-- Positive Anti-Cramping Effect of FLX-787 Reported in Recent MS
-- FLX-787 Phase 2 ALS & CMT Clinical Studies Ongoing --
Conference Call Scheduled Today at
"The past few months have been particularly rewarding on the clinical
front, as we achieved significant milestones with positive data in two
serious and distinctly different neurological diseases: MS and ALS. We
believe these data demonstrate the clear potential of FLX-787 to reduce
painful cramps and spasms in these patient populations,” stated
- Clinical Efforts
In March, the Company announced positive topline data for FLX-787
from its exploratory Phase 2 trial in MS patients with frequent
muscle cramps/spasms and spasticity. FLX-787 at a dose of 19 mg,
taken orally twice daily, in a liquid formulation was evaluated in
an exploratory Phase 2 randomized, double-blinded,
placebo-controlled, cross-over trial in 57 MS patients. In the
evaluation of FLX-787 for its impact on MS patients’ cramps/spasms
and spasticity, pre-specified analyses of the parallel portion of
the study showed the following:
- A statistically significant 27.3% reduction in the frequency of cramps/spasms compared with control (p=0.001)
- A 1.4 day increase in cramp/spasm-free days per 14 day period compared with control (p=0.046)
- Clinician-rated improvement in spasticity with FLX-787 treatment was significantly better than control (p=0.010)
- Treating physicians reported that 7 of 28 (25%) patients on FLX-787 had “Much Improved” or “Very Much Improved” spasticity versus 0 of 26 (0%) on control based upon the Clinical Global Impression of Change in Spasticity
- FLX-787 was generally well tolerated and resulted in no drug-related serious adverse events. GI-related adverse events (diarrhea and nausea) were infrequently reported with FLX-787.
- In April, the Company initiated an open-label, single dose study in ALS patients to assess the impact of FLX-787 on bulbar functions, including swallowing.
- In March, the Company announced positive topline data for FLX-787 from its exploratory Phase 2 trial in MS patients with frequent muscle cramps/spasms and spasticity. FLX-787 at a dose of 19 mg, taken orally twice daily, in a liquid formulation was evaluated in an exploratory Phase 2 randomized, double-blinded, placebo-controlled, cross-over trial in 57 MS patients. In the evaluation of FLX-787 for its impact on MS patients’ cramps/spasms and spasticity, pre-specified analyses of the parallel portion of the study showed the following:
For the quarter ended
March 31, 2018, the Company recorded approximately $179,000in total revenue for its consumer product, HOTSHOT®.
January 2018, the Company announced that it engaged an investment banking firm to assist with the consideration of strategic alternatives for the HOTSHOT consumer business. That review is in progress and the Company expects to report the results of the review in the near future.
- For the quarter ended
First Quarter 2018 Financial Results
- Cash Position: As of
March 31, 2018, Flex Pharmahad cash, cash equivalents and marketable securities of $23.9 million, estimated to fund operations to mid-2019. During the three months ended March 31, 2018, cash, cash equivalents and marketable securities decreased by $9.4 million, which is higher than the estimated spend for future quarters. The timing of clinical trial billings and annual bonus payments related to 2017 impacted the cash used in operations during the first quarter, and spend on the consumer business is expected to be lower.
- Total Revenue: Total revenue for the three months ended
March 31, 2018was approximately $179,000.
- Cost of Product Revenue: Cost of product revenue for the three
March 31, 2018was approximately $84,000. There were no inventory write-offs during the three months ended March 31, 2018.
- R&D Expense: Research and development expense for the three
March 31, 2018was $4.7 million. Research and development expense for this period primarily included costs associated with the Company’s clinical studies of FLX-787, personnel costs (including salaries and stock-based compensation costs), FLX-787 production costs, and external consultant costs.
- SG&A Expense: Selling, general and administrative expense
for the three months ended
March 31, 2018was $3.7 million. Selling, general and administrative expense for this period primarily included personnel costs (including salaries and stock-based compensation costs), sales, marketing and 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, 2018was ($8.2) million, or ($0.46)per share and included $0.9 millionof stock-based compensation expense. As of March 31, 2018, Flex Pharmahad 17,980,852 shares of common stock outstanding. The net loss for the first quarter of 2018 was primarily driven by the Company’s operating expenses related to its research and development efforts, costs associated with HOTSHOT, and general and administrative costs.
Based on its current operating plans and cash, cash equivalents and
marketable securities position,
Upcoming Events and Presentations
Jefferies2018 Global Healthcare Conference, June 5-8, 2018in New York, NY.
Conference Call and Webcast
The company will host a conference call and webcast today at
This press release contains forward-looking statements for purposes of
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. These forward-looking statements include statements
regarding our intentions, beliefs, projections, outlook, analyses or
current expectations concerning, among other things: the design and
timing of ongoing and anticipated clinical studies; and our expectations
regarding the availability of our capital resources. These
forward-looking statements are based on management's expectations and
assumptions as of the date of this press release and are subject to
numerous risks and uncertainties, which could cause actual results to
differ materially from those expressed or implied by such statements.
These risks and uncertainties include, without limitation: the status,
timing, costs, results and interpretation of our clinical studies; the
uncertainties inherent in conducting clinical studies; results from our
ongoing and planned preclinical development; expectations of our ability
to make regulatory filings and obtain and maintain regulatory approvals;
our ability to successfully commercialize our consumer product; results
of early clinical studies as indicative of the results of future trials;
availability of funding sufficient for our foreseeable and unforeseeable
operating expenses and capital expenditure requirements; other matters
that could affect the availability or commercial potential of our
consumer or drug product candidates; and the inherent uncertainties
associated with intellectual property. Other factors that may cause
actual results to differ from those expressed or implied in the
forward-looking statements in this press release are discussed in our
filings with the
|Flex Pharma, Inc.|
|Unaudited Selected Consolidated Balance Sheet Information|
|Cash and cash equivalents||$||21,948||$||19,186|
|Prepaid expenses and other current assets||1,261||777|
|Property and equipment, net||267||331|
|Liabilities and stockholders' equity:|
|Accounts payable and accrued expenses||$||4,062||$||5,717|
|Total liabilities and stockholders’ equity||$||26,033||$||34,993|
|Unaudited Condensed Consolidated Statements of Operations|
|(in thousands, except loss per share amounts)|
Three Months Ended
Three Months Ended
|Net product revenue||$||177||$||241|
|Costs and expenses:|
|Cost of product revenue||84||79|
|Research and development||4,680||3,915|
|Selling, general and administrative||3,697||4,595|
|Total costs and expenses||8,461||8,589|
|Loss from operations||(8,282||)||(8,346||)|
|Interest income, net||59||78|
|Net loss per share-basic and diluted||$||(0.46||)||$||(0.49||)|
|Weighted-average number of common shares outstanding (1)||17,894||16,874|
In 2014, the Company issued approximately 5.4 million shares of restricted stock that vested over four years, through February 2018. These shares were considered outstanding for purposes of computing weighted average shares as they vested. All of these shares have vested and are considered outstanding as of March 31, 2018.
Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
SVP, Investor Relations & Corporate Communications