SLRX - Undervalued, Well Funded Biotech Clicking On All Cylinders With THREE (3) ASCO 2021 Posters And Significant Growth Ahead

Summary

• Salarius will present three posters at the 2021 ASCO meeting in June as a stand alone therapy and in combination with chemotherapy agents being used to treat Ewing Sarcoma.
• By mid-2021 Salarius expects to have up to three total separate and active clinical trials underway evaluating seclidemstat (SLD1 reversible inhibitor) in up to five distinct patient populations.
• Salarius will announce additional clinical trials in the near future thus maximizing the use of the $36.6M in cash and cash equivalents it ended with in 1Q 2021.
• Salarius now has the capital resources to fund current clinical trials through completion and beyond, while at the same time developing seclidemstat in significantly larger commercial markets, including hematological cancers and other potential therapy combinations such as immunotherapy.
• Bristol-Myers Squibb has an LSD1 reversible inhibitor and other other companies are entering the fast-growing epigenetics oncology arena. This should reassure investors that the field is being actively investigated. Because the field is growing in size and interest, it's just a matter of time for large pharma to swallow and/or to form partnerships with smaller players with proven drugs such as Salarius. This has happened to Essa Pharma, another CPRIT grant recipient, and its valuation has skyrocketed in the last 12 months.

Recent Accomplishments And Three Upcoming ASCO Posters

Update (May 20, 2021): 

• The three abstracts to be presented at ASCO 2021 can be seen here

During the May 12, 2021 1Q 2021, Company management discussed the following key accomplishments in recent months

1) Completed the dose escalation phase of the Phase 1/2 clinical trial in Ewing sarcoma and accomplished the following:

• Determined LSD1 inhibitor seclidemstat's safety profile,
• Confirmed that we can reach seclidemstat plasma concentration levels above where efficacy was observed in animal and cell models
• Established the recommended Phase 2 dose.

2) Dose escalation across Ewing and advanced solid tumor trials,

• Seclidemstat demonstrated signs of drug activity in patients with Ewing sarcoma and in additional sarcomas that share a similar biology to Ewing. These additional sarcomas are also referred to as Ewing-related sarcomas or FET-rearranged sarcomas.
• As a result of the above and as another milestone, the company initiated the dose expansion stage of the clinical trial – expanding to include three distinct patient populations, Ewing sarcoma, myxoid liposarcoma and other FET-rearranged sarcomas.
• With each of these three patient groups:
  • Have separate potential regulatory paths to approval,
  • There is potential for accelerated regulatory approval and a
  • Have distinct commercial opportunity

Completion of the dosing data phase of the seclidemstad program is a significant achievement as it confirms the ability to treat patients with a twice daily oral regimen (Note - this is NOT chemotherapy). It is also transcendental that this regimen can achieve drug levels in humans where efficacy was observed in animal models.

LSD1 inhibition is a relatively new and potentially game-changing area of cancer research and opportunity as the effect and properties of LSD1 were first reported in 2004. Because of this and being a pioneer in this field, Salarius received an $18.4M grant from the Cancer Research and Prevention Institute of Texas (CPRIT) in 2016. The company still has $4.8M non-dilutive funds left from the award which it receives upon accomplishing certain milestones agreed upon with CPRIT. Another example of CPRIT's involvement in the development of novel cancer therapies was the 2014 $12M grant to Essa Pharma (NASDAQ:EPIX) for its novel approach to fighting prostate cancer. EPIX market cap is now over $1B and it's also an early-stage biotech like SRLX with only $59M market cap and having $37M in cash and no debt. I believe the market will recognize Salarius' significant potential and will reward it with richer valuations just like like it did to EPIX.

Regarding the most recent seclidemstad program accomplishments, CEO David Arthur stated:

“Building upon the preliminary safety and efficacy data observed during the dose escalation stage of the Ewing trial, the trial was amended to explore the use of seclidemstat in combination with chemotherapy agents, topotecan and cyclophosphamide. These are common second or third line treatments for Ewing sarcoma.”

