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Soligenix Announces Recent Accomplishments And First Quarter 2019 Financial Results

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Wednesday, May 15, 2019

PRINCETON, USA -- 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, announced its recent accomplishments and financial results for the quarter ended March 31, 2019.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We have completed the approximate 90 subject enrollment necessary to support the interim efficacy analysis of our pivotal double-blind, placebo-controlled Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy. This interim analysis, to be conducted by the independent Data Monitoring Committee (DMC) for the trial, is anticipated to occur in September 2019. We expect completion of full enrollment in the study in the second half of 2019, with final top-line results expected in the first half of 2020, pending the DMC recommendation."

Dr. Schaber continued, "Following the positive recommendation received from the independent DMC for our double-blind, placebo-controlled Phase 3 study for the treatment of cutaneous T-cell lymphoma (CTCL) with SGX301 (synthetic hypericin), we continue to enroll patients and anticipate completing study enrollment in the second half of 2019, with final top-line results in the first quarter of 2020."

Soligenix Recent Accomplishments:

On April 23, 2019, the Company issued an update letter from Dr. Schaber. This letter provided an update as well as further guidance on the development programs for 2019. To view this press release, please click here.
On April 18, 2019, the Company announced it had reached a significant milestone in the Phase 3 clinical study (the "DOM-INNATE" study) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer. Patient enrollment is sufficient to support the planned interim efficacy analysis by the independent DMC. In accordance with the clinical protocol, approximately 90 subjects have been enrolled into the study as required for the planned interim efficacy analysis. To view this press release, please click here.
On April 15, 2019, the Company announced it had received approximately $611,000, net of transaction costs, in non-dilutive financing via the state of New Jersey's Technology Business Tax Certificate Transfer Program. To view this press release, please click here.
On April 9, 2019, the Company announced that the Pediatric Committee of the European Medicines Agency agreed to the Company's Pediatric Investigation Plan (PIP) for SGX942 (dusquetide). It was also agreed that the Company may defer conducting the PIP until successful completion of its ongoing pivotal Phase 3 clinical study evaluating SGX942 as a treatment for oral mucositis in patients with head and neck cancer. To view this press release, please click here.
On April 4, 2019, the Company announced that the US Patent Office would be issuing the patent titled "Novel Peptides for Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity". The new patent (#10,253,068) claims composition of matter for novel innate defense regulator analogs, expanding patent protection to more diverse analog structures. Therapeutic use claims in oral mucositis, colitis, and infectious disease, both alone and in conjunction with antibiotics, will also issue. To view this press release, please click here.
Financial Results – First Quarter Ended March 31, 2019

Soligenix's revenues for the quarters ended March 31, 2019 and 2018 were each $1.1 million. Revenues included payments on a contract in support of RiVax®, in addition to the grants received to support the development of SGX301 for the treatment of CTCL and SGX942 for the treatment of oral mucositis in head and neck cancer, as well as the subaward from the Ebola collaboration with the University of Hawai'i at Mānoa.

Soligenix's basic net loss was $1.6 million, or ($0.09) per share for the quarter ended March 31, 2019, as compared to $2.4 million for the quarter ended March 31, 2018, or ($0.27) per share.

Research and development expenses were $1.6 million as compared to $1.8 million for the quarters ended March 31, 2019 and 2018, respectively. The decrease in research and development spending for the three months ended March 31, 2019 was primarily attributable to higher clinical trial site fees incurred during the period ended March 31, 2018 compared to the same period in 2019.

General and administrative expenses were $0.9 million as compared to $0.7 million for the quarters ended March 31, 2019 and 2018, respectively. This increase was primarily attributable to higher professional fees incurred during the period ended March 31, 2019.

As of March 31, 2019, the Company's cash position was approximately $7.2 million.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

 

Source: Soligenix
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