On November 14, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported financial results for the third quarter ended September 30, 2022 (Press release, Tracon Pharmaceuticals, NOV 14, 2022, View Source [SID1234624026]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"Enrollment in the ENVASARC Phase 2 pivotal trial continues to be ahead of schedule and we look forward to reporting the interim efficacy analysis on the initial 36 patients in the fourth quarter, after each patient has had two on-study scans," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Additionally, we have been notified by the ICC Tribunal that it is far along in its deliberations but invited additional information on two discrete issues and requested arbitration costs prior to determining the final award of the binding arbitration with I-Mab. We now expect to receive the decision in the first quarter of 2023."

Recent Corporate Highlights

In August, we announced that the U.S. Food and Drug Administration (FDA) approved our Investigational New Drug (IND) application for the initiation of a Phase 1/2 clinical trial of our CTLA-4 antibody YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy.

In September, we announced entry into a $35 million non-dilutive long-term debt facility with Runway Growth Finance Corp., with $10 million funded at closing which extended the Company’s runway to mid-2023.

In September, we announced that we received fast track designation from the FDA for the development of envafolimab for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.

In October, the Independent Data Monitoring Committee (IDMC) recommended the ENVASARC Phase 2 pivotal trial proceed as planned following the review of more than 12 weeks of safety data from more than 20 patients who received the 600 mg dose of envafolimab as a single agent or in combination with Yervoy (ipilimumab).
Expected Upcoming Milestones

Report the interim efficacy analysis by the IDMC following the review of more than 12 weeks of efficacy data from 36 patients who received the 600 mg dose of envafolimab as a single agent or in combination with Yervoy.

Initiate dosing in the Phase 1/2 clinical trial of envafolimab with our potential best in class CTLA-4 antibody YH001, as well as with doxorubicin chemotherapy.

Report the binding decision of the International Chamber of Commerce (ICC) Arbitration Panel on the ongoing arbitration involving the TJ4309 and bispecific antibody agreements with I-Mab Biopharma where we are seeking to recover over $200 million in damages, which we expect in the first quarter of 2023.
Third Quarter 2022 Financial Results

Cash and cash equivalents were $17.0 million at September 30, 2022, compared to $24.1 million at December 31, 2021, and is expected to fund the company into mid-2023.

Research and development expenses for the third quarter of 2022 were $4.1 million, compared to $2.7 million for the third quarter of 2021.

General and administrative expenses for the third quarter of 2022 were $2.3 million, compared to $4.2 million for the third quarter of 2021. The decrease was primarily attributable to legal expenses incurred in the third quarter of 2021 due to the arbitration with I-Mab.

Net loss for the third quarter of 2022 was $6.4 million, compared to $7.0 million for the third quarter of 2021.
Conference Call Details

To access the call by phone, please register using this link and you will be provided with dial-in details.

A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients as well as multiple Phase 1 and Phase 2 clinical trials in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

About YH001

YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity and complement dependent cytotoxicity in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being studied with envafolimab and doxorubicin in a Phase 1/2 clinical trial sponsored by TRACON (NCT05448820), and in multiple Phase 1 trials in China and Australia sponsored by TRACON’s corporate partner Eucure, a division of Biocytogen.

About TRC102

TRC102 (methoxyamine) is a novel small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the FDA in malignant glioma, including glioblastoma.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On November 14, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported important updates relating to its ongoing Phase 3 open-label registrational clinical trial (the REGAL study) for galinpepimut-S (GPS) in acute myeloid leukemia (AML) patients who have achieved complete remission following second-line salvage therapy (CR2 patients) (Press release, Sellas Life Sciences, NOV 14, 2022, View Source [SID1234624025]).

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The primary endpoint of the REGAL study is overall survival (OS). The trial was originally designed using certain assumptions regarding OS for both the GPS treatment arm and the control arm receiving best available treatment (BAT) which are reflected in the protocol and statistical analysis plan (SAP) for the study. A review of preliminary data to date, which was pooled (i.e., GPS arm plus control arm) and which remains blinded as to treatment arm, suggests that the median OS in the pooled study population is likely considerably longer, by approximately two-fold, than originally anticipated and upon which the SAP was based. Accordingly, the overall duration of the REGAL study is now expected to be longer than initially predicted.

