On August 7, 2024 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided immunotherapies for the treatment of cancer, reported it has entered into a three-year, multi-target strategic partnership to design and co-research T cell receptor (TCR)-guided T Cell Engagers (TCR-TCEs) for the treatment of solid tumors (Press release, MediGene, AUG 7, 2024, https://www.pressetext.com/news/20240808017 [SID1234645513]). The collaboration combines the respective expertise of each company with Medigene’s 3S (sensitive, specific and safe) TCR generation and characterization capabilities and WuXi Biologics’ anti-CD3 mAb, its TCE platform and proprietary bispecific antibody platform WuXiBody.

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The companies aim to co-research TCR-TCE constructs, which will be owned by both cooperation partners with options to Medigene to further advance their development. The resulting constructs will leverage Medigene’s highly specific 3S TCRs for comprehensive target recognition, coupled with WuXi Biologics’ anti-CD3 mAb, bispecific antibody technology and TCE platform to activate T cells. The resultant bispecific therapeutics are expected to provide highly specific targeted immune responses that direct T cells to effectively attack and kill cancer cells while minimizing off-target effects, and thereby improve patient outcomes.

On August 7, 2024 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the second quarter of 2024 (Press release, Charles River Laboratories, AUG 7, 2024, View Source [SID1234645492]). For the quarter, revenue was $1.03 billion, a decrease of 3.2% from $1.06 billion in the second quarter of 2023.

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The impact of foreign currency translation reduced reported revenue by 0.3%, a divestiture reduced reported revenue by 0.2%, and an acquisition contributed 0.5% to consolidated second-quarter revenue. Excluding the effect of these items, revenue also declined 3.2% on an organic basis. On a segment basis, organic revenue growth in the Manufacturing Solutions (Manufacturing) segment was more than offset by lower revenue in the Discovery and Safety Assessment (DSA) and Research Models and Services (RMS) segments.

In the second quarter of 2024, the GAAP operating margin decreased to 14.8% from 15.6% in the second quarter of 2023. This GAAP decrease was primarily driven by lower operating margins in the RMS and DSA segments, due in part to costs associated with the Company’s restructuring initiatives. On a non-GAAP basis, the second-quarter operating margin increased to 21.3% from 20.4%, driven primarily by lower performance-based compensation accruals, as well as operating margin improvement in the Manufacturing segment.

On a GAAP basis, second-quarter net income attributable to common shareholders was $90.0 million, a decrease of 7.2% from $97.0 million for the same period in 2023. Second-quarter diluted earnings per share on a GAAP basis were $1.74, a decrease of 7.9% from $1.89 for the second quarter of 2023. The GAAP net income and earnings per share decreases were driven primarily by lower revenue and operating income, which included higher costs associated with the Company’s restructuring initiatives. On a non-GAAP basis, net income was $144.9 million for the second quarter of 2024, an increase of 4.8% from $138.3 million for the same period in 2023. Second-quarter diluted earnings per share on a non-GAAP basis were $2.80, an increase of 4.1% from $2.69 per share for the second quarter of 2024. The increases in non-GAAP net income and earnings per share were driven primarily by lower performance-based compensation accruals, as well as higher revenue and operating income in the Manufacturing segment.

James C. Foster, Chair, President and Chief Executive Officer, said, "Our financial performance through the first half of this year has been largely in line with our initial outlook; however, forward-looking DSA trends suggest that demand will not improve during the second half of the year as we had previously anticipated, and in fact, will decline for global biopharmaceutical clients. This has caused us to take a much more negative view of our growth prospects for the second half of the year. We believe that our clients are currently more focused on reassessing their budgets and reprioritizing their pipelines, but continue to view strategic outsourcing as a compelling solution to improve their cost efficiency and speed to market, presenting a longer-term opportunity for us."
"Therefore, it is imperative for us to navigate through this period of softer demand by aggressively managing our cost structure, initiating new and innovative ways to transform our business, being disciplined with our investments, and enhancing our commercial efforts to win new business. We firmly believe that our clients will continue to seek life-saving treatments for rare diseases and other unmet medical needs, which drives us to take further steps to position Charles River for the future. These steps will enable us to emerge as a stronger, leaner partner to help our clients achieve their goals by utilizing our scientific expertise and flexible solutions," Mr. Foster concluded.

