generate early revenue.
Developed Nu.Q Capture, which investigates the use of NucleosomicsTM to purify or enrich tumor associated nucleosomes. Initial studies have demonstrated that Nu.Q Capture has been able to deplete/enrich nucleosomes by 70-90% using magnetic beads in serum and plasma. This is a still a work in progress, but it is a great first step and one that excites our scientific team.
Clinical Trials

Added to our extensive clinical trial program with the execution of a contract to conduct our first large-scale lung cancer study in conjunction with the prestigious National Taiwan University ("NTU"). The study will be conducted under the supervision of Professor Chen Jin-Shing in the Department of Surgery of NTU and will include 1,200 subjects receiving Low-Dose Computed Tomography scans, including 1,000 with lung cancer.
Executed a non-binding Memorandum of Understanding with Shanghai Fosun Long March Medical Science Co., Ltd. with the shared intention to enter into a binding agreement and to conduct three small-scale clinical trials in China. One of the trials is in lung cancer, and the others are in colorectal cancer and ovarian cancer, with preliminary data expected in 2019.
Upcoming Milestones

We expect to achieve the following milestones during 2019 and beyond:

Advance our previously announced large-scale colorectal cancer trials in Europe, the U.S. and Asia.
Advance the clinical trial program for Lung Cancer, focusing initially on the significant need in Asia, most notably in China.
Through our to be formed Texas-based subsidiary, determine and announce the route to revenue for Nu.Q Vet with the aim of having a USDA-approved product in 2020.
Announce the results of multiple proof of concept cancer studies to include prostate, pancreatic and ovarian, in addition to our 27-cancer study, and to initiate larger studies.
Announce preliminary results of Nu.Q’s performance in other disease conditions, including endometriosis.
Advance the development of Nu.Q Capture by determining the level of discrimination of tumor associated nucleosomes using mass spectrometry and sequencing.
Mr. Reynolds concluded, "We are extremely proud of the accomplishments we have achieved thus far. I thank the dedicated Volition team for their tireless efforts. I, along with the rest of the Board and indeed the whole company, look forward to sharing the results of key studies over the coming year."

For further details please contact [email protected].

VolitionRx Limited First Quarter 2019 Earnings and Business Update Conference Call

Date: Thursday, May 9, 2019
Time: 8:30 a.m. U.S. Eastern time
U.S. & Canada Dial-in: 1-855-327-6837 (toll free)
U.K. Dial-in: 0 808-101-2791 (toll free)
Toll/International: 1-631-891-4304
Conference ID: 10006803
Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on recent developments and Volition’s activities, including details of new and ongoing clinical trials, important events which have taken place in the first quarter of 2019, and milestones for 2019 and beyond.

On May 8, 2019 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the first quarter ended March 31, 2019 (Press release, Nektar Therapeutics, MAY 8, 2019, View Source [SID1234535966]).

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Cash and investments in marketable securities at March 31, 2019 were approximately $1.8 billion as compared to $1.9 billion at December 31, 2018.

"Nektar continues to advance our immuno-oncology and immunology pipeline with clinical trials initiating for multiple drug candidates across multiple indications," said Howard W. Robin, President and CEO of Nektar. "We are working with our partner, Bristol-Myers Squibb, to execute on our broad joint development program for bempegaldesleukin in combination with nivolumab, with registrational trials in melanoma, RCC, urothelial and non-small cell lung cancer underway and additional trials planned to begin in the coming months."

"NKTR-181 is under review with the FDA and we are planning for a potential launch later this year," continued Robin. "With respect to NKTR-358, we will report the first data for this exciting drug candidate in an oral presentation at the EULAR Congress in June and our multiple-ascending dose trial in lupus patients is continuing. With our partner Lilly, we continue to advance development of NKTR-358 with two new Phase 1b studies in additional auto-immune disorders planned to start in 2019. We are also completing our IND-enabling activities for our next immuno-oncology candidate, NKTR-255, which activates the IL-15 pathway."

Revenue in the first quarter of 2019 was $28.2 million as compared to $38.0 million in the first quarter of 2018. Revenue in the first quarter of 2019 was lower primarily due to the recognition of $10.0 million received in the first quarter of 2018 from Takeda for the approval of Adynovi in Europe.

