On August 9, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported recent business highlights and financial results for the second quarter and first half of 2018 (Press release, BeiGene, AUG 9, 2018, View Source;p=irol-newsArticle&ID=2363005 [SID1234528592]).

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"We continued to make excellent progress with encouraging new clinical data, including initial topline data from pivotal trials for our lead drug candidates, zanubrutinib and tislelizumab," said John V. Oyler, Founder, Chief Executive Officer and Chairman of BeiGene. "We have also continued to expand our clinical programs and have now enrolled more than 3,000 patients worldwide in over 50 ongoing or planned clinical trials, including 17 pivotal or potentially registration-enabling trials of our drug candidates, with two new Phase 3 trials in China of tislelizumab in first-line non-small cell lung cancer having recently initiated. We are on track to submit new drug applications for zanubrutinib and tislelizumab in China this year and are planning to accelerate the U.S. NDA filing of zanubrutinib by seeking accelerated approval."

"Our commercial organization in China is expanding its footprint to prepare for potential new product launches, and we have seen good growth of our commercial product revenue in China since the transition of these products to BeiGene since last September," said Dr. Xiaobin Wu, General Manager of China and President of BeiGene, Ltd.

Recent Business Highlights and Upcoming Milestones

Clinical Programs

Zanubrutinib (BGB-3111), an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK)

Received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with Waldenström macroglobulinemia (WM);
Announced plans to submit a New Drug Application (NDA) with the FDA in the first half of 2019 to pursue accelerated approval of zanubrutinib for WM based on the results from the ongoing global Phase 1 trial. A final determination to submit the NDA will be made subsequent to the pre-NDA meeting with the FDA after obtaining mature data from the trial this fall;
Announced preliminary topline data from the independent review of response data from the 86-patient single-arm pivotal Phase 2 trial of zanubrutinib in Chinese patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). With a median follow-up time of 8.3 months at the data cutoff, the overall response rate was 84 percent, including 59 percent complete response;
Completed enrollment in the global Phase 3 trial comparing zanubrutinib to ibrutinib in patients with WM; and
Presented clinical data at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), including updated Phase 1 data from patients with WM and pooled safety data from zanubrutinib monotherapy trials.
Expected Upcoming Milestones in 2018

Submit first NDA in China for MCL later this year;
Present full results of the pivotal Phase 2 trial in Chinese patients with R/R MCL at an upcoming major medical conference;
Initiate a global head-to-head Phase 3 trial versus ibrutinib in R/R chronic lymphocytic leukemia; and
Present updated Phase 1 monotherapy or combination data at medical conferences.
Tislelizumab (BGB-A317), an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1

Announced preliminary topline results from the independent review of response data from the pivotal Phase 2 trial of tislelizumab in 70 Chinese patients with R/R classical Hodgkin’s lymphoma (cHL). With a minimum of 24 weeks of follow-up and a median follow-up time of 7.85 months at the data cutoff, overall response rate was 85.7 percent, including 61.4 percent complete response;
Completed the dose-escalation phase of the combination trial with zanubrutinib in patients with B-cell malignancies and initiated the dose- expansion phase in 8 patients; and
Initiated the following trials:
Phase 3 trial in China of tislelizumab combined with chemotherapy, as a potential first-line treatment in patients with Stage IIIB or IV non-squamous non-small cell lung cancer (NSCLC); and
Phase 3 trial in China of tislelizumab combined with chemotherapy as a potential first-line treatment in patients with Stage IIIB or IV squamous NSCLC.
Expected Upcoming Milestones in 2018

Submit NDA in China for cHL later this year;
Complete enrollment in the Phase 2 pivotal trial in China for urothelial carcinoma;
Present updated Phase 1 data and China pivotal trial data at a medical conference; and
Initiate additional pivotal trials in 2018 or early 2019.
Pamiparib (BGB-290), an investigational small molecule PARP inhibitor

Initiated the following trials:
Global Phase 3 trial as maintenance therapy in patients with inoperable locally advanced or metastatic gastric cancer who responded to platinum-based first-line chemotherapy;
Phase 3 trial as maintenance therapy in China in patients with platinum-sensitive recurrent ovarian cancer; and
Phase 2 trial in China in patients with metastatic HER2-negative breast cancer with BRCA mutation.
Expected Upcoming Milestones in 2018

Present updated Phase 1 monotherapy and/or combination data at a medical conference.
Sitravatinib, an investigational tyrosine kinase inhibitor of receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET; licensed from Mirati Therapeutics in Asia (excluding Japan), Australia, and New Zealand