Regarding the trial amendment, Salarius CEO David Arthur commented:

"I want to pause here and I want to highlight this trial amendment or change because we believe this is an important development and I would like to discuss this in more detail. This change makes it easier for physicians to utilize seclidemstat earlier in the treatment continuum and potentially improves outcomes for Ewing sarcoma patients. Because topotecan and cyclophosphamide are routinely administered as second or third line therapy, we believe the addition of seclidemstat to that combination will integrate seclidemstat into the existing treatment regimen for Ewing patients earlier and increase the number of Ewing patients who can receive seclidemstat."

"Treating Ewing sarcoma patients through seclidemstat in combination with a common chemotherapy is a second or third line treatment is in stark contrast to the Ewing trial's dose escalation stage where patients were treated with single-agent seclidemstat, meaning without any other anti-cancer therapies. Additionally and also in stark contrast, patients treated during dose escalation were treated later in the continuum of care, as in patients received two to 12 prior lines of therapy before receiving seclidemstat versus the new amended protocol where patients only received one or two prior lines of therapy before receiving seclidemstat."

"In summary, we are expanding the addressable Ewing population and now treating Ewing patients earlier in the continuum of care with combination chemotherapy, which we believe will result in improved patient outcomes. In addition to increasing the addressable Ewing patient population, the trial expansion includes new patient populations of FET-rearranged sarcoma patients including, as I mentioned earlier, myxoid liposarcoma and other FET-rearranged sarcoma patients, which also significantly increases seclidemstat' overall potential addressable market."

"As you can see, compared to a year ago, our clinical activities have expanded dramatically. What's more, Salarius substantially strengthened its capital position by completing a series of financial transactions during the first quarter that raised more than $30 million. We currently have the capital resources to fund our current clinical trials through completion and beyond, while at the same time developing seclidemstat in larger commercial markets, including hematological cancers and other potential therapy combinations."

In the Q1 2021 conference call, CEO David Arthur made the following closing remarks:

"Our ultimate goal is to maximize the potential of seclidemstat and by doing so, make a difference in the lives of patients and their families fighting cancers with limited treatment options. Expanding seclidemstat into new and larger markets is the second prong of our two-pronged development strategy of speed to market and expand the market. To that end, we hope by mid-2021 to have up to three total separate and active clinical trials underway evaluating seclidemstat in up to five distinct patient populations and we are planning for these trials to explore seclidemstat not only as single agent therapy but also as a component in up to three different combination therapies."

"As discussed earlier, completing the dose escalation stage of our Ewing trial was a major accomplishment and we believe that the trial achieved all key endpoints established at its initiation, including demonstrating early evidence of seclidemstat antitumor activity. Full findings will be disclosed next month during a poster session and poster discussion at the 2021 annual meeting of the American Society of Clinical Oncology, also known as ASCO."

"When the clinical evidence is considered in the context of Salarius now treating Ewing patients second and third line with seclidemstat in combination with topotecan and cyclophosphamide, we believe there is potential for positive patient outcomes. We believe this potential is also supported by our internal preclinical research demonstrating that in Ewing sarcoma cell lines, seclidemstat has a synergistic effect when combined with topotecan and cyclophosphamide."

"In addition to the Ewing clinical evidence, we also observed encouraging clinical data from a small subset of patients with relapsed or refractory FET-rearranged sarcomas who are enrolled in the Salarius advanced solid tumor trial. All patients in this small subset demonstrated indications of single agent drug activity despite being treated at dose levels below the recommended Phase 2 dose. This data along with patient data from other cancer types will also be presented next month during an ASCO poster session."

Importantly,

"Salarius has also completed much of the necessary work to begin clinical trials in additional cancer indications such as gynecological cancers and hematologic cancers and we look forward to announcing additional trials in the near future. We believe there is substantial unexplored potential ahead for seclidemstat in other underserved cancers, including areas that we have previously discussed, such as the use of seclidemstat in combination with checkpoint inhibitors."

