On August 8, 2023 Bio-Techne Corporation (NASDAQ: TECH) reported its financial results for the fourth quarter ended June 30, 2023 (Press release, Bio-Techne, AUG 8, 2023, View Source [SID1234634009]).

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Fourth Quarter FY2023 Highlights

Fourth quarter organic revenue increased by 5% (5% reported) to $301.3 million. Full year organic revenue increased 5% (3% reported) to $1.1 billion.
GAAP earnings per share1) (EPS) was $0.47 versus $0.38 one year ago. Delivered adjusted EPS1) of $0.55 compared to $0.51 one year ago. Full year GAAP EPS was $1.76 versus $1.66 one year ago. Full year adjusted EPS was $1.99 versus $1.97 one year ago.
Strong commercial execution in Diagnostics and Genomics led to 10% organic segment growth (10% reported) in the fourth quarter and 8% organic segment growth (6% reported) for fiscal year 2023.
Our ExoDx prostate test and GMP proteins strategic growth platforms continued to deliver record performance with fourth quarter revenue growth of 68% and 58% and fiscal year 2023 revenue growth of 92% and 30%, respectively.
Enhanced Bio-Techne’s leading spatial biology franchise with the acquisition of Lunaphore whose fully automated, high-throughput COMET instrument enables the identification of spatial biomarkers in tumors and other tissues at single-cell and subcellular resolution.
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.

"We finished fiscal 2023 largely in-line with our expectations, as the Bio-Techne team continued to successfully grow on top of high year-over-year comparisons and navigate dynamic end market conditions that included a lower biotech funding environment and soft macro-economic conditions in China," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "We delivered these results with a continued focus on operational efficiencies, leading to an adjusted operating margin of 37.1%."

Kummeth continued, "We finalized the acquisition of Lunaphore, which closed on July 7, adding the fully automated, high throughput COMET instrument to our portfolio of spatial biology solutions. The combination of Lunaphore and Bio-Techne will enable the first fully automated spatial multiomic solution capable of same-slide detection of protein and RNA biomarkers. This novel solution positions Bio-Techne to further its leadership position in the nascent and high growth spatial biology market."

Kummeth concluded, "In fiscal 2023, we demonstrated the strength of our portfolio to grow in even the most challenging of times, which this year included very high comps from the prior year, lower biotech funding, customer de-stocking, and unprecedented China economic malaise… all largely due to the "COVID hangover". Our differentiated platforms in Cell & Gene Therapy, Liquid Biopsy, Spatial Biology, and Analytical Instruments finished the year with double-digit growth and it will be these platforms that carry our company back to overall double-digit growth as the markets normalize."

Fourth Quarter Fiscal 2023

Revenue

Net sales for the fourth quarter increased 5% to $301.3 million. Organic growth was 5% compared to the prior year with foreign currency exchange and acquisitions having an immaterial impact.

GAAP Earnings Results

GAAP EPS was $0.47 per diluted share, versus $0.38 in the same quarter last year. GAAP operating income for the fourth quarter of fiscal 2023 increased 17% to $94.5 million, compared to $80.6 million in the fourth quarter of fiscal 2022. GAAP operating margin was 31.4%, compared to 28.0% in the fourth quarter of fiscal 2022. Current year GAAP operating margin was favorably impacted by changes in the fair value of performance-based stock compensation awards.

Non-GAAP Earnings Results

Adjusted EPS increased to $0.55 per diluted share compared to $0.51 in the same quarter last year. Adjusted operating income for the fourth quarter of fiscal 2023 increased 5% compared to the fourth quarter of fiscal 2022. Adjusted operating income growth was driven by organic revenue growth. Adjusted operating margin was 37.1%, compared to 37.4% in the fourth quarter of fiscal 2022. Adjusted operating margin decreased from the prior year primarily due to the acquisition of Namocell this year.

Full Year Fiscal 2023

Revenue

Net sales for the full year fiscal 2023 increased 3% to $1,136.7 million. Organic growth was 5% with foreign currency exchange having an unfavorable impact of 2% and acquisitions having an immaterial impact.

