On August 14, 2023 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics to treat rare fibro-inflammatory diseases with high unmet need, reported financial and operating results for the second quarter ended June 30, 2023, and provided a corporate update (Press release, Chemomab, AUG 14, 2023, View Source [SID1234634382]).

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"I am pleased to report that the company continued to make good progress during the second quarter," said Adi Mor, PhD, co-founder, Chief Executive Officer and Chief Scientific Officer of Chemomab. "In June, the Board of Directors re-appointed me to the CEO position and re-appointed then Vice President of Finance Sigal Fattal as Chief Financial Officer. Our extensive prior experience in these roles and ongoing active involvement in company management have made for a seamless transition."

Dr. Mor continued, "During the quarter we sharpened our corporate strategy. We extended our cash runway to take us through the end of 2024 and the readout of topline results from our Phase 2 trial of CM-101 in patients with primary sclerosing cholangitis (PSC), expected in the second half of 2024. Extension of the cash runway was achieved by tightening our focus and selectively pruning expenses. Enrollment in the PSC trial continues to go very well and we are pleased to have the resources on-board to take us through this major milestone. In addition, we are increasingly optimistic about the potential prospects for the PSC program based on additional positive biomarker data from our Phase 2 liver fibrosis trial that may also be applicable to PSC. As part of our strategic refresh, we suspended the planned start of our Phase 2 systemic sclerosis (SSc) trial; however, we remain enthusiastic that CM-101 may have disease-modifying potential in this poorly-treated condition and the SSc program remains fully Phase 2-ready."

Dr. Mor added, "The second quarter was notable for our many scientific presentations at important European medical meetings like EASL and EULAR. We also published a research article in a respected peer-reviewed journal, JCI Insight. As a group, the studies reinforce our extensive data highlighting the central role of CCL24 in the pathophysiology of fibro-inflammatory diseases and confirm that our CCL24-neutralizing antibody, CM-101, has potential therapeutic utility in these conditions."

"Promising new data from secondary analyses of our Phase 2 liver fibrosis trial in NASH patients was presented in a late-breaking poster at the 2023 EASL Congress in July. The new results show encouraging improvements in additional inflammatory and fibrogenesis-related biomarkers. Overall, the improvements in biomarkers seen in the Phase 2 liver fibrosis trial reinforce our belief that these data may serve as a potential bridge to other anti-fibrotic indications such as PSC, providing additional evidence that CM-101 could be a valuable therapy for this potentially fatal disease that lacks effective treatment options."

Corporate Developments

Implemented Executive Changes
In June, Chemomab announced that Adi Mor, PhD, co-founder and former Chief Executive Officer (CEO), and then Director and Chief Scientific Officer, had been reappointed to the role of CEO, replacing Dale Pfost, PhD. Sigal Fattal, former Chief Financial Officer (CFO) and then Vice President, Finance, had been reappointed to the role of CFO, replacing Donald Marvin. Nissim Darvish, MD, PhD, was appointed Chairman of the Board, replacing Dr. Pfost. All the appointments were effective June 1, 2023. The company also announced that it was implementing additional cost-reduction measures that extend its cash runway from mid-year 2024 to the end of 2024, after the expected topline data readout from the Phase 2 CM-101 PSC trial.

Presented Data at 2023 EASL Biliary Conference Reinforcing the Proinflammatory Role of CCL24 in Cholestatic Disease
In a poster presentation at the 2023 EASL Biliary Conference in May, researchers used patient proteomic and animal data to demonstrate the proinflammatory role of CCL24 in cholestatic disease. In these studies, CM-101 demonstrated an anti-inflammatory effect by interfering with the migration of monocytes and neutrophils to the damaged biliary area in a PSC animal model, thereby reducing fibrosis and biliary hyperplasia.

Presented Patient Data at 2023 EULAR Congress Showing that Serum CCL24 Levels Can Predict Vascular and Fibrotic Complications of Systemic Sclerosis
In a poster presentation at the 2023 EULAR European Congress of Rheumatology in June, researchers presented results from a patient sample study demonstrating that high serum levels of CCL24 were correlated with SSc severity, including a higher incidence of fibrosis-associated symptoms; a three-fold increased risk of interstitial lung disease progression; and a shorter SSc-related 5-year survival time.

