On May 3, 2023 Lytix Biopharma – Lytix Biopharma AS ("Lytix") (Euronext Growth Oslo: LYTIX), a Norwegian immuno-oncology company – reported that Dr Øystein Rekdal, CEO in Lytix Biopharma, will give an oral presentation at the `Frontiers in Cancer Immunotherapy 2023′ conference, which is taking place in New York, USA (Press release, Lytix Biopharma, MAY 3, 2023, View Source [SID1234630950]).

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Dr Rekdal has been invited by the New York Academy of Sciences to discuss how tumor-directed strategies enable superior immune-stimulation of `cold’ non-infiltrated tumors, in a joint presentation with Lorenzo Galluzzi, PhD, Weill Cornell Medicine. In his presentation, Rekdal will put particular emphasis on the efficacy data achieved in human clinical trials performed with LTX-315 and how oncolytic molecules can address the challenge represented by the modest activity of immune checkpoint inhibitors (ICIs) in patients with immunologically `cold’ tumors. The presentation will be performed in Session 9: Cancer Vaccines, on May 3.

"Our technology platform delivers molecules with the potential to recruit immune cells into the tumor microenvironment in support of strong anticancer immunity, solving one of the major hurdles in cancer treatment. We are grateful for being invited by the New York Academy of Sciences (NYAS) to this conference and to present our clinical data confirming the strong pre-clinical evidence of our proposed solution to the problem of `cold’ tumors in cancer immunotherapy", says Dr. Øystein Rekdal.

Title: `Clinically Viable Tumor-Directed Strategies to Enable Superior Immunostimulation in Cold Neoplasms’

Date and time: Wednesday May 3, 2023, at 14.30-15.00 ET

About the Congress

Over the last 10 years, cancer immunotherapy has seen tremendous scientific development and clinical success. The field of immuno-oncology continues to advance at a rapid pace, with great potential to further revolutionize patient outcomes. The conference provides an opportunity to be part of the leading forum for scientists and clinicians to keep up with the latest trends and developments in the field. At the conference world-renowned leaders in the field like Nobel Laureate Dr. James Allison (University of Texas, MD Anderson Cancer Center), Dr. Nina Bhardwaj (Icahn School of Medicine, Mount Sinai), and Dr. Robert D. Schreiber (Washington University School of Medicine in St. Louis) will deliver keynote presentations. Speakers from leading biotech and life sciences companies including Enable Medicine, Gritstone Bio, Infinity Pharmaceuticals, and Lytix Biopharma will complement the presentations with evidence from industrial-academic collaborations.

On May 3, 2023 Convergent Therapeutics Inc., a clinical-stage biotechnology company focused on the development of next-generation radiopharmaceuticals for the treatment of cancer, reported the completion of a $90 million Series A financing, led by OrbiMed and RA Capital Management with participation from Invus (Press release, Convergent Therapeutics, MAY 3, 2023, View Source [SID1234630949]). The financing will support the development of a pipeline of novel radioantibodies, including its lead program with CONV01-α, for the treatment of advanced prostate cancer.

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Dr. Philip Kantoff, Convergent CEO, and Dr. Neil Bander, Chief Scientific Advisor to Convergent, co-founded the company with technology developed in the Bander Lab and licensed from Cornell University. Dr. Bander is the Bernard & Josephine Chaus Professor of Urologic Oncology at Weill Cornell Medicine and is recognized worldwide for his contributions to prostate-specific membrane antigen (PSMA) biology and the related advancement of PSMA directed imaging and therapeutics. Dr. Bander and his colleagues were the first to validate PSMA as a target in cancer.

Dr. Kantoff is the former Chairman of the Department of Medicine at Memorial Sloan Kettering Cancer Center, former Chief of Solid Tumor Oncology at the Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg Chair Emeritus at Harvard Medical School. Dr. Kantoff contributed to the advancement of clinical biomarkers and multiple FDA-approved treatments for prostate cancer over his three decades of work as an academic oncologist.

"While considerable progress has been made in the search for effective treatments for prostate cancer, it continues to be the second leading cause of cancer death in men1, representing a significant unmet need," said Dr. Kantoff. "This financing is an important milestone for Convergent and accelerated development of novel radioantibodies, beginning with CONV01-α. We view this program as a best-in-class, targeted treatment for prostate cancer and will be advancing CONV01-α clinical development over the immediate term. With the founding of Convergent, our focus has been on the amalgamation of world-class expertise to identify and develop new radiopharmaceutical treatments for a wide range of cancers."

