On November 12, 2019 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three- and nine-month periods ended September 30, 2019 (Press release, Eagle Pharmaceuticals, NOV 12, 2019, View Source [SID1234551001]). Third quarter and recent highlights include:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Invested $12 million in research and development and external legal costs to advance Eagle’s pipeline.
Eagle’s Japanese marketing partner, SymBio Pharmaceuticals Limited, submitted a New Drug Application ("NDA") for TREAKISYM, bendamustine ready-to-dilute liquid formulation, in Japan in September. Approval is expected in Q4 2020, which would trigger a $5 million milestone payment to Eagle. Potential payments to Eagle could reach $10 to $25 million per year in royalties and milestones.
Advanced clinical development plans for Eagle’s innovative fulvestrant program, which has the potential to change the treatment of estrogen receptor-positive breast cancer. The program aims to determine if the unique properties of Eagle’s product will result in greater inhibition of estrogen receptors and better patient outcomes compared to currently available treatment options. The Company expects to dose the first subject in December.
Enrolled additional patients in its controlled clinical study of RYANODEX (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke ("EHS") patients during the 2019 Hajj pilgrimage held from August 9-14 in Saudi Arabia. The Company has recruited a total of 41 patients at the 2015, 2018 and 2019 Hajj pilgrimages. Eagle has submitted a plan to the U.S. Food and Drug Administration ("FDA") that proposes reviewing the data collectively for all 41 patients. If FDA agrees with this plan, Eagle plans to resubmit the NDA for EHS in response to the Complete Response Letter received in 2017.
The Company, in dialogue with FDA, has received further clarity regarding RYANODEX for the treatment of brain damage secondary to nerve agent exposure. FDA has recommended that, under the animal rule, an additional study be conducted in a second species. Eagle expects to file a supplement to the current NDA in the second half of 2020.
Total revenue for Q3 2019 was $41.1 million, compared to $51.3 million in Q3 2018, primarily reflecting lower BENDEKA royalty revenue and lower product sales of BELRAPZO and RYANODEX, partially offset by higher product sales of BENDEKA.
Q3 2019 net loss was $2.4 million, or $0.17 per basic and diluted share, compared to net income of $14.0 million, or $0.94 per basic and $0.91 per diluted share in Q3 2018.
Q3 2019 adjusted non-GAAP net income was $3.7 million, or $0.27 per basic and $0.26 per diluted share, compared to adjusted non-GAAP net income of $18.3 million, or $1.22 per basic and $1.18 per diluted share, in Q3 2018.
Cash and cash equivalents were $117.2 million, net accounts receivable was $44.8 million, and debt was $40.0 million as of September 30, 2019.
"In the third quarter, we invested over $12 million to further advance our pipeline. This includes $9 million in non-GAAP R&D expense as well as $3 million in external legal expense related to the pemetrexed and vasopressin litigations. We are advancing our pipeline, as evidenced by the news today on EHS, nerve agent and the planned initiation of our next clinical trial for fulvestrant. We are also pleased that our bendamustine program is expanding to Japan, and we are expecting $10-$25 million in annual royalty and milestone payments beginning in 2021. This is an exciting time for Eagle as we move closer to realizing the full potential of many of our late-stage products," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Third Quarter 2019 Financial Results

Total revenue for the three months ended September 30, 2019 was $41.1 million, as compared to $51.3 million for the three months ended September 30, 2018.

Royalty revenue was $26.5 million in the third quarter of 2019, compared to $35.2 million in the third quarter of 2018. BENDEKA royalties were $26.2 million in the third quarter of 2019, compared to $33.8 million in the third quarter of 2018. A summary of total revenue is outlined below:

Gross Margin was 64% during the third quarter of 2019, as compared to 75% in the third quarter of 2018. The compression in gross margin in the third quarter of 2019 was primarily driven by an increase in BENDEKA product sales to our marketing partner, on which Eagle earns no profit, and the decrease in BENDEKA royalty revenue.

R&D expense was $10.2 million for the third quarter of 2019, compared to $6.0 million in the third quarter of 2018. The increase is largely attributable to spending on fulvestrant and vasopressin. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the third quarter of 2019 was $9.0 million.

