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U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma

On February 10, 2020 Kite, a Gilead Company (Nasdaq: GILD), reported that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Priority Review designation for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) (Press release, Kite Pharma, FEB 10, 2020, View Source [SID1234554096]).

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The BLA is supported by data from the single arm, open-label, Phase 2 ZUMA-2 trial, which showed that 93 percent of patients responded to a single infusion of KTE-X19, including 67 percent of patients achieving a complete response, as assessed by an Independent Radiologic Review Committee (IRRC; median follow-up of 12.3 months). In the safety analysis, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 15 percent and 31 percent of patients, respectively. No Grade 5 CRS or neurologic events occurred. Detailed findings from this trial were recently presented during an oral session at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando.

"Despite recent advances, patients with relapsed/refractory mantle cell lymphoma currently face a significant lack of effective treatment options once their disease no longer responds to currently available therapy," said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. "Based on the encouraging results for KTE-X19, we are eager to continue discussions with the FDA on how to bring this innovative treatment to these patients who may benefit from CAR T therapy."

The Prescription Drug User Fee Act (PDUFA), or target action date, is August 10, 2020. The European Medicines Agency (EMA) recently validated the Marketing Authorization Application for KTE-X19 in the European Union. KTE-X19 has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) designation by the EMA for relapsed or refractory MCL.

KTE-X19 is investigational and not yet approved in any country globally. Its efficacy and safety have not been established. A final decision by the FDA is anticipated by August. More information about clinical trials with KTE-X19 is available at www.clinicaltrials.gov.

About MCL

MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the "mantle zone" of the lymph node and typically affects men over the age of 60.

About ZUMA-2

ZUMA-2 is a single-arm, multicenter, open-label Phase 2 study involving 74 enrolled/leukapheresed adult patients (≥18 years old) with MCL whose disease is refractory to or has relapsed following up to five prior lines of therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy and the BTK inhibitors ibrutinib or acalabrutinib. The objectives of the study are to evaluate the efficacy (60 patients) and safety (68 patients) after a single infusion of KTE-X19 in this patient population. The primary endpoint for the study is objective response rate (ORR). ORR in this trial is defined as the combined rate of complete responses and partial responses as assessed by an IRRC.

Secondary endpoints include duration of response, progression-free survival, overall survival, incidence of adverse events, incidence of anti-CD19 CAR antibodies, levels of anti-CD19 CAR T cells in blood, levels of cytokines in serum, and changes over time in the EQ-5D scale score and visual analogue scale score. The study is ongoing.

About KTE-X19

KTE-X19 is an investigational, autologous, anti-CD19 CAR T cell therapy. KTE-X19 uses the XLP manufacturing process that includes T-cell selection and lymphocyte enrichment. Lymphocyte enrichment is a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature. KTE-X19 is currently in Phase 1/2 trials in acute lymphoblastic leukemia (ALL), mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).

ALLERGAN REPORTS FOURTH QUARTER AND FULL-YEAR 2019 FINANCIAL RESULTS

On February 10, 2020 Allergan plc (NYSE: AGN) reported its full-year and fourth quarter 2019 financial results including full-year 2019 GAAP net revenues of $16.1 billion, a 1.9 percent increase from 2018 (Press release, Allergan, FEB 10, 2020, View Source [SID1234554095]). Fourth quarter 2019 GAAP net revenues were $4.35 billion, a 6.6 percent increase from the prior year quarter.

Executive Commentary

"I am proud of Allergan’s colleagues who achieved many important milestones in 2019 that will make a difference to patients for years to come. They achieved FDA approval of UBRELVY, a first-in-class oral treatment for migraine; two new approvals for BOTOX for pediatric spasticity; approval for VRAYLAR for bipolar depression; and filings for two new eye care drugs – Bimatoprost SR for glaucoma and Abicipar for Age-related Macular Degeneration," said Brent Saunders , Chairman and CEO of Allergan. "Our colleagues also grew our core business1 by 7.1 percent in 2019 and by 11.0 percent in the fourth quarter (excluding exchange), creating strong momentum for 2020 and our proposed combination with AbbVie."

