On July 26, 2023 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported its financial results for the second quarter ending June 30, 2023 (Press release, Integra LifeSciences, JUL 26, 2023, View Source [SID1234633456]).

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Second Quarter 2023 Highlights
•Second quarter revenues of $381.3 million declined 4.2% on a reported basis and declined 2.7% on an organic basis compared to the prior year.

•Second quarter GAAP earnings per diluted share of $0.05, compared to $0.54 in the prior year; adjusted earnings per diluted share of $0.71, compared to $0.82 in the prior year
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•Appointed Lea Daniels Knight as executive vice president and CFO

Share repurchase and 2023 guidance

•Planning a $125 million share repurchase in the third quarter

•Updating full-year 2023 revenue and adjusted earnings per share guidance with a range of $1.548 billion to $1.560 billion and $3.10 to $3.18 respectively, reflecting the impact of the Boston recall and the solid performance of the underlying business

"The strong organic growth of our Codman Specialty Surgical segment and several product lines in our Tissue Technologies business demonstrate the resilience of our diversified portfolio of leading brands and technologies and strong market recovery. Excluding the impact of the Boston recall, we delivered solid, mid-single digit organic growth from the underlying business," said Jan De Witte, Integra LifeSciences’ president and chief executive officer. "We are confident in our plans for the CereLink relaunch and the restart of our Boston manufacturing facility, and we continue to advance our implant-based breast reconstruction (IBBR) PMA strategy."

Second Quarter 2023 Consolidated Performance

Total reported revenues of $381.3 million declined 4.2% on a reported basis and declined 2.7% on an organic basis compared to the prior year.
The Company reported GAAP gross margin of 54.3%, compared to 62.7% in the second quarter of 2022. Adjusted gross margin was 67.6%, compared to 68.0% in the prior year.
Adjusted EBITDA for the second quarter of 2023 was $88.8 million, or 23.3% of revenue, compared to $102.8 million, or 25.8% of revenue, in the prior year.
The Company reported GAAP net income of $4.2 million, or $0.05 per diluted share, in the second quarter of 2023, compared to a GAAP net income of $44.8 million, or $0.54 per diluted share, in the prior year.
Adjusted net income for the second quarter of 2023 was $57.4 million, or $0.71 per diluted share, compared to $68.3 million, or $0.82 per diluted share, in the prior year.

Second Quarter 2023 Segment Performance
Codman Specialty Surgical (~71% of Revenues)
•Total revenues were $271.0 million, representing reported growth of 5.1% and organic growth of 6.3% compared to the second quarter of 2022, due to high single-digit growth in Advanced Energy driven by CUSA capital and disposables; mid-single-digit growth in CSF management driven by Certas Plus valves and BactiSeal; mid-single-digit growth in Dural Access and Repair driven by Mayfield and DuraGen; low single-digit decline in Neuro Monitoring driven by CereLink and low double-digit growth in Instruments.

Tissue Technologies (~29% of Revenues)

•Total revenues were $110.2 million, representing reported decline of 21.2% and organic decline of 19.7% compared to the second quarter of 2022, due to the impact of the lost revenue and return provision for the Boston recall which was partially offset by double digit growth from MicroMatrix, Cytal, MediHoney and nerve franchise.
Key Products and Business Highlights

•Positive global demand performance across the portfolio
•Expect to restart manufacturing at the Boston facility late Q4’23 and resume commercial distribution in mid- to late Q2’24
•Relaunch of CereLink expected late Q3’23 in international markets and late Q4’23 in the US
•Advancing IBBR PMA strategy
◦Submitted clinical PMA amendment for SurgiMend
◦Completed enrollment In DuraSorb Monofilament Mesh U.S. investigational device exemption study
•Expanded global DuraGen portfolio with approvals in China and Japan
•Launched CUSA Lap Tip in Japan, Canada, South Africa and Israel
•Positive clinical and economic outcomes for Codman Bactiseal EVD Catheter from real-world evidence study in Europe
•Opened Dr. Richard E. Caruso Center of Innovation and Learning in Plainsboro, New Jersey

Balance Sheet, Cash Flow and Capital Allocation
The Company generated cash flow from operations of $28.3 million in the quarter. Total balance sheet debt and net debt at the end of the quarter were $1.44 billion and $1.13 billion, respectively, and the consolidated total leverage ratio was 2.6x.

As of quarter end, the Company had total liquidity of approximately $1.61 billion, including $309.2 million in cash and the remainder available under the revolving credit facility.

Share Repurchase Program

The Company is planning for a $125 million share repurchase during the third quarter under an authorization of the Company’s board of directors.

2023 Outlook
For the full year 2023, the Company is updating its revenue and adjusted EPS expectations to $1.548 to $1.560 billion and $3.10 to $3.18, respectively. The revenue range represents reported growth of -0.6% to 0.2%, with organic growth of 0.3% to 1.1% and reflects the full year impact of the Boston recall and the solid performance of the underlying business.

