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Soleno Therapeutics, Inc. (SLNO)

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  • Soleno Therapeutics Provides Corporate Update and Reports First Quarter 2021 Financial Results
    GlobeNewswire

    Soleno Therapeutics Provides Corporate Update and Reports First Quarter 2021 Financial Results

    REDWOOD CITY, Calif., May 05, 2021 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the three months ended March 31, 2021. “We are continuing our dialogue with the U.S. Food and Drug Administration (FDA) to evaluate the appropriate next steps in our DCCR program for the treatment of Prader-Willi Syndrome (PWS) and work towards obtaining regulatory approval as expeditiously as possible,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “The Soleno team remains committed to the development of DCCR and building an appropriate data set to support its development. To this end, we were excited to recently present behavioral outcomes data from caregiver interviews that summarized individual patient experiences during treatment with DCCR. We were also pleased to speak to the PWS community directly during the recent PWS DCCR Town Hall meeting where we reiterated our continued focus on DCCR and outlined the proposed necessary steps for submitting a marketing application to the FDA in the U.S. More importantly, we were able to listen to the stories about the individual study participants’ experiences during our completed Phase III clinical trial of DCCR, DESTINY PWS, and the ongoing long-term safety extension study.” Dr. Bhatnagar continued, “We are grateful for the work completed by the Foundation for Prader-Willi Research and Prader-Willi Syndrome Association | USA in collecting the experiences of PWS patients and caregivers treated with DCCR. This petition, which was submitted to the FDA, was signed by more than 26,000 individuals in support of DCCR.” First Quarter 2021 and Recent Corporate Highlights Continued discussions with FDA and currently evaluating appropriate next steps for DCCR program in PWSPresented behavioral outcomes data from the Company’s ongoing open-label extension study (C602) of DCCR in PWS at the Pediatric Academic Societies (PAS) 2021 Virtual Annual Meeting (poster available here) A majority of patients (83%) reported positive changes in multiple behavioral outcome domains, including food-seeking behaviors, mealtime behaviors and daily life behaviors in a preliminary analysis of data from interviews of caregivers of participants in C602 Presented assessment of baseline renal function in PWS patients enrolled in clinical study C601 at the Endocrinology Society (ENDO) 2021 Virtual Annual Meeting (poster available here)With researchers from the U.S. National Institutes of Health, presented resting energy expenditure data for a limited number of subjects enrolled in clinical studies C601 and C602 at the Pediatric Academic Societies (PAS) 2021 Virtual Annual Meeting (poster available here) DCCR treated subjects showed progressive increases in resting energy expenditure Presented a post-hoc analysis of C601 taking into account data prior to the ‘COVID impact’ (defined as 1 March 2020) at the PES 2021 Virtual Annual Meeting (poster available here) The primary endpoint, change in hyperphagia using HQ-CT, and all key secondary endpoints showed significant improvements in DCCR treated subjects compared with placeboThere were significant improvements in a number of behavioral and cardiometabolic endpoints in DCCR treated subjects compared with placebo Participated in PWS DCCR Town Hall Highlighted the proposed necessary steps to submit a marketing application for DCCR in the U.S. and reaffirmed the Company’s commitment to this processListened to individual patient and caregiver experiences with DCCR Participated in a fireside chat at the 31st Annual Oppenheimer Healthcare Conference Financial ResultsSoleno’s current research and development efforts are primarily focused on advancing its lead product candidate, DCCR, for the treatment of PWS, through late-stage clinical development. First Quarter Ended March 31, 2021 Financial Results Research and development expenses were $7.2 million for the quarter ended March 31, 2021, compared to $6.7 million in the same period of 2020. The increase was primarily due to increased activities related to the DCCR development program. General and administrative expense was $3.0 million for the quarter ended March 31, 2021, compared to $2.0 million in the same period of 2020. The change in the fair value of contingent consideration results from Soleno’s obligation to make cash payments to Essentialis stockholders upon the achievement of certain future commercial milestones associated with the sale of DCCR in accordance with the terms of the Essentialis merger agreement. The fair value was estimated to be approximately $9.3 million at March 31, 2021, resulting in a decrease in expense of approximately $1.0 million from the estimate at December 31, 2020. Total other income was $0.2 million for the quarter ended March 31, 2021, compared to $3.4 million in the same period of 2020, and consisted primarily of the change in the fair value of our outstanding warrants. Net loss for the quarter ended March 31, 2021, was approximately $9.0 million, or a net loss of $0.11 per basic and diluted share, compared to a net loss of approximately $5.9 million, or $0.13 per basic and diluted share, for the quarter ended March 31, 2020. As of March 31, 2021, Soleno had cash and cash equivalents of approximately $41.6 million, compared to $49.2 million at December 31, 2020. About PWSThe Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births in the U.S. The hallmark symptom of this disorder is hyperphagia, a chronic feeling of insatiable hunger that severely diminishes the quality of life for PWS patients and their families. Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development. Hyperphagia can lead to significant morbidities (e.g., obesity, diabetes, cardiovascular disease) and mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior). In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parent and caregivers) rated hyperphagia as the most important or a very important symptom to be relieved by a new medicine. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder. Diazoxide choline has received Orphan Drug Designation for the treatment of PWS in the U.S. and EU, and Fast Track Designation in the U.S. About Soleno Therapeutics, Inc.Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s lead candidate, DCCR extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi Syndrome (PWS), is currently being evaluated in a Phase 3 clinical development program. For more information, please visit www.soleno.life. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding timing of any regulatory process or ultimate approvals and determining a path forward for DCCR for the treatment of PWS. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with market conditions, as well as risks and uncertainties inherent in Soleno’s business, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Corporate Contact:Brian RitchieLifeSci Advisors, LLC212-915-2578 Soleno Therapeutics, Inc.Condensed Consolidated Balance Sheets(In thousands except share and per share data) March 31,2021 December 31,2020 Assets (Unaudited) Current assets Cash and cash equivalents $41,607 $49,224 Prepaid expenses and other current assets 921 1,019 Total current assets 42,528 50,243 Long-term assets Property and equipment, net 20 19 Operating lease right-of-use assets 50 124 Finance lease right-of-use assets 13 15 Intangible assets, net 14,095 14,581 Total assets $56,706 $64,982 Liabilities and stockholders’ equity Current liabilities Accounts payable $4,669 $3,489 Accrued compensation 411 1,005 Accrued clinical trial site costs 4,140 3,789 Operating lease liabilities 57 139 Other current liabilities 232 196 Total current liabilities 9,509 8,618 Long-term liabilities 2018 PIPE Warrant liability 338 539 Contingent liability for Essentialis purchase price 9,291 10,278 Total liabilities 19,138 19,435 Commitments and contingencies (Note 6) Stockholders’ equity Common stock, $0.001 par value, 250,000,000 shares authorized, 79,723,680 and 79,615,692 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively. 80 80 Additional paid-in-capital 228,887 227,912 Accumulated deficit (191,399) (182,445)Total stockholders’ equity 37,568 45,547 Total liabilities and stockholders’ equity $56,706 $64,982 Soleno Therapeutics, Inc.Condensed Consolidated Statements of Operations(unaudited)(In thousands except share and per share data) Three Months EndedMarch 31, 2021 2020 Operating expenses Research and development $7,164 $6,695 General and administrative 2,979 2,003 Change in fair value of contingent consideration (987) 584 Total operating expenses 9,156 9,282 Operating loss (9,156) (9,282)Other income Change in fair value of warrants liabilities 201 3,413 Interest income 1 11 Total other income 202 3,424 Net loss $(8,954) $(5,858)Net loss per common share, basic and diluted $(0.11) $(0.13)Weighted-average common shares outstanding used to calculate basic and diluted net loss per common share 79,694,781 44,679,858

