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SNGX Per 11/12 earnings: current $90mm sales with forecast of $700mm AND $29m in CASH on hand + additional $865,000 grant from July, 2021 !
SNGX is SOLID with a very healthy & advanced Pipeline...
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SNGX tiny 40m float getting tore through this morning!
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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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SNGX January 4,2022-Dusquetide Demonstrates Positive Anti-tumor Efficacy.
"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 dusquetide is effective at reducing tumor size in nonclinical xenograft models. Recent studies, recapitulating results from previously published studies, have confirmed the efficacy of dusquetide as a stand-alone and combination anti-tumor therapy, with radiation, chemotherapy and targeted therapy, in the context of the MCF-7 breast cancer cell line. 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).
Based on the biological proof of principle shown both nonclinically and clinically with dusquetide, a novel synthetic peptide that modulates the body's innate immune system, Soligenix continues to explore product opportunities, both in the reduction of oral mucositis in HNC and as a potential anti-cancer treatment. Dusquetide binds to p62 or SQSTM-1, a scaffold protein implicated in a number of intracellular signaling networks implicated in tumor cell survival, including autophagy. The role of p62 is best characterized in multiple myeloma and breast cancer. All variants of breast cancer, including metastatic breast cancer, estrogen receptor positive (ER+), human epidermal growth factor receptor 2 high expressing (HER2+) and triple negative expressing cell lines, have demonstrated a significant role for p62 in tumorigenesis.
The MCF-7 cell line tested in the xenograft studies with dusquetide is both ER+ and responsive to anti-HER2 treatment. Treatment with dusquetide was effective not only as a stand-alone treatment (p<0.01 for tumor size), but also in conjunction with radiation (p<0.05 vs radiation only for survival), chemotherapy (paclitaxel) and targeted treatment (trastuzumab; p<0.001 vs. placebo only for tumor size), reducing tumor size and enhancing overall survival. Other tumor types also have been shown to be dependent on p62 expression, including multiple myeloma, liver cancer (hepatocellular carcinoma), lung cancer (non-small cell lung cancer, EGFR-TKI-resistant lung cancer), intestinal cancer (small intestinal adenocarcinoma and gastric cancer), and colorectal cancer and ovarian cancer (multi-drug resistant).
"Soligenix continues to pursue potential product opportunities with our new chemical entity dusquetide, including in oncology," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With the supportive data from the Phase 2 and 3 oral mucositis trials, and the nonclinical anti-tumor efficacy demonstrated, we continue to pursue potential partnership for this novel molecule."
About Dusquetide
Dusquetide (the active ingredient in SGX942) is an innate defense regulator (IDR), a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory, anti-infective and tissue healing response. IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, macrophage activation syndrome (MAS) as well as bacterial infections, including melioidosis. Potential anti-tumor activity has been demonstrated in in vitro and in vivo xenograft studies.
SGX942 has demonstrated safety and tolerability in a Phase 1 clinical study in 84 healthy human volunteers. Positive efficacy results were demonstrated in an exploratory Phase 2 clinical study (Study IDR-OM-01) in 111 patients with oral mucositis due to CRT for HNC, including potential long term ancillary benefits. The Phase 3 multinational, placebo-controlled, randomized study evaluated the impact of dusquetide on the duration of SOM in 268 subjects with squamous cell carcinoma of the oral cavity and oropharynx, scheduled to receive a minimum total cumulative radiation dose of 55 Gy with concomitant cisplatin chemotherapy. A clinically meaningful reduction in the duration of SOM was observed in the ITT population and a clinically and statistically significant reduction was observed in the per protocol population.
SGX942 has received Fast Track Designation from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in HNC patients, as well as Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare products Regulatory Agency for the treatment of severe oral mucositis in HNC patients receiving CRT. In addition, products containing the same active ingredient, dusquetide, have been granted Fast Track Designation as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis and Orphan Drug Designations in the treatment of MAS and the treatment of acute radiation syndrome.
Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada. Soligenix has received partial funding from NIH for its oral mucositis clinical studies. The Phase 2 study was supported with a Phase I SBIR grant (#R43DE024032) award, with the Phase 3 study being supported by a Phase II SBIR grant (#R44DE024032) award.
In addition, a high level review of the IDR technology platform is available here."
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How Strong Is Soligenix's Balance Sheet?
We can see from the most recent balance sheet that Soligenix had liabilities of US$4.80m falling due within a year, and liabilities of US$9.87m due beyond that. On the other hand, it had cash of US$28.9m and US$148.0k worth of receivables due within a year. So it actually has US$14.4m more liquid assets than total liabilities.
