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Latest News
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SOUTH SAN FRANCISCO, Calif., July 28, 2021 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced randomization of the first subject in its SUMMIT Phase 3 efficacy trial of STS101 for the acute treatment of migraine.
Satsuma's President and Chief Executive Officer, John Kollins, commented, "We are pleased to have initiated the SUMMIT trial and begun randomizing subjects in accordance with our previously communicated timeline objectives. We believe the likelihood of success for SUMMIT is high given the utilization of the second-generation STS101 nasal delivery device and improved subject training in combination with the trial design and conduct adjustments we've made based on our analyses of results from the previous EMERGE Phase 3 trial. We believe SUMMIT will provide the basis for STS101, with subsequent FDA approval, to become the first and only DHE product to have established efficacy on the current standard and FDA-accepted endpoints for acute treatment of migraine in a randomized, placebo-controlled trial."
The SUMMIT Phase 3 efficacy trial of STS101 is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in approximately 1,400 subjects with migraine that is being conducted in the United States. The SUMMIT study was designed in accordance with FDA recommendations outlined in the FDA Guidance Migraine: Developing Drugs for Acute Treatment, February 2018. The study design and conduct take into account learnings from the Company's previously-completed EMERGE Phase 3 efficacy trial. After establishing full eligibility, SUMMIT trial participants are randomized (1:1) to receive either STS101 5.2 mg or matching placebo and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication. The co-primary endpoints of the SUMMIT trial, to be assessed at two hours after STS101 administration, are freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia or nausea). The trial is designed for greater than 99% statistical power for the freedom from pain endpoint and greater than 95% statistical power for the freedom from most bothersome symptom endpoint. In addition, the SUMMIT trial incorporates a number of secondary endpoints and prospective evaluations of the clinical performance of STS101 that could differentiate the clinical profile of STS101.
Consistent with its previous communications, Satsuma expects to report top-line data from the SUMMIT trial in the second half of 2022.
For further information regarding the STS101 SUMMIT Phase 3 efficacy trial, see www.ClinicalTrials.gov, identifier NCT04940390: A Randomized, Double-Blind, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine (SUMMIT).
About Satsuma Pharmaceuticals and STS101
Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product, STS101, for the acute treatment of migraine. STS101 is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE), administered via Satsuma's proprietary 2nd-generation nasal delivery device. STS101 is designed to provide significant benefits versus existing acute treatments for migraine, including the combination of quick and convenient self-administration and other clinical advantages, that current DHE liquid nasal spray products and injectable dosage forms lack. Satsuma's dry powder DHE formulation has demonstrated fast absorption, rapid achievement of high DHE plasma concentrations which Satsuma believes is necessary for early efficacy, and sustained plasma levels over time with low dose to dose variability. STS101 also now incorporates an improved 2nd-generation nasal delivery device designed to provide more consistent nasal dosing, irrespective of user administration technique. Although DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration processes and/or sub-optimal clinical performance, have limited the widespread use of DHE. Featuring a compact and convenient dosage form, STS101 is designed to overcome these shortcomings and provide patients an improved therapeutic solution for acutely treating migraines that consistently delivers robust clinical performance.
Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com.
INVESTOR AND CORPORATE CONTACTS:
Corey Davis, PhD
LifeSci Advisors, LLC
[email protected]Tom O'Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.
[email protected]
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SOUTH SAN FRANCISCO, Calif., June 22, 2021 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced that John Kollins, President and Chief Executive Officer, is scheduled to present at the SVB Leerink CNS Forum on Tuesday, June 29, 2021 at 3:40 PM Eastern Time. The conference will be held virtually with participants joining remotely on June 29th & 30th.
Date: Tuesday, June 29th, 3:40pm - 4:10pm (ET) Title: Bringing DHE Back for Migraine Speaker: John Kollins, President & CEO of Satsuma Pharmaceuticals Format: Fireside Chat hosted by Marc Goodman, Senior Research Analyst If you are interested in arranging a virtual one-on-one meeting, please contact your SVB Leerink representative or contact Corey Davis at LifeSciAdvisors.
