On March 27, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported financial results for the year ended December 31, 2019 (Press release, Can-Fite BioPharma, MAR 27, 2020, View Source [SID1234555950]).

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Clinical Developments and Corporate Highlights Include:

Piclidenoson as Potential Treatment for Coronavirus – Piclidenoson’s anti-rheumatic and anti-viral effects, combined with its excellent safety profile, make it a potential candidate for the treatment of coronavirus. Can-Fite recently submitted Piclidenoson to the Institutional Review Board at Rabin Medical Center for a compassionate use program to treat coronavirus patients. If approved, the compassionate use program will be led by Dr. Dror Diker, M.D., Head of Internal Medicine D at the Rabin Medical Center. Concurrently, through a collaborative research agreement with the Lewis Katz School of Medicine at Temple University in Philadelphia, Can-Fite is conducting studies on the anti-viral activity of Piclidenoson on the coronavirus. The anti-viral effect of Piclidenoson is protected by US patent US7589075. Rheumatoid arthritis drugs are now being evaluated for the treatment of coronavirus in global studies, and China recently approved the use of Roche’s Actemra, a rheumatoid arthritis drug, to treat coronavirus.

Namodenoson Phase II NASH Data Expected in April 2020 – Can-Fite completed enrollment of 60 patients with NAFLD (non-alcoholic fatty liver disease) with or without NASH (non-alcoholic steatohepatitis), and plans to announce topline results during April 2020. The end points of this study include serum ALT levels, percentage change in liver fat, as measured by PDFF (proton density fat fraction), weight loss and additional serum parameters.

Namodenoson is Headed into Pivotal Phase III Liver Cancer Study – Following a successful End-of-Phase II Meeting with the U.S. Food and Drug Administration (FDA) regarding Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer, the FDA agreed with Can-Fite’s proposed pivotal Phase III trial design to support a New Drug Application submission and approval. The Phase III study protocol and registration plan have also been submitted to the European Medicines Agency (EMA). Namodenoson is currently being used to treat liver cancer patients in a compassionate use program in Israel, which has enrolled seven patients. In addition, two patients who were enrolled in the Company’s former Phase II study, who responded well to the drug, are continuing treatment. Those two advanced liver cancer patients have reached an overall survival of over 2.5 years while being treated with Namodenoson.

Piclidenoson Phase III Rheumatoid Arthritis and Psoriasis Studies Complete 50% Enrollment; Interim Data for Rheumatoid Arthritis Expected Q4 2020 – Can-Fite continues to enroll patients in its Phase IIII study for psoriasis. An interim analysis is being implemented for the rheumatoid arthritis study. Data will be monitored by an independent data monitoring committee (IDMC) which will have un-blinded access to the data in Q3 2020, with an announcement of interim results expected in Q4 2020.

Developing Cannabinoid-based Drug Candidates – During 2019, Can-Fite signed an agreement with Univo Pharmaceuticals (TASE:UNVO), a medical cannabis company, to identify and co-develop specific formulations of cannabis components for the treatment of diseases in which there is an overexpression of A3AR, Can-Fite’s target. Based on its recent scientific findings, Can-Fite has filed patents for the use of cannabinoid-based drugs to treat cancer, autoimmune, inflammatory and metabolic diseases. The Company’s most recent research revealed that cannabis-derived CBD enriched fractions inhibit fat cell expansion and have beneficial effects against liver cancer.

Cash Infusion of $11 Million from Distribution Deals and Equity Raise – During 2019, Can-Fite raised a total of $9.2 million through equity offerings, and received upfront payments from distribution agreements for its drugs in specific territories and indications in the amount of $1.75 million. The upfront payments from distributors were part of agreements that totaled $10 million plus royalties based on the achievement of milestones. Following the end of 2019, Can-Fite received an additional cash infusion of $8.4 million through a combination of $5 million raised through an equity offering and $3.4 million through cash exercises of warrants.