GAAP Earnings Results

GAAP EPS was $1.76 per diluted share compared to $1.66 last fiscal year. Current year GAAP EPS was favorably impacted by gains on the sale of our ChemoCentryx investment and our investment in Eminence. GAAP operating income for full year fiscal 2023 increased 1% to $298.9 million, compared with $296.6 million in the full year fiscal 2022. GAAP operating margin was 26.3%, compared to 26.8% in the full year fiscal 2022. GAAP operating margin was unfavorably impacted by foreign currency exchange and strategic growth investments including the Namocell acquisition.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.99 per diluted share compared to $1.97 last year. Adjusted operating margin for full fiscal year 2023 decreased to 36.1%, compared with 38.3% in full year fiscal 2022. Adjusted operating margin compared to the prior year was unfavorably impacted by 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 fourth quarter fiscal 2023 net sales were $223.0 million, an increase of 3% from $217.0 million for the fourth quarter of fiscal 2022. Organic growth for the segment was 4%, with foreign currency exchange having an unfavorable impact of 1% and acquisitions having an immaterial impact. Protein Sciences segment’s operating margin was 44.7% in the fourth quarter of fiscal 2023 compared to 44.9% in the fourth quarter of fiscal 2022. The segment’s operating margin compared to the prior year was negatively impacted by acquisitions.

Protein Sciences segment’s full year fiscal 2023 net sales were $845.7 million, an increase of 2% from $832.3 million for fiscal 2022. Organic growth for the segment was 4% for the fiscal year, with foreign currency exchange having an unfavorable 2% impact on revenue and acquisitions having an immaterial impact.

Protein Sciences segment’s operating margin was 44.2% in fiscal 2023 compared to 45.4% in fiscal 2022. Segment operating margin compared to the prior year was unfavorably impacted by foreign currency exchange and strategic growth investments including 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 spatial biology products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s fourth quarter fiscal 2023 net sales were $79.0 million, an increase of 10% from $71.7 million for the fourth quarter of fiscal 2022. Organic revenue for the segment increased by 10% from the prior year, with foreign exchange having an immaterial impact. The Diagnostics and Genomics segment’s operating margin was 18.5% in the fourth quarter of fiscal 2023 compared to 15.7% in the fourth quarter of fiscal 2022. The segment’s operating margin increased primarily due to volume leverage.

The Diagnostics and Genomics segment’s full year fiscal 2023 net sales were $292.6 million, an increase of 6% from $274.8 million for fiscal 2022. Organic growth for the segment was 8% with foreign currency exchange having an unfavorable impact of 2% on revenue growth. The Diagnostics and Genomics segment’s operating margin was 14.7% in fiscal 2023 compared to 17.8% in fiscal 2022. Fiscal 2023 operating margin was unfavorably impacted due to the prior year revenue related to the ExoTru kidney transplant rejection agreement as well as strategic investments to drive future revenue growth, which was partially offset by volume leverage.

Conference Call

Bio-Techne will host an earnings conference call today, August 8, 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 10180893. 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 10180893. The replay will be available from 11:00 a.m. CDT on Tuesday, August 8, 2023, until 11:00 p.m. CDT on Friday, September 8, 2023.

On August 8, 2023 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer, reported an update from its currently enrolling multi-center open-label Phase 1b clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS) (Press release, Monopar Therapeutics, AUG 8, 2023, View Source [SID1234634008]). Both patients treated to date at the 650 mg/m2 dose level have experienced tumor size reductions – of 18% and 20% respectively – after the first two cycles of camsirubicin treatment. Both patients are set to receive additional cycles of camsirubicin treatment, as well, which may result in further tumor size reduction.

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The Phase 1b clinical trial data is continuing to support Monopar’s dose-response hypothesis with camsirubicin. The best response seen prior to the current 650 mg/m2 dose level was at the immediately prior dose level (520 mg/m2), which was a 21% reduction in tumor size in a patient after receiving six cycles of camsirubicin treatment. This patient’s cancer was unresectable at study entry, but after the tumor size reduction, became eligible and the patient underwent successful surgical removal of their cancer with clear margins. Furthermore, all three patients at the 520 mg/m2 dose level achieved stable disease and had either a net reduction or no overall change in tumor size per RECIST 1.1 while on study drug.

Additionally, no drug­related cardiotoxicity has been observed in the trial to date as evaluated by the industry standard left ventricular ejection fraction (LVEF), and no toxicities have been experienced by any patient that have required expanding the size of a dose cohort. Further, 71% of camsirubicin patients have experienced no hair loss, and only approximately 14% have experienced >50% hair loss, with the remainder having low grade hair loss. This compares favorably to the approximately 50% of doxorubicin treated patients in recent ASTS clinical trials reporting some amount of hair loss, with the majority of these patients experiencing >50% hair loss. Only 14% of camsirubicin patients in the Phase 1b trial have experienced mild-to-severe oral mucositis. This compares favorably to the roughly 35-40% of doxorubicin-treated patients in recent ASTS clinical trials that experienced mild-to-severe oral mucositis.

