On November 12, 2020 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company with a pipeline of novel T cell therapies for patients suffering from cancer, reported financial results for the third quarter ended September 30, 2020 and provided a corporate update (Press release, TCR2 Therapeutics, NOV 12, 2020, View Source [SID1234570769]).

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"The third quarter was marked by consistency in the clinical benefit provided by our lead TRuC-T cell program, TC-210, previously shown to have produced RECIST partial responses at its very first dose level, as well as the completion of a successful financing," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "As we prepare for the expansion portion of the TC-210 trial, we are excited to bring on additional clinical sites to increase patient recruitment and we have also launched a strategic partnership with ElevateBio, whose state-of-the-art manufacturing center will support the Phase 2 clinical trial of TC-210 and planned investigator-initiated studies. We look forward to providing a clinical data update on TC-210 in the fourth quarter."

Recent Developments

TCR2 announced a partnership with ElevateBio, LLC, a Cambridge, MA-based creator and operator of a portfolio of innovative cell and gene therapy companies. The agreement with ElevateBio provides TCR2 access to ElevateBio BaseCamp, its centralized 140,000 square foot, world-class cell and gene therapy manufacturing facility based in Waltham, MA. The BaseCamp partnership enables TCR2 Therapeutics to establish additional manufacturing capacity and technical capabilities in the U.S., in addition to its existing Stevenage, UK, manufacturing facility, and will support the Phase 2 expansion portion of the TC-210 Phase 1/2 clinical trial once a recommended Phase 2 dose is defined.
Anticipated Milestones

TCR2 anticipates an interim update from the Phase 1 portion of the TC-210 Phase 1/2 clinical trial for patients with mesothelin-expressing solid tumors in 4Q20.
TCR2 anticipates an interim update from the Phase 1 portion of the TC-110 Phase 1/2 clinical trial for patients with CD19+ non-Hodgkin lymphoma or adult acute lymphoblastic leukemia in 2021.
TCR2 anticipates certification of its manufacturing facility in Stevenage, UK, in 4Q20.
TCR2 anticipates an IND filing for a third TRuC-T cell program in 2021.
Financial Highlights

Cash Position: TCR2 ended the third quarter of 2020 with $246.7 million in cash, cash equivalents, and investments compared to $158.1 million as of December 31, 2019. Net cash used in operations was $10.8 million for the third quarter of 2020 compared to $10.1 million for third quarter of 2019. TCR2 projects net cash use of $65-70 million for 2020.

R&D Expenses: Research and development expenses were $12.8 million for the third quarter of 2020 compared to $11.3 million for the third quarter of 2019. The increase in R&D expenses were primarily related to increases in headcount, activities related to the Phase 1/2 clinical trial of TC-210 and activities related to the Phase 1/2 clinical trial of TC-110.

G&A Expenses: General and administrative expenses were $4.4 million for the third quarter of 2020 compared to $3.5 million for the third quarter of 2019. The increase in general and administrative expenses was primarily due to an increase in personnel costs and costs associated with operations as a public company.

Net Loss: Net loss was $16.9 million for the third quarter of 2020 compared to $13.8 million for the third quarter of 2019, driven predominantly by increased personnel expenses.
Upcoming Events

TCR2 Therapeutics management is scheduled to participate at the following upcoming conferences.

Jefferies Virtual London Healthcare Conference: Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics, will provide a company update using a virtual platform on Wednesday, November 18, 2020 at 9:40am ET
Piper Sandler 32nd Annual Virtual Healthcare Conference: Ian Somaiya, Chief Financial Officer of TCR2 Therapeutics, and Alfonso Quintás Cardama, M.D., Chief Medical Officer of TCR2 Therapeutics, will participate in a fireside chat using a virtual platform on Monday, November 23, 2020 at 10:00am ET

On November 12, 2020 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported financial results for the third quarter ended September 30, 2020. The company also highlighted recent progress and upcoming milestones for its pipeline programs (Press release, Forma Therapeutics, NOV 12, 2020, View Source [SID1234570767]).