About Satsuma Pharmaceuticals, STS101 and the SUMMIT Phase 3 Efficacy Trial
Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product, STS101, for the acute treatment of migraine. STS101 is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE), administered via Satsuma's proprietary 2nd-generation nasal delivery device. STS101 is designed to provide significant benefits versus existing acute treatments for migraine, including the combination of quick and convenient self-administration and other clinical advantages, that current DHE liquid nasal spray products and injectable dosage forms lack. Satsuma's dry powder DHE formulation has demonstrated fast absorption, rapid achievement of high DHE plasma concentrations which Satsuma believes is necessary for early efficacy, and sustained plasma levels over time with low dose to dose variability. STS101 also incorporates an improved 2nd-generation nasal delivery device designed to provide more consistent nasal dosing, irrespective of user administration technique. Although DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration processes and/or sub-optimal clinical performance, have limited the widespread use of DHE. Featuring a compact and convenient dosage form, STS101 is designed to overcome these shortcomings and provide patients an improved therapeutic solution for acutely treating migraines that consistently delivers robust clinical performance.
Satsuma is initiating the SUMMIT Phase 3 efficacy trial, which is designed to evaluate the efficacy and safety of STS101 in treating migraine attacks. The SUMMIT trial is a multi-center, single-treatment, randomized, double-blind, placebo-controlled, parallel group study to be conducted in the United States which seeks to enroll approximately 1,400 migraine patients. The SUMMIT study is designed in accordance with FDA recommendations outlined in the FDA Guidance Migraine: Developing Drugs for Acute Treatment, February 2018. After establishing full eligibility, SUMMIT trial participants will be randomized (1:1) to receive either STS101 DHE 5.2 mg or matching placebo and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication. The two co-primary endpoints of the SUMMIT trial are freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia or nausea), both of which are assessed at two hours after administration of study medication.
Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com.
INVESTOR AND CORPORATE CONTACTS:
Corey Davis, PhD
LifeSci Advisors, LLC
[email protected]Tom O'Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.
[email protected] -
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- All three dose strengths of STS101, administered with improved 2nd-generation nasal delivery device were well-tolerated and achieved target pharmacokinetic profile -
- Initiating SUMMIT Phase 3 efficacy trial to evaluate STS101 5.2 mg in the acute treatment of migraine attacks -
SOUTH SAN FRANCISCO, Calif., June 16, 2021 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced positive pharmacokinetic, tolerability and safety results from a Phase 1 trial of STS101. The Phase 1 data showed that all three dose strengths (5.2 mg and two higher dose strengths) administered with Satsuma's improved second-generation nasal delivery device were well-tolerated and achieved the target pharmacokinetic profile. Based on results from this Phase 1 trial and other data, including preliminary results to date from the ongoing Phase 3 ASCEND long-term, open-label safety trial of STS101 5.2 mg, Satsuma is initiating its SUMMIT Phase 3 efficacy trial with the 5.2 mg dosage strength of STS101. As previously communicated, top-line results from the SUMMIT trial are expected in the second half of 2022.
"The totality of data generated in our STS101 development program, including these new Phase 1 data and improved delivered dose results, strongly support evaluating the 5.2 mg dosage strength of STS101 in the upcoming SUMMIT Phase 3 efficacy trial," stated John Kollins, Satsuma's President and Chief Executive Officer. "With the second-generation STS101 device and improved instructions-for-use, we expect subjects in SUMMIT will consistently self-administer the full DHE dose with less variability than in the previous EMERGE Phase 3 trial. We believe these improvements, in combination with the adjustments to the conduct of the trial, should result in STS101 demonstrating robust anti-migraine activity in the SUMMIT trial that could support product approval with differentiated labeling."
