BridgeBio Pharma to Participate in the Morgan Stanley 21st Annual Global Healthcare Conference

On September 7, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that members of its management team will present at the Morgan Stanley 21st Annual Global Healthcare Conference in New York, NY on Tuesday, September 12 at 10:50 am ET (Press release, BridgeBio, SEP 7, 2023, View Source [SID1234634984]).

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To access the live webcast of BridgeBio’s presentation, please visit the "Events & Presentations" page within the Investors section of the BridgeBio website at View Source A replay of the webcast will be available on the BridgeBio website for 90 days following the event.

Biodesix Announces Two Presentations on Lung Cancer Treatment Guidance Tests at the IASLC 2023 World Lung Conference on Lung Cancer

On September 7, 2023 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that two abstracts will be presented at the International Association for the Study of Lung Cancer (IASLC) 2023 World Lung Conference on Lung Cancer (WCLC) (Press release, Biodesix, SEP 7, 2023, View Source [SID1234634983]). The first presentation showcases a new analysis of the large multi-center observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat Testing and Validation of Immunotherapy Tests in NSCLC Subjects, NCT03289780) demonstrating the ability of the VeriStrat host immune classifier to predict response to immune checkpoint inhibitor (ICI) regimens in patients with advanced stage non-small cell lung cancer (NSCLC).

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The INSIGHT trial, which recently reached its enrollment goal of 5,000 patients with NSCLC, previously yielded data showing that patients with ≥50% PD-L1 status classified as Host Immune Classifier Cold (HIC-C), also known as VeriStrat Poor, had superior median overall survival when receiving ICI plus chemotherapy versus ICI alone. The expanded analysis confirms these findings and concludes that patients with <50% PD-L1 status classified as Host Immune Classifier Hot (HIC-H), also known as VeriStrat Good, had comparable overall survival when receiving either ICI alone or in combination with chemotherapy.

"These findings highlight the importance of characterizing a patient’s immune response to lung cancer to guide immunotherapy treatment decisions," said Wallace Akerley, MD, principal investigator of the INSIGHT study. "The growing body of evidence shows the VeriStrat test is complementary to current standard of care and its use would improve overall patient outcomes by identifying subsets of patients who would benefit from Veristrat-directed selection of immunotherapy regimen."

The second presentation details the performance of a pre-surgical, blood-based Risk of Recurrence test in three independent cohorts. Patients with early stage lung cancer have favorable outcomes, but many of these patients experience a recurrence which results in a poor prognosis. The test was designed to identify patients with a high probability of recurrence that could be considered for more aggressive treatment or enhanced surveillance. This initial validation study evaluated nearly 800 patients with Stage I NSCLC and demonstrated the test’s ability to stratify three distinct groups of patients based on their proteomic profile with high, intermediate, or low risk of recurrence. Furthermore, incorporating the adenocarcinoma grade, a conventional risk factor for recurrence, improved the performance of the test.

"It is crucial to be able to determine which 10-15% of early stage lung cancer patients will recur within 3-5 years after their tumor is completely removed by surgery, and we are encouraged that our model, especially when incorporating the IASLC Histologic Grading System, may lead to more accuracy in this regard," said Harvey Pass, MD lead author of the abstract. "Nevertheless, this work requires further external validation with other cohorts of Stage I lung cancer patients before it could be used clinically to determine who needs appropriate adjuvant therapy."

Following are details about the presentations at the 2023 WCLC:

Title (P2.07-06): Real World Efficacy of First-Line Immunotherapy +/- Chemotherapy in Advanced NSCLC Stratified by Serum Proteomics

Presenter: Wallace Akerley, MD, Director of Lung Cancer Disease Center of Excellence at Huntsman Cancer Institute, University of Utah

Session P2.07: Metastatic Non-small Cell Lung Cancer – Immunotherapy – Retrospective

Date & Time: Monday, Sept. 11, 2023, 18:00 – 20:00 (SGT)

Location: Exhibit Hall, Level 4 (Row 10)

Title (P1.25-13): Enhanced Assessment of Recurrence Risk of Stage I NSCLC by Combined Adenocarcinoma Grading System and Serum Proteomic Testing

Presenter: Harvey Pass, MD, Vice Chair, Research for Cardiothoracic Surgery at NYU Langone Health, and executive committee member for the NYU Lung Cancer Center of the Perlmutter Cancer Institute Session P1.25: Early-Stage Non-small Cell Lung Cancer – Pushing the Boundaries: Changing Paradigms and Outcomes

Date & Time: Sunday, Sept. 10, 2023, 17:30 – 19:30 (SGT)

Location: Exhibit Hall, Level 4 (Row 32)

Avid Bioservices Reports Financial Results for First Quarter Ended July 31, 2023

On September 7, 2023 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the first quarter ended July 31, 2023 (Press release, Avid Bioservices, SEP 7, 2023, View Source [SID1234634982]).