Second-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $206.4 million in the second quarter of 2024, a decrease of 1.7% from $209.9 million in the second quarter of 2023. The Noveprim acquisition in November 2023 contributed 2.7% to second-quarter RMS reported revenue, and the impact of foreign currency translation reduced revenue by 0.5%. Organic revenue decreased by 3.9%, due primarily to lower revenue for non-human primates (NHPs) in China. In addition, lower revenue for research model services and the Cell Solutions business also contributed to the decline. The decline was partially offset by higher sales of small research models, particularly in Europe and China.
In the second quarter of 2024, the RMS segment’s GAAP operating margin decreased to 14.5% from 23.3% in the second quarter of 2023. On a non-GAAP basis, the operating margin decreased to 23.1% from 26.4%. The GAAP and non-GAAP operating margin declines were driven primarily by lower NHP revenue. On a GAAP basis, the lower operating margin also reflects higher costs associated with the Company’s restructuring initiatives, including site consolidation costs related to the Company’s CRADL operations in California.
Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $627.4 million in the second quarter of 2024, a decrease of 5.4% from $663.5 million in the second quarter of 2023. A divestiture of a small Safety Assessment site reduced reported revenue by 0.3% and the impact of foreign currency translation reduced DSA revenue by 0.1%. Organic revenue decreased by 5.0%, driven by lower revenue in the Discovery Services and Safety Assessment businesses.

In the second quarter of 2024, the DSA segment’s GAAP operating margin decreased to 22.1% from 24.3% in the second quarter of 2023. On a non-GAAP basis, the operating margin decreased to 27.1% from 27.6% in the second quarter of 2023. The GAAP and non-GAAP operating margin decreases were driven primarily by the impact of lower sales volume, partially offset by lower performance-based compensation accruals. On a GAAP basis, the lower operating margin also reflects higher costs associated with the Company’s restructuring initiatives, as well as higher acquisition-related adjustments associated with Noveprim.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $192.3 million in the second quarter of 2024, an increase of 3.1% from $186.5 million in the second quarter of 2023. The impact of foreign currency translation reduced Manufacturing revenue by 0.6%. Organic revenue growth of 3.7% reflected higher revenue across all of the segment’s businesses.
In the second quarter of 2024, the Manufacturing segment’s GAAP operating margin increased to 19.4% from 13.1% in the second quarter of 2023, and on a non-GAAP basis, the operating margin increased to 26.6%, from 22.9% in the second quarter of 2023. The GAAP and non-GAAP operating margin increases were driven primarily by improved profitability for each of segment’s businesses. On a GAAP basis, lower third-party legal costs related to the Microbial Solutions business and lower acquisition-related adjustments also contributed to the increase.
New Stock Repurchase Authorization
The Company’s Board of Directors has approved a new stock repurchase authorization of $1.0 billion. This new authorization replaces a prior stock repurchase authorization of $1.3 billion that had $129.1 million remaining on the plan when it was terminated.

Revises 2024 Guidance

The Company is revising its financial guidance for 2024, which was previously updated on May 9, 2024. The reduced guidance primarily reflects the lack of a recovery in demand from our small and mid-sized biotechnology clients in the second half of the year, as well as softer demand trends from global biopharmaceutical clients whose deterioration has become increasingly evident in the past couple of months. As a result, the Company no longer expects that overall demand trends will improve during the second half of the year. In particular, these trends will have a meaningful impact on the outlook for the DSA segment. The Company is implementing restructuring initiatives that are expected to result in annualized cost savings of over $150 million (inclusive of actions implemented last year through the third quarter of 2024), of which approximately $100 million will be realized in 2024.