Reported Secondary Analyses of CM-101 Phase 2 Liver Fibrosis Trial
In a late-breaking poster presentation at the 2023 EASL Congress in July, Chemomab reported secondary analysis data from its Phase 2a liver fibrosis trial of CM-101 in patients with non-alcoholic steatohepatitis (NASH). The data showed improvements across an additional set of inflammatory and fibrotic biomarkers that are consistent with the positive topline clinical results Chemomab released in January. Additionally, in NASH patients at greater risk of disease progression, CM-101 treatment resulted in a greater biomarker response than in patients with lower risk disease or in placebo-treated patients.

Reported Data Reinforcing the Clinical Potential of CM-101 as a Novel Treatment for PSC
At the 2023 EASL Congress in July, Chemomab presented two posters discussing the potential of CM-101 as a novel treatment for PSC. One of the posters reported on a new proteomic study demonstrating a direct relationship between the pro-inflammatory, pro-fibrotic activity of CCL24 and PSC disease-related pathways. The other poster described the clinical design of Chemomab’s double-blind, placebo-controlled, multiple dose Phase 2 trial of CM-101 in PSC patients.

Published Peer-Reviewed Research Article Demonstrating the Key Role of CCL24 in PSC
This peer-reviewed research article published in the June issue of JCI Insight was produced through collaborations with prominent academic groups and supports the key role of CCL24 in driving the self-perpetuating fibrosis and inflammation that result in the severe liver damage characterizing PSC.

Second Quarter 2023 Financial Highlights

Cash Position: Cash, cash equivalents and short-term bank deposits were $26.7 million as of June 30, 2023, compared to $32.8 million on March 31, 2023.
Research and Development (R&D) Expenses: R&D expenses were $5.0 million for the second quarter ended June 30, 2023, compared to $2.9 million for the same quarter in 2022. The increase was primarily due to increased clinical activities.

General and Administrative (G&A) Expenses: G&A expenses were $3.2 million for the quarter ended June 30, 2023, compared to $3.3 million for the same quarter in 2022.
Net Loss: Net loss was $8.0 million, or a net loss of approximately $0.04 per basic and diluted ordinary share for the second quarter of 2023, compared to a net loss of $6.2 million, or a net loss of approximately $0.03 per basic and diluted ordinary share for the second quarter of 2022. The weighted average number of ordinary shares outstanding, basic and diluted, was 221,674,130 (equal to approximately 11.1 million ADSs) for the quarter ended June 30, 2023.

On August 14, 2023 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported a business update and provided financial results for the second quarter of 2023 (Press release, Viracta Therapeutics, AUG 14, 2023, View Source [SID1234634381]).

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"In the second quarter of 2023, we achieved key milestones in the pivotal NAVAL-1 study of Nana-val by enabling the advancement of this global clinical trial into Stage 2 and establishing EBV-positive PTCL as Nana-val’s leading indication. This milestone was based on a strong signal of efficacy with a favorable safety profile, consistent with our promising Phase 1b/2 clinical trial data," said Mark Rothera, President and Chief Executive Officer of Viracta. "Given the high unmet medical need in patients with EBV-positive PTCL and our positioning of Nana-val as a potential important treatment option for these patients, our goal is to move forward rapidly towards registration in the U.S. We intend to complete Stage 2 enrollment and meet with the U.S. Food and Drug Administration in 2024 to discuss additional requirements for regulatory approval."

Darrel P. Cohen, M.D., Ph.D., Chief Medical Officer of Viracta commented, "We are thrilled to have our Phase 1b/2 study results published in a high-quality peer-reviewed journal, such as Blood Advances, which underscores the potential of Nana-val to treat patients with EBV-positive lymphoma and elevates the importance of the NAVAL-1 trial. Following the advancement of the PTCL cohort and to optimize our resources behind this trial, we have strategically prioritized key subtypes of EBV-positive lymphoma where we can address high unmet medical needs, increase the probability of success, and focus on the largest EBV-positive lymphoma patient populations."