Satsuma has provided further detail on the STS101 development program, including STS101 Phase 1 trial results, preliminary results from the ongoing ASCEND trial, and further details on the design of the SUMMIT trial, in its latest corporate presentation available for download from its website: https://investors.satsumarx.com/events
About Satsuma Pharmaceuticals and STS101
Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product, STS101, for the acute treatment of migraine. STS101 is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE), administered via Satsuma's proprietary 2nd-generation nasal delivery device. STS101 is designed to provide significant benefits versus existing acute treatments for migraine, including the combination of quick and convenient self-administration and other clinical advantages, that current DHE liquid nasal spray products and injectable dosage forms lack. Satsuma's dry powder DHE formulation has demonstrated fast absorption, rapid achievement of high DHE plasma concentrations which Satsuma believes is necessary for early efficacy, and sustained plasma levels over time with low dose to dose variability. STS101 also now incorporates an improved 2nd-generation nasal delivery device designed to provide more consistent nasal dosing, irrespective of user administration technique. Although DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration processes and/or sub-optimal clinical performance, have limited the widespread use of DHE. Featuring a compact and convenient dosage form, STS101 is designed to overcome these shortcomings and provide patients an improved therapeutic solution for acutely treating migraines that consistently delivers robust clinical performance.
About the SUMMIT Phase 3 Trial
The STS101 SUMMIT Phase 3 efficacy trial is a multi-center, single-treatment, randomized, double-blind, placebo-controlled, parallel group study to be conducted in the United States which seeks to enroll approximately 1,400 migraine patients. The SUMMIT study is designed in accordance with FDA recommendations outlined in the FDA Guidance Migraine: Developing Drugs for Acute Treatment, February 2018. After establishing full eligibility, SUMMIT trial participants will be randomized (1:1) to receive either STS101 DHE 5.2 mg or matching placebo and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication. Consistent with the previous EMERGE Phase 3 trial, the two co-primary endpoints of the SUMMIT trial are freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia or nausea), both of which are assessed at two hours after administration of study medication.Satsuma is headquartered in South San Francisco, California with offices in both South San Francisco and Durham, North Carolina. For further information, please visit www.satsumarx.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the "Company"), as well as the Company's plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "predict," "potential," "positioned," "seek," "should," "target," "will," "would," and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the Company's expectations regarding the potential safety and efficacy of STS101, the potential results of the ASCEND and SUMMIT trials, the timing of initiation and data readouts for ongoing and planned clinical trials, and the potential for STS101 to be an important and differentiated acute treatment option for migraine. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The Company's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company's ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the results of preclinical and clinical studies may not be predictive of future results; and the risk that the COVID-19 worldwide pandemic may negatively impact the Company's business, operations, clinical trials or ability to raise capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
INVESTOR AND CORPORATE CONTACTS:
Corey Davis, PhD
LifeSci Advisors, LLC
[email protected]John Kollins, President and Chief Executive Officer
Satsuma Pharmaceuticals, Inc.
[email protected] -
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-New STS101 Phase 3 efficacy trial (the SUMMIT trial) expected to begin mid-2021 with topline results expected second half of 2022-
-Results expected in Q2 from ongoing Phase 1 trial to inform dose selection for Phase 3-
-$133 million in cash, cash equivalents and marketable securities as of March 31, 2021 provides runway into second half of 2023-
SOUTH SAN FRANCISCO, Calif., May 11, 2021 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA), a clinical-stage biopharmaceutical company developing STS101, a novel therapeutic product candidate for the acute treatment of migraine, today reported financial results for the first quarter of 2021 and summarized recent business highlights.
"Our team continues to execute well against our updated STS101 development plan," stated John Kollins, Satsuma's President and Chief Executive Officer. "We look forward to completing and sharing results in the near future from our ongoing Phase 1 trial to evaluate the pharmacokinetics, safety and tolerability of STS101 5.2 mg and two higher dose strengths. Results from this Phase 1 trial will inform dose selection for our new pivotal SUMMIT study, a Phase 3 efficacy trial for which we are actively preparing to initiate patient enrollment."