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"We are very pleased with our strong pipeline progress during the quarter amid such challenging times," said Frank Lee, President and Chief Executive Officer of Forma. "We look forward to presenting new data from our ongoing Phase 1 trial of FT-4202 in sickle cell disease at the ASH (Free ASH Whitepaper) meeting in December, as well as beginning enrollment of patients for our Phase 1 trial of FT-7051 in men living with metastatic castration-resistant prostate cancer. The recent positive top-line results from the olutasidenib registrational Phase 2 clinical trial in relapsed/refractory acute myeloid leukemia with an IDH1 mutation further underscores our commitment to developing transformative therapies for patients."

Key Business and Clinical Highlights

PKR Program in Sickle Cell Disease (SCD):

Both planned dose cohorts enrolling in the multiple ascending dose (MAD) trial. The MAD1 cohort is designed to dose 9-12 SCD patients with 300 mg of FT-4202. Clinical measures being assessed include change in hemoglobin, indirect bilirubin, reticulocytes and lactate dehydrogenase, as well as the monitoring of tolerability and safety during the 14-day dosing and 7-day follow-up period. The MAD2 cohort is assessing a higher 600 mg dose and is now enrolling patients. Patients completing the 600 mg MAD2 cohort may enter the 12-week Open Label Extension (OLE) portion of the trial.
FT-4202 abstract selected for oral presentation at the virtual 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition December 5-8, 2020. The FT-4202 abstract describes blinded data from three patients receiving the 300 mg dose, measuring changes in parameters over the 14-day treatment and 7-day follow-up period including hemoglobin and reticulocytes, as well as tolerability and safety. Updated data will be presented at the ASH (Free ASH Whitepaper) annual meeting on December 7, 2020.
CPB/p300 Program in Prostate Cancer:

Phase 1 clinical trial of FT-7051 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) on track to start by year end. This trial will enroll patients who have progressed while on standard anti-androgen therapy. Patients’ prostate cancer will be profiled for mutations in the androgen receptor (AR)-signaling pathway that drive resistance to AR-receptor antagonists, such as ARv7 mutations.
IDH1 Program in AML and Glioma:

Announced positive data for olutasidenib in relapsed/refractory acute myeloid leukemia (R/R AML). In October 2020, Forma announced positive results from the planned interim analysis (IA2) of the Phase 2 registration trial in R/R AML patients with isocitrate dehydrogenase 1 gene mutations (IDH1m). Olutasidenib demonstrated a favorable tolerability profile as a monotherapy, and for the primary efficacy endpoint of composite complete remission (CR+CRh, or complete remission plus complete remission with partial hematologic recovery), achieved a rate of 33.3% (30% CR and 3% CRh). While a median duration of CR/CRh has not been reached, a sensitivity analysis (with a hematopoietic stem cell transplant as the end of a response) indicates the median duration of CR/CRh to be 13.8 months. Safety results are consistent with previously reported Phase 1 clinical trial results.
Olutasidenib is also being evaluated in an exploratory Phase 1 trial for glioma as presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in June 2020, as well as in other IDH1m solid tumor indications.
Corporate:

In September 2020, Forma announced the appointment of industry veteran Thomas G. Wiggans to Forma’s board of directors. Mr. Wiggans has led successful biopharmaceutical companies from start-up stage into the clinic and later global commercialization, served on the boards of numerous public and private companies, and was instrumental in the formation of the Biotechnology Industry Organization, now Biotechnology Innovation Organization (BIO).
Upcoming Milestones

