8-K
false 0001692830 0001692830 2022-11-14 2022-11-14

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 14, 2022

 

 

SATSUMA PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39041   81-3039831

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification Number)

400 Oyster Point Boulevard, Suite 221

South San Francisco, CA 94080

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (650) 410-3200

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock   STSA   The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

 

 

 


Item 8.01

Other Events.

On November 14, 2022, Satsuma Pharmaceuticals, Inc. (“Satsuma” or the “Company”) issued a press release announcing topline results from its SUMMIT Phase 3 trial of STS101 for the acute treatment of migraine. The full text of the press release is furnished as Exhibit 99.1 hereto. In addition, the Company hosted a conference call on Monday, November 14, 2022 at 8:30 a.m. Eastern Time to discuss the results. A copy of the press release and the presentation materials are attached hereto as Exhibits 99.1 and 99.2, respectively, and are incorporated herein by reference.

 

Item 9.01

Financial Statements and Exhibits.

 

Exhibit
No.
  

Description

99.1    Press Release dated November 14, 2022
99.2    Company presentation dated November 14, 2022
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    SATSUMA PHARMACEUTICALS, INC.
Date: November 14, 2022     By:  

/s/ Tom O’Neil

      Tom O’Neil
      Chief Financial Officer
     
EX-99.1

Exhibit 99.1

 

LOGO

PRESS RELEASE

Satsuma Pharmaceuticals Announces Topline Results from SUMMIT Phase

3 Trial of STS101 for the Acute Treatment of Migraine

 

   

STS101 was not statistically superior to placebo at two hours post-administration on the co-primary endpoints of freedom from pain and most bothersome symptom

 

   

STS101 showed superiority (p<0.001) differences versus placebo on freedom from pain and most bothersome symptom at all timepoints after two hours post-administration (3, 4, 6, 12, 24 and 48 hours), as well as on multiple key secondary endpoints, including pain relief at 2 hours post-administration and all timepoints thereafter

 

   

STS101 demonstrated a favorable safety and tolerability profile, consistent with clinical trial experience to date

 

   

Based on previous interactions with the FDA, Satsuma believes results from the STS101 Phase 1 PK and ASCEND Phase 3 long-term, open-label safety trials will support NDA filing and approval

 

   

Company does not plan to invest in commercializing STS101 and will actively explore alternatives to maximize value for shareholders, while minimizing cash expenditures

 

   

Estimated cash and equivalents as of October 31, 2022: $59.4 million

 

   

Management to host investor call and webcast at 8:30 am EST today

South San Francisco, CA, November 14, 2022Satsuma 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 reported topline results from the STS101 SUMMIT Phase 3 efficacy trial.

Although topline data showed numerical differences in favor of STS101 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) (MBS-free) at two hours post-administration, these differences did not achieve statistical significance (p-value <0.05).

STS101 did, however, demonstrate significant effects on both freedom-from-pain and MBS-free endpoints by three hours post-dose and at all subsequent timepoints at which efficacy was assessed (4, 6, 12, 24 and 48 hours). (See Figures 1 and 2 below.)

 

1


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Figure 1: % of subjects Pain Free over time following single dose of STS101 or placebo

 

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Figure 2: % of subjects free from MBS over time following single dose of STS101 or placebo

 

LOGO

 

 

2


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In addition, STS101 was statistically superior to placebo on multiple key secondary endpoints considered clinically relevant and recommended for assessment in acute-treatment-of-migraine efficacy trials by the U.S. Food and Drug Administration (FDA) in its current industry guidance document and/or the International Headache Society’s guidelines for controlled trials:1,2

 

   

Proportion of subjects with pain relief at 2 hours post-dose (p=0.0017) and at all timepoints thereafter

 

   

Proportion of subjects requiring rescue medication within 24 hours and 48 hours post-treatment (p<0.0001 and p=0.0001, respectively)

 

   

Proportion of subjects with 24-hour sustained freedom from pain, i.e., the proportion of subjects who reported no headache pain at 2 hours post-dose who remained free from pain at all timepoints through 24 hours (p=0.0479)

Consistent with clinical trial experience to date, STS101 demonstrated a favorable safety and tolerability profile in SUMMIT. The only treatment-emergent adverse event reported by more than 5% of SUMMIT subjects who self-administered STS101 was nasal discomfort, reported by 8.3% of subjects. No treatment-related serious adverse events or cardiovascular events occurred.