For the third quarter 2023, the Company expects reported revenues in the range of $386 million to $390 million, representing reported growth of 0.2% to 1.3% and organic growth of 0.3% to 1.3%. Adjusted earnings per diluted share are expected to be in the range of $0.76 to $0.80, including the impact of the Boston recall.

The Company’s guidance for the third 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 excludes sales from the divestiture of the Company’s traditional wound care (TWC) business as of September 1, 2022, and sales from the acquisition of Surgical Innovation Associates, Inc. (SIA) through December 1, 2023. Adjusted earnings per share guidance reflects the impact of the divestiture of the TWC business, the SIA acquisition and the impact of foreign currency.

Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 a.m. ET on Thursday, July 27, 2023, to discuss second quarter 2023 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.

A live webcast will be available on the Investors section of the Company’s website at investor.integralife.com. For those planning to participate on the call, register here to receive dial-in details and an individual pin. While not required, it is recommended to join 10 minutes prior to the event’s start. A webcast replay of the conference call will be available on the Investors section of the Company’s website following the call.

On July 26, 2023 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based in vivo gene editing and ex vivo allogeneic CAR T therapies, reported that it has received final meeting minutes from its recent Type B End of Phase 1 meeting with the U.S. Food and Drug Administration (FDA) for its lead investigational allogeneic CAR T therapy azercabtagene zapreleucel (azer-cel) (Press release, Precision Biosciences, JUL 26, 2023, View Source [SID1234633442]).

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"The objective of our meeting with the FDA was to gain further clarity on the potential registration path for azer‑cel including study design, endpoints and the recommended phase 2 dose for the CAR T relapsed patient setting – a patient population with dire need for better therapeutic options," said Alan List, MD, Chief Medical Officer at Precision BioSciences. "We were able to accomplish the meeting objective and are appreciative of the FDA’s clear and thoughtful advice."

The meeting with the FDA provided clarity and direction on azer-cel development, including a potential pathway toward registration. Based on the advice received from the FDA and clinical data shared during the May 2023 CAR T update, Precision is currently advancing discussions with multiple potential strategic partners for its cell therapy assets, including hematologic and non-hematologic applications.

"The ongoing collaborative discussions are intended to help us meet two key objectives: securing the right partner to build on our clinical-stage CAR T assets and allowing us to focus on core capabilities of in vivo gene editing," said Michael Amoroso, Chief Executive Officer at Precision BioSciences. "We look forward to providing additional updates on our cell therapy strategic partnering initiatives as they develop."

In Vivo R&D Day to be Held on September 12, 2023

Precision will host its in vivo gene editing R&D Day on September 12, 2023. This presentation will be focused on providing an update on ARCUS in vivo gene editing candidates and the broad potential and versatility of the platform. Additionally, this timing will allow strategic partnering discussions around the ex vivo allogeneic cell therapies to mature and enable full investor attention on our in vivo gene editing pipeline.

On July 26, 2023 Nexo Therapeutics reported to have emerged from stealth with a $60 million Series A financing led by founding investor Versant Ventures with participation from New Enterprise Associates and Cormorant Asset Management (Press release, Nexo Therapeutics, JUL 26, 2023, View Source [SID1234633441]). The company also announced a multi-year strategic research collaboration with The University of Texas MD Anderson Cancer Center, the details of which are described in a separate announcement.

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The financing supports Nexo’s platform that combines the power of covalent ligand discovery and chemical biology to unlock a pipeline of novel cancer therapies directed against previously intractable targets.

"For many cancer patients there are no therapies that target the fundamental drivers of their disease," said Andrew Phillips, Ph.D., founder and CEO of Nexo. "At Nexo, we are leveraging innovations in covalent chemistry and chemical biology to enable targeting these fundamental drivers. Our deep expertise in cancer biology and medicinal chemistry will allow us to efficiently advance therapies that provide new treatment options."

Many of the most compelling targets in oncology present significant hurdles for conventional approaches to ligand discovery, selectivity optimization and pharmacology. The reason is ligand discovery often relies on decades-old approaches, many of which struggle to find hits of sufficient quality. Even when there are identified starting points, it is hard to optimize for selectively, potency and pharmacological properties.

The Nexo platform systematically addresses each of the above issues by combining a chemistry engine with chemical biology capabilities.

The company’s chemistry engine, CODON (Covalent Discovery and Optimization), is tailored to solve challenges of ligand discovery. CODON combines a proprietary library that leverages chemical diversity and innovative covalent chemistries with scalable biochemical and in-cell proteomics. This allows the company to identify promising hit compounds and conduct rapid optimization to produce compounds for in vivo studies.

Importantly, the CODON engine uses covalent fragments against all ligandable amnio acids, thus expanding beyond conventional approaches that are constrained to cysteine and enabling discovery against targets that have been refractory to prior approaches. Coupled with the scale and breadth of the internal library and both biochemical and in-cell mass spectrometry capabilities, Nexo will be able to pursue challenging, high-value targets.

