On October 27, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported its diagnostic 64Cu SAR-bisPSMA trial (COBRA NCT052491271) for patients with prostate cancer has reached the fifty percent recruitment milestone, with 25 out of 50 participants now having been enrolled and imaged (Press release, Clarity Pharmaceuticals, OCT 26, 2022, View Source [SID1234622404]).

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COBRA (Copper-64 SAR-BisPSMA in Biochemically Recurrent prostAte cancer) is a Phase I/II Positron Emission Tomography (PET) trial of participants with biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-bisPSMA in 50 participants. The primary objectives of the trial are to investigate the safety and tolerability of 64Cu-SAR-bisPSMA as well as its ability to correctly detect the recurrence of prostate cancer.

Dr Neal Shore MD, FACS, Lead Principal Investigator in the COBRA trial and CMO – Urology/Surgical Oncology, GenesisCare, US and the Medical Director of Carolina Urologic Research Centre, commented, "We are very pleased with the progress of the COBRA trial, specifically in regard to the pace of recruitment and the quality of data we are generating to explore and validate the clinical benefits associated with the novel SAR-bisPSMA agent. The growing amount of data from Clarity’s three clinical trials with the 64Cu SAR-bisPSMA product, namely, COBRA, PROPELLER and SECuRE trials, all indicate high uptake of the diagnostic agent by prostate cancer cells. This is especially important for patients with suspected prostate cancer recurrence where SAR-bisPSMA shows promise of improving prostate cancer detection.

"We look forward to recruiting the remaining participants in the COBRA trial and commencing the analysis of the study data. Ultimately, we want to enhance diagnostic accuracy for patients with BCR of prostate cancer as well as improve ease of access to the product across the US, enabled by the logistical advantages of Clarity’s Targeted Copper Theranostic platform."

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to have recruited half of the patients planned for the COBRA trial so quickly. We now have 6 sites actively recruiting the remaining participants with suspected recurrence of their prostate cancer across the US.

"Since opening recruitment into the COBRA trial in March 2022, we have been able to generate strong preliminary data and further strengthen and validate our on-demand distribution model of TCTs with all three of our 64Cu-labelled products, SAR-bisPSMA, SARTATE and SAR-Bombesin, being shipped to numerous trial sites in the US from a central manufacturing facility. TCTs have the potential to enable patient access to critical treatments that are safe and efficacious, on time and at any treatment centre with a positron emission tomography camera.

"This shows promise of substantially growing the radiopharmaceutical field into the large oncology market, moving towards the big pharma model with ready-to-use products on-demand and minimising logistical hindrances associated with the current generation of products. We believe this advancement will help us reach our goal of improving treatment outcomes for children and adults with cancer by focusing on the needs of the patients and their treating staff," said Dr Taylor.

Clarity’s Prostate Cancer clinical trial program overview

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two prostate-specific membrane antigen (PSMA) binding motifs to Clarity’s proprietary sarcophagene (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide2. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease3.

On October 26, 2022 NuCana plc (NASDAQ: NCNA) reported that non-clinical data from two poster presentations at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Annual Meeting being held from October 26 to 28, 2022 (Press release, Nucana BioPharmaceuticals, OCT 26, 2022, View Source [SID1234622403]).

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Abstract 185: NUC-3373 is a potent TS inhibitor and induces DNA damage in NSCLC cancer cells regardless of histological subtype

Pemetrexed is an important therapeutic option for first-and second-line adenocarcinoma lung cancers, but is not recommended in squamous lung cancer due to higher levels of thymidylate synthase (TS) expression. NUC-3373 was shown to be a more potent inhibitor of TS than both pemetrexed and 5-FU. NUC-3373 generated high intracellular levels of the anti-cancer metabolite FUDR-MP, resulting in TS inhibition, and the DNA-targeting metabolite, FUDR-TP. This resulted in extensive DNA damage in both adenocarcinoma and squamous carcinoma cell lines. These data highlight that NUC-3373 may be an effective treatment for non-small cell lung cancer (NSCLC) regardless of histological subtype and basal TS expression.

Abstract 128: NUC-3373 induces DAMPs from NSCLC cells potentiating a favorable immunogenic microenvironment

NUC-3373 causes NSCLC cells to release damage associated molecular patterns (DAMPs), molecular signals that activate immune cells leading to immunogenic cell death (ICD). NUC-3373 also enhanced the cell surface expression of the transmembrane protein PD-L1 in lung cancer cell lines, highlighting a potential role for NUC-3373 to enhance immunotherapy efficacy. The addition of pembrolizumab, an anti-PD-1 antibody, to NUC-3373 in a co-culture system where NSCLC cells were incubated alongside human-derived immune cells also enhanced ICD, highlighting a potential role for NUC-3373 as an attractive combination partner for immune checkpoint inhibitors in NSCLC.

Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer, said: "These data are highly supportive of our strategy to combine NUC-3373 with pembrolizumab and to investigate NUC-3373 in patients with NSCLC. We have initiated the NuTide:303 study evaluating NUC-3373 in combination with either pembrolizumab in patients with advanced solid tumors or in combination with docetaxel in patients with non-small cell lung cancer. We have also initiated a randomized study in second-line CRC patients comparing NUFIRI plus bevacizumab to FOLFIRI plus bevacizumab, the global standard of care, and we look forward to sharing data from both of these studies in 2023."

On October 26, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that it will be presenting two preclinical posters at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) ("ENA") annual meeting to be held October 26-28, 2022 (Press release, Cogent Biosciences, OCT 26, 2022, View Source [SID1234622402]). Presentations and posters are available to registered attendees for on-demand viewing at View Source and will also be posted to the "Posters and Publications" page of Cogent’s website.

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The first poster discussion will provide an update on Cogent’s next-generation fibroblast growth factor receptor 2 (FGFR2) program, which retains potency across all primary, gatekeeper and molecular brake resistance mutations. The poster includes an overview of ongoing optimization of the Cogent lead series, pharmacokinetic and pharmacodynamic assessment of an FGFR1-sparing novel molecule, as well as robust efficacy in model of FGFR2 clinical resistance (N549K).

The second poster will provide initial preclinical results from Cogent’s novel ErbB2 mutant selective program. Currently available oral ErbB2 inhibitors struggle to provide broad mutant coverage while sparing EGFR activity. Cogent’s exemplar molecule demonstrates robust cellular inhibition of all key resistance and primary driver mutations, while sparing wild type EGFR target engagement. In addition, the advanced compound demonstrates dose ascendable pharmacokinetics, robust tumor phospho-ErbB2 suppression (L755S), and superior tumor growth inhibition when compared to tucatinib.

"The preclinical data presented today highlight an update on two of the first programs undertaken by the Cogent Research Team," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "In the case of both FGFR2 and ErbB2 driven cancers, we believe there remains significant unmet need for therapeutic options with better product profiles than available therapies. Starting with bezuclastinib and continuing with these two targets, our singular focus is to deliver best-in-class medicines for patients fighting genetically driven diseases."

On October 26, 2022 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the third quarter ending September 30, 2022 (Press release, Integra LifeSciences, OCT 26, 2022, View Source [SID1234622401]).

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Third Quarter 2022 Highlights

Third quarter revenues of $385 million decreased 0.4% on a reported basis and increased 3.5% on an organic basis compared to the prior year.

Third quarter GAAP earnings per diluted share of $0.60, compared to $0.51 in the prior year; adjusted earnings per diluted share of $0.86, compared to $0.86 in the prior year.

The Company completed the sale of its non-core traditional wound care ("TWC") business at the end of August 2022.

The Company is raising its earnings per share outlook to a range of $3.29 to $3.33 and reaffirming its full-year 2022 revenue guidance at the midpoint of its prior guidance with a tightened range of $1,551 million to $1,563 million. The revenue range represents reported growth of 0.5% to 1.3%, inclusive of the divestiture of the TWC business and an updated foreign currency outlook, with organic growth of 3.7% to 4.5%.
"We are pleased with our sales performance in the third quarter. Our diverse portfolio continues to deliver solid, profitable growth for our shareholders," said Jan De Witte, Integra’s president and chief executive officer. "We continue to see strong demand for our products globally and are focused on our execution in achieving our short- and long-term targets."

Third Quarter 2022 Consolidated Performance

Total reported revenues of $385.2 million decreased 0.4% on a reported basis and increased 3.5% on an organic basis compared to the prior year.

The Company reported GAAP gross margin of 61.5%, compared to 62.7% in the third quarter of 2021. Adjusted gross margin was 66.7%, compared to 68.3% in the prior year.

Adjusted EBITDA for the third quarter of 2022 was $105.3 million, or 27.3% of revenue, compared to $104.3 million, or 27.0% of revenue, in the prior year.

The Company reported GAAP net income of $49.9 million, or $0.60 per diluted share, in the third quarter of 2022, compared to a GAAP net income of $43.2 million, or $0.51 per diluted share, in the prior year.

