Stoke Therapeutics, Inc. (STOK) closed the last trading session at $13.27, gaining 16.4% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $22.14 indicates a 66.8% upside potential.The average comprises seven short-term price targets ranging from a low of $14 to a high of $35, with a standard deviation of $7.38. While the lowest estimate indicates an increase of 5.5% from the current ...

Financial Performance - Total revenue for the three months ended September 30, 2024, was $4.894 million, an increase of 48% compared to $3.308 million for the same period in 2023[12]. - The net loss for the three months ended September 30, 2024, was $26.430 million, compared to a net loss of $24.542 million for the same period in 2023[12]. - The company reported a comprehensive loss of $26.249 million for the three months ended September 30, 2024, compared to a comprehensive loss of $24.310 million in the same period of 2023[12]. - For the nine months ended September 30, 2024, the net loss was $78.5 million, slightly higher than the $77.7 million loss for the same period in 2023, indicating a year-over-year increase of about 1.0%[52]. - The company incurred net losses of $26.4 million and $24.5 million for the three months ended September 30, 2024 and 2023, respectively, and $78.5 million and $77.7 million for the nine months ended September 30, 2024 and 2023, respectively[125]. Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $34.897 million, up 14% from $30.542 million in the prior year[12]. - Research and development expenses for the three months ended September 30, 2024, were $22.2 million, up 4.6% from $20.3 million in the same period of 2023[65]. - General and administrative expenses increased to $12.7 million for the three months ended September 30, 2024, compared to $10.3 million for the same period in 2023, representing a 23.3% increase[66]. - Research and development expenses for the nine months ended September 30, 2024, were $65.710 million, an increase from $60.453 million in the prior year[12]. - General and administrative expenses for the nine months ended September 30, 2024, were $36.0 million, compared to $30.7 million for the same period in 2023, reflecting a 17.1% increase[72]. Cash and Liquidity - Cash and cash equivalents decreased to $150.016 million as of September 30, 2024, from $191.442 million at the end of 2023[10]. - The company had cash, cash equivalents, and marketable securities totaling $269.2 million as of September 30, 2024, up from $201.4 million as of December 31, 2023[50]. - The company expects existing cash resources to fund operations at least until the end of 2025[74]. - The company had cash, cash equivalents, and restricted cash of $150,585,000 at the end of the reporting period, down from $192,011,000 at the beginning of the period[15]. - The company experienced a net cash used in operating activities of $63,658,000 for the nine months ended September 30, 2024, compared to $60,418,000 for the same period in 2023[15]. Stockholder Equity and Shares - The company had total stockholders' equity of $232.113 million as of September 30, 2024, up from $159.565 million at the end of 2023[10]. - The weighted-average common shares outstanding for the three months ended September 30, 2024, were 56,341,074, compared to 44,266,017 for the same period in 2023[12]. - The total number of common stock shares outstanding increased to 52,941,191 as of September 30, 2024, from 39,439,575 as of December 31, 2022[13]. - The company granted options to purchase 729,300 shares of common stock during the three months ended September 30, 2024[42]. - As of September 30, 2024, there was $35.1 million of unrecognized compensation cost related to unvested stock options[43]. Collaboration and Milestones - The Company is eligible to receive up to $907.5 million in potential milestone payments from the collaboration with Acadia Pharmaceuticals[39]. - The Company received an upfront payment of $60 million from Acadia Pharmaceuticals as part of the license and collaboration agreement[39]. - As of September 30, 2024, the Company had $39.9 million in upfront consideration associated with the Acadia agreement relating to unsatisfied or partially unsatisfied performance obligations[40]. - The company entered into a collaboration agreement with Acadia Pharmaceuticals, receiving an upfront payment of $60.0 million and is eligible for up to $907.5 million in potential milestone payments[56]. Regulatory and Clinical Development - The company is developing zorevunersen for Dravet syndrome, with ongoing studies and plans for a regulatory update on Phase 3 registrational plans in the second half of 2024[53]. - The company has submitted an investigational new drug application for its lead product candidate, zorevunersen, and began dosing patients in a Phase 1/2a study in August 2020[99]. - The FDA previously placed a partial clinical hold on certain doses of zorevunersen pending additional preclinical testing[102]. - The company has received regulatory authorization for its Clinical Trial Authorization application for STK-002 in April 2023, although patient enrollment and dosing have not yet commenced[99]. - The company is currently evaluating zorevunersen in human clinical trials, with ongoing assessments of safety and efficacy[102]. Risks and Challenges - The company is subject to risks typical of early-stage biotechnology firms, including competition and the need for significant capital for product development[18]. - The company faces significant risks in obtaining regulatory approvals, which may delay or prevent product commercialization[107]. - The company may face challenges in establishing sales for its product candidates due to ethical, social, and legal concerns surrounding genetic treatments[116]. - The company is exposed to product liability risks related to clinical trials, which could result in substantial liabilities and impact commercialization efforts[166]. - The company may face limitations on utilizing its net operating loss carryforwards due to ownership changes[127]. Intellectual Property - The company relies on intellectual property protection for its proprietary technologies and product candidates, including TANGO, zorevunersen, and STK-002, which are critical for commercial success[130]. - The patenting process is described as expensive and time-consuming, with potential challenges in securing and maintaining patent protection across relevant markets[130]. - The company holds multiple issued U.S. and foreign patents covering zorevunersen and STK-002, but there is uncertainty regarding the adequacy of these protections against competitors[133]. - The company may need to redesign technology or obtain additional licenses to advance research or commercialization, which could be costly and time-consuming[130]. - The company may face disputes regarding the scope of rights under licensing agreements, which could impair its ability to commercialize product candidates[132]. Market and Economic Conditions - Global economic conditions, including potential recessions and banking instability, could adversely affect the company's financial condition and operational capabilities[159]. - The company anticipates pricing pressures due to increasing efforts by governmental and third-party payors to cap healthcare costs, which may limit coverage and reimbursement for new products[119]. - The market price of the company's stock may be volatile, influenced by various factors including clinical trial results and regulatory developments[167]. - The company is classified as an "emerging growth company" and a "smaller reporting company," with total annual gross revenue expected to remain below $1.235 billion until at least December 31, 2024[168]. - The company has never declared or paid cash dividends on its capital stock, with capital appreciation being the sole source of gain for investors in the foreseeable future[173].