“We are surprised and disappointed that STS101 did not demonstrate statistically significant superiority over placebo at two-hours post treatment on the SUMMIT study co-primary endpoints,” stated John Kollins, Satsuma’s President and Chief Executive Officer. “However, based on our interactions to date with the FDA, we believe the results from the STS101 Phase 1 pharmacokinetic and ASCEND Phase 3 open-label, long-term safety trials will support the STS101 NDA filing and marketing approval. A large proportion of people with migraine do not achieve sufficient and sustained relief with current treatments, and we believe that in total, the data from the STS101 clinical program, in which more than 1,600 subjects treated more than 8,500 migraine attacks with more than 10,000 doses of STS101, demonstrate that STS101 has a differentiated profile and may address the unmet needs of many patients.”

In addition, Satsuma announced that it does not plan to invest in commercializing STS101 and will actively explore alternatives to maximize value for shareholders, while minimizing cash expenditures. As of October 31, 2022 the company had estimated cash and equivalents $59.4 million.

 

1 

FDA Guidance, Migraine: Developing Drugs for Acute Treatment, February 2018

2 

Diener et al., Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth Edition, Cephalalgia, 2019

 

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Conference Call and Webcast Details

Satsuma management will host a conference call and accompanying webcast for investors at 8:30 am EST this morning. Interested participants may register for the call using the following link: https://conferencingportals.com/event/yMGurUMf

The call can then be accessed by dialing 888-330-2513 (toll free) or 240-789-2726 (toll) and referencing conference ID 49226-446.

The accompanying webcast, which will feature a slide presentation, can be accessed at the following link: https://event.on24.com/wcc/r/4024205/07BAE6AA1EF580725929A36DE3450D67

Participants are asked to dial in approximately ten minutes prior to the start of the call.

The webcast slide presentation is also available in the Events and Presentations page of our 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 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 robust efficacy, and sustained DHE 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. 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. However, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration and/or sub-optimal clinical performance, have limited the widespread use of DHE. Featuring an easy-to-carry and easy-to-use 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.

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

 

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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 data readouts for ongoing clinical trials, the anticipated timing for a potential STS101 NDA submission, the potential for STS101 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, 2022, 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

212-915-2577

cdavis@lifesciadvisors.com

Tom O’Neil, Chief Financial Officer

Satsuma Pharmaceuticals, Inc.

tom@satsumarx.com

 

5

EX-99.2

Slide 1

STS101 for the acute treatment of migraine SUMMIT Phase 3 efficacy trial topline results November 14, 2022 conference call Exhibit 99.2


Slide 2

Disclaimer Important Notice This Presentation 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 ASCEND and SUMMIT trials; the Company’s expectations regarding the potential market size and size of the potential patient populations for STS101, if approved for commercial use; the Company’s commercialization, marketing and manufacturing plans and expectations; the pricing and reimbursement of STS101, if approved; the implementation of the Company’s business model and strategic plans for its business and STS101; the scope of protection the Company is able to establish and maintain for intellectual property rights covering STS101, including the projected terms of patent protection; estimates of the Company’s expenses, future revenue, capital requirements, its need for additional financing and its ability to obtain additional capital; the Company’s future financial performance; and developments and projections relating to the Company’s competitors and the Company’s industry, including competing therapies and procedures. 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, 2022, 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 accuracy of the Company’s estimates relating to its ability to initiate and/or complete clinical trials; the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the Company’s ability to select suitable dosing regimens; 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; the Company’s ability to raise additional capital; and the risk that costs of clinical trials and preclinical activities will exceed expectations. 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 Presentation discusses STS101, a product candidate that is under clinical study, 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.


