On May 14, 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 first quarter ended March 31, 2020 (Press release, Salarius Pharmaceuticals, MAY 14, 2020, View Source [SID1234558045]).

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Financial Highlights:

•Closed $11 million gross proceeds in an underwritten public offering
•Three-month period ended March 31, 2020 net loss per common share – basic and diluted – for continuing operations of $0.22, compared to $0.64 for the same period ended March 31, 2019
•Total cash and cash equivalents of $9.65 million as of March 31, 2020
•Up to $9.10 million remains available to draw from the Cancer Prevention and Research Institute of Texas (CPRIT) Award, upon meeting certain requirements
•National Pediatric Cancer Foundation (NPCF) continues to provide significant funding for Ewing sarcoma study

Recent Business and Corporate Highlights:

•Phase 1/2 clinical study of seclidemstat in Ewing sarcoma advanced into the sixth level dosing cohort with Maximum Tolerated Dose (MTD) expected to be reached in mid-2020
•Scientific paper published highlighting potential of combining seclidemstat with cancer immunotherapies
•In vitro data shows that seclidemstat helps overcome tumor resistance to checkpoint inhibitors
•European Patent Office (EPO) issued a notice of allowance for Patent EP274430 for seclidemstat
•William "Bill" McVicar, Ph.D., named as new Chairman of the Board of Directors

"Salarius is anticipating the potential for multiple clinical data releases and value building events throughout 2020 and beyond," said David Arthur, President and CEO of Salarius. "Our clinical programs for seclidemstat continue to progress, and in the first quarter, we advanced dose-escalation in our Phase 1/2 clinical trial of seclidemstat in Ewing sarcoma. We eagerly anticipate releasing data from both the Ewing sarcoma clinical trial and our second clinical trial in advanced solid tumors (AST) in 2020."

Mr. Arthur continued, "Salarius has worked to adapt to the unexpected and challenging circumstances resulting from the COVID-19 pandemic. At this time, we are experiencing minimal COVID-19 disruptions to our ongoing clinical programs and continue to enroll patients in our clinical trials."

Mr. Arthur concluded, "Our goal is to maximize the potential of seclidemstat and bring hope to patients fighting rare, pediatric and other cancers. To that end, Salarius is well-capitalized and has the resources, including $9.1 million in non-dilutive funding that remains available from the 2016 $18.7 million CPRIT award, that we believe will advance both our Ewing sarcoma and AST programs, as well as early research on the potential for combining seclidemstat with immunotherapies, well into 2021."

Three-Month Financial Results:
For the three-month period ended March 31, 2020, Salarius’ reported net loss was $2.08 million, or $0.22 per basic and diluted share, compared to a net loss of $1.52 million, or $0.64 per basic and diluted share for the same period in 2019. The loss before other income for the three-month period ended March 31, 2020 increased by $0.84 million compared to the loss before other income for the same time span last year, which was primarily due to an increase of $0.94 million in research and development expenses resulting from increased clinical trial expenses and drug manufacturing costs. Salarius also reported a net increase of $0.37 million in general and administrative costs resulting from Salarius’ transformation into a public company and increased personnel expenses during the current quarter, somewhat offset by lower professional fees and legal costs compared to same period in 2019.

As of March 31, 2020, total cash, cash equivalents and restricted cash was $9.65 million, compared to $5.77 million as of March 31, 2019 and $3.74 million at year-end 2019.

$11 Million Underwritten Public Offering
On February 11, 2020, Salarius completed a public offering with total gross proceeds of approximately $11 million, prior to deducting underwriting discounts and commissions and offering expenses payable by Salarius. Salarius intends to use the net proceeds from the offering for general working capital purposes.

Summary of Corporate and Operational Events:

Ewing Sarcoma Dose Escalation Clinical Trial Advances into Sixth Dosing Cohort
Salarius is conducting two Phase 1/2 clinical trials for the company’s lead investigational drug candidate, seclidemstat – one in patients with relapsed or refractory 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 with a primary objective to characterize the pharmacokinetics (PK), Maximum Tolerated Dose (MTD), and initial safety profile of seclidemstat and a secondary objective to assess the preliminary efficacy.

