On November 8, 2018 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its first quarter ended September 30, 2018 (Press release, MEI Pharma, NOV 8, 2018, View Source [SID1234531199]).

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"Fiscal 2019 is off to a strong start both financially and strategically, with more than $90 million in cash and investments on our balance sheet at the start of the quarter, $10 million additional cash due under the recently executed Japan licensing agreement with Kyowa Hakko Kirin, a new clinical collaboration with BeiGene, and progress in preparations to start the ME-401 Phase 2 study around year-end," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "With the planned start of the ME-401 Phase 2 study, we will have two ongoing clinical trials with the potential to support FDA marketing approval."

Dr. Gold continued: "We are also excited by our continued progress in the other programs across our pipeline, including interim data from the Phase 2 study of pracinostat in MDS, the evaluation of our CDK9 inhibitor, voruciclib, in B-cell malignancies and data from the investigator-initiated study of ME-344 in breast cancer."

Recent Program Highlights and Upcoming Milestones

Upcoming Milestones

MEI will present data from three clinical stage drug development programs at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 1-4, 2018 in San Diego:
Updated results from the Phase 1b study evaluating ME-401 in relapsed/refractory follicular lymphoma (FL) and other indolent B-cell malignancies.
Data from an interim analysis of pracinostat in an ongoing Phase 2 study evaluating patients with high/very high-risk myelodysplastic syndrome (MDS).
Results from a preclinical study demonstrating that voruciclib and venetoclax synergistically induce apoptosis in acute myeloid leukemia (AML) cells in vitro.
MEI plans to initiate the Phase 2 study to support accelerated approval of ME-401 in relapsed or refractory FL around year-end of calendar 2018.
MEI expects to report updates regarding the ongoing voruciclib Phase 1 study at medical meetings in 2019.
MEI expects to report additional data from the investigator-sponsored Phase 1 study evaluating ME-344 at medical meetings in 2019.
Clinical Development Highlights

In October 2018, MEI announced a clinical collaboration to evaluate the safety and efficacy of MEI’s ME-401, an investigational phosphatidylinositol 3-kinase (PI3K) delta inhibitor, in combination with BeiGene’s zanubrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of patients with B-cell malignancies.
In July 2018, the Company discussed with FDA a ME-401 monotherapy accelerated approval strategy in patients with relapsed or refractory FL. Informed by the discussions with the FDA, the Company is advancing ME-401 into a Phase 2, single-agent study for the treatment of adults with relapsed or refractory FL. The Phase 2 study is intended to support accelerated approval and is planned to begin around the end of 2018. Accelerated approval of ME-401 will be subject to FDA review of the improvement provided by ME-401 over other therapies available at the time of the regulatory action.
Corporate Highlights

In November 2018, MEI announced the execution of a license development and commercialization agreement granting Kyowa Hakko Kirin exclusive rights to develop and commercialize ME-401 in Japan. Under the terms of the agreement, MEI will receive a $10.0 million upfront payment and is eligible to receive up to $87.5M in additional development and commercialization milestones, and royalties on sales.
In July 2018, the Company announced that David M. Urso, J.D., senior vice president of corporate development and general counsel, was promoted to chief operating officer. Mr. Urso is also continuing as the Company’s general counsel and head of corporate development.
Financial Highlights

As of September 30, 2018, MEI had $90.8 million in cash, cash equivalents and short-term investments, with no outstanding debt. Additionally, a $10 million upfront payment is due under the Japan license agreement executed with Kyowa Hakko Kirin.
Research and development expenses were $6.1 million for the quarter ended September 30, 2018, compared to $6.1 million for the same period in 2017. Research and development expenses reflect increased costs for the development of ME-401, offset by a reduction in expenses related to voruciclib, as the prior year amounts included acquisition costs for voruciclib.
General and administrative expenses were $3.4 million for the quarter ended September 30, 2018, compared to $2.5 million for the same period in 2017. The increase primarily relates to professional services expenses, share-based compensation, and general corporate expenses.
The Company recognized revenues of $0.5 million for the quarter ended September 30, 2018, compared to $0.3 million for the same period in 2017. The increase is related to higher levels of research and development activities performed pursuant to the Helsinn license agreement.
Net loss for the quarter ended September 30, 2018, was $14.5 million, or $0.21 per share compared $8.8 million, or $0.24 per share for the same period in 2017. The Company had 71,115,444 shares of common stock outstanding as of September 30, 2018, compared with 36,950,177 shares as of September 30, 2017.
The adjusted net loss, excluding non-cash expenses related to changes in the fair value of the warrants issued in connection with the May 2018 financing (a non-GAAP measure) for the quarter ended September 30, 2018, was $9.6 million, or $0.14 per share.
Cash expenditures for operating activities were $12.8 million for the quarter ended September 30, 2018, compared to $6.6 million for 2017. The increase in cash used for the three months ended September 30, 2018 primarily relates to changes in working capital associated with our clinical development programs, including start-up costs related to the ME-401 Phase 2 accelerated approval study.

