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Avadel Pharmaceuticals plc (AVDL)

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7.28-0.12 (-1.62%)
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Previous close7.40
Open7.46
Bid7.24 x 1100
Ask7.27 x 1100
Day's range7.18 - 7.51
52-week range4.83 - 10.33
Volume110,282
Avg. volume252,287
Market cap425.627M
Beta (5Y monthly)1.40
PE ratio (TTM)56.00
EPS (TTM)N/A
Earnings dateN/A
Forward dividend & yieldN/A (N/A)
Ex-dividend dateN/A
1y target estN/A
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News
  • Globe Newswire

    Avadel Pharmaceuticals Provides Corporate Update and Reports First Quarter 2021 Financial Results

    Announced FDA acceptance of NDA for once-nightly FT218 and an October 15, 2021 target action PDUFA date Presented positive secondary endpoint data at the AAN 2021 Annual Meeting, which further highlights the overall clinical value proposition of FT218 FT218 launch preparation progressing Management to host a conference call today at 8:30 a.m. ET DUBLIN, Ireland, May 10, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today provided a corporate update and announced its financial results for the first quarter ended March 31, 2021. “We entered 2021 with positive momentum which included the announcement of several significant milestones for the FT218 program that will help shape our company’s future, including FDA acceptance of the NDA filing for once-nightly FT218, which was assigned a PDUFA target action date of October 15th. We are now approaching the mid-point of the review timeline and remain confident in our regulatory filing strategy. We also announced the appointment of Richard Kim as Chief Commercial Officer to lead the launch of FT218, if approved. We are continuing to build our team and capabilities, and we are incredibly pleased with the experience and caliber of talent we are attracting to Avadel. We believe this is a testament to both confidence in the potential approval of FT218 and the opportunity that FT218 represents,” said Greg Divis, Chief Executive Officer of Avadel. “During the AAN annual meeting, we presented positive secondary endpoint data that further highlights the consistency with which once-nightly FT218 improved both subjective and objective symptoms of narcolepsy, as early as week three with the 6 g dose. Notably, the clinical data from the REST-ON phase 3 study presented at AAN shows that FT218 improved disturbed nocturnal sleep, with a single dose taken at bedtime. We believe the overwhelmingly positive data from this pivotal trial along with our Special Protocol Assessment agreement with FDA provides a strong foundation for our NDA,” said Dr. Jennifer Gudeman, Vice President of Medical and Clinical Affairs. “Educating the medical community on the clinical data from the REST-ON study is an important part of our broader strategy for FT218. We will be presenting the secondary data and additional clinical data from the REST-ON study at future medical congresses, including the Associated Professional Sleep Societies’ annual SLEEP meeting, as well as publishing in peer-reviewed journals throughout the remainder of 2021,” concluded Dr. Gudeman. First quarter and recent Company highlights Announced that the New Drug Application (NDA) for FT218 was accepted for filing by the U.S. Food and Drug Administration (FDA) during the first quarter of 2021, and was assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2021Presented positive secondary endpoint data from the REST-ON trial at the American Academy of Neurology (AAN) annual meeting, which further bolster the previously announced positive data regarding the three co-primary endpoints, including: FT218 demonstrated significant consolidation of sleep, significant increase in time in deep sleep and significant decrease in light sleep compared to placebo, for all doses evaluated (6 g, 7.5 g, and 9 g), beginning by week threeFT218 demonstrated significant improvement in the Epworth Sleepiness Scale, a patient-reported outcome, as well as significantly improving patient perceptions of both the quality and refreshing nature of sleep, and a reduction of sleep paralysis, also for all doses evaluated (6 g, 7.5 g, and 9 g) Scheduled to present additional data from the REST-ON trial at the SLEEP congress in June 2021Continued the expansion and enrollment of the RESTORE open-label extension/switch study of FT218 designed to generate long-term safety, tolerability, and efficacy data, as well as data on switching from twice-nightly sodium oxybate and patient preference Overview of First Quarter Results As a result of the sale of the sterile injectable products to Exela Sterile Medicines LLC