On February 5, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported its financial results for the second quarter ending December 31, 2024 (Press release, Bio-Techne, FEB 5, 2025, View Source [SID1234650063]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Second Quarter FY2025 Highlights

Second quarter organic revenue increased by 9% (9% reported) to $297.0 million.
GAAP earnings per share (EPS) was $0.22 versus $0.17 one year ago. Delivered adjusted EPS of $0.42 compared to $0.40 one year ago.
Improving biopharma end-market conditions combined with continued momentum of our cell and gene therapy workflow solutions, led to 8% organic growth in our Protein Sciences Segment (7% reported).
Strong commercial execution in Diagnostics & Spatial Biology led to 12% organic growth (12% reported) in the segment.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted diluted EPS, adjusted net earnings, adjusted gross margin, adjusted operating income, adjusted tax rate, organic revenue, adjusted operating margin, earnings before interest, taxes, depreciation, and amortization (EBITDA), and adjusted EBITDA are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"The Bio-Techne team once again executed at a high level and delivered strong second quarter results," said Kim Kelderman, President and Chief Executive Officer of Bio-Techne. "It is encouraging to see early signs of improvement in the biopharma end-market, which was evident in our cell and gene therapy and protein analysis instrumentation businesses. We delivered this top-line result with a continued focus on profitability, which resulted in a 30.1% adjusted operating margin, an increase of 110 basis points sequentially."

Kelderman added, "The Bio-Techne growth vectors empower the discovery of novel biological insights, the development and manufacturing of advanced therapeutics and, enable precision diagnostics. Our portfolio plays a key role in the healthy aging of global populations. The combination of this unique portfolio with the talented Bio-Techne team positions the Company for continued differentiated financial performance."

Bio-Techne will host an earnings conference call today, February 5, 2025, at 8:00 a.m. CST. To listen, please dial 1-877-407-9208 or 1-201-493-6784 (for international callers), and reference conference ID 13751305. The earnings call can also be accessed via webcast through the following link View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512- 2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13751305. The replay will be available from 11:00 a.m. CST on Wednesday, February 5, 2025, until 11:00 p.m. CST on Wednesday, March 5, 2025.

Second Quarter Fiscal 2025

Revenue

Net sales for the second quarter increased 9% to $297.0 million. Organic revenue increased 9% compared to the prior year. Foreign currency exchange and a business held-for-sale did not have a material impact.

GAAP Earnings Results

GAAP EPS was $0.22 per diluted share, versus $0.17 in the same quarter last year. GAAP operating income for the second quarter of fiscal 2025 increased 25% to $47.4 million, compared to $38.0 million in the second quarter of fiscal 2024. GAAP operating margin was 16.0%, compared to 13.9% in the second quarter of fiscal 2024. Current year GAAP operating margin was favorably impacted by volume leverage and a non-recurring prior year impairment of a business held-for-sale.

Non-GAAP Earnings Results

Adjusted EPS increased to $0.42 per diluted share compared to $0.40 in the same quarter last year. Adjusted operating income for the second quarter of fiscal 2025 increased 8% to $88.7 million, compared to $81.9 million in the second quarter of fiscal 2024. Adjusted operating margin remained flat at 30.1% for the second quarter of fiscal 2025 compared to the second quarter of fiscal 2024. Adjusted operating margin was impacted by favorable volume leverage offset by re-instatement of incentive compensation accruals.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biopharma and academic research communities. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s second quarter fiscal 2025 net sales were $211.6 million, an increase of 7% from $197.7 million for the second quarter of fiscal 2024. As of December 31, 2023, a business within the Protein Sciences Segment met the criteria as held-for-sale; this held-for-sale business has been excluded from the segment’s second quarter fiscal 2025 operating results. The exclusion of fiscal 2025 sales related to this held-for-sale business reduced sales by 1%. Organic revenue growth was 8% for the second quarter of fiscal 2025, with foreign currency exchange not having a material impact. The Protein Sciences segment’s operating margin increased to 41.2% in the second quarter of fiscal 2025 compared to 40.3% in the second quarter of fiscal 2024. The segment’s operating margin increased primarily due to volume leverage offset by re-instatement of incentive compensation accruals.

