Corporate Presentation September 2021 | Soleno Therapeutics Certain Notices and Disclaimers Forward-Looking Statements This presentation contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements appear in a number of places throughout this presentation and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development and clinical tr ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36593 SOLENO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 77-0523891 (State or other jurisdi ...

Corporate Presentation May 2021 | Soleno Therapeutics Certain Notices and Disclaimers Forward-Looking Statements This presentation contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements appear in a number of places throughout this presentation and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development and clinical trials; ...

Financial Performance - The company reported a net loss of $8.95 million for the three months ended March 31, 2021, compared to a net loss of $5.86 million for the same period in 2020, representing a 53% increase in losses[79]. - General and administrative expenses rose by 49% to $2.98 million for the three months ended March 31, 2021, compared to $2.00 million in the prior year[79]. - The company has an accumulated deficit of $191.4 million as of March 31, 2021, primarily due to research and development and general administrative expenses[77]. - Operating activities used net cash of $7.5 million during the three months ended March 31, 2021, compared to $5.7 million in the same period in 2020[87]. Research and Development - Research and development expenses increased by 7% to $7.16 million for the three months ended March 31, 2021, up from $6.70 million in the same period in 2020[79]. - The company has not yet commenced commercialization of its lead product, DCCR, and has generated no revenue from operations as of March 31, 2021[80]. - The company is in communication with regulatory authorities regarding the next steps for DCCR after the FDA indicated an additional clinical trial would be necessary for New Drug Approval[75]. Cash Position - Cash and cash equivalents stood at $41.6 million as of March 31, 2021, which management believes is sufficient to meet obligations for at least the next twelve months[77]. - The company raised $53.7 million in net proceeds from a public offering completed in June 2020[77]. Contingent Consideration - The fair value of contingent consideration related to the acquisition of Essentialis was estimated at $9.3 million as of March 31, 2021, a decrease of $1.0 million from the previous estimate[83].

Corporate Presentation February 2021 | Soleno Therapeutics Certain Notices and Disclaimers Forward-Looking Statements This presentation contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements appear in a number of places throughout this presentation and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned product development and clinical tri ...

Drug Development and Clinical Trials - The company is focused on developing DCCR for the treatment of Prader-Willi syndrome (PWS) and has received Fast-Track designation and orphan drug designation in the U.S. and E.U. for this drug[14] - DCCR was evaluated in a Phase 3 study (DESTINY PWS) with 127 patients, although it did not meet its primary endpoint, significant improvements were observed in two of three key secondary endpoints[15] - A Phase 2 clinical trial showed a statistically significant reduction in hyperphagia from baseline, with greater improvements in subjects with moderate to severe hyperphagia receiving higher DCCR doses[30] - The company reported a mean decrease in body fat mass and increases in lean body mass during the open-label treatment phase of the Phase 2 trial[30] - Statistically significant reductions in LDL cholesterol and non-HDL cholesterol were observed during the Phase 2 trial[30] - The DESTINY PWS clinical trial enrolled approximately 105 children and adults with PWS, with treatment emergent adverse events (TEAEs) occurring in 83.3% of DCCR treated subjects compared to 73.8% in the placebo group[31][33] - The Phase 3 clinical trial, DESTINY PWS, enrolled approximately 105 children and adults, with the Data Safety Monitoring Board recommending continuation without changes[31] - The safety profile of DCCR showed treatment emergent adverse events (TEAEs) in 83.3% of treated subjects, with most events being Grade 1 in severity[33][35] - The company is in communication with regulatory authorities to determine next steps following the Phase 3 clinical trial results, which showed significant improvements in key secondary endpoints despite not meeting the primary endpoint[36][58] - The FDA may require Phase 4 studies to further characterize safety and efficacy during commercial use[59] Market Opportunity and Strategy - The estimated incidence of PWS is 1 in 15,000 live births, with a mortality rate of 3% per year across all ages[21] - An estimated 300,000 to 400,000 individuals worldwide have PWS, with a birth incidence ranging from 1:15,000 to 1:25,000, indicating a significant market opportunity for DCCR[37] - DCCR may be the first effective treatment for hyperphagia in PWS patients, potentially leading to a large market share in both the U.S. and Europe[37] - The company plans to market DCCR without a partner in the U.S. by targeting major PWS treatment centers, while seeking a marketing partner for Japan and other regions[38] - The pricing strategy for DCCR at launch will be influenced by the product label negotiated with the FDA and pharmacoeconomic data[40] - Currently, the only approved products for PWS are Genotropin® and Omnitrope®, which do not address hyperphagia, highlighting DCCR's competitive advantage[41] - The company anticipates that DCCR may be the first effective treatment for hyperphagia in PWS patients to reach the market in both the U.S. and Europe[37] Regulatory and Compliance - The FDA designated the DCCR development program for PWS as a Fast Track program, which facilitates earlier access to new drugs for patients with serious conditions[32][36] - Orphan-designated drugs in the U.S. are granted up to 7-year market exclusivity, while in the E.U., they receive 10 years of market exclusivity[64] - Drug manufacturers are subject to periodic unannounced inspections by the FDA to ensure compliance with cGMP requirements[66] - The FDA strictly regulates the marketing and promotion of drugs, allowing only approved indications for use[70] - Changes to the manufacturing process generally require prior FDA approval before implementation[66] - The company must comply with extensive regulations post-approval, including recordkeeping and reporting of adverse experiences[65] - The FDA can withdraw product approval if ongoing regulatory requirements are not met or if safety problems arise after market entry[62] - The company is subject to federal and state antifraud laws, with potential penalties for violations including fines and exclusion from federal healthcare programs[76] - The Stark law prohibits physicians with ownership interests from referring patients to their own laboratories for Medicare-reimbursable tests[79] - The company must ensure compliance with HIPAA and other privacy laws to avoid penalties and operational disruptions[72] - The company has implemented a compliance plan to mitigate risks associated with healthcare regulations and laws[88] - The company is subject to significant civil penalties for failure to report financial arrangements with healthcare professionals as mandated by the PPACA[89] - The company maintains compliance with the Foreign Corrupt Practices Act, ensuring accurate accounting and internal controls for international operations[91] Financial and Investment Activities - The joint venture agreement with OptAsia Healthcare Limited involved an investment of up to $2.2 million, with OAHL purchasing shares at a price of $1.00 per share once cumulative investments reached $1.2 million[92] - Capnia issued 1,690,322 shares to OAHL on October 16, 2018, resulting in a 53% ownership transfer and a $1.9 million gain recognized in Q4 2018[93] - The remaining 47% investment in Capnia was sold to Sinon Investments LLC for $0.5 million, terminating the previous joint venture agreement[94] - In October 2019, the company raised $14.5 million by selling 12,841,667 shares at $1.20 per share in a public offering[96] - A subsequent public offering in June 2020 raised $53.7 million from the sale of 34,848,484 shares at $1.65 per share[97] - As of December 31, 2020, the company had 17 full-time employees and 14 consultants, with no employees represented by a labor union[98] - The company aims to attract and retain talent through equity and cash incentive plans to enhance stockholder value[99] Intellectual Property - The company has a patent portfolio consisting of 9 issued U.S. patents and 3 pending applications, with expiration dates ranging from 2026 to 2035[46] - The patent portfolio for DCCR includes 9 issued U.S. patents and 3 pending applications, providing protection for the active ingredient and methods of treatment[46]