Following consultation with members of the Independent Data Monitoring Committee for the REGAL study and AML key opinion leaders, as well as the recommendations of the Company’s biostatistics experts, SELLAS is implementing changes to the SAP and protocol for the REGAL study as follows:

The total targeted enrollment in the study will increase from 116 patients to a range of 125 to no more than 140 patients.
The targeted number of events (deaths) for the interim analysis will be reduced to 60 from 80 and is currently expected to occur in late 2023 or early 2024.
The targeted number of events (deaths) for the final analysis will be reduced to 80 from 105 and is currently expected to occur by the end of 2024.
Statistical significance would be achieved by an estimated hazard ratio (HR) for OS of 0.636, corresponding to an OS of 12.6 months versus eight months for GPS versus BAT, respectively.
The Company has developed these changes using a conservative application of the O’Brien-Fleming statistical theory, which is suitable when regulatory approval is expected to be based predominantly on results from a single clinical trial and when mortality is the primary endpoint. The Company has notified the U.S. Food and Drug Administration of these changes through a filing to the investigational new drug application (IND) for GPS.

Additionally, SELLAS’ development and commercialization partner for the Greater China territory, 3D Medicines (3DMed), has agreed to participate in the REGAL trial through the inclusion of approximately 20 patients from the Greater China territory. Such participation by 3DMed is possible due to the increase in the target patient enrollment in the study and will trigger significant milestone payments, which SELLAS expects to receive in the first half of 2023. If the REGAL study meets its primary endpoint for efficacy and the Chinese regulatory authorities determine that the REGAL data is sufficient for approval in China, GPS could potentially reach the market in Greater China much earlier than had been anticipated by SELLAS and 3DMed when the parties entered into the license agreement providing rights to 3DMed, triggering additional regulatory and commercialization milestones and royalties for SELLAS.

"The review of the pooled blinded dataset from the REGAL study shows that the entire trial population has a longer than originally expected OS duration," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "The causative reason for this result remains unknown and could be attributed to many factors, including the potential for, and extent of, increased clinical benefit accorded by the active GPS arm as well as an evolving treatment landscape and potentially better care for the patients receiving BAT. However, without unblinding the study, it is currently impossible to confirm or refute any of the possibilities. Upon examining the pooled blinded dataset, we worked expeditiously with our biostatisticians and other clinical advisors to refine our SAP, taking into account the observed longer OS, which has resulted in a reduction of the number of events needed for the interim and final analyses while maintaining a similar hazard ratio."

"Furthermore, our team has agreed on a path forward with our partner 3DMed to allow for 3DMed to participate in the REGAL trial and to enroll Chinese patients in a Phase 3 study much earlier than anticipated. This has been made possible by the refinements we are making for the REGAL study. Assuming a statistically significant and clinical beneficial outcome of the REGAL study, as well as agreement by the Chinese regulatory authorities that such data is sufficient for approval in China, GPS may become available to patients in China far earlier than originally thought, which would be a positive outcome for patients in need of better AML therapies," continued Dr. Stergiou.

Phase 3 REGAL Study Update Virtual Investor Event

SELLAS will hold a virtual investor event today, November 14, 2022, at 8:30 a.m. ET at which the Company will discuss these updates. The event will be facilitated by SELLAS management, including the Company’s President and CEO, Angelos Stergiou, MD, ScD h.c., and Dragan Cicic, MD, Senior Vice President, Clinical Development, who will be joined by leading cancer researcher, M. Yair Levy, M.D., Director of Hematologic Malignancies Research at the Baylor University Medical Center and member of the REGAL Steering Committee.

On November 14, 2022 Scholar Rock (NASDAQ: SRRK), a Phase 3 clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported financial results and corporate updates for the third quarter ended September 30, 2022 (Press release, Scholar Rock, NOV 14, 2022, View Source [SID1234624024]).

