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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): June 3, 2024
Structure Therapeutics Inc.
(Exact name of registrant as specified in its
charter)
Cayman Islands |
|
001-41608 |
|
98-1480821 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
601 Gateway Blvd., Suite 900
South San Francisco, California |
|
94080 |
(Address of principal executive offices) |
|
(Zip Code) |
(Registrant’s telephone number, including area code): (628) 229-9277
Not Applicable
(Former name or former address, if changed since
last report)
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 (see General Instruction A.2.
below):
¨ |
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:
|
|
Name Of Each Exchange |
|
|
Title of Each Class |
|
Trading Symbol(s) |
|
On Which Registered |
American Depositary Shares (ADSs), each representing three ordinary shares, par value $0.0001 per ordinary share |
|
GPCR |
|
Nasdaq Global Market |
|
|
|
|
|
Ordinary shares, par value $0.0001 per share* |
|
True |
|
Nasdaq Global Market* |
* Not for trading, but only in connection with the registration of
the American Depositary Shares
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 x
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 7.01 Regulation FD Disclosure.
On June 3, 2024, Structure Therapeutics
Inc. (the Company) issued a press release and will be hosting a conference call and webcast to discuss positive topline data from its
Phase 2a obesity study and capsule to tablet PK study for its oral non-peptide small molecule GLP-1 receptor agonist, GSBR-1290.
Copies of the press release and investor presentation
the Company intends to use during the conference call and webcast are attached as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K,
respectively.
The
information set forth in this Item 7.01 and in the press release and investor presentation attached hereto as Exhibits 99.1
and 99.2, respectively, is deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18
of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that Section. The
information set forth in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed incorporated by reference into any filing
under the Exchange Act or the Securities Act of 1933, as amended, except to the extent that the Company specifically incorporates it by
reference.
Item 8.01 Other Events.
GSBR-1290 – Phase 2a Topline Results Summary
| · | In the Phase 2a obesity study, GSBR-1290 demonstrated a clinically meaningful and statistically significant placebo-adjusted mean
decrease in weight of 6.2% (p<0.0001, using least-squares means (LSM) and analyzed based on the primary efficacy estimand using a mixed
model for repeated measures) at 12 weeks. At Week 12, 67% of GSBR-1290 treated participants achieved ≥6% weight loss and 33% achieved
≥ 10% weight loss, compared to 0% for placebo. |
| · | A capsule to tablet PK study designed to explore a new tablet formulation of GSBR-1290 demonstrated a placebo-adjusted mean weight
loss of up to 6.9% (p<0.0001, using LSM and analyzed based on the primary efficacy estimand using a mixed model for repeated measures)
with the tablet formulation at 12 weeks. In addition, the tablet formulation demonstrated comparable exposure to the prior capsule formulation
and pharmacokinetic data support dose proportional exposure and a once-daily dose profile of GSBR-1290. |
| · | GSBR-1290 demonstrated generally favorable safety and tolerability results following repeated, daily dosing up to 120mg. As expected
for the GLP1-RA drug class, leading adverse events (AEs) were gastrointestinal (GI)-related and the two most common AEs were nausea and
vomiting. GI-related adverse events were generally observed early in treatment and attenuated after titration was completed. AE-related
study discontinuations ranged from 5% in the Phase 2a obesity study to 11% in the capsule to tablet PK study. There were zero cases of
drug-induced liver injury or persistent liver enzyme elevations reported across the two studies. |
GSBR-1290 Phase 2b Obesity Study Expected to Begin in Fourth
Quarter 2024
The Company plans to submit an IND to the FDA in the third quarter
of 2024 to support initiation of trials in chronic weight management and thereafter initiate a Phase 2b obesity study of GSBR-1290 in
the fourth quarter of 2024. The 36-week global study is expected to use the tablet formulation of GSBR-1290 and include approximately
300 participants to be treated with multiple doses and dose titration regimens.
Phase 2a Study of GSBR-1290 in Obesity
The double-blind, 12-week placebo-controlled Phase 2a clinical trial
enrolled 64 healthy overweight or obese participants that were randomized to GSBR-1290 120mg (n=37) or placebo (n=27), dosed once daily
with weekly dose titrations.
GSBR-1290 Capsule to Tablet PK Study
The 12-week placebo-controlled capsule to tablet PK study (n=54) was
designed to evaluate the tolerability, safety and pharmacokinetics of a new tablet formulation of GSBR-1290 and assess three different
dosing and titration regimens, while exploring changes in weight during the 12-week duration. Based on the results with the new tablet
formulation, Structure anticipates using the tablet formulation for future studies starting with the planned 36-week Phase 2b obesity
study.
Forward Looking Statements
This Current Report on Form 8-K contains “forward-looking
statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.
All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without
limitation, statements concerning the Company’s future plans and prospects, the potential to become a best-in-class oral small molecule
GLP-1RA as well as an ideal backbone for future combination therapeutics for the treatment of obesity and related diseases, any expectations
regarding the safety, efficacy, tolerability or once-daily dosing of GSBR-1290, including based on the clinical update from the Company’s
Phase 2a obesity study and capsule to tablet PK study, and other candidates under development, the ability of GSBR-1290 to treat T2DM,
obesity or related indications, the planned IND submission and initiation and number of expected patients of the Company’s Phase
2b obesity study and Phase 2 development plan in T2DM and the timing thereof, respectively and the planned timing of the continued development
of GSBR-1290. In addition, when or if used in this press release, the words “may,” “could,” “should,”
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,”
“predict” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements.
Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations
reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be
correct. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could
differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties,
which include, without limitation, risks and uncertainties related to topline results that the Company reports is based on a preliminary
analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical
trial and such topline data may not accurately reflect the complete results of a clinical trial, the preliminary nature of the results
due to length of the study and sample size and results from earlier clinical trials not necessarily being predictive of future results,
including the results using the LSM and mixed model for repeated measures which uses all available data, including data
from patients who did not follow-up at 12 weeks, and estimates how patients with missing data would have responded based on patients who
continued the study and had similar baseline characteristics (implicit imputation), potential delays in the IND submission or commencement,
enrollment and completion of the Company’s planned Phase 2 trials, including the Company will need to receive allowance from the
FDA to proceed before initiating the planned Phase 2b trial, the Company’s ability to advance GSBR-1290, LTSE-2578, ANPA-0073 and
its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the Company’s therapeutic candidates,
competitive products or approaches limiting the commercial value of the Company’s product candidates, the timing and results of
preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the impact
of any global pandemics, inflation, supply chain issues, rising interest rates and future bank failures on the Company’s business,
its ability to protect its intellectual property and other risks and uncertainties described in the Company’s filings with the Securities
and Exchange Commission (SEC), including the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024,
as filed with the SEC on May 9, 2024, and future reports the Company may file with the SEC from time to time. All forward-looking
statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions
and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances
that exist after the date on which they were made, except as required by law.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
Structure Therapeutics Inc. |
|
|
|
Date: June 3, 2024 |
By: |
/s/ Raymond Stevens |
|
|
Raymond Stevens, Ph.D. |
|
|
Chief Executive Officer |
Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-1img001.jpg)
Structure Therapeutics Reports Positive Topline
Data from its Phase 2a Obesity Study and Capsule to Tablet PK Study for its Oral Non-Peptide Small Molecule GLP-1 Receptor Agonist GSBR-1290
GSBR-1290 achieved a clinically meaningful and
statistically significant placebo-adjusted mean weight loss of 6.2% (p<0.0001) in the Phase 2a obesity study and up to 6.9% (p<0.0001)
in capsule to tablet PK study, in both cases at 12 weeks
GSBR-1290 demonstrated generally favorable safety
and tolerability results
with low AE-related study discontinuations
Pharmacokinetic data support dose proportional
exposure and once-daily oral dosing of GSBR-1290
36-week Phase 2b study in obesity on track to
begin in the fourth quarter of 2024
Company to host conference call today at 8:30
a.m. ET
SAN FRANCISCO – June 3, 2024 – Structure Therapeutics
Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic
and cardiopulmonary diseases, today announced positive 12-week topline obesity data from its Phase 2a study of GSBR-1290, along with positive
topline results from its capsule to tablet PK study. Both studies achieved their primary and secondary objectives.
Topline Results Summary
| · | In the Phase 2a obesity study, GSBR-1290 demonstrated a clinically meaningful and statistically significant placebo-adjusted mean
decrease in weight of 6.2%1 (p<0.0001) at 12 weeks.
At Week 12, 67% of GSBR-1290 treated participants achieved ≥6% weight loss and 33% achieved ≥ 10% weight loss, compared to 0% for
placebo. |
| · | A capsule to tablet PK study designed to explore a new tablet formulation of GSBR-1290 demonstrated a placebo-adjusted mean weight
loss of up to 6.9%1 (p<0.0001) with the tablet formulation at 12 weeks. In addition, the tablet formulation demonstrated
comparable exposure to the prior capsule formulation and pharmacokinetic data support dose proportional exposure and a once-daily dose
profile of GSBR-1290. |
| · | GSBR-1290 demonstrated generally favorable safety and tolerability results following repeated, daily dosing up to 120mg. As
expected for the GLP1-RA drug class, leading adverse events (AEs) were gastrointestinal (GI)-related and the two most common AEs were
nausea and vomiting. GI-related adverse events were generally observed early in treatment and attenuated after titration was completed.
AE-related study discontinuations ranged from 5% in the Phase 2a obesity study to 11% in the capsule to tablet PK study. There were zero
cases of drug-induced liver injury or persistent liver enzyme elevations reported across the two studies. |
1 Least-squares means and analyzed based on primary
efficacy estimand using a Mixed Model for Repeated Measures
“These topline results demonstrate the substantial weight loss
effect of GSBR-1290 and its potential to become a best-in-class oral small molecule GLP-1RA as well as an ideal backbone for future combination
therapeutics for the treatment of obesity and related diseases,” said Raymond Stevens, Ph.D., Founder and CEO of Structure. “We
designed GSBR-1290 to be dosed once-a-day, and are pleased to see the competitive treatment effect at 12 weeks, dose proportional exposure
and target engagement over 24 hours.”
