On August 14, 2025 CPTx, a biotechnology company developing in vivo genetic medicines built with programmable single-stranded DNA (ssDNA), reported the QUIET-CAR collaborative project with NanoCell Therapeutics has received a Eurostars Grant from the European Union through the Horizon Europe program and Eureka Network (Press release, CPTx Bio, AUG 14, 2025, View Source [SID1234655419]). The focus of the QUIET-CAR project is development of targeted lipid nanoparticles carrying novel immune-silent ssDNA for in vivo CAR T therapy.

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"CPTx is committed to bringing in vivo CAR T therapies to patients through our proprietary pipeline development programs and now also through the QUIET-CAR project with NanoCell," said Hendrik Dietz, CEO of CPTx. "The QUIET-CAR project represents another innovative approach to CAR T, and we look forward to advancing it together. Being selected from so many high-quality submissions underscores the promise of the project and the strength of our technology."

Eurostars, part of the European Partnership on Innovative SMEs and supported by Horizon Europe, is a funding initiative to accelerate transnational innovation. With participation from 37 countries, the program selects only the most promising technological breakthroughs, evaluated by independent experts. The selection of the CPTx – NanoCell project from more than 120 proposals reflects QUIET-CAR’s strong scientific and clinical potential across oncology and autoimmune diseases. NanoCell Therapeutics is a privately held biotechnology company pioneering transformative in vivo cell engineering through its non-viral, DNA-based gene therapy platform, primarily targeting oncology and autoimmune diseases.

On August 14, 2025 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the second quarter ended June 30, 2025 and other recent business developments (Press release, Celcuity, AUG 14, 2025, View Source [SID1234655284]).

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"We have had an eventful past few months at Celcuity. Last month, we announced positive topline data from the PIK3CA wild-type cohort of the pivotal Phase 3 VIKTORIA-1 clinical trial, which showed unprecedented reduction in risk of disease progression or death and incremental improvement in progression free survival in patients with HR+/HER2- advanced breast cancer," said Brian Sullivan, CEO and co-founder of Celcuity. "We believe topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing. We are on track to submit the New Drug Application for gedatolisib, based on data from the PIK3CA wild-type cohort, later this year and to report topline data from the PIK3CA mutant cohort in the fourth quarter of 2025. Additionally, with our recent financing and our growing body of clinical data, we believe we are in a unique position to advance multiple potential blockbuster indications in breast and prostate cancer."

Second Quarter 2025 Business Highlights and Other Recent Developments

● In July 2025, the Company announced positive topline data for both primary endpoints of the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial that evaluated gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in patients with HR+/HER2- ABC whose disease had progressed on or after prior treatment with a CDK4/6 inhibitor. The efficacy results established several new milestones in the history of drug development for HR+/HER2- ABC.

○ The gedatolisib triplet (gedatolisib, fulvestrant and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant based on a hazard ratio ("HR") of 0.24. The median PFS was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months.

○ The gedatolisib doublet (gedatolisib and fulvestrant) reduced the risk of disease progression or death by 67% compared to fulvestrant based on a hazard ratio of 0.33. The median PFS was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months.

○ Both gedatolisib regimens showed lower rates of hyperglycemia and stomatitis and the rate of discontinuation of all treatment due to a treatment-related adverse event ("AE"), was lower than was reported in a Phase 1b study in this patient population.

○ Full data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later this year.

○ Celcuity expects to submit an NDA to the FDA in the fourth quarter of 2025 for gedatolisib based on data from the PIK3CA wild-type cohort.

○ Enrollment is ongoing in the PIK3CA mutant cohort of the VIKTORIA-1 trial and remains on track to report topline data by the end of 2025.

● In July 2025, the first patient was dosed in VIKTORIA-2, a Phase 3 clinical trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for patients with HR+/HER2- ABC who are endocrine therapy resistant.

● In July 2025, the US Patent and Trademark Office issued a new patent for gedatolisib covering the dosing regimen used in the VIKTORIA-1 clinical trial, extending the patent exclusivity in the U.S. into 2042.

● In July 2025, the Company conducted a concurrent public offering of 2.750% convertible senior notes due 2031, common stock and pre-funded warrants. The net proceeds from the offerings were $286.5 million, after deducting underwriting discounts and commissions and the Company’s estimated offering expenses.

