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.

On August 9, 2018 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, reported financial results and recent corporate highlights for the second quarter ended June 30, 2018 (Press release, Fortress Biotech, AUG 9, 2018, View Source [SID1234528835]).

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "During the second quarter, our Fortress Company subsidiaries reported significant value-driving milestones, including positive Phase 3 data from Avenue Therapeutics’ IV tramadol, which, if approved, would be the only Schedule IV intravenous opioid in the U.S. and could replace highly addictive Schedule II narcotics in many patients with moderate to moderately severe postoperative pain. Additionally, Cyprium Therapeutics was granted FDA Fast Track Designation for its CUTX-101 Copper Histidinate injection in patients with Menkes disease, a rare pediatric disease with no FDA-approved treatments. Also during the quarter, Mustang Bio expanded its infrastructure with the launch of a proprietary 27,000 sq. ft. CAR T cell manufacturing facility that will enable us to oversee product safety from needle-to-needle and help improve supply chain efficiencies from clinical development into commercialization."

Dr. Rosenwald continued, "We believe in the value proposition represented by our company and strive to protect the best interests of our shareholders and those of our subsidiaries. As we continue to build long-term value, our novel and efficient business model provides benefits for all stakeholders and offers unique synergies not typical of traditional biopharma companies."

Financial Results:

·As of June 30, 2018, Fortress’ consolidated cash, cash equivalents, short-term investments (certificates of deposit), cash deposits with clearing organizations and restricted cash totaled $151.8 million, compared to $168.3 million as of December 31, 2017, a decrease of $16.5 million year-to-date.
·Net revenue totaled $63.8 million for the second quarter of 2018, compared to $50.7 million for the second quarter of 2017. Total revenue as of June 30, 2018, includes $6.8 million of Fortress revenue, primarily from the sale of Journey Medical Corporation products, and $57.0 million of revenue from National Holdings Corporation1 ("National Holdings"). Total revenue as of June 30, 2017, included $4.4 million of Fortress revenue and $46.3 million of revenue from National Holdings.
·Research and development expenses were $17.5 million for the second quarter of 2018, of which $15.1 million was related to Fortress Companies. This compares to $11.7 million for the second quarter of 2017, of which $9.5 million was related to Fortress Companies. Non-cash, stock-based compensation expenses included in research and development were $0.8 million for the second quarter of 2018, compared to $2.4 million for the second quarter of 2017.
Research and development expenses from license acquisitions were nominal for the second quarter of 2018, compared to $1.8 million for the second quarter of 2017.
·General and administrative expenses were $13.1 million for the second quarter of 2018, of which $7.7 million was related to Fortress Companies. This compares to $11.1 million for the second quarter of 2017, of which $6.6 million was related to Fortress Companies. Non-cash, stock-based compensation expenses included in general and administrative expenses were $2.4 million for the second quarter of 2018, compared to $2.2 million for the second quarter of 2017.
·National Holdings’ operating expenses totaled $56.2 million for the second quarter of 2018, compared to $48.4 million for the second quarter of 2017.
·Net loss attributable to common stockholders was $21.6 million, or $0.50 per share, for the second quarter of 2018, compared to a net loss attributable to common stockholders of $17.4 million, or $0.43 per share, for the second quarter of 2017. For the first six months of 2018, net loss was $42.6 million or $0.99 per share, compared to $29.3 million or $0.73 per share in the first six months of 2017.

1Fortress acquired approximately 56 percent of National Holdings in September 2016.

Recent Fortress and Fortress Company Highlights:

Fortress Biotech, Inc.

·In June 2018, data from a Phase 1 trial evaluating Fortress’ CNDO-109-activated allogeneic natural killer (NK) cells in acute myeloid leukemia (AML) patients were published in the journal Biology of Blood and Marrow Transplantation. The data demonstrated that CNDO-109-activated NK cells are safe, well tolerated and may be capable of extending complete remissions in high-risk AML patients.

Aevitas Therapeutics, Inc.

·In August 2018, Aevitas announced that it entered a sponsored research agreement with the laboratory of Wenchao Song, Ph.D., at the University of Pennsylvania to evaluate Aevitas’ adeno-associated virus ("AAV") gene therapy technology in Penn’s proprietary animal models of complement-mediated diseases.

Avenue Therapeutics, Inc.

·In May 2018, Avenue announced that its first pivotal Phase 3 trial of IV tramadol achieved the primary endpoint of a statistically significant improvement in Sum of Pain Intensity Difference over 48 hours (SPID48) compared to placebo in patients with moderate to moderately severe postoperative pain following bunionectomy surgery. In addition, the trial met its key secondary endpoints and demonstrated a clear dose response. Avenue plans to initiate a second pivotal Phase 3 trial of IV tramadol in patients following abdominoplasty surgery in the second half of 2018.

Caelum Biosciences, Inc.

·In June 2018, Caelum announced a complete analysis of cardiac data from a Phase 1b trial of CAEL-101 (mAb 11-1F4) for the treatment of relapsed or refractory amyloid light chain ("AL") amyloidosis demonstrating CAEL-101’s potential to improve myocardial function as assessed by global longitudinal strain and generate a sustained decrease in N-terminal pro-brain natriuretic peptide levels in AL amyloidosis patients experiencing cardiac involvement. The data were presented by Columbia University at the American Society of Echocardiography 29th Annual Scientific Sessions.

Checkpoint Therapeutics, Inc.

