On November 12, 2019 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 second fiscal quarter ended September 30, 2019 (Press release, Myovant Sciences, NOV 12, 2019, View Source [SID1234550942]).

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"Myovant continues to make great progress towards our milestones and is poised for a strong commercial launch of relugolix if approved, with two positive Phase 3 studies evaluating relugolix combination therapy in women with uterine fibroids and approximately $500 million in total cash and committed financing, including the Sumitomo Dainippon Pharma term loan facility," said Lynn Seely, M.D., President and CEO of Myovant Sciences. "Bringing a new treatment to the millions of women who suffer from uterine fibroids and endometriosis has been the key vision for the development of Myovant’s relugolix combination tablet. The use of a priority review voucher enables us to expedite the review of our NDA while strengthening the data package in the submission to support this objective."
Second Fiscal Quarter 2019 and Recent Business Highlights
Relugolix Phase 3 Clinical Programs

In July 2019, Myovant announced positive top-line data from LIBERTY 2, the second of two Phase 3 studies evaluating relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids and heavy menstrual bleeding. Results from a separate bioequivalence study support submission to the FDA of a potential one tablet, once-daily dosing regimen of relugolix combination therapy. In addition, the 12-month safety data from the LIBERTY open-label extension study are expected in the first quarter of calendar year 2020.

Roivant Sciences and Sumitomo Dainippon Pharma have committed to Myovant a priority review voucher (PRV) expected to become available in early December 2019. Myovant plans to use the PRV in conjunction with its NDA submission for a once-daily, relugolix combination tablet for the treatment of heavy menstrual bleeding and uterine fibroids, potentially decreasing the standard FDA review time. Myovant has decided to defer its NDA submission for a once-daily, relugolix combination tablet for the treatment of heavy menstrual bleeding and uterine fibroids until April 2020, which would allow inclusion of the complete 12-month safety data from the LIBERTY open-label extension study, key data that may positively impact the labeled duration of use of the combination tablet. The terms regarding how the PRV will be transferred to Myovant will be determined in connection with the closing of the Roivant-Sumitomo Dainippon Pharma transaction. The transfer is expected to be a related-party transaction and will not involve the issuance of Myovant shares. Myovant still plans to submit a Marketing Authorisation Application (MAA) to the European Medicines Agency in the first quarter of calendar year 2020.

In July 2019, Myovant completed enrollment of an additional cohort of 139 men with metastatic prostate cancer in the Phase 3 HERO study in order to assess the secondary objective of demonstrating that relugolix can delay the time to progression of the lethal state of the disease, castration-resistant prostate cancer, as compared to leuprolide. Myovant expects the top-line data readout for the HERO study by the end of calendar year 2019, with results from this additional cohort, including the castration resistance-free survival endpoint, expected in the third quarter of calendar year 2020. Myovant also anticipates submitting its NDA for its once-daily, oral relugolix monotherapy tablet for men with advanced prostate cancer in the second quarter of calendar year 2020.

In August and October 2019, Myovant completed patient recruitment for the Phase 3 SPIRIT 2 and SPIRIT 1 studies, respectively, evaluating the safety and efficacy of relugolix combination therapy 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.
Corporate

In October 2019, Myovant entered into a landmark agreement with Sumitomo Dainippon Pharma to secure a $350 million low-interest, five-year term loan facility, with no payments due until the end of the term, and an Investors Rights Agreement, which is intended to provide safeguards to minority shareholders. The term loan facility and Investors Rights Agreement are expected to become effective in connection with the closing of Sumitomo Dainippon Pharma’s transaction with Roivant.
Second Fiscal Quarter 2019 Financial Summary
Research and development (R&D) expenses for the quarter ended September 30, 2019, were $50.8 million compared to $53.8 million for the comparable prior year period. R&D expenses in both periods primarily include expenses related to Myovant’s Phase 3 clinical studies, manufacturing expenses as well as personnel-related expenses for employees engaged in R&D activities. R&D expenses related to Myovant’s clinical studies have continued to decline driven primarily by the wind down of Myovant’s LIBERTY 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 in multiple indications and jurisdictions, as well as increases in personnel expenses, share-based compensation expense, and other R&D expenses.
General and administrative (G&A) expenses for the quarter ended September 30, 2019, were $16.6 million compared to $10.3 million for the comparable prior year period. The increase primarily reflects increases in personnel-related expenses, share-based compensation, professional service fees, expenses related to commercial operations activities in advance of potential regulatory approvals of relugolix, and other general overhead and administrative expenses to support Myovant’s headcount growth and expanding operations which was in part driven by the assumption of activities previously provided by Roivant.
Interest expense for the quarter ended September 30, 2019, was $3.8 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 agreements as compared to the prior year period.

