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Xilio Therapeutics Announces Pipeline and Business Updates and Third Quarter 2023 Financial Results

On November 9, 2023 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, reported pipeline progress and business updates and announced financial results for the third quarter ended September 30, 2023 (Press release, Xilio Therapeutics, NOV 9, 2023, View Source [SID1234637429]).

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"Colorectal cancer is the third largest solid tumor cancer in terms of number of patients diagnosed annually and the second leading cause of cancer-related deaths globally," said René Russo, Pharm.D., president and chief executive officer of Xilio. "Rates of MSS colorectal cancer are rising in younger people, particularly in men under 50 years old, and patients often present with advanced Stage 4 disease along with liver metastases. Despite these alarming trends, there are few treatment options and no approved immunotherapies for these patients today. We believe the unique tumor-selective mechanism of XTX101 combined with atezolizumab has the potential to treat MSS colorectal cancer, and we are focused on initiating the co-funded collaboration with Roche to study this combination in patients. We are also encouraged by the recent Phase 1/2 data reported at SITC (Free SITC Whitepaper) for XTX202 demonstrating a 50% disease control rate at higher doses (≥2.8 mg/kg), including patients with cold tumors, and a generally well-tolerated safety profile across all dose levels. We look forward to evaluating the 4 mg/kg dose for XTX202 in Phase 2 for patients with melanoma and renal cell carcinoma."

Pipeline and Business Updates

XTX101: tumor-activated, Fc-enhanced anti-CTLA-4

XTX101 is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 designed to block CTLA-4 and deplete regulatory T cells when activated (unmasked) in the tumor microenvironment (TME). XTX101 is currently being evaluated at the recommended Phase 2 dose and schedule of 150 mg once every six weeks in monotherapy dose expansion of an ongoing Phase 1 clinical trial in patients with advanced solid tumors.

● In the third quarter of 2023, Xilio reported updated data from the Phase 1 trial for XTX101, including an ongoing durable confirmed partial response through 36 weeks as of an August 3, 2023 data cutoff date in a patient with Stage 4 non-small cell lung cancer treated with XTX101 monotherapy, including resolution of liver metastases.
● Additionally, Xilio recently reported pharmacokinetic (PK) data showing activation of XTX101 in two on-treatment biopsies from patients in the Phase 1 trial, which included a primary melanoma tumor and a metastatic lesion in the liver from a patient with microsatellite stable colorectal cancer (MSS CRC). For both patients, XTX101 was more than 70% activated in the tumor while maintaining a peripheral activation level of 13%, consistent with the tumor-selective design for XTX101.
● In the third quarter of 2023, Xilio entered into a clinical trial collaboration with Roche to evaluate XTX101 in combination with atezolizumab in Phase 1 combination dose escalation in patients with advanced solid tumors and a planned Phase 2 trial in patients with MSS CRC. Xilio anticipates activating clinical trial sites for the Phase 1 combination dose escalation in the fourth quarter of 2023.
In addition, subject to obtaining sufficient additional capital, Xilio plans to:

● Complete Phase 1 combination dose escalation and select a recommended Phase 2 dose for XTX101 in combination with atezolizumab in the second quarter of 2024.
● Subject to the results of Phase 1 combination dose escalation, initiate a Phase 2 trial for XTX101 in combination with atezolizumab in patients with MSS CRC in the third quarter of 2024.
● Report initial Phase 2 data for XTX101 in combination with atezolizumab in approximately 20 patients with MSS CRC in the fourth quarter of 2024 and in approximately 20 additional patients (40 patients total) in the first quarter of 2025.
XTX202: tumor-activated, engineered, beta-gamma biased IL-2

XTX202 is an investigational tumor-activated, engineered, beta-gamma biased IL-2 molecule designed to potently stimulate CD8+ effector T cells and natural killer (NK) cells without concomitant stimulation of regulatory T cells when activated (unmasked) in the TME. XTX202 is currently being evaluated in an ongoing Phase 1/2 clinical trial in patients with advanced solid tumors.