SG&A expense in the third quarter of 2019 increased to $18.5 million compared to $13.9 million in the third quarter of 2018. External legal spend associated with litigation on pemetrexed and vasopressin as well as higher stock compensation expense account for the year-over-year increase. Excluding stock-based compensation and other non-cash and non-recurring items, third quarter 2019 SG&A expense was $13.4 million.

Net loss for the third quarter of 2019 was $2.4 million, or $0.17 per basic and diluted share, compared to net income of $14.0 million, or $0.94 per basic and $0.91 per diluted share, in the third quarter of 2018, due to the factors discussed above.

Adjusted non-GAAP net income for the third quarter of 2019 was $3.7 million, or $0.27 per basic and $0.26 per diluted share, compared to adjusted non-GAAP net income of $18.3 million or $1.22 per basic and $1.18 per diluted share in the third quarter of 2018. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

2019 Expense Guidance

R&D spend in 2019, on a non-GAAP basis, is expected to be $32.0-$36.0 million, as compared to $38.0 million in 2018.
SG&A spend in 2019, on a non-GAAP basis, is expected to be $51.0-$54.0 million, as compared to $43.0 million in 2018.
The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.

Liquidity

As of September 30, 2019, the Company had $117.2 million in cash and cash equivalents plus $44.8 million in net accounts receivable, $34.4 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $40.0 million in outstanding debt. Therefore, at September 30, 2019, the Company had net cash plus receivables of $122.0 million.

Conference Call

As previously announced, Eagle management will host its third quarter 2019 conference call as follows:

Date

Tuesday, November 12, 2019

Time

8:30 A.M. EST

Toll free (U.S.)

866-342-8591

International

203-518-9713

Webcast (live and replay)

www.eagleus.com, under the "Investor + News" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-4577 (US) or 402-220-2682 (International) and entering conference call ID EGRXQ319. The webcast will be archived for 30 days at the aforementioned URL.

On November 12, 2019 NANOBIOTIX (Paris:NANO) (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’) reported promising results from its pre-clinical collaboration1 with The University of Texas MD Anderson Cancer Center (Press release, Nanobiotix, NOV 12, 2019, View Source [SID1234551000]). The research, which evaluated first-in-class radioenhancer NBTXR3 activated by radiation therapy in combination with anti-PD-1 and anti-CTLA-4 immune checkpoint inhibitors, was presented last week at the 2019 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Combination of a radiation-enhancing nanoparticle, radiotherapy, and immune checkpoint inhibitors for treating metastasized lung cancer in mice – SITC (Free SITC Whitepaper) 2019 Poster – 508
Yun Hu1, Sébastien Paris2, Hampartsoum B. Barsoumian1, Mark Wasley1, Ahmed Younes1, DaweiChen1, Liang P. Yang1, Fatemeh Masrorpour1, Maria Angelica Cortez1, James W. Welsh1
1 Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
2 Nanobiotix, Department of Translational Science, Paris, France

This pre-clinical research studied NBTXR3 activated by radiation therapy in combination with anti-PD-1 in immunocompetent mice bearing an anti-PD-1 resistant tumor on each flank—only one tumor on each mouse was irradiated. According to the data from this model, the combination treatment that included NBTXR3 and anti-PD-1 increased local control of the irradiated tumor, generated a marked abscopal effect, decreased the number of spontaneous lung metastases, and significantly increased survival when compared to other treatments in the study including anti-PD-1 combined with radiation therapy alone.

The results also show that the combination that included NBTXR3 and anti-PD-1 has the potential to achieve an equivalent abscopal effect at a lower dose of radiation. This opens the possibility for radiation de-escalation, meaning the amount of radiation therapy could be reduced without decreasing efficacy.

Additionally, the study included an in vivo RadScopal model where the second tumor received a low dose of radiation while the first tumor received a full dose. In the RadScopal model, researchers evaluated NBTXR3 activated by radiation therapy combined with anti-PD-1 and anti-CTLA-4. The data show that this combination triggered superior local control along with significant increases in abscopal effect and survival when compared to all other tested combinations. Several complete responses were observed in the second tumor of the group that received the NBTXR3 combination while none were observed in the other groups.