Interest income for the quarter ended September 30, 2019, was $0.9 million. There was no interest income for the quarter ended September 30, 2018. During the quarter ended September 30, 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 September 30, 2019, was $70.6 million, compared to $65.8 million for the comparable prior year period. The increase in the net loss for the quarter was driven primarily by the increase in costs outlined above. On a per common share basis, net loss was $0.79 and $0.99 for the quarters ended September 30, 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 $157.6 million as of September 30, 2019. Myovant’s term loan facility to be entered into with Sumitomo Dainippon Pharma, which is expected to become effective in connection with the close of the Sumitomo-Roivant transaction, is expected to provide an additional $350.0 million of capital to support Myovant’s operations.
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 Sciences 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 endometriosis-associated pain. Myovant is also evaluating relugolix monotherapy (120 mg once daily) 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 study in healthy female volunteers to characterize the dose-response curve in a minimal controlled ovarian stimulation setting has been completed.

On November 12, 2019 Verastem, Inc. (NASDAQ: VSTM) (the "Company") reported that it has entered into privately negotiated agreements among the Company and a limited number of investors who are accredited investors (within the meaning of Rule 501 promulgated under the Securities Act of 1933, as amended (the "Securities Act")) and/or qualified institutional buyers (as defined in Rule 144A under the Securities Act) who are holders of the Company’s existing 5.00% convertible senior notes due 2048 (the "existing notes") to exchange approximately $114.3 million aggregate principal amount of existing notes for (i) approximately $62.9 million aggregate principal amount of newly issued 5.00% convertible senior second lien notes due 2048 (the "exchange notes") and (ii) an aggregate of approximately $11.6 million in cash (such transactions, collectively, the "exchange") (Press release, Verastem, NOV 12, 2019, View Source [SID1234550941]). For each $1,000 principal amount of existing notes being exchanged, the Company will deliver to the exchanging investor $550 principal amount of exchange notes and a cash payment of $100, together with accrued and unpaid interest on the existing notes (plus, if applicable, an adjustment in lieu of issuing fractional exchange notes). The exchange is expected to close on November 14, 2019, subject to customary closing conditions. The Company will not receive any cash proceeds from the exchange.

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The exchange notes will be issued pursuant to an indenture by and between the Company and Wilmington Trust, National Association (the "indenture"). After giving effect to the issuance of the exchange notes and the exchange of the existing notes pursuant to the exchange, approximately $62.9 million aggregate principal amount of the exchange notes is expected to be issued and outstanding and approximately $35.7 million aggregate principal amount of the existing notes is expected to remain issued and outstanding.

The exchange notes will be senior secured obligations of the Company and pay interest semiannually in arrears at a rate of 5.00% per annum on May 1 and November 1 of each year, beginning on May 1, 2020. The exchange notes will mature on November 1, 2048 (the "maturity date"), unless earlier converted, redeemed or repurchased by us, and will be secured by a second lien on the assets of the Company securing indebtedness issued under its existing senior secured credit facility. The exchange notes will be convertible at the option of the holder into shares of common stock of the Company, par value $0.0001 per share ("common stock"), at any time prior to the close of business on the scheduled trading day immediately preceding the maturity date. The conversion rate for the exchange notes is 606.0606 shares of the Company’s common stock per $1,000 principal amount of the exchange notes (subject to certain adjustments), which is equivalent to an initial conversion price of approximately $1.65 per share, representing an approximately 52.8% premium to the last reported sale price of $1.08 per share of common stock on November 11, 2019, as reported on the Nasdaq Global Market.

Upon conversion of the exchange notes, holders will receive a cash payment equal to the accrued and unpaid interest on the converted exchange notes. In addition, prior to November 1, 2020, holders who convert their exchange notes (other than in connection with the exercise of the Company’s issuer conversion option) will also be entitled to an interest make-whole equal to the sum of all regularly scheduled stated interest payments, if any, due on such exchange notes on each interest payment date occurring after the conversion date for such conversion and on or before November 1, 2020.

The Company will have the right, exercisable at its option, to cause all exchange notes then outstanding to be converted automatically if the volume-weighted average price per share of the Company’s common stock equals or exceeds 121% of the conversion price for a specified period of time and certain other conditions are satisfied.

Prior to November 1, 2022, the Company will not have the right to redeem the exchange notes. On or after November 1, 2022, the Company may elect to redeem the exchange notes, in whole or in part, at a cash redemption price equal to the principal amount of the exchange notes to be redeemed, plus accrued and unpaid interest, if any.

Holders of the exchange notes will have the right, at their option, to require the Company to purchase their exchange notes (i) on November 1, 2023, November 1, 2028, November 1, 2033, November 1, 2038 and November 1, 2043, or (ii) if a "fundamental change" (as defined in the indenture) occurs, in each case, at a repurchase price equal to 100% of the principal amount of the exchange notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date.

In connection with the exchange, the Company intends to enter into an amendment to its senior secured credit agreement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the notes or any other securities, and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful.

The offer and sale of the exchange notes or the shares of common stock issuable upon their conversion have not been registered under the Securities Act or any state securities laws. The notes and such shares may not be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any applicable state securities laws.

On November 12, 2019 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported financial results for the third quarter ended September 30, 2019, and provided a corporate update (Press release, Cellectar Biosciences, NOV 12, 2019, View Source [SID1234550940]).

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Third Quarter and Recent Corporate Highlights

. Presented data from the DLBCL cohort in the company’s Phase 2 CLOVER-1 study of CLR 131 in relapsed or refractory select B-cell malignancies at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019. The oral presentation featured data from 6 subjects, who received up to a single 30-minute intravenous (IV) dose of 25mCi/m2 of CLR 131. Data showed durable responses with a mean of 312 days (ongoing) and includes a 33% overall response rate (ORR), a 16.6% complete response rate (CR) and a 50% clinical benefit rate (CBR). CLR 131 had activity in both DLBCL subtypes (germinal center B-cell and activated B-cell) and patients with highly resistant/aggressive cytogenetics (known as "dual hit"). All patients enrolled in the study received an average of 3 prior lines of systemic therapy, 5 of 6 patients were refractory to at least one prior line of therapy.

·Presented a poster entitled: "Phospholipid ether delivery vehicle shows specificity for a broad range of tumor cells and provides a novel and improved approach for targeted therapy," at the Cancer Research UK-AACR Joint Conference on Engineering and Physical Sciences in Oncology. The poster featured data demonstrating that phospholipid ether drug conjugates (PDCs) were capable of delivering small molecule cytotoxins selectively to tumor cells and were well tolerated in animal models.

·Presented data from cohort 6 of its Phase 1 dose escalation study of CLR 131 in relapsed or refractory MM, in a late breaker poster at the 17th International Myeloma Workshop. Data highlighted 4 subjects in cohort 6 who received a fractionated dose of 37.5mCi/m2. Subjects in this cohort achieved a 50% ORR, with two subjects achieving partial responses (PR) and two subjects achieving minimal responses (39% and 48% reduction in M protein). CLR 131 was deemed safe and tolerated in all subjects with cytopenias being the only reported treatment emergent adverse events of grade 3 or higher. The majority (75%) of the subjects had high risk cytogenetics where median bone marrow plasma cell involvement was 25%. Patients’ median age was 72.5 and they averaged 5 prior systemic therapies, with one patient being dual class refractory, one being quad-refractory, and two penta-refractory.

