On August 7, 2024 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will present at the Canaccord Genuity 44th Annual Growth Conference in Boston at 3:30 p.m. Eastern Time on Wednesday, August 14, 2024 (Press release, Neurocrine Biosciences, AUG 7, 2024, View Source [SID1234645509]). Kyle Gano, Chief Business Development and Strategy Officer, and Todd Tushla, Vice President of Investor Relations, will present at the conference.

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The live presentation will be webcast and may be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On August 7, 2024 Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company, reported its financial and operating results for the second quarter ended June 30, 2024 (Press release, Biodesix, AUG 7, 2024, View Source [SID1234645491]).

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"The second quarter marks sustained excellence in our execution, resulting in outstanding revenue growth coupled with consistently strong gross margins, and continued improvement on our path to profitability," said Scott Hutton, CEO of Biodesix. "The team’s performance led to 51% growth in revenue and as a result we are raising our 2024 total revenue guidance to $70-$72 million, up from previously provided guidance of $65-$68 million. In combination with our revenue growth, our cost-disciplined approach resulted in improvements of 19% in Net Loss and 38% in Adjusted EBITDA, demonstrating progress on our path to profitability."

"It is important to note that our industry-leading commercial engine is continuing to drive market adoption of our five on-market lung diagnostic tests. These tests are transforming the diagnosis and treatment of patients with lung cancer. We have an incredible team of professionals dedicated and driven to making a difference in patients’ lives. I continue to be thankful for the team and our intentional focus on workplace culture so that we attract and retain the best talent."

Second Quarter Ended June 30, 2024 Business Highlights

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Named to Inc. Magazine’s 2024 Best Workplaces list. The ranking is based on a comprehensive, data- driven measurement process through anonymous employee surveys to identify which American companies have excelled in creating high-engagement workplaces and excellent company cultures.
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Grew Lung Diagnostic test volume to 13,900, a 42% improvement over the second quarter of 2023 and 17% over the first quarter of 2024.
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Quarterly gross profit margin of 78.4% versus 72.7% for the second quarter of 2023 and 78.6% for the first quarter of 2024.
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Presented compelling new data1 at the American Thoracic Society (ATS) Conference, May 2024, that highlighted the Nodify XL2 test and its ability to identify benign nodules in patients with emphysema, demonstrating further test utility in patients with common comorbidities.

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Peer-reviewed data was published in June in the Annals of Oncology2 that highlight the role of Biodesix diagnostic services in monitoring efficacy of new therapeutic regimens.

Second Quarter Ended June 30, 2024 Financial Highlights

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Total revenue of $17.9 million, an increase of 51% over the second quarter 2023. This results in now eight consecutive quarters of over 40% revenue growth and is driven by strong year-over-year growth in both lines of business:
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Lung Diagnostic revenue of $16.5 million reflected a year-over-year increase of 44% driven primarily by the continued adoption of Nodify Lung nodule risk assessment tests;
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Biopharmaceutical Services of $1.4 million increased 228% year-over-year, a result of both delivering against the Company’s book of contracted business and securing new agreements;
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Second quarter 2024 gross profit of $14.0 million, or 78.4% gross margin compared to 72.7% gross margin in the comparable prior year period, primarily driven by growth in Lung Diagnostic testing and optimization of testing workflows that resulted in improvements in costs per test, and increased process efficiencies in the Company’s Biopharmaceutical Services business;
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Operating expenses (excluding direct costs and expenses) of $22.3 million, an increase of approximately $2.7 million, or 14% as compared to the second quarter 2023 (includes $2.7 million of non-cash stock compensation expense, depreciation and amortization, and asset impairment as compared to $1.9 million). This increase is primarily attributable to an increase in sales and marketing costs to support lung diagnostic sales growth to enhance product awareness and drive adoption, an increase in depreciation expense related to the leasehold improvements in the Company’s new Louisville, Colorado offices and laboratory, partially offset by a decrease in research and development and general and administrative costs;
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Net loss of $10.8 million, an improvement of approximately $2.5 million, or 19% as compared to the same period of 2023. Net loss included $0.6 million of one-time cash and non-cash Other Expenses, net primarily related to our probability of not utilizing the Lincoln Park Capital Equity Line of Credit prior to expiration and costs associated with debt-extinguishment;
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Adjusted EBITDA was a loss of $5.6 million, an improvement of $3.5 million, or 38% over the second quarter of 2023 and fifth straight quarter of year-over-year improvement in Adjusted EBITDA;
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Cash and cash equivalents of $42.2 million as of June 30, 2024, an increase of $30.7 million from March 31, 2024;
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Cash and cash equivalents as of June 30, 2024, includes $55.0 million in gross proceeds raised from an oversubscribed and upsized offering of common stock and concurrent private placement completed on April 5, 2024.
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Includes the second quarter scheduled milestone payment of $5.3 million and pre-payment of the third quarter $8.4 million scheduled milestone payment paid in April 2024 for the acquisition of Integrated Diagnostics in 2018. The pre-payment of the third quarter milestone resulted in cash savings from interest that was eliminated by the pre-payment. The Company has one final payment of $6.1 million remaining, which does not accrue interest and is expected to be paid at the end of the third quarter 2024.

2024 Financial Outlook

The Company is increasing its 2024 revenue forecast and now expects to generate between $70 million and $72 million in total revenue in 2024, versus prior guidance of $65 million and $68 million in total revenue in 2024.

Conference call and webcast information

Listeners can register for the webcast via this link. Analysts who wish to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the Company’s investor relations page on the website approximately two hours after the call’s conclusion. Participants are advised to join 15 minutes prior to the start time.

For a full list of Biodesix press releases and webinars, please visit biodesix.com.

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.