CEO David Arthur stated the following when asked by an analyst about the three ASCO 2021 posters the company will present in early June:

"So the abstract, when it's released, as you know, is a short summary of the findings. What I will share with you is, we have submitted three posters along with two recorded presentations to ASCO. And the posters for the Ewing sarcoma dose escalation trial and advanced solid tumor dose escalation trial contain all the information that I think you are looking for."

"It will have an update on safety and the most common adverse events. It will have swimmer plots of both trials identifying length of treatment and any adjustments to dosage. It will also have the response data that you would expect to see based on RECIST criteria and also other assessments of drug activity that we think are relevant."

Answering a follow-up question about the ASCO posters, CEO Arthur further commented:

"The posters that we have submitted for ASCO that support the abstracts that I think you are referring to, contain extensive information in detail about the two studies. Abstracts, as you know, are short and really only provide summary comments on the findings. The posters and I have mentioned and maybe previously, include significant detailed information on safety findings, on response criteria. They include summary plots and they include assessment of not only the RECIST criteria but also other assessments that we feel demonstrate the drug activity that we see and we really believe is supporting the continued drug, the development of this drug in the clinic. So I think the information you are looking for is really going to come out in the poster sessions."

CEO Arthur concluded the call with the following remarks:

"So as you heard from today's discussion, Salarius had never been in a stronger position. We entered this year firing on all cylinders and with positive momentum and we are now actively enrolling multiple patient populations for treatment with seclidemstat in combination with a common chemotherapy treatment and for treatment as a single agent."

"We are planning to announce additional clinical trials in the near future and we closed the first quarter with $36.6 million in cash and cash equivalents, enough to fund our ongoing clinical trials through completion and beyond. We look forward to maintaining and building upon this momentum as we continue to advance and expand the clinical development of seclidemstat."

Regarding the three ASCO 2021 posters that CEO Arthur and other members of management discussed during the 1Q 2021 conference call, the company announced on April 29, 2021 the following posters:

Abstract #11514: "Phase 1 trial of seclidemstat (SP-2577) in patients with relapsed/refractory Ewing sarcoma."Session: Poster Discussion Session, Sarcoma

Abstract #TPS11577: "Phase 1 expansion trial of the LSD1 inhibitor seclidemstat (SP-2577) with and without topotecan and cyclophosphamide (TC) in patients (pts) with relapsed or refractory Ewing sarcoma (ES) and select sarcomas."Session: Poster Session, Sarcoma

Abstract #3073: "Preliminary efficacy from an ongoing phase 1 dose escalation study of seclidemstat (SP-2577) in patients (pts) with advanced solid tumors (AST)."Session: Poster Session, Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

The titles of the abstracts are currently available on ASCO’s 2021 Meeting Library with full abstracts, including the dates and times of presentations, scheduled for publication at 5 p.m. ET on May 19, 2021. 

David Arthur, President and CEO of Salarius Pharmaceuticals commented:

“We are pleased to have all three of our submitted abstracts highlighting clinical research involving seclidemstat accepted for poster presentations at the 2021 ASCO Annual Meeting. As previously noted, the full findings from the dose-escalation stage of the Phase 1/2 trial of seclidemstat in patients with relapsed and refractory Ewing sarcoma, including details on safety, dosing, and initial efficacy signals, will be reported at the conference. Moreover, we will report preliminary data from a second clinical trial in patients with advanced solid tumors, which include additional select sarcomas that share a similar biology to Ewing sarcoma, also referred to as Ewing-related or FET-translocated sarcomas.”

Discussion

Salarius Pharmaceuticals (NASDAQ:SLRX) is a clinical-stage oncology company targeting the epigenetic causes of cancers. The company website provides an extensive explanation on Epigenetics. 

The company website summarizes its technology platform as follows:

"Our technology targets the epigenetic causes of cancer which is the study of the regulatory system that controls how genes are turned “on” or “off.” In certain cancers, the proteins that regulate gene expression become dysregulated and incorrectly turn genes “on” or “off,” which in some cases leads to cancer progression. Drugs that are able to safely modify the activity of these epigenetic regulators may correct the gene changes that are driving disease. Our technology may also apply to hormonal cancers such as prostate, breast, ovarian cancer and perhaps other conditions like leukemia."