Results from the ongoing randomized placebo-controlled multicenter Phase 1 trial evaluating FT-4202 in patients with SCD to be presented at ASH (Free ASH Whitepaper). Clinical data on the safety results, PK/PD and laboratory measurements in 9-12 patients from the 300 mg MAD1 cohort will be presented during an oral presentation at the virtual, 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition December 5-8, 2020. Subsequently, results from the MAD2 600 mg cohort are expected in the first quarter of 2021, and 12-week OLE results are anticipated in the second quarter of 2021.
Initiation of registrational trial of FT-4202 for people living with SCD: The global pivotal Phase 2/3 trial is expected to initiate in the first quarter of 2021. This adaptive, randomized, placebo-controlled, double-blind, multi-center study will enroll approximately 344 adults and adolescents with SCD. The trial will evaluate FT-4202 doses of 200 mg and 400 mg administered once daily in the Phase 2 portion. Primary endpoints in the Phase 3 portion of the trial are hemoglobin response rate at week 24 (increase of > 1 g/dL from baseline), and annualized vaso-occlusive crisis rate during the 52-week blinded treatment period.
Initiation of FT-7051 Clinical Development in mCRPC: Patient enrollment in the Phase 1 trial of FT-7051 in mCRPC patients is expected to begin prior to the end of 2020. Safety and tolerability data from the trial are anticipated in 2021 and clinical activity results in 2022.
Non-core Partnering Strategy: Following the recent positive registrational trial results in R/R AML with an IDH1 mutation, Forma remains focused on partnership opportunities for olutasidenib, as well as for the non-core FASN inhibitor for NASH (FT-8225).
Possibility of COVID-19 Impact: The COVID-19 pandemic remains a factor in the successful completion of these milestones. Many clinical trials across the biopharma industry have been impacted by the COVID-19 pandemic, with clinical trial sites implementing new policies in response to COVID-19, resulting in potential delays to enrollment of clinical trials or changes in the ability to access sites participating in clinical trials.
Upcoming Investor Events

Dec. 7, 2020: Forma will conduct a conference call and webcast on Dec. 7 at 6 p.m. Eastern Standard Time (EST) to discuss updated results from the ongoing Phase 1 trial of FT-4202 in SCD, as well as an overview of the company’s development plans for FT-4202. A live webcast will be available in the "News & Investors" section of Forma’s website www.formatherapeutics.com.
Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $384.3 million as of September 30, 2020, as compared to $173.2 million as of December 31, 2019.
Research and Development (R&D) Expenses: R&D expenses were $24.8 million for the quarter ended September 30, 2020, compared to $27.6 million for the quarter ended September 30, 2019. The decrease was primarily due to planned reductions in spending on FT-2102, FT-4101, FT-8225, research activities, and internal R&D personnel-related costs, which were partially offset by increases in FT-4202 expenses to conduct the Phase 1 trial, clinical product manufacturing, and preparations for the pivotal Phase 2/3 trial.
General and Administrative (G&A) Expenses: G&A expenses were $7.5 million for the quarter ended September 30, 2020, compared to $7.0 million for the quarter ended September 30, 2019. The increase in general and administrative expense was primarily attributable to a $1.3 million increase in equity-based compensation, and a $0.6 million increase in insurance related expense, and a $0.5 million increase in other related general and administrative costs, partially offset by a reduction of $2.0 million related to legal, consulting and other professional fee expenses.
Net Income/Loss: Net loss was $27.6 million for the quarter ended September 30, 2020, compared to $31.0 million for the quarter ended September 30, 2019.

On November 12, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported corporate updates and financial results for the second quarter fiscal year 2020 (Press release, Myovant Sciences, NOV 12, 2020, View Source [SID1234570766]).

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"I am very pleased with the significant progress we made during the second fiscal quarter in advancing both relugolix monotherapy tablet and relugolix combination tablet toward potential regulatory approvals, while preparing for commercialization in advanced prostate cancer, uterine fibroids, and endometriosis," said Lynn Seely, M.D., chief executive officer of Myovant Sciences, Inc. "We have assembled a strong and highly-experienced team, spanning medical affairs, market access, commercial operations, marketing, and sales, which will enable us to rapidly and efficiently deliver relugolix monotherapy tablet to urologists, medical oncologists, and their patients, if approved, for our first commercial launch."

Second Quarter Fiscal Year 2020 and Recent Corporate Updates

Relugolix Clinical Programs

Prostate Cancer:

Relugolix monotherapy tablet is under Priority Review by the U.S. Food and Drug Administration (FDA) and is on track for a decision by its December 20, 2020 target action date. The NDA is supported by the positive Phase 3 HERO study results, including a 97% responder rate and six positive key secondary endpoints. Relugolix also demonstrated a lower incidence of major adverse cardiovascular events compared to leuprolide acetate, the current standard of care. The Phase 3 HERO study results were published in the New England Journal of Medicine on June 4, 2020.