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"We continue to build conviction in our clinical programs with recent TOPAZ data indicating apitegromab’s potential for sustained improvements of quality-of-life measures over 24 months, and with the most recently available SRK-181 data from DRAGON that we presented at SITC (Free SITC Whitepaper)," said Jay Backstrom, M.D., M.P.H., Chief Executive Officer & President of Scholar Rock. "I am excited to strengthen our experienced executive team with the addition of Scholar Rock’s new CMO, Dr. Jing Marantz. I am confident the continued momentum of the Phase 3 SAPPHIRE trial and the DRAGON trial will be further bolstered under her leadership."

Company Highlights and Upcoming Milestones

Pipeline Updates

Apitegromab is a selective inhibitor of myostatin activation being developed as the potential first muscle-targeted therapy for the treatment of spinal muscular atrophy (SMA).

Presented new Phase 2 TOPAZ trial data indicating positive trends in quality-of-life measures over 24 months with apitegromab for nonambulatory patients with Types 2 and 3 SMA. Scholar Rock presented these data, which indicate the potential for sustained improvement in quality-of-life measures for patients with symptomatic SMA and offer further signs of possible durable effects of apitegromab, at the World Muscle Society (WMS) Hybrid Congress and the International Scientific Congress on Spinal Muscular Atrophy in October.

Continued enrollment of the Phase 3 SAPPHIRE clinical trial. SAPPHIRE, a randomized, double-blind, placebo-controlled clinical trial evaluating apitegromab for patients with non-ambulatory Types 2 and 3 SMA on either nusinersen or risdiplam, is actively enrolling SMA patients across 55 sites in the U.S. and Europe. The anticipated enrollment is approximately 156 patients aged 2-12 in the main efficacy population.
SRK-181 is an investigational selective inhibitor of latent TGFβ1 activation and is being developed with the aim of overcoming resistance in patients with advanced cancer.

Data from the Phase 1 DRAGON trial presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting show that SRK-181 continues to be generally well tolerated with early indications of efficacy (as of the data cut-off date of August 29, 2022).
No dose-limiting toxicities were observed in patients participating in Part A, and all dose levels were generally well tolerated, including the recommended SRK-181 dose of 1500 mg q3w or 1000 mg q2w in combination with anti‑PD-(L)1 for Part B.
In Part A2 of the trial (n=15), there was one confirmed partial response ("PR") in a patient with anti-PD-1 resistant clear cell renal cell carcinoma at 800mg who remained in the study for 30 weeks. Response was assessed based on RECIST 1.1 by principal investigators. One ongoing patient in the 2400 mg dose group of Part A2 with head and neck cancer experienced a 29.4% tumor reduction.
Enrollment in DRAGON Part B is ongoing. Across the cohorts, 14 patients have been dosed as of the data cut-off date. The recommended dose of 1500mg q3w or 1000mg q2w SRK-181 in combination with anti-PD-(L)1 was generally well tolerated. There was a confirmed PR in one ongoing patient with anti-PD-1 resistant clear cell renal cell carcinoma. Scholar Rock will continue to provide updates at future scientific meetings.
Corporate Updates

Announced key leadership appointments:
Jay Backstrom, M.D., M.P.H. was appointed President & CEO in October, bringing an exceptional range of research and development, regulatory, and leadership experience spanning several decades in the biopharmaceutical industry. He has been instrumental in organizing and executing development strategies and has led programs in a broad range of therapeutic areas through regulatory approvals. Dr. Backstrom most recently served as Executive Vice President, Research and Development at Acceleron Pharma, which was acquired by Merck in 2021.
Jing L. Marantz, M.D., Ph.D., M.B.A., was appointed Chief Medical Officer in November. Dr. Marantz is an accomplished biopharmaceutical executive with over 20 years of industry experience spanning multiple specialties, including neurology, hematology/oncology, and rare diseases. Most recently, she served as the Executive Vice President and Chief Business Officer at Krystal Biotech. Previously, she was Senior Vice President and Head of Medical Affairs at Acceleron Pharma, where she also was a member of the R&D leadership team.
Amended debt facility with Oxford Finance and Silicon Valley Bank. Scholar Rock amended the existing debt facility with Oxford Finance and Silicon Valley Bank. Under the agreement, an additional $25 million tranche is available at the company’s discretion and subject to meeting certain criteria. The amendment also extends both the interest-only period for an additional 24 months to November 2024, and the loan maturity date to November 2027.
Third Quarter 2022 Financial Results

For the quarter ended September 30, 2022, net loss was $43.3 million or $0.55 per share compared to a net loss of $37.5 million or $1.02 per share for the quarter ended September 30, 2021.

