On November 13, 2024 Aurealis Therapeutics, a synthetic biology company developing multi-targeting, scalable, low cost of goods cell and gene therapies for high unmet medical needs, reported that it has raised CHF 8 million from existing investors and shareholders (Press release, Aurealis Therapeutics, NOV 13, 2024, View Source [SID1234648194]).

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The funds will be primarily used to complete Phase 2 clinical studies with Aurealis lead product AUP-16 for Chronic Wounds, such as Diabetic Foot Ulcer (DFU), and accelerate the preclinical and CMC development of the lead candidate AUP-55 for cancers such as ovarian cancer, other peritoneal carcinomatosis and bladder cancer.

Chronic Wounds, deadly cancers, and inflammatory conditions are complex, multi-factorial diseases which represent massive unmet medical needs and require multi-targeting to be cured. Aurealis Therapeutics is committed to developing multi-targeting therapies based on its unique, proprietary platform. Aurealis platform consists of live, biosafety level 1 lactic acid bacteria, genetically modified to synthesize multiple human therapeutic proteins, acting as millions of nanoscale drug bioreactors in the human body, directly at the disease site. The company’s ambition is to create solid clinical and health economic data in Chronic Wounds, deadly cancers and beyond. This, while engaging with strategic partners to enable market entry and ensure this game-changing technology platform will benefit millions of patients throughout the world.

"We are excited to announce this successful funding round and want to express our gratitude for the trust and support that we have received from the investors. We have exciting times ahead as our Phase 2 study in Diabetic Foot Ulcer is close to completion, and our oncology program is moving towards the clinic" said Juha Yrjänheikki, CEO of Aurealis Therapeutics.

"We have successfully developed our platform and key assets AUP-16 for Chronic Wounds and AUP-55 for Cancer. Positive clinical data, existing and new partnerships, and growing investor base and interest at the market makes us highly confident about completing our next CHF 35M equity round and creating substantial value to all stakeholders" continued Laurent Décory, COO of Aurealis Therapeutics.

On November 12, 2024 GenScript reported its financial results for the third quarter 2024 (Press release, GenScript, NOV 12, 2024, View Source [SID1234652217]).

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On November 12, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported third quarter financial results and operational highlights (Press release, Oncolytics Biotech, NOV 12, 2024, View Source [SID1234649454]).

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Wayne Pisano, Chair of Oncolytics’ Board of Directors and Interim CEO, stated, "With positive BRACELET-1 results, we have two randomized phase two studies confirming pelareorep’s potential in HR+/HER2- metastatic breast cancer. After discussions with regulators and key opinion leaders and based on an estimated overall survival benefit of more than a year provided by pelareorep-based therapy, a registration-enabling study that is designed to support an accelerated approval is the next logical step for the development of pelareorep." Pisano continued, "We continue to develop our gastrointestinal cancer program and look forward to presenting updated efficacy data from our anal cancer cohort and safety data from our new modified FOLFIRNOX pancreatic cancer cohort. Both of these indications represent a significant unmet medical need, and we have shown pelareorep provides the potential to meaningfully improve patient outcomes. This coming year will be critical for pelareorep, as well as for Oncolytics, and I’ve never been more confident in the potential pelareorep can deliver to cancer patients in need."

Third Quarter Highlights

BRACELET-1 data exceeds expectations, providing clear evidence of pelareorep’s ability to improve outcomes in patients with advanced HR+/HER2- breast cancer (link to press release), demonstrating progression-free survival of 12.1 months for pelareorep + paclitaxel compared to 6.4 months for paclitaxel alone, yielding a benefit of 5.7 months. Additionally, 64% of patients treated with pelareorep + paclitaxel lived at least two years compared to only 33% of patients treated with paclitaxel alone. Overall survival could not be calculated as more than half of the pelareorep + paclitaxel patients were alive at the end of the study. Assuming the remaining patients survived only until their next planned follow-up visit, the median overall survival would have been 32.1 months, which compares favorably to the 18.2 months recorded for patients who received paclitaxel monotherapy.

Financial Highlights

As of September 30, 2024, the Company reported $19.6 million in cash and cash equivalents. The Company has a projected cash runway through key milestones and into 2025.
The net loss for the third quarter of 2024 was $9.5 million, compared to a net loss of $9.9 million for the third quarter of 2023. The basic and diluted loss per share was $0.12 in the third quarter of 2024, compared to a basic and diluted loss per share of $0.14 in the third quarter of 2023.
Research and development expenses for the third quarter of 2024 were $6.8 million, compared to $5.8 million for the third quarter of 2023. The increase was primarily due to higher manufacturing expenses and clinical trial expenses.
General and administrative expenses for the third quarter of 2024 were $3.1 million, compared with $5.2 million for the third quarter of 2023. The decrease was primarily due to lower investor relations activities and transaction costs as part of our public offering in 2023.
Net cash used in operating activities for the nine months ended September 30, 2024 was $19.1 million, compared to $22.3 million for the nine months ended September 30, 2023. The decrease reflected non-cash working capital changes, partly offset by higher net operating activities in 2024.
Recent and Anticipated Milestones

H1 2025: Finalize master protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line pancreatic ductal adenocarcinoma (PDAC) with the Global Coalition for Adaptive Research (GCAR) and submit it to the FDA
H1 2025: Safety run-in data from cohort 5 of the GOBLET study, investigating pelareorep and modified FOLFIRNOX (mFOLFIRINOX) with or without atezolizumab in newly diagnosed pancreatic cancer
H1 2025: updated efficacy data from cohort 4 of the GOBLET study, investigating pelareorep and atezolizumab in second-line or later anal cancer
Mid 2025: First patient enrolled in registration-enabling study evaluating pelareorep and paclitaxel in metastatic HR+/HER2- breast cancer
H2 2025: Initial efficacy results from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancer

On November 12, 2024 Bayer reported Quarterly Statement Third Quarter of 2024 (Presentation, Bayer, NOV 12, 2024, View Source [SID1234648968]).

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On November 12, 2024 Crescent Biopharma, Inc. ("Crescent"), a private biotechnology company dedicated to advancing novel precision engineered molecules targeting validated biology to advance care for patients with solid tumors, reported management will present at the JeCeries London Healthcare Conference on November 19, 2024, at 12:30 pm GMT/7:30 am EDT (Press release, Crescent Biopharma, NOV 12, 2024, View Source [SID1234648709]).

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A live webcast of the presentation will be available at wsw.com/webcast/jeC315/cresc/1987776. An archived recording will be available for 90 days following the event.

In late October, Crescent entered into an acquisition agreement with Rockville, Marylandbased GlycoMimetics, Inc. (NASDAQ: GLYC). Following closing, the combined company will operate under the name Crescent and advance its portfolio of precision-engineered biologics to improve outcomes for patients with solid tumors.