On August 9, 2024 Oncolys BioPharma reported non-consolidated Financial Results for the Six Months Ended June 30, 2024 (Press release, Oncolys BioPharma, AUG 9, 2024, View Source [SID1234646913]).

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On August 9, 2024 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended June 30, 2024 (Press release, Soligenix, AUG 9, 2024, View Source [SID1234645693]).

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"This is a pivotal time for Soligenix with a great deal of clinical activity and upcoming milestones," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "While we prepare for the upcoming initiation of our confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients with early-stage disease, we are incredibly encouraged by the recent positive clinical results from our comparability study evaluating HyBryte against Valchlor (mechlorethamine gel), which demonstrated a three-fold higher response rate over a 12-week treatment period and more favorable safety profile for HyBryte in the treatment of CTCL. These findings, coupled with the promising interim data from the ongoing open-label, investigator-initiated study evaluating extended HyBryte treatment, reinforce our excitement about the future of HyBryte as a potential front-line treatment option for patients with early-stage CTCL. Additionally, we will be initiating a Phase 2 study with SGX945 (dusquetide) in Behçet’s disease later this year with top-line results expected in the first half of 2025, along with top-line results expected during the same timeframe from our ongoing SGX302 (synthetic hypericin) Phase 2 study in mild-to-moderate psoriasis."

Dr. Schaber continued, "With approximately $9.1 million in cash at June 30, 2024, exclusive of the approximately $4.1 million in net proceeds from recent warrant exercises, we continue to prioritize resource allocation to achieve our goals. We have a clear vision for the future, and we are actively pursuing strategies to create long-term value for our shareholders, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

On July 24, 2024, the Company received a letter from Nasdaq confirming that the Company had regained compliance with the Minimum Bid Price Rule. Accordingly, the Nasdaq Hearings Panel determined to continue the listing of the Company’s common stock and closed the matter.
On July 9, 2024, the Company announced an interim update on the open-label, investigator-initiated study evaluating extended HyBryte treatment for up to 12 months in patients with early-stage CTCL. To view this press release, please click here.
On June 25, 2024, the Company announced positive clinical results from a comparability study evaluating HyBryte versus Valchlor in the treatment of CTCL. To view this press release, please click here.
On May 16, 2024, the Company announced the publication of results of its compatibility study evaluating HyBryte for the treatment of CTCL in the Journal of the European Academy of Dermatology & Venereology (JEADV) Clinical Practice. To view the publication, please click here. To view this press release, please click here.
Financial Results – Quarter Ended June 30, 2024

Soligenix’s revenues for the quarter ended June 30, 2024 were less than $0.1 million as compared to $0.2 million for the quarter ended June 30, 2023. Revenues primarily relate to government contracts and grants awarded in support of SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases; development of CiVax, our vaccine candidate for the prevention of COVID-19, and evaluation of HyBryte for expanded treatment in patients with early-stage CTCL.

Soligenix’s net loss was $1.6 million, or ($1.31) per share, for the quarter ended June 30, 2024, as compared to $1.6 million, or ($3.56) per share, for the quarter ended June 30, 2023. The increase in net loss was primarily due to decreases in gross profit and tax credits as well as an increase in operating expenses, offset by increases in interest income and changes in the fair value of debt during the three months ended June 30, 2024.

Research and development expenses were $0.5 million as compared to $0.8 million for the quarters ended June 30, 2024 and 2023, respectively. The decrease was primarily due to adjustment of estimated accruals for completed clinical trials offset by preliminary costs associated with the anticipated initiation of our Phase 2 study in Behçet’s Disease and the second Phase 3 CTCL trial.

General and administrative expenses were $1.2 million and $0.9 million for the quarters ended June 30, 2024 and 2023, respectively. The increase in general and administrative expenses for the three months ended June 30, 2024 was primarily attributable to an increase in legal and professional fees associated with the 2024 annual meeting of stockholders, the April 2024 public offering and the June 2024 reverse stock split of our issued and outstanding shares of common stock.

As of June 30, 2024, the Company’s cash position, exclusive of the approximately $4.1 million in net proceeds from recent warrant exercises, was approximately $9.1 million.

On August 9, 2024 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the quarter ended June 30, 2024, and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, AUG 9, 2024, View Source [SID1234645694]).

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"While we faced challenges this quarter with regards to the ongoing partial clinical hold on azenosertib, we remain steadfast in our confidence in the program’s therapeutic potential and in our commitment to bringing this investigational medicine to patients with gynecological malignancies," said Kimberly Blackwell, M.D., Chief Executive Officer. "We continue to engage with regulators to resolve the hold and advance our clinical development efforts, which have already made important progress this year. Notably, we announced this quarter that we look forward to sharing the results of Cohort 1b of our DENALI study, a study that enrolled heavily pretreated platinum resistant ovarian cancer patients. We are grateful to our study investigators who continue to believe in the potential of azenosertib, to our employees who are laser-focused on our goal of making azenosertib available to patients, and most importantly, our clinical study participants and their families for their support."

Program Updates
•Azenosertib development update. On June 18, 2024, Zentalis disclosed that the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on certain clinical studies of azenosertib. The action followed two recent deaths in the DENALI study. Zentalis will provide additional updates to the azenosertib clinical development and certain data timelines following resolution of the partial clinical hold.
•Phase 1 azenosertib clinical data in osteosarcoma presented at ASCO (Free ASCO Whitepaper). In accordance with the Company’s guidance, Phase 1 results of azenosertib in combination with gemcitabine in adult and pediatric patients with relapsed or refractory (R/R) osteosarcoma were presented in a poster session at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
•Acute myeloid leukemia (AML) program update. Today, Zentalis is disclosing that it is no longer developing the combination of its BCL-2 inhibitor, ZN-d5, with azenosertib, and is discontinuing development of ZN-d5. The combination of ZN-d5 and azenosertib was studied in 27 patients with R/R AML in a Phase 1 study. Thirteen patients were evaluable for efficacy, and the other 14 patients experienced progressive disease prior to efficacy evaluation or withdrew. The combination demonstrated clinical activity in patients who had been previously treated with venetoclax. Of the 6 patients who completed at least two cycles of therapy and underwent a cycle 3, day 1 bone marrow (BM) aspirate: 1 achieved a complete remission with incomplete hematologic recovery (CRi) and became transplant eligible, 2 patients had decreased BM blast counts, 2 had stable BM blasts, and 1 patient had increased BM blasts. The safety profile was manageable and in-line with other combinations in the R/R AML disease setting.

Corporate Updates
•Today, Zentalis is disclosing that effective August 8, 2024, Diana Hausman, M.D., has stepped down and is no longer serving as the Company’s Chief Medical Officer. The Company is conducting a search for a new Chief Medical Officer. Dr. Blackwell will serve as the Company’s Interim Chief Medical Officer.
•On May 29, 2024, Zentalis announced the appointment of Luke Walker, M.D., to its Board of Directors. Dr. Walker is the Chief Medical Officer of Harpoon Therapeutics, a subsidiary of Merck & Co., Inc., Rahway, NJ, and brings nearly three decades of experience as a practicing oncologist and drug developer advancing new cancer therapies.

Anticipated Upcoming Milestones
•2H 2024
◦Topline results from Cohort 1b of the Phase 2 DENALI study (ZN-c3-005) of azenosertib monotherapy in platinum resistant high-grade serous ovarian cancer
◦Presentation of final results of Phase 1b (ZN-c3-001) azenosertib monotherapy trial in solid tumors
◦Topline data from Phase 1/2 MAMMOTH (ZN-c3-006) azenosertib + PARP inhibitor (niraparib) and azenosertib monotherapy trial in platinum resistant ovarian cancer in partnership with GSK
◦Presentation of initial data from Phase 1 (ZN-c3-016) azenosertib + BEACON regimen (encorafenib + cetuximab) trial in BRAF mutant metastatic colorectal cancer in partnership with Pfizer
◦Additional updates to the azenosertib clinical development and other data timelines to be provided following resolution of the partial clinical hold.

Second Quarter 2024 Financial Results
•Cash, Cash Equivalents and Marketable Securities Position: As of June 30, 2024, Zentalis had cash, cash equivalents and marketable securities of $426.4 million, which includes $27.8 million representing the June 30, 2024 fair value of Immunome common stock received by the Company as part of its upfront payment for the out-licensing of its ROR1 antibody-drug conjugate (ADC) product candidate and ADC platform in January 2024. The Company believes that its existing cash, cash equivalents and marketable securities (excluding the Immunome stock) as of June 30, 2024 will be sufficient to fund its operating expenses and capital expenditure requirements into mid-2026.

•Research and Development Expenses: Research and development (R&D) expenses for the three months ended June 30, 2024, were $48.4 million, compared to $42.7 million for the three months ended June 30, 2023. The increase of $5.7 million was primarily due to increases of $7.4 million for clinical and certain translational expenses and $1.0 million for drug manufacturing and supplies costs. The Company also saw increases of $1.4 million resulting from no R&D cost sharing arrangement with Zentera. These increases were partially offset by a decrease of $2.7 million of personnel expense of which $1.5 million is related to non-cash stock-based compensation and $1.4 million of facilities and allocated expenses.

•General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2024, were $16.8 million, compared to $15.7 million during the three months ended June 30, 2023. This increase of $1.1 million was primarily attributable to an increase in personnel expenses of $1.3 million and lease termination costs of $0.5 million. This was partially offset by a decrease of other expenses of $0.7 million, net.

About Azenosertib

Azenosertib is a novel, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated as a monotherapy and combination clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

On August 9, 2024 Invenio Imaging, a leader in intraoperative fresh tissue imaging and artificial intelligence (AI), reported the enrollment of the first patients in a US pivotal study of its AI-based image analysis module for lung cancer (Press release, Invenio, AUG 9, 2024, View Source [SID1234645695]). The ON-SITE study, a multicenter study in bronchoscopy combining Stimulated Raman Histology with Artificial Intelligence for rapid lung cancer detection, is in collaboration with Johnson & Johnson Enterprise Innovation Inc. and will be conducted at multiple centers including The University of Texas MD Anderson Cancer Center, Corewell Health, Memorial Sloan Kettering Cancer Center, and University of North Carolina at Chapel Hill.

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Lung cancer is the leading cause of cancer-related deaths in the United States. This has led to the institution of large-scale screening programs for high-risk patients, which results in an estimated 3.1 million new primary lung nodules identified each year. Despite major sector investment in minimally-invasive biopsy technology, obtaining adequate tissue for biomarker and treatment determination remains a challenge. For this reason, bronchoscopy guidelines recommend rapid-on-site tissue evaluation (ROSE) for lung biopsies.

"ROSE requires that a cytologist or highly trained cytotechnician be physically present in the procedure room, and thus it is not available at many centers performing lung biopsy due to resource limitations," said Jason Akulian, MD, Director of Interventional Pulmonlogy at UNC, "we are excited by the NIO’s potential to extend the benefits of ROSE to the proceduralist when the service is not available."

The NIO Laser Imaging System allows rapid imaging of fresh tissue biopsies in the treatment room. Sample preparation does not require staining or sectioning and can be performed by the existing OR-staff. NIO Slides are also designed to allow retrieval of the sample for downstream analysis. NIO images are natively digital and can be shared in near real-time. The ON-SITE study aims to develop and validate an AI-based image analysis module for the NIO Laser Imaging System that is intended to assist physicians in the detection of cancer in bronchoscopic lung biopsies in situations where ROSE is not available for the sample type.

"Artificial intelligence aiding healthcare may seem utopic, but the future is coming. While still investigational, the promise of fast, in-room, accurate identification of tissue that is suspicious for cancer has the potential to ultimately lead to improved outcomes, a beneficial cost/benefit profile, and personalized treatments," said Gustavo Cumbo-Nacheli, MD, pulmonologist at Corewell Health and one of the site PIs for the ON-SITE study.

"Enrolling the first patient in the ON-SITE study is an important milestone for Invenio, as we aim to develop the first FDA-cleared AI to identify cell/tissue morphology suspicious for cancer in lung biopsies," said Jay Trautman, PhD, co-founder and CEO of Invenio Imaging. "Near real-time image analysis on the NIO Laser Imaging System completes the end-to-end solution for streamlined intraoperative histology."

On August 9, 2024 GenScript Biotech Corporation, a leading global technology and service provider of life science R&D and manufacture, reported its first half 2024 financial results for the six months ended June 30, showcasing impressive revenue growth, significant improvements in gross profit, and strategic advances across its business segments (Press release, GenScript, AUG 9, 2024, https://www.genscript.com/genscript-biotech-reports-first-half-2024-results.html [SID1234647130]). GenScript is also deepening its commitment to environmental, social, and governance (ESG) practices, marking a significant step towards sustainable development.

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Sherry Shao, GenScript’s rotating CEO, said, "In the first half of 2024, the Group showcased strong market adaptability and growth potential. With a diversified business strategy, exceptional innovation, and efficient operations, GenScript not only maintained solid profitability in the life sciences sector but also saw promising growth in cell therapy product sales. Our subsidiary, Bestzyme, has also outperformed the industry, thanks to years of hard work from the team. While the CDMO sector has been under pressure due to current investment challenges, we’re starting to see signs of recovery. We’re ready to accelerate our business in the second half of the year. GenScript will continue to strengthen its core competencies across all business lines and foster synergies across divisions to achieve shared growth with our global partners."