·In April 2018, preclinical data was presented on Checkpoint’s BET inhibitor, CK-103, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. CK-103 demonstrated combinatorial effects in an in vivo model with anti-PD-1 antibodies, which may support the development of CK-103 as an anti-cancer agent alone and in combination with Checkpoint’s anti-PD-L1 antibody CK-301.

Cyprium Therapeutics, Inc.

·In July 2018, Cyprium announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to CUTX-101, a product candidate for patients diagnosed with classic Menkes disease who have not demonstrated significant clinical progression.

Mustang Bio, Inc.

·In May 2018, Mustang announced the publication of preclinical data in JCI Insight demonstrating that glioblastoma-targeted CD4+ CAR T cells mediate superior antitumor activity over CD8+ CAR T cells. The data, published by research partner City of Hope, will be applied in the ongoing Phase 1 trial of Mustang’s IL13Rα2-specific CAR T MB-101 in glioblastoma.
·In June 2018, Mustang opened a proprietary CAR T cell therapy manufacturing facility at UMass Medicine Science Park in Worcester, Mass. The facility will support the clinical development and commercialization of Mustang’s CAR T product candidates and enable proprietary cell therapy research.
·Also in June 2018, Mustang was added to the Russell 2000, 3000 and Microcap Indexes.
·In July 2018, Mustang completed a pre-Investigational New Drug (pre-IND) meeting with the FDA for MB-102 (CD123 CAR T). Based on the meeting, Mustang expects to file an IND in the fourth quarter of 2018 to support a Phase 1/2 trial of MB-102 in AML, blastic plasmacytoid dendritic cell neoplasm and high-risk myelodysplastic syndrome.

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 ChemoCentryx, Inc., (Nasdaq:CCXI), reported financial results for the second quarter ended June 30, 2018 and provided an overview of the Company’s recent corporate highlights (Press release, ChemoCentryx, AUG 9, 2018, View Source [SID1234528752]).

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"A most important milestone has recently been achieved at ChemoCentryx: we completed enrollment of over 300 patients in our landmark ADVOCATE Phase III trial in ANCA-associated vasculitis," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We’re targeting the fourth quarter of 2019 for the release of top-line data from ADVOCATE, and expect that successful trial results would form the basis of our new drug application to the FDA. Our very healthy balance sheet also enables us to simultaneously pursue other high unmet need, high value disease indications. Specifically, controlled clinical trials are underway for avacopan in C3G and for our other innovative kidney asset, CCX140 in FSGS. These are all orphan renal diseases with no approved therapies. Our plan to expand into orphan dermatological disease is also progressing extremely well. We intend to launch a large controlled clinical trial of avacopan in hidradenitis suppurativa later this year. In sum, 2018 is shaping up to be a watershed year for the Company, and we believe our momentum is building."

Recent Highlights

ChemoCentryx has completed enrollment of 316 patients in the Phase III ADVOCATE pivotal trial of avacopan for the treatment of ANCA-associated vasculitis. The trial will evaluate the safety and efficacy of avacopan following 52 weeks of treatment.

Expanded commercial alliance with Vifor Pharma to provide Vifor with commercialization rights in China for avacopan and CCX140, in exchange for upfront cash payments to ChemoCentryx totaling $21.5 million, plus tiered royalties between the teens and mid-twenties on potential net future sales in the Vifor territories.

Surpassed 45% of the patient enrollment target in the Company’s clinical trial evaluating avacopan for C3G. C3G is a rare disorder that often affects the young, requiring dialysis and often kidney transplant with relapsing disease common. There is no approved effective treatment.

Reported $91.5MM in cash receipts year-to-date; current balance sheet >$200MM in cash and equivalents.

Developed plan to launch clinical trials by the end of 2018 of avacopan in HS, an inflammatory and chronic skin disease characterized by recurrent, painful, boil-like nodules under the skin.

Launched clinical development of CCR2 inhibitor CCX140 in two sub-populations of primary FSGS, an orphan kidney disease with no approved treatment option.

Second Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled approximately $201.8 million at June 30, 2018. In the first six months of 2018, ChemoCentryx received $91.5 million in cash from milestone and upfront payments and credit facility advances. Cash utilized for the first six months of the year was $25MM. For the full year, the Company expects to utilize cash and investments between $60 million and $70 million.

Revenue was $15.0 million for the second quarter of 2018, compared to $8.9 million for the same period in 2017. Revenue recognized represents amortization of the upfront license fee commitments, milestone payments and collaboration funding from Vifor pursuant to the Avacopan Agreement, Avacopan Amendment and CCX140 Agreement. The increase from 2017 to 2018 was primarily due to the Company’s adoption of Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers effective January 1, 2018.

Research and development expenses were $17.8 million for the second quarter of 2018, compared to $14.3 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to the patient enrollment of the avacopan Phase II clinical trial in patients with C3G and start-up expenses related to the CCX140 Phase II clinical trials in patients with FSGS.

General and administrative expenses were $4.7 million for the second quarter of 2018, compared to $4.2 million for the same period in 2017. The increase from 2017 to 2018 was primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, partially offset by a decrease in professional fees.

Net loss for the second quarter of 2018 was $6.9 million, compared to $9.2 million for the same period in 2017.

Total shares outstanding at June 30, 2018 were approximately 50.3 million shares.

Conference Call and Webcast

The Company will host a conference call and webcast today, August 9, 2018 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial 877-303-8028 (Domestic) or 760-536-5167 (International). The conference ID number is 6238899. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the conference call.

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.