"We are focused on delivering our advanced stage drug candidates to meet the immediate medical needs of patients who lack safe and effective treatments to life threatening conditions. This includes Piclidenoson for the treatment of coronavirus and Namodenoson for advanced liver cancer," stated Can-Fite CEO Pnina Fishman. "In 2019, we achieved very significant progress in our Phase III trials of Piclidenoson and are now over 50% complete with patient enrollment. In 2020, we are well positioned for achieving milestones which we believe may generate more non-dilutive funding for Can-Fite through new global distribution agreements, as well as trigger milestone payments from our current agreements."

Financial Results

Revenues for the year ended December 31, 2019 were $2.0 million, a decrease of $1.8 million, or 47.3%, compared to $3.8 million for the year ended December 31, 2018. The decrease in revenue was mainly due to the recognition of a $2 million advance payment received in August 2018 under the License, Collaboration and Distribution Agreement with CMS Medical.

Research and development expenses for the year ended December 31, 2019 were $10.9 million, an increase of $4.9 million, or 81.6%, compared to $6 million for the year ended December 31, 2018. Research and developments expenses for the year ended 2019 comprised primarily of expenses associated with the Phase II studies for Namodenoson and Phase III studies of Piclidenoson. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis. We expect that the research and development expenses will increase through 2020 and beyond.

General and administrative expenses were $3.0 million for the year ended December 31, 2019 a decrease of $0.1 million, or 3.1%, compared to $3.1 million for the year ended December 31, 2018. The decrease is primarily due to decrease in investor relations expense and a decrease in salary and related expenses which was partly offset by an increase in insurance expenses. We expect that general and administrative expenses will remain at the same level through 2020.

Financial income, net for the year ended December 31, 2019 were $2.4 million compared to financial expenses, net of $1.1 million in the same period in 2018. The decrease in financial expense, net was mainly due to decrease in a loss from short-term investment revaluation and increase in income from changes in fair value of warrants liability exercisable into shares.

Net loss for the year ended December 31, 2019 was $9.5 million compared with a net loss of $6.6 million for the year ended December 31, 2018. The increase in net loss for the year ended December 31, 2019 was primarily attributable to decrease in revenues in 2019 and an increase in research and development expenses which were partly offset by an increase in finance income, net.

As of December 31, 2019, Can-Fite had cash and cash equivalents of $2.7 million as compared to $3.6 million at December 31, 2018. The decrease in cash during the year ended December 31, 2019 is due to increase in net cash provided by financing activity which was offset by an increase in net cash used in operating activity. In February 2020, Can-Fite raised $5 million in a registered direct offering, and in January and March 2019 the Company received approximately $3.4 million through warrant exercises.

More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2019, a copy of which has been filed with the Securities and Exchange Commission (SEC). The Annual Report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at View Source as well as via the Company’s investor relations website at View Source The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Can-Fite Investor Relations at 10 Bareket Street, Kiryat Matalon, Petah-Tikva 4951778, Israel or by phone at +972-3-9241114.

On March 27, 2020 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that the Company has submitted a New Drug Application (NDA) to the Taiwan Food and Drug Administration (TFDA) for avapritinib, a precision therapy being developed for the treatment of gastrointestinal stromal tumor (GIST), and had received priority review designation from the TFDA on March 9, 2020 (Press release, CStone Pharmaceauticals, MAR 27, 2020, View Source [SID1234555949]). This NDA is for the indication of adult patients with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. Discovered by CStone’s partner, Blueprint Medicines, avapritinib is the second drug candidate for which CStone has submitted an NDA.

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"Within just one year, CStone has submitted NDAs for two first-in-class targeted-therapies, demonstrating our commitment to addressing urgent clinical needs and the Company’s rapid transformation toward commercialization," said Dr. Frank Jiang, Chairman and CEO of CStone. "GIST is a rare tumor type, and PDGFRA D842V mutant GIST is resistant to currently approved therapies in Greater China. In addition to Taiwan, we plan to submit an NDA for the same indication in Mainland China in the first half of this year with the goal of benefitting more patients suffering from this devastating condition."