● In June 2025, the Phase 1b portion of the CELC-G-201 study reported positive topline data, and additional preliminary results will be presented at a medical conference later this year.

○ As of the May 30, 2025 data cut-off, the preliminary efficacy and safety analyses for the combined arms showed the six-month radiographic progression free survival rate was 66%, no patients discontinued treatment due to a treatment-related AE, and no dose reductions were required with gedatolisib or darolutamide.

● In June 2025, the Company presented key efficacy and safety results from an investigator-sponsored Phase 2 clinical trial in 44 patients with HER2+/ PIK3CA mutated mBC, who were treated with gedatolisib plus standard doses of trastuzumab-pkrb, at the American Society of Clinical Oncologists meeting, which showed the objective response rate among all patients enrolled was 43%.

Second Quarter 2025 Financial Results

Unless otherwise stated, all comparisons are for the second quarter ended June 30, 2025, compared to the second quarter ended June 30, 2024.

Total operating expenses were $44.0 million for the second quarter of 2025, compared to $24.3 million for the second quarter of 2024.

Research and development ("R&D") expenses were $40.2 million for the second quarter of 2025, compared to $22.5 million for the prior-year period. Of the approximately $17.7 million increase in R&D expenses, $6.6 million was related to increased employee and consulting expenses, $6.1 million was related to increased research and development costs primarily attributable to activities supporting our ongoing clinical trials, and $5.0 million is related to an anticipated development milestone payment under the license agreement with Pfizer.

General and administrative ("G&A") expenses were $3.8 million for the second quarter of 2025, compared to $1.8 million for the prior-year period. Of the approximately $2.0 million increase in general and administrative expenses, $1.6 million was related to increased employee and consulting expenses. The remaining $0.4 million of the $2.0 million increase resulted from professional fees, expanding infrastructure and other administrative expenses.

Net loss for the second quarter of 2025 was $45.3 million, or $1.04 loss per share, compared to a net loss of $23.7 million, or $0.62 loss per share, for the second quarter of 2024. Non-GAAP adjusted net loss for the second quarter of 2025 was $40.5 million, or $0.93 loss per share, compared to non-GAAP adjusted net loss of $22.2 million, or $0.58 loss per share, for the second quarter of 2024. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ("GAAP") to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the second quarter of 2025 was $36.2 million, compared to $18.1 million for the second quarter of 2024.

At June 30, 2025, Celcuity reported cash, cash equivalents and short-term investments of $168.4 million. However, on a proforma basis, taking into account the net proceeds of the Celcuity’s financing activities in the third quarter, cash, cash equivalents, and short-term investments as of the end of Q2 2025 was $455 million, which, we believe, when including drawdowns on our debt facility, will fund operations through 2027.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the second quarter 2025 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=047c56f7b8. A replay of the webcast will be available on the Celcuity website following the live event.

On August 14, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported its financial results and business update to shareholders for the second quarter ended June 30, 2025 (Press release, Renovorx, AUG 14, 2025, View Source [SID1234655315]).

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"We are pleased to report second quarter 2025 revenue of over $400,000. This growth highlights the strong clinical need and market demand for our patented RenovoCath device as a standalone targeted drug-delivery product among both new and existing customers. We are proud of the initial organic revenue growth over the first two full quarters since launching RenovoCath commercial sales, especially since this was achieved without a dedicated sales and marketing team. With the recent hiring of Phil Stocton as our Senior Director of Sales and Market Development, our goal is to stay lean, while also continuing to build commercialization momentum. We will continue to gather important data about our market (such as such as sales cycles, activation times, individual customer preferences and other commercial matters), as we seek to grow our customer base, fulfill repeat RenovoCath orders, and position ourselves for commercial growth over the long term," said Shaun Bagai, CEO of RenovoRx.

"At the same time, we are very excited to report that the independent Data Monitoring Committee (DMC) for our ongoing Phase III TIGeR-PaC trial recently completed their review of our second pre-planned interim analysis and has recommended that we continue the study. This is great news, as we believe the DMC’s recommendation is an expression of confidence in the potential for a positive outcome in the trial overall," continued Mr. Bagai.