Revenue was $0 for the quarter ended September 30, 2022, compared to $5.5 million for the quarter ended September 30, 2021.
Research and development expense was $33.4 million for the quarter ended September 30, 2022, compared to $31.3 million for the quarter ended September 30, 2021. The increase was primarily attributable to expenses related to non-cash equity-based compensation expense, a component of employee compensation and benefits costs.
General and administrative expense was $10.5 million for the quarter ended September 30, 2022, compared to $11.3 million for the quarter ended September 30, 2021. The decrease was attributable to the reduction of employee severance and benefits expenses that were recognized during the same period in the prior year.
As of September 30, 2022, Scholar Rock had cash, cash equivalents, and marketable securities of approximately $343.7 million, which is expected to fund the Company’s anticipated operating and capital expenditure requirements into 2025.
"With the successful equity financing that we completed in the second quarter and the added flexibility provided by the amendment of our debt facility, we are well funded to advance our pipeline through key milestones," said Ted Myles, Chief Operating Officer and Chief Financial Officer of Scholar Rock. "We believe the company is well positioned to deliver value to patients with unmet medical needs. With sufficient capital to complete the topline data readout from the SAPPHIRE study, progress Part B of the DRAGON trial, and continue advancing select preclinical programs, we are laser focused on the successful execution of these priorities."

On November 14, 2022 Roivant Sciences Ltd. (Nasdaq: ROIV) reported its financial results for the second quarter ended September 30, 2022 and provided an update on the Company’s operations (Press release, Roivant Sciences, NOV 14, 2022, View Source [SID1234624023]).

Roivant’s chief executive officer, Matt Gline, noted: "This has been a great quarter for Roivant. In addition to VTAMA’s strong performance and the enthusiastic feedback we’ve received from patients and providers, we executed our first major PBM contract. This provides immediate coverage for millions of lives associated with that PBM, establishes a national template for unrestricted access to VTAMA, and supports a paradigm shift to VTAMA as the mainstay of psoriasis therapy. Our fully enrolled potentially registrational SLE study for brepocitinib, which reads out next year, and Immunovant’s broadened anti-FcRn portfolio, represent notable progress in our immunology pipeline. Between cost reduction and multiple recent infusions of capital, we’ve extended our runway into the second half of calendar year 2025 – and we’re looking forward to multiple key catalysts between now and then, including many in the next year."

Recent Developments

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•Roivant: On November 8, priced $150 million total gross primary and secondary offering, consisting of gross primary proceeds to Roivant of $100 million. Roivant continued its cost optimization and pipeline reprioritization initiatives initially announced in June 2022 in order to focus capital on the most valuable and meaningful opportunities in the pipeline, while maintaining the financial flexibility to opportunistically in-license assets. Roivant expects that its consolidated cash, cash equivalents and restricted cash of $1.6 billion at September 30, 2022, or $1.9 billion after giving effect to subsequent Roivant and Immunovant follow-on offerings and anticipated proceeds from the sale of Myovant equity rights to Sumitomo Pharma, along with continued cost savings initiatives, support cash runway into second half of calendar year 2025.

•Dermavant: Through November 4, VTAMA has had over 54,000 prescriptions written by approximately 6,400 unique prescribers, based on IQVIA data. For the quarter ended September 30, 2022, Roivant reported VTAMA net product revenue of $5.0 million, representing a gross-to-net yield of approximately 12%. Dermavant also entered into a reimbursement contract with one of the three largest PBMs, effective October 1, 2022. Finally, Dermavant announced results from its maximal use pharmacokinetic study of VTAMA in atopic dermatitis, which showed minimal to no systemic absorption and favorable tolerability when used in pediatric patients down to age two.