On September 29, 2020, Myovant announced results of an additional secondary endpoint of castration resistance-free survival assessed in the subgroup of men with metastatic prostate cancer from the Phase 3 HERO study of relugolix monotherapy in advanced prostate cancer. Relugolix monotherapy had a similar rate of castration resistance-free survival compared to leuprolide acetate (74% vs. 75%, respectively), and did not achieve statistical superiority (p = 0.84).

On October 19, 2020, Myovant presented an economic analysis of the Phase 3 HERO data at the Academy of Managed Care Pharmacy (AMCP) Nexus 2020 Virtual Meeting, demonstrating that treatment with oral relugolix may prevent one major adverse cardiovascular event for every 31 patients treated versus patients receiving leuprolide injections.

Uterine Fibroids:

In August 2020, the FDA accepted Myovant’s NDA for once-daily, oral relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids, setting a target action date of June 1, 2021.

On September 14, 2020, Myovant announced one-year data on bone mineral density (BMD) from the Phase 3 LIBERTY program. The BMD results from the LIBERTY program demonstrated maintenance of BMD through one year and were consistent with those observed in a separate prospective observational study of untreated, age-matched women with uterine fibroids. These findings were presented at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting Virtual Event, held on September 11-15, 2020.

On October 21, 2020, Myovant announced the presentation of data at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress, including long-term extension data in women with symptomatic uterine fibroids. Results indicated that women experienced, on average, a 90% reduction in menstrual blood loss from baseline at one year. Additionally, 87.7% of women achieved the responder criteria for reduction in menstrual blood loss at one year, and lumbar spine and total hip BMD were maintained over one year. A poster presentation also described a validated exposure-response model simulating long-term effects of relugolix combination therapy on BMD at the lumbar spine that projected maintenance of BMD for at least three years. Other data from the LIBERTY program – including improvement in quality of life, reduction in menstrual blood loss in the first treatment cycle, and reduction in uterine fibroid-associated pain – were also presented.

Additional data from the Phase 1 ovulation inhibition study from 67 healthy women treated with relugolix combination therapy, resulting in 100% ovulation inhibition and 100% return to ovulation or menses after discontinuation of treatment, were also presented at the ASRM 2020 Virtual Congress.

Endometriosis:

Data from the replicate Phase 3 SPIRIT 1 and SPIRIT 2 studies were presented at the ASRM 2020 Virtual Congress on October 20, 2020 in an oral presentation named the Prize Paper by the Endometriosis Special Interest Group. Relugolix combination therapy resulted in clinically meaningful reductions in dysmenorrhea and non-menstrual pelvic pain, compared with placebo over 24 weeks of therapy (p < 0.0001) in each study. Changes in BMD over 24 weeks were minimal in the relugolix combination therapy groups.
COVID-19 Pandemic Environment

Myovant’s priorities during the COVID-19 pandemic are protecting the health and safety of its employees and patients while continuing its mission to redefine care for women and for men. To date, the impact of the COVID-19 pandemic on Myovant’s ability to advance its clinical studies, regulatory activities, and preparation for the potential commercialization of its product candidates has been limited, and all of Myovant’s publicly announced milestones remain on track. However, if the COVID-19 pandemic persists, and depending on the further evolution of the pandemic and its effects on Myovant’s activities, Myovant may experience more significant impacts on its business operations.
Expected Upcoming Milestones

Relugolix monotherapy tablet for advanced prostate cancer FDA target action date of December 20, 2020.

Data from the LIBERTY randomized withdrawal study expected in the first quarter of calendar year 2021.

One-year efficacy and safety data from the SPIRIT extension study expected in the first quarter of calendar year 2021.

Relugolix combination tablet for uterine fibroids FDA target action date of June 1, 2021.

Marketing Authorization Application (MAA) submission to European Medicines Agency (EMA) for relugolix monotherapy tablet for advanced prostate cancer in the first half of calendar year 2021.