On August 7, 2024 Lantern Pharma (NASDAQ: LTRN), a clinical-stage biopharmaceutical company leveraging artificial intelligence (AI) and machine learning to transform the cost, pace, and timeline of oncology drug discovery and development, reported a significant advancement demonstrating the preclinical synergy of LP-184 with checkpoint inhibitors and the ability of LP-184 to resensitize tumors that have become non-responsive to Anti-PD1 therapies (Press release, Lantern Pharma, AUG 7, 2024, View Source [SID1234645514]). The company will be presenting preliminary data from the recent work done in conjunction with Drs. Yong Du and Shiaw-Yih (Phoebus) Lin at MD Anderson at The Immuno-Oncology Summit 2024 in Philadelphia.

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The data will be presented in the form of poster entitled, LP-184, a Novel Acylfulvene, Sensitizes Immuno-Refractory Triple Negative Breast Cancers (TNBCs) To Anti-PD1 Therapy by Affecting the Tumor Microenvironment, (assigned Poster # P17). The poster highlights the following key points:

LP-184 seems to potentiate anti-PD1 response in a mouse model of TNBC that is non-hypermutated and resistant to immunotherapy in the absence of LP-184.
LP-184 can potentially transform immunologically "cold" tumors (non-responsive to IO therapies) into "hot" tumors (responsive to IO therapies) by modulating T cell activity in the tumor microenvironment and inducing a replication stress response defect.1
LP-184 seems to reshape the tumor microenvironment (TME) by significantly reducing the amount of M2 macrophages – which are associated with tumor drug resistance, tumor cell proliferation and are involved in helping the tumor cells escape immune cell death2.
LP-184 combined with an anti-PD1 agent elicited a greater anti-tumor response than monotherapies in mouse TNBC tumors that are non-hypermutated and resistant to immune checkpoint inhibitors
LP-184 is being investigated in an ongoing first-in-human Phase 1 trial (NCT05933265) in advanced recurrent solid tumors to establish a maximum tolerated dose and assess its overall safety and suitability in more targeted cancer indications, including TNBC.

Immunotherapy with checkpoint inhibitors (CPI) account for nearly $48 billion in sales annually according to Grand View Research and has profoundly changed the landscape of treatment in oncology since their introduction by providing outstanding durable responses and potential long-term remission in a significant proportion of cancer patients.3 Treatments are now approved for more than thirty cancer indications including melanoma, lung, colon, renal, urothelial, gastric, liver, lymphoma, head and neck but only a minority of patients benefit (10% to 50% depending on the stage and site of the tumor) and often patients will be non-responsive to CPI.

"Our drug-candidate, LP-184 has shown very promising preclinical evidence supporting its role in immuno-oncology to help patients improve response and durability of response to IO therapies. This work in collaboration with MD-Anderson supports our initial AI-driven hypothesis regarding the role of LP-184 to synergize with PD1 and PDL1 drugs and potentially improve the lives of a greater number of cancer patients globally. We look forward to developing combination drug studies and clinical trials with LP-184 and checkpoint inhibitors," said Lantern Chief Scientific Officer, Kishor Bhatia, PhD, FRCP.

The entirety of the data and poster to be presented at The Immuno-Oncology Summit 2024 in Philadelphia will be available on the Lantern website after 6pm Eastern today, August 7th 2024.

On August 7, 2024 ChromaDex Corp. (NASDAQ:CDXC) reported financial results for the second quarter of 2024 (Press release, ChromaDex, AUG 7, 2024, View Source/news/news-details/2024/ChromaDex-Corporation-Reports-Second-Quarter-2024-Financial-Results/default.aspx" target="_blank" title="View Source/news/news-details/2024/ChromaDex-Corporation-Reports-Second-Quarter-2024-Financial-Results/default.aspx" rel="nofollow">View Source [SID1234645493]).