The literature suggests that environmental factors and lifestyle can alter the way our genes are expressed influencing a network of chemical switches within our cells collectively known as the Epigenome. Among the epigenetic mechanisms orchestrating the gene expression, methylation is of foremost importance. Dysregulations of histone methylation patterns lead to the repression or activation of signaling pathways that often promote the genesis and progression of disease states such as cancer.

Salarius’ lead candidate, seclidemstat, is based on the emerging science of epigenetics, is in clinical development for the treatment of Ewing sarcoma. Its is also being advanced as a potential therapy for several cancers with high unmet medical need, with a second Phase 1/2 clinical study in advanced solid tumors, including prostate, breast, and ovarian cancers.

Seclidemstat is a reversible LSD1 inhibitor which inhibits LSD1's demethylation and scaffolding properties, providing a validated relatively new therapeutic option for patients with solid and liquid tumors in a wide range of cancer types.

LSD1 inhibition is a relatively new area of cancer research and opportunity as the effect and properties of LSD1 were first reported in 2004.

Salarius has received non-dilutive financial support from the National Pediatric Cancer Foundation to advance the Ewing sarcoma clinical program and was also the recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). 

The $18.4M non-dilutive financing received from CPRIT is particularly important 

Seclidemstad has received the following FDA designations for Ewing sarcoma:

(1) Rare Pediatric Disease Designation,

(2) Orphan Drug Designation, 

(3) Fast Track Approval.

Ewing sarcoma is a devastating pediatric illness and represents a major unmet clinical need. Currently, chemotherapy, radiation and tumor resection surgery are the only options for patients, and in many cases the tumors reoccur or is in too delicate of a location to risk surgery. There is a 70%-90% five-year mortality rate for patients whose tumors recur after treatment or who are initially diagnosed with metastatic disease. Translocations involving the EWS gene are the sole driver for over 85% of Ewing sarcoma, and the EWS protein must complex with LSD1 to induce a cancer phenotype. Seclidemstat blocks this LSD1-EWS interaction to reverse cancer pathology resulting in cures in animal models."

Seclidemstad, a Reversible LSD1 Inhibitor

Seclidemstat is a small molecule inhibitor of an epigenetic enzyme called lysine-specific demethylase 1 (LSD1), highly expressed in certain cancers and associated with aggressive disease and poor prognosis. Depending on the specific type of cancer, LSD1 can associate with a myriad of proteins to drive tumor growth. For instance, in prostate cancer LSD1 can associate with the androgen receptor to activate genes that promote cancer cell growth and metastasis. Seclidemstat is able to block these interactions and reduce tumor burden.

Seclidemstat is a novel, oral, reversible LSD1 inhibitor that regulates gene expression and is currently in Phase 1/2 Ewing and Ewing-related sarcoma and Phase 1/2 solid tumor clinical trials.

Looking further into the role of LSD1 in cancer therapy, it has been reported that it plays key roles during carcinogenesis. Therefore, targeting LSD1 is becoming an emerging option for the treatment of cancers. Numerous LSD1 inhibitors have been reported to date and are currently undergoing clinical trials for cancer therapy, particularly for small lung cancer cells (SCLC) and acute myeloid leukemia (AML), and others like Salarious' Seclidemstat addressing Ewing sarcoma and a variety of solid tumors.

It has been indicated that LSD1 and its downstream targets are involved in a wide range of biological courses, including embryonic development and tumor-cell growth and metastasis. LSD1 has been reported to be overexpressed in variety of tumors. Inactivating LSD1 or downregulating its expression inhibits cancer-cell development. LSD1 targeting inhibitors may represent a new insight in anticancer drug discovery

It has been reported that LSD1 plays an essential role in the control of wide-ranging biological processes, including regulation of genes involved in pluripotency and lineage commitment in stem cells and during embryonic development. The importance of LSD1 in differentiation suggests that dysregulation of LSD1 activity may alter pathways associated with stem-cell-like phenotypes. In support of this, overexpression of LSD1 has been shown to promote cell proliferation, migration, and invasion in a variety of human cancers. In addition to being implicated in the pathogenesis of multiple hematologic malignancies and solid tumors, aberrant expression of LSD1 may impede differentiation and contribute to metastasis and recurrence.