•Priovant: Completed enrollment for its ongoing potentially registrational global trial evaluating oral brepocitinib for the treatment of SLE in August 2022. Oral brepocitinib is a potential first-in-class dual, selective inhibitor of TYK2 and JAK1 licensed from Pfizer that has been evaluated in 14 completed Phase 1 and Phase 2 trials, including 5 placebo-controlled Phase 2 trials in psoriatic arthritis, plaque psoriasis, ulcerative colitis, alopecia areata and hidradenitis suppurativa that generated statistically significant and clinically meaningful efficacy results. With over 1,000 patients exposed in these studies, brepocitinib showed a safety and tolerability profile in line with other class agents. Priovant is also developing oral brepocitinib for the treatment of dermatomyositis, for which it recently initiated a single potentially registrational Phase 3 trial.

•Immunovant: At Roivant’s Investor Day on September 28, Immunovant unveiled IMVT-1402, a next generation anti-FcRn which showed deep IgG lowering similar to batoclimab with no or minimal impact observed on albumin and LDL levels in a head-to-head animal study with batoclimab and placebo. Additionally, on September 7 Immunovant unveiled two new development programs for batoclimab in Graves’ disease and chronic inflammatory demyelinating polyneuropathy (CIDP). Immunovant also completed a $75.0 million follow-on offering in October, with leading life sciences investors including Logos Capital, Deep Track Capital, Frazier Life Sciences, TCGX, BVF Partners, and Commodore Capital participating.

•Genevant: On November 2, the federal district court in Delaware issued an opinion and order in the patent infringement suit brought by Genevant and Arbutus against Moderna. The court denied Moderna’s partial motion to dismiss the suit based on the government-contractor defense under 28 U.S.C. Section 1498, which was an attempt by Moderna to shift liability for an unspecified portion its alleged infringement to the US government and taxpayers. The case is now expected to proceed to the pre-trial discovery phase.

•Proteovant: Disclosed today data from its preclinical estrogen receptor (ER) degrader demonstrating equal or better tumor reduction in an in vivo model in a head-to-head comparison with the most advanced degrader in its class.

•Affivant: Affivant and Affimed jointly unveiled AFVT-2101 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Boston on November 8. AFVT-2101 is a tetravalent, bispecific ICE (innate cell engager) that selectively targets folate receptor alpha (FRα) and CD16A (FcγR3A). AFVT-2101 directs innate immune cells to kill tumor cells selectively and potently with a wide range of FRα expression. Due to the high avidity for CD16A, AFVT-2101 is more efficacious and potent in both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) assays than farletuzumab, a monoclonal antibody targeting FRα.

Major Upcoming Milestones

•Dermavant: Expects to provide updates on the commercial launch of VTAMA for psoriasis on a periodic basis and to report topline data from the Phase 3 trials of VTAMA for the treatment of atopic dermatitis in the first half of calendar year 2023.

•Priovant: Plans to announce topline results from the potentially registrational trial evaluating brepocitinib for the treatment of patients with SLE in the second half of calendar year 2023.

•Immunovant: Phase 3 trials of batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED) progressing and expects to have top-line results from the MG trial in the second half of calendar year 2024 and from the two TED trials in the first half of calendar year 2025. A pivotal Phase 2b trial in CIDP is planned to be initiated by the end of calendar year 2022, with initial results from the open label period expected in the first half of calendar year 2024. In Graves’ disease, a Phase 2 trial is planned to be initiated in early calendar year 2023 with initial results expected in the second half of calendar year 2023. Immunovant plans to finalize the lead asset and trial design in WAIHA following an expected engagement with the hematology division of the FDA before the end of calendar year 2022. Immunovant plans to submit an IND and initiate a Phase 1 study for IMVT-1402 in early 2023 with initial human data expected in mid-2023; Immunovant believes these Phase 1 results together with strong IgG biomarker data from batoclimab may accelerate the development program for 1402.

•Hemavant: Plans to announce data from the ongoing open-label Phase 1/2 trial evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk MDS patients in the second half of calendar year 2023.

•Kinevant: Plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the first half of calendar year 2024.