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Highlights from the Quarter Ended July 31, 2023, and Other Events:

"The first quarter was a continuation of the trajectory established during fiscal 2023. During the period, we continued to successfully navigate what has been a challenging financing environment for our customers, as our revenues and backlog remained strong, and our commercial team continued to win new projects. Fortunately, Avid has continued to attract and sign later clinical stage and commercial business during the period, which has the potential to add significant upside in the medium to longer term," stated Nick Green, president and CEO of Avid Bioservices.

"On the operational front, our recent mammalian capacity expansions are now online, and we are pleased with the market interest in our new capabilities and capacity, and the impact this is also having on our later-stage project portfolio. In addition, we continue to make progress with the buildout of our cell and gene therapy facility. We remain on track to bring this new capability online by the end of the third quarter of calendar 2023, at which time our state-of-the-art facilities will have a revenue-generating capacity of up to $400 million annually."

Financial Highlights and Guidance

The company is reiterating revenue guidance for full fiscal year 2024 of between $145 million and $165 million.

Revenues for the first quarter of fiscal 2024 were $37.7 million, representing a 3% increase over revenues of $36.7 million recorded in the prior year period. The increase was primarily attributed to an increase in manufacturing revenues from late-stage programs.

As of July 31, 2023, the company’s revenue backlog was $189 million, representing an increase of 20% compared to $157 million at the end of the same quarter last year. The company expects a growing portion of its backlog will extend beyond a year.

Gross profit for the first quarter of fiscal 2024 was $4.1 million (11% gross margin), compared to a gross profit of $9.1 million (25% gross margin) for the first quarter of fiscal 2023. The decrease in gross margin during the three months ended July 31, 2023, as compared to the prior year period was primarily driven by costs related to ongoing expansions of both the company’s capacity and technological capabilities. This included adding staff and associated overhead, including depreciation expense, that will provide critical capacity for near and medium-term growth. Margins during the current quarter were also impacted by a terminated project relating to the insolvency of one of the company’s smaller customers and a delay in the company’s ability to recognize the revenues of one product pending the implementation of a process change.

Selling, general and administrative expenses for the first quarter of fiscal 2024 were $6.3 million, largely consistent with $6.4 million recorded for the first quarter of fiscal 2023.

During the first quarter of fiscal 2024, the company recorded a net loss of approximately $2.1 million or $0.03 per basic and diluted share, as compared to net income of $1.6 million or $0.03 per basic and $0.02 per diluted share for the first quarter of fiscal 2023.

Avid reported $24.9 million in cash and cash equivalents as of July 31, 2023, compared to $38.5 million as of April 30, 2023.
More detailed financial information and analysis may be found in Avid Bioservices’ Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Recent Corporate Developments

The company’s commercial team signed multiple new orders during the first quarter of fiscal 2024, totaling approximately $36 million net. These orders span from process development to commercial manufacturing.

The company remains on track to launch its cell and gene therapy CGMP manufacturing suites by the end of the third quarter of calendar 2023.
Statement Regarding Use of Non-GAAP Financial Measures

The company uses certain non-GAAP financial measures such as non-GAAP adjusted net income, free cash flow, as well as adjusted EBITDA. The company uses these non-GAAP financial measures for financial and operational decision making and as a means to evaluate period-to-period comparisons. The company believes that they provide useful information about operating results, enhance the overall understanding of its operating performance and future prospects, and allow for greater transparency with respect to key metrics used by management in its financial and operational decision making. These non-GAAP financial measures exclude amounts that the company does not consider part of ongoing operating results when planning and forecasting and when assessing the performance of the organization and its senior management. The company computes non-GAAP financial measures primarily using the same consistent method from quarter to quarter and year to year, and may consider whether other significant items that arise in the future should be excluded from its non-GAAP financial measures.