Elevated levels of LSD1 has been found in diverse cancers and shows close relationship with many cellular effects such as epithelial-mesenchymal transition (EMT), cell proliferation and differentiation, stem cell biology, and malignant transformation. Inhibition of LSD1 has shown that it leads to inhibition of proliferation, differentiation, invasion, and migration in vitro and in vivo.  LSD1 inhibition also affects replication machinery and cell cycle, and interrupts downstream signaling of EGFR (epidermal growth factor receptor).  

In summary, inhibiting LSD1 genetically or pharmacologically enhances tumor immunogenicity by stimulating endogenous retrovirus expression and downregulating RNA induced silencing complex, supporting the promise of LSD1 inhibition in overcoming resistance to checkpoint blockade in cancer treatment.

According to  Ahmed F. Abdel-Magid, 

"LSD1 inhibitors and may be useful for the treatment of LSD1-mediated diseases or disorders including, but are not limited to, B cell lymphoma, acute myeloid leukemia, gastric cancer, hepatocellular carcinoma, prostate cancer, breast carcinoma, neuroblastoma, glioblastoma, nasopharyngeal carcinoma, colon cancer, gallbladder cancer, esophageal cancer, head and neck cancer, lung cancer, ovarian cancer, pancreatic cancer, endometrial carcinoma, and soft tissue sarcomas such as rhabdomyosarcoma (RMS), chondrosarcoma, osteosarcoma, Ewing’s sarcoma, liver fibrosis, and sickle cell disease."

On December 17, 2019 the FDA granted Seclidemsta Fast Track Designation for the treatment of relapsed/refractory patients with Ewing sarcoma.

David Athrur, Salarius President and CEO commented on the accomplishment:

“Securing FDA Fast Track Designation for Seclidemstat in Ewing sarcoma is an achievement for Salarius in the ongoing development of the drug and recognition that there is an unmet need to bring much needed hope to patients and their families suffering through this devastating disease. Coupled with Seclidemstat’s previously granted Orphan Drug Designation and Rare Pediatric Disease Designation by the U.S. Food and Drug Administration, we feel well positioned to take advantage of the FDA’s expedited programs for drug development and review.”

Salarius began enrolling for a Phase 1 trial in Ewing sarcoma in 2018. Ewing sarcoma is a devastating pediatric illness and represents a major unmet clinical need. Currently, chemotherapy, radiation and tumor resection surgery are the only options for patients, and in many cases the tumors reoccur or is in too delicate of a location to risk surgery

There is a 70-90% five-year mortality rate for patients suffering of Ewing's Sarcoma (EWS) whose tumors recur after treatment or who are initially diagnosed with metastatic disease. Translocations involving the EWS gene are the sole driver for over 85% of Ewing sarcoma, and the EWS protein must complex with LSD1 to induce a cancer phenotype. Seclidemstat blocks this LSD1-EWS interaction to reverse cancer pathology resulting in cures in animal models.

Patients diagnosed with metastatic Ewing sarcoma, or cancer that has already spread at the time of diagnosis, have five year survival rates between only 18% and 30%. The prognosis for patients with recurrent Ewing sarcoma is particularly poor. The five year survival after a recurrence of Ewing is approximately 10 to 15%. And unfortunately, the median age of diagnosis of patients with Ewing is only 15 years of age.

As a potential twice-daily oral treatment, that is not a cytotoxic agent, meaning seclidemstat is not chemotherapy. Seclidemstat represents a potential breakthrough, a breakthrough in the treatment of select pediatric cancers.