Expected Upcoming Milestones

Initiate Phase 1 trial in combination with tislelizumab in China in 2018 or early 2019.
BGB-A425, an investigational humanized monoclonal antibody against T-cell immunoglobulin and mucin-domain containing-3(TIM-3)

Received clearance for an investigational new drug (IND) application in the United States.
Expected Upcoming Milestones in 2018

Initiate Phase 1/2 trial investigating the safety, tolerability, pharmacokinetics and preliminary antitumor activity in combination with tislelizumab in patients with advanced solid tumors.
Commercial Programs

Generated 35% increase in quarter-over-quarter revenue from sales in China of ABRAXANE, REVLIMID and VIDAZA, and 101% growth vs. the fourth quarter of 2017, the first full quarter following the license of these products from Celgene.

Continued to expand potential patient access to ABRAXANE (nanoparticle albumin-bound paclitaxel) in China through inclusion in the provincial reimbursement drug list in Hunan and critical illness insurance in Shandong.
Corporate Developments

Completed an initial public offering as a dual primary listing on the Main Board of the Hong Kong Stock Exchange and a global offering in which we raised approximately $903 million in gross proceeds;
Appointed Vivian Bian as China Co-Commercial Head, with strategic focus on marketing, strategy, new product introductions and business model innovation; and
Continued the construction of the Guangzhou biologics manufacturing facility with the state-of-the-art KuBio prefabricated biomanufacturing equipment delivered by General Electric. The first phase of the facility is expected to be completed and operational in 2019.
Second Quarter 2018 Financial Results

Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $1,401.22 million as of June 30, 2018, compared to $1,481.48 million as of March 31, 2018 and $837.52 million at December 31, 2017. Cash, cash equivalents, restricted cash and short-term investments as of June 30, 2018 include approximately $145.28 million held by our 95%-owned joint venture, BeiGene Biologics, to build a commercial biologics manufacturing facility under construction in Guangzhou, China, and restricted cash of $31.59 million related to BeiGene Biologics’ secured deposits. In the quarter, BeiGene Biologics received $42.32 million in proceeds from a new long-term loan with China Construction Bank for the continued construction of the manufacturing facility.

Cash used by operations for the three months ended June 30, 2018 was $117.14 million, compared to $51.89 million for the same period in 2017. The increase in the use of cash was primarily attributable to the continued ramp-up in operating expenses in support of our ongoing and newly initiated late-stage pivotal clinical programs, preparation for regulatory filings and commercial launch of our late-stage drug candidates, and organizational growth. Capital expenditures for the three months ended June 30, 2018 were $10.61 million, compared to $13.62 million for the same period in 2017. The decrease was primarily attributable to the purchase in the prior year period of the land use right in Guangzhou.

Revenue for the three months ended June 30, 2018 were $52.80 million, compared to nil in the same period in 2017, primarily attributable to product and collaboration revenue under our collaboration with Celgene.

Product revenue from sales of ABRAXANE, REVLIMID and VIDAZA in China totaled $31.43 million for the second quarter of 2018.
Collaboration revenue totaled $21.38 million for the second quarter of 2018, reflecting $18.18 million of research and development reimbursement revenue from Celgene, $1.70 million of research and development service revenue from deferred recognition of upfront fees, and $1.50 million of milestone revenue under the collaboration agreement for pamiparib with Merck KGaA, Darmstadt, Germany.
Expenses for the three months ended June 30, 2018 were $215.85 million, compared to $58.02 million in the same period in 2017, consisting primarily of the following:

Cost of sales for the three months ended June 30, 2018 were $6.26 million, compared to nil in the second quarter of 2017. Cost of sales relates to the cost of acquiring ABRAXANE, REVLIMID and VIDAZA for distribution in China.

R&D Expenses for the three months ended June 30, 2018 were $164.25 million, compared to $47.25 million in the same period in 2017. The increase in R&D expenses was primarily attributable to increased spending on our ongoing and newly initiated late-stage pivotal clinical trials, preparation for regulatory filings and commercial launch of our late-stage drug candidates, manufacturing costs related to pre-commercial activities and supply as well as increases in spending related to our preclinical-stage programs. The overall increase in R&D expenses was also attributable to increased R&D-related employee compensation expense, which was $10.72 million for the three months ended June 30, 2018, compared to $4.75 million for the same period in 2017, due to increased headcount and a higher share price.