These results could pave the way for the use of NBTXR3 to improve treatment outcomes for immuno-oncology patients, including checkpoint inhibitor non-responders.

About NBTXR3

NBTXR3 is a first-in-class product designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers.

NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or oropharynx in elderly and frail patients unable to receive chemotherapy or cetuximab with limited therapeutic options. Promising results have been observed in the phase I/II trial regarding local control. In the United States, based on discussions with the Food and Drug Administration (FDA) that occurred in the first half of 2019, the Company plans to begin the clinical trial authorization process in the second half of 2019 and commence a phase II/III clinical trial in locally advanced head and neck cancers.

Nanobiotix is also running an Immuno-Oncology development program. The Company received approval FDA to launch a clinical trial of NBTXR3 activated by radiotherapy in combination with anti-PD-1 antibodies in locoregional recurrent (LRR) or recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) and lung or liver metastasis (mets) with HNSCC not amenable to re-irradiation or non-small cell lung cancer (NSCLC) as the primary tumor .

The other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma. Furthermore, the company has a large-scale, comprehensive clinical research collaboration with MD Anderson (9 new phase I/II clinical trials in the United States) to evaluate NBTXR3 across head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.

On November 12, 2019 Oncology Venture A/S ("OV" or the Company) reported an update on the progress of its ongoing U.S. Phase 2 clinical trial for its PARP inhibitor, 2X-121, for the treatment of ovarian cancer, sited at the Dana-Farber Cancer Institute (Boston, MA, U.S.A.) (Press release, Oncology Venture, NOV 12, 2019, View Source [SID1234550999]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The cancer drug 2X-121 (formerly E7449) is a small molecule, targeted inhibitor of Poly ADP-Ribose Polymerase (PARP), a key DNA damage repair enzyme active in cancer cells, which was originally developed by the pharmaceutical company Eisai. The company has recently announced this drug as one of its top priority programs.

2X-121 is currently being evaluated for the treatment of advanced ovarian cancer in a DRP-guided Phase 2 clinical trial at the Dana-Farber Cancer Institute (Boston, MA U.S.A.). Thus far, 8 patients are enrolled in the study, with ongoing enrollment towards a target of 30 patients. The Company is opening a second trial site, at Guy’s Hospital (London, UK) to accelerate patient accrual to the trial. Guy’s Hospital was the site of the prior Phase 1 study of 2X-121 under sponsorship by Eisai. Through use of DRP patient selection, OV aims to provide a superior clinical benefit, to ovarian cancer patients receiving 2X-121, as compared to other approved PARP inhibitors. The global PARP inhibitor market is projected to reach USD 9 billion by 2027 in ovarian cancer.

Steve R. Carchedi, CEO of Oncology Venture, commented "We are excited to announce the ongoing progress of our key Phase 2 clinical trial for 2X-121 at one of the world’s leading cancer and personalized medicine centers. The approval and use of PARP inhibitors for the treatment of a variety of cancers is an exciting area that is rapidly expanding, and we are confident our Phase 2 study will prove the merits of our drug, together with its DRP companion diagnostic, as we advance towards approval and commercialization of this priority asset in our pipeline."

On November 12, 2019 KemPharm, Inc. (Nasdaq:KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, reported that the Company will host a conference call and live audio webcast on Thursday, November 14, 2019, at 5:30 p.m. ET, to discuss its corporate and financial results for the third quarter 2019 (Press release, KemPharm, NOV 12, 2019, View Source [SID1234550998]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Conference Call Information:
Interested participants and investors may access the conference call by dialing either:

(866) 395-2480 (U.S.)
(678) 509-7538 (international)
Conference ID: 8076615
An audio webcast with slide presentation will be accessible via the Investor Relations section of the Company’s website View Source An archive of the webcast and presentation will remain available for 90 days beginning at approximately 6:30 p.m. ET, on November 14, 2019.

