STSA Satsuma Pharmaceuticals Inc.
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STS101 (ASCEND)
Migraine
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STS101 (SUMMIT )
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Latest News
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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.
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SOUTH SAN FRANCISCO, Calif., March 10, 2021 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA) a clinical-stage biopharmaceutical company, today announced that management will present a corporate overview at the 31st Annual Oppenheimer Healthcare Conference on March 16, 2021 at 3:10 PM Eastern Time. The conference will be held virtually with participants joining remotely from March 16th to the 18th.
A webcast of the presentation can be followed live online via the link below: https://wsw.com/webcast/oppenheimer9/stsa/2746007 or please visit the "Events and Presentations" page within the "Investors" section of the Satsuma Pharmaceuticals website at www.satsumarx.com.
If you are interested in arranging a one-on-one meeting, please contact your Oppenheimer & Co. Inc. representative or contact Corey Davis at LifeSci Advisors.
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.
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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-New STS101 Phase 3 efficacy trial planned to begin mid-2021 with topline results expected second half of 2022-
-Proceeds from $80 million private placement and existing cash expected to fund operations into second half of 2023-
-Conference call this morning at 8:00 AM ET; dial in details are listed below-
SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA) a clinical-stage biopharmaceutical company, today announced an update to the development plan for STS101 (dihydroergotamine (DHE) nasal powder), an investigational acute treatment for migraine. The updated STS101 development plan includes a new Phase 3 efficacy trial, which the Company anticipates initiating in mid-2021, with topline results expected in the second half of 2022. The new Phase 3 trial takes into account findings from the EMERGE pivotal study in which STS101 showed numerical differences in favor of STS101 5.2 mg and 3.9 mg versus placebo but did not achieve statistical significance versus placebo on the co-primary endpoints of freedom from pain and most bothersome symptom at two hours post-administration. In addition, the Company plans to explore dose strengths greater than 5.2 mg by conducting a Phase 1 trial in the second quarter of 2021 to evaluate the pharmacokinetics, safety, and tolerability of STS101 5.2 mg and two higher dose strengths. The Company plans to select the STS101 dose strength to utilize in its next Phase 3 efficacy trial based on the results of this Phase 1 trial.
Satsuma also announced today that it has entered into a securities purchase agreement with existing and new investors for an $80 million private placement financing. The Company believes that net proceeds from the private placement financing, together with its existing cash, cash equivalents and short-term investments of $68.2 million as of December 31, 2020, will be sufficient to fund company operations into the second half of 2023.
The Company is holding a conference call this morning to discuss its updated STS101 development plan, as well as preliminary results to date from the ongoing open-label ASCEND long-term safety trial of STS101 5.2 mg, and a synopsis of key EMERGE trial findings.
"We continue to have strong conviction that STS101 has the potential to be an important and differentiated acute treatment option that can address the unmet needs of many people with migraine. After conducting a comprehensive, multi-functional review of our STS101 program, including EMERGE trial findings and preliminary results to date from our ongoing ASCEND open-label, long-term safety trial, we believe there is a compelling rationale for continuing development of STS101 and undertaking a second Phase 3 efficacy trial," said John Kollins, President & Chief Executive Officer of Satsuma. "We are pleased to have strong support for our updated STS101 development plan from our expert clinical advisors and leading specialist healthcare investors."
EMERGE Phase 3 efficacy trial results
On September 10, 2020, the Company announced topline results from the EMERGE Phase 3 efficacy trial of STS101. As detailed in the table below, although topline data showed numerical differences in favor of STS101 3.9 mg and 5.2 mg versus placebo on the pre-specified co-primary endpoints of freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia and nausea) at two hours post-administration, these differences did not achieve statistical significance for either dose strength.