SG&A Expenses for the three months ended June 30, 2018 were $45.16 million, compared to $10.78 million in the same period in 2017. The increase in SG&A expenses was primarily attributable to increased headcount, including the expansion of our commercial team to support the distribution of our existing commercial products in China and the potential launches of our late-stage drug candidates, higher professional service fees and costs to support our growing operations, and higher SG&A-associated share-based compensation expense which was $7.92 million for the three months ended June 30, 2018, compared to $2.33 million for the same period in 2017, due to increased headcount and a higher share price.

Net Loss for the second quarter of 2018 was $156.89 million, or $2.92 per American Depositary Share (ADS), compared to a net loss of $60.55 million, or $1.52 per ADS in the same period in 2017. For the second quarter of 2018, net loss per ordinary share was $0.22, compared to $0.12 in the same period in 2017.

On August 9, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the first patient was dosed in a Phase 3 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, combined with chemotherapy, as a potential first-line treatment in China for patients with Stage IIIB or IV squamous non-small cell lung cancer (NSCLC) (Press release, BeiGene, AUG 9, 2018, View Source;p=irol-newsArticle&ID=2363006 [SID1234528591]).

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Tislelizumab is also being studied in global Phase 3 trials in solid tumors, including second-line NSCLC, first-line hepatocellular carcinoma, and second-line esophageal squamous cell carcinoma; two global Phase 2 trials in previously treated advanced hepatocellular carcinoma and relapsed/refractory mature T- and natural killer-cell lymphomas; a Phase 3 trial in China in non-squamous NSCLC; and two pivotal Phase 2 trials in China in relapsed/refractory classical Hodgkin’s lymphoma and second-line urothelial cancer.

"With the start of this important Phase 3 trial in China for patients with squamous NSCLC, our broad development program for tislelizumab, an advanced immuno-oncology therapy, continues to make great progress in China and globally. More than 1,500 patients have been enrolled in clinical trials with tislelizumab over the past three years, and we are excited to evaluate its potential when combined with both paclitaxel and carboplatin, the worldwide standard of care, or nab-paclitaxel (ABRAXANE) and carboplatin, a newer regimen which has not yet gained approval in China but is approved in other geographies," commented Amy Peterson, M.D., Chief Medical Officer for Immuno-Oncology at BeiGene.

"Despite some recent developments, available data indicate that outcomes in patients with squamous NSCLC may be worse than those in patients with other forms of lung cancer. As shown by most recent data with other checkpoint inhibitors, combining immunotherapy and chemotherapy consisting of platinum and paclitaxel or nab-paclitaxel improves anti-tumor activity and significantly improves outcomes for patients with advanced squamous NSCLC. This Phase 3 study, in addition to our Phase 3 first line trial in China for patients with non-squamous NSCLC, will assess the impact of tislelizumab given in combination with chemotherapy, as a potential way to improve outcomes in Chinese patients with advanced lung cancer, for whom prognoses are typically quite poor," commented Lai Wang, Ph.D., Head of China Development at BeiGene.

The Phase 3, open-label, multi-center trial is expected to enroll approximately 340 chemotherapy naïve patients with Stage IIIB or IV squamous NSCLC in mainland China who will be randomized to receive i) carboplatin and paclitaxel, ii) carboplatin, paclitaxel and tislelizumab, or iii) carboplatin, nab-paclitaxel (ABRAXANE, which is commercialized by BeiGene in China) and tislelizumab. The trial is designed to compare progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) per RECIST v1.1. Key secondary endpoints include overall survival, overall response rate, duration of response, PFS by investigator assessment, and safety and tolerability.

For more information about the trial, patients and physicians should email BeiGene at [email protected].

About Non-Small Cell Lung Cancer

In China, there were an estimated 733,300 new cases of lung cancer in 2015.[1] Lung cancer is the leading cause of cancer-related death in both men and women, with an estimated 610,200 deaths in China in 2015.[1] According to the American Cancer Society, about 80 to 85 percent of lung cancers are non-small cell lung cancer (NSCLC) and there are three main subtypes: adenocarcinoma, squamous cell (epidermoid) carcinoma and large cell (undifferentiated). For patients with advanced NSCLC, five-year survival rates are approximately 26 percent for Stage IIIB, 10 percent for Stage IVA, and 1 percent for Stage IVB.[2]

About Tislelizumab

Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. Discovered by BeiGene scientists in Beijing, tislelizumab is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is potentially differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells, based on preclinical data. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).