In Q1 2020, the Safety Review Committee overseeing the Ewing sarcoma clinical trial approved the advancement of the study to the sixth dosing cohort (1,200mg BID) out of seven potential cohorts, and patient enrollment is ongoing. Thus far, PK data from the trial suggest that plasma drug levels measuring the concentration of seclidemstat in a patient’s plasma remain dose proportional and there is no evidence of a plateau in exposure levels.

Dose escalation continues with the Phase 1/2 clinical trial in AST, which is now in the fourth dosing cohort (600mg BID) out of seven possible cohorts. The AST study enrolls patients with a focus on prostate, breast, ovarian, melanoma, colorectal, non-Ewing sarcomas and other cancers where seclidemstat demonstrated single-agent preclinical activity.

Based on current projections, Salarius believes both clinical trials are on track to reach MTD in 2020, and shortly after, begin the dose-expansion phase of each study. Salarius expects to report early safety and pharmacokinetic data before year-end 2020.

Scientific Paper Highlights Use of Seclidemstat in Combination with Checkpoint Inhibitors
Salarius is exploring additional indications for seclidemstat to expand the drug’s market potential, and this includes seclidemstat’s potential for use in combination with a type of cancer immunotherapy commonly known as checkpoint inhibitors. Checkpoint inhibitors, estimated at $15 billion in annual global sales, are designed to unleash an immune attack on cancer cells. However, these therapies do not work in about 70% of cancer patients, and in patients who do show an initial response, many suffer a return of the disease.

On February 4, 2020, a scientific paper entitled, "The Novel Reversible LSD1 Inhibitor SP-2577 Promotes Anti-Tumor Immunity in SWItch/Sucrose-NonFermentable (SWI/SNF)1," was published on bioRxiv.com. The paper highlighted data from in vitro studies conducted by Sunil Sharma, M.D., Salarius’ scientific founder, and his team at the Translational Genomic Institute (TGen) in Phoenix, Ariz., that demonstrate the potential for seclidemstat (also known as SP-2577) to be used in combination with checkpoint inhibitors to treat cancers with identifiable mutations in proteins of the SWI/SNF complex. In this study, seclidemstat modulated the tumor microenvironment to help overcome the resistance to checkpoint inhibitors

The SWI/SNF complex plays an important role in modulating gene expression, and mutations in proteins of the SWI/SNF complex occur in roughly 20% of human cancers. In this study, Dr. Sharma’s team investigated the ability of seclidemstat to promote anti-tumor immunity and T-cell infiltration in two types of ovarian cancer – small cell carcinoma of the ovary hypercalcemic type and ovarian clear cell carcinoma — that both carry mutations in proteins of the SWI/SNF complex.

Salarius Strengthens IP Portfolio Around Seclidemstat
On March 4, 2020, Salarius announced the continued enhancement of the U.S. and global intellectual property (IP) portfolio governing seclidemstat. The European Patent Office issued a notice of allowance for Patent EP274430 exclusively licensed to Salarius from the University of Utah Research Foundation indicating that the agency is satisfied that the patent application meets all EPO requirements.

In all, Salarius holds 22 issued patents in the U.S. and abroad. The company’s current IP estate includes five patents issued in the U.S. and another 17 patents issued in Europe, Australia, Brazil, China, Eurasia, Israel, India, Japan, Korea, Mexico, New Zealand, Singapore, and South Africa. Meanwhile, Salarius has 11 patent applications pending approval in Europe, Brazil, Canada, Israel, India, Korea, Mexico, Singapore, and China. All 22 issued patents and the 11 pending applications are directed to seclidemstat or structurally similar compounds.

Salarius Names New Chairman of the Board
On April 29, 2020, Salarius announced that Board member William "Bill" McVicar, Ph.D., was named by the Board as its new Chairman. Dr. McVicar is a seasoned pharmaceutical industry executive with more than 30 years of clinical development experience. He recently served as Chief Executive Officer of Flex Pharma, and previously served as Chief Scientific Officer and President at Inotek Pharmaceuticals.