Tal Zaks, M.D., Ph.D., Partner at OrbiMed, said, "In our goal of improving healthcare for patients, we believe that Convergent Therapeutics’ radioantibody approach is ideally suited to treat cancer and bring effective breakthrough treatments to patients. We look forward to collaborating with the Convergent team, whose extensive expertise in prostate cancer, foundational leadership in radiopharmaceuticals and patient-focused mindset will be invaluable in taking the company forward."

Jake Simson, Ph.D., Partner at RA Capital Management, added, "We are proud to support Convergent and believe its radioantibody technology is an exciting approach to radiopharmaceuticals that will have significant implications for patients. As we witness encouraging progress in the radiopharmaceutical field with new emerging therapies to treat various types of cancer, we believe that Convergent is well-positioned."

In addition to initiating the next phase of clinical development for CONV01-α, Convergent Therapeutics is pursuing additional radioantibody targets to treat cancer. The company is currently evaluating other in-licensing and pipeline acquisition opportunities.

Citigroup acted as the sole placement agent for this transaction.

On May 3, 2023 Reprocell USA, a CRO, reported that it has been awarded a contract to provide support for Lantern Pharma’s Phase 2 clinical trial entitled "A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers with Advanced Lung Adenocarcinoma (HARMONIC)" (Press release, Lantern Pharma, MAY 3, 2023, View Source [SID1234630948]). The Harmonic study is being conducted to determine clinical advantages for Lantern Pharma’s investigational new drug LP-300 in combination with carboplatin and pemetrexed in patients who are never smokers with lung adenocarcinoma and have relapsed after treatment with tyrosine kinase inhibitors (TKIs).

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"We are excited to select Reprocell to support our Phase 2 Harmonic trial for never smokers with advanced non-small cell lung cancer," stated Reggie Ewesuedo, M.D., M.Sc., MBA, Lantern’s VP of Clinical Development. "Reprocell has an excellent and proven track record of processing and storing clinical trial samples and we are confident that this partnership will further the advancement of the Harmonic trial."

Reprocell will produce Specimen Collection Kits, process patient samples and store biomaterial from patients in this study. Additionally, Reprocell will provide isolation of cell free DNA from plasma, genomic DNA and/or RNA from the buffy coat fraction, and archive pathology FFPEs and associated H&E-stained slides from selected patients. These services are routine procedures utilized at Reprocell and will be performed at the conclusion of specimen collection and processing. Reprocell will retain all biomaterials and pathology materials on-site until required by Lantern Pharma later.

"We are pleased to support Lantern Pharma in the Harmonic clinical trial. We believe that our capabilities in building kits, managing shipments to and from clinical sites and processing the bio samples will help Lantern Pharma in successfully conducting this trial," said Rama Modali, CEO, REPROCELL USA.

About the Harmonic Trial

The Harmonic trial (NCT05456256) is a Phase 2 clinical trial that is assessing the effect of Lantern’s investigational new drug LP-300 in combination with standard-of-care (SOC) chemotherapy, pemetrexed and carboplatin, on the overall and progression-free survival of never smoker patients with advanced non-small cell lung cancer (NSCLC). The study has been designed as a 90 patient trial with approximately 2/3rds of the patients receiving LP-300 with chemotherapy and the remaining 1/3rd receiving chemotherapy alone. Lantern has activated 5 clinical trial sites, across 12 locations in the US including Gabrail Cancer Center, Northwest Oncology, New York Cancer and Blood Specialists, Texas Oncology, and Cancer and Blood Specialty Clinic. The first patient in the trial was recently dosed and there are multiple additional potential patients that have been pre-screened and are being monitored for possible enrollment.

In a previous multi-center Phase 3 clinical trial, a subset of never smoker NSCLC patients who received LP-300 with chemotherapy showed increased overall and two-year survival of 91% and 125%, respectively, compared to patients who only received chemotherapy. In addition, LP-300 has been administered in multiple clinical trials to more than 1,000 people and has been generally well tolerated. Additional information on the Harmonic trial can be found at the Harmonic clinical trial website, on ClinicalTrials.gov, or on the first-of-its-kind Harmonic trial iPhone app, which is focused on education & awareness for never smoker NSCLC patients and the NSCLC community.