Diagnostics and Spatial Biology Segment

The Company’s Diagnostics and Spatial Biology segment develops and provides spatial biology products, carrier screening and oncology kits, as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Spatial Biology segment also provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Spatial Biology segment’s second quarter fiscal 2025 net sales were $84.1 million, an increase of 12% from $75.4 million for the second quarter of fiscal 2024. Organic revenue growth was 12% for the second quarter of fiscal 2025, with foreign exchange not having a material impact. The Diagnostics and Spatial Biology segment’s operating margin was 3.9% in the second quarter of fiscal 2025 compared to 6.0% in the second quarter of fiscal 2024. The segment’s operating margin decreased primarily due to re-instatement of incentive compensation accruals, partially offset by favorable volume leverage.

On February 5, 2025 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that Robert I. Blum, President and Chief Executive Officer, reported to participate in a virtual fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on Wednesday, February 12, 2025 at 4:40 PM Eastern Time (Press release, Cytokinetics, FEB 5, 2025, View Source [SID1234650062]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Interested parties may access the live webcast of the fireside chat by visiting the Investors & Media section of the Cytokinetics website at View Source The webcast replay will be archived on the Cytokinetics website for 90 days following the conclusion of the event.

On February 5, 2025 Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that the New England Journal of Medicine (NEJM) published results of the registrational phase 2 eNRGy trial for Bizengri (zenocutuzumab), the first and only treatment indicated for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy (Press release, Merus, FEB 5, 2025, View Source [SID1234650061]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This manuscript provides comprehensive data on the safety and efficacy of Bizengri and demonstrates the meaningful results observed in the eNRGy trial," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "We continue to make significant progress across our clinical pipeline of important and new cancer therapeutic candidates, all from our own Biclonics antibody technologies."

NRG1 fusions are unique cancer drivers that create oncogenic chimeric ligands rather than the more widely described chimeric receptors (TRK, RET, ROS1, ALK, and FGFR fusions). This is the first reported prospective clinical trial targeting cancers with this rare genomic alteration, a population enriched for cancer types with limited effective treatment options.1, 2, 3

The publication reviews the results of 204 patients with 12 tumor types enrolled and treated on the eNRGy study, concluding "Zenocutuzumab demonstrated durable efficacy in patients with advanced NRG1+ cancer, notably NSCLC and pancreatic adenocarcinoma, with a favorable safety profile."

"This medicine fills an important need among patients with NRG1 fusion pancreatic adenocarcinoma and lung cancer who have not previously had targeted treatment options," said Alison Schram M.D., an attending medical oncologist in the Early Drug Development Service at Memorial Sloan Kettering Cancer Center, a principal investigator for the eNRGy trial, and lead author on the NEJM manuscript.

In December, Merus announced it had entered into an agreement with Partner Therapeutics, Inc. (PTx), a private, fully-integrated biotechnology company with a focus in hematology and oncology, in which Merus has exclusively licensed to PTx the right to commercialize zenocutuzumab (Zeno, tradename Bizengri) for the treatment of NRG1 fusion-positive (NRG1+) cancer in the United States (U.S.).

Indications:

BIZENGRI (zenocutuzumab-zbco) is indicated for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy. These indications are approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

BOXED WARNING: EMBRYO-FETAL TOXICITY

Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception.

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions/Hypersensitivity/Anaphylactic Reactions

BIZENGRI can cause serious and life-threatening infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions. Signs and symptoms of IRR may include chills, nausea, fever, and cough.

In the eNRGy study, 13% of patients experienced IRRs, all were Grade 1 or 2; 91% occurred during the first infusion.

Administer BIZENGRI in a setting with emergency resuscitation equipment and staff who are trained to monitor for IRRs and to administer emergency medications. Monitor patients closely for signs and symptoms of infusion reactions during infusion and for at least 1 hour following completion of first BIZENGRI infusion and as clinically indicated. Interrupt BIZENGRI infusion in patients with ≤ Grade 3 IRRs and administer symptomatic treatment as needed. Resume infusion at a reduced rate after resolution of symptoms. Immediately stop the infusion and permanently discontinue BIZENGRI for Grade 4 or life-threatening IRR or hypersensitivity/anaphylaxis reactions.

Interstitial Lung Disease/Pneumonitis

BIZENGRI can cause serious and life-threatening interstitial lung disease (ILD)/pneumonitis. In the eNRGy study, ILD/pneumonitis occurred in 2 (1.1%) patients treated with BIZENGRI. Grade 2 ILD/pneumonitis (Grade 2) resulting in permanent discontinuation of BIZENGRI occurred in 1 (0.6%) patient. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold BIZENGRI in patients with suspected ILD/pneumonitis and administer corticosteroids as clinically indicated. Permanently discontinue BIZENGRI if ILD/pneumonitis ≥ Grade 2 is confirmed.

