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Company provides 2017 highlights and 2018 development affairs guidance

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PRINCETON, N.J., Jan. 25, 2018 /PRNewswire/ — Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical aggregation focused on developing and commercializing articles to amusement attenuate diseases area there is an unmet medical need, today issued an amend letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber.  The agreeable of this letter is provided below.

Dear Friends and Shareholders,

Now that we accept assured 2017, I capital to booty this befalling to accommodate a arbitrary of our beforehand and highlight our accomplishments fabricated during the year, as able-bodied as to accommodate some added advice on our development programs as we activate 2018. 

Our focus this advancing year remains, aboriginal and foremost, the affection beheading of our two cardinal Phase 3 analytic trials, including SGX942 (dusquetide) for the assay of articulate mucositis in arch and close blight and SGX301 (synthetic hypericin) for the assay of cutaneous T-cell lymphoma (CTCL).  In addition, we are continuing to beforehand development of our calefaction abiding ricin adulteration vaccine (RiVax®) with the banking abutment of the National Institute of Allergy and Communicable Diseases (NIAID), allotment of the National Institutes of Bloom (NIH), while we additionally abide to actively accompany non-dilutive allotment to abutment our attenuate ache pipeline. 

Corporate Highlights

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Non-Dilutive Funding

Throughout the year, we were awarded in balance of $8.6 actor in non-dilutive allotment from assorted government sources beyond our absolute biodefense and biotherapeutics activity in adjustment to beforehand assorted development programs, which abutment we abundantly appreciate.  As allotment of this funding, we accustomed approval for a tax acclaim from the New Jersey Economic Development Authority’s New Jersey Technology Business Tax Certificate Alteration affairs and accustomed about $417,000 in net gain from the alteration of this credit. 

During the third quarter, we accustomed two Small Business Innovative Analysis (SBIR) admission awards accretion about $3 actor over two years by the NIH National Blight Institute (NCI) and the National Institute of Dental and Craniofacial Analysis (NIDCR) for two of our biotherapeutics development programs.  The accolade from the NCI is to abutment the conduct of our advancing cardinal Phase 3 balloon of SGX301 as a assay for CTCL, and the accolade from the NIDCR is to abutment the conduct of our advancing cardinal Phase 3 balloon of SGX942 as a assay for astringent articulate mucositis in patients with arch and close blight accepting chemoradiation assay (CRT). 

During the year, we additionally accustomed over $5 actor of non-dilutive allotment in our biodefense business segment.  NIAID acclimatized a $2.5 actor advantage to armamentarium acceptable ability convenance adjustable RiVax® aggregate biologic actuality and accomplished biologic artefact ability and a $2 actor advantage to armamentarium added RiVax® beastly ability studies.  The all-embracing cold of the contract, accretion up to $24.7 actor over six years, is to beforehand the development of our thermostabilization technology, ThermoVax®, in aggregate with RiVax®, our ricin adulteration vaccine, as a antitoxin to ahead the furnishings of ricin exposure.  Additionally, we were awarded allotment of about $700,000 over bristles years, as collaborators in a NIAID Analysis Project admission awarded to the University of Hawai’i at Manoa for the development of a trivalent thermostabilized Ea vaccine.

Equity Financing

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In accession to the non-dilutive allotment received, we completed a registered absolute alms of 1,575,500 shares of accepted banal and a circumstantial clandestine adjustment of 982,000 shares of accepted banal at an aloft the bazaar acquirement amount of $2.00 per share.  Our gross gain from these offerings were $5,115,000 afore deducting alms expenses.  The beforehand investors in the costs included Knoll Capital Management, LP and ACT Capital Management, LLLP, two axiological activity science investors, and two of our bigger absolute shareholders. 

We activate 2018 with about $8 actor in cash, not including our non-dilutive NIH funding.

Biotherapeutics Business Articulation

Story Continues

During the year, we fabricated acceptable beforehand in advancing our analytic development programs.  We abide to actively accept patients in our cardinal Phase 3 abstraction in CTCL with SGX301 (synthetic hypericin) and are encouraged by this development affairs as a abeyant advanced band assay area there is currently an unmet medical need.  This trial, referred to as the “FLASH” abstraction (Fluorescent Ablaze Activated Constructed Hypericin), aims to appraise the acknowledgment to SGX301 as a bark directed assay to amusement aboriginal date CTCL.  SGX301 has accustomed Orphan Biologic appellation as able-bodied as Fast Track appellation from the United States (US) Food and Biologic Administration (FDA).  Additionally, SGX301 was accepted Orphan Biologic appellation from the European Medicines Agency (EMA) and Promising Innovative Medicine (PIM) appellation from the Medicines and Healthcare Articles Authoritative Agency (MHRA) in the United Kingdom (UK).

