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ESSA Pharma Reports Financial Results for Fiscal First Quarter Ended December 31, 2024

On February 11, 2025 ESSA Pharma Inc. ("ESSA," or the "Company") (NASDAQ: EPIX), a pharmaceutical company, prior to the discontinuation of its clinical trials and development programs, has been focused on developing novel therapies for the treatment of prostate cancer, reported financial results for the fiscal first quarter ended December 31, 2024 (Press release, ESSA, FEB 11, 2025, View Source [SID1234650182]).

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"Following our decision to terminate the clinical development of masofaniten, we have been evaluating and reviewing strategic options with a focus on maximizing shareholder value," said David Parkinson, MD, President and CEO of ESSA. "We look forward to providing updates in the near future."

First Quarter 2025 and Recent Updates

Following the decision to terminate all clinical trials evaluating masofaniten and to withdraw the related IND and CTAs, ESSA is conducting a comprehensive process to explore and review a range of strategic options focused on maximizing shareholder value. These options may include, but are not limited to, a merger, amalgamation, take-over, business combination, asset sale or acquisition, shareholder distribution, wind-up, liquidation and dissolution, or other strategic direction. The process is expected to involve headcount and other cost reductions.
Summary of Financial Results
(Amounts expressed in U.S. dollars)

Net Loss. ESSA recorded a net loss of $8.5 million for the first quarter ended December 31, 2024, compared to $6.0 million for the first quarter ended December 31, 2023. Investment and other income was $1.1 million for the first quarter ended December 31, 2024, compared to $1.6 million for the first quarter ended December 31, 2023.
Research and Development ("R&D") expenditures. R&D expenditures for the first quarter ended December 31, 2024 were $5.5 million compared to $5.4 million for the first quarter ended December 31, 2023, and include non-cash costs related to share-based payments of $729,780 for the first quarter ended 2024 compared to $526,241 for the first quarter ended 2023. The increase in the first quarter was primarily attributed to the initiation and wind-down of clinical site closures.
General and Administration ("G&A") expenditures. G&A expenditures for the first quarter ended December 31, 2024 were $4.2 million compared to $2.2 million for the first quarter ended December 31, 2023 and include non-cash costs related to share-based payments of $1,972,151 for the first quarter ended 2024 compared to $277,177 for the first quarter ended 2023.
Liquidity and Outstanding Share Capital

As of December 31, 2024, the Company had available cash reserves and short-term investments of $120.6 million and net working capital of $118.8 million. The company has no long-term debt facilities.
As of December 31, 2024, the Company had 44,388,550 common shares issued and outstanding, and there were 2,920,000 common shares issuable upon the exercise of prefunded warrants at an exercise price of $0.0001.

Lion TCR’s Liocyx-M004 Receives FDA Clearance to Launch Global Multicenter Phase 2 Clinical Trial in HBV-Related Hepatocellular Carcinoma

On February 11, 2025 Lion TCR reported that its mRNA-encoded T-cell receptor (TCR)-T cell therapy product Liocyx-M004 has received clearance from the U.S. Food and Drug Administration (FDA) to initiate an international multicenter Phase 2 clinical trial (Press release, Lion TCR, FEB 11, 2025, View Source [SID1234650181]). This significant progress further solidifies Lion TCR’s leading position in the mRNA-based TCR-T field and brings new hope to patients with hepatocellular carcinoma (HCC).

Hepatitis B and liver cancer are significant global public health challenges. Hepatitis B virus (HBV) infection is a leading risk factor for liver cancer, particularly HCC. Globally, an estimated 296 million people live with chronic HBV infection. Liver cancer is the sixth most common cancer worldwide. In 2020 alone, there were approximately 905,000 new cases and 830,000 deaths from liver cancer globally. Liocyx-M004 is the world’s first mRNA-encoded TCR-T cell therapy targeting HBV-related hepatocellular carcinoma. The FDA-approved international multicenter Phase 2 clinical trial will evaluate the efficacy of Liocyx-M004 as a monotherapy and in combination with lenvatinib. Lenvatinib, a well-established first-line treatment for advanced hepatocellular carcinoma, demonstrates the ability to reprogram the immunosuppressive tumour microenvironment into an immune-supportive state, thereby enhancing tumour-killing efficacy. When combined with Liocyx-M004, this therapy is anticipated to create synergistic effects, further amplifying its anti-tumour potential and improving patient outcomes.