On November 8, 2018 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported financial results for the third quarter ended September 30, 2018 (Press release, AmpliPhi Biosciences, NOV 8, 2018, View Source [SID1234531191]). AmpliPhi Biosciences will not be conducting a conference call in conjunction with this financial release.

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"We made significant progress in the third quarter of 2018. We announced an updated set of positive outcomes from our ongoing expanded access program for seriously ill patients, who suffer from resistant bacterial infections. Additionally, we received agreement from the FDA to proceed to randomized clinical trials for our lead product candidates, AB-SA01 and AB-PA01," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "AmpliPhi now intends to initiate one of the FDA agreed clinical trials for AB-SA01 in 2019, the bacteremia trial, and also to seek non-dilutive financing for our AB-PA01 program."

Recent Business Highlights

Announced in September 2018 that 84% of patients achieved treatment success at the end of therapy for the company’s expanded access program. Twenty-one patients at 7 hospitals, with serious or life-threatening infections not responding to antibiotics, were treated with AB-SA01 or AB-PA01. Over 1,000 doses of AmpliPhi’s bacteriophage product candidates have now been administered as part of the program since mid-2017. Treatment was generally well tolerated, with no treatment-related serious adverse events.
Received positive U.S. Food and Drug Administration (FDA) feedback for AB-SA01 in September 2018, following a Type B pre-IND meeting. AmpliPhi announced that the FDA is in general agreement with the design of two proposed randomized clinical trials of AB-SA01, for S. aureus bacteremia and prosthetic joint infections, and that no additional preclinical or clinical data are required to proceed with both trials. In addition, AmpliPhi continues to investigate if AB-SA01 may be eligible for approval under the limited population pathway for antibacterial and antifungal drugs (LPAD) which is intended to facilitate development of therapeutics to treat serious or life-threatening infections in a limited population of patients with unmet need.
Received positive feedback from the FDA for AB-PA01 in September 2018. The company announced that the FDA is in general agreement with the design of two proposed randomized clinical trials of AB-PA01, hospital-acquired and ventilator-associated pneumonia (HAP/VAP) due to P. aeruginosa and for P. aeruginosa bacteremia, and no additional preclinical or clinical data are required to proceed. AmpliPhi intends to seek non-dilutive financing and explore other opportunities to conduct these clinical trials.
Presented clinical case data from the expanded access program at the ID Week 2018 Conference in October 2018. Thirteen patients with serious and life-threatening S. aureus infections were treated with AB-SA01 at the Westmead Hospital in Sydney. 83% (10 out of 12) patients in the modified intent-to-treat (mITT) population achieved treatment success at the end of therapy as reported by treating physicians. Bacteriophage treatment was well tolerated, with no adverse events attributable to the therapy.
Completed an underwritten public offering in October 2018 that raised gross proceeds of $6.8 million, before deducting underwriting discounts and commissions and other offering expenses. AmpliPhi anticipates using the net proceeds from the offering for general corporate purposes, including manufacturing, research and development and general and administrative expenses.
Third Quarter and Nine Months Ended September 30, 2018 Financial Results