Conference Call Information:
Salarius Pharmaceuticals will host a conference call and live audio webcast on Thursday, May 14, 2020, at 4:30 p.m. ET, to discuss its corporate and financial results for the first quarter 2020. Interested participants and investors may access the conference call by dialing either:

An audio webcast will be accessible via the Investors Events and Presentations section of the Company’s website View Source An archive of the webcast will remain available for 90 days beginning at approximately 6:00 p.m. ET, on May 14, 2020.

On May 14, 2020 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company focused on developing targeted therapies to inhibit frontier cancer targets, reported its financial results for the first quarter ended March 31, 2020, and provided an update on its R&D pipeline and other corporate developments (Press release, Revolution Medicines, MAY 14, 2020, View Source [SID1234558044]).

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Highlights from the Quarter Ended March 31, 2020

"Revolution Medicines achieved important scientific, clinical and operational milestones during this quarter," said Mark A. Goldsmith, M.D., Ph.D., president, chief executive officer and chairman of Revolution Medicines. "In January, we presented initial data from our ongoing Phase 1 monotherapy trial evaluating our investigational new drug designed to inhibit SHP2, RMC-4630, in patients with KRAS mutant non-small cell lung cancer (NSCLC) at the AACR (Free AACR Whitepaper)-IASLC International Joint Conference. The findings represent the first reported evidence of clinical activity against KRAS mutant lung cancers by a SHP2 inhibitor, as well as initial evidence of the potential benefit of an intermittent dosing schedule. Our ongoing Phase 1/2 clinical program evaluating RMC-4630 in a range of tumor types continues to advance and enrollment has been in line with our expectations. We also continued to make progress across our broad preclinical pipeline that supports our strategy to target multiple nodes in the oncogenic RAS pathway and bring forward potential monotherapies and combination treatment regimens. During the period, the company also completed a successful IPO, raising gross proceeds of more than $273 million. Revolution Medicines’ strong balance sheet will support continued development of our promising pipeline on behalf of cancer patients."

"We acknowledge the severe health and economic impact of the COVID-19 pandemic we are all experiencing and the burden it has placed on our healthcare system and the clinical trial landscape. Early on, Revolution Medicines made appropriate adjustments to our operating approach, and we’ve continued to make progress on both our preclinical and clinical programs. At present, we do not expect material delays in our ongoing clinical trials, but it is reasonable to anticipate that for planned future studies some site initiations may be delayed, and enrollment may be slowed for some period of time. We are continuing to refine our approach as needed to minimize these impacts."

Scientific and Clinical Highlights

Revolution Medicines demonstrates first ever clinical activity against KRAS mutant lung cancers with SHP2 inhibitor – In January 2020, at the 6th AACR (Free AACR Whitepaper)-IASLC International Joint Conference, the company presented preliminary evidence demonstrating that RMC-4630, the company’s investigational SHP2 inhibitor, showed initial clinical activity in patients with NSCLC bearing KRAS mutations, particularly KRASG12C. Findings also demonstrated the potential benefit of an intermittent RMC-4630 dosing schedule.

RMC-4630 clinical program continues to advance – Revolution Medicines continues to explore optimal dosing and scheduling of RMC-4630 in both its ongoing Phase 1 monotherapy and Phase 1b/2 combination therapy trials. The company plans to expand its RMC-4630 combination therapy program and is prepared for the initiation of new studies evaluating the compound in combination with Amgen’s investigational KRASG12C(OFF) inhibitor, AMG 510, with the EGFR inhibitor osimertinib (Tagrisso), and with a PD-1 inhibitor. While the COVID-19 pandemic may indirectly cause some delays in the initiation of new clinical studies, the company currently expects enrollment in these studies to begin in 2020.