Dr. Tina Wang, Chief Medical Officer and Chief Operating Officer of Lion TCR, explained: "In patients with HBV-related hepatocellular carcinoma, HBV-specific T cells are often functionally exhausted, leading to a significant impairment in their ability to eliminate liver cancer cells and HBV-infected liver cells with HBV-DNA integration. Our research has shown that HBV-specific TCR-T cells can effectively target and destroy these cancerous cells. This makes the adoptive transfer and supplementation of autologous HBV-specific TCR-T cells a promising therapeutic strategy, with the potential to restore the HBV-specific T cell pool in patients. This approach enables targeted killing of liver cancer cells and infected liver cells expressing HBV antigens, providing a novel treatment option for HBV-related hepatocellular carcinoma. While systemic therapies for advanced hepatocellular carcinoma have made significant strides in recent years, including the development of targeted combination immunotherapies, precision treatments for HBV-related hepatocellular carcinoma remain limited. By investigating the combination of Liocyx-M004 with lenvatinib, we aim to further improve response rates and survival outcomes for these patients. The FDA’s approval of this international multicenter Phase 2 clinical trial is a major milestone that strengthens our confidence and commitment to advancing mRNA-encoded TCR-T therapies for hepatocellular carcinoma. Moving forward, we will accelerate the trial’s progress and gather clinical data to bring this innovative treatment to patients as soon as possible."

Dr. Xiaoming Peng, CEO of Lion TCR, remarked: "Liocyx-M004 is the first TCR-T therapy targeting HBV viral antigens to receive IND approval from the U.S. FDA and the first of its kind to be granted Fast Track designation. This approval for Liocyx-M004 to proceed with international multicenter Phase 2 clinical trials underscores its significance as an innovative therapy for liver cancer and represents a major milestone for Lion TCR. It also signifies a critical step in Lion TCR’s transition from the clinical stage to commercialization. While advancing our lead product through these critical trials, we are simultaneously accelerating the development of an ‘off-the-shelf’ (or ‘universal’) in vivo TCR-T product platform, leveraging mRNA-LNP delivery technology to significantly reduce production costs. In parallel, we are enhancing our AI-powered TCR discovery platform to expand our pipeline into treatments for various solid tumors with high unmet needs, including lung cancer, breast cancer, and gastrointestinal cancers."

Liocyx-M004 has already demonstrated promising outcomes in earlier clinical trials, achieving a median overall survival of 33.1 months in patients with HBV-related hepatocellular carcinoma.

New Breast Cancer Therapy to Reduce Risk of Recurrence and Improve Disease-Free Survival Now Approved in Thailand

On February 11, 2025 Specialised therapeutics reported that a new breast cancer therapy shown to significantly reduce the risk of cancer recurrence and improve disease-free survival in women is now approved for use in Thailand (Press release, Specialised Therapeutics Asia, FEB 11, 2025, View Source [SID1234650180]).

NERLYNX (neratinib), an oral medication, has been approved by the Thailand Food and Drug Administration (Thailand FDA) as a single agent "for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago."[1] Additionally, NERLYNX has been approved in combination with capecitabine"for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting."

In early breast cancer, NERLYNX has been shown to significantly reduce the ongoing risk of recurrence in women positive for human epidermal growth factor receptor 2 (HER2+), with the greatest benefit seen in women who are also hormone-receptor positive (HR+) and who commence therapy within 12 months of completing trastuzumab-based therapy.[2,3] For these women, the five-year risk of recurrence is reduced by up to 42%.

In women with advanced or metastatic HER2+ breast cancer, NERLYNX in combination with capecitabine (N+C) was found to significantly improve mean progression free survival (PFS) by 2.2 months over treatment with lapatinib plus capecitabine (L+C).[5] The duration of treatment response was longer for patients administered N+C (8.5 months) versus L+C (5.6 months), while the risk of disease progression or death was reduced by up to 24% among those treated with N+C at a median follow-up of 30 months.

NERLYNX is being made available in Thailand by independent pharmaceutical company, Specialised Therapeutics (ST), under exclusive license from Puma Biotechnology, Inc.

ST Chief Executive Officer, Mr Carlo Montagner, said the approval of NERLYNX in Thailand was an important milestone for the company.