Company Performance - Stoke Therapeutics reported a quarterly loss of $0.47 per share, better than the Zacks Consensus Estimate of a loss of $0.52, and an improvement from a loss of $0.55 per share a year ago, representing an earnings surprise of 9.62% [1] - The company posted revenues of $4.89 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 41.65%, compared to revenues of $3.31 million in the same quarter last year [2] - Over the last four quarters, Stoke Therapeutics has surpassed consensus EPS estimates four times and topped consensus revenue estimates three times [2] Stock Performance - Stoke Therapeutics shares have increased approximately 149.1% since the beginning of the year, significantly outperforming the S&P 500's gain of 19.8% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.56 on revenues of $2.96 million, and for the current fiscal year, it is -$2.10 on revenues of $14.82 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Stoke Therapeutics belongs, is currently ranked in the top 38% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Financial Performance - Revenue recognized for the three months ended September 30, 2024, was $4.9 million, a 48.5% increase from $3.3 million in the same period in 2023[5] - Year-to-date revenue for the nine months ended September 30, 2024, was $13.9 million, compared to $6.0 million for the same period in 2023, representing a 131.7% increase[6] - Revenue for Q3 2024 was $4.894 million, up 48% from $3.308 million in Q3 2023[13] - Total other income for Q3 2024 was $3.573 million, up from $2.692 million in Q3 2023, a 33% increase[13] Net Loss - Net loss for the three months ended September 30, 2024, was $26.4 million, or $0.47 per share, compared to a net loss of $24.5 million, or $0.55 per share, for the same period in 2023[5] - Year-to-date net loss for the nine months ended September 30, 2024, was $78.5 million, or $1.48 per share, compared to a net loss of $77.7 million, or $1.78 per share, for the same period in 2023[6] - Net loss for Q3 2024 was $26.430 million, slightly higher than the $24.542 million loss in Q3 2023[13] - The company reported a net loss of $78.499 million for the nine months ended September 30, 2024, compared to $77.741 million for the same period in 2023[13] Expenses - Research and development expenses for the three months ended September 30, 2024, were $22.2 million, up from $20.3 million in the same period in 2023[5] - General and administrative expenses for the three months ended September 30, 2024, were $12.7 million, compared to $10.3 million for the same period in 2023[5] - Total operating expenses increased to $34.897 million in Q3 2024 from $30.542 million in Q3 2023, representing a 14% rise[13] - Research and development expenses rose to $22.205 million in Q3 2024, compared to $20.271 million in Q3 2023, a 9% increase[13] Share Information - Net loss per share improved to $(0.47) in Q3 2024 from $(0.55) in Q3 2023[13] - Weighted-average common shares outstanding increased to 56,341,074 in Q3 2024 from 44,266,017 in Q3 2023[13] Cash and Securities - As of September 30, 2024, the company had $269.2 million in cash, cash equivalents, and marketable securities[1] - The unrealized gain on marketable securities was $181,000 in Q3 2024, down from $232,000 in Q3 2023[13] Clinical Developments - The FDA has removed the Partial Clinical Hold on zorevunersen, allowing the company to proceed with its clinical studies[3] - The company plans to provide an update on Phase 3 registrational plans for zorevunersen by year-end 2024[4] - The company will present new data at the American Epilepsy Society meeting in December 2024, including data from patients treated with initial 70mg doses followed by 45mg maintenance dosing[2]