Full-Year 2019 Financial Results

GAAP operating loss in 2019 was $4.45 billion compared with $6.25 billion in 2018. Non-GAAP operating income, which excludes the impact of impairments, amortization and other items, was $7.31 billion in 2019 compared to $7.56 billion in 2018. GAAP cash flow from operations for the full year of 2019 totaled $7.24 billion. Cash flow from operations for the full year of 2019 includes a one-time $1.6 billion refund of taxes previously paid on capital gains. The tax refund was accrued in a prior period and the cash was received in the third quarter of 2019.

Fourth Quarter 2019 Financial Results

GAAP operating loss in the fourth quarter of 2019 was $276.6 million. Non-GAAP operating income in the fourth quarter of 2019 was $2.08 billion, an increase of 8.4 percent versus the prior year quarter. GAAP cash flow from operations for the fourth quarter of 2019 totaled $1.67 billion.

Operating Expenses

Total GAAP Selling, General and Administrative (SG&A) Expense was $1.64 billion for the fourth quarter of 2019, compared to $1.19 billion in the prior year quarter. Total non-GAAP SG&A expense was $1.16 billion for the fourth quarter of 2019, an increase of 1.9 percent from the prior year quarter, primarily related to an increase in spending to support key products and new product launches. GAAP R&D investment for the fourth quarter of 2019 was $452.5 million, compared to $678.1 million in the fourth quarter of 2018. Non-GAAP R&D investment for the fourth quarter of 2019 was $414.8 million, a decrease of 4.9 percent compared to the prior year quarter.

Amortization, Tax and Capitalization

Amortization expense for the fourth quarter of 2019 was $1.52 billion, compared to $1.57 billion in the fourth quarter of 2018. The Company’s GAAP tax rate was 24.8 percent in the fourth quarter of 2019. The Company’s non-GAAP adjusted tax rate was 10.3 percent in the fourth quarter of 2019. As of December 31, 2019, Allergan had cash and marketable securities of $5.91 billion and outstanding indebtedness of $22.6 billion.

Operating Charges and Impairments

Allergan recorded a pre-tax charge of $302.5 million in the three months ended December 31, 2019 related to settlements reached in principle by subsidiaries Warner Chilcott and Watson with direct and indirect purchasers of LOESTRIN 24 Fe and MINASTRIN 24 Fe, resolving class action litigations pending in the U.S. District Court for the District of Rhode Island. Additionally, Allergan recorded a pre-tax charge of $78.8 million in the three months ended December 31, 2019 related to settlements reached in principle by its Allergan Inc. subsidiary with a putative plaintiff class of direct purchasers of RESTASIS, as well as a group of pharmaceutical retailers, in the previously disclosed direct purchaser class action antitrust litigation pending in the U.S. District Court for the Eastern District of New York. Also in the fourth quarter of 2019, Allergan recorded a $314.0 million GAAP intangible asset impairment related to CARAFATE due to the entry of a generic competitor. The Company excludes operating charges, asset sales and impairments, net and in-process research and development impairments from its Non-GAAP performance net income attributable to shareholders as well as Adjusted EBITDA and Non-GAAP Operating Income.

1 Core business = Promoted Brands & Brands with Ongoing Exclusivity + Other Product Revenues & Other Revenues (See Table 12)

FOURTH QUARTER 2019 BUSINESS SEGMENT RESULTS

U.S. Specialized Therapeutics

U.S. Specialized Therapeutics net revenues were $1.82 billion in the fourth quarter of 2019, an increase of 0.7 percent versus the prior year quarter. Demand growth in BOTOX Therapeutic, BOTOX Cosmetic, ALLODERM and JUVÉDERM Collection was offset by a decline in sales of CoolSculpting and lower RESTASIS revenues compared to the prior year quarter. Segment gross margin for the fourth quarter of 2019 was 91.4 percent. Segment contribution for the fourth quarter of 2019 was $1.24 billion.

Medical Aesthetics

Facial Aesthetics
BOTOX Cosmetic net revenues in the fourth quarter of 2019 were $271.8 million, an increase of 5.3 percent from the prior year quarter. For full-year 2019, BOTOX Cosmetic net revenues were $991.3 million, an increase of 9.3 percent from 2018.
JUVÉDERM Collection (defined as JUVÉDERM, VOLUMA and other fillers) net revenues in the fourth quarter of 2019 were $166.4 million, an increase of 5.1 percent versus the prior year quarter. For full-year 2019, JUVÉDERM Collection net revenues were $587.5 million, an increase of 7.2 percent from 2018.
Regenerative Medicine
ALLODERM net revenues in the fourth quarter of 2019 were $104.7 million, an increase of 10.3 percent versus the prior year quarter.
Body Contouring
CoolSculpting net revenues (including both CoolSculpting Systems/Applicators and Consumables) in the fourth quarter of 2019 were $53.3 million, a decrease of 34.4 percent from the prior year quarter.
CoolTone received regulatory clearance in the U.S. in 2019 and full launch began in January 2020.
Neurosciences & Urology

BOTOX Therapeutic net revenues in the fourth quarter of 2019 were $463.0 million, an increase of 6.9 percent versus the prior year quarter.
Eye Care

RESTASIS net revenues in the fourth quarter of 2019 were $309.0 million, a decrease of 4.9 percent versus the prior year quarter.
ALPHAGAN/COMBIGAN net revenues in the fourth quarter of 2019 were $94.5 million, a decrease of 3.3 percent versus the prior year quarter.
OZURDEX net revenues in the fourth quarter of 2019 were $31.6 million, an increase of 7.8 percent versus the prior year quarter.
U.S. General Medicine

U.S. General Medicine net revenues in the fourth quarter of 2019 were $1.61 billion, an increase of 15.2 percent versus the prior year quarter. Demand growth in VRAYLAR, LINZESS, VIIBRYD and Lo LOESTRIN was partially offset by lower revenues from products that lost exclusivity. Segment gross margin for the fourth quarter of 2019 was 82.1 percent. Segment contribution for the fourth quarter of 2019 was $1.03 billion.

Central Nervous System

VRAYLAR net revenues were $283.1 million in the fourth quarter of 2019, an increase of 88.1 percent from the prior year quarter. For full-year 2019, VRAYLAR net revenues were $857.5 million, an increase of 76.0 percent from 2018.
VIIBRYD/FETZIMA net revenues in the fourth quarter of 2019 were $114.2 million, an increase of 19.6 percent from the prior year quarter.
Gastrointestinal, Women’s Health & Diversified Brands

LINZESS net revenues in the fourth quarter of 2019 were $231.2 million, an increase of 12.7 percent versus the prior year quarter.
Lo LOESTRIN net revenues in the fourth quarter of 2019 were $156.2 million, an increase of 8.6 percent versus the prior year quarter.
BYSTOLIC/BYVALSON net revenues in the fourth quarter of 2019 were $169.6 million, an increase of 11.8 percent from the prior year quarter.
International

International net revenues in the fourth quarter of 2019 were $917.7 million, an increase of 8.1 percent versus the prior year quarter excluding foreign exchange impact, partly due to growth in Facial Aesthetics, BOTOX Therapeutic and OZURDEX. Segment gross margin for the fourth quarter of 2019 was 83.8 percent. Segment contribution was $515.8 million.

