On July 12, 2023, Bicycle Therapeutics plc (the "Company") reported to have entered into an underwriting agreement (the "Underwriting Agreement") with Goldman Sachs & Co. LLC, Jefferies LLC and SVB Securities LLC (the "Representatives"), as representatives of the several underwriters named therein (collectively, the "Underwriters"), pursuant to which the Company agreed to issue and sell 9,411,766 American Depositary Shares ("ADSs"), each representing one of the Company’s ordinary shares, nominal value £0.01 per share, and, in lieu of ADSs to investors that so choose, non-voting ordinary shares, nominal value £0.01 per share ("Non-Voting Ordinary Shares"), each at a public offering price of $21.25 per share (the "Offering") (Filing, Bicycle Therapeutics, JUL 12, 2023, View Source [SID1234633217]). The net proceeds to the Company from the Offering are expected to be approximately $187.3 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company also granted the Underwriters an option to purchase 1,411,764 additional ADSs at the public offering price.

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The Offering is being made pursuant to the Company’s automatic shelf registration statement on Form S-3ASR (File No. 333-272248), which became effective upon filing with the Securities and Exchange Commission (the "SEC") on May 26, 2023, a base prospectus dated May 26, 2023 and the related prospectus supplement dated July 12, 2023. The Offering is expected to close on or about July 17, 2023, subject to customary closing conditions.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended (the "Securities Act"), other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement and may be subject to limitations agreed upon by the contracting parties. The Company’s directors and executive officers have agreed, subject to certain exceptions, not to sell or transfer any ordinary shares (including ADSs representing ordinary shares) for 60 days, and the Company has agreed not to sell or transfer any ordinary shares or non-voting ordinary shares (including ADSs representing ordinary shares) for 60 days, in each case, after July 12, 2023, without first obtaining the written consent of the Representatives.

For information on the Non-Voting Ordinary Shares, reference is made to the description of Non-Voting Ordinary Shares, which is filed as Exhibit 4.1 hereto and incorporated by reference herein.

The foregoing description of the terms of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to the Underwriting Agreement, which is filed as Exhibit 1.1 hereto and incorporated by reference herein.

A copy of the opinion of Cooley (UK) LLP relating to the legality of the issuance and sale of ADSs and Non-Voting Ordinary Shares sold in the Offering is attached as Exhibit 5.1 hereto.

On July 12, 2023 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that the prospective, real-world ORACLE study (An Observational Registry Study to Evaluate the Performance of the Nodify XL2 Test [NCT03766958]) achieved the primary endpoint of a statistically significant change in the proportion of benign lung nodules managed by Nodify XL2 experiencing invasive procedures (Press release, Biodesix, JUL 12, 2023, View Source [SID1234633206]). The data was published in PLOS ONE this week.

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Lung nodules are a common clinical finding with the increased use of medical imaging for general diagnostic purposes and the expansion of lung cancer screening eligibility. Lung nodules represent an opportunity for early detection of lung cancer but pose a diagnostic dilemma because up to 95% of lung nodules are benign. In this patient population, high rates of invasive procedures, such as biopsies or surgeries, on benign nodules have been documented in the pursuit of lung cancer diagnosis and an analysis of Medicare claims has showed that greater than 40% of the total cost of lung cancer diagnosis was accounted for by biopsied patients without a lung cancer diagnosis.

In ORACLE, the prospective, real-world clinical utility study, patients with benign nodules managed with the Nodify XL2 test were 74% less likely to undergo an unnecessary invasive procedure compared to the control group. Additionally, the proportion of patients sent to CT surveillance with malignant nodules did not differ between the Nodify XL2 group and the control group.

"The findings from the ORACLE study represent a significant advancement in the clinical evidence for use of the Nodify XL2 test in nodule management," said Scott Hutton, President and CEO of Biodesix. "Clinical utility is an important step to demonstrate that the test is informing diagnostic decision making in a clinical setting. Avoiding diagnostic procedures on benign nodules reserves healthcare resources for patients with a higher risk of lung cancer, avoids unnecessary interventions for patients, and supports increases in early diagnosis and treatment."

On July 12, 2023 Tempus, a leader in artificial intelligence and precision medicine, reported its GEMINI Non-small Cell Lung Cancer (NSCLC) study (NCT05236114) (Press release, Tempus, JUL 12, 2023, View Source [SID1234633205]). The Tempus-sponsored study, being run in collaboration with AstraZeneca, aims to create a robust multi-omic dataset for patients with NSCLC to facilitate future novel research related to precision medicine, diagnostic development, and biomarker discovery.

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The study is open for enrollment for two cohorts of patients, one of which will focus on patients who have been recently diagnosed with Stage IV NSCLC and will receive standard of care checkpoint inhibitor therapy, and the other cohort will focus on patients who have early-stage NSCLC and are candidates for surgery. Tempus is leveraging its comprehensive molecular profiling portfolio – including its solid tumor assay, xT, liquid biopsy, xF, and an investigational minimal residual disease (MRD) assay – throughout the study to better understand this high-need patient population on a longitudinal basis. Patients enrolled in the trial will be studied for up to three years to assess the impact of their underlying tumor biology on disease progression and therapy efficacy. The results of this study will be used for biomarker discovery, including potential use of circulating tumor DNA (ctDNA) testing to measure MRD.