Slide 3

Large and growing multi-billion dollar market Summary STS101 (DHE nasal powder) Next steps 10/31/22 cash: $59.4M Developing innovative and differentiated treatment Satsuma does not plan to invest in commercializing STS101 We believe STS101 is approvable based on Ph1 and ASCEND results 40M U.S. prevalence Underdiagnosed and undertreated Project ~20M Rx’s for migraine-specific treatments written in 2022 ~20-40% of patients do not obtain adequate relief with current treatments ~50% of gepant Rx’s not refilled within 60 days Market for non-oral treatments >4M unit doses/year and growing Complete analysis of SUMMIT results Actively explore alternatives to maximize value for shareholders Potential NDA filing (Q1 2023) Minimize cash expenditures Quick and easy to self-administer Favorable safety and tolerability demonstrated in >1,600 subjects who have self-administered > 11,000 doses of STS101 Advantages versus DHE liquid nasal sprays, DHE for injection and other non-oral products for acute treatment of migraine STS101 STS101 did not meet co-primary endpoints in Ph3 double-blind, placebo-controlled efficacy trial STS101 demonstrates favorable safety and tolerability in long-term, open-label safety trial DHE is differentiated and well-established Not orally bioavailable Available injectable and liquid nasal spray dosage forms are suboptimal in terms efficacy, ease-of-use, and/or safety / tolerability Acute treatment of migraine


Slide 4

STS101 SUMMIT Phase 3 trial results


Slide 5

SUMMIT trial design R STS101 5.2 mg* Placebo* up to 30 days 56 days Within 10 days of treatment Screening Randomization & treatment End-of-study visit * All investigative product utilized improved, second-generation nasal delivery device (“Mk2”) End-of-study visit 1,591 subjects randomized Treat single migraine of attack of moderate or severe pain intensity Co-primary endpoints: % free from headache pain at 2h post-treatment % free from most bothersome symptom at 2h post-treatment (from among photophobia, phonophobia or nausea) Key inclusion criteria: 18-65 years of age 1-year history of migraine 2-8 migraines per month No significant CV disease or risk factors   1:1 randomization Designed per published FDA guidance for developing acute treatment of migraine drugs (Feb 2018) Key secondary endpoints % Pain-free and MBS-free over time Pain relief at 2h and over time Use of rescue medication Sustained 2-24h pain- and MBS- freedom


Slide 6

Endpoint definitions Patients report pain severity in electronic diary on a 4-point scale 0 No Pain 1 Mild Pain 2 Moderate Pain 3 Severe Pain SUMMIT subjects treated migraine attacks with Moderate or Severe Pain (i.e., rated as a “2” or “3”) immediately prior to treatment Pain free: Subject reports No Pain (“0”) at time point, i.e., a 2- or 3-point change Pain relief: Subject reports Mild Pain (“1”) or No Pain (“0”) at time point, i.e., a 1-, 2- or 3-point change (Note that change from “Severe Pain” to “Moderate Pain” DOES NOT qualify as a Pain Relief response) Pain Freedom and Pain Relief Most Bothersome Symptom Immediately prior to treatment, SUMMIT subjects declared their “Most Bothersome Symptom” from among Photophobia, Phonophobia or Nausea MBS-free: the Most Bothersome Symptom that subject declared immediately prior to treatment is no longer present


Slide 7

Demographics & migraine history Subjects’ demographics and migraine history were representative of typical migraine patient population STS101 Placebo Age (mean; SD) 38.2 yrs (11.4) 38.9 yrs (11.5) Gender (% M/F) 21/79 20/80 Race (%) White African American Asian Other 82.5 12 3.5 2.0 81.4 13.7 3.4 1.5 BMI (mean; kg/m2) 27.7 27.2 Years since onset (mean; SD) 16.2 (11.3) 16.9 (11.4) Self-reported migraines/month and headache days/month during 90 days prior to screening visit # of moderate/severe migraines (SD) # of headache days (SD) 4.5 (1.7) 6.9 (2.7) 4.5 (1.7) 6.9 (3.0) Subjects on prevention medication at randomization (%) 10.2 10.2