● In November 2023, Xilio announced initial Phase 1/2 monotherapy safety, PK, pharmacodynamic (PD) and anti-tumor activity data for XTX202 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting. As of a data cutoff date of October 26, 2023, these data included:
● Initial evidence of a dose-dependent increase in disease control rate (DCR) for XTX202 across all dose levels in a range of solid tumors, including cold tumors, with a 50% DCR in response-evaluable patients at higher doses (≥2.8 mg/kg) and a 31% DCR in response-evaluable patients across all dose levels, including a patient with Stage 4 MSS CRC with ongoing stable disease at 57 weeks and resolution of three out of four non-target lesions.
● No signs or symptoms of vascular leak syndrome were reported by investigators through the 4.0 mg/kg dose. In addition, XTX202 was generally well-tolerated with treatment-related adverse events (TRAE) primarily Grade 1 or 2 and no treatment discontinuations due to TRAEs.
● Preliminary PK analysis demonstrated tumor-selective activation of XTX202, including an approximately 40-fold higher concentration of activated XTX202 in the tumor as compared to peripheral blood based on an analysis of an on-treatment biopsy from a patient at the 2.8 mg/kg dose level, which demonstrated approximately 15% activated XTX202 in the tumor compared to <1% activated XTX202 in plasma across patients at the 2.8 mg/kg dose level.
● Consistent with IL-2 beta-gamma biology, preliminary PD analysis of four available on-treatment tumor samples showed an average increase >200% of CD8+ effector T cells in the tumor as compared to pre-treatment biopsies.
● For more information, read the press release here.
● As previously announced, XTX202 recently cleared dose level seven (4.0 mg/kg) in Phase 1 monotherapy dose-escalation, and Xilio recently opened enrollment at a second dose level of 4.0 mg/kg in the ongoing Phase 2 monotherapy trial for XTX202. Based on the initial monotherapy data for XTX202, Xilio also plans to explore opportunities for strategic partnerships to evaluate XTX202 as a combination therapy.
● Subject to obtaining sufficient additional capital, Xilio plans to report Phase 2 monotherapy data for XTX202 in approximately 20 patients treated at the 4.0 mg/kg dose with metastatic renal cell carcinoma (RCC) or unresectable or metastatic melanoma in the second quarter of 2024.
XTX301: tumor-activated, engineered IL-12

XTX301 is an investigational tumor-activated, engineered IL-12 molecule designed to potently stimulate anti-tumor immunity and reprogram the TME of poorly immunogenic "cold" tumors towards an inflamed or "hot" state.

● Xilio is currently dosing patients in monotherapy dose escalation of an ongoing Phase 1 clinical trial evaluating the safety and tolerability of XTX301 in patients with advanced solid tumors.
● As previously announced, Xilio anticipates reporting preliminary safety data from the Phase 1 clinical trial into the third dose level in the fourth quarter of 2023.
● Subject to obtaining sufficient additional capital, Xilio plans to report Phase 1 safety and PK/PD data for XTX301 in advanced solid tumors in the second half of 2024.
Corporate Highlights

● In September 2023, Xilio announced the promotions of Katarina Luptakova, M.D., to Chief Medical Officer and Scott Coleman, Ph.D., to Chief Development Officer.
Upcoming Presentations

Xilio will present a poster for XTX101 with updated preliminary Phase 1 data and outlining the planned Phase 2 trial design at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Annual Congress on December 6-8, 2023.

Title: Phase 1/2 study of XTX101, a masked, tumor-activated Fc-enhanced anti-CTLA-4 in patients with advanced solid tumors

Presentation Date and Time: Thursday, December 7, 2023, from 12:00 to 1:00 p.m. CET

Abstract number: 490

Third Quarter 2023 Financial Results

● Cash Position: Cash and cash equivalents were $59.8 million as of September 30, 2023, compared to $120.4 million as of December 31, 2022.
● Research & Development (R&D) Expenses: R&D expenses were $11.1 million for the quarter ended September 30, 2023, compared to $13.0 million for the quarter ended September 30, 2022. The decrease was primarily driven by decreased manufacturing and preclinical activities for XTX301 and a reduction of XTX101 costs due to a cost-sharing payment earned under the clinical trial collaboration with Roche. These decreases were partially offset by increases in clinical activities for XTX202 and XTX301, preclinical activities for other early programs and indirect research and development expenses.
● General & Administrative (G&A) Expenses: G&A expenses were $6.3 million for the quarter ended September 30, 2023, compared to $7.2 million for the quarter ended September 30, 2022. The decrease was primarily driven by a decrease in professional and consulting fees.
● Net Loss: Net loss was $16.7 million for the quarter ended September 30, 2023, compared to $19.8 million for the quarter ended September 30, 2022.
Financial Guidance

Xilio continues to anticipate that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the end of the second quarter of 2024.