On May 3, 2023 Taiho Oncology, Inc. and Servier reported the publication of results from the pivotal Phase 3 SUNLIGHT* clinical trial of trifluridine/tipiracil (LONSURF), alone or in combination with bevacizumab, in refractory metastatic colorectal cancer (mCRC) in the May 4, 2023, issue of the New England Journal of Medicine (NEJM) (Press release, Taiho, MAY 3, 2023, View Source [SID1234630947]).

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Results of this multinational trial, led by Professor Josep Tabernero, MD, PhD, Head of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain, showed that treatment with the investigational combination of trifluridine/tipiracil and bevacizumab resulted in statistically significant and clinically meaningful improvements in overall survival and progression-free survival for patients with refractory mCRC following disease progression or intolerance on two prior chemotherapy regimens compared to trifluridine/tipiracil alone. In addition, the median time to worsening of ECOG (Eastern Cooperative Oncology Group) performance-status score was significantly delayed in patients receiving the investigational combination of trifluridine/tipiracil and bevacizumab. The safety profile of the investigational combination was consistent with that of each agent.

"Individuals living with metastatic colorectal cancer and who have progressed following fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and anti-Epidermal Growth Factor Receptor (EGFR) antibodies – if RAS wild-type – have limited treatment options. There is a growing need for new approaches that improve survival in this population," said Marwan Fakih, MD, Professor, Medical Oncology and Therapeutics Research, City of Hope, and lead U.S. investigator for the SUNLIGHT trial. "The publication of the SUNLIGHT results in the New England Journal of Medicine speaks to the quality of the science and potential impact of this investigational combination on the treatment of metastatic colorectal cancer."

Added Professor Tabernero: "Trifluridine/tipiracil plus bevacizumab may represent a meaningful new treatment option in patients with mCRC who have progressed after two lines of therapy."

Based on results of the SUNLIGHT trial, Servier and Taiho Oncology submitted respectively a type II variation for approval to the European Medicines Agency (EMA) and a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for trifluridine/tipiracil in combination with bevacizumab for the treatment of adult patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. Taiho Oncology announced on April 18, 2023, that the FDA accepted the sNDA for Priority Review and set an anticipated Prescription Drug User Fee Act (PDUFA) action date of August 13, 2023.

Please click here for the Original Article, "Trifluridine–Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer."

Please click here for a NEJM "Quick Take" video summarizing the article findings.

About Colorectal Cancer
Colorectal cancer is the third most common cancer worldwide1 with nearly 1.4 million people diagnosed with colorectal cancer (CRC) each year equating to 10% of the global cancer cases.1 CRC is the second most common cause of cancer mortality, accounting for 881,000 deaths globally in 2018.2 The worldwide incidence of colorectal cancer is expected to exceed 3 million cases annually by 2040,3 and the number of deaths is predicted to increase by more than 70% to 1.6 million per year.3

About the SUNLIGHT Trial
SUNLIGHT is a multinational, randomized, active-controlled, open-label, two-arm Phase 3 clinical trial to investigate the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in patients with refractory mCRC following two chemotherapy regimens. A total of 492 patients were randomly allocated (in a 1:1 ratio) to receive trifluridine/tipiracil in combination with bevacizumab or trifluridine/tipiracil monotherapy. The primary objective was to assess trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in terms of OS (primary endpoint). Key secondary endpoints were PFS, overall response rate (ORR), disease control rate (DCR) and quality of life (QoL), as well as the safety and tolerability of trifluridine/tipiracil used in combination with bevacizumab in comparison with trifluridine/tipiracil monotherapy.

The SUNLIGHT trial was conducted by Servier and Taiho Oncology, Inc. For more information on SUNLIGHT, please visit: View Source

About LONSURF
LONSURF is an oral nucleoside antitumor agent discovered and developed by Taiho Pharmaceutical Co., Ltd. LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.

Indications and Use in the United States
LONSURF is indicated for the treatment of adult patients with:

Metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy; and
Metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy
IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS

Indications and Use
LONSURF is indicated for the treatment of adult patients with:

Metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy
metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Severe Myelosuppression:
LONSURF caused severe and life-threatening myelosuppression (Grade 3-4) consisting of neutropenia (38%), anemia (18%), thrombocytopenia (5%), and febrile neutropenia (3%). Two patients (0.2%) died due to neutropenic infection. A total of 12% of LONSURF-treated patients received granulocyte-colony stimulating factors. Obtain complete blood counts prior to and on day 15 of each cycle of LONSURF and more frequently as clinically indicated. Withhold LONSURF for febrile neutropenia, absolute neutrophil count less than 500/mm3, or platelets less than 50,000/mm3. Upon recovery, resume LONSURF at a reduced dose as clinically indicated.