Clinical Trial Updates and Anticipated Milestones

Pivotal NAVAL-1 study of Nana-val in patients with relapsed or refractory (R/R) EBV+ lymphoma

The EBV+ peripheral T-cell lymphoma (PTCL) cohort of the pivotal NAVAL-1 clinical trial met the efficacy threshold for expansion into Stage 2 of the study, which was based upon a pre-specified minimum number of objective responses achieved; initial data are consistent with results from the Phase 1b/2 study and establish EBV+ PTCL as Nana-val’s leading indication.
Strategically prioritized three lymphoma subtypes: (1) EBV+ PTCL, a T-cell lymphoma with high unmet medical need; (2) EBV+ diffuse large B-cell lymphoma (DLBCL), an aggressive and distinct B-cell lymphoma subtype characterized by adverse clinical outcomes, and (3) EBV+ PTLD, a potentially fatal complication after transplantation, which is highly associated with EBV.
Prioritization also enables the allocation of resources to those indications with the greatest probability of success and market opportunity in key geographies.
Enrollment into HIV-lymphoma and Hodgkin lymphoma cohorts will be discontinued.
Patients with extranodal NK/T-cell lymphoma (ENKTL) and other ultra-rare subtypes of EBV+ lymphoma will continue to be enrolled.
Completion of enrollment into Stage 2 of the R/R EBV+ PTCL cohort and engagement with FDA on additional requirements for regulatory approval is anticipated in 2024.
Phase 1b/2 clinical trial of Nana-val in patients with R/R EBV+ lymphoma

In August 2023, Viracta announced the publication in Blood Advances featuring results from an open-label, multicenter, Phase 1b/2 study of Nana-val in patients with R/R EBV+ lymphoma titled, "Targeted therapy with nanatinostat and valganciclovir in recurrent Epstein-Barr virus-positive lymphoid malignancies: a Phase 1b/2 study."
The publication included a more recent data cut reflecting multiple patients with an ongoing durable response exceeding 30 months across multiple EBV+ lymphoma subtypes, including EBV+ PTCL and EBV+ DLBCL, and two patients with an ongoing response of approximately 36 months.
Nana-val was generally well tolerated with reversible low-grade toxicities. The most commonly observed treatment emergent adverse events were reversible cytopenias, low-grade creatinine elevations, and gastrointestinal symptoms.
Phase 1b/2 study of Nana-val in patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors

Enrollment completed through the fifth dose level of the Phase 1b dose escalation portion of the trial without any dose-limiting toxicities reported.
The Company remains on track to report complete Phase 1b dose escalation data and select a Recommended Phase 2 Dose (RP2D) of Nana-val in the second half of 2023.
Initiation of the trial’s randomized Phase 2 expansion cohort designed to evaluate Nana-val at the RP2D with or without pembrolizumab in patients with R/M EBV+ NPC is expected in the second half of 2023.
Initiation of the trial’s exploratory Phase 1b expansion cohort designed to evaluate Nana-val at the RP2D in patients with other advanced EBV+ solid tumors, including gastric carcinoma, leiomyosarcoma, and lymphoepithelioma, is expected in the second half of 2023.
Business Updates

Strengthened the leadership team with the appointment of Darrel P. Cohen, M.D., Ph.D. as Chief Medical Officer (CMO)

In August 2023, Dr. Cohen was appointed as CMO to oversee the clinical development and regulatory advancement of Viracta’s pipeline. Dr. Cohen is a highly accomplished physician and biopharmaceutical executive with more than 25 years of oncology clinical research and drug development experience in both solid tumors and hematologic malignancies. Dr. Cohen was involved in multiple successful regulatory submissions of new targeted cancer drugs such as SUTENT (sunitinib), XALKORI (crizotinib), and IBRANCE (palbociclib) while at Pfizer Oncology.
Strengthened intellectual property estate

In July 2023, Viracta received a Notice of Allowance from the US Patent and Trademark Office on Viracta’s patent claims directed to a next-generation formulation of nanatinostat. This Notice of Allowance supports Viracta’s life-cycle management strategy, and upon issuance, the claims will expire in October 2041.
Second Quarter 2023 Financial Results