Recent Business Highlights
$80 Million Private Placement of Common Stock Financing
- In March 2021, Satsuma closed an $80 million private placement of common stock. As of March 31, 2021, the Company had $133 million in combined cash, cash equivalents and marketable securities, which it believes is sufficient to fund operations into the second half of 2023 and through projected completion of the STS101 Phase 3 clinical development program and potential filing of a New Drug Application for STS101 by the end of 2022.
STS101 development update
- In March 2021, Satsuma announced an updated STS101 development plan which includes a new double-blind, randomized, placebo-controlled Phase 3 efficacy trial (the SUMMIT trial) designed to enroll approximately 1,400 subjects. The new Phase 3 SUMMIT trial, which the Company anticipates initiating in mid-2021 with topline results expected in the second half of 2022, will take into account findings from analyses of the EMERGE Phase 3 pivotal trial results.
- In addition, the Company is conducting a new Phase 1 trial to evaluate the pharmacokinetics, safety, and tolerability of STS101 5.2 mg (the highest STS101 dose strength evaluated in the EMERGE trial) and two higher dose strengths. The Company anticipates completing this Phase 1 trial in the second quarter of 2021 and based on trial results, plans to select the STS101 dose strength to evaluate in the new Phase 3 SUMMIT trial.
ASCEND Phase 3 open-label, long-term safety trial
In August 2020, Satsuma announced the initiation of patient enrollment in the ASCEND trial, a multi-center, open-label, 12-month trial to evaluate the safety and tolerability of STS101 as an acute treatment for migraine.
- As of May 6, 2021, the Company has enrolled more than 290 subjects in the ASCEND trial who had treated more than 3,300 migraine attacks with STS101 5.2 mg. To date, STS101 5.2 mg continues to be generally well-tolerated, with low adverse event rates and no treatment-related serious adverse events reported.
Upcoming 2021 & 2022 expected milestones
- Complete ongoing Phase 1 trial with STS101 5.2 mg and two higher dose strengths in the second quarter of 2021
- Initiate new STS101 SUMMIT Phase 3 efficacy trial in mid-2021 with a single STS101 dose selected from the Phase 1 trial
- Report top-line results from SUMMIT Phase 3 efficacy trial in second half of 2022
- Complete ASCEND Phase 3 open-label safety trial in second half of 2022
- File STS101 NDA by the end of 2022
Financial results for the first quarter of 2021
Net losses for the first quarter of 2021 were $10.5 million, or $0.48 per common share. This compared to a net loss of $11.8 million, or $0.68 per common share, for the same period in 2020. As of March 31, 2021, the Company had $133.1 million of cash, cash equivalents and marketable securities. The Company believes it has sufficient financial resources to fund operations into the second half of 2023.
Research and development expenses were $7.2 million for the first quarter 2021, compared to $9.6 million for the same period of 2020. First quarter expenses decreased by $2.5 million, primarily due to a decrease in the clinical expenses from EMERGE and partially offset by increases for the ASCEND trial and higher payroll and personnel expenses, including salaries, benefits and stock-based compensation expenses.
General and administrative expenses were $3.3 million for the first quarter 2021, compared to $2.5 million for the same period of 2020. First quarter expenses increased by $0.8 million, primarily due to higher stock-based compensation expense, D&O insurance, legal expenses and other administrative costs.
About Satsuma Pharmaceuticals and STS101
Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product candidate for the acute treatment of migraine. Its product candidate, STS101, is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, or DHE, which is designed to be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device. DHE products have long been recommended as a first-line therapeutic option for the acute treatment of migraine and have significant advantages over other therapeutics for many patients. However, broad use has been limited by invasive and burdensome administration and/or sub-optimal clinical performance of available injectable and liquid nasal spray products. STS101 is specifically designed to deliver the clinical advantages of DHE while overcoming these shortcomings.
Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the "Company"), as well as the Company's plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "predict," "potential," "positioned," "seek," "should," "target," "will," "would," and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the Company's expectations regarding the potential safety and efficacy of STS101, the potential results of the ASCEND trial, the timing of initiation and data readouts for ongoing and planned clinical trials, the anticipated timing for a potential NDA filing of STS-101, the potential for STS-101 to be an important and differentiated acute treatment option, and the expected cash runway of the Company. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The Company's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, to be filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company's ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the results of preclinical and clinical studies may not be predictive of future results; and the risk that the COVID-19 worldwide pandemic may negatively impact the Company's business, operations, clinical trials or ability to raise capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
INVESTOR AND CORPORATE CONTACTS:
Corey Davis, PhD
LifeSci Advisors, LLC
[email protected]Tom O'Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.
[email protected]SATSUMA PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
(unaudited)Three Months Ended March 31, 2021 2020 Operating expenses Research and development $ 7,156 $ 9,648 General and administrative 3,294 2,523 Total operating expenses $ 10,450 $ 12,171 Loss from operations (10,450 ) (12,171 ) Interest income 50 502 Interest expense (57 ) (104 ) Net loss $ (10,457 ) $ (11,773 ) Unrealized loss on marketable securities (26 ) (32 ) Comprehensive loss $ (10,483 ) $ (11,805 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.48 ) $ (0.68 ) Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 21,975,407 17,383,016 SATSUMA PHARMACEUTICALS, INC.
BALANCE SHEET DATA
(in thousands)
(unaudited)March 31, December 31, 2021 2020 Balance Sheet Data: Cash, cash equivalents and marketable securities $ 133,120 $ 68,236 Working capital 131,065 65,740 Total assets 144,057 81,033 Debt 2,549 3,032 Accumulated deficit (101,021 ) (90,564 ) Total stockholders' equity 138,145 71,936 - In March 2021, Satsuma closed an $80 million private placement of common stock. As of March 31, 2021, the Company had $133 million in combined cash, cash equivalents and marketable securities, which it believes is sufficient to fund operations into the second half of 2023 and through projected completion of the STS101 Phase 3 clinical development program and potential filing of a New Drug Application for STS101 by the end of 2022.
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Announced updated STS101 development plan featuring a new Phase 3 efficacy trial scheduled to begin enrollment mid-2021 with topline results expected in second half of 2022
Closed $80 million private placement of common stock financing with new and existing investors
Cash runway into second half of 2023 and through readout of Phase 3 clinical trials and potential NDA filing by end of 2022
SOUTH SAN FRANCISCO, Calif., March 25, 2021 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA), a clinical-stage biopharmaceutical company developing STS101, a novel therapeutic product candidate for the acute treatment of migraine, today reported financial results for the quarter and full year ended December 31, 2020 and summarized recent business highlights.
"Having significantly strengthened our balance sheet with the recent completion of a private placement financing, we are well-positioned to execute against our updated STS101 development plan," stated John Kollins, Satsuma's President and Chief Executive Officer. "Our team remains steadfast in its commitment to developing STS101 as an important and differentiated acute treatment option for people living with migraines and to initiating a new Phase 3 efficacy trial this summer."
Recent Business Highlights
$80 Million Private Placement of Common Stock Financing
- In March 2021, Satsuma closed an $80 million private placement of common stock financing led by Commodore Capital and New Enterprise Associates, L.P. with participation from new and existing investors including RA Capital Management, Vivo Capital, Samlyn Capital, Surveyor Capital (a Citadel company), Aspire Capital Fund, funds managed by Ghost Tree Capital Group, LP, Point72 Asset Management and Logos Capital as well as Satsuma co-founder, Shin Nippon Biomedical Laboratories.
