8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): December 22, 2020

Commission File No. 000-16929

Soligenix, Inc.

(Exact name of small business issuer as specified in its charter)

DELAWARE	41-1505029
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification Number)
29 Emmons Drive, Suite B-10 Princeton, NJ	08540
(Address of principal executive offices)	(Zip Code)

(609) 538-8200

(Issuer’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $.001 per share	SNGX	The Nasdaq Capital Market
Common Stock Purchase Warrants	SNGXW	The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company      ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.     ☐

Item 7.01 Regulation FD Disclosure.

On December 22, 2020, Soligenix, Inc. (the “Company”) issued a press release and hosted a conference call for purposes of preliminary top-line results for its pivotal Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) trial evaluating SGX942 (dusquetide) in the treatment of severe oral mucositis (SOM) in patients with head and neck cancer (HNC) receiving chemoradiation. The press release and conference call contain forward-looking statements regarding the Company, and include cautionary statements identifying important factors that could cause actual results to differ materially from those anticipated.

The press release issued December 22, 2020 is filed herewith as Exhibit 99.1, to this Current Report on Form 8-K and a copy of the Company’s conference call script is filed herewith as Exhibit 99.2.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press release of Soligenix, Inc. dated December 22, 2020.
99.2	Soligenix, Inc. Conference Call Script dated December 22, 2020.

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Soligenix, Inc.
December 22, 2020	By:	/s/ Christopher J. Schaber
		Christopher J. Schaber, Ph.D.
		President and Chief Executive Officer
		(Principal Executive Officer)

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EX-99.1

EXHIBIT 99.1

Soligenix Announces Topline Results from its Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients

Company to Host Investor Conference Call Today at 8:30AM EST

Princeton, NJ – December 22, 2020 – 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 preliminary top-line results for its pivotal Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) trial evaluating SGX942 (dusquetide) in the treatment of severe oral mucositis (SOM) in patients with head and neck cancer (HNC) receiving chemoradiation. The study enrolled 268 patients randomized 1:1 to receive either SGX942 or placebo. The primary endpoint of median duration of SOM did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group. Despite this clinically meaningful improvement, the variability in the distribution of the data yielded a p-value that was not statistically significant.

Other secondary endpoints supported the biological activity of dusquetide, including a statistically significant 50% reduction in the duration of SOM in the per-protocol population, which decreased from 18 days in the placebo group to 9 days in the SGX942 treatment group (p=0.049), consistent with the findings in the Phase 2 trial. Similarly, incidence of SOM also followed this biological trend as seen in the Phase 2 study, decreasing by 16% in the SGX942 treatment group relative to the placebo group in the per-protocol population. The per-protocol population was defined as the population receiving a minimum of 55 Gy radiation and at least 10 doses of study drug (placebo or SGX942) throughout the intended treatment period, with no major protocol deviations (e.g. breaks in study drug administration longer than 8 days between successive doses).  

“We are obviously very disappointed with the unanticipated outcome of the study,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. “Despite the fact that SGX942 demonstrated clinically meaningful reductions in oral mucositis consistent with the Phase 2 study, the Phase 3 trial did not achieve the statistically significant benefit we expected. Over the coming weeks, we will be analyzing the data to better determine why the study did not meet expectations. If there is any clarity gained from further analysis of the dataset, especially with respect to specific subsets of patients that may benefit from SGX942 therapy, we will certainly communicate our findings and explore follow-up discussions with the FDA and the EMA.”

Dr. Schaber continued, “With approximately $20 million of cash and our non-dilutive government funding, we will evaluate strategic options as we continue to execute on the multiple development programs across our rare disease pipeline. Most importantly, this will include the preparation of a New Drug Application for SGX301 in the treatment of cutaneous T-cell lymphoma, which demonstrated statistical significance in its pivotal Phase 3 clinical trial earlier this year, as well as continuing activities towards SGX301 U.S. commercialization where we expect peak annual sales to exceed $75 million.”

