Soligenix: A Trail of Triumphs Unveiled Alongside Spectacular Q2 2023 Financial Results

Unveiling Triumphs from the Heart of Princeton: Soligenix’s Remarkable Journey and Q2 2023 Financial Feats

PRINCETON, N.J., August 21, 2023 /PRNewswire/ – Brace yourself for a tale of innovation and perseverance as Soligenix, Inc. (NASDAQ: SNGX), a visionary late-stage biopharmaceutical force, takes center stage. With a mission to champion rare diseases and fill the voids of unmet medical needs, the company has proudly unveiled its recent accomplishments and unveiled the dazzling financial symphony of the quarter that ended on June 30, 2023.

Christopher J. Schaber, PhD, the maestro behind this symphony, exclaimed, “The second quarter was a whirlwind of advancement, where we not only propelled multiple clinical trials forward but also engaged in inspiring dialogues with the U.S. Food and Drug Administration (FDA) for the blueprint of a transformative second Phase 3 pivotal study for our game-changing HyBryte™ (synthetic hypericin sodium). This revolutionary treatment targets cutaneous T-cell lymphoma (CTCL), where we previously showcased statistically significant triumphs in our first Phase 3 clinical trial.”

A crescendo of accomplishments resonated as Dr. Schaber shared the latest triumphs: “A new dawn for CTCL treatment emerged with the commencement of a HyBryte™ expanded trial at the University of Pennsylvania, welcoming patients through a $2.6 million FDA-backed Orphan Products Development grant. Our Phase 2a trial for SGX302 (synthetic hypericin sodium), a beacon of hope for mild-to-moderate psoriasis, echoed with promise. The biological signal shone brightly in the initial five patients, with the majority dancing to the tune of improved PASI scores.”

Adding to the masterpiece, “Harmonious clinical results from a compatibility study starring HyBryte™ in CTCL treatment validated and extended our triumphs from the Phase 3 study of yore.”

But the story didn’t end there. “In a defining moment of financial fortitude,” Dr. Schaber narrated, “the second quarter of 2023 saw us complete a triumphant public offering, securing an impressive $8.5 million. This treasure has empowered us to propel our rare disease initiatives with unwavering zeal. With a robust $13.2 million in our coffers by June 30, 2023, we are masterfully managing our resources, guiding them with precision toward our imminent milestones. Amid this tapestry of progress, we explore a world of strategic avenues – partnerships, mergers, and acquisitions – all to ensure our mission continues to flourish.”

From triumphs in labs to a financial symphony that resonates with promise, Soligenix’s journey through Q2 2023 paints a portrait of determination, innovation, and hope.

Soligenix Recent Accomplishments

  • Amidst the summer breeze of August 10, 2023, a jubilant proclamation echoed from the heart of progress: Patient enrollment for the transformative HyBryte™ expanded treatment investigator-initiated CTCL study commenced at the esteemed University of Pennsylvania. This groundbreaking endeavor, fueled by a remarkable $2.6 million Orphan Products Development grant from the FDA, is poised to rewrite the narrative of CTCL treatment. The stage is set for a symphony of healing, where innovation and hope intertwine in a dance of medical marvels.
  • A thrilling moment swept across July 11, 2023, as the Company unfurled its grand plans: The Phase 2a trial of SGX302, a beacon of promise for mild-to-moderate psoriasis treatment, was set to bloom even further. A triumphant crescendo echoed as the initial five subjects painted a resounding masterpiece of biological effect. The journey ahead holds the promise of rewriting the story of psoriasis, where hope and science meet in a dance of transformation.
  • In a moment of triumph that will echo through history, May 16, 2023, marked a symphony of innovation as the Company proudly announced the European Patent Office’s grant of a patent with a resounding title: “Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis.” Like a treasure map to relief and healing, this patent stands as a testament to the power of human ingenuity in the quest to conquer challenges and enhance lives.

Financial Results – Quarter Ended June 30, 2023

As the curtain fell on both June 30, 2023 and 2022, a chorus of financial achievements echoed in harmony. Soligenix’s quarterly revenues danced to the tune of $0.2 million, a symphony woven from the threads of third-party licensing, government contracts, and grants that breathe life into transformative initiatives. Picture a canvas painted with the vibrant hues of HyBryte™, igniting hope for early-stage CTCL, and SGX943, an avenger against antibiotic-resistant infectious diseases. ThermoVax® and CiVax™ stand as sentinels of innovation, united in the fight against the formidable adversary named COVID-19.

In the realm of numbers, Soligenix’s net loss underwent a transformation. The tale of the quarter ending June 30, 2023, unveiled a net loss of $1.6 million, akin to the complex notes of a well-composed melody. Compare it to the previous year, where the quarter ending June 30, 2022, witnessed a more profound loss of $2.4 million. A transformation, fueled by a reduction in operating expenses, painted a brighter picture, exemplifying the power of resourceful navigation.

Dive into the intricacies, and you’ll find the heartbeat of research and development expenses, once $2.0 million, now sculpted down to $0.8 million. As the stage shifted, manufacturing and regulatory costs bowed in harmony with the HyBryte™ new drug application filing. Meanwhile, general and administrative expenses took their own dance, moving from $1.4 million to $0.9 million. This transformation was orchestrated by the gentle hum of legal and consulting expenses finding their balance.

As the financial tapestry unfurled, one number stood out: Soligenix’s cash position. At June 30, 2023, it stood tall at an impressive $13.2 million, a testament to careful stewardship and a commitment to transformational progress.

About Soligenix, Inc.

Prepare to journey through the corridors of innovation with Soligenix, a beacon of hope in the biopharmaceutical realm. With an unwavering focus on rare diseases where medical needs remain unmet, this company is scripting a tale of transformation and healing.

Enter the realm of Specialized BioTherapeutics, where dreams are shaped into reality. Behold the star of the show: HyBryte™, an illuminating photodynamic therapy for cutaneous T-cell lymphoma (CTCL). With the resounding success of Phase 3 trials, the path to regulatory approval and commercialization in the U.S. unfolds. But the story doesn’t end here. SGX302 emerges as a beacon of light, extending its potential to the realm of psoriasis, accompanied by our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942), and the potential of proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) to combat severe inflammation, including pediatric Crohn’s disease (SGX203).

In a parallel narrative, Public Health Solutions takes center stage. RiVax®, a beacon against ricin toxin, stands tall, while vaccine programs target the menacing specters of filoviruses (Marburg and Ebola) and the insidious COVID-19. The tale wouldn’t be complete without a nod to ThermoVax®, the secret weapon behind Soligenix’s vaccine initiatives, holding the power to rewrite the rules of stability.

Through a symphony of numbers, Soligenix paints a canvas of financial achievement. The net loss narrative transforms: from $2.4 million to $1.6 million for the quarters ending June 30, 2022, and 2023, respectively. The stage is shared by research and development expenses, whittled down from $2.0 million to $0.8 million, and general and administrative expenses that dance from $1.4 million to $0.9 million.

As June 30, 2023, emerges, Soligenix’s cash position stands tall at $13.2 million – a treasure chest that fuels their journey of transformation. This isn’t just a story; it’s a saga of resilience, innovation, and hope.

As you venture forward, remember that the journey of science and healing is as dynamic as it is promising. Forward-looking statements resonate through these passages, echoing Soligenix’s commitment to blazing a trail of innovation. With each step, this company redefines the limits of possibility, weaving a tale of transformation that defies the ordinary.

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