NDA submission for relugolix combination tablet for the treatment of women with endometriosis-associated pain expected in the first half of calendar year 2021.

European Commission decision on the uterine fibroids MAA expected in 2021. If approved, this launch will be executed by Gedeon Richter, Myovant’s commercialization partner for relugolix combination tablet for the uterine fibroids and endometriosis indications in Europe and certain other international markets.

MAA submission to EMA for relugolix combination tablet for the treatment of women with endometriosis-associated pain expected in 2021. Gedeon Richter will be the MAA sponsor.
Second Quarter Fiscal Year 2020 Financial Summary

Research and development (R&D) expenses in the three months ended September 30, 2020, were $40.5 million compared to $50.8 million for the comparable prior year period. The decrease in R&D expenses reflects a decrease in clinical study costs as a result of the completion and continued wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies. This decrease was partially offset primarily by increased expenses by the medical affairs organization in preparation for Myovant’s anticipated commercial launches, if approved, of relugolix monotherapy tablet for men with advanced prostate cancer and relugolix combination tablet for the women’s health indications, as well as an increase in personnel expenses.

General and administrative (G&A) expenses in the three months ended September 30, 2020, were $31.3 million compared to $16.6 million for the comparable prior year period. The increase was primarily due to increases in expenses related to commercial readiness activities, personnel-related expenses, and other general overhead expenses to support Myovant’s organizational growth and anticipated commercial launches, if approved, of relugolix monotherapy tablet for men with advanced prostate cancer and relugolix combination tablet for the women’s health indications.

Interest expense was $2.1 million in the three months ended September 30, 2020, compared to $3.8 million in the comparable prior year period. The decrease in interest expense was driven by lower interest rates associated with the Sumitomo Dainippon Pharma Loan Agreement as compared to Myovant’s previously outstanding debt obligations, which were repaid in December 2019.

Interest income in the three months ended September 30, 2020, was less than $0.1 million compared to $0.9 million for the comparable prior year period. The decrease was primarily due to decreases in interest rates and lower balances in cash equivalents and marketable securities.

Other (income) expense, net in the three months ended September 30, 2020, was income of $6.7 million compared to expenses of $0.1 million for the comparable prior year period. This was primarily the result of a foreign currency exchange gain on Myovant’s outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement during the three months ended September 30, 2020 for which there was no such gain in the comparable prior year period.

Net loss for the three months ended September 30, 2020, was $67.1 million compared to $70.6 million for the comparable prior year period. On a per common share basis, net loss was $0.75 and $0.79 for the three months ended September 30, 2020, and 2019, respectively.

Capital resources: Cash, cash equivalents, marketable securities, and committed amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled $257.6 million as of September 30, 2020, and consisted of $111.3 million of cash, cash equivalents, and marketable securities and $146.3 million of available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement.

On August 5, 2020, Myovant obtained a debt commitment letter (amended on September 29, 2020) from Sumitomo Dainippon Pharma, pursuant to which, subject to the terms and conditions set forth therein, Sumitomo Dainippon Pharma has committed to provide Myovant with an additional $200.0 million, low-interest, five-year term loan, which, subject to negotiation of a definitive agreement, will bring its total financing support for Myovant to $600.0 million. Including the additional debt commitment, cash and committed funding as of September 30, 2020 totaled approximately $460.0 million.

Conference Call
As previously announced, Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) today, November 12, 2020, to discuss corporate updates and financial results for its second fiscal quarter 2020, ended September 30, 2020. Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S.

The webcast will be archived on Myovant’s Investor Relations website following the call.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis.

On November 12, 2020 Oncorus, Inc. (Nasdaq:ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported third quarter 2020 financial results and highlighted recent achievements and developments (Press release, Oncorus, NOV 12, 2020, View Source [SID1234570765]).

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"We’ve made significant strides thus far in 2020 advancing our mission to realize the full promise of viral immunotherapy for cancer patients, including the commencement of a Phase 1 clinical trial for our lead clinical candidate, ONCR-177, as well as entering into a clinical trial collaboration with Merck to study ONCR-177 in combination with KEYTRUDA as part of the trial," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus.