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Second Quarter 2024 Financial and Recent Operational Highlights

Total net sales were $22.7 million, with $18.6 million from Tru Niagen, up 12%, and 10%, respectively, from the prior year quarter.
Solid gross margin of 60.2% and a $0.7 million reduction in total operating expenses from the prior year quarter.
Net loss and loss per share were approximately breakeven, a $2.2 million and $0.03 per share improvement from the prior year quarter.
Adjusted EBITDA, a non-GAAP measure, improved to $1.6 million from $0.2 million in the prior year quarter.
In June 2024, ChromaDex announced U.S. FDA Orphan Drug Designation and Rare Pediatric Disease Designation for nicotinamide riboside chloride, ChromaDex’s product candidate for the treatment of Ataxia Telangiectasia (AT). AT is a rare, progressive disease that typically presents in early childhood and affects the function of the nervous system, the immune system, and several other body systems. Plans are underway to file an Investigational New Drug application with the U.S. FDA in anticipation of conducting human clinical trials. If the application is approved, ChromaDex will pursue grant funding or other non-dilutive financing for the human clinical trials.
In June 2024, ChromaDex unveiled Niagen+, a product line featuring pharmaceutical-grade Niagen (patented nicotinamide riboside chloride or NRC). U.S. FDA-registered 503B outsourcing facilities will compound and distribute pharmaceutical-grade Niagen, which will be available in intravenous (IV) and injectable forms exclusively at clinics with prescription. Beginning this month, Niagen IV and injections will debut at select IV clinics. Clinical study results (1) support Niagen IV offering a 75% shorter infusion time, a higher and faster rise in NAD+ blood levels three hours post-infusion, based on dried blood spot analysis, and is well-tolerated as compared to the common alternative, NAD+ IV.
In July 2024, ChromaDex launched Niagen+ NAD+ Test Kits, available exclusively to healthcare practitioners. The Niagen+ NAD+ Test Kits provide a reliable method for measuring patient blood NAD+ levels, enabling practitioners to create more personalized and effective protocols using ChromaDex’s NAD+-boosting products, Tru Niagen and Niagen+.
"We delivered solid financial results in the second quarter, with $22.7 million in revenue and lower operating expenses resulting in virtually breakeven net loss and operating cash flows, as well as positive Adjusted EBITDA of $1.6 million," said ChromaDex Chief Executive Officer, Rob Fried. "Moreover, we are thrilled to finally unveil our new product line, Niagen+, for healthcare practitioners and clinics. This launch marks a significant milestone for ChromaDex, as we believe we are the first company to offer NR in both oral and intravenous forms, reinforcing our position as the global authority in the NAD+ market."

(1) Source: MedRxiv Randomized, placebo-controlled, pilot clinical study evaluating acute Niagen+ IV and NAD+ IV in healthy adults

Results of operations for the three months ended June 30, 2024 compared to the prior year quarter

ChromaDex recorded net sales of $22.7 million, an increase of 12% or $2.4 million from the prior year quarter. The growth in total net sales was primarily due to higher Tru Niagen and Niagen ingredient sales.

Gross margin percentage declined 60 basis points to 60.2% primarily driven by changes in business mix.

Operating expense decreased 5%, or $0.7 million, to $13.9 million driven by lower general and administrative expense, partially offset by increased investments in sales and marketing expense.

Net loss and loss per share were approximately breakeven, both up compared to a net loss of $2.2 million, or $0.03 loss per share, for the second quarter of 2023. Adjusted EBITDA, a non-GAAP measure, improved to $1.6 million from $0.2 million in the second quarter of 2023. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP Adjusted EBITDA to net loss, the most directly comparable GAAP measure.

Net cash inflow from operating activities was approximately breakeven for the six months ended June 30, 2024 compared to a net cash inflow of $6.1 million in the prior year. The approximately $6.0 million reduction in cash provided by operating activities was largely driven by a relatively greater increase in trade receivables of $4.2 million and a greater reduction in accounts payable of $2.5 million.

2024 Full Year Outlook

Looking forward, for the full year, the Company expects between 10% – 15% revenue growth year-over-year, driven by continued revenue growth through our e-commerce business as well as established partnerships, and assumes upside from opportunities with new partnerships, channels, and products. The Company projects that gross margin will improve slightly year-over-year. Moreover, selling and marketing expense will increase in absolute dollars but remain stable as a percentage of net sales, as the Company continues to make focused investments to drive brand awareness and support new market launches, while maintaining efficiency. The Company plans to continue to invest in research and development to drive future innovation and expects general and administrative expense to be down $1.5 million year over year.

