On May 1, 2019 Flex Pharma, Inc. (NASDAQ: FLKS), reported its financial results for the three months ended March 31, 2019 (Press release, Flex Pharma, MAY 1, 2019, View Source [SID1234535500]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On January 3, 2019, Flex Pharma (the "Company") and Salarius Pharmaceuticals, LLC ("Salarius") entered into an Agreement and Plan of Merger (the "Merger Agreement") pursuant to which, among other things, Falcon Acquisition Sub, LLC, a wholly owned subsidiary of the Company, will merge with and into Salarius, with Salarius continuing as a wholly owned subsidiary of the Company and the surviving company. The Company has filed a registration statement on Form S-4 with the Securities and Exchange Commission (the "SEC") that provides additional information related to the merger. The Company is holding a special meeting of its stockholders on June 14, 2019, in order to obtain the necessary stockholder approvals to complete the merger and related matters. The merger is expected to close in the first half of 2019. The Company continues to sell HOTSHOT, its consumer product that helps to prevent and treat exercise associated muscle cramps.

The Merger Agreement (i) values Flex Pharma at $10.5 million, subject to adjustment, on a dollar-for-dollar basis, based on Flex Pharma’s net cash balance at the closing of the merger compared to a target net cash of $3.3 million, and (ii) values Salarius at $36.6 million, subject to adjustment, on a dollar-for-dollar basis, based on the sale of Series A Preferred Units pursuant to subscription agreements that Salarius entered into prior to the Merger Agreement compared to the target sale of $7.0 million of Series A Preferred Units.

Under the Merger Agreement, immediately following the effective time of the merger, Flex Pharma’s current stockholders will own approximately 19.9% of the combined company, on a partially-diluted basis, and Salarius’ current members will own approximately 80.1% of the combined company, on a partially-diluted basis.

In addition, at or prior to the closing of the merger, Flex Pharma will pay a dividend of or distribute one right per share of the Company’s common stock to its stockholders of record as of a date and time determined by the Company’s board of directors. Each right will entitle such stockholders to receive a warrant to purchase shares of Flex Pharma’s common stock ("Warrant") six months and one day following the closing date of the merger.

The aggregate value of all of the Warrants to be issued to Flex Pharma’s stockholders generally represents the difference between (i) Flex Pharma’s value per the Merger Agreement and (ii) the value of Flex Pharma’s common stock that Flex Pharma’s current stockholders will have in the combined company.

"We continue to believe that a merger with Salarius is the best opportunity for significant near- and long-term value creation for Flex stockholders. Salarius’ lead compound, Seclidemstat, is currently enrolling patients in an open-label Phase 1 dose escalation/dose expansion study in Ewing sarcoma and Salarius is also preparing to initiate additional studies in advanced solid tumors, including prostate, breast and ovarian cancers. We believe that Salarius could be poised to address significant unmet needs in oncology and we look forward to completing the merger with Salarius," stated William McVicar, Ph.D., Flex Pharma’s President and Chief Executive Officer.

First Quarter 2019 Financial Results

Cash Position: As of March 31, 2019, Flex Pharma had cash and cash equivalents of $7.3 million. The Company held no marketable securities at March 31, 2019. During the three months ended March 31, 2019, cash and cash equivalents decreased by $2.5 million.
Total Revenue: Total revenue for the three months ended March 31, 2019 was approximately $105,000.
Cost of Product Revenue: Cost of product revenue for the three months ended March 31, 2019 was approximately $47,000. There were no inventory write-offs during the three months ended March 31, 2019.
R&D Expense: Research and development expense for the three months ended March 31, 2019 was approximately $2,000.
SG&A Expense: Selling, general and administrative expense for the three months ended March 31, 2019 was $2.3 million, including merger related costs of $1.2 million. Selling, general and administrative expense for this period also included personnel costs (including salaries and stock-based compensation costs), fulfillment costs related to HOTSHOT, legal and professional costs, and external consultant costs.
Net Loss and Cash Flow: Net loss for the three months ended March 31, 2019 was ($2.2) million, or ($0.12) per share and included $0.2 million of stock-based compensation expense. As of March 31, 2019, Flex Pharma had 18,068,017 shares of common stock outstanding. The net loss for the first quarter of 2019, was primarily driven by the Company’s operating expenses related to its merger related costs, costs associated with HOTSHOT, and general and administrative costs.