The company reports non-GAAP financial measures in addition to, and not as a substitute for, or superior to, measures of financial performance prepared in accordance with U.S. generally accepted accounting principles (GAAP). These non-GAAP financial measures are not based on any comprehensive set of accounting rules or principles, differ from GAAP measures with the same names, and may differ from non-GAAP financial measures with the same or similar names that are used by other companies. The company believes that non-GAAP financial measures should only be used to evaluate its results of operations in conjunction with the corresponding GAAP financial measures and encourages investors to carefully consider its results under GAAP, as well as the supplemental non-GAAP information and the reconciliations between these presentations, to more fully understand its business.

Non-GAAP net income (loss) excludes stock-based compensation; business transition and related costs including corporate initiatives into new business activities such as severance and related expenses; non-cash interest expense on debt; and other income or expense items and is adjusted for income taxes. Adjusted EBITDA excludes non-cash operating charges for stock-based compensation, depreciation, and amortization as well as non-operating items such as interest income, interest expense, and income tax expense or benefit and is adjusted for income taxes. For the reasons explained above, adjusted EBITDA also excludes certain business transition and related costs. The company also uses measures such as free cash flow, which represents cash flow provided by or (used in) operations less cash used in the acquisition and disposition of capital.

Additionally, non-GAAP net income (loss) and adjusted EBITDA are key components of the financial metrics utilized by the company’s compensation committee to measure, in part, management’s performance and determine significant elements of management’s compensation. The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP financial measures are included at the end of this press release.

Webcast

Avid will host a webcast this afternoon, September 7, 2023, at 4:30 PM EDT (1:30 PM PDT).

To listen to the live webcast, or access the archived webcast, please visit: View Source

Ariceum Therapeutics doses first patient with its first-in-class targeted radiopharmaceutical drug satoreotide in its Phase Ib study in small cell lung cancer

On September 7, 2023 Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, reported that the first patient has been dosed with its first-in-class lead molecule, satoreotide, targeting extensive stage small cell lung cancer (ES-SCLC), at the Murdoch University Health Center in Perth, Australia (Press release, Ariceum Therapeutics, SEP 7, 2023, View Source [SID1234634981]).

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Ariceum has successfully initiated its multicentre, open label Phase Ib study which will investigate the safety and tolerability of the ‘theranostic pair’ of somatostatin receptor antagonist 68Ga-Satoreotide Trizoxetan (SSO120) and 177Lu-satoreotide tetraxetan (SSO110) in patients with ES-SCLC. The main objective of the study is to establish a recommended Phase 2 dose and schedule.

‘Theranostics’ is the approach of using two paired drugs – the first, a diagnostic agent to identify cells which exhibit a particular biomarker; and the second, a therapeutic drug, to act on those cells. Both the diagnostic agent and therapeutic drug contain Ariceum’s proprietary peptide satoreotide, a first-in-class and best-in-class antagonist of the somatostatin receptor 2 (SST2), a cell surface protein often overexpressed in certain cancers including small cell lung cancer (SCLC).

The study, entitled LuSato-1 study, includes patients with ES-SCLC who will each receive an infusion containing the diagnostic imaging agent, somatostatin receptor antagonist before undergoing a positron emission tomography (PET) scan. This will determine if a patient’s tumours express the SST2. Patients identified with confirmed SST2 expression will receive escalating doses of satoreotide, in addition to the immunotherapy atezolizumab, a PD-L1 checkpoint inhibitor, during the maintenance phase of their treatment until a recommended phase 2 dose can be defined. Additional patients may be enrolled in an expansion cohort. Further details on the study can be found on Australian Clinical Trials, under identifier Ariceum SSO11O-01.

Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: "The initiation of this Phase Ib study is an important milestone reached by the Company in close collaboration with our partners in Australia and Europe. We believe that our lead targeted systemic radiopharmaceutical product satoreotide has the potential to demonstrate positive results in patients with extensive stage small cell lung cancer. Theranostics holds great hope as a highly targeted form of cancer therapy, using a ‘search and destroy’ approach to seek out tumours while sparing healthy tissue."

Germo Gericke, Chief Medical Officer of Ariceum Therapeutics, said: "Although immune checkpoint blockade has improved the treatment of ES-SCLC, disease recurrence often occurs early in the maintenance phase. Adding targeted radiotherapy with satoreotide to immune checkpoint blockade in the maintenance setting holds the promise to improve the therapeutic effect of the maintenance therapy."