RMC-5552 – IND-enabling work continuing – RMC-5552, the company’s potent and selective inhibitor of mTORC1, continues to advance through investigational new drug (IND)-enabling development. The company remains on track to be IND-ready with this compound by the end of 2020.

Mutant-selective RAS(ON) inhibitor program advancing; development candidate to be nominated – Revolution Medicines is developing a portfolio of mutant-selective RAS(ON) inhibitors that it believes may be the first potent, selective, cell-active inhibitors of the active, GTP-bound form of RAS, or RAS(ON). The company continues to make significant progress toward optimizing key properties of such inhibitors. In line with previous projections, the company continues to anticipate nomination of its first development candidate from this portfolio in 2020.

SOS1 inhibitor program advances into lead optimization. Revolution Medicines’ program targeting SOS1, a protein that plays a central role in driving oncogenic signals through the RAS pathway, continues to advance. Our growing collection of potent and selective inhibitors exhibiting attractive preclinical profiles has enabled the program to progress into the lead optimization stage in pursuit of a development candidate.

Findings recently published in Cancer Research support combination of RMC-4630 with an anti-PD-1 antibody – In a paper published on April 29, 2020, Revolution Medicines researchers described ways in which a SHP2 inhibitor enhances the immune response to tumors, representing a second group of anti-tumor mechanisms beyond its direct effects within cancer cells themselves. The paper also reported deep and durable tumor growth inhibition following combination treatment with a SHP2 inhibitor and anti-PD-1 inhibitor in mouse cancer models, yielding complete tumor regressions and sustained immunological memory.

Multiple abstracts selected for presentation at upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II – Revolution Medicines has been notified that four of the company’s submissions have been selected for presentation at the upcoming virtual AACR (Free AACR Whitepaper) meeting scheduled to take place in June 2020. Titles and abstracts of these presentations will be disclosed by AACR (Free AACR Whitepaper) on May 15, 2020.

Anticipated Scientific and Clinical 2020 Milestones

Clinical data update from RMC-4630 program

Clinical trial initiations:

RMC-4630 combination with AMG 510

RMC-4630 combination with osimertinib

RMC-4630 combination with PD-1 inhibitor

Nomination of first development candidate for RAS(ON) inhibitor program

RMC-5552 IND-readiness

Corporate Highlights

Closed initial public offering – In February 2020, Revolution Medicines closed its initial public offering of 16,100,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase an additional 2,100,000 shares of common stock, at a public offering price of $17.00 per share. The gross proceeds from the offering were $273.7 million, before deducting underwriting discounts, commissions and other offering expenses payable by Revolution Medicines.

The company expects to use the net proceeds from this offering to fund the development of its multiple RAS inhibitor programs, including the RAS(ON) portfolio, SOS1 inhibitor program, and 4EBP1/mTORC1 program, and other general corporate purposes, which may include the hiring of additional personnel, capital expenditures and the costs of operating as a public company.

USPTO grants key RMC-4630 patent – In March 2020, the United States Patent and Trademark Office issued U.S. Patent No. 10,590,090 to the company, providing, in part, composition of matter protection for its SHP2 inhibitors, including RMC-4630.

Facilities Expansion – To support Revolution Medicines’ expanding operations, the company completed a lease transaction in April 2020 that will provide an additional 19,483 square feet in Redwood City, CA. The company campus now includes two buildings that house office, laboratory and research and development space.

Q1 2020 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities were $347.9 million as of March 31, 2020, compared to $122.8 million as of December 31, 2019. The increase was primarily due to proceeds from the IPO in February 2020.

Revenue: Total revenue, consisting of revenue from our collaboration agreement with Sanofi, was $11.5 million for the quarter ended March 31, 2020, compared to $13.2 million for the quarter ended March 31, 2019. This decrease was primarily due to lower reimbursed research and development services in the quarter ended March 31, 2020 resulting from lower manufacturing costs. During the quarter ended March 31, 2019, we incurred upfront manufacturing costs related to the supply of RMC-4630 for our clinical trials.