Facial Aesthetics

BOTOX Cosmetic net revenues in the fourth quarter of 2019 were $182.9 million, an increase of 19.8 percent versus the prior year quarter excluding foreign exchange impact. For full-year 2019, BOTOX Cosmetic net revenues were $671.7 million, an increase of 11.2 percent from 2018 excluding foreign exchange impact.
JUVÉDERM Collection net revenues in the fourth quarter of 2019 were $180.9 million, an increase of 5.7 percent versus the prior year quarter excluding foreign exchange impact. For full-year 2019, JUVÉDERM Collection net revenues were $656.1 million, an increase of 12.1 percent from 2018 excluding foreign exchange impact.
Eye Care

LUMIGAN/GANFORT net revenues in the fourth quarter of 2019 were $95.6 million, an increase of 1.4 percent versus the prior year quarter excluding foreign exchange impact.
OZURDEX net revenues in the fourth quarter of 2019 were $66.7 million, an increase of 132.8 percent versus the prior year quarter excluding foreign exchange impact. OZURDEX growth was primarily related to a return to full stock in 2019 following a 2018 recall of OZURDEX in certain international markets.
Botox Therapeutic

BOTOX Therapeutic net revenues in the fourth quarter of 2019 were $102.5 million, an increase of 8.9 percent versus the prior year quarter excluding foreign exchange impact.
PIPELINE UPDATE

Allergan R&D continues to advance its pipeline. During the fourth quarter of 2019, the Company’s key clinical developments included:

Allergan received approval from the U.S. Food and Drug Administration (FDA) for the Company’s New Drug Application (NDA) for UBRELVY (ubrogepant) for the acute treatment of migraine with or without aura in adults. UBRELVY is a first-in-class oral CGRP receptor antagonist (gepant) for the treatment of migraine attacks once they start. Launch began in January 2020.
Allergan announced the FDA has granted Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation for ATM-AVI (aztreonam and avibactam) for the treatment of antibiotic-resistant gram-negative infections including complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI) and hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP). ATM-AVI is an investigational, fixed-dose, intravenous combination antibiotic being developed jointly with Pfizer.
The FDA approved Allergan’s supplemental Biologics License Application (sBLA) to expand the BOTOX (onabotulinumtoxinA) label for the treatment of pediatric patients ages two years and older with lower limb spasticity, excluding spasticity caused by cerebral palsy. This marks the 14th approved indication for BOTOX and BOTOX Cosmetic combined in the U.S., and the 11th BOTOX therapeutic indication. The FDA approved BOTOX (onabotulinumtoxinA) for pediatric upper limb spasticity in the second quarter of 2019.
In addition to fourth quarter 2019 pipeline developments listed above, Allergan expects two additional significant launches in the next twelve months:

FDA action is expected in the first half of 2020 on Allergan’s NDA for Bimatoprost Sustained-Release, a biodegradable implant for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Launch is expected to follow in the first half of 2020.
The FDA is currently reviewing a Biologics License Application (BLA) for Abicipar pegol, a novel, investigational DARPin therapy, in patients with neovascular (wet) age-related macular degeneration (nAMD). The FDA is expected to take action on the BLA in mid-2020, with launch expected to follow. The European Medicines Agency (EMA) is also reviewing a Marketing Authorisation Application (MAA) for Abicipar in patients with nAMD. A decision from the European Commission is expected in the second half of 2020.
UPDATE ON PROPOSED ABBVIE TRANSACTION

On January 10, 2020, AbbVie and Allergan received conditional approval from the European Commission for AbbVie’s proposed acquisition of Allergan, subject to the approved divestiture of brazikumab (IL-23 inhibitor) and other conditions.

On January 27, 2020, Allergan announced that it entered into definitive agreements to divest brazikumab and ZENPEP (pancrelipase) in conjunction with the ongoing regulatory approval process for the proposed transaction.

AstraZeneca will acquire brazikumab, currently in Phase 2b/3 development for Crohn’s Disease and in Phase 2 development for ulcerative colitis, including global development and commercial rights.