"We are proud to have obtained approval of NERLYNX in Thailand for adults with HER2 positive breast cancer. This is a significant milestone for Specialised Therapeutics, but importantly also for women diagnosed with breast cancer in Thailand who will be presented with an opportunity to access a treatment that will help reduce the risk of disease recurrence and improve outcomes, in either the early or advanced stages of their disease."

Breast cancer is the most common cancer diagnosed in Thai women, and the second leading cause of cancer mortality in females, behind liver cancer.[7] The incidence of breast cancer in Thailand has been rising at an alarming rate, with the annual age-standardised incidence rate doubling over the past 20 years (from 17.8/100,000 in 1998, to 35.7/100,000 in 2020).[8,9] In 2022, 21,628 Thai women were newly diagnosed with breast cancer, accounting for almost a quarter (23.2%) of all new cancer diagnoses in females.[7]

Coinciding with the NERLYNX approval, ST is also pleased to announce the growth of its Thailand office, with new field force members due to join the company in March 2025.

"We are extremely excited about the new journey we are undertaking in Thailand," said Mr Montagner. "Hiring our first field force employees, who have an extensive understanding of the local healthcare landscape, enables us to connect with oncologists around the country at the earliest opportunity, ahead of launching NERLYNX and making it available for eligible breast cancer patients as soon as possible.

"As we continue to seek approvals for our strong pipeline of specialised medicines and technologies, we remain committed to meeting the needs of patients with rare diseases across Thailand, and making a difference to their lives. We look forward to working with the Thailand FDA and local specialists as we endeavour to provide timely access to these new treatments for the patients that need them."

About NERLYNX

NERLYNX (neratinib) is an irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.[10] It is an oral tablet and works by binding to multiple receptors inside the cancer cell, blocking signals that tell cancer cells to grow and multiply.[11,12]

NERLYNX has received approval for the treatment of certain patients with extended adjuvant and/or metastatic HER2-positive breast cancer in more than 40 countries outside the United States (US), including the European Union (EU), China, Latin America, Australia, Canada, and Hong Kong.

About HER2-Positive (HER2+) Breast Cancer

Approximately 20-25% of breast cancer tumours over-express the HER2 protein. HER2-positive (HER2+) breast cancer is a highly heterogeneous tumour that is often more aggressive than other types of breast cancer and has a poor prognosis, increasing the risk of disease progression and death.[10,13,14]

While trastuzumab has helped to improve the survival and prognosis of patients with HER2+ breast cancer, around 20-30% of patients will experience recurrence and metastases after trastuzumab targeted therapy.[14]

About the ExteNET Study

The ExteNET trial was a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in patients with early-stage HER2-positive breast cancer.

The ExteNET trial randomised 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomised to receive neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of five years after randomisation.

The primary endpoint of the trial was invasive disease-free survival (iDFS). The trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.73, p = 0.008). The 5-year iDFS rate for the neratinib arm was 90.2%, versus 87.7% for the placebo arm. An additional five-year sub-group analysis demonstrated a 42% reduction in risk of recurrence and 59% reduction in risk of CNS recurrence or death of any cause in women who were HR+ and who had commenced neratinib therapy within 12 months of completing treatment with trastuzumab.

The most common adverse reactions (≥ 5%) were diarrhoea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.

About the NALA Study

The NALA trial was a randomised, active-controlled, Phase III trial investigating the efficacy of neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, a reversible dual TKI, plus capecitabine (L+C) in patients with centrally confirmed HER2+ metastatic breast cancer who had received two or more prior anti-HER2 based regimens in the metastatic setting. 621 patients were enrolled at 203 sites in 28 countries across Europe, North and South America, Asia, and Australia.

The primary outcome measures for the trial were progression-free survival (PFS), and overall survival (OS). Median PFS was 5.6 months for patients who received N+C and 5.5 months for those receiving L+C (hazard ratio = 0.76, p = 0.0059). The PFS rate at 12 months was 29% versus 15%, respectively. Median OS was 21 months for patients receiving N+C, compared to 18.7 months for those receiving L+C (hazard ratio = 0.88, p = 0.2086).