"Avapritinib is an investigational, orally available, potent, and selective inhibitor of KIT and PDGFRA. In January this year, avapritinib received an approval from the U.S. FDA for the treatment of adults with unresectable or metastatic PDGFRA exon 18 mutant GIST and became the first and only U.S. FDA-approved targeted therapy for this indication," said Dr. Jason Yang, Chief Medical Officer of CStone. "Clinical data submitted to the TFDA show unprecedented antitumor activity of avapritinib in advanced GIST patients with a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, with an overall response rate (ORR) of 84% and most adverse events reported as Grade 1 or 2. In addition, the median duration of response (DOR) was not reached and 61% of these patients had a DOR ≥6 months. "

GIST is the most common mesenchymal tumor of the GI tract, and it is most prevalent in patients aged 50 to 80. Around 90% of all GIST cases are associated with dysregulated cell growth due to mutations in KIT and PDGFRA tyrosine kinases. As GIST patients do not respond well to chemotherapy and radiotherapy, current treatment for advanced GIST is primarily based on sequential treatment with tyrosine kinase inhibitors (TKIs). However, GIST patients harboring PDGFRA D842V mutations are not sensitive to existing approved TKIs in Greater China, with studies showing an ORR of 0%, a median progression-free survival of just three to five months, and a median overall survival of about 15 months1. Similarly, these approved therapies have shown limited effects against other rare PDGFRA exon 18 mutations.

CStone Pharmaceuticals and Blueprint Medicines have an exclusive collaboration and license agreement for the development and commercialization of avapritinib and certain other drug candidates in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for these licensed products in the rest of the world.

About Avapritinib

Avapritinib is an investigational, selective and potent inhibitor of KIT and PDGFRA mutant kinases. It is a type 1 inhibitor that works by directly binding to the active kinase conformation from which mutant KIT and PDGFRA signal. Avapritinib has demonstrated inhibition of a broad range of KIT and PDGFRA mutations associated with GIST, including potent clinical activity against activation loop mutations that are associated with resistance to currently approved therapies in Greater China.

Blueprint Medicines is pursuing a broad clinical development program for avapritinib across multiple lines of GIST treatment, as well as for advanced, smoldering and indolent systemic mastocytosis.

Avapritinib is a kinase inhibitor approved by the U.S. FDA under the brand name AYVAKIT for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.

Avapritinib is not approved for the treatment of any other indication in the U.S. or for the treatment of any indication by the TFDA in Taiwan, by the National Medical Products Administration in China or by any other health authority in any other jurisdiction.

On March 27, 2020, Vaccinex, Inc. (the "Company") reported that it has entered into an Open Market Sale AgreementSM (the "Sale Agreement") with Jefferies LLC ("Jefferies"), under which the Company may issue and sell shares of its common stock, par value $0.0001 per share (the "Common Stock"), from time to time for an aggregate sales price of up to $11,500,000 through Jefferies as sales agent (the "ATM Offering") (Filing, 8-K, Vaccinex, MAR 27, 2020, View Source [SID1234555948]).

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Sales of the Common Stock, if any, under the Sale Agreement will be made by any method that is deemed to be an "at the market" offering as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended (the "Securities Act"), including but not limited to sales made directly on or through the Nasdaq Capital Market or any other existing trading market for the Common Stock. Subject to the terms and conditions of the Sale Agreement, Jefferies will use its commercially reasonable efforts to sell the Common Stock from time to time, as the sales agent, based upon the Company’s instructions.

The Company has no obligation to sell Common Stock pursuant to the Sale Agreement and may at any time suspend offers under the Sale Agreement or terminate the Sale Agreement.

The Company has provided Jefferies with customary indemnification rights and Jefferies will be entitled to a commission at a fixed commission rate in an amount equal to 3.0% of the gross proceeds for each sale of the Common Stock.