R&D Expenses: Research and development expenses were $27.5 million for the quarter ended March 31, 2020, compared to $21.2 million for the quarter ended March 31, 2019. This increase was primarily due to an increase in research expenses associated with our RAS inhibitor programs.

G&A Expenses: General and administrative expenses were $5.2 million for the quarter ended March 31, 2020, compared to $2.4 million for the quarter ended March 31, 2019. This increase was primarily due to an increase in expenses associated with transitioning to and becoming a public company.

Net Loss: Net loss was $19.5 million for the quarter ended March 31, 2020, compared to net loss of $10.1 million for the quarter ended March 31, 2019.

On May 14, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported financial results for the first quarter ended March 31, 2020 and provided a corporate update (Press release, Regulus, MAY 14, 2020, View Source [SID1234558043]).

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"We have completed the second cohort and have initiated the dosing for the third and final cohort in the Phase 1 multiple ascending dose ("MAD") clinical study for RGLS4326" said Jay Hagan, CEO of Regulus. "Additionally, preparations for the Phase 1b study in patients with autosomal dominant polycystic kidney disease ("ADPKD") are well underway with plans to initiate in the second half of 2020."

Program Highlights

Initiated Dosing of the Third and Final Cohort in RGLS4326 Phase 1 for ADPKD: In April 2020, the Company initiated dosing of the third and final cohort of the MAD clinical study of RGLS4326, a novel oligonucleotide designed to inhibit miR-17 for the treatment of ADPKD. The Company expects to complete this study in mid-2020 with topline results available thereafter. The Company is planning to initiate a Phase 1b short-term dosing study in patients with ADPKD in the second half of 2020 to evaluate RGLS4326 for safety, pharmacokinetics, and biomarkers of pharmacodynamic activity.

Financial Results

Cash Position: As of March 31, 2020, Regulus had $28.1 million in cash and cash equivalents.

Research and Development (R&D) Expenses: R&D expenses were $3.1 million for the three months ended March 31, 2020, compared to $6.0 million for the same period in 2019. The aggregate decrease was driven by a $1.5 million reduction in personnel and internal expenses and a $1.0 million reduction in external development expenses, both of which were primarily attributable to a reduction in costs associated with the partial clinical hold of the RGLS4326 MAD study. In December 2019, the U.S. Food and Drug Administration ("FDA") lifted the partial clinical hold on the MAD study and it was recommenced in February 2020.

General and Administrative (G&A) Expenses: G&A expenses were $2.4 million for the three months ended March 31, 2020 compared to $3.5 million for the same period in 2019. These amounts reflect personnel-related and ongoing general business operating costs. The decrease is primarily attributable to continued cost reduction efforts subsequent to our corporate restructuring in the third quarter of 2018.

Revenue: Revenue was less than $0.1 million for the three months ended March 31, 2020. Revenue was $6.8 million for the three months ended March 31, 2019, attributable to revenue recognition of the upfront payments received under the 2018 Sanofi Amendment related to the transfer of the RG-012 program to Sanofi.

Net Loss: Net loss was $5.9 million, or $0.25 per share (basic and diluted), for the three months ended March 31, 2020, compared to $3.3 million, or $0.31 per share (basic and diluted), for the same period in 2019.

About ADPKD

ADPKD, caused by the mutations in the PKD1 or PKD2 genes, is among the most common human monogenic disorders and a leading cause of end-stage renal disease. The disease is characterized by the development of multiple fluid filled cysts primarily in the kidneys, and to a lesser extent in the liver and other organs. Excessive kidney cyst cell proliferation, a central pathological feature, ultimately leads to end-stage renal disease in approximately 50% of ADPKD patients by age 60.

About RGLS4326

RGLS4326 is a novel oligonucleotide designed to inhibit miR-17 and designed to preferentially target the kidney. Preclinical studies with RGLS4326 have demonstrated direct regulation of PKD1 and PKD2 in human ADPKD cyst cells, a reduction in kidney cyst formation, improved kidney weight/body weight ratio, decreased cyst cell proliferation, and preserved kidney function in mouse models of ADPKD. The RGLS4326 IND is currently on a Partial Clinical Hold for treatment of extended duration by the U.S. Food and Drug Administration until the second set of requirements outlined by FDA have been satisfactorily addressed. Information from the Phase 1 clinical studies, together with information from additional nonclinical studies, will be used to address the second set of requirements to support studies of extended duration.

