Soligenix Inc (SNGX)

[TruckingAngler]

SNGX: PR 1/4 and all recent progress for Cancer, Psoriasis, and Thermo Vaccine solutions:

-- 1/4/2022: SNGX Dusquetide previously demonstrated benefits in reducing the duration of severe oral mucositis (SOM) in a Phase 2 clinical trial and reduction in SOM rates in the per protocol population in a Phase 3 study. In addition to the reduction of severe oral mucositis, an acceleration in the clearance of tumor response and an increase in overall survival were also observed in the Phase 2 clinical study as an ancillary benefit to treating oral mucositis in patients receiving chemo-radiation for their head and neck cancer (HNC). https://finance.yahoo.com/news/dusquetide-demonstrates-positive-anti-tumor-123000840.html

-- Nov 12, 2021 - Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended September 30, 2021. Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "There continues to be a great deal of activity across our Specialized BioTherapeutics and Public Health Solutions business segments. We continue to work diligently to prepare the new drug application (NDA) for HyBryte(TM) (SGX301 or synthetic hypericin) following the positive pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in cutaneous T-cell lymphoma (CTCL). The Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) granted orphan drug designation to the active ingredient hypericin for the treatment of T-cell lymphoma, expanding the treatment population beyond CTCL. Dr. Schaber continued, "With approximately $29 million in cash, not including our non-dilutive government funding, we anticipate having the necessary capital to achieve our upcoming milestones, including NDA filing and expansion into psoriasis with the conduct of the Phase 2a clinical trial. We are also continuing to actively assess various strategic options, including but not limited to, partnership and merger and acquisition opportunities."

-- November 8, 2021, SNGX announced it had been granted a Pediatric Investigation Plan (PIP) product-specific waiver in the United Kingdom from the Medicines and Healthcare products Regulatory Agency for HyBryte(TM) in the treatment of CTCL.

-- November 4, 2021, SNGX announced the publication of pre-clinical immunogenicity studies for RiVax(R) (heat stable ricin toxin vaccine) demonstrating enduring protection for at least 12 months
post-vaccination. The article titled "Durable Immunity to Ricin Toxin
Elicited by a Thermostable, Lyophilized Subunit Vaccine" has been
accepted for publication in the journal mSphere.

-- September 28, 2021, SNGX announced the publication of
pre-clinical immunogenicity studies for CiVax(TM) demonstrating durable
broad-spectrum neutralizing antibody responses, including against the
Beta, Gamma and Delta variants of concern. The article, titled "Protein
Vaccine Induces a Durable, More Broadly Neutralizing Antibody Response in Macaques than Natural Infection with SARS-CoV-2 P.1", has been posted as an accelerated preprint on bioRxiv.

-- September 16, 2021, SNGX announced that following the
validation of synthetic hypericin's biologic activity in the positive
pivotal Phase 3 FLASH study in CTCL, as well as PoC demonstrated in a
small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, the
Company will be expanding this novel therapy under the research name
SGX302 into psoriasis, a large and underserved market affecting between
60-125 million people worldwide.

-- September 14, 2021: 9/14: Soligenix Develops Groundbreaking Vaccine Platform to Target Future Pandemics. Soligenix Develops Groundbreaking Vaccine Platform to Target Future Pandemics. "The COVID-19 pandemic has already cost the United States an estimated $16 trillion in lost economic output, and has resulted in the loss of over 600,000 lives. At the end of last month, the country reached the dubious milestone of 39 million diagnosed cases of COVID, however, researchers have estimated a further 4.8 undiagnosed cases per diagnosis, bringing the nation's total number of infections closer to 200 million.

-- On September 9, 2021, SNGX announced that the Office of Orphan Products Development of the U.S. FDA had granted orphan drug designation to the active ingredient hypericin for the treatment of T-cell lymphoma, extending the target population beyond CTCL as previously granted.

-- On August 23, 2021, SNGX announced a publication describing the formulation of single-vial platform presentations of monovalent (single antigen), bivalent (two antigens) and trivalent (three antigens)
combinations of filovirus vaccine candidates. In collaboration with
University of Hawai i at M noa (UHM) and University of Colorado
co-authors, the manuscript titled "Single-Vial Filovirus Glycoprotein
Vaccines: Biophysical Characteristics and Immunogenicity after
Co-lyophilization with Adjuvant", has been published in Vaccine. To read
the publication, please click here.

-- August 18, 2021, SNGX announced positive data demonstrating the efficacy of multiple filovirus vaccine candidates in NHPs, including thermostabilized multivalent vaccines in a single vial platform presentation. Collaborators at UHM describe the potent efficacy of vaccine candidates protecting against three life-threatening filoviruses, Zaire ebolavirus, Sudan ebolavirus and Marburg Marburgvirus in an article titled "Recombinant Protein Filovirus Vaccines Protect Cynomolgus Macaques from Ebola, Sudan, and Marburg Viruses", published in Frontiers in Immunology.

--June 10, 2021: Soligenix Receives Pediatric Investigational Plan Waiver For HyBryte In CTCL From European Medicines Agency.
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 today that it has received a Pediatric Investigation Plan (PIP) waiver from the European Medicines Agency (EMA) for HyBryte (SGX301 or hypericin), which has recently and successfully concluded a Phase 3, pivotal clinical study for the treatment of early stage cutaneous T-cell lymphoma (CTCL).

-- December 2021: SNGX:”A number of hedge funds have recently added to or reduced their stakes in SNGX. Geode Capital Management LLC raised its stake in shares of Soligenix by 11.7% in the second quarter. Geode Capital Management LLC now owns 244,085 shares of the biopharmaceutical company’s stock valued at $270,000 after acquiring an additional 25,549 shares during the last quarter. Millennium Management LLC acquired a new position in shares of Soligenix during the 3rd quarter worth about $31,000. State Street Corp bought a new stake in shares of Soligenix in the 2nd quarter valued at about $50,000. Goldman Sachs Group Inc. bought a new stake in shares of Soligenix in the 2nd quarter valued at about $60,000. Finally, Two Sigma Securities LLC bought a new stake in shares of Soligenix in the 3rd quarter valued at about $62,000. 10.31% of the stock is currently owned by institutional investors and hedge funds.”

SNGX has 6 others in later 50% half of pipeline/progress. Besides Hybryte delay they have: SGX942, SGX203, SGX 201, Rivax, SGX943, and ThermoVax) not to mention $29m in CASH + additional $865,000 grant in July ++ current $90mm sales with forecast of $700mm !
Soligenix Pipeline: https://www.soligenix.com/pipeline-programs/

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