Embryo-Fetal Toxicity:
LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the final dose.

USE IN SPECIFIC POPULATIONS

Lactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assess the effects of LONSURF or its metabolites on the breast-fed infant or the effects on milk production. Because of the potential for serious adverse reactions in breast-fed infants, advise women not to breastfeed during treatment with LONSURF and for 1 day following the final dose.

Male Contraception: Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with LONSURF and for at least 3 months after the final dose.

Geriatric Use: Patients 65 years of age or over who received LONSURF had a higher incidence of the following compared to patients younger than 65 years: Grade 3 or 4 neutropenia (46% vs 32%), Grade 3 anemia (22% vs 16%), and Grade 3 or 4 thrombocytopenia (7% vs 4%).

Hepatic Impairment: Do not initiate LONSURF in patients with baseline moderate or severe (total bilirubin greater than 1.5 times ULN and any AST) hepatic impairment. Patients with severe hepatic impairment (total bilirubin greater than 3 times ULN and any AST) were not studied. No adjustment to the starting dose of LONSURF is recommended for patients with mild hepatic impairment.

Renal Impairment: No adjustment to the starting dosage of LONSURF is recommended in patients with mild or moderate renal impairment (CLcr of 30 to 89 mL/min). Reduce the starting dose of LONSURF for patients with severe renal impairment (CLcr of 15 to 29 mL/min) to a recommended dosage of 20 mg/m2.

ADVERSE REACTIONS

Most Common Adverse Drug Reactions in Patients Treated With LONSURF (≥5%): The most common adverse drug reactions in LONSURF-treated patients vs placebo-treated patients with mCRC, respectively, were asthenia/fatigue (52% vs 35%), nausea (48% vs 24%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), infections (27% vs 16%), abdominal pain (21% vs 18%), pyrexia (19% vs 14%), stomatitis (8% vs 6%), dysgeusia (7% vs 2%), and alopecia (7% vs 1%). In metastatic gastric cancer or gastroesophageal junction (GEJ), the most common adverse drug reactions, respectively were, nausea (37% vs 32%), decreased appetite (34% vs 31%), vomiting (25% vs 20%), infections (23% vs 16%) and diarrhea (23% vs 14%).

Pulmonary emboli occurred more frequently in LONSURF-treated patients compared to placebo: in mCRC (2% vs 0%) and in metastatic gastric cancer and GEJ (3% vs 2%).

Interstitial lung disease (0.2%), including fatalities, has been reported in clinical studies and clinical practice settings in Asia.

Laboratory Test Abnormalities in Patients Treated With LONSURF: The most common laboratory test abnormalities in LONSURF-treated patients vs placebo-treated patients with mCRC, respectively, were anemia (77% vs 33%), neutropenia (67% vs 1%), and thrombocytopenia (42% vs 8%). In metastatic gastric cancer or GEJ, the test abnormalities, respectively, were neutropenia (66% vs 4%), anemia (63% vs 38%), and thrombocytopenia (34% vs 9%).

On May 3, 2023 Bio-Techne Corporation (NASDAQ: TECH) reported its financial results for the third quarter ended March 31, 2023 (Press release, Bio-Techne, MAY 3, 2023, View Source [SID1234630946]).

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Third Quarter FY2023 Highlights

Third quarter organic revenue increased by 3% (1% reported) to $294.1 million and 4% (2% reported) in the first nine months of fiscal 2023 to $835.4 million.

GAAP earnings per share1) (EPS) was $0.43 versus $0.37 one year ago. Delivered adjusted EPS1) of $0.53, consistent with prior year adjusted EPS.

Successful execution within our cell and gene therapy growth platform with another record quarter in GMP protein sales and completion of a 20% ownership stake in Wilson Wolf.

Increased ExoDx Prostate test adoption and utilization continued to accelerate with test volume and associated revenue growing over 70%. The ExoDx Prostate test increased its addressable market by approximately 50% after receiving expanded Medicare coverage to include an annual test for patients with a prior negative biopsy but are thought to be at high risk for prostate cancer and are considering a repeat biopsy.