The most common adverse reactions of any grade (>5%) in the N+C arm were diarrhoea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, decreased weight, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

Tyra Biosciences to Present at Upcoming Investor Conferences

On February 11, 2025 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that company management will participate in the following investor conferences (Press release, Tyra Biosciences, FEB 11, 2025, View Source [SID1234650179]):

Oppenheimer 35th Annual Healthcare Life Sciences Conference, February 11-12, 2025
Format: Fireside chat and one-on-one investor meetings
Presentation Date/Time: Wednesday, February 12, 2025, at 2:00 PM ET
Location: Virtual
TD Cowen 45th Annual Healthcare Conference, March 3-5, 2025
Format: Fireside chat and one-on-one investor meetings
Presentation Date/Time: Monday, March 3, 2025, at 9:50 AM ET
Location: Boston
Jefferies Biotech on the Beach Summit, March 11-12, 2025
Format: One-on-one investor meetings
Location: Miami
Barclays 27th Annual Global Healthcare Conference, March 11-13, 2025
Format: Fireside chat and one-on-one investor meetings
Presentation Date/Time: Wednesday, March 12, 2025, at 8:30 AM ET
Location: Miami

A live and archived webcast of the fireside chats will be available via the For Investors page on the Investor section of the TYRA website.

Veracyte Announces 17 Abstracts Demonstrating Its Decipher Tests’ Leadership in Urologic Cancers to Be Presented at the 2025 ASCO GU Symposium

On February 11, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported that 17 Decipher-focused abstracts will be presented at the 2025 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) (Press release, Veracyte, FEB 11, 2025, View Source [SID1234650178]). The findings demonstrate the market leadership of its Decipher tests in better informing treatment decisions for patients with prostate and bladder cancers, compared to standard approaches, and in helping to drive innovation that will inform the future of urologic cancer care. The conference will take place February 13-15 in San Francisco.

"The scale and scope of data to be presented at the ASCO (Free ASCO Whitepaper) GU meeting underscore the impact our whole-transcriptome-based Decipher tests are having in treating patients with urologic cancers, and how our GRID, or Genomic Resource for Intelligent Discovery, research tool is helping to advance scientific understanding of these diseases," said Elai Davicioni, Ph.D., Veracyte’s medical director, Urology. "Our commitment to generating robust clinical evidence with collaborators has led to our market-leading Decipher Prostate test achieving the highest status among gene expression tests in the most recent, and prior, NCCN guidelines.* We look forward to using a similar approach for our Decipher Bladder test in bladder cancer."

"Clinical rigor and robust evidence generation are important for a molecular test to gain widespread adoption and inclusion in guidelines for helping physicians and their patients with prostate cancer make better-informed treatment decisions," said Daniel Spratt, M.D., of the University Hospitals Seidman Cancer Center, Case Western Reserve University. "National guidelines have acknowledged the large body of work from randomized Phase 3 trials that have been profiled with Decipher and include the Decipher test as an advanced risk-stratification tool that can aid in shared-decision making for patients."

Key Decipher-focused findings to be presented at the ASCO (Free ASCO Whitepaper) GU Symposium are:

Title:

Decipher Score as a Predictor of Response to Treatment Intensification in the NRG Oncology-RTOG 0534 (SPPORT) Phase III Randomized Post-Prostatectomy Salvage Radiotherapy Trial

Presenter:

Alan Pollack, M.D., Ph.D., University of Miami Health System

Format:

Poster (#K29)

Abstract #:

399

Date/Time:

Thursday, February 13, 2025; 11:25 a.m.—12:45 p.m. PST

Location:

Level 1, West Hall; On Demand

Summary:

A post-hoc analysis of the NRG Oncology/RTOG 05-34 (SSPORT) Phase 3, randomized trial shows that the Decipher Prostate test may inform treatment intensification strategies in patients undergoing salvage radiotherapy by identifying those who will benefit from pelvic nodal radiation.

Title:

A non-coding RNA based classifier for favorable outcomes in clinically organ confined bladder cancer

Presenter:

Yair Lotan, M.D., UT Southwestern Medical Center

Format:

Poster (#G27)

Abstract #:

831

Date/Time:

Friday, February 14, 2025; 11:30 a.m.—12:45 p.m. PST

Location:

Level 1, West Hall; On Demand

Summary:

Study findings show that the Decipher Bladder test accurately identifies patients whose bladder cancer has a luminal molecular subtype, which is associated with favorable outcomes. Such findings could help clinicians determine which patients are less likely to benefit from intensified therapy.