Research and development (R&D) expenses for the third quarter of 2018 were $0.4 million compared to an $0.8 million benefit for the third quarter of 2017. The change was primarily attributable to a $1.2 million tax incentive payment received in July 2018 from the Australian tax authority, compared to a $2.0 million tax incentive payment from the Australian tax authority received in the same quarter of 2017. Excluding any benefit from tax incentive payments, R&D expense was $1.6 million in the third quarter versus $1.2 million in the prior year period. The increase of $0.4 million was primarily attributable to a $0.3 million increase in clinical costs and a $0.1 million increase in payroll-related costs.
R&D expenses for the nine months ended September 30, 2018, net of incentive tax payments, were $3.5 million, up from $1.8 million for the nine months ended September 30, 2017. Excluding any benefit from tax incentive payments, R&D expense for the nine months ended September 30, 2018 and 2017 were $4.7 million and $3.8 million, respectively. The increase of $0.9 million was primarily related to a $0.7 million increase in clinical costs, a $0.1 million increase in professional and consulting fees, and a $0.1 million increase in payroll-related costs.
General and administrative (G&A) expenses were $1.3 million for the third quarter of 2018 compared to $1.6 million for the third quarter of 2017. The decrease was primarily due to lower legal and professional fees, as well as a $0.1 million decrease in certain non-cash charges.
G&A expenses for the nine months ended September 30, 2018 decreased by $2.1 million to $4.2 million from $6.3 million for the nine months ended September 30, 2017. The decrease was primarily attributable to a decrease in payroll-related costs and professional fees and the non-recurrence of a non-cash fair value adjustment charge of $0.5 million.
Net cash used in operating activities for the nine months ended September 30, 2018 was $7.0 million compared to $6.8 million for the nine months ended September 30, 2017.
Cash and cash equivalents as of September 30, 2018 totaled $4.5 million, which excludes the proceeds from the company’s October 2018 public offering.
As of November 5, 2018, there were approximately 32.3 million shares of common stock outstanding.

On November 8, 2018 Cue Biopharma, Inc. (NASDAQ: CUE), an innovative immunotherapy company developing a novel, proprietary class of biologics engineered to selectively modulate the human immune system to treat cancer, autoimmune and chronic infectious diseases, reported that it has entered into a multi-target strategic collaboration with LG Chem Life Sciences, the life sciences division of LG Chem Ltd., to develop multiple Immuno-STAT biologics focused in the field of oncology (Press release, Cue Biopharma, NOV 8, 2018, View Source [SID1234531185]).

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The collaboration provides LG Chem with the rights to develop and commercialize, in Asia, Cue Biopharma’s lead product, CUE-101, as well as Immuno-STAT biologics that target T cells against two additional cancer antigens. Under the terms of the collaboration, Cue Biopharma will engineer the selected Immuno-STATs for up to three alleles, while LG Chem will leverage its experience in biologics manufacturing to establish a quality chemistry, manufacturing and controls (CMC) process for development and commercialization of the selected candidates. LG Chem will also retain the right to elect one additional Immuno-STAT biologic within two years of the agreement for a worldwide development and commercialization license, and Cue Biopharma will retain an option to co-develop and co-commercialize the additional program worldwide. Cue Biopharma retains rights to develop and commercialize all assets included in the agreement in the United States and in global markets outside of Asia.

Under the terms of the agreement, LG Chem will make an undisclosed upfront payment as well as a $5M equity investment at a 20% premium. Cue Biopharma will be eligible to receive up to an additional $400M in research, development, regulatory and sales milestone payments with tiered royalties on sales of collaboration products in the LG Chem territory. In addition, LG Chem will further contribute to the collaboration by providing Cue Biopharma with research funding, CMC process development and potentially additional downstream manufacturing capabilities, including clinical and commercial supply for the collaboration products. LG Chem in return will receive royalties on sales of collaboration products in Cue Biopharma’s territories outside of Asia. If LG Chem elects the option for an additional program worldwide, Cue Biopharma will receive an undisclosed payment and be eligible to receive greater than $500M in fees and milestone payments. Cue Biopharma will also receive tiered royalties on future global sales. In addition, prior to the first pivotal trial for the optional Immuno-STATs, Cue Biopharma will have the option to elect worldwide co-development rights for the additional program.