About XTX101 (anti-CTLA-4) and the Phase 1 Monotherapy and Phase 1/2 Combination Clinical Trials

XTX101 is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated (unmasked) in the tumor microenvironment (TME). The Phase 1 clinical trial is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX101 for the treatment of adult patients with advanced solid tumors. Xilio has completed monotherapy dose escalation (Part 1A) and is currently enrolling patients at the recommended Phase 2 dose and schedule of 150 mg once every six weeks in monotherapy dose expansion (Part 1B). Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

In addition, Xilio plans to evaluate the safety, tolerability and efficacy of XTX101 in combination with atezolizumab (Tecentriq) in the Phase 1/2 clinical trial. The Phase 1 portion is designed to assess the safety and tolerability of XTX101 in combination with atezolizumab in dose escalation in patients with advanced solid tumors. The planned Phase 2 portion is designed to evaluate the safety and efficacy of the combination in patients with microsatellite stable colorectal cancer (MSS CRC).

About XTX202 (IL-2) and the Phase 1/2 Clinical Trials

XTX202 is an investigational tumor-activated beta-gamma biased, engineered IL-2 molecule designed to potently stimulate CD8+ effector T cells and natural killer (NK) cells without concomitant stimulation of regulatory T cells when activated (unmasked) in the tumor microenvironment (TME). The Phase 1 clinical trial for XTX202 is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX202 as a monotherapy in patients with advanced solid tumors. The Phase 2 clinical trial for XTX202 is a multi-center, open-label trial designed to evaluate the safety and efficacy of XTX202 as a monotherapy in patients with unresectable or metastatic melanoma and metastatic renal cell carcinoma who have progressed on standard-of-care treatment. Please refer to NCT05052268 on www.clinicaltrials.gov for additional details.

About XTX301 (IL-12) and the Phase 1 Clinical Trial

XTX301 is an investigational tumor-activated, engineered IL-12 molecule designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic "cold" tumors towards an inflamed or "hot" state. The Phase 1 clinical trial for XTX301 is a first-in-human, multi-center, open-label trial designed to evaluate the safety and tolerability of XTX301 as a monotherapy in patients with advanced solid tumors. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details.

Viracta Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

On November 9, 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 reported financial results for the third quarter of 2023 (Press release, Viracta Therapeutics, NOV 9, 2023, View Source [SID1234637428]).

"During our recently held R&D Day, we provided multiple clinical and strategic updates, which further positioned Nana-val as a differentiated potential therapeutic option for patients with EBV-associated cancers," said Mark Rothera, President and Chief Executive Officer of Viracta. "Preliminary results from the PTCL cohort of the NAVAL-1 trial demonstrated overall and complete response rates of 40%, which are consistent with results from our previous Phase 1b/2 study and exceeds the current standard of care for this patient population with high unmet medical need. We continue to believe that Nana-val is an ideal candidate for the accelerated approval pathway and we remain on track to complete enrollment of the Nana-val PTCL Stage 2 cohort and engage with FDA in 2024."

"We also reported interim data from the Phase 1b/2 trial of Nana-val in advanced EBV-positive solid tumors with partial responses confirmed at higher doses. Given there have been no dose-limiting toxicities observed to date, we plan to evaluate higher doses of Nana-val that incorporate a novel split daily dosing schedule and determine the recommended Phase 2 dose of Nana-val for our solid tumor program in 2024. We have a well-defined strategic path forward, and with the PTCL indication leading the way, we continue to explore opportunities to maximize the therapeutic potential of Nana-val across other indications."

Clinical Trial Updates and Anticipated Milestones

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

As of the data cutoff date of June 30, 2023, initial results from the first five patients with R/R EBV+ peripheral T-cell lymphoma (PTCL) treated with Nana-val showed an overall response rate (ORR) and complete response rate (CRR) of 40%.
Completion of enrollment into the nanatinostat monotherapy arm (n=10) and Nana-val combination arm (n=10) of the NAVAL-1 R/R EBV+ PTCL cohort is anticipated by year-end 2023.
Amended the NAVAL-1 protocol to additionally enroll second-line patients across all cohorts, including diffuse large B-cell lymphoma (DLBCL) and post-transplant lymphoproliferative disorder (PTLD).
Anticipated 2024 milestones:
Stage 1 data from both arms of the R/R EBV+ PTCL cohort (in patients treated with nanatinostat with or without valganciclovir).
Completion of enrollment into Stage 2 of the Nana-val R/R EBV+ PTCL cohort (n=21).
U.S. Food and Drug Administration (FDA) meeting to discuss additional requirements for accelerated approval for the treatment of patients with R/R EBV+ PTCL.
Stage 2 data from the Nana-val R/R EBV+ PTCL cohort.
Additional response and durability assessments from the Phase 1b/2 trial (Study 201) of Nana-val in patients with R/R EBV+ lymphoma as of the May 4, 2023 data cutoff date