Cash position – Cash, cash equivalents, and short-term investments totaled approximately $72.9 million as of June 30, 2023, which Viracta expects will be sufficient to fund its operations into late 2024 excluding any additional borrowing under a $50.0 million credit facility, of which $25.0 million remains available, at the Company’s request and subject to the discretion of the lenders.
Research and development expenses – Research and development (R&D) expenses were approximately $8.2 million and $15.8 million for the three and six months ended June 30, 2023, respectively, compared to approximately $6.3 million and $12.4 million for the same periods in 2022. This increase in R&D expenses was primarily driven by increases in costs incurred to support the advancement and expansion of our clinical development programs, including incremental costs to support NAVAL-1, our pivotal study of Nana-val in patients with R/R EBV+ lymphoma, and the initiation of our Phase 1b/2 study of Nana-val for the treatment of patients with EBV+ solid tumors, as well as an increase in personnel-related costs.
General and administrative expenses – General and administrative (G&A) expenses were approximately $4.3 million and $8.9 million for the three and six months ended June 30, 2023, respectively, compared to $4.2 million and $8.5 million for the same periods in 2022. The increase in G&A expenses can be primarily attributed to an increase in personnel-related costs.
Net loss – Net loss was approximately $12.5 million, or $0.32 per share, (basic and diluted) for the quarter ended June 30, 2023, compared to a net loss of $10.6 million, or $0.28 per share, (basic and diluted) for the same period in 2022. Net loss was approximately $24.7 million, or $0.64 per share, (basic and diluted) for the six months ended June 30, 2023, compared to a net loss of $21.1 million, or $0.56 per share, (basic and diluted) for the same period in 2022.
About NAVAL-1
NAVAL-1 (NCT05011058) is a global, multicenter, clinical trial of Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma. This trial employs a Simon two-stage design where, in Stage 1, participants are enrolled into one of six indication cohorts based on EBV+ lymphoma subtype. If a pre-specified antitumor activity threshold is reached within a lymphoma subtype in Stage 1 (n=10), then additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV+ lymphoma subtypes demonstrating promising antitumor activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration.

About the Phase 1b/2 Study of Nana-val in R/M EBV+ NPC and Other EBV+ Solid Tumors
This Phase 1b/2 trial (NCT05166577) is an open-label, multinational clinical trial evaluating Nana-val alone and in combination with pembrolizumab. The Phase 1b dose escalation part is designed to evaluate safety and to determine the Recommended Phase 2 Dose (RP2D) of Nana-val in patients with recurrent or metastatic (R/M) Epstein-Barr virus-positive (EBV+) nasopharyngeal carcinoma (NPC). In Phase 2, up to 60 patients with R/M EBV+ NPC will be randomized to receive Nana-val at the RP2D with or without pembrolizumab to further evaluate antitumor activity, safety and tolerability, pharmacokinetics, and potential pharmacodynamic biomarkers. Additionally, patients with other advanced EBV+ solid tumors will be enrolled to receive Nana-val at the RP2D in a Phase 1b dose expansion cohort.

About Nana-val (Nanatinostat and Valganciclovir)
Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory (R/R) EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 clinical trial in patients with recurrent or metastatic (R/M) EBV+ NPC and other EBV+ solid tumors.

About EBV-Associated Cancers
Approximately 90% of the world’s adult population is infected with EBV. Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV-positive (EBV+) lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer.

On August 14, 2023 Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the three months ended June 30, 2023 (Press release, Galectin Therapeutics, AUG 14, 2023, View Source [SID1234634380]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said:
"We are increasingly optimistic as we oversee and manage our adaptively designed Phase 2b/3 NAVIGATE trial for the prevention of esophageal varices in patients with NASH cirrhosis, which completed randomization of 357 patients in February 2023. To help manage NAVIGATE and prepare for the interim analysis from the phase 2b portion, which is expected in the fourth quarter of 2024, we have added several key staff members over the past few months in the areas of biostatistics, quality assurance and clinical operations. The Company’s results will be the first, and as of now, the only data generated from a late-stage trial focusing on compensated cirrhosis caused by NASH that has progressed to portal hypertension. Currently, this patient population has no curative option, other than a liver transplantation.

Additionally, we are continuing to evaluate options and develop plans for a potential Phase 2 clinical trial of belapectin in combination with Keytruda© in patients with advanced head and neck cancers. Our team is fully committed to maximizing the value of our company for the stockholders by advancing our programs for patients."