"With a view towards preserving the integrity of the TIGeR-PaC trial for FDA purposes, and following our review of general FDA guidance, discussions with the DMC, and consultation with regulatory advisors, we are deferring publishing our second interim data. Outside of our Chief Medical Officer, Dr. Ramtin Agah, who has been speaking directly with the DMC, our entire team will remain blinded to the interim data. We will revisit publishing the actual second interim data, most likely upon completion of the study as is common for pivotal Phase III trials. As of August 12, 2025, 95 patients have been randomized and 61 events have occurred, putting us on target to complete enrollment this year or early next year," concluded Mr. Bagai.

RenovoCath Commercialization Update

RenovoRx continued its RenovoCath commercialization progress, with thirteen cancer center customers approved to purchase the device, including several high-volume, National Cancer Institute (NCI)-designated academic and community centers, an increase from five centers in the first quarter of 2025. Four of these thirteen cancer centers have used the device in patients, and all have made repeat purchase orders subsequently. RenovoRx believes that many of the 18 cancer centers that have used RenovoCath as part of its ongoing, pivotal Phase III TIGeR-PaC trial could also be potential customers for RenovoCath after the completion of TIGeR-PaC enrollment, which is expected later this year or early next year. All of this is being accomplished in-house by RenovoRx without a dedicated sales and marketing team. RenovoRx plans to strategically add a small number of sales personnel in the second half of 2025 as it looks to widen market penetration in 2026.

RenovoRx believes that the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an estimated initial $400 million peak annual U.S. sales opportunity. Beyond historical RenovoCath usage, RenovoRx commercial efforts are already indicating the adoption of RenovoCath technology for the treatment of other solid tumors. This serves as the basis for our belief in the potential for a several-billion-dollar TAM as we expand into additional applications.

Ongoing Pivotal Phase III TIGeR-PaC Trial Update

In the TIGeR-PaC trial, RenovoRx is evaluating its first investigational drug-device combination oncology product candidate which uses the proprietary Trans-Arterial Micro-Perfusion (TAMP) therapy platform enabled by RenovoCath for the treatment of locally advanced pancreatic cancer (LAPC). RenovoRx’s combination product candidate utilizes RenovoCath for the intra-arterial administration of the chemotherapy gemcitabine (or IAG).

The current protocol and statistical analysis plan for the Phase III TIGeR-PaC trial requires 114 randomized patients, with 86 events, or deaths, necessary to complete the final analysis.

In the second quarter of 2025, the 52nd death triggered the second pre-planned interim analysis to be reviewed by the independent Data Monitoring Committee. The DMC has concluded its review and has recommended that the Company continue with the trial. To avoid compromising the integrity of the trial with the FDA, and after discussions with the DMC and consultation with its regulatory advisors, RenovoRx elected to defer publishing the interim data. RenovoRx will revisit publishing the actual second interim data, most likely upon completion of the study as is common for pivotal Phase III trials.

Second Quarter 2025 and Subsequent Key Highlights

During the second quarter of 2025, RenovoRx increased production of the RenovoCath device to meet increased demand for the targeted delivery of diagnostic and/or therapeutic agents from oncologists and interventional radiologists. The principal manufacturer of RenovoCath devices is Medical Murray Inc., based in the U.S. in North Barrington, IL.

RenovoRx highlighted strong progress in its commercialization efforts. Since launching its commercial efforts in December 2024, RenovoRx has established commercial momentum for RenovoCath, with thirteen cancer center customers approved to purchase the device, including several high-volume, National Cancer Institute (NCI)-designated academic and community centers, an increase from five centers in the first quarter of 2025. Four of these thirteen cancer centers have used the device in patients, and all have made repeat purchase orders subsequently.

This momentum highlights the growing clinical demand across the United States for novel, localized solid tumor drug-delivery options beyond methods like systemic intravenous delivery of chemotherapy. RenovoRx believes that many of the 18 cancer centers that have used RenovoCath as part of its ongoing, pivotal Phase III TIGeR-PaC trial could also be potential customers for RenovoCath after the completion of TIGeR-PaC enrollment, which is expected later this year or early next year.

To coordinate, execute, and expand its commercial efforts for RenovoCath, subsequent to the quarter, RenovoRx hired Philip Stocton as Senior Director of Sales and Market Development. Mr. Stocton brings over 25 years of experience in MedTech sales, marketing, and leadership from various commercial positions at Terumo, Johnson & Johnson, Varian (acquired by Siemens), and, most recently, Sirtex Medical. Over the past 10 years, he has specialized in interventional oncology in both domestic and international roles. Prior to his hiring, Mr. Stocton had been consulting for RenovoRx in connection with its RenovoCath commercial launch planning efforts.