  • Soleno Therapeutics' DCCR Treatment Shows Improvement In Multiple Behavioral Domains In Prader-Willi Syndrome Patients
    Benzinga

    Soleno Therapeutics' DCCR Treatment Shows Improvement In Multiple Behavioral Domains In Prader-Willi Syndrome Patients

    Soleno Therapeutics Inc (NASDAQ: SLNO) has announced the presentation of behavioral outcomes data from its ongoing open-label extension study (C602) of DCCR (diazoxide choline) for Prader-Willi Syndrome (PWS). Prader-Willi Syndrome is characterized by a chronic feeling of insatiable hunger that severely diminishes the quality of life. Data were presented at the Pediatric Academic Societies (PAS) 2021 Virtual Annual Meeting. Through the 48 interviews, 39 behavioral outcomes were identified in seven outcome domains, with an average of 22±5.9 behaviors reported. The three most frequently reported domains were Food-seeking Behaviors, Mealtime Behaviors, and Daily Life Behaviors. 83% of the participants reported a positive change in one or more behavioral outcomes on DCCR, more than 70% reported positive changes in one quarter or more of behaviors. In comparison, 48% reported positive changes in more than half of behaviors. 23% of participants reported a negative behavior change, and 6% reported more than one negative change Price Action: SLNO shares are down 0.8% at $1.18 in the premarket session on the last check Tuesday. See more from BenzingaClick here for options trades from BenzingaBausch Health Reports Wider Q1 Loss, Hit By Impairment Charges On Ortho DermatologicsBioLineRx Stock Is Trading Higher As Motixafortide-G-CSF Combo Shows Promise In Transplant Setting For Multiple Myeloma Patients© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

  • Soleno Therapeutics Announces Presentation of Positive Behavioral Data from Ongoing Extension Study of DCCR for Treatment of Prader-Willi Syndrome
    GlobeNewswire

    Soleno Therapeutics Announces Presentation of Positive Behavioral Data from Ongoing Extension Study of DCCR for Treatment of Prader-Willi Syndrome