Dr. Stevens continued: “We are pleased that our new tablet
performed well and that a start low and go-slow titration strategy proved beneficial and we will carry these observations into our planned
Phase 2b study. As previously reported, we believe our large safety window will allow us the option to explore higher doses in future
studies. As a non-peptide small molecule, our large-scale manufacturing process is expected to be more than capable of meeting the anticipated
global demand of a product with the profile of GSBR-1290. We are excited to move into a Phase 2b study in overweight and obese individuals.
”
“By 2030, the global prevalence of obesity is expected to reach
1 billion. There is a need for oral treatments, including small molecules, which are easier to make at scale, more stable thus easier
to transport and store, and more cost-effective,” said Ania Jastreboff, M.D., Ph.D., Associate Professor of Medicine and Pediatrics
at Yale School of Medicine; Director, Yale Obesity Research Center (Y-Weight), and co-Director of the Yale Center for Weight Management.
“All these factors may enable greater treatment reach for this worldwide disease. The phase 2 data with GSBR-1290 demonstrate safety
to date and clinically meaningful weight reduction with 12 weeks of treatment and are encouraging for its development as a potential future
therapeutic for obesity.”
GSBR-1290 Phase 2b Obesity Study Expected to Begin in Fourth Quarter
2024
Structure plans to submit an IND to the FDA in the third quarter of
2024 to support initiation of trials in chronic weight management and thereafter initiate a Phase 2b obesity study of GSBR-1290 in the
fourth quarter of 2024. The 36-week global study is expected to use the tablet formulation of GSBR-1290 and include approximately 300
participants to be treated with multiple doses and dose titration regimens.
About the Phase 2a Study of GSBR-1290 in Obesity
The double-blind, 12-week placebo-controlled Phase 2a clinical trial
enrolled 64 healthy overweight or obese participants that were randomized to GSBR-1290 120mg (n=37) or placebo (n=27), dosed once daily
with weekly dose titrations.
About the GSBR-1290 capsule to tablet PK study
The 12-week placebo-controlled capsule to tablet PK study (n=54) was
designed to evaluate the tolerability, safety and pharmacokinetics of a new tablet formulation of GSBR-1290 and assess three different
dosing and titration regimens, while exploring changes in weight during the 12-week duration. Based on the results with the new tablet
formulation, Structure anticipates using the tablet formulation for future studies starting with the planned 36-week Phase 2b obesity
study.
Conference Call and Webcast Information
Structure will host a conference call and webcast today, June 3,
2024 at 8:30 a.m. Eastern Time. A live webcast of the call will be available on the Investor Relations page of Structure’s
website at https://ir.structuretx.com/events-presentations/events. To access the call by phone, participants should visit this
link (registration link) to receive dial-in details. The webcast will be made available for replay on the company’s website
beginning approximately two hours after the live event. The replay of the webcast will be available for 90 days.
About GSBR-1290 and Structure’s Oral Metabolic Franchise
GSBR-1290 is an orally-available, small molecule agonist of the glucagon-like-peptide-1
(GLP-1) receptor, a validated drug target for the treatment of type 2 diabetes mellitus (T2DM) and obesity. Through the Company’s
structure-based drug discovery platform, GSBR-1290 was designed to be a biased GPCR agonist, which selectively activates the G-protein
signaling pathway. Structure has completed a Phase 2a study of GSBR-1290 in participants with obesity or who are overweight and T2DM with
high body mass index (BMI) ≥27. A Phase 2b study in obesity is expected to start in the fourth quarter of 2024, and the Phase 2 development
plan in T2DM is expected to be determined in the second half of 2024. Beyond GSBR-1290, Structure is developing next generation combination
GLP-1R candidates together with GIP, amylin, glucagon and apelin oral small molecules.
About Structure Therapeutics
Structure Therapeutics is a science-driven
clinical-stage biopharmaceutical company focused on discovering and developing innovative oral small molecule treatments for chronic
metabolic and cardiopulmonary conditions with significant unmet medical needs. Utilizing its next generation structure-based drug discovery
platform, the Company has established a robust GPCR-targeted pipeline, featuring multiple wholly-owned proprietary clinical-stage small
molecule compounds designed to surpass the manufacturing scalability limitations of traditional biologic and peptide therapies and be
accessible to more patients around the world. For additional information, please visit www.structuretx.com.
Forward Looking Statements
This press release contains “forward-looking statements”
within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements
other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation,
statements concerning the Company’s future plans and prospects, the potential to become a best-in-class oral small molecule GLP-1RA
as well as an ideal backbone for future combination therapeutics for the treatment of obesity and related diseases, any expectations regarding
the safety, efficacy, tolerability or once-daily dosing of GSBR-1290, including based on the clinical update from the Company’s
Phase 2a obesity study and capsule to tablet PK study, and other candidates under development, the ability of GSBR-1290 to treat T2DM,
obesity or related indications, the planned IND submission and initiation and number of expected patients of the Company’s Phase
2b obesity study and Phase 2 development plan in T2DM and the timing thereof, respectively and the planned timing of the continued development
of GSBR-1290. In addition, when or if used in this press release, the words “may,” “could,” “should,”
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,”
“predict” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements.
Forward-looking statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations
reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be
correct. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could
differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties,
which include, without limitation, risks and uncertainties related to topline results that the Company reports is based on a preliminary
analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical
trial and such topline data may not accurately reflect the complete results of a clinical trial, the preliminary nature of the results
due to length of the study and sample size and results from earlier clinical trials not necessarily being predictive of future results,
including the results using the LSM and mixed model for repeated measures which uses all available data, including data
from patients who did not follow-up at 12 weeks, and estimates how patients with missing data would have responded based on patients who
continued the study and had similar baseline characteristics (implicit imputation), potential delays in the IND submission or commencement,
enrollment and completion of the Company’s planned Phase 2 trials, including the Company will need to receive allowance from the
FDA to proceed before initiating the planned Phase 2b trial, the Company’s ability to advance GSBR-1290, LTSE-2578, ANPA-0073 and
its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the Company’s therapeutic candidates,
competitive products or approaches limiting the commercial value of the Company’s product candidates, the timing and results of
preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the impact
of any global pandemics, inflation, supply chain issues, rising interest rates and future bank failures on the Company’s business,
its ability to protect its intellectual property and other risks and uncertainties described in the Company’s filings with the Securities
and Exchange Commission (SEC), including the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024,
as filed with the SEC on May 9, 2024, and future reports the Company may file with the SEC from time to time. All forward-looking
statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions
and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances
that exist after the date on which they were made, except as required by law.
CONTACTS
Investors:
Danielle Keatley
Structure Therapeutics Inc.
ir@structuretx.com
Media:
Dan Budwick
1AB
Dan@1abmedia.com
Exhibit 99.2
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img001.jpg)
| 1
GSBR-1290
Obesity Topline Data
Presentation
June 2024 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img002.jpg)
| 2
Disclaimers and Forward Looking Statements
This presentation contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements other
than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the Company’s future plans and
prospects, any expectations regarding the safety, efficacy, tolerability and chemistry, manufacturing and controls and scalability of GSBR-1290 under development based on the topline
clinical data from the Phase 2a study of GSBR-1290 in patients with type 2 diabetes mellitus (T2DM) and obesity, including the potential for maintained or increased efficacy results with
longer duration of treatment, the ability of GSBR-1290 to treat T2DM, obesity, chronic weight management or related indications, the planned initiation and study design of the Company's
Phase 2b study for GSBR-1290 in patients with obesity and the timing thereof; the update from the capsule to tablet formulation bridging optimization study of GSBR-1290; the planned
timing to submit an investigational new drug application to support a Phase 2b study for chronic weight management for GSBR-1290; the planned timing of the Company's data results and
continued development of GSBR-1290 and next generation combination GLP-1R candidates; the Company’s anticipated milestones; the anticipated market opportunity for GSBR-1290 and
oral small molecules and the Company’s expected cash runway until 2026. In addition, when or if used in this presentation, the words “may,” “could,” “should,” “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the Company may identify forward-looking statements. Forward-looking
statements are neither historical facts nor assurances of future performance. Although the Company believes the expectations reflected in such forward-looking statements are reasonable,
the Company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and
circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without
limitation, risks and uncertainties related to topline results that the Company reports is based on a preliminary analysis of key efficacy and safety data, and such data may change following
a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial, the preliminary nature of the
results due to length of the study and sample size and results from earlier clinical trials not necessarily being predictive of future results, including the results using the least square means
and mixed model for repeated measures which uses all available data, including data from patients who did not follow-up at 12 weeks, and estimates how patients with missing data would
have responded based on patients who continued the study and had similar baseline characteristics (implicit imputation), potential delays in the IND submission or commencement,
enrollment and completion of the Company's planned Phase 2 trials, including the Company will need to receive allowance from the FDA to proceed before initiating the planned Phase 2b
trial, the Company's ability to advance GSBR-1290, LTSE-2578, ANPA-0073 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the Company's
therapeutic candidates, competitive products or approaches limiting the commercial value of the Company's product candidates,the timing and results of preclinical and clinical trials, the
impact of any data collection omissions at any of our clinical trial sites, the Company’s ability to fund development activities and achieve development goals, the Company's reliance on
third parties, including clinical research organizations , manufacturers, suppliers and collaborators, over which it may not always have full control, the impact of any global pandemics,
inflation and supply chain issues on the Company’s business, its ability to protect its intellectual property and other risks and uncertainties described in the Company’s filings with the
Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 8, 2024, Quarterly
Report on Form 10-Q for the quarter ended March 31, 2024 filed with the SEC on May 9, 2024, and future reports the Company may file with the SEC from time to time. All forward-looking statements contained in this presentation speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The
Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img003.jpg)
| 3
Agenda
Opening Remarks and Overview Raymond Stevens, Ph.D.
Chief Executive Officer
GSBR-1290 Obesity Topline Data
• Efficacy Summary
• Safety and Tolerability Summary
• Pharmacokinetic (PK) summary
Blai Coll, M.D., Ph.D.
VP Clinical Development
GSBR-1290 Planned Next Steps
• Phase 2b 36-week Obesity study Blai Coll, M.D., Ph.D.
GSBR-1290 Opportunity &
Building a Leading Oral Small Molecule Portfolio Raymond Stevens, Ph.D.
Q&A
Raymond Stevens, Ph.D., CEO
Blai Coll, M.D., Ph.D., VP Clinical Development
Mark Bach, M.D., Ph.D., Chief Medical Officer
Xichen Lin, Ph.D., Chief Scientific Officer
Jun Yoon, Chief Financial Officer |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img004.jpg)
| 4
Our Mission is to Make Medicines More Accessible to All
PEPTIDE OR BIOLOGIC
MEDICINES
ACCESSIBLE FOR ALL
ORAL SMALL MOLECULE |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img005.jpg)
| 5
We believe GSBR-1290 Obesity Data Position for Potential Best-in-Class Oral GLP-1RA
Best-in-Class Criteria GSBR-1290 Performance through Phase 2a
Competitive Efficacy 6.2 – 6.9% placebo-adjusted weight loss at 12 weeks
Safety No liver liability
Large safety window – potential to go higher in dose
Tolerability 5 – 11% AE-related study discontinuations
Once-Daily Dosing PK supports QD dosing
No fasting requirement
Manufacturable
at Scale and Low COGS
Scalable to potentially serve >120 million patients
GMP batches for Phase 2b studies completed
|
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img006.jpg)
| 6
GSBR-1290 Obesity Topline Results
Efficacy Summary |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img007.jpg)
| 7
GSBR-1290 Phase 2a Study Design in Overweight or Obese Participants
5 mg 15 mg 30 mg 60 mg 90 mg 120 mg Follow up
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 weeks
PBO PBO PBO PBO PBO PBO Follow up
(n=37)
(n=27)
Healthy
Overweight
/ Obese
Participants
N= 64*
* Cohort of 24 participants added as replacements
** Analysis based on the primary efficacy estimand
Key Eligibility Criteria:
• Healthy overweight/obese adult
men and women
• BMI ≥27.0 and ≤40.0 kg/m2
• HbA1c ≤6.5%
• Age ≥18 and ≤75 years
Primary Endpoint:
• Safety and tolerability
Secondary Endpoint:
• Change in body weight (%) from baseline to Week 12**
Once Weekly Titrations |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img008.jpg)
| 8
GSBR-1290 Phase 2a Study Baseline Characteristics
Phase 2a Obesity Study (12 week)
N=64, Randomized
GSBR-1290 capsule
Characteristics
Mean (SD) or N (%)
120 mg
(N=37)
Placebo
(N=27)
Age, years 45.1 (14.3) 44.7 (12.0)
Sex, female, N (%) 20 (54.1) 11 (40.7)
Hispanic or Latino, N (%) 16 (43.2) 13 (48.1)
Weight, kg 90.2 (14.3) 91.5 (14.4)
BMI, kg/m2 31.5 (3.2) 31.6 (3.0)
HbA1c, % 5.5 (0.3) 5.5 (0.4)
No significant differences in baseline characteristics
between original and replacement cohorts |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img009.jpg)
| 9
• 6.2% placebo-adjusted weight loss
observed after 12 weeks
• Statistically significant weight reduction
over 12 weeks with a clear separation
compared to placebo
GSBR-1290
120 mg
% Change in Body Weight,
placebo-adjusted -6.2
95% Confidence Interval (CI) -8.9, -3.6
P-value vs placebo* <0.0001
GSBR-1290
Dosing/
Titration (mg)
5 15 30 60 90 120
GSBR-1290 Phase 2a Results:
Significant Weight Loss Observed at 12 Weeks
* Least-Squares Means, CI and p value from Mixed Model for Repeated Measures.
-6.2
0.0
-8
-7
-6
-5
-4
-3
-2
-1
0
1
2
0 2 4 6 8 10 12
Body Weight Change From Baseline (%)
LSM ± SE
Weeks
Absolute % Body Weight Change
From Baseline Over 12 Weeks
Placebo GSBR-1290 120 mg |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img010.jpg)
| 10
• 67% participants receiving GSBR-1290 achieved at least a 6% weight loss
• 33% achieved at least a 10% weight loss
• 0% of participants receiving placebo achieved at least a 5% weight loss
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
≥ 6% ≥ 8% ≥ 10%
Percentage of GSBR-1290 dosed participants achieving weight loss over 12 weeks*
67%
56%
33%
GSBR-1290 Phase 2a Results:
Two Thirds of Participants Reported at least 6% Weight Loss
Percentage of weight loss over 12 weeks
Percentage of participants
*Analysis based on the primary efficacy estimand |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img011.jpg)
| 11
GSBR-1290 Capsule to Tablet PK Study Design
Healthy
Overweight
/ Obese
Participants
N= 54 * Cohort 3
15:3 PBO Screening 5mg 15mg 30mg
60mg capsule 60mg tablet
Follow up 60mg tablet 60mg capsule
-4 -3 -2 -1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Cohort 2
15:3 PBO Screening 15mg 30mg 60mg 90mg 120mg Follow up
Cohort 1
15:3 PBO Screening 10mg 20mg 30mg 60mg 90mg 120mg Follow up
Key Eligibility Criteria:
• Healthy overweight/obese adult
men and women
• BMI ≥27.0 and ≤40.0 kg/m2
• Age ≥18 and ≤75 years
Objectives:
• Safety and tolerability of the tablet formulation, with different
starting doses and titration schemes
• Assess comparability of capsule and tablet at 60 mg
• Exploratory effects of GSBR-1290 on change from baseline in
body weight **
* Tablet formulation used with the exception of Cohort 3 crossover Weeks 8-12
** Analysis based on the primary efficacy estimand
Weeks
Key baseline demographics similar across cohorts
Mean baseline BMI of 30 kg/m2 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img012.jpg)
| 12
GSBR-1290
120 mg (C1)
GSBR-1290
120 mg (C2)
GSBR-1290
60 mg (C3)
% Change in Body Weight,
placebo-adjusted -6.9 -6.8 -6.2
95% CI -9.4, -4.3 -9.4, -4.2 -8.8, -3.7
P-value vs placebo* <0.0001 <0.0001 <0.0001
-7
-6
-5
-4
-3
-2
-1
0
1
2
0 2 4 6 8 10 12
Body Weight Change From Baseline (%)
LSM ± SE
Weeks
Absolute % Body Weight Change
From Baseline Over 12 Weeks
Placebo Cohort 1 Cohort 2 Cohort 3
* LSM, CI and p value from Mixed Model for Repeated Measures.