Second Quarter Ended September 30, 2022 Financial Summary

Cash Position

As of September 30, 2022, we had cash, cash equivalents and restricted cash of approximately $1.6 billion. Giving effect to Immunovant’s October 2022 follow-on offering for $75 million in gross proceeds, Roivant’s November follow-on offering for $100 million in gross primary proceeds, and $115 million in expected proceeds from the planned sale of the Myovant top-up shares in connection with the pending acquisition of Myovant by Sumitomo Pharma, Roivant’s consolidated cash, cash equivalents and restricted cash would have been approximately $1.9 billion. The Myovant transaction is expected to close in the first calendar quarter of 2023, subject to customary closing conditions.

Research and Development Expenses

Research and development (R&D) expenses were $132.0 million for the three months ended September 30, 2022 compared to $132.1 million for the three months ended September 30, 2021. The quarter-over-quarter decrease was primarily due to a decrease in share-based compensation expense due to the achievement of the liquidity event vesting condition for certain equity instruments upon the closing of the Business Combination with MAAC in September 2021, resulting in the recognition of a one-time catch-up expense. This decrease was offset by increases in personnel-related expenses and program-specific costs, reflecting the progression of our programs and drug discovery. Non-GAAP R&D expenses were $123.3 million for the three months ended September 30, 2022 compared to $103.2 million for the three months ended September 30, 2021.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $157.7 million for the three months ended September 30, 2022 compared to $437.8 million for the three months ended September 30, 2021. The quarter-over-quarter decrease was primarily due to a decrease in share-based compensation expense, partially offset by higher selling, general and administrative expenses at Dermavant as a result of the commercial launch of VTAMA. The decrease in share-based compensation resulted from the achievement of the liquidity event vesting condition for certain equity instruments upon the closing of the Business Combination with MAAC in September 2021, resulting in the recognition of a one-time catch-up expense. This decrease was partially offset by continued vesting of the equity instruments. Non-GAAP SG&A expenses were $101.5 million for the three months ended September 30, 2022 compared to $68.0 million for the three months ended September 30, 2021.

Net Loss

Net loss was $315.9 million for the three months ended September 30, 2022 compared to $225.6 million for the three months ended September 30, 2021. On a per common share basis, net loss was $0.42 for the three months ended September 30, 2022 and $0.32 for the three months ended September 30, 2021. Non-GAAP net loss was $226.8 million for the three months ended September 30, 2022 compared to $290.0 million for the three months ended September 30, 2021.

(1) Represents non-cash amortization of intangible assets associated with milestone payments made in connection with regulatory approvals.

(2) Represents non-cash share-based compensation expense.

(3) Represents non-cash depreciation and amortization expense, other than amortization of intangible assets associated with milestone payments made in connection with regulatory approvals.

(4) Represents the unrealized loss (gain) on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings.

(5) Represents a one-time gain on sale of investment resulting from the merger of Datavant and CIOX Health in July 2021.

(6) Represents the change in fair value of debt and liability instruments, which is non-cash and primarily includes the unrealized (gain) loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.

(7) Represents the one-time gain on termination of the options held by Sumitomo Dainippon Pharma Co., Ltd. to purchase Roivant’s ownership interest in certain Vants (the "Sumitomo Options").

(8) Represents the one-time gain on deconsolidation of a subsidiary.

(9) Represents the estimated tax effect of the adjustments.

Beginning in the fourth quarter of the fiscal year ended March 31, 2022, the Company no longer excludes from its non-GAAP financial measures acquired IPR&D expenses, which include consideration for the purchase of IPR&D through asset acquisitions and license agreements as well as payments made in connection with asset acquisitions and license agreements upon the achievement of development milestones. Previously, these items were excluded from the Company’s non-GAAP financial measures. In conjunction with this change, acquired IPR&D expenses are now reported as a separate line item in its consolidated statements of operations. Prior period amounts have been revised to conform to the current presentation.

There was no acquired IPR&D expense for the three and six months ended September 30, 2022. For the three and six months ended September 30, 2021, acquired IPR&D expense was $122.2 million and $122.3 million, respectively.