During the quarter, RenovoRx initiated patient enrollment with Johns Hopkins Medicine for the Phase III TIGeR-PaC clinical trial, becoming the newest addition to a distinguished network of clinical cancer sites across the United States participating in the trial.

RenovoRx also received an Issue Notification from the U.S. Patent and Trademark Office (USPTO) indicating that U.S. patent No. 12,290,564 became effective on May 6. This patent, titled "Methods for Treating Tumors," expands protection of methods for drug delivery with RenovoRx’s TAMP therapy platform, enabled by RenovoCath. The patent covers new methods for treating a tumor by delivering drugs locally to a region of an artery or blood vessel that is near the tumor after treating this region to reduce the microvasculature. The new patent provides protection through November of 2037.

Subsequent to the quarter, RenovoRx launched a multi-center post-marketing registry study to follow patients undergoing cancer treatment delivered by its RenovoCath device to solid tumors. The PanTheR study is an important initiative aimed at evaluating the safety and effectiveness of RenovoCath in real-world clinical settings. This multi-center, post-marketing observational registry study is designed to assess long-term safety and survival outcomes in patients with solid tumors who receive targeted drug delivery via RenovoCath. By collecting real-world data on the use of RenovoCath across a broader range of tumor types, PanTheR aims to provide valuable insights into patient outcomes and support the generation of additional safety data.

Financial Highlights for the Second Quarter Ended June 30, 2025

Revenue: RenovoRx reported second quarter revenues of approximately $422,000 from commercial sales of the RenovoCath device, driven by new customer purchase orders and early repeat orders from our initial sites. June 30, 2025 marked our second full quarter of revenue generation from RenovoCath sales.

Cash Position: As of June 30, 2025, the Company had $12.3 million in cash and cash equivalents. The Company’s plan is for revenues from RenovoCath sales to reduce its burn rate over time. The Company believes that cash as of June 30, 2025 will fully fund both ongoing RenovoCath scale-up efforts and additional progress towards the completion in the Phase III TIGeR-PaC trial.

R&D Expenses: Research and development expenses were $1.4 million, for the quarter ended June 30, 2025, compared to $1.5 million for the quarter ended June 30, 2024. The $0.1 million decrease was primarily driven by a decrease in other clinical and regulatory expenses including an allocation of selling, general and administrative expenses to research and development of $0.2 million. This decrease was offset by an increase in non-recurring engineering costs to scale manufacturing and the development of our next generation RenovoCath delivery system by $0.1 million to support and expand our commercial program.

SG&A Expenses: Selling, general, and administrative expenses were approximately $1.5 million, for the quarter ended June 30, 2025, remaining relatively unchanged from the same period in the prior year.

Net Loss: Net loss was $2.9 million for the quarter ended June 30, 2025, compared to a net loss of $2.4 million for the quarter ended June 30, 2024. The $0.5 million increase was primarily due to the change in the fair value of the warrant liability of $0.9 million offset by a decrease in loss from operations of $0.4 million.

Shares Outstanding: As of August 11, 2025, shares of common stock outstanding totaled 36,645,884.

Conference Call Details

Event: RenovoRx Second Quarter 2025 Financial Results Conference Call
Date: Thursday, August 14, 2025
Time: 4:30 p.m. ET
Live Call: 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)
Webcast: View Source

For interested individuals unable to join the conference call, a dial-in replay of the call will be available until September 14, 2025, and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number: 13754672.

On August 14, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported financial results for the quarter ended June 30, 2025, and provided a corporate update on its promising portfolio of clinical and pre-clinical radiopharmaceutical therapeutics (Press release, Cellectar Biosciences, AUG 14, 2025, View Source [SID1234655285]).

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Second Quarter and Subsequent Corporate Highlights

· Announces plans to pursue an NDA submission to the FDA for the accelerated approval of iopofosine I 131 as a treatment for WM subject to sufficient funding and once the confirmatory trial is underway

o The submission would be supported by data from the Phase 2b CLOVER WaM clinical trial demonstrating a statistically significant major response rate compared to a null hypothesis of 20% and meaningful duration of response. The data set now includes the FDA-requested 12-month follow-up results on all patients from the trial and new subset analysis of data from patients immediately following Bruton Tyrosine Kinase inhibitor (BTKi) treatment failures regardless of line of therapy.

o The Company plans to share these new data at an upcoming medical or scientific conference.