Total operating costs and expenses in the first quarter of 2019 were $148.9 million as compared to $124.8 million in the first quarter of 2018. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

R&D expense in the first quarter of 2019 was $118.5 million as compared to $99.4 million for the first quarter of 2018. R&D expense was higher in the first quarter of 2019 as compared to the same period in 2018 primarily because of expenses for our pipeline programs, including the continued development of bempegaldesleukin in Phase 2 and registrational studies and related manufacturing costs, costs related to Phase 1 clinical studies of NKTR-358 and IND-enabling activities for NKTR-255.

General and administrative expense was $25.0 million in the first quarter of 2019 as compared to $18.7 million in the first quarter of 2018 and increased primarily due to costs related to commercialization readiness activities for NKTR-181 and increased non-cash stock-based compensation.

In the first quarter of 2019, net loss was $118.5 million, or $0.68 loss per share as compared to net loss of $95.8 million, or $0.60 loss per share in the first quarter of 2018.

2019 Business Highlights

In April, Nektar presented positive preclinical data on its immuno-oncology pipeline candidates, bempegaldesleukin and NKTR-255, an IL-15 receptor agonist, at the 2019 AACR (Free AACR Whitepaper) Annual Meeting.
In March, Nektar presented preliminary immune activation, safety and clinical activity data from the ongoing dose-escalation stage of the REVEAL study at the 2019 ASCO (Free ASCO Whitepaper)-SITC Meeting. The REVEAL Phase 1/2 study is evaluating the safety and efficacy of NKTR-262, a novel TLR agonist, in combination with bempegaldesleukin.
In February, Nektar presented clinical data from first-line Stage IV urothelial carcinoma patients enrolled in the PIVOT-02 study of bempegaldesleukin with nivolumab at the 2019 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium.
The company also announced upcoming presentations at the following scientific congresses during the second quarter of 2019:

4th Drug Discovery Nexus, Boston, MA:

Presentation: "Harnessing cytokines to develop immune therapeutic agents"
Presenter: Loui Madakamutil, Ph.D., Nektar Therapeutics
Date: Friday, May 17, 2019, 9:30 a.m. Eastern Daylight Time
4th Annual Advances in Immuno-Oncology Congress 2019, London, U.K.:

Presentation: "Bempegaldesleukin (NKTR-214): Targeting the IL-2 Pathway for Immuno-Oncology Applications"
Presenter: Jonathan Zalevsky, Ph.D., Nektar Therapeutics
Session: Immuno-Oncology Therapeutic Approaches, Clinical Research & Clinical Trials
Date: Tuesday, May 21, 2019, 16:30 British Summer Time
American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting, Chicago, IL:

Oral Abstract # 11010: "Pilot study of bempegaldesleukin (NKTR-214) and nivolumab in patients with sarcomas"
Presenter: Sandra D’Angelo, M.D., Memorial Sloan-Kettering Cancer Center
Session: Clinical Science Symposium: Emerging Combinations in Sarcoma Immunotherapy
Date: Monday, June 3, 2019, 11:30 a.m. – 1:00 p.m. Central Daylight Time
Poster #228/Abstract # 2584: "Overcoming genetically-based resistance mechanisms to PD-1 blockade", Torrejon, D., et al.
Session: Developmental Immunotherapy and Tumor Immunobiology
Date: Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. Central Daylight Time
Poster #267/Abstract # 2623: "Baseline tumor immune signatures associated with response to bempegaldesleukin (NKTR-214) and nivolumab", Hurwitz, M., et al.
Session: Developmental Immunotherapy and Tumor Immunobiology
Date: Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. Central Daylight Time
Poster #416b/Abstract # TPS4595: "A phase III randomized open label study comparing bempegaldesleukin (NKTR-214) plus nivolumab to sunitinib or cabozantinib (investigator’s choice) in patients with previously untreated advanced renal cell carcinoma", Tannir, N., et al.
Session: Genitourinary (Nonprostate) Cancer
Date: Monday, June 3, 2019, 1:15 p.m. – 4:15 p.m. Central Daylight Time
Poster 168b/Abstract # TPS9601: "A phase III, randomized, open-label study of bempegaldesleukin (NKTR-214) plus nivolumab (NIVO) versus NIVO monotherapy in patients (pts) with previously untreated, unresectable or metastatic melanoma (MEL)", Khushalani, N., et al.
Session: Melanoma/Skin Cancers
Date: Monday, June 3, 2019, 1:15 p.m. – 4:15 p.m. Central Daylight Time
Pharmaceutical & Bioscience Society Symposium: Advances in Immuno-Oncology, Foster City, CA:

Presentation: "Bempegaldesleukin (NKTR-214), a first-in-class, CD122-preferential IL-2 pathway agonist"
Presenter: Willem Overwijk, Ph.D., Nektar Therapeutics
Date: Tuesday, June 11, 2019, 8:45 a.m. Pacific Daylight Time
24th Congress of European Hematology Association (EHA) (Free EHA Whitepaper), Amsterdam, Netherlands:

Abstract # PS1208: " Effects Of NKTR-255, A Polymer Conjugated Human IL-15, on Efficacy of CD19 CAR T Cell Immunotherapy in a Preclinical Lymphoma Model"
Presenter: Cassie K. Chou, M.D., Ph.D., Fred Hutchinson Cancer Research Center
Session: Gene therapy, cellular immunotherapy and vaccination – Biology & Transitional Research
Date: Saturday, June 15, 2019, 17:30 – 19:00 Central European Summer Time
Poster Pitch: Saturday, June 15, 2019, 16:30 – 16:45 Central European Summer Time
Location: Hall G106
Annual European Congress of Rheumatology (EULAR) 2019, Madrid, Spain:

Abstract # OP0195: "Selective Expansion of Regulatory T-Cells in Humans by a Novel IL-2 Conjugate T-reg Stimulator, NKTR-358, Being Developed for the Treatment of Autoimmune Diseases"
Presenter: Brian Kotzin, M.D., Nektar Therapeutics
Session: Genetics, epigenetics and immunity
Date: Thursday, June 13, 2019, 11:15 Central European Summer Time
Conference Call to Discuss First Quarter 2019 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Daylight Time/2:00 p.m. Pacific Daylight Time, Wednesday, May 8, 2019.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Monday, June 10, 2019.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 8249707 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

On May 8, 2019 Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, reported financial results for the three months ended March 31, 2019 (Press release, Synthetic Biologics, MAY 8, 2019, View Source [SID1234535965]).

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"During the first quarter, we remained keenly focused on executing our strategy to advance our portfolio of GI and microbiome-focused clinical programs," stated Steven A. Shallcross, Chief Executive & Financial Officer of Synthetic Biologics. "Enrollment into our investigator-sponsored Phase 2b clinical trial of SYN-010 in breath methane positive irritable bowel syndrome with constipation (IBS-C) patients is ongoing and we believe we are on track to announce a topline data-readout during the second half of 2019. Importantly, we believe dose-response data derived from this clinical study will further fortify the already well-established clinical data set for SYN-010 and enable regulatory discussions to potentially simplify future registration studies."

Mr. Shallcross continued, "During the first quarter, we continued to pursue our strategy for a potential secondary clinical indication for SYN-004 (ribaxamase) in a specialized patient population which may allow for more narrow and cost-efficient clinical development opportunities. Discussions with key opinion leaders are progressing to determine an optimal development pathway for SYN-004 to reduce the incidence and/or severity of adverse outcomes in allogeneic hematopoietic cell transplant (HCT) recipients. These adverse outcomes include acute graft-versus-host-disease (aGVHD) and colonization of opportunistic pathogens such as vancomycin resistant Enterococci (VRE), each of which are associated with poor outcomes and increased mortality in allogeneic HCT recipients. We believe SYN-004 may provide a distinct benefit to patient outcomes in allogeneic HCT recipients, where gut microbiome damage resulting from prolonged beta-lactam antibiotic use has been linked to the development of aGVHD and colonization by VRE. We look forward to sharing important updates and progress for this potential indication."