• 6.2% to 6.9% placebo-adjusted weight loss
observed after 12 weeks
• Statistically significant weight reduction
at 12 weeks for both 60 mg and 120 mg doses
GSBR-1290
120 mg
(Cohort 1)
GSBR-1290
120 mg
(Cohort 2)
GSBR-1290
60 mg
Cohort 3
GSBR-1290 Capsule to Tablet PK Study Results:
Significant Weight Loss Observed with Tablet Formulation
-5.8
-6.3
-6.4
0.5 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img013.jpg)
| 13
GSBR-1290 Obesity Data Compare Favorably to for Other Oral Selective GLP-1RAs
Peptide
Selective
GLP-1R Agonist
Sample size indicate total number of subjects enrolled study drug and placebo
☨ Indicates approximate 12 week weight loss, extrapolated by the Company using data from 36 week study (Orforglipron, NEJM 2023) and 68 week study (Semaglutide, The Lancet 2023). * EASD 2022: OP#588
**No head-to-head study has been conducted evaluating GSBR-1290 against the other product candidates included herein. Differences exist between study designs and conditions, and caution should be exercised when comparing data across studies.
Oral Small Molecule Selective GLP-1R Agonists
GSBR-1290
Cross trial comparison of 12 Week Placebo-adjusted % Change in Body Weight
-6.9% -6.8%
-6.2% -6.2% -6.5% -6.6%
-3.7%
-10%
-9%
-8%
-7%
-6%
-5%
-4%
-3%
-2%
-1%
0%
120 mg QD
(Tablet)
Obesity
12 wk Cohort 1
(n=18)
120 mg QD
(Tablet)
Obesity
12 wk Cohort 2
(n=18)
120 mg QD
(Capsule)
Obesity
12 wk Ph 2a
(n=64)
60 mg QD
(Tablet)
Obesity
12 wk Cohort 3
(n=18)
Orforglipron
45 mg QD
Obesity
@12 wk in 36 wk☨
(n=111)
Danuglipron*
200 mg BID
Obesity
12 wk
(n=28)
Semaglutide
(oral peptide)
50 mg QD
Obesity
@12 wk in 68 wk☨
(n=667)
__ |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img014.jpg)
| 14
GSBR-1290 Obesity Topline Results
Safety and Tolerability |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img015.jpg)
| 15
GSBR-1290 Phase 2a Study Participant Disposition
Phase 2a Obesity Study (12 week)
N=64, Randomized
GSBR-1290 capsule
Number of Participants Reporting
N (%)
120mg
(N=37)
Placebo
(N=27)
Discontinued study not due to AEs 5 (13.5) 1 (3.7)
Discontinued study due to AEs related to treatment 2 (5.4)* 0
Dose discontinuation, down titrated or hold due to AEs
Dose discontinuation 2 (5.4)* 0
Dose reduced 15 (40.5) 0
Dose temporarily on hold 2 (5.4) 0
Completed study 30 (81.1) 26 (96.3)
• Low (5.4%) AE-related study discontinuations
*Same two participants, both with GI-related AEs |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img016.jpg)
| 16
Participants with at least one event
during 12 week period, N (%)
120 mg
(N=37)
Placebo
(N=27)
Serious Adverse Events 0 0
Nausea
Mild
Moderate
Severe
33 (89.2)
15 (40.5)
18 (48.6)
0
3 (11.1)
3 (11.1)
0
0
Vomiting 23 (62.2) 1 (3.7)
Constipation 16 (43.2) 4 (14.8)
Decreased appetite 15 (40.5) 3 (11.1)
GSBR-1290 Phase 2a Study: Safety and Tolerability
Gastrointestinal-related AEs Most Common in Rapid 12 Week Titration
Dose Titration Phase
0
10
20
30
40
50
60
70
80
90
100
1 2 3 4 5 6 7 8 9 10 11 12
Percent of participants
Weeks GSBR-1290 5 15 30 60 90 120
Dosing/Titration
weeks (mg)
Incidence of Nausea Over Time
(at least one event during 12 week period)
Titration
Completion
weeks
• All AEs mild or moderate
• No serious adverse events
• Incidence of nausea decreased over time
• Similar attenuation with other GI-AEs
GI Tolerability Summary |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img017.jpg)
| 17
Phase 2a Obesity Study
(GSBR-1290 capsule)
Capsule to Tablet PK Study
(GSBR-1290 tablet)
Number of Participants
Reporting N (%)
120 mg
(N=37)
Placebo
(N=27)
120 mg (C1, C2)
(N=30)
60 mg (C3)
(N=15)
Placebo
(N=9)
Serious Adverse Events 0 0 0 0 0
Drug Induced Liver Injury (DILI) 0 0 0 0 0
Hepatic enzymes increased* 0 0 0 0 0
Mean Change from Baseline to
Week 12
ALT**, (U/L) Mean (SD) -2.2 (11.7) -1.4 (8.1) -0.9 to 2.6 1.6 (11.2) -3.0 (5.2)
AST**, (U/L) Mean (SD) -1.4 (7.2) -3.0 (11.5) 1.1 to 2.5 -1.4 (5.7) -1.7 (3.4)
3 or > ULN in ALT or AST 1 (2.7)1 1 (3.7) 2 1 (3.3)3 0 0
5 or > ULN in ALT or AST 0 0 0 0 0
10 or > ULN in ALT or AST 0 0 0 0 0
1 Female participant with a sporadic increase in ALT (3.9xULN) and AST (2xULN) at day 44, and returned to normal at day 48 without stopping study drug 2 Male participant with fluctuations in ALT/AST throughout the study with a peak at day 30 (both ALT and AST @3xULN) associated with an increase in