Adjusted net income for the third quarter of 2022 was $71.7 million, or $0.86 per diluted share, compared to $73.1 million, or $0.86 per diluted share, in the prior year.

Third Quarter 2022 Segment Performance

Codman Specialty Surgical (~65% of Revenues)

Total revenues were $249.8 million, representing reported decline of 2.6% and organic growth of 1.6% compared to the third quarter of 2021, driven by strength in both advanced energy and CSF management partially offset by the impact of the CereLink recall in neuro monitoring.
Tissue Technologies (~35% of Revenues)

Total revenues were $135.4 million, representing reported growth of 3.9% and organic growth of 7.2% compared to the third quarter of 2021, driven by sales of Integra skin, amniotics and ACell MicroMatrix.
Key Products and Business Highlights

Advancing Key Products

Return-to-market plans for the CereLink ICP monitor are progressing, targeting first half of 2023.
Third quarter results include a $1.5 million recall returns provision and a $0.8 million rework accrual in cost of goods sold, both of which impacted gross margin.

Expanded the CUSA Clarity portfolio
CUSA Clarity extended laparoscopic tip launched in the U.S., bringing the benefits of ultrasonic ablation technology to minimally invasive laparoscopic liver procedures.

CUSA single-sided bone tip received 510(k) approval. Commercial launch is expected in the first quarter of 2023.

Advanced the science for the Aurora Surgiscope with the publication, in Operative Neurosurgery, of the first peer-reviewed journal article. The Aurora Surgiscope is intended for use in neurosurgery and endoscopic neurosurgery and pure neuroendoscopy (i.e., ventriculoscopy) for visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
Business Highlights

Completed the previously announced sale of the non-core TWC business to Gentell, LLC for $28.8 million, which consists of $27.8 million in cash plus $1.0 million in contingent consideration which may be received upon achieving certain revenue-based performance milestones. The transaction included the sale of the Company’s TWC products, such as sponges, gauze and conforming bandages, and certain advanced wound care dressings, such as supportive, calcium alginate, hydrogel, and foam dressings.

Issued our inaugural Environmental, Social and Governance (ESG) report. The report highlights 2021 performance in key areas such as employee health and safety, diversity and inclusion, community impact, ethics and compliance, and environmental responsibility. The report also includes the company’s ESG strategy and roadmap to long-term sustainability.

Appointed two new key executives

Harvinder Singh, EVP & President, International, based in Singapore with a focus on setting and executing product-market strategies and building out Integra’s local commercial capabilities in international markets.
Mark Jesser, CVP & Chief Digital Officer, based in our Princeton, N.J. headquarters with a focus on partnering with our commercial, strategic marketing and business development teams to define and execute digital proposition strategies that enhance Integra’s device portfolio and its positioning within the digital health ecosystem.
Balance Sheet, Cash Flow and Capital Allocation

The Company generated cash flow from operations of $68 million in the quarter. Net debt at the end of the quarter was $1.04 billion, and the consolidated total leverage ratio was 2.4x.

As of quarter end, the Company had total liquidity of approximately $1.75 billion, including approximately $512 million in cash and the remainder available under the revolving credit facility.

2022 Outlook

For the full year 2022, the Company is reaffirming its revenue expectations at the midpoint of its August 2022 guidance with a tightened range of $1,551 million to $1,563 million. The revenue range represents reported growth of 0.5% to 1.3%, inclusive of the divestiture of the TWC business and an updated foreign currency outlook, with organic growth of 3.7% to 4.5%. Our guidance reflects our solid revenue performance through the first 9 months while considering the macro environment, continuing supply constraints, and potential adjustments to the CereLink reserve.

Full-year 2022 reported revenue guidance reflects an additional 25 basis points of unfavorable foreign currency impact relative to guidance provided in August 2022. Foreign currency is now expected to unfavorably impact full year reported growth by approximately 250 basis points compared to the prior year due to the continuing strength of the US Dollar.

Full year 2022 adjusted EPS guidance is being raised to a range of $3.29 to $3.33, an increase of $0.15 at the mid-point compared to the Company’s August guidance.

For the fourth quarter 2022, the Company expects reported revenues in the range of $391 million to $403 million, representing reported growth of -3.5% to -0.6% and organic growth of 1.3% to 4.3%. Adjusted earnings per diluted share is expected to be in a range of $0.87 to $0.91.