Dr. Pol Boudes, Chief Medical Officer stated: "Compared to pre-cirrhotic NASH stages, cirrhosis of the liver is characterized by a distinct pathophysiology, with activated macrophages, the target of belapectin, playing a central role in the progression of the disease to portal hypertension and, ultimately, liver failure. We are pleased by the continued apparent safety and tolerance profile of belapectin in the NAVIGATE patient population, and we remain encouraged that the NAVIGATE results can one day bring a therapy to patients with NASH cirrhosis that currently can only contemplate liver transplantation as a therapeutic option."

Financial Results

For the three months ended June 30, 2023, the Company reported a net loss applicable to common stockholders of $9.2 million, or ($0.15) per share, compared to a net loss applicable to common stockholders of $9.7 million, or ($0.16) per share for the three months ended June 30, 2022. The decrease is largely due to a decrease in 2023 research and development expenses related to the timing of certain costs related to the Company’s NAVIGATE trial.

Research and development expenses for the three months ended June 30, 2023, were $7.4 million compared with $8.1 million for the three months ended June 30, 2022. The decrease was primarily due to timing of certain costs related to our NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the three months ended June 30, 2023, were $1.6 million, compared to $1.6 million for the three months ended June 30, 2022.

As of June 30, 2023, the Company had $18.0 million of cash and cash equivalents. Additionally, the Company has $30 million remaining available under a $60 million line of credit provided by its chairman to fund operations. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through at least December 31, 2024.

The Company expects that it will require more cash to fund operations after December 31, 2024, and believes it will be able to obtain additional financing as needed. However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.

About Belapectin

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH when it has progressed to the liver cirrhosis stage as well as advanced cancers. Galectin-3 is produced by activated macrophages, a key inflammatory cell, and plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart, as well as in the cancerous tumor microenvironment. Belapectin binds to galectin-3 and disrupts its function. Belapectin, because of its unique structure, is also captured by activated macrophages and exerts its activity directly at the source of galectin-3 production. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis associated with liver cirrhosis, a disease that is characterized by an invasion of activated macrophages into the liver parenchyma. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (www.NAVIGATEnash.com), titled "A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis," completed randomization of 357 patients in February 2023 with top-line data expected from the Phase 2b portion in the fourth quarter of 2024, and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 has a significant role in cancer, in making the tumor microenvironment resistant to immunological treatment, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and Keytruda in advanced melanoma and in head and neck cancers. This trial provided a strong rationale for moving forward into a Company-sponsored Phase 2 development program, which the company is exploring.

On August 14, 2023 Roivant (Nasdaq: ROIV) reported its financial results for the first quarter ended June 30, 2023, and provided an update on the business (Press release, Roivant Sciences, AUG 14, 2023, View Source [SID1234634379]).

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"This was an incredibly busy quarter with multiple clinical readouts and trial initiations. We reported positive data from the chronic period of the Phase 2b study of RVT-3101 in ulcerative colitis, in addition to positive data from the ADORING 1 trial evaluating VTAMA in patients as young as 2 years old with moderate-to-severe atopic dermatitis. We also initiated two separate trials, the TAHOE Phase 2 study of RVT-3101 in Crohn’s disease and the Phase 1 study of IMVT-1402 in healthy volunteers. We’re incredibly excited about the progress we’ve made in this quarter alone and look forward to announcing additional clinical results in the upcoming months," said Matt Gline, CEO of Roivant. "On the commercial side, we saw another three months of continued product revenue growth for the company from VTAMA sales."

Recent Developments

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Telavant: In June 2023, Telavant reported positive data from the chronic period of TUSCANY-2, a large, global Phase 2b study evaluating RVT-3101 for the treatment of ulcerative colitis. Outcomes were measured at week 56 for the chronic period (vs. week 14 from the previously reported induction period). At the expected Phase 3 dose in the overall population and in the biomarker positive populations, RVT-3101 treatment produced clinically meaningful efficacy results with improved Clinical Remission, Endoscopic Improvement, and Endoscopic Remission at week 56. In July 2023, Telavant announced the first patient was dosed in the TAHOE study, a global Phase 2 trial of RVT-3101 in patients with moderate to severe Crohn’s disease.

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Immunovant: In August 2023, Immunovant reported that initial data from the Phase 1 clinical trial of IMVT-1402 remains on track for September 2023 (single-ascending dose) and October / November 2023 (multiple-ascending dose).