"The GEMINI study addresses research gaps in a high-need patient population that the Tempus platform is uniquely positioned to undertake," said Kate Sasser, PhD, Chief Scientific Officer at Tempus. "By taking a multi-omics approach, we believe that we can generate one of the most comprehensive analyses of early and late stage NSCLC patients, and one that will power significant advancements in biomarker discovery."

The study employs the full power of Tempus’ platform, including its intelligent diagnostics, multimodal data library, and clinical trial matching program (TIME), to develop a powerful multi-omic dataset at scale. In leveraging its TIME Trial Network, Tempus is broadening access to patients in communities across the country, while also helping to ensure that the study’s results are representative of this patient population in the United States.

On July 12, 2023 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as "Dr. Reddy’s"), a global pharmaceutical company, reported that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, JUL 12, 2023, View Source [SID1234633204]). This closely follows acceptance of its rituximab biosimilar dossier for review by two other regulatory agencies – the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).

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In January 2023, Dr. Reddy’s had announced the successful completion of the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, European Union, and other regions. The submission of its dossier in April 2023 was based on a comprehensive data package including robust structural and functional analytical comparison data using multiple orthogonal techniques, pre-clinical, and head-to-head clinical studies that demonstrate similarity in pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity with the EU* and U.S.** reference products.

DRL_RI is being developed as a biosimilar of Rituxan / MabThera (rituximab), a cluster of differentiation 20 (CD20) directed cytolytic antibody. Rituxan / MabThera is approved for various indications including for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.

Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, said: "This milestone underscores our capability for global clinical development of high-quality biosimilar products for highly regulated and global markets. It also reinforces the potential of DRL_RI as a safe and effective treatment option for patients across the globe. Development and commercialisation of biological drugs is an important growth lever for our business. We expect to bring many more biosimilar and other critical biological products to meet patient needs as we work towards our goal of serving over 1.5 billion patients by 2030."

Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets. The company is currently collaborating with its partner Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, to commercialise its proposed biosimilar of rituximab in the United States. The company intends to commercialise the product in Europe and other geographies directly.

About Dr. Reddy’s clinical studies for its proposed biosimilar of rituximab, DRL_RI:

RI-01-003: This study demonstrated pharmacokinetic equivalence and similarity in pharmacodynamics, safety and immunogenicity between DRL_RI and EU reference medicinal product* and U.S. reference product**.
RI-01-006 (FLINTER): This study demonstrated efficacy equivalence and similarity in safety and immunogenicity between DRL_RI and EU reference medicinal product* in patients with Low Tumour Burden Follicular Lymphoma
RI-01-007: This study demonstrated similar safety and immunogenicity profile between the DRL_RI, EU reference medicinal product* and U.S. reference product** groups upon single transition from either of them, in subjects with active rheumatoid arthritis.
*EU reference medicinal product is MabThera
**U.S. reference product is Rituxan
MabThera and Rituxan are registered trademarks of Roche.

On July 12, 2023 Immunovia (Nasdaq Stockholm: IMMNOV), the diagnostics company focused on early detection of pancreatic cancer, reported plans to restructure its operations (Press release, Immunovia, JUL 12, 2023, View Source [SID1234633203]). The company will cease commercialization of its IMMray PanCan-d test in the United States to focus its resources on the further development and clinical testing of the Company’s promising next generation pancreatic cancer detection test.

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The next generation assay currently in development is intended to work equally well across multiple patient risk groups. The new test is expected to provide accurate results in patients who do not produce CA19-9, and to reduce reliance on CA19-9, which have been limitations of IMMray PanCan-d. The next generation test will be performed on a widely used commercial platform, enabling the company to better scale production. Immunovia expects to release further details about the next-generation test later this year, with an anticipated launch date in 2024.

Immunovia’s strategic decision to focus on its next generation assay will result in significant layoffs in both Sweden and the United States in multiple functions. Importantly, the staffing reductions and the elimination of other operating expenses will lower the company’s cash burn rate and extend the Company’s cash reserves well into 2024.

"In the current financial climate, we have decided to focus our resources on our next generation pancreatic cancer detection test," said Jeff Borcherding, Immunovia’s CEO. "We are very excited about the potential of the new test to deliver high accuracy across the full spectrum of high-risk individuals. The test currently in development gives us the best opportunity to demonstrate significant improvements in patient outcomes, which is necessary to secure broader reimbursement of our test. In the U.S., Reimbursement is a fundamental driver of value for Immunovia and is foundational for securing the long-term success of the company."

The company will host a conference call to elaborate on the planned changes and answer questions on the changes on Wednesday, July 12, 2023 at 15:00 CET. Log-in details will be available at Immunovia.com prior to the call.