TRACON to Report Second Quarter 2022 Financial Results and Provide Corporate Update on August 10, 2022

On July 27, 2022 TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that it will report its second quarter 2022 financial and operating results after the close of U.S. financial markets on Wednesday, August 10, 2022 (Press release, Tracon Pharmaceuticals, JUL 27, 2022, View Source [SID1234616990]). In addition, management will host a conference call to provide an update on corporate activities and discuss the financial results.

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

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

                  Schedule Your 30 min Free Demo!

A replay of the webcast will be available for 60 days on the website.

Oxford Vacmedix announces filing of new patent for Anti-Microbial Resistance diagnostic test

On July 27, 2022 Oxford Vacmedix (OVM), the UK clinical stage biopharma company, focused on the development of a new generation of cancer vaccines, reported that project work to develop a novel diagnostic test for anti-microbial resistance, funded by Innovate UK, has been filed as a patent in the UK (Press release, Oxford Vacmedix, JUL 27, 2022, View Source;utm_medium=rss&utm_campaign=new-patent-for-anti-microbial-resistance-diagnostic-test [SID1234616989]).

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

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

                  Schedule Your 30 min Free Demo!

The need to monitor and control resistance to antimicrobial therapy has been identified as an urgent global priority by both the WHO and UN. The rise in carbapenem resistance has been identified as of particular concern given the importance of this class of antibiotics.

The research project carried out in collaboration with Imperial College in London and the Ditan hospital in Beijing, has been to develop a fast and economic lateral flow immune assay (LFIA) diagnostic test to detect bacterial resistance to carbapenem antibiotics. This has advantages in terms of speed, simplicity and cost-effectiveness, especially important for low- and middle-income countries. The prototype assays, produced at Changzhou Biotech under contract to OVM, have been trialled at several leading hospitals in Beijing where antibiotic resistance is a serious problem, particularly in intensive care patients. Preliminary clinical tests show that the kits can detect the bacteria of antibiotic resistance directly from clinical samples in about 15 minutes, without prior bacterial culture.

The AMR diagnostic project has been mainly outsourced and run alongside OVM’s main development programmes to allow the company to focus on the development of its two lead cancer vaccines; OVM-100, an HPV vaccine targeted at cervical cancer; and OVM-200 a new type of vaccine based on survivin that targets solid tumours, and which is in Phase 1. Both vaccines address areas of significant unmet medical need with potential both as single agents and also in combination with other immune-oncology agents.

William Finch CEO of Oxford Vacmedix said:

"Whilst our primary focus is in the development of cancer vaccines, our technology also has applications for infectious diseases and this novel diagnostic test addresses an important need in treating seriously ill patients. We have a lot of confidence in our initial results and with a patent application now made, we look forward to working with a partner to complete development and to commercialise the test."

Shisong Jiang, Founder and CSO of Oxford Vacmedix said:

"I am very pleased that we have been able to use the Innovate UK funding and work with our collaboration partners to develop this AMR test. I would like particularly to recognise the development work at Changzhou Biotech where the team has done an excellent job. The sensitivity and specificity of the diagnostic test demonstrate its potential and I look forward to seeing this work taken further, to help patients."

Intellia Therapeutics to Hold Conference Call to Discuss Second Quarter 2022 Earnings and Company Updates

On July 27, 2022 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapeutics leveraging CRISPR-based technologies, reported that it will present its second quarter 2022 financial results and operational highlights in a conference call on August 4, 2022, at 8 a.m. ET (Press release, Intellia, JUL 27, 2022, View Source [SID1234616988]).

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

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

                  Schedule Your 30 min Free Demo!

To join the call:

U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726, approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call.
Please visit this link for a simultaneous live webcast of the call.
A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at www.intelliatx.com, beginning on August 4, 2022, at 12 p.m. ET.

Integra LifeSciences Reports Second Quarter 2022 Financial Results

On July 27, 2022 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the second quarter ending June 30, 2022 (Press release, Integra LifeSciences, JUL 27, 2022, View Source [SID1234616987]).

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

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

                  Schedule Your 30 min Free Demo!