·Received a second FDA Fast Track Designation for CLR 131 for relapsed/refractory DLBCL. CLR 131 is currently being evaluated in patients with select B-cell lymphomas, including MM and DLBCL in the Phase 2 CLOVER-1 clinical study.

·Successfully completed the first cohort of malignant brain tumor patients in the ongoing Phase 1 study of CLR 131 in children and adolescents with select solid tumors, lymphoma, and malignant brain tumors, including relapsed or refractory neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma, and osteosarcoma. The independent Data Monitoring Committee determined the 15mCi/m2 single dose to be safe and tolerated and recommended the company progress to a second cohort utilizing a 30mCi/m2 single dose of CLR 131.

· Received orphan drug designation from the European Commission for CLR 131 in the treatment of multiple myeloma. The designation provides ten years of market exclusivity for the treatment of multiple myeloma.

·Strengthened the management team with the appointment of Dov Elefant, Chief Financial Officer.

"We continue to effectively manage our financial resources to fund our budgeted operations into 2021 while advancing multiple clinical and preclinical programs. The third quarter proved to be highly productive for Cellectar with CLR 131 receiving FDA Fast Track Designation for DLBCL and Orphan Drug Designation for multiple myeloma from the European Commission. In addition, we presented incremental positive data at international scientific conferences," said Jim Caruso, CEO of Cellectar. "We continue to anticipate data from our ongoing clinical studies by the end of this year and in early 2020."

Third Quarter and Nine Months Summary of Financial Results

Cash and Cash Equivalents: As of September 30, 2019, cash and cash equivalents were approximately $13.3 million compared to $13.3 million as of December 31, 2018. The company believes the cash balance is adequate to fund its budgeted operations into the first quarter 2021. Cash used in operating activities was approximately $9.0 million during the nine months ended September 30, 2019 as compared to $8.7 million used during the nine months ended September 30, 2018.

Research and Development Expense: Research and development (R&D) expense for the three months ended September 30, 2019 was $2.7 million compared to $2.0 million in the three months ended September 30, 2018. The cumulative R&D spending for the first nine months of 2019 was $6.8 million as compared to $5.8 million for the first nine months of 2018. The majority of the company’s R&D spend for year-to-date 2019 was dedicated to the start-up costs and support of our pediatric study. Clinical project costs and manufacturing expenses were $2.1 million and $5.0 million for the three and nine months ending September 30, 2019, respectively.

General and Administrative Expense: General and administrative (G&A) expense for the three months ended September 30, 2019 was approximately $1.3 million compared to approximately $1.1 million in the three months ended September 30, 2018. The cumulative G&A spending for the first nine months of 2019 were of $4.0 million as compared to $3.6 million for the first nine months of 2018.

Net Loss: Net loss attributable to common stockholders for the three months ended September 30, 2019 was $(3.9) million, or a loss of $(0.42) per diluted share, compared to a net loss of $(5.3) million, or a loss of $(1.65) per diluted share, in the three months ended September 30, 2018. Net loss attributable to common stockholders for the nine months ended September 30, 2019 was $(10.7) million, or a loss of $(1.51) per diluted share, compared to a net loss of $(11.7) million, or a loss of $(5.29) per diluted share, in the nine months ended September 30, 2018.

About CLR 131

CLR 131 is a small-molecule, targeted Phospholipid Drug Conjugate (PDC) designed to deliver cytotoxic radiation directly to cancer cells, while limiting exposure to healthy cells. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and two Phase 1 dose-escalating clinical studies, one in multiple myeloma and one in pediatric solid tumors and lymphoma. CLR 131 was granted Orphan Drug designation for the treatment of multiple myeloma, and was granted Orphan Drug and Rare Pediatric Disease designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.

On November 12, 2019 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported financial results for the three and nine months ended September 30, 2019 and highlighted recent corporate updates (Press release, Heron Therapeutics, NOV 12, 2019, View Source [SID1234550939]).