Expansion of our spatial biology platform through a strategic partnership with Lunaphore to develop the first fully automated same-slide spatial multiomics solution.
1)On November 29, 2022, the company executed a four-for-one split of Bio-Techne’s common stock in the form of a stock dividend to all shareholders of record on November 14, 2022. All references made to share or per share amounts in this press release have been retroactively adjusted to reflect the effects of the stock split.

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 growth, 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.

"Our third quarter performance was consistent with our expectations, as we continue to lap high growth rates from the prior year, China continued to recover from Covid-related restrictions, and biotech funding considerations impacted a subset of our biopharma customers," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "The team continued to effectively execute our strategy across the organization, enabling a 150 basis point sequential adjusted operating margin expansion to 37.0%."

Kummeth continued, "Two of our highest growth businesses, Cell Therapy and Exosome Diagnostics, both had strong quarters. Our broad portfolio of Cell Therapy enabling workflow solutions remained in high demand, once again delivering double-digit growth, including a second consecutive record quarter for our GMP Proteins business. Our ExoDx Prostate test continued its streak of record-breaking quarters, as test volume increased over 70% for the fifth consecutive quarter and associated revenue grew over 85%."

Kummeth concluded, "We are already seeing encouraging signs of a strong recovery in China, which combined with continued traction of our portfolio of innovative tools, bioactive reagents, and technologies positions the Company incredibly well for the future. We will continue to execute our long-term strategic plan, with a focus on delivering value to all of our stakeholders."

Third Quarter Fiscal 2023

Revenue

Net sales for the third quarter increased 1% to $294.1 million. Organic growth was 3% compared to the prior year with foreign currency exchange having an unfavorable impact of 2% and acquisitions having an immaterial impact.

GAAP Earnings Results

GAAP EPS was $0.43 per diluted share, versus $0.37 in the same quarter last year. Prior year GAAP EPS was unfavorably impacted by a non-recurring loss of approximately $17.2 million on our ChemoCentryx investment. GAAP operating income for the third quarter of fiscal 2023 decreased 11% to $80.2 million, compared to $90.4 million in the third quarter of fiscal 2022. GAAP operating margin was 27.3%, compared to 31.1% in the third quarter of fiscal 2022. Prior year GAAP operating margin was favorably impacted by a non-recurring benefit related to the change in fair value of contingent consideration.

Non-GAAP Earnings Results

Adjusted EPS remained consistent with the same quarter in the prior year at $0.53 per diluted share with a reduction in adjusted operating income being offset by reduced net interest expense. Adjusted operating income for the third quarter of fiscal 2023 decreased 5% compared to the third quarter of fiscal 2022. Adjusted operating margin was 37.0%, compared to 39.6% in the third quarter of fiscal 2022. The decrease from the prior year was due to the non-recurring prior year revenue related to the ExoTru kidney transplant rejection agreement, unfavorable foreign currency exchange, and strategic growth investments including the Namocell acquisition.

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 biotechnology and academic research communities. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s third quarter fiscal 2023 net sales were $218.9 million, an increase of 3% from $213.2 million for the third quarter of fiscal 2022. Organic growth for the segment was 5%, with foreign currency exchange having an unfavorable impact of 2% and acquisitions having an immaterial impact. Protein Sciences segment’s operating margin was 45.1% in the third quarter of fiscal 2023 compared to 45.4% in the third quarter of fiscal 2022. The segment’s operating margin compared to the prior year was negatively impacted by unfavorable foreign currency exchange and the Namocell acquisition.

Diagnostics and Genomics Segment

The Company’s Diagnostics and Genomics segment 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 Genomics segment also develops and provides in situ hybridization products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s third quarter fiscal 2023 net sales were $75.7 million, a decrease of 3% from $77.7 million for the third quarter of fiscal 2022. Organic revenue for the segment reduced by 2% from the prior year, with foreign exchange having an unfavorable impact of 1%. The Diagnostics and Genomics segment’s operating margin was 15.2% in the third quarter of fiscal 2023 compared to 25.0% in the third quarter of fiscal 2022. The segment’s operating margin declined due to the prior year revenue related to the ExoTru kidney transplant rejection agreement as well as strategic investments to drive future revenue growth.