Second Quarter 2022 Highlights

Second quarter revenues of $398 million increased 2.0% on a reported basis and 4.8% on an organic basis compared to the prior year.
Six-month revenues for 2022 were $774 million and increased 3.3% on a reported basis and 5.2% on an organic basis compared to the prior year.
Second quarter GAAP earnings per diluted share of $0.54, compared to $0.41 in the prior year; adjusted earnings per diluted share of $0.82, compared to $0.79 in the prior year.
The Company entered into an agreement for the sale of its non-core traditional wound care ("TWC") business.
The Company is tightening its previous full-year 2022 organic growth guidance of 3.8% to 5.2% to an updated range of 4.0% to 5.2%, reflecting better than expected first half performance. Full-year 2022 reported revenue guidance is updated to a range of $1,557 million to $1,575 million representing reported growth of 1.0% to 2.1%, inclusive of the planned sale of the TWC business and an updated foreign currency outlook. Adjusted earnings per share guidance range is updated accordingly to $3.21 to $3.29.
"We are pleased with our strong sales performance in the first half of the year. Our balanced portfolio continues to deliver solid, profitable growth in a challenging environment and we are on track to deliver our full-year organic growth expectations," said Jan De Witte, Integra’s president and chief executive officer. "We are encouraged by the momentum we see in our key markets, while our growth initiatives and operational focus further strengthens our ability to deliver on our long-term financial targets."

Second Quarter 2022 Consolidated Performance

Total reported revenues of $397.8 million increased 2.0% on a reported basis and 4.8% on an organic basis compared to the prior year.

The Company reported GAAP gross margin of 62.7%, compared to 61.2% in the second quarter of 2021. Adjusted gross margin was 68.0%, compared to 68.1% in the prior year.

Adjusted EBITDA for the second quarter of 2022 was $102.8 million, or 25.8% of revenue, compared to $101.0 million, or 25.9% of revenue, in the prior year.

The Company reported GAAP net income of $44.8 million, or $0.54 per diluted share, in the second quarter of 2022, compared to a GAAP net income of $35.1 million, or $0.41 per diluted share, in the prior year.

Adjusted net income for the second quarter of 2022 was $68.3 million, or $0.82 per diluted share, compared to $67.4 million, or $0.79 per diluted share, in the prior year.

Second Quarter 2022 Segment Performance

Codman Specialty Surgical (65% of Revenues)

Total revenues were $257.9 million, representing reported growth of 0.4% and organic growth of 4.3% compared to the second quarter of 2021, driven by strength in both Instruments and Neurosurgery. Neurosurgery growth was driven by advanced energy and CSF management.
Tissue Technologies (35% of Revenue)

Total revenues were $140.0 million, representing reported growth of 5.1% and organic growth of 5.9% compared to the second quarter of 2021, driven by Private Label customer orders and growth in Wound Reconstruction and Care led by sales in our Integra Dermal Matrices and SurgiMend
Strategic Initiatives and Key Developments

Advancing key products

Launched the Aurora Evacuator with Coagulation device in the U.S., designed to be used in conjunction with our Aurora Surgiscope to safely address and evacuate blood in the brain caused by hemorrhagic stroke.

Launched the Neutus EVD system, our first external ventricular drain in China. The Neutus EVD system is manufactured in China by Shanghai Haoju Medical Technology Co., Ltd. and commercialized by the Company under an exclusive distribution arrangement. The device is used in the management of cerebrospinal fluid and is highly complementary to our Bactiseal catheter and advanced intercranial pressure monitoring products.

Key developments

Closed a manufacturing facility located in France; transfer of production to the Company’s existing Switzerland facility is in process.

Announced plans to outsource certain transactional back-office finance and customer service activities to enhance customer quality, build scale for future growth, and capture cost efficiencies. The transition is expected to be completed by year end 2022.

Recognized as a Great Place to Work-Certified Organization in China and voted to 2022 Best Places to Work in NJ list.
Balance Sheet, Cash Flow and Capital Allocation

The Company generated cash flow from operations of $66 million in the quarter. Net debt at the end of the quarter was $1.12 billion, and the consolidated total leverage ratio was 2.5x.

As of quarter end, the Company had total liquidity of approximately $1.69 billion, including approximately $447 million in cash and the remainder available under the revolving credit facility.

Divestiture of the Traditional Wound Care Business

On May 20, 2022, the Company signed a definitive agreement to sell its TWC business, which includes sponges, gauze and conforming bandages and advanced wound care dressings, to Gentell, a leading manufacturer and distributor of advanced wound, skin, and personal care products, for $28.8 million, consisting of $27.8 million in cash plus $1.0 million in milestone payments. Revenues for the TWC business were approximately $27 million in 2021.

The transaction is expected to close at or around the end of August 2022, subject to the satisfaction of customary closing conditions.