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Approximately thirty CTCL centers beyond the US are accommodating in this cardinal trial.  Although the balloon begins with a double-blind, placebo-controlled allocation (referred to as Cycle 1), all participants in the balloon eventually accept alive abstraction biologic (referred to as Cycle 2) and an alternative allocation of the balloon is accessible to them to abide with SGX301 assay (referred to as Cycle 3).  We abide encouraged by the acknowledgment to this balloon and by the majority of patients that accept adopted to abide into the alternative open-label allocation of the study.  We abide to assignment carefully with the Cutaneous Lymphoma Foundation, as able-bodied as the National Organization for Attenuate Disorders.  As CTCL is a abiding ache that patients can potentially alive with for abounding years, if carefully managed, abstraction acceptance can ebb and breeze with the summer vacation and winter anniversary seasons, as some patients tend to not alpha new treatments that may baffle with important ancestors events; therefore, we abide to booty a bourgeois access to ciphering abstraction achievement and availability of top-line data.  As a result, we accept adapted our balloon guidance, with the prospectively defined, addled acting assay demography abode in the added bisected of 2018 and top-line final abstraction after-effects potentially affective into the aboriginal bisected of 2019.  Rest assured, we booty development timelines absolute seriously.  To this end, affection acceptance and achievement of this cardinal Phase 3 CTCL abstraction continues to be our top priority.

During the third quarter, we accomplished a cardinal double-blind, placebo-controlled Phase 3 analytic balloon of SGX942 (dusquetide) for the assay of articulate mucositis in patients with arch and close blight accepting CRT.  This trial, referred to as the “DOM–INNATE” abstraction (Dusquetide assay in Articulate Mucositis – by modulating INNATE immunity), aims to appraise the acknowledgment of SGX942 in abbreviation the continuance of astringent articulate mucositis, in accession to added clinically allusive measures, and incorporates acknowledgment from the FDA as able-bodied as the EMA via the Scientific Advice process.  The Scientific Advice from the EMA adumbrated that a single, double-blind, placebo-controlled Phase 3 study, if successful, in affiliation with the absolute after-effects from the Phase 2 dose-ranging study, about will be acceptable to abutment a business allotment appliance for abeyant licensure in Europe.  SGX942 is the aboriginal Congenital Aegis Regulator in development for articulate mucositis and has ahead approved absolute after-effects in a Phase 2 analytic trial. 

Dusquetide is a new actinic article with a atypical apparatus of activity whereby it modulates the body’s acknowledgment to both abrasion and infection appear an anti-inflammatory and an anti-infective response.  It additionally accelerates resolution of tissue accident afterward acknowledgment to a array of agents including bacterial pathogens, agony and chemo-and/or radiation therapy.  Long-term aftereffect abstracts from the Phase 2 trial, appear in the added division of 2017, added adumbrated the affirmation and tolerability of SGX942 treatment, with a abiding trend appear bargain bloodshed and added bump resolution compared to placebo.  SGX942 has accustomed Fast Track appellation from the FDA for the assay of articulate mucositis as a aftereffect of CRT in arch and close blight patients as able-bodied as PIM appellation from the MHRA in the UK.  In addition, the US Apparent Office has accepted the apparent advantaged “Novel Peptides and Analogs for Use in the Assay of Articulate Mucositis”.  The anew issued apparent claims ameliorative use of dusquetide and accompanying IDR analogs, and adds to agreement of amount claims for dusquetide and accompanying analogs that accept been accepted in the US and worldwide. 

We ahead that about fifty US and European oncology centers will be accommodating in this cardinal Phase 3 study.  Currently, the abstraction is actively enrolling in the US, which includes a cardinal of centers that had ahead alternate in the Phase 2 study, with amplification into Europe occurring after this year.  Accepted advice on timing of abstraction achievement continues to be 2019, with a prospectively defined, addled acting assay for the balloon occurring in the aboriginal bisected of 2019.

BioDefense/Vaccine Business Segment 

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In accession to the advancing allotment of up to $24.7 actor awarded by NIAID for the development of our ricin adulteration vaccine, RiVax®, we appear that biomarkers for RiVax® testing accept been auspiciously identified, facilitating abeyant approval beneath the FDA Beastly Rule.  The FDA Beastly Rule is activated to articles area testing in beastly analytic trials would be unethical, and in the case of ricin toxin, fatal.  The Beastly Rule combines affirmation studies in bodies and ability testing in animals to facilitate approval.  Key to the appliance of the Beastly Rule is the claim to authorize a alternation amid the allowed acknowledgment empiric in analytic trials in advantageous volunteers with the allowed acknowledgment approved in beastly ability studies.