    Results Show Improvement in Multiple Behavioral Domains Following Treatment with DCCR Data Presented in a Poster at the Pediatric Academic Societies Annual Meeting REDWOOD CITY, Calif., May 04, 2021 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the presentation of positive behavioral outcomes data from the Company’s ongoing open-label extension study (C602) of DCCR (diazoxide choline) Extended-Release tablets for patients with Prader-Willi Syndrome (PWS), at the Pediatric Academic Societies (PAS) 2021 Virtual Annual Meeting. The poster is available here. As part of the ongoing Phase 3 program of DCCR in PWS, interviews are being conducted with caregivers of C602 study participants to characterize individual patient experiences with DCCR. The interviews are performed at multiple timepoints during the Phase 3 program by Casimir Inc., a rare disease research organization. The poster highlights the analysis of a subset of 48 interviews of caregivers whose child had received at least 13 weeks of DCCR treatment in C602. Folia Health, which utilizes a data driven platform to improve the treatment of chronic conditions, utilized a combination of natural language processing (NLP) and qualitative analytic techniques to process and analyze the transcript data from the caregiver interviews. Through the 48 interviews, 39 behavioral outcomes were identified in seven outcome domains, with an average of 22±5.9 behaviors reported. The three most frequently reported domains were Food-seeking Behaviors (100%), Mealtime Behaviors (98%), and Daily Life Behaviors (98%). Twenty three percent of participants reported a negative behavior change and 6% reported more than one negative change. Most participants (83%) reported positive change in one or more behavioral outcomes on DCCR, more than 70% reported positive changes in one quarter or more of behaviors, while 48% reported positive changes in more than half of behaviors. “It is exciting to see the utilization of natural language processing for the first time to determine caregiver sentiment in patients with PWS. NLP and other artificial intelligence techniques are the future of qualitative data analysis and can be particularly useful in rare-disease research. To my knowledge, this is the first report of the use of such techniques to understand the complex world of PWS outcomes,” said Deepan Singh, M.D., Vice Chair of Ambulatory Psychiatry, Maimonides Medical Center in Brooklyn, NY. “Behavioral abnormalities in PWS are heterogenous and very difficult to treat. I am encouraged by DCCR’s potential to impact these intractable problematic behaviors in individuals with PWS.” “These important data provide critical insights into the long-term behavioral responses to DCCR in PWS, and support a more complete view of this promising investigational drug’s therapeutic benefits,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “The growing body of clinical evidence continues to indicate that DCCR has the potential to address the significant need for a safe and effective treatment for individuals with PWS. We remain firmly committed to working with the U.S. Food and Drug Administration to define the path forward for DCCR.” About PWSThe Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births in the U.S. The hallmark symptom of this disorder is hyperphagia, a chronic feeling of insatiable hunger that severely diminishes the quality of life for PWS patients and their families. Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development. Hyperphagia can lead to significant morbidities (e.g., obesity, diabetes, cardiovascular disease) and mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior). In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parent and caregivers) rated hyperphagia as the most important or a very important symptom to be relieved by a new medicine. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder. Diazoxide choline has received Orphan Drug Designation for the treatment of PWS in the U.S. and EU, and Fast Track Designation in the U.S. About DCCR (Diazoxide Choline) Extended-Release TabletsDCCR is a novel, proprietary extended-release dosage form containing the crystalline salt of diazoxide and is administered once-daily. The parent molecule, diazoxide, has been used for decades in thousands of patients in a few rare diseases in neonates, infants, children and adults, but has not been approved for use in PWS. Soleno conceived of and established extensive patent protection on the therapeutic use of diazoxide and DCCR in patients with PWS. The DCCR development program is supported by data from five completed Phase 1 clinical studies in healthy volunteers and three completed Phase 2 clinical studies, one of which was in PWS patients. In the PWS Phase 3 study, DCCR showed promise in addressing hyperphagia, the hallmark symptom of PWS, as well as several other symptoms such as aggressive/destructive behaviors, fat mass and other metabolic parameters. About Soleno Therapeutics, Inc.Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s lead candidate, DCCR extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi Syndrome (PWS), is currently being evaluated in a Phase 3 clinical development program. For more information, please visit www.soleno.life. About Casimir Inc.Casimir is a Contract Research Organization (CRO) that develops novel outcomes for decentralized and hybrid trials in order to better understand disease progression and treatment benefit. Casimir works with sponsors in over 20 rare diseases in every facet of clinical services from preclinical development to Phase IV and siteless studies. About Folia HealthFolia is a patient-driven Health-IOS (Individual Operating System) that enables individuals to easily take an active role in their care, while contributing to precision diagnostics, patient-centered drug development, & better care for complex diseases. Folia’s rich longitudinal data and proprietary analytic methods provide a vital and missing piece in the emergence of a home-centered, data-driven healthcare ecosystem. Discover how to harness the power of patient and caregiver knowledge at www.foliahealth.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding timing of any regulatory process or ultimate approvals and determining a path forward for DCCR for the treatment of PWS. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with market conditions, as well as risks and uncertainties inherent in Soleno’s business, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Corporate Contact:Brian RitchieLifeSci Advisors, LLC212-915-2578