Nestle will acquire and take full operational ownership of ZENPEP upon closing the transaction with customary transition support from Allergan. ZENPEP is a treatment, which is available in the United States, for exocrine pancreatic insufficiency due to cystic fibrosis and other conditions. Nestle also will be acquiring Viokace, another pancreatic enzyme preparation, as part of the same transaction.

The closings of the divestitures of brazikumab and ZENPEP are contingent upon receipt of U.S. Federal Trade Commission and European Commission approval, closing of AbbVie’s pending acquisition of Allergan and the satisfaction of other customary closing conditions.

Allergan expects the close of the pending AbbVie transaction around the end of the first quarter 2020, subject to receipt of required regulatory approvals and other closing conditions.

Due to the pending transaction, Allergan is not hosting a conference call to discuss its fourth quarter and full-year 2019 results.

Entry into a Material Definitive Agreement

On February 7, 2020, OncoSec Medical Incorporated (the "Company") reported the closing (the "Closing") of its previously announced strategic transaction (the "Transaction") with Grand Decade Developments Limited, a direct, wholly-owned subsidiary of China Grand Pharmaceutical and Healthcare Holdings Limited, a company formed under the laws of the British Virgin Islands ("CGP"), and its affiliate, Sirtex Medical US Holdings, Inc., a Delaware corporation ("Sirtex" and, together with CGP, the "Buyers") (Filing, 8-K, OncoSec Medical, FEB 10, 2020, View Source [SID1234554091]). On October 10, 2019, the Company and the Buyers entered into Stock Purchase Agreements (as amended, the "Purchase Agreements") pursuant to which the Company agreed to sell and issue to CGP and Sirtex 10,000,000 shares and 2,000,000 shares, respectively, of the Company’s common stock for a total purchase price of $30 million.

As contemplated by the Purchase Agreements, and in connection with the Closing, on February 7, 2020, the Company entered into Registration Rights Agreements with each of CGP and Sirtex (the "Registration Rights Agreements"), pursuant to which, among other things, CGP and Sirtex will each have the right to deliver to the Company a written notice requiring the Company to prepare and file with the Securities and Exchange Commission a registration statement with respect to resales of shares of some or all of the common stock of the Company held by CGP and Sirtex.

The description of the Registration Rights Agreements does not purport to be complete and is subject to, and qualified in its entirety by the full text of the Registration Rights Agreements, copies of which are filed as Exhibits 4.1 and 4.2 to this Current Report and are incorporated by reference herein.

Concurrently with the execution and delivery of the Purchase Agreements, the Company and CGP entered into a License Agreement (the "License Agreement"), which became effective upon the Closing. In addition, the Company and Sirtex entered into a Services Agreement (the "Services Agreement") which also became effective upon the Closing. For a full description of both the License Agreement and Services Agreement, see the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 11, 2019.

Onconova Therapeutics to Present Update at Noble Capital Markets’ Sixteenth Annual Investor Conference in Hollywood, FL

On February 10, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported that Dr. Steven M. Fruchtman, President and Chief Executive Officer, will present a company update at NobleCon16 – Noble Capital Markets’ Sixteenth Annual Investor Conference, February 17-18, 2020, being held in Hollywood, FL (Press release, Onconova, FEB 10, 2020, View Source [SID1234554090]). Dr. Fruchtman and members of management will be available for 1×1 meetings during the conference.

Presentation details
Date/Time: Monday, February 17th, 10:30 AM
Venue: Seminole Hard Rock Hotel & Casino, Hollywood, FL
Terrace Ballroom D
Presenter: Steven Fruchtman, CEO
A video webcast of the presentation will be available the following day on the Company’s website at View Source, and as part of a complete catalog of presentations available on Noble Capital Markets’ Conference website: www.nobleconference.com and on Channelchek: www.channelchek.com, the investor portal created by Noble. The webcast will be archived on the company’s website, the NobleCon website, and on Channelchek.com for 90 days following the event.