On August 9, 2018 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, reported financial results for the second quarter ended June 30, 2018 and provided a summary of recent events (Press release, Regulus, AUG 9, 2018, View Source [SID1234528589]).

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Second Quarter 2018 and Recent Updates

Corporate Updates

Corporate restructuring: In July 2018, the Company announced a corporate restructuring and workforce reduction of approximately 60% in order to focus its pipeline and extend its cash runway, the activities of which have been substantially completed. In connection with the restructuring, the Company expects to record net charges of approximately $0.8 million for employee severance and other related termination benefits. As a result of the restructuring, the Company’s annual cash burn is expected to be reduced by approximately 50% by year-end, inclusive of debt service costs.
Pipeline Updates

RGLS4326 for autosomal dominant polycystic kidney disease (ADPKD): As previously announced, due to unexpected observations in its 27-week mouse chronic toxicity study, and in consultation with FDA, the Company plans to initiate a new mouse chronic toxicity study with certain changes that are believed to address the unexpected observations. Importantly, RGLS4326 has been generally safe and well-tolerated in humans in the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) studies to date. The Company has voluntarily paused dosing in the Phase 1 MAD study, pending results from the new chronic mouse toxicity study.
Advancement of Hepatitis B virus (HBV) Programs: The Company has determined that advancing its preclinical programs targeting HBV, which affects an estimated 350 million people worldwide, represents the most attractive investment opportunity in its preclinical pipeline. Regulus has identified multiple microRNA targets that serve as host factors for the virus. Targeting host factors with GalNAc-conjugated oligonucleotides directed to the liver represents a potentially attractive approach to treating the disease. Regulus and others have already demonstrated effective delivery to the liver with this technology, and Regulus has demonstrated human proof-of-concept (POC) with this approach previously with a program targeting the Hepatitis C virus. The Company currently expects to file an IND for the HBV program in H2 2019, with the potential of achieving human POC in a Phase 1 study.
RG-012 Program in Alport syndrome: In July 2018, the Company announced it had paused recruitment activities for the RG-012 program in Alport syndrome while it undertook discussions with Sanofi to potentially restructure the partnership. The Company also announced that preliminary results from the first patients through the renal biopsy study were encouraging with kidney tissue concentrations achieved that would be predictive of therapeutic benefit based on animal disease models. In addition, modulation of the target, miR-21, was observed.
Financial Updates

Amendment to Term Loan: In August 2018, the Company and Oxford entered into an amendment to the Term Loan, providing for an additional three-month interest-only period, commencing August 2018 through October 2018. Under the previous terms of the Term Loan, principal payments were due over this 3-month period totaling $2.5 million. Amortization payments will recommence in November 2018. The amendment contains a minimum cash reserve covenant, in addition to a security interest in our intellectual property as additional collateral for the repayment of the Term Loan. In the event we reduce the principal balance of the Term Loan to $10.0 million or less on or before November 1, 2018, the cash reserve covenant described above would no longer apply. There were no changes to the maturity date of the Term Loan, which is June 2020.
"The recent period has been highlighted by a challenging set of circumstances and unexpected setbacks, however we remain committed to our specific near-term objectives, namely coming to an agreement with Sanofi concerning the development of the Alport syndrome program, advancing our investigative and preclinical work on RGLS4326 to enable the Phase 1 MAD to resume, advancing our HBV programs, extending our cash runway, and looking for additional ways to improve shareholder value," said Jay Hagan, President and Chief Executive Officer of Regulus.

Financial Results

Cash Position: As of June 30, 2018, Regulus had cash, cash equivalents and short-term investments of $32.9 million.

Research and Development (R&D) Expenses: R&D expenses were $10.0 million and $21.8 million for the three and six months ended June 30, 2018, respectively, compared to $14.3 million and $30.0 million for the same periods in 2017. The decreases were primarily attributable to reductions in program-related spend for RG-101 and RGLS5040, as these programs were discontinued in 2017, in addition to reductions in personnel-related costs.

General and Administrative (G&A) Expenses: G&A expenses were $3.3 million and $7.1 million for the three and six months ended June 30, 2018, respectively, compared to $7.1 million and $11.0 million for the same periods in 2017. The decreases were primarily attributable to non-recurring severance and non-cash stock-based compensation charges in Q2 2017.