"Our portfolio optimization actions over the past two years have allowed us to increase our focus on Integra’s core portfolio of market-leading products in neurosurgery, surgical instrumentation and regenerative tissue and moves us closer to achieving our long-term organic growth and profitability targets," said Jan De Witte.

2022 Outlook

For the full year 2022, the Company is tightening its organic growth expectations from a prior range of 3.8% to 5.2% to an updated range of 4.0% to 5.2%. This reflects the strong first half 2022 revenue performance, while also balancing the uncertainty in global markets and continuing supply constraints.

Full year 2022 reported revenue guidance has been revised to a range of $1,557 million to $1,575 million, representing reported growth of 1.0% to 2.1%, to reflect the pending sale of the TWC business and an additional 115 basis points of unfavorable foreign currency impact compared to guidance provided in April 2022. Foreign currency is now expected to unfavorably impact full year reported growth by approximately 225 basis points compared to the prior year due to the continuing strength of the USD compared to other currencies in which we transact sales.

Full year 2022 adjusted earnings per diluted share guidance is updated to a range of $3.21 to $3.29 reflecting the planned divestiture of the TWC business and an updated foreign currency outlook.

For the third quarter 2022, the Company expects reported revenues in the range of $383 million to $391 million, representing reported growth of -1.0 to 1.0% and organic growth of 2.6% to 4.8%. Adjusted earnings per diluted share is expected to be in a range of $0.78 to $0.82. Guidance reflects the impacts from the planned divestiture of the TWC business, as well as an updated foreign currency outlook on reported revenue and adjusted earnings per share.

The Company’s guidance for the third quarter and full year organic sales growth excludes acquisitions and divestitures as well as 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 pending TWC divestiture as of September 1, 2022.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET on Wednesday, July 27, 2022, to discuss second 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 (800) 289-0720 and using the passcode 2688312. 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 August 7, 2022 by dialing (888) 203-1112 and using the passcode 2688312 .

IDEAYA Announces Clinical Trial Collaboration with Amgen to Evaluate MAT2A-PRMT5 Synthetic Lethality Combination in MTAP Deleted Tumors

On July 27, 2022 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported it has entered into a clinical trial collaboration and supply agreement with Amgen Inc. to evaluate the efficacy and safety of IDE397, its investigational, potential best-in-class, small molecule MAT2A inhibitor, with Amgen’s AMG 193, an investigational small molecule MTA-cooperative inhibitor of PRMT5, in a Phase 1 clinical trial (Press release, Ideaya Biosciences, JUL 27, 2022, View Source [SID1234616986]).

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

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

                  Schedule Your 30 min Free Demo!

"This clinical collaboration with Amgen builds on IDEAYA’s ongoing clinical evaluation of IDE397 as monotherapy and in selected combinations in our Phase 1/2 clinical trial, including with taxanes and pemetrexed. We are pleased to collaborate with Amgen to also evaluate the MAT2A-PRMT5 synthetic lethality combination in the clinic," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

"Mechanistically, each of MAT2A and PRMT5 are synthetic lethal with MTAP gene deletion in tumors. The synthetic lethality of each of these targets provides a complementary approach for targeting MTAP-null tumors," said Dr. Michael White, Ph.D., Senior Vice President and Chief Scientific Officer, IDEAYA Biosciences.

IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion. The MTAP deletion patient population is estimated to represent approximately 15% of solid tumors, including approximately 15% of NSCLC, 28% of esophageal, 26% of bladder, and 10% of esophagogastric cancers.

IDEAYA is evaluating IDE397 in an ongoing Phase 1/2 clinical trial. The company has initiated and is actively enrolling patients into monotherapy expansion and combination cohorts of the IDE397 Phase 1 clinical trial, including in combination with docetaxel in NSCLC, paclitaxel in esophagogastric cancer and pemetrexed in NSCLC. IDEAYA is leading early clinical development of IDE397 in collaboration with GSK. Subject to exercise of its option, GSK will lead later-stage clinical development of IDE397.

Amgen is developing AMG 193, an investigational small molecule methylthioadenosine (MTA) cooperative inhibitor targeting protein arginine methyltransferase 5 (PRMT5), as monotherapy and in combination with docetaxel in MTAP null solid tumors, in an ongoing Phase 1 clinical trial.

Under the mutually non-exclusive clinical trial collaboration and supply agreement, IDEAYA will provide IDE397 drug supply to Amgen, who will be the sponsor of the Phase 1 clinical combination trial. IDEAYA and Amgen will jointly share external costs of the clinical trial and will jointly oversee clinical development of the combination therapy. IDEAYA and Amgen each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies.