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 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 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 8, 2024 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies to treat a range of solid tumors designed to preserve organ function, reported financial results for the second quarter ended June 30, 2024, and provided recent business highlights (Press release, Aura Biosciences, AUG 8, 2024, View Source [SID1234645587]).

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"We are excited by the progress we made in the second quarter across all our clinical programs and in particular in our bladder cancer clinical trial. We look forward to our upcoming urologic oncology virtual event in October, where we plan to share early data in NMIBC," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "We are well-capitalized and remain focused on the execution of our ongoing clinical trials in ocular and urologic oncology, two areas where novel treatment options are needed that can provide effective local treatment while preserving organ function."

Recent Pipeline Developments

Bladder Cancer

A Phase 1 trial of bel-sar for the treatment of bladder cancer is currently ongoing. The company plans to host a virtual urologic oncology investor event featuring key opinion leaders (KOLs) in October 2024. Early NMIBC data from the ongoing Phase 1 trial is expected to be presented at this event.

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Bladder cancer represents an area of high unmet need with approximately 80,000 patients diagnosed in the United States annually. We believe bel-sar has the potential to selectively treat and induce a tumor specific immune response to prevent disease progression and recurrence, while allowing patients to be treated in-office by urologists and potentially avoiding the need for surgery. The Company received Fast Track designation from the FDA’s Division of Oncology for the treatment of NMIBC.

The ongoing Phase 1 multi-center, open-label clinical trial is expected to enroll approximately 21 adult patients. The trial is designed to assess the safety and feasibility of bel-sar as a monotherapy. The trial includes histopathological evaluation after local treatment to assess bel-sar’s biological activity, including the evaluation of focal necrosis and immune activation after a single dose of treatment.

Primary Uveal Melanoma

Phase 2 end of study data in small choroidal melanoma and indeterminate lesions will be presented at the Retina Society Annual Meeting taking place September 11-15, 2024, in Lisbon, Portugal.

Enrollment continues in global Phase 3 CoMpass trial for the treatment of small choroidal melanoma and indeterminate lesions.

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CoMpass trial continues to progress globally with site activations, patient enrollment and strong endorsement from the ocular oncology community. This trial has a global enrollment target of approximately 100 patients.

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CoMpass is a global, Phase 3, randomized, superiority trial evaluating bel-sar treatment against a sham control arm. Adult participants will be randomized 2:1:2 to undergo three cycles of treatment with either a high or low dose of bel-sar or to receive a sham control. The primary endpoint is time to tumor progression at 15 months of follow-up, as agreed upon with the United States Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA).

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Early-stage choroidal melanoma represents an area of high unmet need with approximately 8,000 patients diagnosed in the United States and Europe annually. The Company received Orphan Drug Designation from the FDA and the European Medicines Agency (EMA) and Fast Track designation from the FDA for the treatment of primary uveal melanoma.

Additional Ocular Oncology Indications:

In addition to primary uveal melanoma, bel-sar is being explored for metastases to the choroid and cancers of the ocular surface. These three ocular oncology indications have a collective incidence of greater than 60,000 patients annually in the United States and Europe.

Metastases to the Choroid

The Company plans to initiate clinical development in metastases to the choroid, an indication with a high unmet medical need and no approved therapies. Metastases to the choroid is the second potential ocular oncology indication for bel-sar, affecting approximately 20,000 patients in the United States and Europe annually. The Company received Fast Track designation from the FDA’s Division of Oncology for the treatment of metastases to the choroid. The Company is on track to initiate a Phase 2 trial in 2024.

Cancers of the Ocular Surface

Cancers of the ocular surface is the Company’s third potential ocular oncology indication affecting approximately 35,000 patients in the United States and Europe annually. The Company continues to advance its preclinical work designed to be IND-enabling in cancers of the ocular surface.

Recent Corporate Events

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The Company hosted a virtual KOL event with global opinion leaders in Ocular Oncology, "Pioneering a New Standard of Care in Ocular Oncology," on May 29, 2024. A replay of the webcast is available on the "Investors & Media" page under the "Events & Presentations" section of Aura’s website at View Source

Second Quarter 2024 Financial Results

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As of June 30, 2024, Aura had cash and cash equivalents and marketable securities totaling $187.4 million. The Company believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into the second half of 2026.

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Research and development expenses increased to $16.9 million for the three months ended June 30, 2024 from $15.1 million for the three months ended June 30, 2023, primarily due to higher personnel expenses related to growth of our Company.

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General and administrative expenses increased to $5.9 million for the three months ended June 30, 2024 from $5.2 million for the three months ended June 30, 2023. General and administrative expenses include $1.6 million and $1.2 million of stock-based compensation for the three months ended June 30, 2024 and 2023, respectively. The increase was primarily driven by personnel expenses, as well as increases in general corporate expenses related to the growth of our Company.

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Net loss for the three months ended June 30, 2024 was $20.3 million compared to $18.3 million for the three months ended June 30, 2023.