Left Ventricular Dysfunction

BIZENGRI can cause left ventricular dysfunction.

Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including BIZENGRI. Treatment with BIZENGRI has not been studied in patients with a history of clinically significant cardiac disease or LVEF less than 50% prior to initiation of treatment.

In the eNRGy study, Grade 2 LVEF decrease (40%-50%; 10 – 19% drop from baseline) occurred in 2% of evaluable patients. Cardiac failure without LVEF decrease occurred in 1.7% of patients, including 1 (0.6%) fatal event.

Before initiating BIZENGRI, evaluate LVEF and monitor at regular intervals during treatment as clinically indicated. For LVEF of less than 45% or less than 50% with absolute decrease from baseline of 10% or greater which is confirmed, or in patients with symptomatic congestive heart failure (CHF), permanently discontinue BIZENGRI.

Embryo-Fetal Toxicity

Based on its mechanism of action, BIZENGRI can cause fetal harm when administered to a pregnant woman. No animal reproduction studies were conducted with BIZENGRI. In postmarketing reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In animal models, studies have demonstrated that inhibition of HER2 and/or HER3 results in impaired embryo-fetal development, including effects on cardiac, vascular and neuronal development, and embryolethality. Advise patients of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of BIZENGRI. Advise females of reproductive potential to use effective contraception during treatment with BIZENGRI and for 2 months after the last dose.

ADVERSE REACTIONS

NRG1 Gene Fusion Positive Unresectable or Metastatic Pancreatic Adenocarcinoma

Serious adverse reactions occurred in 23% of patients with NRG1 Gene Fusion Positive Pancreatic Adenocarcinoma who received BIZENGRI.

There were 2 fatal adverse reactions, one due to COVID-19 and one due to respiratory failure.

In patients with NRG1 Gene Fusion Positive Pancreatic Adenocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were increased alanine aminotransferase (51%), diarrhea (36%), increased aspartate aminotransferase (31%), increased bilirubin (31%), decreased phosphate (31%), increased alkaline phosphatase (28%), decreased sodium (28%) musculoskeletal pain (28%), decreased albumin (26%), decreased potassium (26%), decreased platelets (26%), decreased magnesium (24%), increased gamma-glutamyl transpeptidase (23%), decreased hemoglobin (23%), vomiting (23%), nausea (23%), decreased leukocytes (21%), and fatigue (21%).

NRG1 Gene Fusion Positive Unresectable or Metastatic NSCLC

Serious adverse reactions occurred in 25% of patients with NRG1 Gene Fusion Positive NSCLC who received BIZENGRI. Serious adverse reactions in ≥ 2% of patients included pneumonia (n=4) dyspnea and fatigue (n=2 each). Fatal adverse reactions occurred in 3 (3%) patients and included respiratory failure (n=2), and cardiac failure (n=1). Permanent discontinuation of BIZENGRI due to an adverse reaction occurred in 3% of patients. Adverse reactions resulting in permanent discontinuation of BIZENGRI included dyspnea, pneumonitis and sepsis (n=1 each).

In patients with NRG1 Gene Fusion Positive NSCLC who received BIZENGRI, the most common (>20%) Adverse Reactions, including laboratory abnormalities, were decreased hemoglobin (35%), increased alanine aminotransferase (30%), decreased magnesium (28%), increased alkaline phosphatase (27%), decreased phosphate (26%) diarrhea (25%), musculoskeletal pain (23%), increased gamma-glutamyl transpeptidase (23%), increased aspartate aminotransferase (22%), and decreased potassium (21%).

Please see full Prescribing Information, including Boxed WARNING, at BIZENGRI.com/pi.

About BIZENGRI
BIZENGRI is a bispecific antibody that binds to the extracellular domains of HER2 and HER3 expressed on the surface of cells, including tumor cells, inhibiting HER2:HER3 dimerization and preventing NRG1 binding to HER3. BIZENGRI decreased cell proliferation and signaling through the phosphoinositide 3-kinase-AKT-mammalian target of rapamycin pathway. In addition, BIZENGRI mediates antibody-dependent cellular cytotoxicity. BIZENGRI showed antitumor activity in mouse models of NRG1+ lung and pancreatic cancers.4