Roivant also announced today that it will participate in three additional upcoming investor conferences:

Cantor Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference in Miami from December 7-8. CFO Richard Pulik will participate in the panel "Commercial Successes, Current & Upcoming Launches" at 9:00 a.m. EST on Thursday, December 8

Jefferies Healthcare Summit in Denver from December 14-15

41st Annual J.P. Morgan Healthcare Conference in San Francisco from January 9-12

Investor Conference Call Information

Roivant will host a live conference call and webcast at 8:00 a.m. EST on Monday, November 14, 2022 to report its financial results for the fiscal quarter ended September 30, 2022 and provide a corporate update.

To access the conference call by phone, please register online using this registration link. A webcast of the call will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.

On November 14, 2022 RenovoRx, Inc. (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of difficult-to-treat solid tumors through its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform, reported its financial results for the quarter ended September 30, 2022 (Press release, Renovorx, NOV 14, 2022, View Source [SID1234624022]).

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"Since our Inception, RenovoRx’s mission has been to develop and refine our innovative therapy platform, RenovoTAMP, for targeted intra-arterial (IA) delivery of chemotherapy directly to difficult-to-treat solid tumors with the vision of disrupting the current standard of care," said Shaun Bagai, CEO of RenovoRx. "In Q4 of this year, we are anticipating our most significant milestone to date; the first prospective interim analysis of our Phase III TIGeR-PaC clinical trial. The results of this trial have the potential to revolutionize pancreatic cancer treatment, shifting patient focus from coping with their chemotherapy treatment and its typical harsh side effects, to spending more quality time with their family and loved ones. Additionally, the interim analysis will provide us with an important insight into RenovoTAMP and its possibilities as a therapeutic platform. We also anticipate the launch of our second clinical trial in extrahepatic cholangiocarcinoma (eCCA) in Q4 2022/Q1 2023. This will be an integral step in RenovoRx’s growth trajectory, demonstrating the ability of our therapy platform on another difficult-to-treat and aggressive form of cancer."

Mr. Bagai continued, "I am confident in the team we have in place, especially with the recent addition of Angela Gill Nelms as our COO. Angela’s experience and expertise in clinical trial management, driving innovation, and building high-functioning teams has already proven to be invaluable. This is an exciting time to be a part of the RenovoRx team as we continue to be laser-focused on advancing our Phase III TIGeR-PaC clinical trial, launching our Phase II/III clinical trial in eCCA, and expanding our clinical pipeline to fight difficult-to-treat cancers."

Financial Highlights for the Quarter Ended September 30, 2022

●As of September 30, 2022, the Company had cash and cash equivalents and short-term marketable securities of $8.1 million.
●Research and development expenses were $0.8 million for the quarters ended September 30, 2022, and September 30, 2021, respectively. Clinical consulting expenses increased $0.2 million including preclinical research and development and regulatory expenses of $0.2 million which was offset by a decrease in the Phase III TIGeR-PaC clinical trial costs of $0.4 million compared to the quarter ended September 30, 2021.
●General and administrative expenses were $1.3 million for the quarter ended on September 30, 2022, compared to $0.6 million for the quarter ended on September 30, 2021. This $0.7 million increase was primarily due to a $0.3 million increase in professional and consulting services, including legal fees, related to post-IPO support, $0.2 million increase for higher personnel related costs and $0.2 million for directors’ and officers’ liability premiums.
●Net loss was $2.1 million for the quarter ended on September 30, 2022, compared to a net loss of $1.5 million for Q3 ended September 30, 2021.
●As of September 30, 2022, the Company had 9,072,263 common shares outstanding.

About the Phase III TIGeR-PaC Clinical Trial

TIGeR-PaC is a randomized multi-center Phase III study using RenovoRx’s innovative therapy platform, RenovoTAMPTM (RenovoRx Trans-Arterial Micro-Perfusion). The study is evaluating the Company’s first product candidate, RenovoGemTM, to treat locally advanced pancreatic cancer (LAPC) through the intra-arterial delivery of gemcitabine (FDA-approved chemotherapy). The study has a primary endpoint of overall survival and several secondary endpoints, including quality of life.

TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the US. To learn more about the study and the participating clinical trial sites, visit View Source