Clinical Development and Operational Update

Commenced enrollment in Phase 2b investigator-sponsored clinical study of SYN-010, for the treatment of IBS-C
The Phase 2b clinical study is being conducted by the Medically Associated Science and Technology (MAST) Program at Cedars-Sinai Medical Center and is a 12-week, placebo-controlled, double-blind, randomized clinical trial evaluating two dose strengths of oral SYN-010 (21 mg and 42 mg) in approximately 150 patients diagnosed with IBS-C,
The primary objective for the study will be to determine the efficacy of SYN-010, measured as an improvement from baseline in the weekly average number of complete spontaneous bowel movements (CSBMs) during the 12-week treatment period for SYN-010 21 mg and 42 mg daily doses relative to placebo,
Secondary efficacy endpoints for both dose strengths of SYN-010 will measure changes from baseline in abdominal pain, bloating, stool frequency as well as the use of rescue medication relative to placebo,
A topline data readout is anticipated in 2H 2019,
Cedars-Sinai Medical Center and Synthetic Biologics are co-funding the study. The patent rights covering the use of SYN-010 are owned by Cedars-Sinai Medical Center and are exclusively licensed by Cedars-Sinai Medical Center to Synthetic Biologics;
Continued to evaluate a potential secondary indication for SYN-004 (ribaxamase) to reduce the incidence and/or severity of aGVHD and other adverse outcomes in allogeneic HCT recipients
Identification of key investigators and establishment of clinical protocols are ongoing,
Anticipate initiation of a Phase 1/2 clinical study in allogeneic HCT patients in 2H 2019, contingent upon the identification of a research partner and subsequent Institutional Review Board (IRB) approval;
Evaluated regulatory strategies to advance SYN-020 (intestinal alkaline phosphatase) to and through clinical trials targeting areas of significant unmet medical need, including enterocolitis associated with radiation therapy for cancer
Submitted request for pre-IND meeting with FDA in Q1 2019,
Anticipate filing a US IND application in Q4 2019,
Plan to commence a Phase 1 clinical trial in Q1 2020;
Continued to exercise prudent cash management and financial stewardship
Further reduced cash burn, extending projected cash runway to fund operations through at least the end of Q2 2020;
Quarter Ended March 31, 2019 Financial Results

General and administrative expenses decreased by 30% to $1.1 million for the three months ended March 31, 2019, from $1.6 million for the three months ended March 31, 2018. This decrease is primarily due to decreased stock-based compensation expense related to forfeitures and decreased share price, along with the reduction of investor relations, registration, and legal costs. The charge related to stock-based compensation expense was $65,000 for the three months ended March 31, 2019, compared to $349,000 the three months ended March 31, 2018.

Research and development expenses decreased by 28% to $2.4 million for the three months ended March 31, 2019, from $3.4 million for the three months ended March 31, 2018. This decrease is primarily the result of lower SYN-004 (ribaxamase) indirect program costs for the three months ended March 31, 2019, including salary and related expense reductions resulting from the 2018 restructuring and the fact that no clinical trial activity for SYN-004 (ribaxamase) was ongoing during the quarter, offset by an increase in manufacturing costs for SYN-020. The research and development costs incurred during the quarter were primarily related to the investigator-sponsored Phase 2b clinical study of SYN-010. We anticipate research and development expense to increase in association with the ongoing Phase 2b investigator-sponsored clinical study of SYN-010, a potential Phase 1/2 clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, and the continued development of SYN-020. There was no charge related to stock-based compensation expense for the three months ended March 31, 2019 resulting from the 2018 restructuring, compared to $326,000 for the three months ended March 31, 2018.

Other income was $44,000 for the three months ended March 31, 2019, compared to other income of $2.7 million for the three months ended March 31, 2018. Other income for the three months ended March 31, 2019 is primarily comprised of interest income while the three months ended March 31, 3018 is comprised of non-cash income of $2.7 million from the change in fair value of warrants. The decrease in the fair value of the warrants was due to the decrease in our stock price.

Cash and cash equivalents as of March 31, 2019 was $24.7 million, a decrease of $4.2 million from December 31, 2018.

Conference Call

Synthetic Biologics will hold a conference call today, Wednesday, May 8, 2019, at 4:30 p.m. (ET). The dial-in information for the call is as follows, U.S. toll free: +1 888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source, for 90 days after the call.