An Abstract on the LuSato-1 study will be presented at the European Association of Nuclear Medicine Congress2023 (EANM 2023) in Vienna, Austria, on 10th September 2023. Presentation details below.

Abstract OP-230
Top Rated Oral Presentations (TROP) Session: Oncology & Theranostics Committee
Session: 606 – Neuroendocrine Tumours Treatment
Abstract title: A phase I theranostic study evaluating the safety and tolerability of 177Lu-satoreotide tetraxetan with 68Ga-satoreotide trizoxetan companion imaging in participants with extensive-stage small-cell lung cancer (ES-SCLC) on atezolizumab maintenance therapy
Authors: L. Emmett, J. Cardaci, K. O’Byrne, S. Arulananda, A. Prawira, B. Pais, M. Crumbaker, N. Lenzo
Date & Time: 10 September, 4:45-6:15pm CEST

Ariceum Therapeutics doses first patient with its first-in-class targeted radiopharmaceutical drug satoreotide in its Phase Ib study in small cell lung cancer

On September 7, 2023 Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, reported that the first patient has been dosed with its first-in-class lead molecule, satoreotide, targeting extensive stage small cell lung cancer (ES-SCLC), at the Murdoch University Health Center in Perth, Australia (Press release, Ariceum Therapeutics, SEP 7, 2023, View Source [SID1234634981]).

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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

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Ariceum has successfully initiated its multicentre, open label Phase Ib study which will investigate the safety and tolerability of the ‘theranostic pair’ of somatostatin receptor antagonist 68Ga-Satoreotide Trizoxetan (SSO120) and 177Lu-satoreotide tetraxetan (SSO110) in patients with ES-SCLC. The main objective of the study is to establish a recommended Phase 2 dose and schedule.

‘Theranostics’ is the approach of using two paired drugs – the first, a diagnostic agent to identify cells which exhibit a particular biomarker; and the second, a therapeutic drug, to act on those cells. Both the diagnostic agent and therapeutic drug contain Ariceum’s proprietary peptide satoreotide, a first-in-class and best-in-class antagonist of the somatostatin receptor 2 (SST2), a cell surface protein often overexpressed in certain cancers including small cell lung cancer (SCLC).

The study, entitled LuSato-1 study, includes patients with ES-SCLC who will each receive an infusion containing the diagnostic imaging agent, somatostatin receptor antagonist before undergoing a positron emission tomography (PET) scan. This will determine if a patient’s tumours express the SST2. Patients identified with confirmed SST2 expression will receive escalating doses of satoreotide, in addition to the immunotherapy atezolizumab, a PD-L1 checkpoint inhibitor, during the maintenance phase of their treatment until a recommended phase 2 dose can be defined. Additional patients may be enrolled in an expansion cohort. Further details on the study can be found on Australian Clinical Trials, under identifier Ariceum SSO11O-01.

Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: "The initiation of this Phase Ib study is an important milestone reached by the Company in close collaboration with our partners in Australia and Europe. We believe that our lead targeted systemic radiopharmaceutical product satoreotide has the potential to demonstrate positive results in patients with extensive stage small cell lung cancer. Theranostics holds great hope as a highly targeted form of cancer therapy, using a ‘search and destroy’ approach to seek out tumours while sparing healthy tissue."

Germo Gericke, Chief Medical Officer of Ariceum Therapeutics, said: "Although immune checkpoint blockade has improved the treatment of ES-SCLC, disease recurrence often occurs early in the maintenance phase. Adding targeted radiotherapy with satoreotide to immune checkpoint blockade in the maintenance setting holds the promise to improve the therapeutic effect of the maintenance therapy."

An Abstract on the LuSato-1 study will be presented at the European Association of Nuclear Medicine Congress2023 (EANM 2023) in Vienna, Austria, on 10th September 2023. Presentation details below.

Abstract OP-230
Top Rated Oral Presentations (TROP) Session: Oncology & Theranostics Committee
Session: 606 – Neuroendocrine Tumours Treatment
Abstract title: A phase I theranostic study evaluating the safety and tolerability of 177Lu-satoreotide tetraxetan with 68Ga-satoreotide trizoxetan companion imaging in participants with extensive-stage small-cell lung cancer (ES-SCLC) on atezolizumab maintenance therapy
Authors: L. Emmett, J. Cardaci, K. O’Byrne, S. Arulananda, A. Prawira, B. Pais, M. Crumbaker, N. Lenzo
Date & Time: 10 September, 4:45-6:15pm CEST