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Recent Corporate Updates

Pain Management Franchise

FDA Acceptance of New Drug Application Resubmission for HTX-011: In October 2019, the U.S. Food and Drug Administration (FDA) accepted Heron’s New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of March 26, 2020.
Positive Topline Results from Phase 3b Clinical Study of HTX-011 in Total Knee Arthroplasty: In October 2019, Heron reported positive topline results of a multi-center postoperative pain management study in which 51 patients undergoing total knee arthroplasty (TKA) surgery received HTX-011 together with a scheduled postoperative regimen of generic oral analgesics (acetaminophen and celecoxib). In this study, 75% of patients were discharged from the hospital without a prescription for opioids.
CINV Franchise

CINV 2019 Net Product Sales: For the three months ended September 30, 2019, chemotherapy-induced nausea and vomiting (CINV) franchise net product sales were $42.6 million, up 115% from the same period in 2018, and up 16% from the three months ended June 30, 2019. For the nine months ended September 30, 2019, CINV franchise net product sales were $110.9 million, up 128% from the same period in 2018. Heron is raising its full-year 2019 CINV franchise net product sales guidance from $115–120 million to $135 million.
CINVANTI Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three and nine months ended September 30, 2019 were $36.4 million and $97.6 million, respectively, compared to $16.4 million and $32.8 million, respectively, for the same periods in 2018.
SUSTOL Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three and nine months ended September 30, 2019 were $6.2 million and $13.3 million, respectively, compared to $3.4 million and $15.8 million for the same periods in 2018.
FDA Approval of Supplemental NDA for CINVANTI: In October 2019, the FDA approved Heron’s supplemental New Drug Application (sNDA) for CINVANTI (aprepitant) injectable emulsion for intravenous (IV) use. The sNDA approval resulted in a CINVANTI label expansion that standardizes the CINVANTI 130 mg single-dose regimen for patients receiving HEC and/or MEC as an injection over 2 minutes or an infusion over 30 minutes, further simplifying dosing and administration and eliminating the need to take oral aprepitant on Days 2 and 3 in patients receiving MEC.
"We are pleased with the advances made during the third quarter of 2019 in both our pain management and CINV franchises, highlighted by the FDA acceptance of our recent NDA resubmission for HTX-011 and strong net product sales for our CINV franchise, even amid the launch of generic fosaprepitant," said Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics. "We look forward to continuing our commercial momentum with the launch of HTX-011 for postoperative pain management in the second quarter of 2020, pending FDA approval."

Financial Results

Net product sales for the three and nine months ended September 30, 2019 were $42.6 million and $110.9 million, respectively, compared to $19.8 million and $48.6 million, respectively, for the same periods in 2018.

Heron’s net loss for the three and nine months ended September 30, 2019 was $33.6 million and $146.8 million, or $0.42 per share and $1.85 per share, respectively, compared to $38.3 million and $129.3 million, or $0.49 per share and $1.81 per share, respectively, for the same periods in 2018. Net loss for the three and nine months ended September 30, 2019 included non-cash, stock-based compensation expense of $9.7 million and $40.3 million, respectively, compared to $8.1 million and $23.6 million, respectively, for the same periods in 2018.

As of September 30, 2019, Heron had cash, cash equivalents and short-term investments of $256.3 million. Adjusting for net proceeds of $162.2 million from our October 2019 public offering of common stock, Heron had pro-forma cash, cash equivalents and short-term investments of $418.5 million. This compares to $332.4 million in cash, cash equivalents and short-term investments as of December 31, 2018. Net cash used for operating activities for the nine months ended September 30, 2019 was $97.6 million, compared to $158.3 million for the same period in 2018.

About HTX-011 for Postoperative Pain

HTX-011, an investigational agent, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. HTX-011 was granted Fast Track designation from the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2017 and Breakthrough Therapy designation in the second quarter of 2018. Heron submitted a New Drug Application (NDA) to the FDA for HTX-011 in October of 2018 and received Priority Review designation in December of 2018. A Complete Response Letter (CRL) was received from the FDA regarding the NDA for HTX-011 on April 30, 2019 relating to chemistry, manufacturing and controls and non-clinical information. No issues related to clinical efficacy or safety were noted. Heron resubmitted an NDA to the FDA for HTX-011 in September 2019, and the FDA set a PDUFA goal date of March 26, 2020. A Marketing Authorisation Application (MAA) for HTX-011 was validated by the European Medicines Agency (EMA) in March 2019 for review under the Centralised Procedure.