For patients with R/R EBV+ PTCL, median duration of response (DoR) was 17.3 months with an ORR/CRR of 50%/38% (n=8).
For patients with R/R EBV+ DLBCL, median DoR has not yet been reached, with three patients remaining in response with DoRs of 11.1 months (complete response [CR]), 36.8 months (partial response [PR]), and 41.9 months (CR), with an ORR/CRR of 67%/33% (n=9).
Expanded and extended safety data demonstrated Nana-val regimen was generally well-tolerated with the potential to combine with other chemo/immunotherapies.
New interim clinical data in Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors (Study 301) highlight the opportunity to dose escalate further with a novel dosing regimen to potentially drive additional responses in this patient population. This approach is supported by growing preclinical data.

Enrollment completed through the fifth dose level without any dose-limiting toxicities reported.
Best responses to date included two confirmed PRs at the higher dose levels and five stable diseases in 17 patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC).
In a preclinical murine xenograft model, split daily dosing (SDD) of Nana-val had superior anti-tumor activity than intermittent (four days on/three days off) once-daily dosing, which supports the evaluation of an SDD regimen in patients with advanced EBV+ solid tumors.
Anticipated 2024 milestones:
Additional dose levels are planned with Nana-val on an SDD schedule to select a recommended Phase 2 dose (RP2D); enrollment anticipated to be resumed by year-end 2023.
Initiation of the clinical trial’s randomized Phase 2 expansion cohort designed to further evaluate Nana-val at the RP2D.
Business Update

On October 4, 2023, Viracta hosted an R&D Day highlighting Nana-val clinical programs in EBV-associated cancers. The R&D Day featured key opinion leaders, Pierluigi Porcu, M.D. and Robert A. Baiocchi, M.D., Ph.D.
Drs. Porcu and Baiocchi discussed the current treatment landscape of EBV+ lymphomas and Nana-val’s opportunity to address the unmet medical needs of this unique cancer segment.
Members of Viracta’s senior management team provided updates on the Nana-val clinical development programs in patients with R/R EBV+ lymphoma and in patients with R/M EBV+ NPC.
A replay of the presentation is available here
Third Quarter 2023 Financial Results

Cash position – Cash, cash equivalents, and short-term investments totaled approximately $63.0 million as of September 30, 2023, which is anticipated to fund Viracta’s operations through late 2024 and does not include any adjustments that may arise from uncertainties related to our ability to continue as a going concern. This also excludes 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 $24.0 million for the three and nine months ended September 30, 2023, respectively, compared to approximately $7.1 million and $19.6 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 $13.2 million for the three and nine months ended September 30, 2023, respectively, compared to $10.9 million and $19.5 million for the same periods in 2022. The decrease in G&A expenses was largely due to a non-recurring share-based compensation expense of $5.6 million associated with modifications to certain equity awards in conjunction with a separation agreement for the former Chief Executive Officer in September 2022. In addition, $0.8 million in one-time severance-related charges were recorded in the three and nine months ended September 30, 2022 in accordance with the terms of the separation agreement.
Net loss – Net loss was approximately $12.6 million, or $0.33 per share, (basic and diluted) for the quarter ended September 30, 2023, compared to a net loss of $17.7 million, or $0.47 per share, (basic and diluted) for the same period in 2022. Net loss was approximately $37.3 million, or $0.97 per share, (basic and diluted) for the nine months ended September 30, 2023, compared to a net loss of $38.9 million, or $1.03 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 three 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 Advanced 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.

Verrica Pharmaceuticals Reports Third Quarter 2023 Financial Results

On November 9, 2023 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the third quarter ended September 30, 2023 (Press release, Verrica Pharmaceuticals, NOV 9, 2023, View Source [SID1234637427]).