Conference Call

Bio-Techne will host an earnings conference call today, May 3, 2023 at 8:00 a.m. CDT. To listen, please dial 1-877-300-8521 or 1-412-317-6026 for international callers, and reference conference ID 10177426. 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 10177426. The replay will be available from 11:00 a.m. CDT on Wednesday, May 3, 2023, until 11:00 p.m. CDT on Saturday, June 3, 2023.

Use of non-GAAP Adjusted Financial Measures:

This press release contains financial measures that have not been calculated in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP measures include:

Organic growth
Adjusted diluted earnings per share
Adjusted net earnings
Adjusted tax rate
Adjusted gross margin
Adjusted operating income
Adjusted operating margin
Earnings before interest, taxes, depreciation, and amortization (EBITDA)
Adjusted EBITDA
We provide these measures as additional information regarding our operating results. We use these non-GAAP measures internally to evaluate our performance and in making financial and operational decisions, including with respect to incentive compensation. We believe that our presentation of these measures provides investors with greater transparency with respect to our results of operations and that these measures are useful for period-to-period comparison of results.

Our non-GAAP financial measure of organic growth represents revenue growth excluding revenue from acquisitions within the preceding 12 months, the impact of foreign currency, as well as the impact of partially-owned consolidated subsidiaries. Excluding these measures provides more useful period-to-period comparison of revenue results as it excludes the impact of foreign currency exchange rates, which can vary significantly from period to period, and revenue from acquisitions that would not be included in the comparable prior period. Revenues from partially-owned subsidiaries consolidated in our financial statements are also excluded from our organic revenue calculation, as those revenues are not fully attributable to the Company. There was no revenue from partially-owned consolidated subsidiaries for the quarter ended March 31, 2023 due to the sale of Changzhou Eminence Biotechnology Co., Ltd. (Eminence) in the first quarter of fiscal 2023. Revenue from partially-owned consolidated subsidiaries was $2.0 million for the nine months ended March 31, 2023.

Our non-GAAP financial measures for adjusted gross margin, adjusted operating margin, adjusted EBITDA, and adjusted net earnings, in total and on a per share basis, exclude stock-based compensation, the costs recognized upon the sale of acquired inventory, amortization of acquisition intangibles, acquisition related expenses inclusive of the changes in fair value of contingent consideration, and other non-recurring items including non-recurring costs, goodwill and long-lived asset impairments, and gains. Stock-based compensation is excluded from non-GAAP adjusted net earnings because of the nature of this charge, specifically the varying available valuation methodologies, subjection assumptions, variety of award types, and unpredictability of amount and timing of employer related tax obligations. The Company excludes amortization of purchased intangible assets, purchase accounting adjustments, including costs recognized upon the sale of acquired inventory and acquisition-related expenses inclusive of the changes in fair value contingent consideration, and other non-recurring items including gains or losses on legal settlements, goodwill and long-lived asset impairment charges, and one-time assessments from this measure because they occur as a result of specific events, and are not reflective of our internal investments, the costs of developing, producing, supporting and selling our products, and the other ongoing costs to support our operating structure. Additionally, these amounts can vary significantly from period to period based on current activity. The Company also excludes revenue and expense attributable to partially-owned consolidated subsidiaries in the calculation of our non-GAAP financial measures as the revenues and expenses are not fully attributable to the Company.

The Company’s non-GAAP adjusted operating margin and adjusted net earnings, in total and on a per share basis, also excludes stock-based compensation expense, which is inclusive of the employer portion of payroll taxes on those stock awards, restructuring, impairments of equity method investments, gain and losses from investments, and certain adjustments to income tax expense. Impairments of equity investments are excluded as they are not part of our day-to-day operating decisions. Additionally, gains and losses from other investments that are either isolated or cannot be expected to occur again with any predictability are excluded. Costs related to restructuring activities, including reducing overhead and consolidating facilities, are excluded because we believe they are not indicative of our normal operating costs. The Company independently calculates a non-GAAP adjusted tax rate to be applied to the identified non-GAAP adjustments considering the impact of discrete items on these adjustments and the jurisdictional mix of the adjustments. In addition, the tax impact of other discrete and non-recurring charges which impact our reported GAAP tax rate are adjusted from net earnings. We believe these tax items can significantly affect the period-over-period assessment of operating results and not necessarily reflect costs and/or income associated with historical trends and future results.

Investors are encouraged to review the reconciliations of adjusted financial measures used in this press release to their most directly comparable GAAP financial measures as provided with the financial statements attached to this press release.