On May 8, 2019 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 March 31, 2019, and provided an update on recent clinical developments (Press release, Scynexis, MAY 8, 2019, View Source [SID1234535964]).

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"We are encouraged by the positive interim results and patient cases from our ongoing studies evaluating oral ibrexafungerp in severe and difficult-to-treat fungal infections," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We also continue to advance oral ibrexafungerp in our ongoing Phase 3 VANISH study in patients with VVC, with the goal of sharing top-line data in the first half of 2020. In parallel, with the positive results seen in our complete reproductive and developmental toxicology package, we are moving closer to a potential New Drug Application (NDA) submission for VVC in the second half of 2020."

Ibrexafungerp (formerly SCY-078), the first representative of a novel family of compounds referred to as triterpenoids, is being developed for oral and intravenous administration and is in clinical development for the treatment of several serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. If approved, ibrexafungerp would be the only oral alternative to azoles for the treatment of VVC and prevention of recurrent VVC.

Ibrexafungerp Update

Data presented at the 2019 American College of Obstetrics and Gynecology Annual Clinical and Scientific Meeting (ACOG) support a future NDA submission of oral ibrexafungerp for the treatment of VVC and highlight potential differentiation versus VVC standard-of-care.
Pre-clinical studies, conducted as part of a full reproductive and developmental toxicity package, showed that ibrexafungerp did not cause reproductive harm to adult animals or developmental harm to offspring. These findings are extremely meaningful for women with VVC, often of child-bearing age, and can differentiate oral ibrexafungerp against fluconazole, which has a warning for potential risks of spontaneous abortion and congenital abnormalities in its prescribing information.
Additional data presented further support the utility of ibrexafungerp as a treatment for VVC, including clinical results from a prior Phase 2b dose-finding study of oral ibrexafungerp in patients with VVC and preclinical data demonstrating in vitro activity against fluconazole-resistant Candida spp.
All ACOG 2019 posters and presentations can be found on the SCYNEXIS website.

SCYNEXIS is currently enrolling patients in the VANISH Phase 3 registration program evaluating the safety and efficacy of oral ibrexafungerp in patients with acute VVC and is on track to initiate a planned Phase 3 trial for the prevention of recurrent VVC (the CANDLE study) in the second quarter of 2019.

New data from six presentations at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) shows favorable clinical activity in difficult-to-treat fungal infections, including Candida auris.
An oral presentation showcased results from the first interim analysis of 20 patients with various Candida infections from the FURI study, an open-label trial of oral ibrexafungerp in patients with refractory fungal infections. Oral ibrexafungerp demonstrated a clinical benefit in 17 of the 20 patients, with 11 patients achieving a complete or partial response and six patients achieving a stable disease response. Enrollment in the study continues to progress in the U.S. and Europe.
A poster presentation highlighted clinical findings for two patients with Candida auris candidemia enrolled in the CARES study, who were successfully treated with oral ibrexafungerp. Candida auris is a pathogen defined by the Centers for Disease Control and Prevention (CDC) as "an emerging fungus that presents a serious global health threat."
Preliminary results from the FURI and CARES studies build toward a potential future NDA submission through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).
All ECCMID 2019 posters and presentations can be found on the SCYNEXIS website.
First Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments totaled $39.1 million as of March 31, 2019, with net working capital of $35.4 million.

Research and development expenses increased to $9.7 million for the quarter ended March 31, 2019, compared to $5.3 million in the first quarter of 2018. The increase of $4.4 million, or 82%, was primarily driven by a milestone payment made during the quarter upon initiation of the Phase 3 VVC registration study, an increase of $1.1 million in clinical development, and a net increase of $0.5 million in other research and development expenses, offset in part by a decrease of $0.5 million in chemistry, manufacturing, and controls (CMC) and a decrease of $0.7 million in preclinical development expense.

Selling, general and administrative expenses in the first quarter of 2019 increased to $2.2 million, compared with $2.0 million in the first quarter of 2018.