This description of the Sale Agreement does not purport to be complete and is qualified in its entirety by reference to the Sale Agreement, which is attached hereto as Exhibit 10.1 and incorporated by reference herein.

The Common Stock to be sold under the Sale Agreement, if any, will be issued and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-236416), previously filed with the Securities and Exchange Commission ("SEC") on February 13, 2020 and declared effective by the SEC on March 11, 2020 (the "Registration Statement"). On March 27, 2020, the Company filed a prospectus supplement with the SEC in connection with the offer and sale of the Common Stock pursuant to the Sale Agreement. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Common Stock under the Sale Agreement nor shall there be any sale of the Common Stock in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On March 27, 2020 Cue Biopharma, Inc. (the "Company") reported that it has entered into an At-The-Market Equity Offering Sales Agreement (the "Sales Agreement") with Stifel, Nicolaus & Company, Incorporated, as agent ("Stifel"), pursuant to which the Company may offer and sell, from time to time through Stifel, shares of its common stock, par value $0.001 per share (the "Common Stock"), for aggregate gross proceeds of up to $35.0 million (the "Shares") (Filing, 8-K, Cue Biopharma, MAR 27, 2020, View Source [SID1234555947]). The offer and sale of the Shares will be made pursuant to a shelf registration statement on Form S-3 and the related prospectus (File No. 333-229140) that became effective on February 3, 2019, as supplemented by a prospectus supplement dated March 27, 2020 and filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act").

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Pursuant to the Sales Agreement, Stifel may sell the Shares in sales deemed to be "at-the-market" equity offerings as defined in Rule 415 promulgated under the Securities Act, including sales made directly on or through the Nasdaq Capital Market. If agreed to in a transaction notice, the Company may sell Shares to Stifel as principal, at a purchase price agreed upon by Stifel and the Company. Stifel may also sell Shares in negotiated transactions with the Company’s prior approval. The offer and sale of the Shares pursuant to the Sales Agreement will terminate upon the earlier of (a) the issuance and sale of all of the Shares subject to the Sales Agreement or (b) the termination of the Sales Agreement by Stifel or the Company pursuant to the terms thereof.

The Company has agreed to pay Stifel a commission of up to 3.0% of the aggregate gross proceeds from any Shares sold by Stifel and to provide Stifel with customary indemnification and contribution rights, including for liabilities under the Securities Act. The Company also will reimburse Stifel for certain specified expenses in connection with entering into the Sales Agreement. The Sales Agreement contains customary representations and warranties and conditions to the placements of the Shares pursuant thereto.

A copy of the Sales Agreement is filed as Exhibit 1.1 to this Current Report, and the description of the terms of the Sales Agreement is qualified in its entirety by reference to such exhibit. A copy of the opinion of K&L Gates LLP relating to the legality of the issuance and sale of the Shares is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any offer, solicitation, or sale of the Company’s Common Stock in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On March 27, 2020 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biotechnology company targeting cancers caused by dysregulated gene expression, reported its corporate and financial results for the fourth quarter and full-year ended December 31, 2019 (Press release, Salarius Pharmaceuticals, MAR 27, 2020, View Source [SID1234555946]).

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Financial Highlights:

•In February 2020, closed $11 million underwritten public offering
•In October 2019, entered Stock Purchase Agreement
• $2.6 million stock sales completed in 2019
•12-month period ended December 31, 2019 net loss per common share – basic and diluted – for continuing operations of $2.12, compared to $1.16 for the same period ended December 31, 2018
•Total cash and cash equivalents of $3.7 million as of December 31, 2019
•Up to $9.1 million remains available to draw from the Cancer Prevention and Research Institute of Texas grant (CPRIT), upon meeting certain requirements

Recent Business Highlights:

•Advanced to the sixth level dosing cohort in Phase 1/2 study of Seclidemstat in Ewing sarcoma
•Seclidemstat granted Fast Track Designation by FDA for relapsed or refractory Ewing sarcoma
•Scientific paper published highlighting potential of combining Seclidemstat with checkpoint inhibitors
•Data from in vitro studies conducted by Sunil Sharma, M.D., Salarius’ scientific founder
•Added Memorial Sloan Kettering Cancer Center and Nationwide Children’s Hospital as clinical sites for Phase 1/2 trial of Seclidemstat in Ewing sarcoma

"Salarius achieved much during 2019 and has entered 2020 well positioned to maximize the potential of our lead drug candidate, Seclidemstat," stated David Arthur, President and Chief Executive of Salarius. "Key to this was the completion of our merger with Flex Pharma and the subsequent listing of our stock on the Nasdaq Capital Market. We believe these developments were important in elevating our visibility among investors and providing resources that have allowed us to advance Seclidemstat."

Mr. Arthur continued, "Our ultimate aim as a company is to maximize the potential of Seclidemstat and bring hope to the patients around the world afflicted with cancers resulting from dysregulated gene expression. In this regard, the Phase 1/2 dose-escalation trial of Seclidemstat in Ewing sarcoma, our lead clinical program, continues to advance at trial sites across the country, as has a Phase 1/2 dose-escalation trial in advanced solid tumors. Both clinical trials are expected to report important data

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milestones this year. In addition to these clinical programs, Salarius is also exploring Seclidemstat as a treatment for other cancers and in combination with cancer immunotherapies."

Mr. Arthur continued, "Validating our Seclidemstat development strategy, we were pleased that the FDA granted Seclidemstat Fast-Track status in Ewing sarcoma, a rare and deadly pediatric bone cancer for which there is no approved targeted treatment. Coupled with the previously granted Orphan Drug Designation and Rare Pediatric Disease Designation, we believe Salarius is well-positioned to leverage the FDA’s expedited programs for drug development and review."

Mr. Arthur continued, "Meanwhile, the recently completed $11 million public offering combined with $2.6 million from our stock purchase agreement with Aspire Capital represent only a portion of the funds at our disposal. With the non-dilutive financial support Salarius receives from the National Pediatric Cancer Foundation (NPCF) and the up to $9.1 million in non-dilutive funding that remains to be drawn down from the $18.7 million grant we received in 2016 from the Cancer Prevention and Research Institute of Texas (CPRIT), we believe Salarius has the resources to advance both our Ewing sarcoma and AST programs into the second half of 2021."

Mr. Arthur concluded, "In closing, we must acknowledge that the coronavirus or COVID-19 outbreak is impacting every corner of society and business. We are thankful to report that thus far Salarius’ operations continue with minimal interruption, however the ever-changing nature of the situation makes it challenging to forecast what may occur. This includes the Seclidemstat clinical trials where the health and safety of the patients and their families is paramount. Should developments occur, we will communicate such information."

12-Month Financial Results:
For the 12-month period ended December 31, 2019, Salarius’ reported net loss was $6.9 million, or $2.12 per basic and diluted share, compared to a net loss of $1.8 million, or $1.16 per basic and diluted share for the same period in 2018. The loss from operations before other income for the twelve-month span ended December 31, 2019 increased by $6.6 million compared to the loss from operations for the same time span last year, which was primarily due to an increase of $2.7 million in research and development expenses resulting from increased clinical expenses and an increase of $5.4 million in general and administrative expenses, respectively. Increased general and administrative spending resulted primarily from costs related to the merger between Salarius Pharmaceuticals, LLC and Flex Pharma, Inc. ("Flex Pharma"), which was completed in July 2019, and financing activities. These merger-related costs include a one-time success fee of $1.35 million and $0.8 million in professional fees.

As of December 31, 2019, total cash, cash equivalents and restricted cash was $3.7 million, compared to $3.2 million as of December 31, 2018.

Summary of Corporate and Operational Events:

$11 Million Underwritten Public Offering
On February 11, 2020, Salarius completed a public offering with total gross proceeds of approximately $11 million, which includes the full exercise of the underwriter’s over-allotment option to purchase an additional 1,252,173 shares and warrants prior to deducting underwriting discounts and commissions

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and offering expenses payable by Salarius. Salarius intends to use the net proceeds from the offering for general corporate purposes, including working capital.