Myovant Sciences Provides Recent Corporate Updates and Reports Financial Results for Third Fiscal Quarter Ended December 31, 2019

On February 10, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate cancer, reported recent corporate updates and reported financial results for the third fiscal quarter ended December 31, 2019 (Press release, Myovant Sciences, FEB 10, 2020, View Source [SID1234554089]).

"The next six months promise to be an inflection point for Myovant as we expect to submit NDAs for prostate cancer and uterine fibroids in the U.S. and announce data from two Phase 3 studies in endometriosis," said Lynn Seely, M.D., CEO of Myovant. "We are preparing to potentially bring two distinct one pill, once a day treatments to the many women and men who suffer from these common diseases. The low-interest loan facility from Sumitomo Dainippon Pharma strengthens our financial position and further supports this vision."
Third Fiscal Quarter 2019 and Recent Business Highlights
Relugolix Phase 3 Clinical Programs

In November 2019, Myovant announced that the Phase 3 HERO study evaluating the safety and efficacy of once-daily, oral relugolix monotherapy (120 mg) over 48 weeks in 934 men with advanced prostate cancer met its primary efficacy endpoint with a 96.7% response rate and all tested key secondary endpoints, while demonstrating 54% fewer major cardiovascular events as compared with leuprolide injections administered every 3 months. Myovant anticipates submitting its NDA for relugolix monotherapy tablet for men with advanced prostate cancer in the second quarter of calendar year 2020.

In February 2020, Myovant announced positive one-year safety and efficacy data from the LIBERTY open-label extension study with an 87.7% response rate and, on average, an 89.9% reduction in menstrual blood loss from baseline, while demonstrating maintenance of bone mineral density through one year consistent with LIBERTY 1 and 2. Myovant expects to submit its NDA for relugolix combination tablet for women with heavy menstrual bleeding associated with uterine fibroids in April 2020. The NDA submission, for which Myovant no longer expects to use a priority review voucher, will include complete one-year safety and efficacy data from the LIBERTY open-label extension study, key data that may positively impact the labeled duration of use of the relugolix combination tablet. Myovant also anticipates submitting a Marketing Authorization Application (MAA) to the European Medicines Agency in the first quarter of calendar year 2020.

Myovant completed patient recruitment in SPIRIT 2 in August 2019 and in SPIRIT 1 in October 2019, enrolling 623 women and 638 women, respectively. The SPIRIT 1 and 2 are replicate Phase 3 studies evaluating the safety and efficacy of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with pain associated with endometriosis. Myovant expects to report top-line results from SPIRIT 2 and SPIRIT 1 in the first and second quarters of calendar year 2020, respectively.

In December 2019, Myovant successfully completed one-year stability studies for the relugolix combination tablet in support of potential commercialization.
Corporate

In December 2019, Roivant Sciences transferred a majority of Myovant’s outstanding common shares to Sumitovant Biopharma Ltd. (Sumitovant), a subsidiary of Sumitomo Dainippon Pharma. Concurrent with the transfer of these shares, Myovant entered into a low interest (3-month LIBOR plus 3%) revolving loan facility of up to $400 million with Sumitomo Dainippon Pharma. In addition, Hiroshi Nomura, Representative Director, President and CEO of Sumitomo Dainippon Pharma, and Adele Gulfo, Chief Business and Commercial Development Officer at Sumitovant, joined Myovant’s Board of Directors.

In December 2019, Myovant used initial proceeds of $113.7 million from the Sumitomo Dainippon Pharma loan facility to repay all of Myovant’s outstanding obligations to NovaQuest Capital Management (NovaQuest) and Hercules Capital, Inc. (Hercules).