· Granted FDA Breakthrough Therapy Designation for iopofosine I 131, a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy, for the treatment of relapsed/refractory WM.

· Received the EMA response regarding scientific advice on its submission for Conditional Market Authorization (CMA) and continues to work with the EMA toward a potential submission.

o The submission to EMA included data from the Phase 2b CLOVER WaM clinical trial where the company observed a statistically significant major response rate, meaningful duration of response and integrated summary of safety for all patients treated with iopofosine I 131 for hematologic malignancies.

o Scheduled a follow-up meeting with the EMA and expect to make a final decision to submit for a CMA late in the third quarter or early in the fourth quarter of 2025.

· Submitted a trial protocol with the FDA for a Phase 1b Dose Finding study of our Auger-emitting radiopharmaceutical, CLR 125, for the treatment of relapsed TNBC. CLR 125 is an iodine-125 Auger-emitting drug candidate targeting solid tumors, such as triple negative breast, lung and colorectal cancers.

· Reported a positive initial data update from the Phase 1 clinical trial of iopofosine I 131 in pediatric patients with relapsed/refractory high-grade glioma (pHGG).

o All patients receiving a minimum of 55 mCi total administered dose (n=7) experienced an average of 5.4 months of progression free survival (PFS) and 8.6 months of overall survival (OS), ongoing.

o All patients experienced disease control, which correlates with survival benefit.

o Three patients who received additional dosing cycles (a minimum of four total infusions) had an average PFS of 8.1 months and an OS of 11.5 months (ranging from 4.9 to 14.9 months), ongoing, with two achieving an objective response.

· In active discussions with multiple potential partners for the regional or global licensing of iopofosine I 131 which are designed to provide funding to support the submission of an NDA for accelerated approval and the required confirmatory study.

· Entered a long-term multi-isotope supply agreement with Nusano to provide Cellectar with iodine-125 and actinium-225 for its clinical studies and future commercial needs.

· Raised nearly $9.5 million through separate June and July 2025 financings. Funds from these financings will be used to advance the Company’s next-generation pipeline of radiopharmaceuticals in solid tumors into the clinic and to continue regulatory engagement and partnership discussions for iopofosine I 131.

"Throughout the first half of 2025 we made meaningful progress advancing our pipeline of targeted radiopharmaceuticals and are entering the second half with solid momentum and a clear plan," said James Caruso, president and CEO of Cellectar. We are encouraged by the recent FDA Breakthrough Therapy Designation and the totality of compelling CLOVER WaM safety and efficacy data. Importantly, our regulatory strategy aligns with the FDA’s recently stated mission to accelerate the delivery of lifesaving medicines to patients battling rare diseases, such as WM."

"We continue our interactions with the European Medicines Agency (EMA) and are hopeful that they will recommend that we file for a fast-track, conditional marketing authorization approval. We expect their decision either late third or early in the fourth quarter of 2025. In parallel, we remain in active discussions with multiple potential partners to support the NDA filing for accelerated approval of iopofosine I 131 for the treatment of WM. Currently, we view sufficient funding or collaborations as a precursor to the confirmatory study initiation and submission of an NDA for accelerated approval. Such partnerships may provide non-dilutive capital that preserves stockholder value and could potentially accelerates our path to commercialization across key global markets."

"Beyond iopofosine, we are making tremendous headway advancing our next-generation pipeline of radiopharmaceuticals targeting solid tumors, such as triple-negative breast cancer (TNBC) and pancreatic cancer. We plan to advance CLR 125 into the clinic by late 2025 or early 2026. The FDA has received our Phase 1 protocol submission for the CLR 125 program. We are excited by the opportunities Cellectar possesses to bring transformative radiopharmaceutical therapies to patients in need and look forward to achieving value-creating milestones throughout the balance of the year and beyond," concluded Mr. Caruso.

Second Quarter 2025 Financial Highlights

· Cash and Cash Equivalents: As of June 30, 2025, the company had cash and cash equivalents of approximately $11.0 million, compared to $23.3 million as of December 31, 2024, which includes $2.3 million in net proceeds received in connection with the company’s June warrant exercises but does not reflect net proceeds of approximately $5.8 million from the July 2025 offering. The company believes its cash balance as of June 30, 2025, inclusive of the additional funds raised in July, is adequate to fund its basic budgeted operations into the second quarter of 2026.