Total other expense was $11.0 million in the first quarter of 2019, compared to total other income of $3.2 million in the first quarter of 2018. The increase in other expense is attributable to the non-cash losses recognized during the first quarter of 2019 of $6.5 million and $3.4 million associated with the fair value adjustments for warrant liabilities and derivative liability, respectively. Additionally, during the first quarter of 2019, we recognized a loss on extinguishment of debt of $0.8 million.

Net loss for the first quarter of 2019 was $22.9 million, or $0.46 per share. This compares with a net loss for the first quarter of 2018 of $4.0 million, or $0.12 per share.

About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel family of compounds referred to as "fungerps" (antifungal triterpenoids). This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous formulations. Ibrexafungerp has demonstrated broad spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species, and is being evaluated in multiple clinical programs: the VANISH registration program for the treatment of VVC is enrolling, the Phase 3 trial for the prevention of recurrent VVC is being initiated in the second quarter of 2019, the SCYNERGIA Phase 2 trial for invasive aspergillosis (IA) and the FURI and CARES Phase 3 trials for the treatment of patients with refractory infections are ongoing. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), IA and VVC, and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.

On May 8, 2019 Perrigo Company plc (NYSE; TASE: PRGO) reported financial results for the first quarter ended March 30, 2019 (Press release, Perrigo Company, MAY 8, 2019, View Source [SID1234535963]).

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Perrigo CEO & President Murray S. Kessler commented, "Perrigo began its transformation from healthcare to consumer self-care during the first quarter of 2019, as the company made meaningful progress on portfolio reconfiguration, accelerating the innovation pipeline, pursuing close-in adjacencies, identifying significant cost savings and strengthening the organization’s talent, processes and performance plans. The leadership team and I are excited to share our Board-approved strategy and the significant progress made during the quarter against that strategy at tomorrow’s Investor Conference. Beyond the company-wide effort to initiate over 40 transformation activities, Perrigo delivered consolidated first quarter results that exceeded our internal target and included approximately $5 million in initial consumer transformation investments. It is also worth noting that our RX division was a significant contributor to this solid start to the year as a result of strong new product activity and continued moderation of pricing pressure in the generics sector."

Kessler continued, "While it will take several years and there is much work to do to fully execute the full consumer self-care transformation, I remain excited and confident in our ability to recapture ‘The Perrigo Advantage’ and bring the Company back to profitable and sustainable growth, as well as reduce the uncertainty that has arisen from the Irish and U.S. tax challenges. The Company will provide 2019 guidance tomorrow morning, before the U.S. market opens, as well as its plans to deliver long-term financial results in-line with our consumer peers."

Reporting Segments Update

The Company updated its reporting segments to align with its self-care strategy. Our Israeli diagnostic business was moved from the Consumer Self-Care International ("CSCI") segment to the RX segment and certain adjustments were made to the Company’s allocations between segments. These updates have no impact on the Company’s historical consolidated financial position, results of operations, or cash flows. A Current Report on Form 8-K containing recast quarterly and annual information for calendar years 2018, 2017, and 2016 for this update will be issued tonight.

Refer to Tables I – IV at the end of this press release for a reconciliation of non-GAAP adjustments to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Condensed Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Reported net sales for the first quarter of calendar year 2019 were approximately $1.2 billion, including new product sales of $55 million, which were partially offset by less favorable price/volume mix and discontinued products of $23 million. Net sales were down 1% excluding a $36 million negative impact from currency.

Reported net income was $64 million, or $0.47 per diluted share, versus $81 million, or $0.57 per diluted share, in the prior year. Excluding certain charges as outlined in Table I, first quarter 2019 adjusted net income was $146 million, or $1.07 per diluted share including a discrete tax benefit of $0.06 per share, versus $178 million, or $1.26 per diluted share, for the same period last year.

Consumer Self-Care Americas reported net sales were $582 million, or 3.3% lower than the prior year, driven by lower net sales in: 1) the cough and cold and analgesics categories, due to a less severe cough and cold season versus last year, 2) the infant nutrition category, due primarily to lower net sales from the exited infant foods product line (see the "Infant Foods Product line Exit" section below for details) and 3) the animal health business, due primarily to the previously announced loss of a partnered product. Discontinued products in the quarter were $11 million, of which $5 million were related to the animal health business.