The Company will host a webcast and conference call today at 8:30 AM EST to review the top-line findings.

Conference Call, December 22, 2020 at 8:30 AM Eastern Time

The Company will share information on its Phase 3 top-line results for its SGX942 program in oral mucositis. A question and answer (Q&A) session with management will follow the presentations. If you would like to ask a question during the Q&A, please submit your request via email to ir@soligenix.com at least 15 minutes prior to the scheduled start of the call.

U.S. toll free: 1-866-652-5200
International:   1-412-317-6060
Please request to be entered into the Soligenix call.

A transcript of the presentation will be archived for 30 days following the event.

About Oral Mucositis

Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the U.S. per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.

The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.

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It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in HNC is a subpopulation of approximately 90,000 patients in the U.S., with a comparable number in Europe. Oral mucositis almost always occurs in patients with HNC treated with CRT and is severe, causing inability to eat and/or drink, in >80% of patients. It is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.

In the pediatric population, head and neck cancer is a rarer occurrence and is caused by different underlying pathologies. The major types of HNC in children are lymphoma, sarcomas (including rhabdomyosarcomas), and neuroblastoma rather than squamous cell carcinoma, the major type of adult HNC cancers. Hematopoietic stem cell transplantation (HSCT), especially allogeneic transplantation with higher risk of oral mucositis, is more frequently used in the pediatric population than in adults when treating a number of primary tumor types, as seen in leukemia and lymphoma. Both treatment of HNC and HSCT are associated with high risk of oral mucositis in the pediatric population.

Oral mucositis remains an area of unmet medical need where there are currently no approved drug therapies in the context of any solid tissue tumors.  

About the Phase 3 DOM-INNATE Study

This multinational, placebo-controlled, randomized study enrolled 268 subjects with squamous cell carcinoma of the oral cavity and oropharynx, scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m² every third week. Subjects were randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for two weeks following completion of CRT. The primary endpoint for the study is the median duration of SOM, assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Oral mucositis is evaluated using the WHO (World Health Organization) Grading system. SOM is defined as a WHO Grade of ≥3. A positive interim analysis was conducted in August 2019, resulting in the recommended addition of 35 subjects / group to the study to maintain 90% power. Subjects are being followed for an additional 12 months after the completion of treatment. Soligenix has been working with leading oncology centers internationally, a number of which participated in the Phase 2 study.

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.

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SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers. Positive efficacy results were demonstrated in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to CRT for HNC.

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 SOM 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 supported by a Phase II SBIR grant (#R44DE024032) award.

In addition, a high level review of the IDR technology platform is available here.

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 Specialized 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 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).

Our Public Health Solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company’s website at www.soligenix.com.

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This press release may contain forward-looking statements that reflect Soligenix, Inc.’s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “goal,” “may,” “suggest,” “will,” “potential,” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax^®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix’s reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

Company Contact:

Jonathan Guarino, CPA, CGMA

Senior Vice President and Chief Financial Officer

(609) 538-8200 | www.soligenix.com

Soligenix, Inc.

29 Emmons Drive, Suite B-10

Princeton, NJ 08540

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EX-99.2

EXHIBIT 99.2

Soligenix Corporate Update Conference Call

December 22, 2020

8:30 a.m. Eastern Time

Operator

Welcome to the Soligenix Corporate Update conference call. At this time all participants are in a listen-only mode. Following management’s prepared remarks, we will hold a Q&A session with the questions submitted by email prior to the call.

As a reminder, this is a timed conference call today. I would now like to turn the conference over to Mr. Jonathan Guarino. Please go ahead Sir.

Jonathan Guarino

Good morning, this is Jonathan Guarino, Chief Financial Officer at Soligenix. Thank you all for participating in today’s call.