On May 1, 2019 Triumvira Immunologics Inc. (Triumvira), a privately held biopharmaceutical company developing a novel platform for engineering T cells to attack cancers, has reported simultaneously submitted an IND to the U.S. Food and Drug Administration and a CTA to Health Canada to initiate a Phase 1/2, first-in-human trial of TAC01-CD19, a TAC-T cell therapy product engineered to target CD-19 in patients with Relapsed/Refractory Large B-Cell Lymphoma (TACTIC-19) (Press release, Triumvira Immunologics, MAY 1, 2019, View Source [SID1234535499]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"TAC01-CD19 has the potential to be a next generation solution for cell therapy for patients with different types of cancer," commented Paul Lammers, MD, MSc., President and CEO of Triumvira. "This filing is the result of an intensive preclinical development effort by the Triumvira team including the completion of the necessary IND-enabling studies as well as simultaneously preparing IND and CTA filings. We look forward to opening our first of five prominent clinical trial sites in the early summer of 2019."

Despite transformational efficacy with existing approved Chimeric Antigen Receptor T Cells (CAR-T), a significant unmet need remains due to substantial CAR-T toxicities and limited tumor types where CAR-T is effective. Triumvira is developing a proprietary T Cell Antigen Coupler (TAC) technology platform which is biologically distinct from CAR-T and has the potential to be a next generation solution to these challenges. TAC technology is a novel way to genetically modify T cells and redirect these T cells to target cancer antigens by co-opting the natural T cell receptor (TCR) to eradicate the tumor cells. TAC01-CD19 is the lead program in Triumvira’s pipeline of several TAC programs for both solid tumors and hematological malignancies.

About TAC01-CD19

TAC-01CD19 is a novel genetically engineered T cell therapy product targeting CD19 for use in B-cell malignancies. The product comprises autologous T cells that have been genetically engineered via lentiviral transduction to express the CD19 T cell Antigen Coupler (TAC). Preclinical data suggest that TAC01-CD19 has the potential for being highly efficacious with minimal side effects.

About CD19 and DLBCL

CD19 is a B cell marker and is expressed on the surface of B cell malignancies such as Diffuse Large B Cell Lymphoma (DLBCL). DLBCL is a subtype of Non-Hodgkin Lymphomas (NHLs). DLBCL is expected to impact approximately 26,000 patients in the U.S. in 2018. Even though significant improvements in therapies have occurred in the past years, about 45% of patients with DLBCL die of either their disease or of non-cancerous causes (1).

On May 1, 2019 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapy, is reported that it has received a letter of interest from CATO BioVentures, the venture capital affiliate of Cato Holding, a privately held family fund (Press release, Oncbiomune, MAY 1, 2019, View Source [SID1234535498]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This agreement is in support of the development plan of OncBioMune’s patented CD71-targeted chemotherapy combining paclitaxel, gallium, and transferrin, otherwise known as "PGT."

PGT is designed to deliver the chemotherapeutic agent paclitaxel to cancer cells over-expressing the transferrin receptor (aka CD71). Paclitaxel is currently FDA-approved in two forms: as solvent-based paclitaxel (sb-paclitaxel, Taxol) and protein-based paclitaxel (nab-paclitaxel, ABRAXANE).

PGT binds paclitaxel to the human protein transferrin as opposed to albumin, which is employed in nab-paclitaxel. This creates the potential to target the paclitaxel to CD71, which has been shown to be over-expressed on many different cancer types. Additionally, PGT takes advantage of the fact that the transferrin protein has binding sites for iron that can bind a different metal ion, gallium, which has anti-cancer activity. In theory, this creates a novel protein drug complex which has the capacity to deliver two, non-cross resistant cancer therapeutics in a targeted fashion.

"We are excited that CATO BioVentures has a belief in our science that would motivate them to become a strategic investor in OncBioMune. We are hopeful that this show of support from such a high quality provider will act as a catalyst to assist us in additional favorable fundraising activities," commented Dr. Brian Barnett, Chief Executive Officer at OncBioMune. "It has already been a pleasure working with the team of the CATO Research CRO arm as we start the process of putting together a clinical development plan for our proprietary therapy, PGT, and strive toward the goal of getting PGT accessible to patients with refractory cancers that represents a large area of unmet medical need."