This excess liquidity is a great indication that Soligenix's balance sheet is almost as strong as Fort Knox. Having regard to this fact, we think its balance sheet is as strong as an ox. Simply put, the fact that Soligenix has more cash than debt is arguably a good indication that it can manage its debt safely. The balance sheet is clearly the area to focus on when you are analysing debt. But it is future earnings, more than anything, that will determine Soligenix's ability to maintain a healthy balance sheet going forward. So if you want to see what the professionals think, you might find this free report on analyst profit forecasts to be interesting.
https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-sngx/soligenix/news/is-soligenix-nasdaqsngx-using-too-much-debt
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Looks like TLSS share structure changed? Crazy people selling for that...
"Under the terms of a Securities Purchase Agreement relating to the new financing, the Company issued to certain accredited investors in a private placement an aggregate of 615,000 shares of Series G Convertible Preferred Stock of the Company, par value $0.0001 per share ("Series G Shares") and warrants to purchase 615,000,000 shares of common stock of the Company, par value $0.0001 per share ("Common Stock"), at an exercise price of $0.01 per share ("Warrants"). The conversion price of the Series G Shares is $0.01. The shares of Common Stock issuable upon conversion of the Series G Shares, if the Series G Shares were converted on December 31, 2021, would be approximately 689,655,337 shares."
So + 689mm shares?
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TLSS files 8k 1/3/2022=Got $6.1mm financing for acquisition!
"Transportation and Logistics Systems, Inc. Closes $6,150,000 Financing
8:00 am ET January 3, 2022
Provides SalSon Logistics, Inc. Acquisition Update
JUPITER, FL / ACCESSWIRE / January 3, 2022 / Transportation and Logistics Systems, Inc. (OTCQB:TLSS), ("TLSS" or the "Company"), a growing logistics service provider, today announced that on December 31, 2021, it closed an equity financing which provided gross proceeds of $6,150,000.
According to CEO John Mercadante, "The Company is gearing up for 2022 and believes that this financing provides the Company with adequate working capital for the year and with funds that can be deployed, in part, in connection with acquisition opportunities."
Under the terms of a Securities Purchase Agreement relating to the new financing, the Company issued to certain accredited investors in a private placement an aggregate of 615,000 shares of Series G Convertible Preferred Stock of the Company, par value $0.0001 per share ("Series G Shares") and warrants to purchase 615,000,000 shares of common stock of the Company, par value $0.0001 per share ("Common Stock"), at an exercise price of $0.01 per share ("Warrants"). The conversion price of the Series G Shares is $0.01. The shares of Common Stock issuable upon conversion of the Series G Shares, if the Series G Shares were converted on December 31, 2021, would be approximately 689,655,337 shares.
With regard to the proposed acquisition of SalSon Logistics, Inc. ("SalSon"), the Stock Purchase Agreement pertaining to that transaction expired in accordance with its previously disclosed terms on or about September 15, 2021. Notwithstanding the foregoing, TLSS and SalSon are jointly exploring alternative financing options backed by the significant value of SalSon's assets, even without the benefit of a definitive agreement in place. However, the Company cannot give any assurance that it will, in fact, be able to enter into a new agreement to acquire SalSon or, if it does, that the Company would be able to obtain the significant amount of financing that would be required to consummate an acquisition of SalSon.
Even as it continues to devote time and effort to a possible SalSon acquisition, the Company is also in discussion with several other companies concerning potential acquisition opportunities and given the consummation of the Series G financing, the Company believes that such financing has put the Company in a much stronger financial position than before to execute on strategic acquisition opportunities in 2022."
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GRAY lets go !
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GRAY manipulated down with such Low-volume since July.
GRAY with crazy Low 21m Float has 200% pops when volume hits.
It's about time GRAY...
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SNGX reversal finally...
Back to $2s or over $2.50?
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GRAY's "cup" just spilled out...
What the heck?
STOP selling GRAY !
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What’s with the DWAC after-hours Dip??
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Thanks SL. We've seen GRAY do it before with this low float so...
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SNGX perfect timing with Omicron threat!
And fake news instructed refer as”deadly protest”…
DWAC has billions & billions & billions of potential followers !!!
Hey I’m working still what’s the DWAC deal after hours???
TYIS
Saw this on Bigs coming in 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 4x volume 1st 1hr trading 11/23.
What news is coming ?
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TLSS Tues 11/23/2021. Former Owner Rejoins Company
JUPITER, FL / ACCESSWIRE / November 23, 2021 / Transportation and Logistics Systems, Inc. (OTCQB:TLSS), ("TLSS", or the "Company"), a growing logistics service provider, today announced that former Cougar Express owner John Cerrito Sr. and his son, John Cerrito, Jr. have re-joined Cougar Express.