ASTS is a deadly cancer with inadequate treatment options. Doxorubicin is currently the first-line standard of care treatment for most types of ASTS, and the average life expectancy from time of diagnosis for these patients is only about 12 to 15 months. Because of the risk of irreversible heart damage, patients discontinue doxorubicin treatment after just 6 to 8 cycles. Camsirubicin has been designed to retain the anti-cancer activity while avoiding the irreversible heart damage that is seen with doxorubicin. The value-driving hypothesis for camsirubicin is straightforward: modifying doxorubicin in order to reduce cardiac damage could enable higher and longer dosing, resulting in better efficacy and patient outcomes.

Camsirubicin Clinical Trial Design and GEIS Collaboration

The purpose of this dose escalation Phase 1b trial is to determine the maximum tolerated dose (MTD) of camsirubicin. Once the MTD is reached, Monopar has a clinical collaboration agreement in place with the Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas, or GEIS) to conduct a multi-country randomized Phase 2 clinical trial. The Phase 2 plan is to evaluate camsirubicin head-to-head against doxorubicin in patients with ASTS, with GEIS as the study sponsor with support from Monopar.

Further information about this actively enrolling, open-label, dose-escalation Phase 1b clinical trial is available at www.ClinicalTrials.gov under study identifier NCT 05043649.

On August 8, 2023 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported financial results for the second quarter ended June 30, 2023 and provided a business update (Press release, iTeos Therapeutics, AUG 8, 2023, View Source [SID1234634007]).

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"Our team continues to bring forward innovation in immunotherapy through our differentiated development pipeline, which is expected to make significant progress in the second half of 2023," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "To start, with GSK’s anti-PD-1 mAb, dostarlimab, as the backbone for our ambitious TIGIT-based clinical development plans, we remain confident that its combination with belrestotug has the potential to become a best-in-class program. Furthermore, we are continuing to build our position as a leader unlocking the adenosine pathway with the announcement of enrolling patients in the Phase 1 trial of EOS-984. This program will deepen our understanding of the mechanisms of adenosine-mediated immunosuppression and potentially reinforce the unique, insurmountable profile of inupadenant. Based on the progression of our 9 ongoing clinical trials and solid cash position with runway into 2026, we believe we are poised for an abundance of opportunity in 2024, including the presentation of TIGIT data from the Phase 2 clinical trials treating patients with NSCLC and HNSCC."

Program Highlights:

Belrestotug (EOS-448/GSK4428859A): IgG1 anti-TIGIT monoclonal antibody designed to
engage the Fc gamma receptor (FcγR) and enhance the anti-tumor response through multifaceted mechanisms.

In collaboration with GSK, late-stage development of belrestotug as a potential next-generation immuno-oncology (IO) agent through multiple combination studies are progressing as expected. We plan to present related datasets in 2024. Preparation is underway for Phase 3 registrational studies evaluating belrestotug and dostarlimab combination.
The ongoing trials include:
Randomized Phase 2 trial assessing the doublet of dostarlimab with belrestotug in previously untreated advanced / metastatic non-small cell lung cancer (NSCLC).
Phase 2 expansion study assessing the doublet of dostarlimab with belrestotug in first line advanced or metastatic head and neck squamous cell carcinoma (HNSCC).
Phase 1b trials exploring the addition of chemotherapy and two novel triplets in selected advanced solid tumors: belrestotug with dostarlimab and GSK’s investigational anti-CD96 antibody, and belrestotug with dostarlimab and GSK’s investigational anti-PVRIG antibody.
Additional studies include the continued advancement of the monotherapy dose escalation part of a Phase 1/2 trial evaluating belrestotug as both a monotherapy and in combination with Bristol Myers Squibb’s iberdomide in multiple myeloma.
Adenosine Pathway

Inupadenant (EOS-850): Designed as an insurmountable and highly selective small molecule antagonist of the adenosine A2A receptor, the only high-affinity adenosine receptor expressed on multiple immune cells found in the tumor microenvironment. Highlights include:

Progression of the ongoing two-part Phase 2 trial in post-IO metastatic non-squamous NSCLC to evaluate the combination of inupadenant with platinum-doublet chemotherapy compared to standard platinum-doublet chemotherapy.
EOS-984: First-in-class small molecule program targeting a novel mechanism in the adenosine pathway.