On May 1, 2019 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage pharmaceutical company, reported it has received Food and Drug Administration (FDA) End-of-Phase 2 (EoP2) meeting minutes, helping to guide the Company’s planned Phase 3 program for Brilacidin oral rinse to decrease the incidence of Severe Oral Mucositis (SOM) (WHO Grade ≥3) in Head and Neck Cancer (HNC) patients receiving chemoradiation (Press release, Innovation Pharmaceuticals, MAY 1, 2019, View Source [SID1234535497]). Brilacidin oral rinse is being developed under FDA Fast Track designation for Oral Mucositis (OM).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

During the EoP2 meeting convened in December 2018, the Company and FDA agreed to an acceptable Brilacidin Phase 3 development pathway. The guidance from the FDA now also helps to frame ongoing discussions with the European Medicines Agency (EMA) as part of the Scientific Advice process. The purpose of both of these interactions is to ensure that proposed plans meet regulatory requirements for New Drug Application (NDA)/Marketing Authorization Application (MAA) filings and, ultimately, to obtain approval of Brilacidin for SOM in HNC in both the United States and Europe.

"Productive regulatory meetings for our Brilacidin SOM program with U.S. and European agencies are significant Company milestones," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "Brilacidin oral rinse, to decrease the incidence of SOM, represents a potential future regimen for millions of head and neck cancer patients where no approved drug is available today. Furthermore, our hope is that Brilacidin will eventually emerge as a treatment for other indications where SOM also is a frequent side-effect of cancer therapies."

"It is time that the current standard of care for SOM takes a leap forward and a new market emerges," added Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "I am reminded of drugs for not only rare diseases that were overlooked by the market during development and then went on to become ‘company makers,’ but also a drug such as Tagamet. Eventually, it became the first blockbuster drug ever by treating the common problem of acid reflux, a disease that was casually written off for decades as not having an effective treatment beyond antacids. Treatment-related SOM in cancer patients is a real problem worldwide, affecting millions of patients, with physical and financial ramifications that genuinely must be addressed beyond today’s magic mouthwashes. And, we are currently the only company with an oral drug candidate being advanced into late-stage trials, positioned to fill this unmet need. I greatly look forward to initiating our planned Phase 3 program, adding further credibility and value to our Brilacidin Franchise."

About Brilacidin Phase 2 OM Trial/Comparison with Other OM Drugs in Development

The Company’s Brilacidin oral rinse demonstrated a strong therapeutic benefit in patients receiving the aggressive chemotherapy regimen (cisplatin administered 80-100 mg/m2, every 21 days), which currently is in common use. In this patient population, incidence of Severe OM (WHO Grade ≥ 3) was reduced to 25.0 percent in the modified Intent-to-Treat (mITT) population, versus 71.4 percent of placebo patients. In the Per Protocol (PP) patient group, incidence of Severe OM dropped to 14.3 percent for patients receiving Brilacidin, compared to 72.7 percent among those receiving placebo.

The completed Phase 2 study (see NCT02324335) met its primary endpoint, showing a reduction of Severe OM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of Severe OM and in delaying the onset of Severe OM. Furthermore, Brilacidin showed a favorable safety profile and ­was well-tolerated.

Linked below is information, published in a blog on the Company’s website, elaborating on how Brilacidin is positioned compared to other investigational Oral Mucositis drugs in clinical development.

View Source

About Brilacidin and Severe Oral Mucositis

There currently are no FDA-approved drugs for the prevention of Severe OM (SOM) (WHO Grade ≥ 3) in HNC patients receiving chemoradiation. The additional expenses incurred by patients suffering from SOM are estimated to be as high as $18,000 to $25,000 per case in the U.S. when hospitalization is required. These factors contribute to SOM qualifying as an area of significant unmet medical need. According to published statistics, the number of new annual HNC cases in the U.S. is estimated to be 65,000, and worldwide, ~750,000 cases. Between 60 and 70 percent of these HNC patients typically will develop Severe OM, with the overall incidence of HNC patients developing some grade of OM (WHO Grades 1 to 4) approaching 100 percent. Because it cannot be predicted which patients will develop SOM, a preventative treatment, such as Brilacidin oral rinse, would begin in all patients as soon as starting chemoradiation and continue until its completion (typically a seven-week course). Given Brilacidin is administered as a convenient oral rinse, with plans to package it in an easily transportable sachet form, the Company believes it would be attractive both to doctors and patients—likely translating to widespread and rapid market adoption should Brilacidin oral rinse gain regulatory approval

On May 1, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that first quarter 2019 financial results will be released after the market close on May 9, 2019 (Press release, Inovio, MAY 1, 2019, View Source [SID1234535496]). Following the release, the Company will host a conference call and live webcast at 4:30 p.m. ET, to provide a general business update and financial results for the first quarter 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll free) or 412-317-0088 (international toll) using replay access code 10131163.