On May 14, 2020 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported financial results for the first quarter ended March 31, 2020 and provided an update on recent operational and business progress (Press release, RAPT Therapeutics, MAY 14, 2020, View Source [SID1234558042]).

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"We continue to progress our programs during these challenging times. Our first priority is to protect our employees and our patients. We are practicing social distancing in the lab and conducting a good portion of our work remotely," said Brian Wong, M.D., Ph.D., President and CEO of RAPT Therapeutics. "We remain in close contact with investigators from all of our clinical trial sites. As for our FLX475 trial, sites in Asia and some U.S. sites continue to enroll, although there has been some slowing in some regions as investigators adjust to SARS CoV2-related dynamics. We anticipate reporting initial results from our FLX475 Phase 1/2 trial in the second half of 2020.

Dr. Wong continued, "We also are in contact with our RPT193 investigators. We expect to complete enrollment of patients with atopic dermatitis in the Phase 1b portion of our Phase 1 study and report results from the full Phase 1 study by the end of the year."

Financial Results for the First Quarter Ended March 31, 2020

Net loss for the first quarter of 2020 was $13.1 million, compared to $9.2 million for the first quarter of 2019.

Revenue for the first quarter of 2020 was $0.9 million related to our collaboration with Hanmi Pharmaceutical LTD, signed in December 2019. There was no revenue in the comparable period of 2019.

Research and development expenses for the first quarter of 2020 were $10.7 million, compared to $7.9 million for the same period in 2019. The increase was primarily due to an increase in clinical costs related to FLX475 as it advances in development.

General and administrative expenses for the first quarter of 2020 were $3.3 million, compared to $1.7 million for the same period in 2019. The increase was primarily due to an increase in stock-based compensation expense, as well as an increase in legal, accounting and other fees associated with being a public company.

As of March 31, 2020, we had cash, cash equivalents and marketable securities of $138.2 million, which includes net proceeds of approximately $69.8 million from our follow-on public offering of 2,500,000 shares of common stock.

On May 14, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported data analyzing the applicability of the INTASYL platform as a gene silencing technology that offers an alternative or complementary approach to gene editing technologies, such as CRISPR / Cas9, in the treatment of solid tumors (Press release, Phio Pharmaceuticals, MAY 14, 2020, View Source [SID1234558041]). These data will be presented today at 5:30 p.m. ET at the 23rd Annual Meeting of the American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) in virtual format. The Phio poster presentation will also be available under the "Investors – Events and Presentations" section of the Company’s website (click here) approximately one hour after the event.

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Data from the poster details how INTASYL compares favorably to other technologies for improving cells used in adoptive cell therapy (ACT) for the treatment of solid tumors, especially in cases where permanent gene modification is not required or is undesirable. The poster will be presented by Dr. Simon P. Fricker, Phio’s Vice President of Research.

"We have shown that our INTASYL technology is able to reprogram immune cells, such as T cells or NK cells, and thereby significantly improve their cell killing activity. Alternative approaches to enhancing ACT for solid tumors, such as genetic modification with CRISPR / Cas9, have their merit but also are confronted by significant shortcomings. These data presented today, and also impressive new animal data scheduled to be presented at the upcoming AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper) meetings in the coming weeks, show that the INTASYL platform has great promise for the improvement of ACT therapies without the need for gene editing."

Phio’s technology is also featured on a poster from Glycostem Therapeutics BV presented at ASGCT (Free ASGCT Whitepaper) titled: "oNKord Natural Killer Cells Are Recognized As a Powerful, Versatile and Universal "Off The Shelf" Treatment to Develop Novel Genetically Modified Anti-Cancer Products" (Abstract #1152).