Joining me from Soligenix are:

Dr. Christopher Schaber, President and Chief Executive Officer;

Dr. Richard Straube, Chief Medical Officer;

Dr. Oreola Donini, Chief Scientific Officer; and

Mr. Daniel Ring, Vice President of Business Development and Strategic Planning.

Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Soligenix.

I encourage you to review the Company’s past and future filings with the Securities and Exchange Commission including, without limitation, the Company’s Forms 10-K and 10-Q, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, December 22, 2020. Soligenix undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.

With that said, I would like to turn the call over to Dr. Schaber … Dr. Schaber.

Soligenix Conference Call 1

Chris Schaber

Thank you Jonathan.

Good morning everyone, and thank you for joining us.

Although I wish the occasion for this conference call was more positive, we thought it would be beneficial to our shareholders for us to provide an update on the topline results from the Phase 3 DOM-INNATE study of SGX942 (dusquetide) in the treatment of oral mucositis in head and neck cancer patients.

So with that, I will get right into the subject at hand. As many of you on the call this morning have probably seen, we announced that the DOM-INNATE study did not meet expectations. Unfortunately, after unblinding the double-blind, placebo-controlled, study, it was revealed that the required level of statistical significance for the predetermined primary efficacy endpoint was not achieved. This is obviously extremely disappointing to everyone working on the program … the Soligenix employees, our dedicated investigators and their staffs, you, the shareholders, as well as, and most importantly, the patients suffering from this disease and their families. What makes this result even more frustrating is the fact that there was clear evidence that the drug had a clinically meaningful impact on the disease similar to the improvement seen in the Phase 2 study but this failed to reach the predefined level of statistical significance (p≤0.05). Given that an independent data monitoring committee (DMC) recommendation adjusted sample size to maintain the high 90% statistical power, we were all cautiously optimistic that we had further de-risked the trial for potential success; however, this was not the case.

We are not prepared at this time to provide a definitive reason or reasons for this unexpected result; however, the company will look to initiate analyses of the unblinded data to obtain further clarity as to the potential cause or causes for this outcome. Depending on what we uncover following this review, we may request a meeting to discuss our findings with the FDA and/or EMA and potential next steps forward, if any. We will also provide you with an update on those findings.

Before turning the call over to Dr. Richard Straube, Chief Medical Officer of Soligenix to provide a bit more detail, I want to reiterate that the biologic activity of SGX942 is apparent and we remain committed to determining if there is a path forward so that we may provide treatment options for this area of high unmet medical need.

And even though this call is about the disappointing news with topline results for SGX942 in the treatment of oral mucositis, I would be remiss if I didn’t make note of our robust pipeline across our Specialized Biotherapeutics and Public Health Solutions business segments, including the positive and statistically significant Phase 3 results achieved in the FLASH study of SGX301 in the treatment of cutaneous T-cell lymphoma earlier this year, where we are currently preparing a New Drug Application for submission to the US FDA, while continuing our activities towards US commercialization where we expect the SGX301 market opportunity to exceed $75M annually. We also continue to pursue our Public Health Solutions business segment as well, with an ongoing $21.2M contract supporting RiVax^®, our ricin toxin vaccine development, renewed focus on our Marburg virus vaccine program, continued evaluation of SGX943 as an anti-infective agent under a DTRA sub-award and continued development of our heat stable COVID-19 vaccine program, CiVax™, which is beginning to garner added interest by the US government.

Soligenix Conference Call 2

Also, just a brief note on our financials. Current cash as of our call this morning is approximately $20M. Some of you may recall that our cash burn is offset by non-dilutive funding from the government, along with an approximate $1.1M we anticipate receiving from our NJ NOL tax credit and UK tax incentive credit, which gives us a cash runway of about 24 months. This puts us in a good position to execute on our multiple programs across our rare disease pipeline, including, working towards FDA approval and commercialization of our CTCL product in the US, while in parallel being aggressive in evaluating all strategic options. We are also investigating additional potential assets to fill our clinical program pipeline. In addition, keep in mind that we have an ATM in place with B. Riley FBR, which we can use to supplement cash, if/when the need arises.

With that said, I will now turn the call over to Dr. Richard Straube, our Chief Medical Officer, who will review the Phase 3 OM study.

For those of you not familiar with Rick’s background, he has had a long and distinguished career of more than 30 years in both academia and industry, most notably with the University of California at San Diego, Centocor, and INO Therapeutics. He is a board-certified pediatrician with a deep research background in orphan disease development, oncology, immune modulation and infectious diseases with a number of successful clinical trials and drug approvals under his belt.

Rick ….

Rick Straube

Thank you Chris.

As a background to the discussions concerning the results of this trial, I think it is important to understand the truly difficult nature of this disease. Oral mucositis is a by-product of chemotherapy and radiation therapy for tumor treatment. It is initiated by the direct damage caused by the chemotherapy and radiation that is necessary to treat the tumor and the damage is then amplified by the body’s over-exuberant inflammatory response of the innate immune system leading to the development of ulcers throughout the gastrointestinal mucosal surface that are particularly painful in the mouth. There is no approved drug for oral mucositis in head and neck cancer, or any other solid tumor setting, making it an area of unmet medical need.

Soligenix Conference Call 3

For most patients and doctors, managing OM is about managing through the pain, which is not well controlled by even opioids, and hoping that the subsequent damage, and inability to eat and/or drink, does not result in significant dehydration, malnutrition or infection, resulting in the need for hospitalization. Unfortunately, the pain can be so bad that patients will interrupt or stop their tumor treatment. Treatment gaps lasting more than 1 week have a significant impact on the ability to control the tumor, and cannot be “made up” with longer treatment – so it would be much preferred to treat the oral mucositis and therefore preserve the optimal tumor treatment regimen.

SGX942 does not interfere with the primary tumor treatment but does modulate the downstream inflammatory response, as well as providing enhanced anti-infective activity. In the Phase 2 study, in the subpopulation that included the same patients that were enrolled into the Phase 3 study, SGX942 statistically significantly reduced the duration of oral mucositis. In this trial we measured the development and duration of severe oral mucositis, meaning ulcers in the mouth so painful that they prevented patients from eating or from even drinking. This level of disease has the maximal impact on the patients’ prognosis with regards to secondary hospitalizations, infections, and potential dropout from all cancer therapy. In the patients who strictly adhered to all procedures in the protocol, we saw a statistically significant 50% reduction in the median duration of severe oral mucositis from 18 days in the placebo group to 9 days in the SGX942 group. Unfortunately, in the larger study population, the 56% reduction in median duration of severe OM from 18 days in placebo group to 8 days in the SGX942 group did not cross the required threshold for being statistically significant (p value ≤0.05).

This outcome is extremely disappointing in light of the biologic activity observed in the Phase 3 trial that provided for a clinically meaningful benefit seen that was consistent with the prior Phase 2 study.

Unfortunately, we do not have an understanding of what may have occurred at this time. Over the coming weeks, we will look to analyze the data further to determine if we can more definitively identify what may have occurred. For example, there may have been subpopulations of patients that did OR did not respond to SGX942 treatment or there could have been unexpected variability in the placebo patient population, which could have strongly impacted the statistical methods used.

Based on these findings, we hope to have a clearer understanding that may allow for a path forward for the program. Although this trial demonstrated clinically meaningful benefit, the lack of statistical significance predefined in the protocol makes it unlikely to support regulatory filings in either the US or EU.

Having said that, if we do see something meaningful in the dataset, we would anticipate having a discussion with the FDA and/or EMA about it to better understand the potential path forward with the OM program, if any.

Soligenix Conference Call 4

Given the high level observations we have seen to date with the Phase 3 study,

● we know that SGX942 has biologic activity in this patient population,

● we know that the response rates seen are consistent with previous clinical and preclinical data, and

● we know it was safe and well tolerated.

It is also important to note that dusquetide’s unique mechanism of action that reduces the innate immune system’s response to lower inflammation while at the same time increases both bacterial clearance and wound healing has potential to be used in a variety of other important indications. We have also recently shown that other routes of administration (e.g., intramuscular injection) are feasible, opening the door to use in biodefense and even potential home use.

In summary, although we did not demonstrate statistical significance in the study’s primary endpoint, the biologic activity of SGX942 is clearly evident. In the coming weeks we will be conducting a more thorough analysis of the results to better determine a potential path forward with the OM program.

Finally for clarity, I will also note that although these results are disappointing, they do not in any way diminish the outcomes of our other Phase 3 trial earlier this year, where we saw a strong and efficacious response to our SGX301 drug for the treatment of cutaneous T-cell lymphoma and where we continue to progress towards regulatory approval and commercialization.

I will now hand it to Dr. Donini to provide a brief update on our Public Health Solutions business segment.

Oreola …

Oreola Donini

Thanks Rick.

While we are disappointed by the data produced in the Phase 3 study, our robust rare disease pipeline moves forward. We are continuing to develop the SGX301 product, with its statistically significant Phase 3 result this year, in cutaneous T-cell lymphoma.

We also continue to develop our Public Health Solutions assets, including our ricin toxin vaccine, RiVax. This product has been proven to be safe and efficacious in animal studies, safe in Phase 1 human studies and has also been formulated as a thermostabilized product, stable at room temperature. Further development here will require additional manufacturing and clinical studies, as well as pivotal animal efficacy studies under the Animal Rule (in lieu of Phase 3 clinical studies). We estimate the market for this product would include procurement contracts from the US and potentially other governments. As well, the product may qualify for a priority review voucher, which has the potential to provide added significant value to this asset.

Soligenix Conference Call 5

Using the same thermostabilization technology, we are also working on a COVID-19 vaccine, which has shown very promising responses in preclinical animal studies. Relative to other vaccine candidates, our COVID vaccine, CiVax, would be heat stabilized and delivered in single dose vials which could be reconstituted with sterile water for injection. This would mean the product could be stored and distributed at ambient temperature (no fridges or freezers needed) and could be used on a single dose basis as needed after reconstitution. The vaccine platform is a protein subunit, one of the best characterized platforms with a well-established track record of safety. Moreover, the platform can also be used to produce multivalent vaccines – potentially including antigens for multiple versions of the SARS-CoV-2 virus, should that be necessary. While our product is earlier in development, and will not be ready for first generation use in the developed world, it may make significant contributions to protecting the world wide population and to supporting any need for annual or seasonal re-vaccinations. We continue to pursue funding for this program and to develop it in partnership with our collaborators at the University of Hawaii.

With this high level update, I will now hand it back to Dr. Schaber to conclude the call.

Chris …

Chris Schaber

Thank you Rick and Oreola for those comments. Before going to Q&A, I wanted to briefly provide some concluding remarks.

As you can tell from this morning’s call, we are all very disappointed in this outcome, especially in light of the biologic activity that has been observed with SGX942 in the Phase 3 and in previous trials. Over the coming weeks, we will work to better understand what may have occurred with the trial; however, we will also be focusing on advancing towards regulatory filings and commercialization for SGX301.

Now, prior to going to Q&A, I would also like to again caution everyone, that at this time, we are unfortunately limited in what we can say regarding the Phase 3 data.

With that – we will now take your questions.

Operator.

Operator

With the time remaining, we will now open the line for electronic questions.

Soligenix Conference Call 6

Q&A

Operator

As there are no further questions at this time, I would like to turn the call back to Dr. Schaber for closing remarks.

Chris Schaber

Thank you Operator. As I noted, we will continue to keep you all updated.

Thank you for taking the time to participate this morning. I hope everyone has a happy and healthy Holiday Season.

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Soligenix Conference Call 7