Net Loss: Net loss was $13.8 million, or $0.13 per share (basic and diluted), and $29.9 million, or $0.29 per share (basic and diluted), for the three and six months ended June 30, 2018, respectively, compared to $21.6 million, or $0.41 per share (basic and diluted), and $41.6 million, or $0.78 per share (basic and diluted), for the same periods in 2017.

On August 9, 2018 Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing and developing proprietary liquid biopsy tests that provide clinically actionable information to physicians to improve cancer treatment, reported that it will release financial results for the three and six months ended June 30, 2018, after the market closes on Tuesday, August 14, 2018 (Press release, Biocept, AUG 9, 2018, View Source [SID1234528588]). The Company will host a conference call for the investment community to discuss the results and answer questions at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).

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Individuals interested in participating on the conference call may do so by dialing (855) 656-0927 for domestic callers, (855) 669-9657 for Canadian callers, or (412) 902-4109 for other international callers. Those interested in listening to a webcast of the live conference call may do so by visiting View Source

A replay of the conference call will be available for 48 hours following the conclusion of the call by dialing (877) 344-7529 for domestic callers, (855) 669-9658 for Canadian callers, or (412) 317-0088 for other international callers, and entering the replay access code 10122826. A webcast replay will be available for 90 days at http://ir.biocept.com/events.cfm.

On August 9, 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 June 30, 2018, and provided an update on recent operational and clinical developments (Press release, Scynexis, AUG 9, 2018, View Source [SID1234528587]).

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"With the positive results from our Phase 2b DOVE study in vulvovaginal candidiasis (VVC), we achieved a meaningful milestone in our efforts to make ibrexafungerp available to patients in need and to bring to market the first new antifungal class in nearly 20 years," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "While we continue to face challenges with the development of our IV formulation, we are pleased with the advancement and further de-risking of oral ibrexafungerp, which has the potential to address unmet medical needs in a variety of severe infections and improve the lives of patients."