Title:

Gene signature predictor of dose-response to prostate radiation: validation of PORTOS in phase III trials

Presenter:

Shuang Zhao, M.D., University of Wisconsin-Madison

Format:

Oral Presentation

Abstract #:

308

Date/Time:

Thursday, February 13, 2025; 8:00 a.m.—9:40 a.m. PST

Location:

Level 3, Ballroom; Live Stream

Summary:

Analyses of two prospective, randomized, Phase 3 trials (RTOG 01-26 and SAKK 09/10) show that the PORTOS gene expression signature – currently part of the Decipher GRID research tool – predicts which patients will benefit from dose-escalated radiation therapy in both primary and salvage treatment settings.

Additional notable Decipher-focused presentations include:

Title:

Decipher Risk Stratification of Radiorecurrent Prostate Cancer: Correlative Analysis of the F-SHARP Trial of Salvage Reirradiation

Presenter:

Abhishek Solanki, M.D., M.S., Loyola University Chicago

Format:

Poster (#L15)

Abstract #:

419

Date/Time:

Thursday, February 13, 2025; 11:25 a.m.—12:45 p.m. PST

Location:

Level 1, West Hall; On Demand

Summary:

Radiation therapy is increasingly used for patients whose prostate cancer has recurred following initial radiation treatment. This study suggests the Decipher Prostate test can identify patients who are likely to benefit from more radiation alone versus those who may also need further treatment intensification.

Title:

Androgen receptor activity in biopsy specimens at initial diagnosis of prostate cancer and correlation with outcomes and treatment response

Presenter:

Nicole Handa, M.D., Northwestern University, Feinberg School of Medicine

Format:

Poster (#L5)

Abstract #:

409

Date/Time:

Thursday, February 13, 2025; 11:25 a.m.—12:45 p.m. PST

Location:

Level 1, West Hall; On Demand

Summary:

Using the Decipher GRID research tool to assess transcriptome-wide expression data and clinical factors, investigators found that low androgen receptor activity (AR-A) was associated with poor outcomes for prostate cancer patients. They suggest such patients could potentially benefit from post-operative radiation therapy and PARP inhibitors.

Title:

Risk Stratification Using the Decipher 22-gene Genomic Classifier (GC) and Digital Pathology Artificial Intelligence (DPAI) in Nearly 10,000 Localized Prostate Cancer Patients

Presenter:

Daniel Spratt, M.D., University Hospitals Seidman Cancer Center, Case Western Reserve University

Format:

Poster (#L4)

Abstract #:

408

Date/Time:

Thursday, February 13, 2025; 11:25 a.m.—12:45 p.m. PST

Location:

Level 1, West Hall; On Demand

Summary:

This large study found that adding digital pathology artificial intelligence (DPAI) tools to the Decipher Prostate Genomic Classifier did not further improve the molecular test’s prognostic performance. Ongoing research is underway to explore whether there may be specific clinical states where the combination of DPAI and the Decipher test may add meaningful clinical utility.

"The extensive Decipher-focused data at the 2025 ASCO (Free ASCO Whitepaper) GU Symposium demonstrate the power of our novel Veracyte Diagnostics Platform, which begins with delivering high-performing tests using a comprehensive, whole-transcriptome approach. This enables additional research, which in turn supports further innovation to help more patients," said Phillip Febbo, M.D., Veracyte’s chief scientific officer and chief medical officer.

Veracyte’s Decipher team will be at Booth #37 at the 2025 ASCO (Free ASCO Whitepaper) GU Symposium. More information, including a full list of Decipher-focused abstracts being presented, can be found here.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients with prostate cancer. The test is performed on biopsy or surgically resected samples and provides an accurate risk of developing metastasis with standard treatment. Armed with this information, physicians can better personalize their patients’ care and may recommend less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test has been validated in many dozens of published studies involving more than 100,000 patients. It is the only gene expression test to achieve "Level 1B" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

About Decipher Bladder

The Decipher Bladder Genomic Classifier is a 219-gene test, developed using RNA whole-transcriptome analysis and machine learning, that is designed for use in patients following bladder cancer diagnosis who face questions regarding treatment intensity. The test classifies bladder tumors into five molecular subtypes, each having distinct tumor biology and potential clinical implications. This information can help physicians and their patients better understand the degree of benefit that would likely be gained from neoadjuvant chemotherapy and/or the likelihood of harboring non-organ-confined disease at time of surgery, respectively. More information about the Decipher Bladder test can be found here.

About Decipher GRID

The Decipher GRID database includes more than 200,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis. More information about Decipher GRID can be found here.