In July 2020, the company announced plans to expand enrollment in the Ewing sarcoma clinical trial to include several additional sarcomas that share a similar gene rearrangement to Ewing sarcoma. These additional sarcomas are also known as Ewing related sarcomas. These Ewing related sarcomas of interest include myxoid liposarcoma, Desmoplastic small round cell tumors and other sarcomas that share a similar biology to Ewing sarcoma.

Regarding the expansion into additional sarcomas, CEO David Arthur commented in 3Q 2020 CC:

"This expansion allows us to now treat up to 50 patients with Ewing and Ewing related sarcomas with the phase II recommended doses seclidemstat. We and our clinical investigators are excited about the potential to treat these additional patients who are seeking new treatment options."

CEO Arthur added:

"Also, during third quarter, Salarius completed much of the work necessary to begin additional clinical trials, and we look forward to announcing these trials in the near future. One area of interest we had previously discussed is the use of seclidemstat in combination with immuno-oncology therapy, specifically checkpoint inhibitors."

"Checkpoint inhibitors are a class of immunotherapy treatment designed to unleash a patient's immune system attack on cancer cells. However, these drugs, these checkpoint inhibitors do not work in all cancer patients or in all cancer types. In addition, patients that do show an initial response can become resistant to checkpoint inhibitor treatment and experience a return of the disease, commonly known as a disease relapse."

"Interestingly, data from preclinical studies conducted by the Translational Genomics Research Institute in Phoenix, Arizona, and published in the peer-reviewed journal, PLOS ONE demonstrated the potential of using seclidemstat in combination with checkpoint inhibitors to overcome cancers ability to hide from the patient's immune system. This prevents checkpoint inhibitors from attacking the cancer."

"In simple terms, seclidemstat may turn tumors concealed from a patient's immune system called cold tumors into hot tumors or tumors the immune system is able to identify and infiltrate, these now hot tumors could then respond to treatment of checkpoint inhibitors. This approach provides a significant opportunity for seclidemstat, because it could be used to treat patients with a wide variety of cancers that are currently unresponsive to checkpoint inhibitors."

"So far, early clinical results and clinical observations in our two clinical programs have been encouraging. Data supports twice daily dosing, and we have observed drug concentration levels in humans or in our patients, at or above where we noted efficacy in preclinical cell and animal studies. This dosing data is significant achievement as it confirms our ability to treat patients with a twice daily oral regimen, and that the regimen can achieve the drug levels in humans where we observed efficacy in animal models"

Also, as noted earlier, a patient with Ewing sarcoma who was treated with seclidemstat for six months after failing standard-of-care therapy saw an 80% decrease in the size of their prospectively identified target lesions, which are, as I mentioned, are generally the patient's largest measurable tumors. We believe this patient data and other clinical observations from both clinical trials demonstrate preliminary drug activity, and when coupled with preclinical data support our decision to expand the Phase 2 dose-expansion phase of the Ewing sarcoma trial to include these patients with Ewing-related sarcomas.

"In addition, the ongoing solid tumor clinical trial is providing an opportunity to investigate the potential seclidemstat in treating larger market cancers such as prostate, breast, or ovarian cancers, while also helping identify tumors were seclidemstat may show increased likelihood of activity."

"In all, the progress that we have made since the beginning of the year, and certainly and specifically over the past three months is substantial. These accomplishments have in turn positioned Salarius for growth on several fronts over the next several quarters."

Pipeline

Below is the updated pipeline showing extensive work being done in preclinical to advance seclidemstad in the immunotherapy and hematological cancer arenas which would expand the its market opportunity 10-fold and beyond. Recall that CEO Arthur stated the following in his 1Q 2021 conference call closing remarks:

"We currently have the capital resources to fund our current clinical trials through completion and beyond, while at the same time developing seclidemstat in larger commercial markets, including hematological cancers and other potential therapy combinations."