Slide 8

Patient disposition STS101 Placebo Randomized 796 795 Modified Intent-to-Treat* 716 708 Safety** 731 729 *Subject treated qualifying migraine attack with study medication and has at least 1 post-treatment diary entry **Subject used study medication


Slide 9

Characteristics of treated migraine attacks Note: Allodynia was considered present if subject had 2 positive responses in 6 question allodynia questionnaire immediately before study drug administration (Ashkenazi 2007; Tepper 2011) Symptoms just before treatment (% of subjects with symptom) STS101 Placebo Moderate headache pain / severe headache pain 61.6 / 38.4 63.4 / 36.6 Nausea 69 68 Photophobia 95 97 Phonophobia 91 91 Aura 50 50 Allodynia 63 63 High proportion of SUMMIT subjects had pre-treatment attack characteristics indicative of difficult-to-treat attacks that are poorly responsive to treatment


Slide 10

Co-primary endpoints MBS: Most-bothersome symptom from among photophobia, phonophobia or nausea declared by subject at time of treated attack Subjects who took study medication, entered efficacy data at any timepoint, but did not report data at 2 hr were imputed to be treatment failures STS101 (n=716) Placebo (n=708) Difference p-value 20.4% 17.5% 2.9% 0.1661 STS101 (n=701) Placebo (n=699) Difference p-value 37.8% 32.9% 4.9% 0.0552


Slide 11

Pain freedom over time (single dose) p=0.1661 p=0.0009 p<0.0001 p<0.0001 p<0.0001 p<0.0001 p=0.0004 STS101 was numerically superior to placebo at all but one time point (1h) Did not achieve statistical significance (p<0.05) at 2h Statistically significant at all time points after 2h Subjects who did not report data at a timepoint or who used any rescue medication prior to timepoint were imputed to be treatment failures


Slide 12

MBS freedom over time (single dose; no rescue medications) p=0.0552 p=0.0002 p<0.0001 p<0.0001 p<0.0001 p<0.0001 p=0.0001 STS101 was numerically superior to placebo at all but one time point (0.5h) Did not achieve statistical significance (p<0.05) at 2h Statistically significant at all time points after 2h Subjects who did not report data at a timepoint or who used any rescue medication prior to timepoint were imputed to be treatment failures


Slide 13

Pain relief over time (single dose; no rescue medications) p=0.0017 p<0.001 p<0.0001 p=0.0001 p<0.0001 p<0.0001 p=0.0003 STS101 was statistically significant vs placebo (p<0.05) at 2h and all time points thereafter Subjects who did not report data at a timepoint or who used any rescue medication prior to timepoint were imputed to be treatment failures


Slide 14

STS101 showed effects on key secondary endpoints Endpoint p-value Relief from Headache Pain at 2h post-dose (and all timepoints thereafter) 0.0017 (at 2h) Use of rescue medication within 24h and 48h post-dose 0.0001 Sustained freedom from Headache Pain from 2-24h post-dose (with no relapse or use of rescue medications) 0.0479 Sustained relief from Headache Pain from 2-24h and 2-48h post-dose (with no relapse or use of rescue medications) 0.0001 / 0.0006 Endpoint p-value Relief from Headache Pain at 2h post-dose (and all timepoints thereafter) 0.0017 (at 2h) Use of rescue medication within 24h and 48h post-dose Sustained freedom from Headache Pain from 2-24h post-dose (with no relapse or use of rescue medications) 0.0479 Sustained relief from Headache Pain from 2-24h and 2-48h post-dose (with no relapse or use of rescue medications) 0.0001 / 0.0006 STS101 demonstrates effects on key secondary endpoints considered clinically relevant and recommended for assessment in efficacy trials by the FDA and/or International Headache Society guidelines* * FDA Guidance, Migraine: Developing Drugs for Acute Treatment, February 2018 * Diener et al., Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth Edition, Cephalalgia, 2019