Dr. Ashburn further commented, "Bolstered by the completion of our IPO last month and a strong cash position, we continue to progress our pipeline of intratumorally and intravenously administered viral immunotherapies across our oncolytic Herpes Simplex Virus (oHSV) and Synthetic Virus Platforms. Our goal is to treat a broad spectrum of cancers to bring the full potential of this therapeutic class to as many patients as possible."

Third Quarter 2020 and Recent Highlights

Completed initial public offering (IPO) in October. Oncorus’s common stock commenced trading on the Nasdaq Global Market under the ticker symbol "ONCR" on October 2, 2020. The IPO, at a public offering price of $15.00 per share, raised $98.4 million in aggregate gross proceeds, including shares sold to the underwriters pursuant to the partial exercise of their option to purchase additional shares.
Initiated Phase 1 clinical trial of ONCR-177. In June, Oncorus initiated a Phase 1 clinical trial of its lead product candidate, ONCR-177, an intratumorally administered oHSV viral immunotherapy being developed for multiple solid tumor indications. The Phase 1 open-label, multi-center, dose escalation and expansion clinical trial is designed to evaluate the safety and tolerability of ONCR-177 and to determine the recommended Phase 2 dose, as well as its preliminary anti-tumor activity, alone and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors. Oncorus anticipates reporting interim data from the Phase 1 clinical trial in the second half of 2021 through the second half of 2022.
Announced clinical trial collaboration with Merck. In July, Oncorus announced a clinical trial collaboration and supply agreement with Merck, known as MSD outside of the United States and Canada, through a subsidiary, to evaluate the combination of ONCR-177 with KEYTRUDA, as part of the ongoing Phase 1 clinical trial of ONCR-177 in adult patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors.
Continued to advance lead Synthetic Virus Platform programs toward clinical candidate nominations. Oncorus continues to advance its lead synthetic, intravenously (IV) administered viral immunotherapy programs based on the coxsackievirus A21 (CVA21) and the Seneca Valley Virus and expects to nominate clinical candidates for both programs in the first half of 2021. IV administration of viral immunotherapies is an attractive approach for improving the standard of care for many oncology patients because it allows for all tumors in a patient, including the micro-metastases that are sometimes difficult to detect and treat, to be treated directly. In addition, it allows for the potential treatment of certain tumors, such as those of the lung, that are less amenable to repeat intratumoral injection of anti-cancer therapies for both safety and feasibility reasons. Oncorus’s Synthetic Virus Platform includes its novel lipid nanoparticle delivery strategy designed to overcome the challenges caused by neutralizing antibodies that have limited the efficacy of previous industry efforts to treat tumors utilizing IV administration of CVA21.
Continued to advance second oHSV viral immunotherapy candidate, ONCR-GBM. Leveraging its oHSV Platform, Oncorus is pursuing ONCR-GBM to specifically target brain cancer, including glioblastoma multiforme (GBM). Oncorus is utilizing its knowledge of microRNA expression to engineer a microRNA attenuation strategy to protect healthy brain tissue and select a combination of payloads that address the specific drivers of immune suppression in brain cancer. Oncorus plans to nominate its ONCR-GBM clinical candidate in the second half of 2021.
Third Quarter Financial Results

Cash and cash equivalents were $54.0 million as of September 30, 2020, excluding the proceeds from the Company’s initial public offering in October 2020, compared to $45.3 million as of December 31, 2019.
Research and development expenses for the quarter ended September 30, 2020 were $6.9 million compared to $6.2 million for the corresponding period in 2019. The increase in research and development expenses was mainly attributable to increases in clinical trial costs for the Company’s Phase 1 clinical trial as well as increased personnel-related expenses driven by increased headcount.
General and administrative expenses for the quarter ended September 30, 2020 were $2.0 million compared to $1.5 million for the corresponding period in 2019. The increase in general and administrative expenses was primarily attributable to increases in audit and legal activity and related expenses as well as personnel-related expenses driven by increased headcount.
Other income (expense), net, for the quarter ended September 30, 2020 was an expense of $10.6 million compared to income of $0.2 million for the quarter ended September 30, 2019. Other expense in 2020 included a non-cash charge of $10.6 million related to an increase in the fair market value of the Company’s Series B preferred stock tranche rights liability that was settled in September 2020, upon the closing of the second tranche of the Series B financing, which occurred prior to the IPO.
Net loss attributable to common stockholders for the quarter ended September 30, 2020 was $22.4 million, or $(21.73) per share, compared to a net loss attributable to common stockholders of $9.2 million, or $(9.67) per share for the same period in 2019. The share and loss per share amounts do not reflect the impact of the Company’s IPO, which closed in October 2020.
Financial Guidance