About CINVANTI (aprepitant) injectable emulsion

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC, including high-dose cisplatin, and nausea and vomiting associated with initial and repeat courses of MEC. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the United States prescribing information for CINVANTI is a 30-minute IV infusion or a 2-minute IV injection.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL (granisetron) extended-release injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

On November 12, 2019 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported financial results for the third quarter ended September 30, 2019, and provided an update on recent company developments (Press release, SpringWorks Therapeutics, NOV 12, 2019, View Source [SID1234550938]).

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"The third quarter of 2019 was a productive period for SpringWorks as we completed a successful initial public offering while simultaneously achieving important regulatory and clinical development milestones, including dosing the first patient in our Phase 2b ReNeu trial of mirdametinib for patients with plexiform neurofibromas," said Saqib Islam, Chief Executive Officer of SpringWorks. "Our team is focused on enrolling patients in our two potentially registrational trials in rare oncology indications and our Phase 1b trial in patients with RAS and RAF mutated solid tumors, and collaborating with our partners to initiate two additional Phase 1 studies in genetically defined cancers by early next year. We also continue to evaluate new business development opportunities to expand our pipeline and maximize the value of our portfolio."

Third Quarter 2019 Business Highlights

·Initiated Potentially Registrational ReNeu Clinical Trial: In October 2019, SpringWorks announced the initiation of the Phase 2b ReNeu clinical trial evaluating mirdametinib in children and adults with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN).
·Completed Successful Initial Public Offering: In September 2019, SpringWorks completed its initial public offering of 10,350,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,350,000 additional shares of its common stock, at the public offering price of $18.00 per share. The Company raised $186.3 million in aggregate gross proceeds.
·Received EU Orphan Drug Designation for Nirogacestat: In September 2019, the European Commission granted Orphan Drug Designation for nirogacestat for the treatment of soft tissue sarcoma.
·Received Breakthrough Therapy Designation for Nirogacestat: In August 2019, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to nirogacestat for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.
·Strengthened Leadership Team and Board of Directors: In August 2019, SpringWorks appointed Francis (Frank) I. Perier, Jr. as Chief Financial Officer and Alan Fuhrman to its Board of Directors and as Audit Committee Chair.
·Received EU Orphan Drug Designation for Mirdametinib: In July 2019, the European Commission granted Orphan Drug Designation for mirdametinib for the treatment of neurofibromatosis type 1 (NF1).

Third Quarter and Year to Date 2019 Financial Results

·Research and Development (R&D) Expenses: R&D expenses as of September 30, 2019 were $10.7 million and $30.4 million for the third quarter and year-to-date periods, respectively, compared to $3.4 million and $6.2 million for the comparable periods of 2018, respectively. The increases in R&D expenses in 2019 are primarily attributable to increased clinical study and drug supply costs related to the ongoing Phase 3 DeFi and Phase 2b ReNeu trials, as well as growth in employee costs, including non-cash share-based compensation associated with increases in the number of R&D personnel.
·General and Administrative (G&A) Expenses: G&A expenses as of September 30, 2019 were $4.6 million and $11.5 million for the third quarter and year-to-date periods, respectively, compared to $1.8 million and $5.9 million for the comparable periods of 2018, respectively. The increases in G&A expenses in 2019 are primarily attributable to growth in employee costs, including non-cash share-based compensation associated with increases in the number of G&A personnel, and increases in consulting and professional services related to the expansion of our business activities.
·Net Loss Attributable to Common Stockholders: As of September 30, 2019, SpringWorks reported net losses of $16.8 million, or $1.77 loss per share, and $34.4 million, or $9.24 loss per share, for the third quarter and year-to-date periods respectively. This compares to net losses of $5.0 million, or $11.55 loss per share, and $11.6 million, or $44.20 loss per share, for the comparable periods of 2018, respectively.
·Cash Position: Cash and cash equivalents were $343.8 million as of September 30, 2019. This includes net proceeds of $169.7 million from SpringWorks’ initial public offering completed in September 2019.