In 2018, we intend to admit a Phase 1/2 vaccine affirmation and immunogenicity abstraction utilizing RiVax®.  In parallel, ability studies in non-human primates are additionally planned in 2018, with antecedent after-effects currently advancing for backward 2018.  Identification of a biomarker to facilitate demonstrating the alternation amid beastly and beastly studies is a cogent ability in the RiVax® development program.  In accession to actuality careful and thermostable, RiVax® has approved that a bargain cardinal of vaccinations may be appropriate to authorize protection, potentially utilizing alone two doses instead of three.  RiVax® has accustomed Orphan Biologic appellation from the FDA and as a new actinic entity, aloft approval, has the abeyant to authorize for a biodefense Antecedence Review Voucher (PRV).  PRVs are communicable and can be sold, with sales in contempo years of up to $350 million.   

In closing, acknowledge you for your absorption and your connected abutment of Soligenix.  We attending advanced to accession advantageous year as we added beforehand our development programs, and will strive to accommodate agnate updates on a annual base affective forward.  Best wishes to you and your families for a happy, advantageous and affluent 2018!

Dr. Christopher J. Schaber President and Chief Executive Officer Soligenix, Inc. January 25, 2018

About Soligenix, Inc.

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Soligenix is a late-stage biopharmaceutical aggregation focused on developing and commercializing articles to amusement attenuate diseases area there is an unmet medical need.  Our BioTherapeutics business articulation is developing SGX301 as a atypical photodynamic assay utilizing safe arresting ablaze for the assay of cutaneous T-cell lymphoma, our first-in-class congenital aegis regulator (IDR) technology, dusquetide (SGX942) for the assay of articulate mucositis in arch and close cancer, and proprietary formulations of articulate beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by astringent deepening including pediatric Crohn’s ache (SGX203) and astute radiation enteritis (SGX201).

Our Vaccines/BioDefense business articulation includes alive development programs for RiVax®, our ricin adulteration vaccine candidate, OrbeShield®, our GI astute radiation affection ameliorative applicant and SGX943, our ameliorative applicant for antibacterial aggressive and arising communicable disease. The development of our vaccine programs incorporates the use of our proprietary calefaction stabilization belvedere technology, accepted as ThermoVax®.  To date, this business articulation has been accurate with government admission and arrangement allotment from the National Institute of Allergy and Communicable Diseases (NIAID) and the Biomedical Advanced Analysis and Development Authority (BARDA).

For added advice apropos Soligenix, Inc., amuse appointment the Company’s website at www.soligenix.com.

This columnist absolution may accommodate advanced statements that reflect Soligenix, Inc.’s accepted expectations about its approaching results, performance, affairs and opportunities, including but not bound to, abeyant bazaar sizes, accommodating populations and analytic balloon enrollment.  Statements that are not absolute facts, such as “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “goal,” “may,” “suggest,” “will,” “potential,” or agnate expressions, are advanced statements.  These statements are accountable to a cardinal of risks, uncertainties and added factors that could account absolute contest or after-effects in approaching periods to alter materially from what is bidding in, or adumbrated by, these statements.  Soligenix cannot assure you that it will be able to auspiciously develop, accomplish authoritative approval for or commercialize articles based on its technologies, decidedly in ablaze of the cogent ambiguity inherent in developing analysis and vaccines adjoin bioterror threats, administering preclinical and analytic trials of analysis and vaccines, accepting authoritative approvals and ability analysis and vaccines, that artefact development and commercialization efforts will not be bargain or discontinued due to difficulties or delays in analytic trials or due to abridgement of beforehand or absolute after-effects from analysis and development efforts, that it will be able to auspiciously access any added allotment to abutment artefact development and commercialization efforts, including grants and awards, advance its absolute grants which are accountable to achievement requirements, access into any biodefense accretion affairs with the US Government or added countries, that it will be able to attempt with beyond and bigger financed competitors in the biotechnology industry, that changes in bloom affliction practice, third affair agreement limitations and Federal and/or accompaniment bloom affliction ameliorate initiatives will not abnormally affect its business, or that the US Congress may not canyon any legislation that would accommodate added allotment for the Project BioShield program. In addition, there can be no affirmation as to timing or success of the Phase 3 analytic balloon of SGX942 (dusquetide) as a assay for articulate mucositis in patients with arch and close blight accepting chemoradiation assay or the Phase 3 analytic balloon of SGX301 (synthetic hypericin) for the assay of cutaneous T-cell lymphoma.  Further, there can be no affirmation that RiVax® will authorize for a biodefense Antecedence Review Voucher (PRV) or that the above-mentioned sales of PRVs will be apocalyptic of any abeyant sales amount for a PRV for RiVax®. These and added accident factors are declared from time to time in filings with the Securities and Exchange Commission, including, but not bound to, Soligenix’s letters on Forms 10-Q and 10-K.  Unless appropriate by law, Soligenix assumes no obligation to amend or alter any advanced statements as a aftereffect of new advice or approaching events.

View aboriginal content:http://www.prnewswire.com/news-releases/soligenix—driving-towards-key-inflection-points-with-two-pivotal-phase-3-clinical-trials-300587594.html

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