Ibrexafungerp (formerly SCY-078) Update

600mg Oral Dose of Ibrexafungerp Identified for Phase 3 VVC Development; Phase 3 On Track for Initiation in the Fourth Quarter of 2018, with Potential NDA Filing in 2020.
In July 2018, SCYNEXIS reported positive top-line data from the Phase 2b DOVE study evaluating several dose regimens of oral ibrexafungerp for the treatment of VVC, compared to fluconazole (FLU), the standard of care for VVC. The 600mg dose of ibrexafungerp was well-tolerated, with strong overall clinical and mycological activity and improved sustained effect compared to FLU.
Pending the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), we believe the 600mg dose of ibrexafungerp for one day (given as two doses of 300mg 12 hours apart) is the optimal dose regimen. We intend to use this dose in the VVC Phase 3 registration program, on track for initiation in the fourth quarter of 2018, and, pending successful completion of this trial, we anticipate filing an initial NDA for the treatment of VVC in 2020. Ibrexafungerp may represent the first new oral treatment for this indication in 25 years, and we believe it may provide significant benefits for the large number of patients not well-served by existing therapies.
Development Delay with IV Formulation of Ibrexafungerp. In January 2018, we announced encouraging pre-clinical results for the prototype liposomal IV formulation of ibrexafungerp, showing improved local tolerability profile at the infusion site in head-to-head pre-clinical evaluations with the cyclodextrin-based IV formulation. As part of our development plans, the process for the liposomal formulation was transferred for scale-up purposes at a manufacturing site intended to provide clinical supplies. Additional preclinical evaluations were performed with the scaled-up formulation, which unexpectedly revealed differences in tolerability at the injection site, delaying advancement of the IV product into human trials. As it is generally recognized that changes to manufacturing processes and/or scale-up can impact the characteristics of drug products, particularly for more technically complex formulations such as liposomal products, we are currently working with our vendors and CMC experts to enable us to resume the pre-IND pre-clinical activities for the IV formulation of ibrexafungerp.
Continued Progress on Company’s Strategy to Expand the Use of Ibrexafungerp in Indications Where the Oral Formulation is a Viable Treatment Option to Address Significant Unmet Needs.
Initiation of Phase 2 Combination Study Testing Oral Ibrexafungerp in Invasive Aspergillosis on Track for this Quarter. Encouraged by the improved outcomes and survival rates seen in an animal model of pulmonary aspergillosis, we plan to start a study in patients with invasive aspergillosis (IA) in the third quarter of 2018. The study will assess the safety and efficacy of oral ibrexafungerp in combination with azole therapy, the standard of care for this indication.
Open-label FURI and CARES Studies Ongoing with Preliminary Data Review Planned for the Fourth Quarter of 2018. These studies are designed to enroll patients with a wide range of Candida spp. infections with limited or no treatment options and are designed for potential expedited regulatory approval via the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).
SCY-078 Granted "Ibrexafungerp" as Non-proprietary Name by WHO. In assigning ibrexafungerp as the generic name of SCY-078, the World Health Organization (WHO) incorporated a novel stem (-fungerp), recognizing ibrexafungerp as the first member of a new triterpenoid drug class. With the last new antifungal class approved in 2001, ibrexafungerp has the potential to impact the rapidly rising resistance rates observed in many fungal species to today’s standards of care.
Oral Ibrexafungerp Granted QIDP and Fast Track Designations for the Treatment of VVC and the Prevention of VVC Recurrence. The Qualified Infectious Disease Product (QIDP) designation allows for priority review and an additional five years of market exclusivity in the U.S. The FDA’s Fast Track Drug Development Program is designed to facilitate the development and expeditious review of drugs to treat serious conditions and fill unmet medical needs.
Presentations at Medical Meetings and Peer-reviewed Publications. SCYNEXIS presented ibrexafungerp data at medical meetings and published data in a peer-reviewed journal. The data demonstrate the potent antifungal activity of ibrexafungerp against a broad range of fungal species, including echinocandin-resistant strains, as well as highlight numerous unique attributes, including lack of teratogenicity, synergistic activity with azoles and low risk of interactions with agents metabolized by CYP enzymes. Collectively, the data support the investigation of ibrexafungerp across a spectrum of antifungal indications, including VVC, invasive candidiasis (IC), IA, resistant fungal infections and prophylaxis indications.
In July 2018, at the 20th Congress of the International Society for Human and Animal Mycology, SCYNEXIS presented pre-clinical data demonstrating that ibrexafungerp has fungicidal activity against C. auris.
In June 2018, at the Teratology Society 58th Annual Meeting, SCYNEXIS presented pre-clinical data demonstrating that ibrexafungerp shows no impact on fertility or early embryo/fetal activity, potentially clinically relevant for women who are pregnant or may become pregnant.
In June 2018, at the 20th International Symposium on Infections in the Immunocompromised Host, SCYNEXIS presented pre-clinical data demonstrating that ibrexafungerp has activity alone, as well as synergistic activity with azole agents, against Aspergillus spp.
In June 2018, at the American Society for Microbiology Microbe 2018, SCYNEXIS presented data demonstrating that ibrexafungerp has potent in vitro activity against echinocandin-resistant Candida, as well as exhibits synergistic activity with isavuconazole against Aspergillus spp.
In June 2018, in The Journal of Clinical Pharmacology, SCYNEXIS published Phase 1 data demonstrating that ibrexafungerp has a low risk of interactions with drugs metabolized by CYP enzymes, potentially clinically relevant for patients with Type 2 diabetes.
In April 2018, at the 28th European Congress of Clinical Microbiology and Infectious Diseases, SCYNEXIS presented data demonstrating the in vitro activity of ibrexafungerp against Aspergillus spp., as well as the in vivo activity of ibrexafungerp against Pneumocystis pneumonia, supporting potential use for prophylaxis indications.
Second Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments totaled $55.2 million as of June 30, 2018, with net working capital of $43.4 million. SCYNEXIS expects its cash, cash equivalents and short-term investments at June 30, 2018 will be sufficient to fund operations into 2020.

Research and development, net expenses increased to $5.6 million in the second quarter of 2018, compared to $4.4 million in the second quarter of 2017. The increase of $1.2 million, or 26%, for the three months ended June 30, 2018, was primarily driven by an increase of $0.8 million in pre-clinical development expense and a $1.0 million increase in clinical development expense; offset by a decrease in regulatory expense of $0.2 million and a decrease of $0.4 million in consulting expense.

Selling, general and administrative expenses decreased to $2.1 million in the second quarter of 2018, compared to $2.4 million in the second quarter of 2017. The decrease of $0.2 million, or 10%, for the three months ended June 30, 2018, was primarily driven by a decrease in business development related expenses and legal fees incurred during the three months ended June 30, 2018.

Total other expense decreased to $3.1 million in the second quarter of 2018 due to a $2.9 million non-cash loss recorded on the fair value adjustment of the warrant liabilities.

Net loss for the second quarter of 2018 was $10.8 million, or $0.23 per share. This compares with a net loss for the second quarter of 2017 of $4.2 million, or $0.16 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 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.