In December 2019, Myovant announced the promotion of Frank Karbe to President and Chief Financial Officer and Matthew Lang to Chief Administrative and Legal Officer.
Third Fiscal Quarter 2019 Financial Summary
Research and development (R&D) expenses for the quarter ended December 31, 2019, were $48.9 million compared to $58.4 million for the comparable prior year period. R&D expenses in both periods primarily include expenses related to Myovant’s Phase 3 clinical programs, manufacturing expenses, as well as personnel-related expenses for employees engaged in R&D activities. R&D expenses related to Myovant’s clinical programs have continued to decline, driven primarily by the wind down of Myovant’s Phase 3 studies. The decrease in study costs were partially offset by increases in other R&D expenses related predominantly to Myovant’s manufacturing activities in connection with preparations for Myovant’s anticipated commercial launches and regulatory submissions for relugolix combination tablet and relugolix monotherapy tablet in multiple indications and jurisdictions, as well as increases in personnel expenses, share-based compensation expense, and other R&D expenses. For the quarter ended December 31, 2019, R&D expenses include $1.8 million of share-based compensation related to the accelerated vesting of certain equity awards as a result of a change in control in Myovant in connection with the closing of the transaction between Roivant and Sumitomo Dainippon Pharma.
General and administrative (G&A) expenses for the quarter ended December 31, 2019, were $29.1 million compared to $10.7 million for the comparable prior year period. The increase primarily reflects a one-off increase in share-based compensation, as well as increases in personnel-related expenses, professional service fees, expenses related to commercial operations activities in advance of potential regulatory approvals of relugolix combination tablet and relugolix monotherapy tablet, other general overhead and administrative expenses to support Myovant’s headcount growth and expanding operations and the assumption of activities previously provided by Myovant’s former majority shareholder, Roivant. For the quarter ended December 31, 2019, G&A expenses include $14.4 million of share-based compensation, of which $10.2 million are related to the accelerated vesting of certain equity awards as a result of a change in control in Myovant.
Interest expense for the quarter ended December 31, 2019, was $3.6 million compared to $1.6 million in the comparable prior year period. The increase for the quarter was primarily the result of higher outstanding debt balances under Myovant’s financing arrangements with NovaQuest and Hercules. On December 31, 2019, Myovant repaid all of its outstanding obligations to NovaQuest and Hercules.
Loss on extinguishment of debt for the quarter ended December 31, 2019, was $4.9 million, which resulted from the early retirement of Myovant’s outstanding obligations to NovaQuest and Hercules. There were no such amounts in the comparable prior year period.

Interest income for the quarter ended December 31, 2019, was $0.6 million. There was no interest income for the quarter ended December 31, 2018. During the quarter ended December 31, 2019, a portion of Myovant’s cash was invested in a combination of money market funds, commercial paper, and short-term corporate bonds. There were no such investments during the comparable prior year period.
Net loss for the quarter ended December 31, 2019, was $85.6 million, compared to $70.6 million for the comparable prior year period. The increase in the net loss for the quarter was driven primarily by the increase in expenses outlined above. On a per common share basis, net loss was $0.96 and $1.04 for the quarters ended December 31, 2019, and 2018, respectively. The decrease in the net loss per common share for the quarter was due to an increase in the weighted-average common shares outstanding primarily as a result of Myovant’s underwritten public equity offering in June 2019.
Capital resources: Cash, cash equivalents, and marketable securities totaled $98.9 million as of December 31, 2019. As of December 31, 2019, Myovant had $286.3 million of available borrowing capacity under the loan facility from Sumitomo Dainippon Pharma. Additional funds may be drawn down by Myovant no more than once any calendar quarter, subject to certain terms and conditions, including consent of Myovant’s Board of Directors.
About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone production, a hormone known to stimulate the growth of prostate cancer. Myovant is developing a relugolix combination tablet (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) for women with heavy menstrual bleeding associated with uterine fibroids and for women with pain associated with endometriosis. Myovant is also developing a relugolix monotherapy tablet (120 mg once daily) for 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 study in healthy female volunteers to characterize the dose-response curve in a minimal controlled ovarian stimulation setting has been completed.