John Mercadante, Chairman and CEO of TLSS, commented, "Having John Sr. come back into the fold, given his years of experience and strong ties in the industry and long-standing relationships with customers, will have an immediate positive impact on operations."
John Cerrito, Sr. has nearly 50 years of experience in the transportation and logistics industry and started Cougar Express in 1991. John Sr. will be responsible for managing and growing the operations of Cougar Express. which is located just eight (8) minutes from JFK airport, servicing Long Island, Westchester, the five boroughs of New York City and New Jersey.
In addition, John Cerrito, Jr. who previously worked with Cougar Express for 15 years, has also returned, to resume his former role overseeing dispatch, customer service and truck drivers.
About Transportation and Logistics Systems, Inc.
TLSS, through its wholly owned operating subsidiaries, Cougar Express, Inc and Shyp FX, Inc., operates as a full-service logistics and transportation company.
For more information, visit the Company's website, www.tlss-inc.com.
Forward Looking Statements
Statements in this press release regarding the Company that are not historical facts are forward-looking statements and are subject to risks and uncertainties that could cause actual future events or results to differ materially from such statements. Any such forward-looking statements, including, but not limited to, financial guidance, are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not directly or exclusively relate to historical facts. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "intend," "plan," "goal," "seek," "strategy," "future," "likely," "believes," "estimates," "projects," "forecasts," "predicts," "potential," or the negative of those terms, and similar expressions and comparable terminology. These include, but are not limited to, statements relating to future events or our future financial and operating results, plans, objectives, expectations and intentions. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these expectations may not be achieved. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they represent our intentions, plans, expectations, assumptions and beliefs about future events and are subject to known and unknown risks, uncertainties and other factors outside of our control that could cause our actual results, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. In addition to the risks described above, these risks and uncertainties include: our ability to successfully execute our business strategies, including integration of acquisitions and the future acquisition of other businesses to grow our company; customers' cancellation on short notice of master service agreements from which we derive a significant portion of our revenue or our failure to renew such master service agreements on favorable terms or at all; our ability to attract and retain key personnel and skilled labor to meet the requirements of our labor-intensive business or labor difficulties which could have an effect on our ability to bid for and successfully complete contracts; the ultimate geographic spread, duration and severity of the coronavirus outbreak and the effectiveness of actions taken, or actions that may be taken, by governmental authorities to contain the outbreak or ameliorate its effects; our failure to compete effectively in our highly competitive industry could reduce the number of new contracts awarded to us or adversely affect our market share and harm our financial performance; our ability to adopt and master new technologies and adjust certain fixed costs and expenses to adapt to our industry's and customers' evolving demands; our history of losses, deficiency in working capital and a stockholders' deficit and our ability to achieve sustained profitability; material weaknesses in our internal control over financial reporting and our ability to maintain effective controls over financial reporting in the future; our substantial indebtedness could adversely affect our business, financial condition and results of operations and our ability to meet our payment obligations; the impact of new or changed laws, regulations or other industry standards that could adversely affect our ability to conduct our business; and changes in general market, economic and political conditions in the United States and global economies or financial markets, including those resulting from natural or man-made disasters.
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SNGX is prime candidate to be acquired:
“We are also continuing to actively assess various strategic options, including but not limited to, partnership and merger and acquisition opportunities."
Soligenix Recent Accomplishments
-- On November 8, 2021, the Company 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. To view this press release, please
click here.
-- On November 4, 2021, the Company 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. To read the publication,
please click here. To view this press release, please click here.
-- On September 28, 2021, the Company 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. To view the publication, please click
here. To view this press release, please click here.
-- On September 16, 2021, the Company 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. To view this press release, please click
here.
-- On September 9, 2021, the Company 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. To
view this press release, please click here.
-- On August 23, 2021, the Company 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
SNGX 4x volume AH & pps +20%
SNGX: Double immunity for Rivax.
https://bit.ly/3nCL64U
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SNGX Q3 results 11/12/2021. $29mm on hand + Gvt Funding. Beats EPS by .03.
"Nov. 12, 2021 -- 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 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. Additionally, we announced expansion of synthetic hypericin development into psoriasis, under the research name SGX302, where we plan to initiate a Phase 2a clinical study in the second half of 2022. This decision follows validation of synthetic hypericin's biologic activity in the FLASH study, as well as positive proof-of-concept (PoC) demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, a large and underserved market with a significant unmet medical need. Under our Public Health Solutions business segment, we remain focused on developing heat-stable vaccines for global use. Most notably, we announced publication of compelling pre-clinical immunogenicity studies for CiVax(TM) (heat stable COVID-19 vaccine program) demonstrating durable broad-spectrum neutralizing antibody responses in non-human primates (NHPs), including against the Beta, Gamma and Delta variants."