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Dermavant: For the first quarter ended June 30, 2023, Roivant reported VTAMA net product revenue of $16.7M, representing a 26% gross-to-net yield for the quarter. As of August 2023, nearly 200,000 VTAMA prescriptions have been written by approximately 11,500 unique prescribers for psoriasis, based on IQVIA data. Coverage has been expanded to 129 million US commercial lives and 87 million government lives and includes coverage by all three of the top pharmacy benefit managers. In May 2023, VTAMA met the primary and all secondary endpoints in ADORING 1, the second of two replicate Phase 3 studies in patients with moderate-to-severe atopic dermatitis. Importantly, no new safety or tolerability signals were observed in this population, which included children as young as 2 years old.

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Priovant: In August 2023, Priovant announced the sixth positive Phase 2 study of oral brepocitinib, out of six conducted, with statistically significant, positive results from the 12-week induction period of Pfizer’s Phase 2 study of brepocitinib in adult patients with moderate to severe Crohn’s disease. The primary and key secondary endpoints were met with safety and tolerability generally consistent with prior brepocitinib studies, further validating TYK2/JAK1 inhibition activity in highly inflammatory autoimmune diseases.

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Roivant: Roivant reported its consolidated cash, cash equivalents and restricted cash of $1.4B at June 30, 2023, supporting cash runway into the second half of calendar year 2025.

Major Upcoming Milestones

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Dermavant plans to submit its sNDA for VTAMA in atopic dermatitis to the FDA in the first quarter of calendar year 2024.

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Immunovant expects IMVT-1402 Phase 1 initial data from single-ascending dose cohorts in September 2023 and initial data from multiple-ascending dose cohorts in October or November 2023. Additionally, for batoclimab: top-line results from the ongoing myasthenia gravis (MG) trial are expected in the second half of calendar year 2024. Top-line results from the Phase 3 thyroid eye disease (TED) program, consisting of two Phase 3 clinical trials, are expected in the first half of calendar year 2025. Immunovant also expects to have initial results from period 1 of the Phase 2B clinical trial in chronic inflammatory demyelinating polyneuropathy (CIDP) in the first half of calendar year 2024. Initial results from the Phase 2 proof-of-concept trial in Graves’ disease (GD) are expected in the fourth quarter of calendar year 2023.

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Telavant has initiated a Phase 2 dose-ranging study of RVT-3101 in Crohn’s disease with data from the induction portion expected in the fourth quarter of calendar year 2024.

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Priovant plans to announce topline results from the potentially registrational trial evaluating brepocitinib for the treatment of patients with systemic lupus erythematosus (SLE) in the fourth quarter of calendar year 2023. Priovant also expects to announce topline results from the Phase 2 POC study in non-infectious uveitis (NIU) in the first quarter of calendar year 2024 and topline results from the Phase 3 trial in dermatomyositis (DM) in calendar year 2025.

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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 myelodysplastic syndromes (MDS) patients in the second half of calendar year 2023.

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Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the second half of calendar year 2024.

First Quarter Ended June 30, 2023, Financial Summary

Cash Position

As of June 30, 2023, the company had consolidated cash, cash equivalents and restricted cash of $1.4 billion.

Research and Development Expenses

Research and development (R&D) expenses decreased by $10.7 million to $125.1 million for the three months ended June 30, 2023, compared to $135.8 million for the three months ended June 30, 2022, primarily due to decreases in program-specific costs of $7.8 million and share-based compensation of $4.3 million, partially offset by an increase in other expenses of $2.2 million.

The decrease of $7.8 million in program-specific costs largely reflects the discontinued development of several programs, including ARU-1801, LSVT-1701 and CVT-TCR-01, as well as our reprioritization of drug discovery efforts. These decreases were partially offset by increases reflecting the progression of our programs, including Immunovant’s anti-FcRn franchise, RVT-3101, and namilumab. The asset acquisition of RVT-3101 was completed in November 2022.

Non-GAAP R&D expenses were $115.7 million for the three months ended June 30, 2023, compared to $122.5 million for the three months ended June 30, 2022.

Acquired In-Process Research and Development Expenses

Acquired in-process research and development was $12.5 million for the three months ended June 30, 2023, relating to the achievement of development and regulatory milestones for batoclimab.