Increased net sales in the gastrointestinal category, driven by strong omeprazole volumes compared to the prior year, and new product sales of $7 million partially offset the net sales decline in CSCA. Excluding net sales from the animal health and exited infant foods product line, along with unfavorable currency movements compared to the prior year, CSCA net sales were down 1.5%.

Total sales volume within the CSCA business decreased 1% in the first quarter versus the prior year as higher volumes in the gastrointestinal and allergy categories were more than offset by lower volumes in the cough and cold and analgesics categories.

Based on the most recent 52-weeks MULO data, total OTC retail market dollars grew 0.5% versus the same 52-weeks a year ago, highlighting a more limited new product launch cycle in the U.S. OTC market. Private label grew 1.4% versus national brand growth of 0.1%, according to the most recent 52-weeks MULO data. Growth in private label was driven primarily by the gastrointestinal, allergy and dermatological categories.

First quarter reported gross profit margin was 31.6%. Adjusted gross profit margin was 32.5% or 350 bps lower than the prior year due primarily to less favorable mix, greater operating inefficiencies and higher input costs versus last year.

Reported operating expenses were relatively flat year over year. Reported distribution, selling, general and administrative ("DSG&A") expenses were relatively flat compared to the prior year as greater advertising and promotional expenses versus last year were partially offset by lower distribution costs. R&D dollar investments were similar to the prior year as the Company continued to invest for future growth.

Reported operating margin was 16.2%. Adjusted operating margin was 18.3%, 400 bps lower than the prior year due primarily to adjusted gross margin flow through.

CSCI reported net sales were $351 million, 1.7% higher than the prior year, excluding unfavorable currency movement of $34 million. This segment continued to realize the benefits of the previously discussed portfolio pruning, leaving the core business primed for growth.

Strong new product sales of $26 million were driven primarily by the launch of XLS Forte 5, a next generation weight loss product within the lifestyle category, along with the launch of a natural cough syrup under the Phytosun brand. Additionally, net sales increased in the dermatological category, driven by the recent launch of the Pure Glow range of products under the ACO brand.

These positive drivers were partially offset by lower net sales in the lifestyle and personal care categories, due primarily to new product cannibalization, and the absence of net sales from discontinued products of $2 million.

According to IRI/InQvia (IMS) data, the markets in which the Company competes have produced low to mid-single-digit growth over the last 12 months, with CSCI maintaining its overall market share.

Reported and adjusted gross margin decreased 120 bps and 130 bps respectively, compared to the prior year due primarily to less favorable product mix and the unfavorable impact of foreign currency on input costs versus last year.

Reported operating expenses were lower compared to the prior year due primarily to the positive impact of foreign currency. CSCI growth investments increased on a constant currency basis versus last year as the Company continued to invest for future growth.

Reported operating margin was 2.3%. Adjusted operating margin decreased 190 bps to 15.4% due to gross margin flow through as well as increased advertising and promotion investments as a percentage of net sales partially offset by lower selling expenses versus last year.

RX reported net sales were $242 million in the quarter, or 1.8% higher than the prior year, due primarily to new product sales of $22 million and improved customer service levels. These positives were partially offset by decelerating pricing pressure in core products and discontinued products of $10 million.

Reported gross margin was 39.9%. Adjusted gross margin was 48.6%, or 260 bps lower than the prior year, due primarily to less favorable product mix versus last year.

Reported operating margin was 25.1%. Adjusted operating margin was 33.9%, or 190 bps lower than the prior year due primarily to adjusted gross margin flow through and increased R&D investments, which were partially offset by lower DSG&A expenses versus last year.

Infant Foods Product Line Exit

In 2018, the Company made the decision to exit its infant foods product line, which contributed $34 million to CSCA’s net sales in 2018. The infant foods product line contributed $5 million in net sales during the first quarter of 2019, and the Company does not expect any further contributions from this product line going forward.

Investor Day Event

The Company will hold its Investor Day tomorrow, May 9, 2019, in New York City to discuss its strategy as well as 2019 guidance and key growth opportunities. The event will feature presentations from Murray S. Kessler, CEO and President, and other members of the Company’s leadership team.

The event is scheduled to begin at 8:00 AM EST and will be webcast live. All interested parties are invited to access the event at View Source