Strong Financial Performance
During the Reporting Period, GenScript generated revenue of approximately US$561.4 million, reflecting a robust 43.5% increase from US$391.3 million in the Prior Period. This growth was largely driven by the cell therapy segment, which saw a remarkable 156% increase, reaching approximately US$280.3 million compared to US$109.5 million previously. On the other hand, revenue from the non-cell therapy business was around US$281.1 million.

Gross profit surged to approximately US$307 million, a 75.4% increase from US$175 million in the Prior Period. The cell therapy segment was a key contributor to this growth, with its gross profit soaring by 323.4% to approximately US$175.3 million.

Improved Loss and Adjusted Net Loss
GenScript’s loss for the Reporting Period narrowed to approximately US$215.6 million, compared to US$245.8 million in the Prior Period. The adjusted net loss saw a significant improvement, decreasing to approximately US$69 million from US$162 million.

For the non-cell therapy business, the adjusted net profit before eliminations was approximately US$29.2 million, a 13.1% decrease from US$33.6 million. Meanwhile, the adjusted net loss for the cell therapy business before eliminations narrowed to approximately US$98.3 million from US$195.7 million.

Segment Highlights
Life-Science Services and Products: Revenue in this segment grew by 9.6% to approximately US$222.4 million, driven by major upgrades in platforms and automation, especially in molecular biology, peptide, and protein technologies. Enhanced manufacturing efficiency in Singapore, Mainland China, and the U.S., along with strong commercial operations in the U.S. and Europe, fueled this growth. Adjusted gross profit increased by 8.5% to approximately US$119.9 million, maintaining a stable margin. Adjusted operating profit rose significantly by 23.8% to approximately US$47.8 million.
Biologics Development Services: This segment saw a revenue decline of 37.9% to approximately US$40.4 million, impacted by reduced demand and increased competition. Adjusted gross profit fell by 69.7% to approximately US$5.9 million, with the adjusted gross profit margin decreasing to 14.7%. Adjusted operating loss widened to approximately US$18.9 million, driven by higher operating costs related to U.S. expansion and strategic investments. The Company plans to refine pricing strategies and enhance global market presence to address these challenges.
Industrial Synthetic Biology Products: Revenue increased by 43.4% to approximately US$26.1 million, driven by a market rebound and growing demand in Mainland China and beyond. Adjusted gross profit rose by 52.8% to approximately US$11 million, with the adjusted gross profit margin improving to 42.2%. Adjusted operating profit improved to approximately US$2.3 million, reflecting higher capacity utilization and process improvements.
Cell Therapy: Revenue from the cell therapy segment grew by 155.7% to approximately US$280.5 million. This growth was fueled by collaboration revenue from CARVYKTI sales under the Janssen Agreement and increased license revenue from agreements with Janssen and Novartis Pharma AG. The adjusted operating loss narrowed to approximately US$119.4 million from US$205.9 million. The Company invested approximately US$196.3 million in research and development, focusing on cilta-cel and solid tumor programs, and incurred approximately US$52.4 million in adjusted selling and distribution expenses and US$49.1 million in adjusted administrative expenses.
Deepening ESG Commitment
In addition to its financial achievements, GenScript is advancing its commitment to sustainability and ESG practices. This year, the Company officially joined the United Nations Global Compact (UNGC), underscoring its commitment to adhere to ten sustainable development principles and drive more responsible, inclusive, and sustainable global business practices.

The Group has also been recognized for its ESG performance, ranking in the top 35% in EcoVadis’ sustainability assessments. This recognition highlights the Company’s efforts in environmental protection, labor rights, supply chain management, fair operations, and the execution of sustainable development strategies. Further demonstrating its dedication, the Company has joined the Science Based Targets initiative (SBTi) and submitted its Science-Based Targets Commitment, reflecting its proactive stance on global climate change and commitment to aligning with the Paris Agreement’s temperature goals.

In environmental management, GenScript is focused on optimizing its carbon footprint through international certifications such as ISO 14064, ISO 14001, and ISO 50001. These certifications enhance energy efficiency and cut greenhouse gas emissions. Additionally, the Company has earned ISO 27001 certification, ensuring top-notch data security and customer privacy protection.