your_photo/iStock via Getty Images I covered Stoke Therapeutics (NASDAQ:STOK) thrice in the last few years. If you read those articles, you will see I have held divergent views about this company over the years. First, I held the view that STOK was overvalued when it had a market cap of $1.88bn - the stock is down 73% since then; then, 3 years later, I thought it was undervalued when it had a market cap of $364mn, and the stock is up 64% since then; but in my last article, after it produced unsatisfactory d ...

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, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |------------------------------------------------------------------------------------------------|-----------------------------------| | For the transition period from | __________ ...

Stoke Therapeutics, Inc. (STOK) came out with a quarterly loss of $0.46 per share versus the Zacks Consensus Estimate of a loss of $0.57. This compares to loss of $0.69 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 19.30%. A quarter ago, it was expected that this company would post a loss of $0.60 per share when it actually produced a loss of $0.57, delivering a surprise of 5%. Over the last four quarters, the company has s ...

EX 99.1 Stoke Therapeutics Reports Second Quarter Financial Results and Provides Business Updates – FDA removes Partial Clinical Hold as company advances toward a Phase 3 registrational study of zorevunersen (STK-001) in children and adolescents with Dravet syndrome – – Company to provide an update on Phase 3 registrational plans for zorevunersen in the second half of 2024 – – Company on track to initiate the Phase 1 study (OSPREY) of STK-002 for the treatment of Autosomal Dominant Optic Atrophy (ADOA) this ...

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 March 31, 2024 ☐ 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: 001-38938 Stoke Therapeutics, Inc. Delaware 47-1144582 (I.R.S. Employer Identification No.) (781) 430-8200 (Regi ...

EX 99.1 – In April, Company strengthened its cash position with $120.3 million in net proceeds from public follow-on offering – BEDFORD, Mass., May 6, 2024 – Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines, today reported financial results for the first quarter of 2024 and provided business updates including those related to STK-001, the Company's proprietary antisense ...