"Following the U.S Food and Drug Administration approval of YCANTH for the treatment of molluscum in July, we continue to build momentum across our commercial operations," said Ted White, Verrica’s President and Chief Executive Officer. "As the only FDA-approved product for the treatment of molluscum, we are seeing broad awareness and interest in prescribing YCANTH across dermatology and pediatric practices. With our commercial and reimbursement teams fully in place, we are focused on executing our launch strategy and expanding our coverage among commercial plans and managed Medicaid plans. To date, over 112 million lives have access to YCANTH through commercial insurance or managed Medicaid plans, and YCANTH has already gained acceptance of fee-for-service Medicaid coverage in Connecticut, Arkansas, New Jersey and Nevada.

As we previously announced, on August 24, 2023 we received our first commercial sale of YCANTH to our exclusive distributor, FFF Enterprises Inc., resulting in net product revenue for the third quarter 2023 of $2.8 million upon its delivery to FFF. This first sale to FFF primarily represented stocking within the channel to allow patients to finally gain access to the first FDA-approved therapy for the treatment of molluscum as we build demand and drive adoption amongst healthcare providers.

We also continue to make progress on our development pipeline. During the quarter, we announced the presentation of lesion clearance data from Part 1 of our ongoing Phase 2 trial for our novel oncolytic peptide, VP-315, at the 2023 AAD Innovation Academy meeting. These data highlighted the antitumor response of VP-315, as determined by clinical and histological clearance of treated BCC lesions. We look forward to the continued advancement of this program for the treatment basal cell carcinoma."

Conference Call and Webcast Information

The Company will host a conference call today, Thursday, November 9, 2023, at 8:30 AM, Eastern Time, to discuss the third quarter 2023 financial results and provide a business update. To participate in the conference call, please utilize the following information:

Domestic Dial-In Number: Toll-Free: 1-877-407-4018

International Dial-In Number: 1-201-689-8471

Conference ID: 13741589

Call me:

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View Source;passcode=13741589&h=true&info=company-email&r=true&B=6

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Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me link for instant telephone access to the event.

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Call me link will be made active 15 minutes prior to scheduled start time.

The call will also be broadcast live over the Web and can be accessed on Verrica Pharmaceuticals’ website: www.verrica.com or directly at View Source;tp_key=9b1d27b193

The conference call will also be available for replay for one month on the Company’s website in the Events Calendar of the Investors section.

Business Highlights and Recent Developments

YCANTH (formerly VP-102)

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On October 11, 2023, the Company hosted a virtual KOL event discussing the approval of YCANTH (cantharidin) topical solution for the treatment of molluscum contagiosum. The event featured Mark Kaufmann, MD (Advanced Dermatology, Miami), Michael Cameron, MD (Cameron Dermatology; Department of Dermatology, Mount Sinai, NY), and Mercedes Gonzalez, MD (Pediatric Dermatology of Miami) who discussed the unmet medical need for patients suffering from molluscum (View Source).

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On August 24, 2023, the Company announced the first commercial sale of YCANTH to its exclusive distributor, FFF Enterprises Inc. Net product revenue for the third quarter 2023 was $2.8 million. As previously disclosed, Verrica recognizes product revenue when the product is delivered to FFF. This first sale to FFF primarily represented stocking within the

channel, and therefore management expects orders during the fourth quarter of 2023 may be less than the order during the third quarter of 2023 as the Company continues to build demand and drive adoption amongst healthcare providers. Management expects inventory in the channel to normalize and more closely align with product demand in the first half of 2024.

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On August 23, 2023, the Company issued a statement in support of the FDA’s recent action against retailers and manufacturers of unapproved products for the treatment of molluscum contagiosum, indicating that molluscum is a serious health problem that requires medical intervention with therapies that have been rigorously tested and properly reviewed.

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On July 21, 2023, Verrica announced that the FDA approved YCANTH topical solution as the first FDA approved treatment of pediatric and adult patients with molluscum contagiosum (molluscum) in adult and pediatric patients 2 years of age and older.

VP-315 for Basal Cell Carcinoma

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On August 10, 2023, the Company announced the presentation of lesion clearance data from Part 1 of an ongoing Phase 2 study of VP-315 for the treatment of basal cell carcinoma (BCC). The presentation was titled "VP-315, an Investigational Non-surgical Immunotherapy in Subjects with Biopsy Proven Basal Cell Carcinoma" and highlighted the antitumor response of VP-315 as determined by clinical and histological clearance of treated BCC lesions. Dr. Neal Bhatia MD, Director of Clinical Dermatology Therapeutics Clinical Research in San Diego and Principal Investigator for the study, presented the data at the 2023 American Academy of Dermatology Innovation Academy.