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."
Soligenix Recent Accomplishments
-- On November 8, 2021, the Company 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. To view this press release, please
click here.
-- On November 4, 2021, the Company 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. To read the publication,
please click here. To view this press release, please click here.
-- On September 28, 2021, the Company 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. To view the publication, please click
here. To view this press release, please click here.
-- On September 16, 2021, the Company 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. To view this press release, please click
here.
-- On September 9, 2021, the Company 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. To
view this press release, please click here.
-- On August 23, 2021, the Company 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. To view this press release, please
click here.
-- On August 18, 2021, the Company 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. To read the article, please click here. To view this press
release, please click here.
Financial Results -- Quarter Ended September 30, 2021
Soligenix's revenues for the quarter ended September 30, 2021 were $0.2 million as compared to $0.6 million for the quarter ended September 30, 2020. Revenues primarily included payments on grants received to support the development of: SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax(R) , our thermostabilization platform technology; and CiVax(TM), our vaccine candidate for the prevention of COVID-19.
Soligenix's basic net loss was $3.6 million, or ($0.09) per share, for the quarter ended September 30, 2021, as compared to $1.8 million, or ($0.06) per share, for the quarter ended September 30, 2020. This increased net loss was primarily due to a reduction in revenue from the expiration of government contracts, an increase in research and development expenses associated with the continued development of HyBryte(TM) and additional interest expense on convertible debt.
Research and development expenses were $2.5 million as compared to $1.3 million for the quarters ended September 30, 2021 and 2020, respectively. The increase in research and development spending for the quarter ended September 30, 2021 was primarily attributable to the increased expenses associated with the continued development of HyBryte(TM)."
GLTA
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SNGX volume LOW, but is this drop really tax sells already?
I see NO news either way to cause drop...
GLTA
GRAY earnings today 11/11, and presenting tomorrow 11/12:
"Graybug Vision To Participate In The American Academy Of Ophthalmology 2021 Annual Meeting Nov. 12-15"
"Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today announced two clinical data presentations at the American Academy of Ophthalmology (AAO) 2021 Annual Meeting to be held on November 12-15, 2021 in New Orleans, Louisiana, as well as a company presentation at the Eyecelerator@AAO 2021 event on November 11, 2021:
-- Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, to present company overview as part of Retina Showcase at Eyecelerator@AAO 2021 on November 11, 2021, at 2:50 p.m. ET / 1:50 p.m. CT / 11:50 a.m. PT, followed by a panel discussion.
-- Arshad Khanani, MD, MA, to present scientific E-Poster titled "Safety and Durability of Intravitreal Sunitinib Malate Depot (GB-102) in Wet Age-Related Macular Degeneration (ALTISSIMO, Phase 2b Trial)". AAO attendees will be able to view E-Poster any time the Exhibit Hall is open from November 12-15. E-Poster will be available for viewing on AAO website after the Annual Session.
-- Veeral Sheth, MD, to present late breaker titled "Intravitreal Sunitinib Malate Depot (GB-102): Durability and Safety in Wet Age-Related Macular Degeneration (ALTISSIMO, Phase 2B)" at AAO Retina Subspecialty Day on November 13, 2021, at 10:02 a.m. ET / 9:02 a.m. CT / 7:02 a.m. PT."
GLTA
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Did GOTU have reverse splits in March & July ?
Did they go ch11?
Why the massive drops ?
TYIA
JNUG with Gold really breaking out pre-market!
GLTA
Also from PR:"The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II Small Business Innovation Research (SBIR) grant (#1R44CA210848-01A1) awarded to Soligenix, Inc."
SNGX consistent progress & great confirmations today !
SNGX keeps progress coming
Nice catch. Hope rebound is Fast !
GLTA
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I am in DWAC... Great day to start... GLTA !
100% old SNGX news from May.
SNGX with 6 others in later 50% half of pipeline/progress. Besides Hybryte (delayed) 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 !
Hybrite delay only which we knew 3mo ago. Baked in to .96 pps.
I can wait for their 6 others.
SNGX after hours announcement ?
I see no filings ???
It is SMALL volume but all red …
What the heck EID ???
Premarket buyers today dumped?
AEI only touched $2.12 twice in past Month so lets see...
I’d like to try these $55s, but $45s likely coming before heads back UP