About the eNRGy Trial
The eNRGy trial (Clinicaltrials.gov NCT02912949) is a multicenter, open-label clinical trial that includes patients with advanced unresectable or metastatic NRG1+ pancreatic adenocarcinoma or NRG1+ NSCLC who have disease progression on or after prior systemic therapy. There were 30 patients in the NRG1+ pancreatic adenocarcinoma group and 64 patients in the NRG1+ NSCLC group. The main outcome measures were ORR and DOR, as determined by BICR according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.4

In the NRG1+ pancreatic adenocarcinoma group, the median age was 49 years (range, 21-72 years); 43% were female; 87% were White, 7% were Asian, and 3.3% were Black or African American. All patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and all patients had metastatic disease. Patients received a median of 2 prior systemic therapies (range, 0-5); 97% had prior systemic therapy with prior chemotherapy.4

In the NRG1+ NSCLC group, the median age was 64 years (range, 32-86 years); 64% were female, 33% were White, 56% were Asian, and 3.4% were Black or African American. ECOG performance status was 0 or 1 in 97% of patients or 2 in 3% of patients, and 98% of patients had metastatic disease. Patients received a median of 2 prior systemic therapies (range, 1-6).

On February 5, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported new data that reinforce the ability of its Decipher Bladder Genomic Subtyping Classifier to help improve staging for patients with bladder cancer, based on their tumors’ molecular subtype (Press release, Veracyte, FEB 5, 2025, View Source [SID1234650060]). The findings, published in European Urology Open Science, show that the test can help clinicians better determine which patients are more likely to harbor more aggressive disease than suggested by their initial clinical staging following transurethral resection of bladder tumor (TURBT).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Researchers analyzed data for 226 patients from eight medical centers who underwent radical cystectomy (RC) without neoadjuvant chemotherapy (NAC). The study cohort included 134 patients with high-risk non-muscle-invasive bladder cancer (NMIBC) and 92 patients with muscle-invasive bladder cancer (MIBC) classified as T2, in which the cancer had grown into, but not through, the bladder’s muscle layer. Key findings included:

Following RC without neoadjuvant chemotherapy, pathological upstaging to non-organ-confined disease was observed in 33% of patients (19% for NMIBC and 53% for T2 disease), demonstrating the challenges in bladder cancer clinical staging.
Using the Decipher Bladder test to determine each tumor’s molecular subtype, researchers found that NMIBC patients with non-luminal tumors were more likely to be upstaged to MIBC, compared to those with luminal tumors (51% vs. 32%, multivariable p=0.03).
Patients with luminal-subtype bladder cancer had better overall survival on multivariable analyses (non-luminal vs. luminal adjusted HR 1.67 [95% CI 1.01-2.78], p=0.05), based on a median follow-up of 33 months.
"Accurate clinical staging in bladder cancer can be challenging, limiting clinicians’ ability to guide treatment decisions for their patients," said Yair Lotan, M.D., professor of urology and chief of urologic oncology at UT Southwestern Medical Center and corresponding author on the study. "Our findings suggest that molecular subtyping information provided by the Decipher Bladder test can help clinicians better identify which patients may benefit from more-intensive treatment with neoadjuvant chemotherapy and which will not and can thus avoid its toxicity."

The study comes on the heels of three recent peer-reviewed, published studies1-3 demonstrating the performance and clinical utility of the Decipher Bladder test and its whole-transcriptome approach. The new publication also builds on Veracyte’s extensive body of clinical evidence supporting its molecular tests in urology where its Decipher Prostate Genomic Classifier is the market leader in prostate cancer.

"We are increasing our collaboration efforts with leading clinician-scientists to improve and further personalize bladder cancer care, similar to our approach in prostate cancer which has amassed over 85 publications from analysis of hundreds of thousands of patient transcriptomes," said Elai Davicioni, Ph.D., medical director, Urology, at Veracyte. "This approach is the lynchpin of our Veracyte Diagnostics Platform, which helps facilitate evidence generation, reimbursement and adoption for our tests. It also provides insights that fuel continued innovation, with the overall goal of supporting physicians to deliver better, more-personalized patient care."

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 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.

On February 5, 2025 Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported that Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, will participate in a fireside chat at the Oppenheimer 35th Annual Healthcare Life Sciences Conference, a virtual event, on Wednesday, February 12, 2025 beginning at 2:00 p.m. Eastern Time (Press release, Quince Therapeutics, FEB 5, 2025, View Source [SID1234650059]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the fireside chat will be accessible on the Events page under the News & Events heading of Quince’s Investor Relations website at ir.quincetx.com. An archive of the webcast will be available shortly following the end of the live event.