The Company’s guidance for fourth quarter and full-year organic sales growth excludes acquisitions and divestitures, the effects of foreign currency and the year-over-year change in revenue from discontinued products. Organic growth includes ACell as of January 20, 2022 and excludes sales from the TWC divestiture as of September 1, 2022. Adjusted earnings per share guidance reflects the impact of the divestiture of the TWC business as well as an updated foreign currency outlook.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET on Wednesday, October 26, 2022, to discuss third quarter 2022 financial results, and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question-and-answer session following the call. Integra’s management team will reference a presentation during the conference call, which can be found on the Investor section of the website at investor.integralife.com.

Access to the live call is available by dialing 866-571-0905 and using the passcode 1121226#. A simultaneous webcast of the call will be available via the Company’s website at www.integralife.com. A webcast replay of the call can be accessed through the Investor Relations homepage of Integra’s website at www.integralife.com. A replay of the call will be available until November 7, 2022 by dialing 866-583-1035 and using the passcode 1121226#.

On October 26, 2022 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the third quarter ended October 1, 2022 (Press release, Thermo Fisher Scientific, OCT 26, 2022, View Source [SID1234622400]).

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Third Quarter 2022 Highlights

Third quarter revenue was $10.68 billion.
Third quarter GAAP diluted earnings per share (EPS) was $3.79.
Third quarter adjusted EPS was $5.08.
Delivered very strong financial results in the third quarter, with 14% Core organic revenue growth and $0.44 billion of COVID-19 testing revenue.
Launched a range of high-impact innovative new products, including the Orbitrap Ascend Tribrid mass spectrometer, which offers new capabilities for quantification and characterization of proteins while delivering high throughput and ease of use for diagnostic and drug discovery applications, as well as the Thermo Scientific Arctis Cryo-Plasma Focused Ion Beam, an automated microscope that streamlines cryo-electron tomography research and provides insights into how proteins and other molecules operate within cells. We also advanced our diagnostic offerings with the CE-IVD certification of the Oncomine Dx Express Test and Oncomine Reporter Dx software, which are designed to run on our Ion Torrent Genexus Next-Generation Sequencing System to advance precision oncology testing.
Continued to strengthen our unique customer value proposition with two new facilities to expand our capacity and capabilities: in Chelmsford, Massachusetts, we expanded our capacity for purification resins used in the production of biologics for a number of diseases; and in Plainville, Massachusetts, we expanded our viral vector manufacturing capacity to support cell and gene therapies.
Advanced on our environmental, social and governance priorities, signing an agreement with Enel North America to source half of our U.S. electricity needs from renewable wind power, continuing to deliver on our emissions-reduction strategy.
"We delivered another quarter of excellent financial performance driven by our proven growth strategy and powered by our PPI Business System. Our strategic investments and innovative new product launches are further enhancing our unique customer value proposition and leading to continued share gain," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "We saw broad-based strength across our businesses, including our new clinical research business, which is performing very well. Customers are excited about our expanded capabilities, the integration continues to progress smoothly, and the long-term synergies remain very compelling."

Casper added, "With a strong nine months behind us, we are on track to deliver another outstanding year."

Third Quarter 2022

Revenue for the quarter grew 14% to $10.68 billion in 2022. Organic revenue was 1% lower; acquisitions increased revenue by 20% and currency translation decreased revenue by 5%. Core organic revenue growth was 14%. COVID-19 testing revenue was $0.44 billion.

GAAP Earnings Results

GAAP diluted EPS in the third quarter of 2022 was $3.79, versus $4.79 in the same quarter last year. GAAP operating income for the third quarter of 2022 was $1.71 billion, compared with $2.28 billion in the year-ago quarter. GAAP operating margin was 16.0%, compared with 24.4% in the third quarter of 2021.

Non-GAAP Earnings Results

Adjusted EPS in the third quarter of 2022 was $5.08, versus $5.77 in the third quarter of 2021. Adjusted operating income for the third quarter of 2022 was $2.37 billion, compared with $2.78 billion in the year-ago quarter. Adjusted operating margin was 22.2%, compared with 29.8% in the third quarter of 2021.

Annual Guidance for 2022

The company will provide updated 2022 financial guidance during its earnings conference call this morning at 8:30 a.m. Eastern Time.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, October 26, 2022, at 8:30 a.m. Eastern Time. To listen, dial (844) 200-6205 within the U.S. or (929) 526-1599 outside the U.S. The conference ID is 406803. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financials." An audio archive of the call will be available under "News & Events" through Friday, November 11, 2022.