Based upon its current operating plans and cash and cash equivalents, including the net proceeds from the IPO, the Company expects to have sufficient capital to fund its operating expenses and capital expenditure requirements into 2023.

On November 12, 2020 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 third quarter financial results for the period ended September 30, 2020 and provided an update on recent company developments (Press release, SpringWorks Therapeutics, NOV 12, 2020, View Source [SID1234570763]).

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"We are very pleased with our achievements in the third quarter of 2020 across our clinical development, business development and corporate initiatives. We completed enrollment in the Phase 3 DeFi trial, advanced our strategy to develop nirogacestat as a cornerstone of BCMA combination therapy for patients with multiple myeloma by signing additional collaborations with industry and academic leaders, and continued to progress our trials in biomarker defined metastatic solid tumors," said Saqib Islam, Chief Executive Officer of SpringWorks. "Our ten clinical development programs are progressing as planned and we look forward to providing further updates as we advance our pipeline and continue to execute on our strategy to build a leading targeted oncology company."

Recent Business Highlights and Upcoming Milestones

Late-Stage Rare Oncology

Completed enrollment in the Phase 3 DeFi trial evaluating nirogacestat in adult patients with progressing desmoid tumors. SpringWorks expects to report topline data from the DeFi study in the second or third quarter of 2021.
Recruiting patients in a Phase 2 study sponsored by the Children’s Oncology Group evaluating nirogacestat in pediatric patients with desmoid tumors.
Highlighted a publication by investigators at the University of Minnesota and the Dana-Farber Cancer Institute in the Pediatric Cancer & Blood journal reporting data from four pediatric and young adult desmoid tumor patients who received nirogacestat under the SpringWorks Expanded Access Program. In these four patients, the investigators reported one complete response, two partial responses, and one stable disease, with no grade 3 or 4 adverse events.
Enrollment is ongoing in the Phase 2b ReNeu trial evaluating mirdametinib in pediatric and adult patients with NF1-associated plexiform neurofibromas. SpringWorks expects to provide an update on the ReNeu trial in the fourth quarter of 2020 or first quarter of 2021.
B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma

Enrollment is ongoing in a Phase 1b trial evaluating nirogacestat in combination with BLENREP (belantamab mafodotin-blmf), GSK’s anti-B-cell maturation antigen (BCMA) antibody-drug conjugate, in patients with relapsed or refractory multiple myeloma.
Entered into a clinical collaboration with Janssen Biotech, Inc. (Janssen) to evaluate nirogacestat in combination with Janssen’s BCMA CD3 bispecific antibody, teclistamab, in patients with relapsed or refractory multiple myeloma. A Phase 1 study is expected to commence by early 2021, pending discussions with regulators.
Entered into a clinical collaboration with Pfizer Inc. (Pfizer) to evaluate nirogacestat in combination with Pfizer’s BCMA CD3 bispecific antibody, PF‐06863135, in patients with relapsed or refractory multiple myeloma. A Phase 1b/2 study is expected to commence in the first half of 2021.
An IND application is expected to be filed by the end of 2020 to evaluate nirogacestat in combination with Allogene’s BCMA AlloCAR T therapy, ALLO-715, in patients with relapsed or refractory multiple myeloma.
Entered into a clinical collaboration with Precision BioSciences, Inc. (Precision) to evaluate nirogacestat in combination with Precision’s allogeneic CAR T candidate targeting BCMA, PBCAR269A, in patients with relapsed or refractory multiple myeloma. A Phase 1/2a clinical study is expected to commence in the first half of 2021, pending discussions with regulators.
Entered into a sponsored research agreement with Fred Hutchinson Cancer Research Center (Fred Hutch) to further explore the ability of nirogacestat to modulate BCMA and potentiate BCMA-targeting therapies in a variety of preclinical and patient-derived multiple myeloma models developed by researchers at Fred Hutch.
Biomarker-Defined Metastatic Solid Tumors