"Cue Biopharma is proud to be launching this strategic collaboration with LG Chem as our partner," stated Dan Passeri M.Sc., J.D., President and CEO of Cue Biopharma. "We believe they offer world-class biologics capabilities as well as clinical development capabilities that will enhance our ability to achieve our global corporate objectives. Our partnership with LG Chem is an important strategic development, as it allows us to expand our reach into more diverse patient populations with our Immuno-STAT Biologics platform and leverage the leading biologics manufacturing and clinical development capabilities that LG Chem has successfully established."

"We are very pleased to enter this strategic collaboration with Cue Biopharma; it is more than a licensing deal, it is a partnership with a shared vision and great strategic fit," said Dr. Jeewoong Son, President of LG Chem Life Sciences. "By combining Cue Biopharma’s pioneering approach to selectively modulating disease-associated T cells with LG Chem’s biologics capabilities in development and manufacturing, we aim to accelerate bringing this novel therapy to a greater number of cancer patients."

About Immuno-STATs

Immuno-STAT Biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology, autoimmune and chronic infectious disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-MHC complex (pMHC) to provide selectivity through the pMHC T-cell receptor (TCR) interaction, and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-stimulatory molecules and pMHC binding mimics the signals delivered by APCs to T cells during a natural immune response. This design enables Immuno-STAT Biologics to engage with the T cell population of interest exclusively, resulting in highly targeted T cell modulation. Because our drugs are delivered in vivo, they are fundamentally different from other T cell therapeutic approaches such as Adoptive Cell Therapy (ACT), which require the patients’ T cells to be extracted, then stimulated and expanded outside the body (ex vivo) and reinfused in an activated state. At Cue Biopharma we are working to develop drugs that will represent a potent pharmaceutical analog to the ex vivo approach deployed by current cellular therapies. Furthermore, we believe the pharmacological effect in the patients can be more precisely controlled via an administered therapeutic.

On November 8, 2018 Constellation Pharmaceuticals, Inc., (Nasdaq: CNST) a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its third-quarter and nine-month 2018 financial results (Press release, Constellation Pharmaceuticals, NOV 8, 2018, View Source [SID1234531184]).

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"We are excited about the progress we have made this year with our clinical programs and our entire epigenetics platform," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "In 2019, we look forward to further progress in our pipeline, as we expect to evaluate proof of concept for both our ProSTAR and MANIFEST clinical trials in mid-2019 as well as initiate clinical development of our second-generation EZH2 inhibitor CPI-0209."

Recent News

Continued enrollment in ProSTAR Phase 1b/2 study of CPI-1205 in metastatic castration-resistant prostate cancer (mCRPC). As planned, 34 sites are activated and enrolling patients in each of the two cohorts of the Phase 1b portion of the study. The Company expects to determine a recommended Phase 2 dose and begin the randomized portion of the trial in the fourth quarter of 2018.

Enhanced and expanded the Phase 2 portion of the ongoing MANIFEST study of CPI-0610 in myelofibrosis (MF). Constellation modified the MANIFEST trial design to stratify for transfusion-dependent status in second-line treatment and to initiate a first-line treatment arm in combination with ruxolitinib in JAK 1/2-inhibitor-naïve patients with MF. These changes are intended to provide additional measures of potential clinical activity and to expand the potential addressable population of MF patients for CPI-0610, thereby enabling multiple potential paths to registration. More than a dozen sites are now open for MANIFEST in the US, Canada, and Europe, with more sites expected to open in the next few months. Preliminary data in this trial as of May 25 included evidence of reductions in spleen volume, improvements in symptom scores, and increased hemoglobin levels, as well as one case of a transfusion-dependent patient achieving transfusion independence.

Announced Fast Track designation for CPI-0610 for the treatment of MF. The FDA awarded CPI-0610 Fast Track status based on preliminary results from the Phase 2 MANIFEST study. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs.

Expanded Board of Directors with experts in mCRPC and MF. Constellation announced the appointments of Dr. Elizabeth G. Tréhu and Steven L. Hoerter to its Board of Directors, bringing considerable experience working in the disease areas of mCRPC and MF.