Selling, General and Administrative Expenses

Selling, general and administrative expenses (SG&A) increased by $7.1 million to $156.2 million for the three months ended June 30, 2023, compared to $149.1 million for the three months ended June 30, 2022, primarily due to a decrease of $19.4 million of share-based compensation expense partially offset by an increase in selling, general and administrative expenses of $27.1 million at Dermavant as a result of the commercial launch of VTAMA.

Non-GAAP SG&A expenses were $113.0 million for the three months ended June 30, 2023, compared to $87.7 million for the three months ended June 30, 2022. The majority of non-GAAP SG&A expenses were related to Dermavant’s SG&A and ongoing VTAMA commercial launch activities.

Net Loss

Net loss was $327.8 million for the three months ended June 30, 2023, compared to $353.8 million for the three months ended June 30, 2022. On a per common share basis, net loss was $0.38 for the three months ended June 30, 2023, and $0.48 for the three months ended June 30, 2022. Non-GAAP net loss was $211.5 million for the three months ended June 30, 2023, compared to $210.7 million for the three months ended June 30, 2022.

On August 14, 2023 Eli Lilly and Company (NYSE: LLY) reported the successful completion of its acquisition of Sigilon Therapeutics, Inc. (NASDAQ: SGTX) (Press release, Eli Lilly, AUG 14, 2023, View Source [SID1234634378]). The acquisition allows Lilly to continue researching and developing encapsulated cell therapies, including SIG-002, for the treatment of type 1 diabetes.

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"Make life better – that’s the phrase that guides everything we do at Lilly," said Ruth Gimeno, Ph.D., group vice president, diabetes, obesity and cardiometabolic research at Lilly. "We are excited to welcome our new colleagues from Sigilon to Lilly; together, we will strive to provide solutions for people living with type 1 diabetes that absolves them of constant disease management, and advance Sigilon’s technology for patients."

The Offer and the Merger

As previously announced, Lilly and Sigilon entered into a Merger Agreement dated as of June 28, 2023, and pursuant thereto, on July 13, 2023, Lilly and a wholly owned subsidiary ("Purchaser") commenced a tender offer (the "Offer") to purchase all of the issued and outstanding shares ("Shares") of Sigilon’s common stock in exchange for (a) $14.92 per Share, net to the stockholder in cash, without interest (the "Cash Consideration") and less any applicable tax withholding, plus (b) one non-tradable contingent value right ("CVR" and, together with the Cash Consideration, the "Offer Price") per Share, which represents the contractual right to receive contingent payments of up to $111.64 per Share in cash, net to the stockholder in cash, without interest and less any applicable tax withholding, upon the achievement of certain specified milestones. There can be no assurance that any payments will be made with respect to the CVRs. The Offer expired as scheduled on Aug. 9, 2023, with 1,718,493 Shares validly tendered and not validly withdrawn, which together with Shares previously owned by Lilly, represented 76.61% of the issued and outstanding Shares. In accordance with the terms of the Offer, Purchaser accepted for payment all such validly tendered and not validly withdrawn Shares.

Following consummation of the Offer, on Aug. 11, 2023, Lilly completed its acquisition of Sigilon through the merger of Purchaser with and into Sigilon in accordance with Section 251(h) of the General Corporation Law of the State of Delaware), with Sigilon surviving such merger as a wholly owned subsidiary of Lilly. In connection with the merger, each Share issued and outstanding immediately prior to the effective time of the merger (other than (i) Shares held in Sigilon’s treasury or owned by Sigilon, or owned by Lilly, Purchaser or any direct or indirect wholly-owned subsidiary of Lilly or Purchaser or (ii) Shares held by any stockholder of Sigilon who was entitled to demand and properly demanded appraisal for such Shares in accordance with Section 262 of the DGCL), including each Share that was subject to vesting or forfeiture restrictions granted pursuant to a Sigilon equity incentive plan, program or arrangement, was canceled and converted into the right to receive the Offer Price, without interest, less any applicable tax withholding. Sigilon’s common stock has been delisted from the NASDAQ Global Select Market and will be deregistered under the Securities Exchange Act of 1934, as amended.

For Lilly, Morgan, Lewis & Bockius LLP is acting as legal counsel. For Sigilon, Lazard is acting as lead financial advisor and Ropes & Gray LLP is acting as legal counsel. Canaccord Genuity also acted as financial advisor to Sigilon.