Enrollment is ongoing in a Phase 1b/2 trial evaluating mirdametinib with BeiGene’s RAF dimer inhibitor, lifirafenib, in patients with RAS/RAF mutant and other MAPK pathway aberrant solid tumors. SpringWorks and BeiGene expect to report initial clinical data in 2021.
Enrollment is ongoing in a Phase 1 trial of BGB-3245 in patients with RAF mutant solid tumors. BGB-3245 is a selective RAF dimer inhibitor being developed by MapKure, LLC, an entity that is jointly owned by SpringWorks and BeiGene, Ltd. Initial clinical data from the Phase 1 study are expected in 2021.
General Corporate

In October 2020, SpringWorks completed a follow-on public offering that raised $269.5 million in net proceeds, which included the underwriters’ full exercise of their option to purchase additional shares of common stock.
SpringWorks and Jazz Pharmaceuticals entered into an asset purchase and exclusive license agreement under which Jazz acquired SpringWorks’ fatty acid amide hydrolase (FAAH) inhibitor program, PF-04457845. Under the terms of the agreement, Jazz assumed all milestone and royalty obligations owned by SpringWorks to Pfizer under the 2017 license agreement pursuant to which SpringWorks obtained rights to this asset. In addition, Jazz made an upfront payment of $35 million to SpringWorks, with potential future milestone payments of up to $375 million payable to SpringWorks based upon the achievement of certain clinical development, regulatory and commercial milestones. SpringWorks is also entitled to receive tiered royalties on future net sales of PF-04457845.
Third Quarter and Year to Date 2020 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $13.9 million and $36.6 million for the third quarter and year-to-date periods, respectively, compared to $10.7 million and $30.4 million for the comparable periods of 2019, respectively. The increases in R&D expenses in 2020 were primarily attributable to growth in employee costs associated with increases in the number of R&D personnel, an increase in non-cash share-based compensation expense and increases in external costs related to drug manufacturing and clinical trial costs.
General and Administrative (G&A) Expenses: G&A expenses were $7.7 million and $20.9 million for the third quarter and year-to-date periods, respectively, compared to $4.6 million and $11.5 million for the comparable periods of 2019, respectively. The increases in G&A expenses in 2020 were primarily attributable to growth in employee costs associated with increases in the number of G&A personnel supporting the growth of the organization, and an increase in non-cash share-based compensation expenses, as well as increases in expenses related to the expansion of business activities.
Net Loss Attributable to Common Stockholders: SpringWorks reported net losses of $21.7 million, or $0.51 loss per share, and $56.8 million, or $1.35 loss per share, for the third quarter and year-to-date periods ended September 30, 2020, respectively. This compares to net losses of $16.8 million, or $1.77 loss per share, and $34.4 million, or $9.24 loss per share, for the comparable periods of 2019, respectively.
Cash Position: Cash, cash equivalents and marketable securities were $276.8 million as of September 30, 2020. This does not include the net proceeds of $269.5 million from the Company’s follow-on public offering completed in October 2020 or the $35 million upfront payment Jazz Pharmaceuticals made to SpringWorks in October 2020.
COVID-19 Update
To date, the COVID-19 pandemic has had a relatively modest impact on SpringWorks’ business operations, in particular on SpringWorks’ clinical trial programs, and SpringWorks is undertaking considerable efforts to mitigate the various challenges presented by this crisis. For further details and descriptions of the risks associated with the COVID-19 pandemic, please see the Risk Factors in SpringWorks’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2020 and refer to the Forward-Looking Statements section in this press release.