Nexo’s chemical biology capability, INFINI-T (Informed Profile Before Initiation of Target), uses the power of chimeric fusion proteins to address target biology and pharmacology questions. The function of these chimeric proteins can be controlled by small molecules in cellular and in vivo models to generate detailed information about the required depth, duration and selectivity of target inhibition. Importantly, the INFINI-T platform provides target product profiles for medicinal chemistry well in advance of lead optimization. This is expected to decrease the time and capital needed to bring drug candidates to the clinic.

"The Nexo platform is a unique combination of capabilities that can be operated at scale and that offers potential to create effective treatments for cancer and other diseases," said Carlo Rizzuto, Ph.D., managing director at Versant Ventures and a Nexo board member. "We are proud to lead this Series A financing and partner with the highly experienced Nexo team to create a pipeline of differentiated therapeutics."

"We are excited to support Nexo’s bold vision," said Ali Behbahani, M.D., general partner at NEA and a Nexo board member. "Cancer biology continues to provide promising but challenging targets that require innovative approaches, and we look forward to working with the team to translate recent discoveries into novel therapies."

On July 26, 2023 CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, reported the publication of preclinical results with Synthetic Enzyme-Armed Killer (SEAKER) cells in solid tumor melanomas in the peer-reviewed journal Cancer Immunology Research (Press release, CoImmune, JUL 26, 2023, View Source [SID1234633440]).

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The recently published paper titled, "Host Interactions with Engineered T cell Micropharmacies," describes seminal work by researchers at Memorial Sloan Kettering Cancer Center (MSK) including David A. Scheinberg, M.D., Ph.D., Chairman of the Center for Experimental Therapeutics and Deputy Director, Therapeutic Discovery, Sloan Kettering Institute (SKI), and Derek S. Tan, Ph.D., Chairman of the Chemical Biology Program, SKI. The work evaluates SEAKER cells designed to target solid-tumor melanomas in syngeneic mouse models using specific targeting with T cell receptor (TCR) engineered T cells. Results demonstrate that SEAKER cells localize specifically to tumors and activate bioactive prodrugs, providing efficacy against melanoma tumors in immunocompetent hosts.

"As we continue to advance a development program based on our proprietary chimeric antigen receptor (CAR) modified cytokine induced killer (CIK) cell platform, we are investigating technologies that could help deliver additional agents locally to tumor sites to mitigate tumor escape by loss of targeted antigens and tumor induced immunosuppression," said Charles Nicolette, Ph.D., Chief Executive Officer of CoImmune. "Our goal is to overcome the barriers to the treatment of solid tumors, and this new publication evaluating SEAKER cells in solid tumor melanoma models is another encouraging step in that direction."

CoImmune has acquired the rights to several technologies developed at MSK including SEAKER cells that combine the target-seeking power of immune cells with the ability to locally generate a potent anticancer drug at the tumor site without systemic toxicity, also referred to as a "micropharmacy."

"Genetically engineered, cytotoxic, adoptive T cells localize to antigen positive cancer cells inside patients, but tumor heterogeneity and multiple immune escape mechanisms have prevented the eradication of most solid tumors," said Dr. Scheinberg. "SEAKER cells can be designed to express a prodrug converting enzyme to achieve high active anti-tumor drug levels at tumor sites. This preclinical work demonstrates that the SEAKER platform is applicable to many adoptive cell therapies."

On July 26, 2023 GC Genome Corporation, a leading genomic diagnostics company, reported the publication of a new study in Journal of the National Cancer Institute (JNCI), shedding light on the remarkable potential of utilizing circulating tumor DNA (ctDNA) copy number aberration (CNA) for prognosis prediction and molecular profiling in cancer patients in collaboration with the team of Dr. Joohyuk Sohn, MD, professor at Severance Hospital (Press release, GC Genome, JUL 26, 2023, View Source [SID1234633439]).

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”We can gain vital insights into patient prognosis and make informed decisions regarding the most effective treatment strategies through ctDNA CNA analysis for breast cancer patients, ultimately improving patients’ outcomes," said Dr. Chang-Seok Ki, MD, CEO at GC Genome.

The study includes Low-pass whole-genome sequencing (LP-WGS)-based ctDNA data from 207 metastatic breast cancer (MBC) patients to investigate the prognostic value of ctDNA CNA burden, which was subsequently validated in 465 stage II-III triple-negative breast cancer (TNBC) patients who received neoadjuvant chemotherapy in phase III trial (NCT02441933).

High baseline ctDNA CNA burden was correlated with poor overall survival (OS) and progression-free survival (PFS) of MBC patients and poor disease-free survival was also observed independently of pathologic complete response (pCR), thereby emphasizing the robust prognostic significance of ctDNA CNA burden. PFS and OS are critical indicators of therapeutic efficacy in cancer patients.

”These results will indeed set a solid foundation in paving the way for the integrating of ctDNA CNA analysis into routine clinical practice, offering personalized and targeted treatment options,” said Dr. Eun-Hae Cho, MD, Chief Technical Officer at GC Genome. "Our dedication to further research aims to ensure that our technology can make valuable contributions to more individuals who are battling against cancer over the world.