EMERGE Co-primary Endpoints1: 3.9 mg 5.2 mg Placebo Patients n=354 n=353 n=358 Freedom from Pain at 2 hours
N
% responders
Difference vs Placebo
p-value
69/354
19.5%
4.7%
0.10
68/353
19.3%
4.5%
0.11
53/358
14.8%
---
---Freedom from Most Bothersome Symptom at 2 hours
N
% responders
Difference vs Placebo
p-value
133/340
39.1%
5.4%
0.14
139/343
40.5%
6.8%
0.06
119/353
33.7%
---
---Both dose strengths of STS101 did, however, demonstrate significant effects (nominal p-value < 0.05) on both freedom from pain and most bothersome symptom endpoints by three hours post-dose and later time points. Consistent with the safety and tolerability results to date observed in other STS101 clinical trials, including the ongoing ASCEND open-label, long-term safety trial, both STS101 dose strengths were well-tolerated in the EMERGE trial, with low adverse event rates and no drug-related serious adverse events reported.
Based on its analyses, the Company believes it has identified, and is taking steps to address in the new Phase 3 efficacy trial, the key reasons that STS101 did not achieve statistical significance versus placebo on the co-primary endpoints in the EMERGE trial.
ASCEND Phase 3 open-label, long-term safety trial preliminary results to date
As of February 23, 2021, the Company has enrolled more than 275 subjects in its ongoing ASCEND open-label, long-term safety trial who have treated a total of more than 2,200 migraine attacks with STS101 5.2 mg. STS101 5.2 mg has been been well-tolerated to date in the ASCEND trial, with low adverse event rates and no drug-related serious adverse events reported. In addition, the Company believes that, based on the preliminary results from the ASCEND open-label, long-term safety trial, STS101 5.2 mg demonstrates anti-migraine activity at the two-hour time point.
1 Per the EMERGE trial Statistical Analysis Plan, subjects who did not report efficacy data for the 2-hour post-treatment time point were imputed to be non-responders, irrespective of response status as of the last time point prior to 2 hours when efficacy data was reported.
Anticipated STS101 development milestones
Second Quarter 2021 – Complete Phase 1 safety and pharmacokinetic study with STS101 5.2 mg and two higher dose strengths Mid-2021 – Initiate second STS101 Phase 3 efficacy trial Second Half 2022 – Read out topline results from second Phase 3 efficacy trial Fourth Quarter 2022 – File STS101 NDA Conference Call and Webcast Details
The Company's management team will host a conference call and webcast this morning, Monday, March 1, at 8:00am ET / 5:00am PT.The call is accessible via the below teleconference numbers and the Conference ID#: 13716986#
USA/Canada: +1 (877) 705-6003
International Dial-In Number: +1 (201) 493-6725The webcast can be followed live online via the link:http://public.viavid.com/index.php?id=143740
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 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 September 30, 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; 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] -
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SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA) a clinical-stage biopharmaceutical company, today announced that it has agreed to sell 14,084,507 shares of its common stock to certain institutional investors in a private investment in public equity (PIPE) financing. The Company anticipates gross proceeds from the PIPE will be approximately $80 million, before deducting fees to the placement agents and other estimated offering expense payable by the Company, based on the offering price of $5.68 per share, the last reported sale price of our common stock on The Nasdaq Global Market on February 26, 2021. The financing was 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, Ltd.
The financing is subject to standard closing conditions and the Company anticipates the closing to occur on March 3, 2021. In addition the financing was executed in compliance with applicable Nasdaq rules and priced at the "Minimum Price" (as defined in the Nasdaq rules).
SVB Leerink served as Satsuma's exclusive financial advisor in connection with the PIPE financing.
"We are pleased to have the continued support of leading healthcare investors as we continue Phase 3 clinical development of STS101 as outlined in our separate press release also announced today," said John Kollins, President & Chief Executive Officer of Satsuma. "We believe there is a compelling rationale for continuing development of STS101, and the proceeds from this financing better position us to deliver this potential migraine treatment to market."
The securities sold in this private placement have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the U.S. except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Satsuma has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in these private placements.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
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 includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements. Accordingly, you should not rely on any of these forward-looking statements, including statements regarding the size, timing or completion of the financing. Additional applicable risks and uncertainties include those identified in the Company's current and future reports filed with the SEC, including its Quarterly Report on Form 10-Q filed with the SEC on November 10, 2020. The forward-looking statements contained in this press release are based on information currently available to Satsuma and speak only as of the date on which they are made. Satsuma does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise, except as required by law.
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]