On November 12, 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 September 30, 2019, and provided an update on recent clinical developments (Press release, Scynexis, NOV 12, 2019, View Source [SID1234550997]). 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 first agent approved for the treatment of VVC and prevention of recurrent VVC and the only oral alternative to azoles.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are thrilled with the positive top-line results from the VANISH-303 study and are increasingly confident in an anticipated NDA submission for the treatment of VVC next year as we work to bring ibrexafungerp, potentially the first new class of antifungals approved in over 20 years, to patients in need," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We believe the VVC market is quite large and underserved by existing agents, with only one FDA-approved oral drug in the market, which has lacked innovation since the introduction of fluconazole in the 1990s. We’re confident in the commercial potential of ibrexafungerp given its differentiated attributes as a new oral, non-azole antifungal and the eagerness of women with VVC and their treating physicians to try new therapies."

Dr. Taglietti continued: "We are also enthusiastically advancing our hospital-based development programs of ibrexafungerp as a novel treatment to fight invasive, increasingly drug-resistant and often life-threatening fungal infections, such as Candida auris. As part of this effort, we recently announced the expansion of our FURI protocol to a broader range of refractory, serious fungal infections that are potentially eligible for a limited-population FDA approval under the LPAD regulatory pathway. Given the robust evidence collected to date across all of our programs, we believe ibrexafungerp can have the same positive impact fluconazole had when it was first introduced nearly 30 years ago, leveraging ibrexafungerp’s versatility and strong attributes in many different treatment settings – from women’s health with VVC to deadly, hospital-based infections."

Ibrexafungerp Update

Positive top-line data reported for the first of two studies in the VANISH Phase 3 program evaluating the safety and efficacy of oral ibrexafungerp (300mg BID for one day) versus placebo as a treatment for women with VVC
SCYNEXIS recently announced positive results from the VANISH-303 study, a Phase 3, randomized, double-blind, placebo-controlled, study that enrolled 376 patients at 28 U.S. centers. These results were reported earlier than originally anticipated due to rapid enrollment in the study.
The primary endpoint required for registration is clinical cure, defined as complete resolution (score of 0) of all signs and symptoms (S&S) at the Day-10 test-of-cure (TOC) visit. The observed clinical cure for ibrexafungerp was 50.5%, showing highly statistically significant superiority to placebo (p=0.001). Mycological eradication (secondary endpoint) at TOC in ibrexafungerp patients was 49.5%, also showing superiority to placebo (p<0.001). Clinical improvement (S&S score of 0 or 1) at TOC, another secondary endpoint that is a clinically relevant assessment of treatment response, was achieved in 64.4% of ibrexafungerp patients (p<0.001 against placebo). The VANISH-303 ibrexafungerp efficacy results confirm results observed in the Phase 2b DOVE study and achieve the superiority versus placebo required for regulatory approval.
Oral ibrexafungerp was generally safe and well tolerated. Severe and serious adverse events (AEs) were rare, with more cases reported in the placebo group than the ibrexafungerp group, and there were no drug-related serious AEs. The majority of Treatment-Emergent AEs (TEAEs) observed at a higher frequency in the ibrexafungerp group were gastrointestinal in nature, with the three most common GI events (diarrhea/loose stool, nausea and abdominal pain) occurring at rates of 25.5%, 16.6% and 7.3%, respectively, similar to the rates seen in the Phase 2b DOVE study. These events were predominantly regarded as mild, of short duration and did not lead to discontinuation.
A second global Phase 3 study (VANISH-306), with identical design, is being conducted in the U.S. and Europe. Enrollment continues to progress rapidly, and the Company anticipates top-line data early in the second quarter of 2020. The combined results from the VANISH-303 and VANISH-306 pivotal studies are expected to provide the safety and efficacy data to support a New Drug Application (NDA) for ibrexafungerp for the treatment of VVC, with submission to the U.S. Food and Drug Administration (FDA) planned in the second half of 2020.

Ongoing enrollment in Phase 3 CANDLE study evaluating the safety and efficacy of oral ibrexafungerp versus placebo for the prevention of recurrent VVC
The CANDLE study is a global Phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of oral ibrexafungerp (300mg BID for one day, given once per month for a total of six treatment days) compared to placebo in female patients with recurrent VVC (defined as three or more episodes of VVC in the past 12 months, including the episode at screening). The study is being conducted at approximately 50 sites and is expected to enroll approximately 320 patients. Pending a positive outcome, the Company anticipates filing a supplemental NDA for the prevention of recurrent VVC with the FDA in 2021.