The company has initiated enrolling patients in its Phase 1 trial of EOS-984.
This complementary clinical development program has the potential to fully reverse the profound immunosuppressive action of adenosine on T and B cells. EOS-984’s effects have been shown preclinically to be enhanced by combining with inupadenant and other standards of care.
Second Quarter 2023 Financial Results

Cash and Investment Position: The company’s cash, cash equivalents, and investments position was $677.5 million as of June 30, 2023, as compared to $791.9 million as of June 30, 2022. The company continues to expect its cash balance to provide runway into 2026.
Research and Development (R&D) Expenses: R&D expenses were $29.2 million and $54.9 million for the quarter and six months ended June 30, 2023, respectively, as compared to $26.9 and $48.0 million for the same quarter and six months of 2022, respectively. The increases in each comparative period were primarily due to increases in activities related to the belrestotug, inupadenant, and EOS-984 programs.
General and Administrative (G&A) Expenses: G&A expenses were $13.4 million and $25.4 million for the quarter and six months ended June 30, 2023, respectively, as compared to $11.5 million and $22.1 million for the same quarter and six months of 2022, respectively. The increases were primarily due to increases in headcount and related costs compared to the same quarter and six months last year.
Net Income/Loss: Net loss attributable to common shareholders was $34.3 million, or net loss of $0.96 per basic and diluted share for the quarter ended June 30, 2023, as compared to a net income of $5.6 million, or a net income of $0.16 per basic share and $0.15 per diluted share for the same quarter of 2022. Net loss attributable to common shareholders was $49.9 million, or net loss of $1.39 per basic and diluted share for the six months ended June 30, 2023, as compared to a net income of $75.2 million, or a net income of $2.12 per basic share and $1.98 per diluted share for the same six months of 2022.

On August 8, 2023 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, reported a key opinion leader roundtable discussion to be held on Friday, August 11, 2023, 8:00 a.m. – 9:00 a.m. ET to discuss the latest data from the ReSPECT-LM clinical trial of rhenium (186Re) obisbemeda that will be presented at the Society for Neuro Oncology (SNO)/American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Central Nervous System (CNS) Cancer Conference on August 10, 2023 (Press release, PLUS THERAPEUTICS, AUG 8, 2023, View Source;_hsmi=269509104&_hsenc=p2ANqtz-89_OBvNFnW0uugglRG4wRRBcKdiDIT1INGLN7Tn-CIPCJ9ScMxixrB48kxKd8Uu3vpBKS9BMOI04QHVJaIree6xQ-Bfw&utm_content=269509104&utm_source=hs_email [SID1234634006]).

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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

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The webinar will feature a comprehensive discussion about the ongoing ReSPECT-LM Phase 1/2a dose escalation clinical trial, including key safety, tolerability, dosing, feasibility and efficacy data. Speakers include:

Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas, Health Services Center at San Antonio and principal investigator of the ReSPECT-GBM trial and co-principal investigator of the ReSPECT-LM trial.
Priya Kumthekar, M.D., Associate Professor of Neurology and Medicine (Hematology and Oncology) at Northwestern University’s Feinberg School of Medicine and co-principal investigator of the ReSPECT-LM trial.
Marc H. Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics
Justin Walsh, Ph.D., Senior Healthcare Analyst, Jones Research will moderate the roundtable and in addition will provide an overview of the radiotherapeutic market.
Webcast Details

A webinar with accompanying slides will be available in the Events page of the Investor Relations section of the Plus Therapeutics website beginning Friday, August 11, 2023 at 8:00 a.m. ET. Participants may also pre-register any time before the call here. Please access the webinar 15 minutes prior to the start time.

The webinar will be available on the Company’s website under the ‘For Investor’ section. The webcast will be available on the Company’s website for 90 days following the live call.

On August 8, 2023 Mirati Therapeutics, Inc. (Nasdaq: MRTX), a commercial stage biotechnology company, reported that it intends to offer and sell $250.0 million of shares of its common stock, and, to certain investors, pre-funded warrants to purchase shares of common stock, in an underwritten public offering (Press release, Mirati, AUG 8, 2023, View Source [SID1234634005]). The purchase price of each pre-funded warrant will equal the price per share at which shares of common stock are being sold to the public in this offering, minus $0.001, which will be the per share exercise price of each pre-funded warrant. In addition, Mirati expects to grant the underwriters of the offering a 30-day option to purchase up to an additional $37.5 million of shares at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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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

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Goldman Sachs & Co. LLC is acting as the book-running manager for the proposed offering. Leerink Partners LLC is acting as financial advisor for the proposed offering.

The securities described above are being offered pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at (866) 471-2526, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.