creatinine kinase in the context of a viral syndrome
3 Male participant with an isolated increase in AST (4XULN) at day 84 associated with an increase in creatinine kinase
GSBR-1290 Obesity Studies: Safety and Tolerability
Liver Profile
• No DILI or permanent elevations in liver enzymes
• No study discontinuations related to liver function *Preferred term in the TEAE reported in the safety database
** Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img018.jpg)
| 18
GSBR-1290
PK Summary and Comparability of Capsule to Tablet Formulation |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img019.jpg)
| 19
GSBR-1290 Overall Properties Confirm Once Daily (QD) Dosing
* Median (min-max) ** At 24h post-dose *** The T1/2 at Day 49 in the capsule study @120 mg does not capture samples
beyond 24h (half-life value might be underestimated)
*10 ng/mL threshold identified through NHP studies that demonstrated maximum insulin secretion
Geometric mean (% CV) plasma PK parameters across studies
10 ng/ml§ Cave for maximum target engagement for
insulin secretion
GSBR-1290
Efficacy
Full agonist and minimal β-arrestin signal
AUC driven efficacy and favorable free drug concentration
Generally proportional exposure between 60 and 120 mg doses
Plasma concentration at 24 hours above 10 ng/mL§ for 120 mg
Safety and Tolerability
Large safety window with minimal tissue accumulation based on
non-clinical data
Different formulations underway to modulate PK characteristics
Molecular and Pharmacokinetic Properties
§ 10 ng/mL Cave correlated with maximum insulin secretion in NHP studies
Phase 2a Study
Obesity
Capsule to Tablet PK Study
(GSBR-1290 capsule to tablet)
120 mg
Capsule
120 mg (C1, C2)
Tablet
60 mg (C3)
Tablet
60 mg
Capsule
AUC0-tau (ng*h/mL) 1370 (60.0) 1500 (60.6) 654 (93.8) 624 (60.9)
Cmax,ss (ng/mL) 190 (92.8) 192 (104) 101 (170) 79.2 (105)
Tmax, ss* (h) 6.0 (2.0–23.9) 3.5 (0.9 – 24.1) 3.5 (2.0-24.0) 8.0 (2.0-23.9)
CTrough (ng/mL)** 11.0 (128) 14.1 (120) 3.8 (134) 5.4 (174)
T½ el (h) 5.3 (36.8) *** 8.5 (24.5) 4.7 (28.8) 6.5 (45.5) |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img020.jpg)
| 20
GSBR-1290 Next Steps and Summary
Phase 2b Obesity Study (36 week) |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img021.jpg)
| 21
Capsule to Tablet PK Study Key Learnings Inform Phase 2b Study Design % of participants reporting at least one event
0%
10%
20%
30%
40%
50%
60%
70%
80%
5 mg 10 mg 15 mg 5 mg 20 mg 30 mg
First week Second week
Nausea Vomiting
Go Slow
Start Low
Week 1
Participants receiving 5 mg associated
with lowest incidence of GI events
Week 2
Improved tolerability
with slower titration
Low (11%) AE-related study discontinuations in Capsule to Tablet PK Study
Cohort 3 Cohort 1 Cohort 2 Cohort 3 Cohort 1 Cohort 2 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img022.jpg)
| 22
GSBR-1290
Multiple maintenance doses
Placebo
R
~ 300 participants
Obesity: BMI ˃ 30
Overweight: BMI ˃ 27
with comorbidity
Phase 2b Dose Selection on going
Start Low, Go Slow
• Lower 5mg starting dose
• Slower 4 week titration to
optimize tolerability
• Preclinical and clinical safety
data enables ability to
increase dose >120mg
Primary Endpoint:
• Mean % weight change at 36 weeks
Secondary Endpoints:
• % of participants with ˃ 5, 10, 15%
weight reduction
• Other parameters: changes in waist
circumference, blood lipids, blood
pressure
• CV biomarkers
• On track to submit IND to FDA to support study for chronic weight management in Q3 2024
• On track to initiate Phase 2b study (36 week) in Q4 2024
GSBR-1290 Phase 2b Obesity Study (36 weeks) Anticipated to Initiate in Q4 2024 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img023.jpg)
| 23
New GSBR-1290 Obesity Data Demonstrate Potential Best-in-Class Profile
Foundational Backbone Asset in
Oral Small Molecule Metabolic Portfolio
EFFICACY RESULTS
6.2% placebo-adjusted weight loss
at 12 weeks in Phase 2a Obesity
6.2 to 6.9% placebo-adjusted
weight loss at 12 weeks with new
tablet formulation
Proportional PK exposure and
once daily dosing
SAFETY RESULTS
More than 200 participants