The offering is comprised of 7,101,307 Class A units, priced at a public offering price of $1.15 per unit, with each unit consisting of one share of common stock and a five-year warrant to purchase one share of common stock at an exercise price of $1.15 per share, and 1,246,519 Class B units, priced at a public offering price of $1.15 per unit, with each unit consisting of one share of Series A convertible preferred stock and a five-year warrant to purchase one share of common stock with and exercise price of $1.15 per share.

The convertible preferred stock issued in this transaction includes a beneficial ownership limitation on conversion but has no dividend rights (except to the extent that dividends are also paid on the common stock). The conversion price of the Series A convertible preferred stock in the offering, as well as the exercise price of the warrants are fixed and do not contain any variable pricing features, or any price-based anti-dilutive features.

Stock Purchase Agreement
On October 24, 2019, Salarius entered into a $10.9 million common stock purchase agreement with a Chicago-based institutional investor. Since then, Salarius has completed stock sales totaling $2.6 million. Under the agreement, and more recently the terms of the capital raise, Salarius may sell shares of its common stock over a 30-month span extending into 2022, but in very limited circumstances including limitations based on the price of Salarius common stock.

Update on Seclidemstat Clinical and Pre-Clinical Programs:

Seclidemstat Clinical Trials in Ewing Sarcoma and Advanced Solid Tumors:
The Safety Review Committee overseeing the ongoing Phase 1/2 clinical study of Seclidemstat in patients with relapsed or refractory Ewing sarcoma has approved the advancement of the study to the sixth dosing cohort, which is now open for patient enrollment.

Salarius is conducting two Phase 1/2 clinical trials for Seclidemstat – one in Ewing sarcoma and the second in patients with advanced solid tumors (AST) resistant to standard-of-care therapies. The trials are designed as open-label dose-finding studies to characterize the pharmacokinetics (PK), maximum tolerated dose (MTD), and initial safety profile of Seclidemstat. Thus far, early PK data from the trials suggest that plasma drug levels measuring the concentration of Seclidemstat in a patient’s plasma remain dose proportional. Based on current projections, Salarius believes both studies are on track to reach maximum tolerated dose in 2020, and shortly after, begin the dose expansion phase of the study. Salarius expects to report early topline patient data before year-end 2020.

The Phase 1/2 clinical trial of Seclidemstat in Ewing sarcoma opened patient enrollment in Q3 2018 and is currently enrolling patients of 12 years of age or older at eight leading cancer centers in the U.S. Meanwhile, the Phase 1/2 AST clinical trial began enrolling patients in June 2019 with a focus on prostate, breast, ovarian, melanoma, colorectal, non-Ewing’s sarcomas and other cancers where Seclidemstat demonstrated single-agent preclinical activity.

Seclidemstat Granted Fast-Track Status by FDA
On December 16, 2019, Salarius announced that the U.S. Food and Drug Administration has granted Seclidemstat Fast Track Designation for the treatment of patients with Ewing sarcoma who have

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relapsed or are refractory to standard-of-care therapy. Fast Track is a process designed by the FDA to expedite the development and review of new drugs with the potential to treat serious or life-threatening conditions and fill unmet medical needs. The program aims to streamline regulatory submissions and enable more frequent communications with the agency to assure that questions and issues are resolved quickly, which often leads to earlier drug approval and access by patients.
New Clinical Trial Sites Added to Ewing Sarcoma Study:
On October 8, 2019, Salarius announced the addition of Memorial Sloan Kettering Cancer Center (MSKCC) in New York City and Nationwide Children’s Hospital (Nationwide Children’s) in Columbus, OH as trial sites in the Phase 1/2 clinical trial of Seclidemstat in Ewing sarcoma patients. This brings the number of active sites to eight and helps facilitate enrollment as the trial advances.