on June 30, 2020, the Company did not report any revenue for the quarter ended March 31, 2021, compared to $12.2 million for the same period in 2020. R&D expenses were $3.9 million in the quarter ended March 31, 2021, compared to $5.5 million for the same period in 2020. The decrease on a year-over-year basis was primarily attributed to the completion of the Phase 3 REST-ON clinical study for FT218, which concluded during the quarter ended March 31, 2020. SG&A expenses were $11.0 million in the quarter ended March 31, 2021, compared to $7.9 million for the same period in 2020. The year-over-year increase is the result of a number of factors including commercial launch planning costs related to FT218 and higher stock-based compensation. Income tax benefit was $2.6 million in the quarter ended March 31, 2021, compared to $9.5 million for the same period in 2020. The decrease in the income tax benefit year-over-year is primarily due to benefits recognized in 2020 from the Coronavirus Aid, Relief and Economic Security Act. Net loss for the quarter ended March 31, 2021 was $13.4 million, or ($0.23) per diluted share, compared to a net loss of $0.9 million, or ($0.02) per diluted share, for the same period in 2020. The increase in net loss and diluted loss per share is primarily the result of the year-over-year decrease in revenue due to the sale of the sterile injectable products. The increase in diluted shares outstanding resulted primarily from equity issuances related to financing activities completed during the first half of 2020. Cash, cash equivalents and marketable securities were $205.0 million as of March 31, 2021. The Company has convertible debt of $143.8 million due in February 2023. Conference CallA conference call to discuss these results has been scheduled for Monday, May 10, 2021 at 8:30 a.m. ET. To access the conference call, investors are invited to dial (877) 407-9716 (U.S. and Canada) or (201) 493-6779 (International). The conference ID number is 13719428. A live audio webcast can be accessed by visiting the investor relations section of the Company’s website, www.avadel.com. A replay of the webcast will be archived on Avadel’s website for 90 days following the event. About FT218FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel’s MicroPump™ controlled-release technology. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. In December 2020, the Company submitted a NDA to the FDA for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. The NDA for FT218 was accepted by the FDA in February 2021 and assigned a PDUFA target action date of October 15, 2021. FT218 has been granted Orphan Drug Designation from the FDA for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product. About Avadel Pharmaceuticals plcAvadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly, extended-release formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com. Cautionary Disclosure Regarding Forward-Looking StatementsThis press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, the FDA’s review of the NDA for FT218, the sufficiency of data supporting the NDA for FT218, the presentation of additional clinical trial data for FT218, the commercial launch of FT218 (if approved), the market acceptance of FT218 (if approved), and the advancement of the RESTORE study to generate long-term safety, tolerability, and efficacy data for FT218. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions, and the negatives thereof (if applicable). The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include the risk that: positive results from the REST-ON trial may not necessarily be predictive of the results of future or ongoing clinical studies; the NDA for FT218 is not approved by the FDA or such approval is delayed; the risk that commercial launch of FT218 (if approved) is delayed or never occurs; the risk that the potential market acceptance of FT218 (if approved) may differ materially from projections; the risk that the RESTORE study may be delayed or may not be completed at all; and the risk that the impact of the current COVID-19 pandemic on the Company’s financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission (SEC) on March 9, 2021 and subsequent SEC filings. Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law. Contacts: Investor ContactsTom McHughChief Financial OfficerPhone: (636) 449-1843Email: tmchugh@avadel.com Tim McCarthyLifeSci Advisors, LLCPhone: (212) 915.2564Email: tim@lifesciadvisors.com Media ContactPatrick BurseyLifeSci Communications, LLCPhone: (646) 970-4688Email: pbursey@lifescicomms.com AVADEL PHARMACEUTICALS PLCCONDENSED CONSOLIDATED STATEMENTS OF LOSS(In thousands, except share and per share data)(Unaudited) Three Months Ended March 31, 2021 2020 Product sales $— $12,243 Operating expenses: Cost of products — 2,457 Research and development expenses 3,852 5,530 Selling, general and administrative expenses 11,012 7,913 Intangible asset amortization — 203 Changes in fair value of contingent consideration — 2,478 Restructuring (income) costs (53) 159 Total operating expense 14,811 18,740 Operating loss (14,811) (6,497) Investment and other income (expense), net 610 (378) Interest expense (1,929) (3,190) Gain from release of certain liabilities 78 — Other expense - changes in fair value of contingent consideration payable — (310) Loss before income taxes (16,052) (10,375) Income tax benefit (2,607) (9,510) Net loss $(13,445) $(865) Net loss per share - basic $(0.23) $(0.02) Net loss per share - diluted (0.23) (0.02) Weighted average number of shares outstanding - basic 58,443 41,057 Weighted average number of shares outstanding - diluted 58,443 41,057 AVADEL PHARMACEUTICALS PLCCONDENSED CONSOLIDATED BALANCE SHEETS(In thousands, except share and per share data) March 31, 2021 December 31, 2020 (unaudited) ASSETS Current assets: Cash and cash equivalents $59,172 $71,722 Marketable securities 145,803 149,680 Research and development tax credit receivable 3,108 3,326 Prepaid expenses and other current assets 34,231 38,726 Total current assets 242,314 263,454 Property and equipment, net 344 359 Operating lease right-of-use assets 2,427 2,604 Goodwill 16,836 16,836 Research and development tax credit receivable 3,303 3,445 Other non-current assets 27,717 24,939 Total assets $292,941 $311,637 LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Current portion of operating lease liability $484 $474 Accounts payable 2,824 2,934 Accrued expenses 4,297 6,501 Other current liabilities 1,515 5,200 Total current liabilities 9,120 15,109 Long-term debt 141,461 128,210 Long-term operating lease liability 1,717 1,840 Other non-current liabilities 4,139 4,212 Total liabilities 156,437 149,371 Shareholders’ equity: Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; 488 issued and outstanding at March 31, 2021 and 488 issued and outstanding at December 31, 2020, respectively 5 5 Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 58,488 issued and outstanding at March 31, 2021 and 58,396 issued and outstanding at December 31, 2020 584 583 Additional paid-in capital 542,093 566,916 Accumulated deficit (383,872) (384,187) Accumulated other comprehensive loss (22,306) (21,051) Total shareholders’ equity 136,504 162,266 Total liabilities and shareholders’ equity $292,941 $311,637 AVADEL PHARMACEUTICALS PLCCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(In thousands)(Unaudited) Three Months Ended March 31, 2021 2020 Cash flows from operating activities: Net loss $(13,445) $(865) Adjustments to reconcile net loss to net cash provided by operating activities: Depreciation and amortization 218 456 Remeasurement of acquisition-related contingent consideration — 2,478 Remeasurement of financing-related contingent consideration — 310 Amortization of debt discount and debt issuance costs 312 1,573 Change in deferred tax and income tax deferred charge (2,534) (8,440) Stock-based compensation expense 1,728 742 Gain from the release of certain liabilities (78) — Other adjustments 561 573 Net changes in assets and liabilities Accounts receivable — (517) Inventories — 47 Prepaid expenses and other current assets (3,736) 899 Research and development tax credit receivable 80 160 Accounts payable & other current liabilities (3,789) (1,187) Accrued expenses (2,112) (4,905) Accrued income taxes — 2,253 Earn-out payments for contingent consideration in excess of acquisition-date fair value — (1,774) Royalty payments for contingent consideration payable in excess of original fair value — (291) Other assets and liabilities (618) (3,148) Net cash used in operating activities (23,413) (11,636) Cash flows from investing activities: Purchases of property and equipment (26) — Proceeds from the disposition of the hospital products 8,250 — Proceeds from sales of marketable securities 40,736 14,788 Purchases of marketable securities (37,769) (1,562) Net cash provided by investing activities 11,191 13,226 Cash flows from financing activities: Proceeds from the February 2020 private placement — 60,733 Proceeds from stock option exercises and employee stock purchase plan 149 1,477 Net cash provided by financing activities 149 62,210 Effect of foreign currency exchange rate changes on cash and cash equivalents (477) (68) Net change in cash and cash equivalents (12,550) 63,732 Cash and cash equivalents at January 1, 71,722 9,774 Cash and cash equivalents at March 31, $59,172 $73,506

  • Globe Newswire

    Avadel Pharmaceuticals to Provide a Corporate Update and Report First Quarter 2021 Financial Results on May 10th

    DUBLIN, Ireland, April 29, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, May 10, 2021, to provide a corporate update and discuss the Company's financial results for the first quarter ended March 31, 2021. To access the conference call, investors are invited to dial (877) 407-9716 (U.S. and Canada) or (201) 493-6779 (International). The conference ID number is 13719428. A live audio webcast can be accessed by visiting the investor relations section of the Company’s website, www.avadel.com. A replay of the webcast will be archived on Avadel’s website for 90 days following the event. Contacts: Investor Contacts Tom McHughChief Financial OfficerPhone: (636) 449-1843Email: tmchugh@avadel.com Tim McCarthyLifeSci Advisors, LLCPhone: (212) 915-2564Email: tim@lifesciadvisors.com Media ContactPatrick BurseyLifeSci Communications, LLCPhone: (646) 970-4688Email: pbursey@lifescicomms.com

  • Globe Newswire

    Avadel Presents New Data from its Pivotal REST-ON Phase 3 Trial of FT218, once-nightly sodium oxybate, at the 2021 American Academy of Neurology Annual Meeting

    Secondary endpoint data for once-nightly FT218 further supports previously announced topline data demonstrating clinically meaningful results at 6 g, 7.5 g, and 9 g doses DUBLIN, Ireland, April 17, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate (ON-SXB) for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the presentation of positive secondary endpoint data at the 2021 American Academy of Neurology Annual (AAN) Meeting being held virtually from April 17-22, 2021. FT218 is currently under review at the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) target date of October 15, 2021. “The positive results previously disclosed from the REST-ON trial, regarding the three co-primary endpoints, are further bolstered by the secondary endpoints presented at AAN. The consistency with which FT218, or once-nightly sodium oxybate, improved both subjective and objective symptoms of narcolepsy – including disturbed nocturnal sleep – represent the promise of a potential new treatment strategy for physicians and patients. I am particularly impressed by the consistency of results as early as three weeks, with only a 6 g dose,” said Michael J. Thorpy, M.D., Investigator on the REST-ON Phase 3 trial and Director at the Sleep-Wake Disorders Center at Montefiore Medical Center and Professor of Neurology at the Albert Einstein College of Medicine. “I know that clinicians have been eager to learn more about a once-nightly form of sodium oxybate, and we appreciate this forum to present these data.” Jennifer Gudeman, PharmD, Vice President of Medical and Clinical Affairs at Avadel, added, “FT218 demonstrated significant (P<0.001) and clinically meaningful results versus placebo at all doses tested for secondary endpoints of the Epworth Sleepiness Scale, sleep quality and refreshing nature of sleep, sleep paralysis, and disturbed nocturnal sleep, representing an improvement on important narcolepsy symptoms. We are pleased that neurologists attending AAN will have the opportunity to learn about a once-nightly form of sodium oxybate. We believe that patient perspective is critical to successful long-term therapy, and we are presenting several positive endpoints supporting symptomatic improvement as determined directly by patients.” To register for the meeting, visit AAN’s website: www.aan.com/conferences-community/annual-meeting. Data highlights from the poster presentations are outlined below: Polysomnographic Measures of Sleep Continuity in Patients with Narcolepsy: Results From the REST-ON Trial, a Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate Formulation FT218 demonstrated significant consolidation of sleep on polysomnography (randomized, n=212) for the 6 g dose at Week 3, the 7.5 g dose at Week 8, and 9 g dose at Week 13 compared to placeboData from the randomized, double-blind, placebo-controlled, multicenter, parallel-group study showed that the mean difference between FT218 and placebo for disturbed nocturnal sleep (shifts from deeper to lighter stages of sleep and wake) was statistically significant (P<0.001) at all doses tested: –22.63 at 9 g (week 13), –17.70 at 7.5 g (week 8), and –11.00 at 6 g (week 3).The mean difference between FT218 and placebo for number of arousals was –23.68 (P<0.001) at 9 g, –19.41 (P<0.001) at 7.5 g and –11.29 (P<0.021) at 6 g.FT218 was generally well tolerated, and the most common adverse reactions were well-known and established sodium oxybate adverse reactions. Daytime Sleepiness, Sleep Quality, Hallucinations, and Sleep Paralysis in Patients with Narcolepsy: Results From the REST-ON Trial, a Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate Formulation FT218 demonstrated significant (P<0.001) improvement in the Epworth Sleepiness Scale (ESS) versus placebo at all doses tested: LS mean difference –3.86 at 9 g (week 13), –3.16 at 7.5 g (week 8), and –2.06 at 6 g (week 3).FT218 showed a statistically significant (P<0.001) improvement compared to placebo at all doses tested for sleep quality and refreshing nature of sleep on a visual analogue scale, and for sleep paralysis on a sleep symptom diary (P=0.037, 0.021, 0.039 at 9, 7.5, 6 g, respectively). FT218 did not demonstrate significant improvement for hypnagogic compared to placebo. Adverse events were similar to the known sodium oxybate safety profile. About Avadel Pharmaceuticals plcAvadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly, extended-release formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com. About FT218FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel’s MicroPump™ controlled-release (CR) technology. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. In December 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. The NDA for FT218 was accepted by the FDA in February 2021 and assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2021. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product. Cautionary Disclosure Regarding Forward-Looking StatementsThis press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, our expectations of the therapeutic benefits of FT218, the timing of the FDA’s review of our NDA for FT218, the sufficiency of data supporting our NDA for FT218, the commercial launch of FT218 (if approved), and the market acceptance of FT218 (if approved). In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions, and the negatives thereof (if applicable). Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include: the risk that positive results from the REST-ON trial may not necessarily be predictive of the results of future or ongoing clinical studies; the risk that the NDA for FT218 is not approved by the FDA or such approval is delayed; the risk that FT218 (if approved) may not receive a 7-year Orphan Drug Exclusivity; the risk that commercial launch of FT218 (if approved) is delayed or never occurs; the risk that the potential market performance for FT218 (if approved) may differ materially from projections; and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2020, which we filed with the Securities and Exchange Commission (SEC) on March 9, 2021 and subsequent SEC filings. Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law. Contacts: Investor ContactsTom McHughChief Financial OfficerPhone: (636) 449-1843Email: tmchugh@avadel.com Tim McCarthyLifeSci Advisors, LLCPhone: (212) 915.2564Email: tim@lifesciadvisors.com Media ContactPatrick BurseyLifeSci Communications, LLCPhone: (646) 970-4688Email: pbursey@lifescicomms.com