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In July 2023, Verrica implemented plans to expand patient enrollment in Part 2 of the ongoing Phase 2 trial of VP-315. The purpose of expanding Part 2 enrollment is to generate enough patient data so that Verrica can bypass Part 3 of the Phase 2 trial and advance VP-315 directly into a later-stage, potentially registration-enabling trial.

VP-102 for Common Warts

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On November 6, 2023, the Company held a Type-C meeting with the FDA regarding the Phase 3 clinical program studying VP-102 for common warts. The Company expects to receive written meeting minutes within 30 days of the meeting.

Debt Financing

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On July 26, 2023, Verrica announced the closing of a $125 million debt facility with OrbiMed. Verrica borrowed $50 million at closing and has the ability to access $75 million in additional capital upon achievement of certain future revenue milestones. As of September 30, 2023 Verrica had $84.3 million in cash on hand, including the net debt proceeds, which is expected to be sufficient to fund operations into the first quarter of 2025.

Financial Results

Third Quarter 2023 Financial Results

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Verrica recognized product revenue of $2.8 million in the third quarter of 2023 related to the initial delivery of YCANTH to FFF, its distribution partner.

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Verrica recognized collaboration revenues of $0.1 and $8.3 million in the third quarter of 2023 and 2022, respectively, related to the Clinical Supply Agreement with Torii Pharmaceutical Col, Ltd (Torii). The decrease of $8.2 million was primarily attributable to a license revenue milestone payment of $8.0 million made in 2022.

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Selling, general and administrative expenses were $20.1 million in the third quarter of 2023, compared to $3.9 million for the same period in 2022. The increase of $16.1 million was primarily a result of higher expenses related to commercial activities for YCANTH of $3.7 million, increase in compensation-related costs due to ramp-up of sales force of $3.8 million and increase in stock compensation expense related to the vesting of restricted stock units of $7.4 million.

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Research and development expenses were $6.5 million in the third quarter of 2023, compared to $2.8 million for the same period in 2022. The increase of $3.7 million was primarily attributable to an increase in clinical costs for VP-315 as well as increased CMC costs related to Verrica’s preapproval activities.

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Interest income was $0.8 million in the third quarter of 2023, compared to $0.1 million for the same period in 2022, primarily due to higher cash balance and higher interest rates.

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Interest expense of $1.7 million for the three months ended September 30, 2023 consisted of interest expense related to the OrbiMed Credit Agreement, while the three month period ended September 30, 2022 consisted of interest expense on Verrica’s previous debt facility with SVB.

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For the third quarter of 2023, net loss was $24.8 million, or $0.54 per share, compared to a net income of $0.1 million, or $0.00 per share, for the same period in 2022.

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For the third quarter of 2023, non-GAAP net loss was $14.8 million, or $0.32 per share, compared to a non-GAAP net income of $2.9 million, or $0.07 per share, for the same period in 2022.

Year-to-Date September 2023 Financial Results

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Verrica recognized product revenue of $2.8 million in the nine months ending September 30, 2023 related to the initial delivery of YCANTH to FFF, our distribution partner.

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Verrica recognized collaboration revenues of $0.3 million for the nine months ended September 30, 2023, compared to $9.0 million for the same period in 2022, related to the Clinical Supply Agreement with Torii. The decrease of $8.7 million was primarily attributable to a license revenue milestone payment of $8.0 million made in 2022.

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Selling, general and administrative expenses were $30.3 million for the nine months ended September 30, 2023, compared to $14.2 million for the same period in 2022. The increase of $16.1 million was primarily a result of higher expenses related to commercial activities for YCANTH including increase in marketing and sponsorship costs, increase in compensation related costs due to ramp-up of sales force in the third quarter and increase in stock compensation expense related to the vesting of restricted stock units of $7.4 million.

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Research and development expenses were $15.0 million for the nine months ended September 30, 2023, compared to $9.2 million for the same period in 2022. The increase of $5.8 million was primarily attributable to an increase of $5.4 million in CMC and clinical costs related to Verrica’s development of VP-102 for molluscum, external genital warts and common warts.

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For the nine months ended September 30, 2023, net loss was $42.4 million, or $0.94 per share, compared to a net loss of $18.6 million, or $0.58 per share, for the same period in 2022.

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For the nine months ended September 30, 2023, non-GAAP net loss was $29.7 million, or $0.66 per share, compared to a non-GAAP net loss of $12.7 million, or $0.40 per share, for the same period in 2022.

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As of September 30, 2023, Verrica had aggregate cash and cash equivalents of $84.3 million.