Presenting preclinical data from EZH2 franchise in prostate cancer. Constellation will be presenting data at the upcoming EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium on November 13-16 in Dublin, Ireland, and at the AACR (Free AACR Whitepaper)-KCA Joint Conference on Precision Medicine in Solid Tumors on November 15-17 in Seoul, South Korea.
Third Quarter 2018 Financial Results

Cash and cash equivalents as of September 30, 2018 grew 45% to $128.5 million compared to June 30, 2018, primarily due to capital raised in the initial public offering in July, partially offset by operating expenses.

Research and development (R&D) expenses increased 66% year over year to $12.7 million in the third quarter of 2018 mainly due to increased clinical trial expenses.

General and administrative (G&A) expenses grew 86% year over year to $3.7 million in the third quarter of 2018, primarily due to costs related to building out the organization as the Company evolved from a preclinical-stage company to a multi-candidate clinical-stage company, as well as costs associated with operating as a public company.

The net loss attributable to common stockholders increased 9% year over year to $15.9 million mainly due to increases in G&A and R&D expenses, partly offset by the inclusion of unpaid cumulative dividends in 2017 that were waived in 2018. The net loss per share attributable to common stockholders decreased 95% to $0.81 per share for the third quarter of 2018 due to an increase in shares outstanding as a result of the initial public offering and conversion of the preferred stock to common stock.
Financial Guidance

We expect that cash as of September 30, 2018, will fund planned operations into the first quarter of 2020.

Anticipated Milestones

The Company continues to anticipate achieving the following milestones during the upcoming twelve months:

Fourth Quarter 2018

Initiate the Phase 2 portion of the ProSTAR study with CPI-1205
Early 2019

Determine safety and the recommended Phase 2 dose in the ORIOn-E trial for CPI-1205 in combination with checkpoint inhibitors in solid tumors
Mid 2019

Initiate the Phase 1 trial with CPI-0209, a second-generation EZH2 inhibitor
Evaluate proof of concept for CPI-1205 in the ProSTAR trial
Evaluate proof of concept for CPI-0610 in the MANIFEST trial
Financial Results (Unaudited)

Constellation Pharmaceuticals, Inc.
Statements of operations and comprehensive loss (unaudited)

On November 8, 2018 Myovant Sciences (NYSE: MYOV), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of women’s health and endocrine diseases, reported corporate updates and reported financial results for the second fiscal quarter ended September 30, 2018 (Press release, Myovant Sciences, NOV 8, 2018, http://investors.myovant.com/news-releases/2018/11-08-2018-210604964 [SID1234531182]).

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"We continue to make significant progress in advancing our Phase 3 clinical trials and have achieved several important milestones," said Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "We completed patient enrollment in both our Phase 3 LIBERTY 1 trial evaluating relugolix in combination with estradiol and a progestin in women with heavy menstrual bleeding associated with uterine fibroids and our Phase 3 HERO trial evaluating relugolix monotherapy in treating men with advanced prostate cancer. Screening has also been completed for our Phase 3 LIBERTY 2 trial. We remain on track to announce top-line safety and efficacy data for relugolix in 2019 in three distinct indications, each with wholly owned North American and European rights."

Recent Business Highlights and Upcoming Milestones

Relugolix Phase 3 Clinical Programs

Completed enrollment in the Phase 3 LIBERTY 1 trial and completed patient screening for the Phase 3 LIBERTY 2 trial. Both trials are evaluating relugolix in combination with estradiol and a progestin in women with heavy menstrual bleeding associated with uterine fibroids. Top-line safety and efficacy data from the LIBERTY 1 trial are expected in the second quarter of 2019, and data from the LIBERTY 2 trial are expected in the third quarter of 2019, with a New Drug Application (NDA) filing expected in the fourth quarter of 2019.
Continued enrolling patients in the Phase 3 SPIRIT 1 and SPIRIT 2 trials, which are evaluating relugolix in women with pain associated with endometriosis. Top-line results are expected in 2019.
Completed patient enrollment in the pivotal Phase 3 HERO trial, which is evaluating the safety and efficacy of relugolix monotherapy for the treatment of men with advanced prostate cancer. Top-line safety and efficacy data are expected in the fourth quarter of 2019, with a NDA filing expected in early 2020.
MVT-602 Clinical Program