Investor Conference Call

A live webcast will be held Wednesday, August 7, 2024 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss ChromaDex’s second-quarter financial results and provide a general business update.

To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investors Relations section of ChromaDex’s website at View Source . The toll-free dial-in information for this call is 1-888-596-4144 with Conference ID: 8584242.

The webcast will be recorded, and will be available for replay via the website from 7:30 p.m. Eastern time on August 7, 2024 through 11:59 p.m. Eastern time on August 14, 2024. The replay of the call can also be accessed by dialing 800-770-2030, using the Replay ID: 8584242.

On August 7, 2024 WestGene Biopharma reported that its mRNA therapeutic cancer vaccine, WGc-043, has received dual IND approvals from China’s National Medical Products Administration (NMPA) and the US FDA (Press release, WestGene Biopharma, AUG 7, 2024, View Source [SID1234645515]). This unprecedented achievement marks the world’s first IND-approved mRNA vaccine for EBV-related cancers in both the United States and China.

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Groundbreaking milestone in cancer immunotherapy

On 6 August, the Center for Drug Evaluation (CDE) of the NMPA approved the clinical trial application for WGc-043 injection, allowing the initiation of Phase I clinical trials. This dual approval further validates WestGene’s expertise in core mRNA technologies such as delivery vectors and sequence design, and accelerates the commercialisation of effective and low-toxicity anti-tumour mRNA vaccines worldwide.

Revolutionary technology

WGc-043 is part of WestGene’s portfolio of more than 20 mRNA vaccine candidates. The innovative aspects of WGc-043 include

1. AI-assisted antigen screening: The use of AI to select the broadest and safest protein sequences with the introduction of a globally unique immuno-enhancer (IE) into the mRNA molecule. This design activates the patient’s anti-tumour immunity, generating cytotoxic T-cells (CTLs), antigen-specific antibodies and memory T-cells, providing highly effective anti-cancer effects comparable to combined CAR-T and monoclonal antibody therapies, and preventing tumour recurrence.

2. Advanced delivery system: The newly developed LNP delivery system, patented in China, the US, Europe, Canada, Australia and South Africa, has demonstrated safety and delivery efficiency in clinical trials of three of WestGene’s proprietary products.

Significant market potential and Innovative immunotherapy for EBV-related cancers

The EBV, classified as a Group 1 carcinogen by the International Agency for Research on Cancer (IARC), infects more than 90% of the world’s population and is associated with more than ten malignancies, including nasopharyngeal carcinoma, lymphoma, gastric cancer, lung cancer, liver cancer, esophageal cancer, breast cancer and cervical cancer. WGc-043 is now approved in both countries for treating EBV-positive solid tumors and hematologic malignancies. This new immunotherapy option, backed by high-quality preliminary data, is expected to demonstrate excellent safety and anti-tumor activity in upcoming clinical trials.

WGc-043 has completed investigator-initiated trials (IITs) in nasopharyngeal carcinoma and natural killer T-cell lymphoma, demonstrating superior safety and efficacy compared to existing mRNA cancer vaccines. Its launch is expected to be a major breakthrough in mRNA immunotherapy for EBV-positive tumours.

Comprehensive pipeline and commercialisation progress

Building on its scientific achievements, WestGene has established five R&D platforms. WestGene’s pipeline includes more than 20 products, including mRNA cancer vaccines, mRNA preventive vaccines for infectious diseases, and therapeutic drugs for conditions such as obesity and ageing. In addition to the IND approval for its cancer product, WestGene’s novel nano-adjuvant WGa01 received EUA in China last year, marking a significant milestone in domestic production.

As WestGene moves forward, its pioneering spirit and commitment to innovation promise to revolutionise the field of mRNA technology and cancer therapy. WestGene is currently open to various forms of commercial collaboration, including but not limited to pipeline licensing, co-development and technology licensing.