TScan Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

On November 9, 2023 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies (TCR-T) for the treatment of patients with cancer, reported financial results and provided a corporate update for the third quarter ended September 30, 2023 (Press release, TScan Therapeutics, NOV 9, 2023, View Source [SID1234637426]).

"During the third quarter we made meaningful progress across both our heme and solid tumor programs and plan to share initial results from our heme program on six to eight patients treated with TCR-T, as well as several control arm patients, at the ASH (Free ASH Whitepaper) Annual Meeting in December," said Gavin MacBeath, Ph.D., Chief Executive Officer. "With the recent FDA clearance of our IND for TSC-203-A0201 targeting PRAME, we remain committed to populating the ImmunoBank with TCRs that address different targets and HLA types to expand the reach of multiplexed TCR-T cell therapy. We are currently on track to file two additional INDs by the end of the year and further expand the ImmunoBank in 2024. TScan is funded to execute on upcoming anticipated milestones into 2026, by which time we expect to have duration of response data for patients treated with multiplex therapy in the solid tumor program and two-year relapse data for patients in the heme program."

Recent Corporate Highlights

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TScan will present a poster at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place in San Diego, CA, and online, December 9–12, 2023:

Title: Initial Results of a Phase 1 Trial of TSC-100 and TSC-101, Engineered T Cell Therapies That Target Minor Histocompatibility Antigens to Prevent Relapse after Allogeneic Hematopoietic Cell Transplantation

Authors: Monzr Al Malki, Alla Keyzner, Hyung C. Suh, Aasiya Matin, Erica Buonomo, Yun Wang, Nina Abelowitz, Jim Murray, Gavin MacBeath, Debora Barton, Shrikanta Chattopadhyay, Ran Reshef

Publication Number: 2090

Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I

Session Date & Time: Saturday, December 9, 2023; 5:30–7:30 p.m. PT

Location: San Diego Convention Center, Halls G-H

The Company will host a virtual KOL event featuring Monzr M. Al Malki, M.D., on Monday, December 11, 2023, at 8:00 a.m. ET to discuss the data presented at ASH (Free ASH Whitepaper). Dr. Al Malki is an Associate Professor in the Department of Hematology & Hematopoietic Cell Transplantation and Director of the Unrelated Donor Bone Marrow Transplant and Haploidentical Transplant Programs at City of Hope. Details for attending the event can be found here.

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During the third quarter, TScan announced U.S. Food and Drug Administration (FDA) clearance of its investigational new drug (IND) application for TSC-203-A0201, a TCR-T targeting PReferentially expressed Antigen in Melanoma (PRAME). TSC-203-A0201 is TScan’s fourth TCR-T cell product cleared for use in its solid tumor program.

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This month, TScan presented six posters at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting. Notable highlights include TScan’s solid tumor Phase 1 trial design supporting a separate screening protocol to identify patients ahead of disease progression, and the disclosure of the previously undisclosed target of TSC-201-B0702 as MAGE-C2. Copies of the presentation materials can be found on the "Publications" section of the Company’s website at www.tscan.com.

Upcoming Anticipated Clinical Milestones

Heme Malignancies Program: TScan’s two lead TCR-T cell therapy candidates, TSC-100 and TSC-101, are designed to target HA-1 and HA-2, respectively, to treat residual disease and prevent relapse in acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS) patients undergoing allogeneic haploidentical hematopoietic cell transplantation (HCT) with reduced intensity conditioning (RIC). (NCT05473910)

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Expects to reach the recommended Phase 2 dose for both TSC-100 and TSC-101 and report interim clinical data for the program by the end of 2023.
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Plans to complete Phase 1 dosing and report prevention of relapse data in 2024.

Solid Tumor Program: TScan remains committed to populating the ImmunoBank, its collection of therapeutic TCRs across novel and validated targets as well as different HLA types, to overcome tumor heterogeneity and address resistance that can arise from HLA loss with multiplexed therapy.

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Anticipates further expansion of the ImmunoBank with IND filings for two additional TCR-Ts by year-end 2023.
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Plans to initiate Phase 1 solid tumor clinical study and enroll the first patient by year-end 2023.
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Expects to report initial multiplexed therapy data for its first combinations of TCR-Ts under T-Plex, as well as response data for singleplex cohorts, in 2024.