Presented data at the American Society for Reproductive Medicine (ASRM) Annual Congress from a Phase 1 trial of MVT-602, a novel oligopeptide kisspeptin-1 receptor agonist in development as a potential treatment for female infertility in women as part of assisted reproduction.
Completed enrollment in a Phase 2a clinical trial in approximately 70 fertile women undergoing a controlled ovarian stimulation. Top-line results are expected in the first half of 2019.
Corporate

Appointed Kim Sablich, formerly Vice President of Primary Care Marketing in the United States for GlaxoSmithKline (GSK), as Chief Commercial Officer, and Jeff Nornhold, formerly Senior Vice President of Technical Operations for Impax Laboratories (now Amneal Pharmaceuticals, Inc.), as Senior Vice President of Pharmaceutical Operations & Development.
Appointed industry veterans Myrtle Potter, Mark Guinan and Frank Torti, M.D., to the company’s Board of Directors, and Ms. Potter to Chairman of the Board.
Raised aggregate net proceeds of approximately $74.4 million from the issuance and sale of 3,533,399 common shares in an underwritten secondary public equity offering.
Second Fiscal Quarter 2018 Financial Summary

Research and development (R&D) expenses for the quarter ended September 30, 2018, were $53.8 million compared to $24.2 million for the comparable period in 2017. The increase for the quarter primarily reflects the progress of Myovant’s ongoing Phase 3 clinical trials of relugolix, which were initiated in 2017, as well as additional personnel-related expenses and MVT-602 clinical trial expenses.

General and administrative (G&A) expenses for the quarter ended September 30, 2018, were $10.3 million compared to $6.1 million for the comparable period in 2017. The increase for the quarter primarily reflects increases in personnel-related expenses, professional service fees, and other administrative expenses to support Myovant’s headcount growth and expanding operations.

Interest expense for the quarter ended September 30, 2018, was $1.6 million compared to no interest expense in the comparable prior year period. Interest expense for the quarter consisted of interest expense related to financing agreements with NovaQuest Pharma Opportunities Fund IV L.P. and Hercules Capital, Inc., as well as the associated non-cash amortization of debt discount and issuance costs.

Net loss for the quarter ended September 30, 2018, was $65.8 million, compared to $29.9 million for the comparable period in 2017. On a per common share basis, net loss was $0.99 and $0.50 for the quarters ended September 30, 2018, and 2017, respectively. The increases in the net loss and net loss per common share for the quarter were driven primarily by the increase in costs outlined above.

Capital resources: Cash and committed funding totaled $246.3 million at September 30, 2018, consisting of $154.3 million in cash and $92.0 million in remaining financing commitments available from NovaQuest under the NovaQuest Securities Purchase Agreement and the NovaQuest Equity Purchase Agreement. An additional $40.6 million of capacity remains available under the "at-the-market" equity offering program that Myovant initiated in April 2018.

About Relugolix

Relugolix is an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone, or GnRH, receptor antagonist. More than 2,150 study participants have received treatment with relugolix in Phase 1, Phase 2 and Phase 3 clinical trials. In completed trials, relugolix was generally well tolerated and suppressed estrogen and progesterone levels in women and testosterone levels in men. Common side effects observed were consistent with suppression of these hormones.

In the ongoing Phase 3 LIBERTY clinical trials in women with heavy menstrual bleeding associated with uterine fibroids and the ongoing Phase 3 SPIRIT clinical trials in women with pain associated with endometriosis, relugolix is undergoing evaluation in combination with estradiol and norethindrone acetate, a progestin, and as monotherapy. Myovant is studying whether the combination decreases estradiol levels to the range required to treat signs and symptoms of endometriosis and uterine fibroids while minimizing the side effects associated with low estrogen levels, which include bone mineral density loss and hot flashes. The ongoing Phase 3 HERO study is evaluating relugolix monotherapy in men with advanced prostate cancer.

About MVT-602

MVT-602 is an oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand, is a naturally-occurring peptide that stimulates GnRH release and is required for puberty and maintenance of normal reproductive function, including production of sperm, follicular maturation and ovulation, and production of estrogen and progesterone in women and testosterone in men.

A Phase 2a clinical trial in healthy female volunteers is under way to characterize the dose-response curve in the controlled ovarian stimulation setting prior to studying MVT-602 in infertile women seeking pregnancy.