- The Company believes the proceeds from this financing, combined with cash, cash equivalents, and marketable securities of $68.2 million at the end of 2020, are sufficient to fund its operations into the second half of 2023 and through key clinical and regulatory milestones, including completion of the STS101 Phase 3 clinical development program in the second half of 2022 and potential filing of a New Drug Application by the end of 2022.
STS101 development plan update
- In March 2021, Satsuma announced an updated STS101 development plan which includes a new Phase 3 efficacy trial that the Company anticipates initiating in mid-2021, with topline results expected in the second half of 2022. The new Phase 3 trial will take into account our findings from analyses of the EMERGE Phase 3 pivotal trial results.
- In addition, the Company plans to explore dose strengths greater than 5.2 mg, the higher of the two STS101 dose strength evaluated in the EMERGE trial, by conducting a Phase 1 trial to evaluate the pharmacokinetics, safety, and tolerability of STS101 5.2 mg and two higher dose strengths. The Company anticipates completing this Phase 1 trial in the second quarter of 2021 and plans to select the STS101 dose strength to utilize in its next Phase 3 efficacy trial based on its results.
ASCEND Phase 3 open-label, long-term safety trial
- In August 2020, Satsuma announced the initiation of patient enrollment in the ASCEND trial, a multi-center, open-label, 12-month study to evaluate the safety and tolerability of STS101 as an acute treatment for migraine.
- In conjunction with its March 2021 STS101 development plan update, the Company reported preliminary results to date from the ASCEND trial. As of February 23, 2021, the Company had enrolled more than 275 subjects in the ASCEND trial who had treated a total of more than 2,200 migraine attacks with STS101 5.2 mg. To date, STS101 5.2 mg has been generally well-tolerated in the ASCEND trial, with low adverse event rates and no treatment-related serious adverse events reported.
Upcoming 2021 & 2022 milestones
- Complete Phase 1 safety and pharmacokinetic study with STS101 5.2 mg and two higher dose strengths in the second quarter of 2021
- Initiate new STS101 Phase 3 efficacy trial in mid-2021
- Report top-line results from new Phase 3 efficacy trial in second half of 2022
- Complete ASCEND Phase 3 open-label safety trial in second half of 2022
- Present further data on STS101, DHE, and the proprietary dry-powder nasal drug delivery technologies incorporated in STS101 at medical meetings in 2021 and 2022
- File STS101 NDA by the end of 2022
Expansion of Intellectual Property Portfolio
Satsuma continues to expand its intellectual property portfolio, with the U.S. Patent and Trademark Office issuing two U.S. patents relating to STS101 in the fall of 2020. These two new patents, one owned and one exclusively licensed by Satsuma, have estimated expiration dates in 2039 and 2037, respectively, not including any potential adjustments or extensions of term. The issuance of these patents brings the total number of issued U.S. patents exclusively licensed or owned by Satsuma to ten, and in total, Satsuma currently owns or has exclusive license rights under more than sixty U.S. and foreign patents and pending applications. The Company believes that the breadth of its intellectual property portfolio reflects the highly innovative and differentiated nature of the proprietary dry-powder nasal delivery and formulation technologies incorporated in STS101.
Financial results for the fourth quarter and full year 2020
Net losses for the fourth quarter and full year 2020 were $12.5 million and $47.6 million, respectively, or $0.72 and $2.73 per common share, respectively. This compared to net losses of $10.8 million and $28.2 million, respectively, or $0.62 and $4.80 per common share, respectively for the same periods in 2019. As of December 31, 2020, the Company had $68.2 million of cash, cash equivalents and marketable securities. Including the recent financing, the Company believes it has sufficient financial resources to fund operations into the second half of 2023.
Research and development expenses were $9.0 million and $36.3 million for the fourth quarter and full year 2020, respectively, compared to $9.2 million and $24.2 million for the same periods of 2019, respectively. Fourth quarter expenses decreased by $0.1 million, primarily due to a decrease in the clinical expenses as the EMERGE study was concluding offset by increases for the ASCEND study and higher payroll and personnel expenses, including salaries, benefits and stock-based compensation expenses.