Continued advancement of oral ibrexafungerp for hospital-based, invasive fungal infections with two Phase 3 studies (FURI in refractory infections and CARES in Candida auris infections) and one Phase 2 study in invasive aspergillosis (SCYNERGIA)
The protocol for the FURI study, investigating the safety and efficacy of oral ibrexafungerp as a salvage treatment for patients with resistant or refractory severe fungal infections, was expanded to include a broader range of infections. Under the amended study design, patients with aspergillosis, coccidioidomycosis, histoplasmosis, blastomycosis and infections caused by other emerging fungi, including yeasts and molds, are now eligible for enrollment along with those suffering from Candida infections. Additionally, the maximum allowed duration of treatment with ibrexafungerp has been extended from 90 days to up to 180 days, as needed, for chronic conditions. Ibrexafungerp will also be available as a combination therapy with standard of care for selected patients.
Continued and expanded patient enrollment is expected to support future NDA submissions and potential approval through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). The Company anticipates reporting a second interim data review from the FURI study by an independent data review committee in the first quarter of 2020.
Enrollment is ongoing for the CARES and SCYNERGIA studies.

Data presented at 3rd International Society of Infectious Diseases in Obstetrics and Gynecology (ISIDOG), IDWeek 2019 and the 9th Congress on Trends in Medical Mycology (TIMM-9) further highlighting the scientific and clinical evidence of ibrexafungerp’s activity against multiple fungal pathogens
Post-hoc data from the Phase 2b DOVE study presented at ISIDOG 2019 highlighted ibrexafungerp’s improved trend in signs and symptoms versus fluconazole on a per patient basis.
Data presented at IDWeek 2019 highlighted a large body of evidence demonstrating the activity and efficacy of ibrexafungerp against Candida auris, both in vivo and in vitro.
In an oral presentation at TIMM-9, studies demonstrating ibrexafungerp’s broad spectrum of activity against Candida, Aspergillus, and Pneumocystis were presented, along with evidence of its activity against resistant organisms and ibrexafungerp’s potential utility for the treatment of hospital-based resistant and refractory fungal infections. Additional posters presented provided in vitro, in vivo and clinical evidence of ibrexafungerp’s broad utility against multiple fungal pathogens.
Corporate Highlight

SCYNEXIS received notification from the State of New Jersey of its available unused Net Operating Losses (NOLs) and R&D credits and expects to receive approximately $3.3 million in cash by the end of 2019.
The New Jersey Economic Development Authority’s (NJEDA) Technology Business Tax Certificate Transfer (NOL) Program allows eligible companies to sell their New Jersey NOLs and research and development tax credits up to a maximum lifetime benefit of $15 million per company. This may be the second non-dilutive NOL-related cash injection through the NJEDA for SCYNEXIS. In January 2019, SCYNEXIS announced the receipt of approximately $6.7 million of net cash proceeds through the sale of unused New Jersey NOLs.
Third Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments totaled $28.1 million as of September 30, 2019, with net working capital of $20.9 million. Based upon its existing operating plan, SCYNEXIS believes its existing cash, cash equivalents, short-term investments, and the sale of a portion of its New Jersey NOLs, may enable SCYNEXIS to fund operating requirements past an anticipated NDA submission for acute VVC in the second half of 2020.

Research and development expenses increased to $9.3 million for the quarter ended September 30, 2019, compared to $3.9 million in the third quarter of 2018. The increase of $5.3 million, or 136%, was primarily driven by an increase of $4.1 million in clinical development costs, an increase of $0.7 million in chemistry, manufacturing, and controls (CMC) costs, and a net increase in other research and development costs of $0.5 million.

Selling, general and administrative expenses in the third quarter of 2019 increased to $2.5 million, compared with $2.4 million in the third quarter of 2018.

Total other income decreased to $3.8 million in the third quarter of 2019, compared to $6.7 million in the third quarter of 2018. The decrease in other income is attributable to a $6.9 million non-cash gain recorded on the fair value adjustment of the warrant liabilities during the third quarter of 2018.

Net loss for the third quarter of 2019 was $7.9 million. This compares with net income for the third quarter of 2018 of $0.4 million.

About Ibrexafungerp
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 intravenous (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 invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and VVC (including prevention of recurrent VVC) and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.