· Research and Development Expenses: R&D expenses for the three months ended June 30, 2025, were approximately $2.4 million, compared to approximately $7.3 million for the three months ended June 30, 2024. The overall lower expense was primarily driven by decreased clinical project costs and manufacturing and related costs resulting from the conclusion of patient enrollment in our CLOVER WaM Phase 2b clinical trial.

· General and Administrative Expenses: G&A expenses for the three months ended June 30, 2025, were approximately $3.6 million, compared to approximately $6.4 million for the same period in 2024. The reduction was the result of decreased commercialization activities and personnel costs.

· Net Loss: The net loss attributable to common stockholders for the three months ended June 30, 2025, was $5.4 million, or $3.39 per primary and diluted share, compared to $0.9 million, or $0.77 per primary share and $5.43 per diluted share in the three months ended June 30, 2024.

Conference Call & Webcast Details

Cellectar management will host a conference call and webcast today, August 14, 2025, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the "Events & Presentations" section of Cellectar’s website at www.cellectar.com. A recording of the webcast will be available and archived on the company’s website for approximately 90 days.

On August 14, 2025 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, 2025 (Press release, Soligenix, AUG 14, 2025, View Source [SID1234655316]).

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"As we quickly approach the latter part of 2025 into 2026, the Company remains confident about its late-stage rare disease pipeline and upcoming key development milestones," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "These include top-line results from our Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) before yearend, as well as continued clinical update for the ongoing investigator-initiated study (IIS) evaluating extended HyBryte (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage cutaneous T-cell lymphoma (CTCL). Further, we anticipate top-line results in 2026 from our actively enrolling confirmatory Phase 3 study of HyBryte (synthetic hypericin) for early-stage CTCL, where we plan to provide an enrollemt update later this year. Recently, we were also pleased to announce the successful completion of our Phase 2a proof of concept study evaluating SGX945 (dusquetide) in the treatment of Behçet’s Disease having achieved the study objective of demonstrating biological efficacy in this difficult to treat chronic disease."

Dr. Schaber continued, "With approximately $5.1 million in cash at June 30, 2025, exclusive of approximately $1.4 million of net cash received via our At-The-Market ("ATM") facility on July 1, 2025, we’re focused on carefully allocating resources to hit our strategic goals and upcoming milestones. While this cash balance provides sufficient operating runway through the first quarter of 2026, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."

Soligenix Recent Accomplishments

On July 31, 2025, the Company announced that it had completed its Phase 2a proof of concept study evaluating SGX945 (dusquetide) in the treatment of Behçet’s Disease and achieved the study objective of demonstrating biological efficacy. To view this press release, please click here.
On July 8, 2025, the Company issued a shareholder update letter, detailing the important and potentially transformational development milestones. To view this letter, please click here.
On July 1, 2025, the Company announced it had successfully completed the transfer of the manufacturing process for its synthetic hypericin active ingredient from Europe to the United States under its partnership agreement with Sterling Pharma Solutions. To view this press release, please click here.
Financial Results – Quarter Ended June 30, 2025

Soligenix reported no revenue for the quarter ended June 30, 2025, consistent with comparable de minimis revenue during the same period of 2024.

Soligenix’s net loss was $2.7 million, or ($0.82) per share, for the quarter ended June 30, 2025, compared to $1.6 million, or ($1.31) per share, for the quarter ended June 30, 2024. This increase in net loss was primarily due to an increase in operating expenses related to ongoing clinical trials and a decrease in other income attributable to the change in the fair value of debt during the three months ended June 30, 2024 with no corresponding change in fair value during the three months ended June 30, 2025.

Research and development expenses were $1.7 million for the quarter ended June 30, 2025 as compared to $0.5 million for the same period in 2024. The increase was primarily due to costs associated with the Phase 2a study in Behçet’s Disease and the second confirmatory Phase 3 CTCL trial as well as increases in third party manufacturing.

General and administrative expenses were $1.1 million for the quarter ended June 30, 2025 as compared to $1.2 million for the same period in 2024. The decrease was primarily attributable to decreases in professional expenses.

As of June 30, 2025, the Company’s cash position was approximately $5.1 million, exclusive of approximately $1.4 million of net cash received via its ATM facility on July 1, 2025.