Third Quarter 2023 Financial Results

As of September 30, 2023, TScan Therapeutics had cash, cash equivalents, and marketable securities of $215.4 million, excluding $5.0 million of restricted cash. Based on current operating

plans, the Company believes that existing cash, cash equivalents, and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into 2026.

Revenue for the third quarter ended September 30, 2023, was $3.9 million, compared to $3.4 million for the third quarter ended September 30, 2022 (2022 Quarter). This increase is primarily due to timing of research activities related to the collaboration agreement with Amgen in the second quarter of 2023 versus timing of research activities related to a collaboration and license agreement with Novartis Institutes for Biomedical Research, Inc. in the 2022 Quarter.

Research and development expenses for the third quarter ended September 30, 2023, were $22.7 million, compared to $15.0 million for the 2022 Quarter. The increase of $7.7 million was primarily driven by increased costs associated with clinical trial start-up fees and patient enrollment, increased personnel costs, and expansion of facilities.

General and administrative expenses for the third quarter ended September 30, 2023, were $5.9 million, compared to $4.9 million for the 2022 Quarter. The increase of $1.0 million in general and administrative expenses was primarily driven by increased legal and professional fees.

For the third quarter ended September 30, 2023, TScan Therapeutics reported a net loss of $23.0 million, compared to a net loss of $16.2 million for the 2022 Quarter.

As of September 30, 2023, the Company had issued and outstanding shares of 47,823,116, which consists of 43,546,528 shares of voting common stock and 4,276,588 shares of non-voting common stock, and outstanding pre-funded warrants to purchase 47,010,526 shares of voting common stock at an exercise price of $0.0001 per share.

TRACON Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update

On November 9, 2023 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, 2023 (Press release, Tracon Pharmaceuticals, NOV 9, 2023, View Source [SID1234637425]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

"We are on track to complete enrollment of 80 patients treated with single agent envafolimab in the ongoing pivotal ENVASARC trial this year. The data monitoring committee recommended the study continue as planned in September based on a review of 46 patients and since then more than 20 additional patients have enrolled. We expect to report updated response rate data before the end of the year, with final data anticipated mid-2024," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "We also expect to license our Product Development Platform to one or more companies this year to allow them to transform their clinical operations."

Recent Corporate Highlights

In September, we announced the ENVASARC Phase 2 pivotal trial more than exceeded the futility threshold at the second and final interim analysis and will proceed as planned. The objective response rate (ORR) in the initial 46 patients treated with single agent envafolimab was 13% by investigator review and 8.7% by blinded independent central review (BICR), all of which were confirmed responses. Envafolimab monotherapy was generally well tolerated and median duration of response by BICR was greater than six months. The primary endpoint of the study is achievement of an ORR in nine of 80 patients (11.25%) treated with envafolimab by BICR and median duration of response of greater than six months is a key secondary endpoint. Since the announcement, more than 20 additional patients have enrolled.

In July, we announced collection of the arbitration award of $22M from I-Mab Biopharma.
Expected Upcoming Milestones

Complete accrual of the ENVASARC pivotal trial in the fourth quarter of 2023 and release updated response rate data before the end of the year.

Continue to leverage TRACON’s cost-efficient, CRO-independent product development platform to generate non-dilutive capital by the end of the year.

Final data from ENVASARC pivotal trial in mid-2024.
Third Quarter 2023 Financial Results

Cash, cash equivalents and restricted cash were $7.8 million at September 30, 2023, compared to $17.5 million at December 31, 2022.

Research and development expenses for the third quarter of 2023 were $2.3 million, compared to $4.1 million for the third quarter of 2022. The decrease was primarily related to enrollment into only cohort C in the ongoing ENVASARC pivotal trial.

General and administrative expenses for the third quarter of 2023 were $1.3 million, compared to $2.3 million for the third quarter of 2022. The decrease was primarily attributable to lower legal expenses.

We received a refund of $2.0 million in arbitration success fees from our law firm in addition to the write off of approximately $0.3 million in legal fees in the third quarter of 2023.

We recorded other income of approximately $13.0 million in the third quarter of 2023 in conjunction with the collection of the arbitration award.

Net income for the third quarter of 2023 was $10.8 million, compared to a net loss of $6.4 million for the third quarter of 2022.
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 and licensed by TRACON, 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 ENVASARC Phase 2 pivotal 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 in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S. Food and Drug Administration for envafolimab (KN035) 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.

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 is enrolling patients in ENVARSAC with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor. A total of 80 patients will receive treatment with single agent envafolimab at 600 mg every three weeks. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.