Salarius Competitive Landscape

Currently, the growing field of epigenetics to combat cancer and other diseases is depicted in the following two slides from Salarius' March 2021 Corporate Presentation:

In the above slides you will see that Bristol-Myers Squibb (NYSE:BMY) too has an LSD1 reversible inhibitor which has some data. There are also several other companies with similar assets. This should reassure investors that the field is being actively investigated. Because the field is growing in size and interest, it's just a matter of time for large pharma to swallow and/or to form partnerships with smaller players with proven drugs such as Salarius. This has happened to Essa Pharma, another CPRIT grant recipient I discussed above, and its valuation has skyrocketed in the last 12 months.

Catalysts and Milestones

The following slide shows a busy 1H and 2H of 2021 with several milestones that could potentially take the share price of SLRX to near or beyond the analysts' consensus $4.4/share price target:

Salarius Market Expansion Plans

The following slide from the company's March 2021 Corporate Presentation shows the ambitious and aggressive market expansion set forth by Salarius' management led by CEO David Arthur:

Finances

Salarius CFO Mark Rosenblum stated the following regarding cash runway during the May 12, 2021 1Q 2021 conference call:

"As of March 31, 2021, total cash, cash equivalents and restricted cash totals $36.6M compared to $11.1M at December 31, 2020 and $9.6M on March 31, 2020. Our original $18.7M CPRIT grant dating back to 2016 contains remaining funds totaling $4.8M.

"We believe that our current cash position, our strongest cash position to-date, will be sufficient to fund our operations through the completion of our current clinical trials in 2022 and beyond."

Analyst Opinion

Two analysts have a BUY rating on the stock with a $4.4/share price target. This represents a 400% potential upside with respect to the current share price

Insider and Institutional Ownership

Fintel reports 68% combined insider and institutional holdings. Several institutions reported recent positions including Armistice Capital (4.99%), CVI Investments (6.9%), etc.

Conclusions

• Salarius will present THREE (3) posters at the 2021 ASCO meeting in June as a stand alone therapy and in combination with chemotherapy agents being used to treat Ewing Sarcoma.
• By mid-2021 Salarius expects to have up to three total separate and active clinical trials underway evaluating seclidemstat (SLD1 reversible inhibitor) in up to five distinct patient populations.
• Salarius will announce additional clinical trials in the near future thus maximizing the use of the $36.6M in cash and cash equivalents it ended with in 1Q 2021. The company is funded to 1Q 2023 with current cash and expected CPRIT non-dilutive funds upon meeting upcoming milestones.
• The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded Salarius $18.6M in grants to help advance development of Seclidemstat to treat Ewing Sarcoma. The company still has $4.8M available to draw from that source of non-dilutive financing.
• Salarius is entering significant growth phase as it seeks to diversify from it's core Ewing sarcoma clinical trials into other types of sarcomas leveraging its unique and powerful LSD1 inhibition into other types of solid and liquid cancers.
• Salarius now has the capital resources to fund current clinical trials through completion and beyond, while at the same time developing seclidemstat in significantly larger commercial markets, including hematological cancers and other potential therapy combinations such as immunotherapy
• Bristol-Myers Squibb has an LSD1 reversible inhibitor and other other companies are entering the fast-growing epigenetics oncology arena with similar and different drug candidates. This should reassure investors that the field is being actively investigated. Because the field is growing in size and interest, it's just a matter of time for large pharma to swallow and/or to form partnerships with smaller players with proven drugs such as Salarius. This has happened to Essa Pharma, another CPRIT grant recipient, and its valuation has skyrocketed in the last 12 months.
• Two analysts have a BUY rating on the stock with a $4.4/share price target. This represents a 400% potential upside with respect to the current share price. My price target is $4 by July 2021.
• The current market cap is only $45M which is roughly the amount of cash the company ended with 1Q 2021.
• Fintel reports 66% combined insider and institutional holdings. Several institutions reported recent positions including Armistice Capital (4.99%), CVI Investments (6.9%), etc. The corresponding public float equates to about 8M shares.
• I recommend that those interested in investing in SLRX to review all the risks and uncertainties as detailed in the company's most recent 10-K and 10-Q filings with the SEC.