General and administrative expenses were $3.4 million and $12.1 million for the fourth quarter and full year 2020, respectively, compared to $2.1 million and $4.7 million for the same periods of 2019, respectively. Fourth quarter expenses increased by $1.3 million, primarily due to higher stock-based compensation expense, D&O insurance, legal expenses and other administrative costs.
About Satsuma Pharmaceuticals and STS101
Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product candidate for the acute treatment of migraine. Its product candidate, STS101, is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, or DHE, which is designed to be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device. DHE products have long been recommended as a first-line therapeutic option for the acute treatment of migraine and have significant advantages over other therapeutics for many patients. However, broad use has been limited by invasive and burdensome administration and/or sub-optimal clinical performance of available injectable and liquid nasal spray products. STS101 is in Phase 3 development and specifically designed to deliver the clinical advantages of DHE while overcoming these shortcomings.Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the "Company"), as well as the Company's plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "due," "estimate," "expect," "goal," "intend," "may," "objective," "plan," "predict," "potential," "positioned," "seek," "should," "target," "will," "would," and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the Company's expectations regarding the potential safety and efficacy of STS101; the Company's clinical and regulatory development plans; the Company's expectations with regard to the initiation and availability of data to be derived from its ongoing and planned clinical trials; the timing and likelihood of regulatory filings and approvals for STS101; and expected cash needs and sufficiency of cash on hand. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The Company's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company's ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the results of preclinical and clinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; and the Company's ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
This press release discusses STS101, a product candidate that is in clinical development, and which has not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of STS101 for the therapeutic use for which STS101 is being studied.
INVESTOR AND CORPORATE CONTACTS:
Corey Davis, PhD
LifeSci Advisors, LLC
[email protected]Tom O'Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.
[email protected]SATSUMA PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
(unaudited)Three Months Ended
December 31,Year Ended
December 31,2020 2019 2020 2019 Operating expenses Research and development $ 9,043 $ 9,150 $ 36,270 $ 24,196 General and administrative 3,444 2,125 12,058 4,685 Total operating expenses $ 12,487 $ 11,275 $ 48,328 $ 28,881 Loss from operations (12,487 ) (11,275 ) (48,328 ) (28,881 ) Interest income 79 587 1,115 1,189 Interest expense (70 ) (117 ) (350 ) (482 ) Other income (expense), net — (4 ) — (1 ) Net loss $ (12,478 ) $ (10,809 ) $ (47,563 ) $ (28,175 ) Unrealized (loss) gains on marketable securities (56 ) 5 12 17 Comprehensive loss $ (12,534 ) $ (10,804 ) $ (47,551 ) $ (28,158 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.72 ) $ (0.62 ) $ (2.73 ) $ (4.80 ) Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 17,429,756 17,365,840 17,405,688 5,863,950 SATSUMA PHARMACEUTICALS, INC.
BALANCE SHEET DATA
(in thousands)
(unaudited)As of December 31, 2020 2019 Balance Sheet Data: Cash, cash equivalents and marketable securities $ 68,236 $ 117,900 Working capital 65,740 106,773 Total assets 81,033 126,276 Debt 3,032 4,930 Accumulated deficit (90,564 ) (43,001 ) Total stockholders' equity 71,936 115,335 - In March 2021, Satsuma closed an $80 million private placement of common stock financing led by Commodore Capital and New Enterprise Associates, L.P. with participation from new and existing investors including RA Capital Management, Vivo Capital, Samlyn Capital, Surveyor Capital (a Citadel company), Aspire Capital Fund, funds managed by Ghost Tree Capital Group, LP, Point72 Asset Management and Logos Capital as well as Satsuma co-founder, Shin Nippon Biomedical Laboratories.