Slide 15

STS101 showed effects on additional and potentially differentiating secondary endpoints Endpoint p-value Free from pain at 4h (and all timepoints thereafter) in attacks with allodynia at time of treatment 0.022 (at 4h) Free from MBS at 4h (and all timepoints thereafter) in attacks with allodynia at time of treatment <0.0001 (at 4h) Free from both pain and MBS at 3h (and all timepoints thereafter) 0.003 (at 3h) Free from nausea (if present at time of treatment) at 3h post-dose (and all timepoints thereafter) 0.004 (at 3h) Free from pain at 3h in subjects with menstrually-associated attacks 0.019 Free from MBS at 2h in subjects with menstrually-associated attacks 0.029 STS101 shows activity in migraine attacks considered “difficult-to-treat”* Attacks with allodynia Attacks with nausea Menstrually-associated attacks * Burstein et al., Ann Neurol 2004; Lipton et al, Headache 2017; Lainez et al., Pat Rel Outcome Measures 2013; Diener et al., Neurology 2004; Diener et al., Cephalalgia 2008; Martelletti et al., Exp Rev Neurotherapeutics 2019


Slide 16

STS101 exhibited favorable safety and tolerability profile STS101 Placebo Safety Population (n) 731 729 Treatment-Emergent Adverse Events reported by >1% of subjects Nasal discomfort 8.3% 1.5% Dysgeusia 3.7% 0.3% Nasal congestion 3.1% 0.8% Nausea 1.9%  0.7% Throat irritation 1.1%  0.3% Rhinorrhea 1.1% 0.1% Consistent with previous clinical trial results, STS101 showed favorable safety & tolerability profile Low incidence of nausea No treatment-related Serious Adverse Events or cardiovascular adverse events


Slide 17

STS101 showed absolute efficacy rates comparable to gepants STS101 / SUMMIT Gepant / Ph3 trials* Pain Free at 2h - Active 20.4% 19.2% – 21.8% Pain Free at 2h - Placebo 17.5% 11.8% - 14.3% MBS Free at 2h - Active 37.8% 35.1% - 38.8% MBS Free at 2h - Placebo 32.9% 25.2% - 27.7% However, placebo response rates across gepant Ph3 trials were lower than with STS101 in SUMMIT trial * Ubrogepant and rimegepant Ph3 efficacy trials (n=5)


Slide 18

Summary and conclusions SUMMIT was a rigorously-conducted, large, placebo-controlled trial that addressed factors thought to contribute to previous EMERGE trial failing to achieve statistical significance on co-primary endpoints at 2h STS101 did not demonstrate statistical significance over placebo on co-primary endpoints at 2h STS101 achieved statistical significance versus placebo on co-primary endpoints by 3h and all subsequent timepoints STS101 showed statistically significant effect on pain relief at 2h and all subsequent timepoints STS101 showed statistically significant effects on multiple clinically relevant and potentially differentiating secondary endpoints Consistent with clinical trial experience to date, STS101 showed favorable safety and tolerability


Slide 19

Summary and conclusions SUMMIT results suggest STS101 may have particular utility for people with migraine who experience: Attacks with allodynia Long-duration migraine attacks, including menstrually-associated migraine Nausea STS101 may be an attractive treatment option for patients who: Desire a long-lasting antimigraine treatment that mitigates need for re-dosing and/or rescue medications Desire an easy-to-use treatment Desire a well-tolerated treatment Would benefit from a non-oral treatment due to nausea, vomiting or gastroparesis secondary to migraine attack Dislike injectable treatments or liquid nasal sprays


Slide 20

STS101 program and plans


Slide 21

STS101 program and plans STS101 is a differentiated asset Satsuma has established automated, commercial-scale manufacturing capability for STS101 Based on feedback from three meetings with FDA, Satsuma believes Phase 1 PK and ASCEND long-term, open-label safety trials will support NDA filing and potential approval FDA has consistently communicated stated that an efficacy trial is not necessary for STS101 approval Assuming NDA filing in Q1 2023 and first-cycle FDA approval, STS101 commercial launch could occur in Q1/Q2 2024 We do not plan to invest in commercialization


Slide 22

Next steps Complete analysis of SUMMIT trial results Potential NDA filing (Q1 2023) Actively explore alternatives to maximize value for shareholders Minimize cash expenditures


Slide 23

Thank you