exposed to GSBR-1290, up to
12 weeks
Safety profile consistent with the
large safety margin seen in
GLP-tox studies
No DILI or discontinuations due
to liver function
TOLERABILITY RESULTS
Low (5 – 11%) AE-related study
discontinuations
Attenuation of GI-related AEs over
time
• Key Learnings: Lower starting dose, monthly titration, tablet formulation
• Potential to go higher in dosing for the 36-week Phase 2b Obesity Study; Expected to Start in Q4 2024
Competitive Efficacy Results and Once Daily Dosing as an Oral Small Molecule |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img024.jpg)
| 24
GSBR-1290 Opportunity |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img025.jpg)
| 25
12-week Data Positions GSBR-1290 as Potential Best-in-Class Oral GLP-1RA
Boye et al, 2021 Diabetes Obesity Metabolism https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7839441/
23.5%
76.5%
>75%
of patients initially
preferred a daily oral
medication over a weekly
injectable1
Weekly
Injection
Daily
Oral
Oral small molecules could potentially help unlock
a > $100 billion GLP-1RA market opportunity
GSBR-1290
More than 800 million patients globally
can benefit with GLP-1RAs
Original GLP-1RA Oral Small Molecule
Aspirational Target Product Profile
Highly potent, non-peptide, full GLP-1R
agonist with minimal β-arrestin signaling
engagement
Weight loss comparable to
injectable GLP-1R peptides
Designed for ~24 hour drug
exposure to enable QD dosing
in a large patient population
Clean 6 and 9 month GLP-tox studies with
high safety margin, rat NOAEL 1000 mg/kg
Ability to modulate Cmax and tolerability
with formulation technologies
Scalability in commercial manufacturing |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img026.jpg)
| 26
1. 2022 World Health Organization https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight
2. Trust for America’s Health Report https://www.tfah.org/report-details/stateofobesity2019/#:~:text=Obesity%20is%20a%20growing%20epidemic,100%20million%20people%20%E2%80%93%20have%20obesity.
3. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages
4. 2023 Sales, GlobalData, Drugs database https://www.globaldata.com/media/pharma/glp1-agonists-set-to-become-the-best-selling-drugs-in-2024-says-globaldata/
We are Committed to Developing Oral Small Molecules to Meet the
Unmet Needs of a Very Large Global Obesity Patient Population
>5
million
in US
Oral Small Molecules – Ability to Scale
GLP-1RA Peptides
Challenging to Scale
Shortage and supply
chain constraints3
1.5 billion people
in 2030
>$100 billion
Total Addressable Market
> $30 billion
Sales4
>800 million
worldwide >100 million 1
in US2 |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img027.jpg)
| 27
We Believe GSBR-1290 can be Commercially Manufactured at Scale
~6,000 tons
• Synthetic route locked and ready for planned batches
• Manufacturing of Phase 2b GMP supply completed1
• Current manufacturing capacity of 6,000 tons/year to supply >120M patients
0.001
0.01
0.1
1
10
100
1000
10000
100000
0
100
200
300
400 CoG Scale
Current Scale
Scale
Up COGS
Down
Cost of Goods
COGS
PRECLINICAL
PHASE 1 AND 2A PHASE 2B PHASE 3 COMMERCIAL
GSBR-1290 API
Cost: ~2x/kg
GSBR-1290 API
Cost: ~5x/kg
GSBR-1290 API
Cost: ~100x/kg
GSBR-1290 API
Cost: ~x/kg
GSBR-1290 API
Cost: ~3x/kg
Scale
1. Based on current clinical study design
120 million patients/year |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img028.jpg)
| 28
We believe GSBR-1290 Obesity Data Position for Potential Best-in-Class Oral GLP-1RA
Best-in-Class Criteria GSBR-1290 Performance through Phase 2a
Competitive Efficacy 6.2 – 6.9% placebo-adjusted weight loss at 12 weeks
Safety No liver liability
Large safety window – potential to go higher in dose
Tolerability 5 – 11% AE-related study discontinuations
Once-Daily Dosing PK supports QD dosing
No fasting requirement
Manufacturable
at Scale and Low COGS
Scalable to potentially serve >120 million patients
GMP batches for Phase 2b studies completed
|
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img029.jpg)
| 29 Number of patients with access
Where does GSBR-1290 fit in the GLP-1RA landscape?
Phase 2a
Proof of Concept
12 weeks
Phase 2b
Dose Range Finding
36 weeks
Phase 3
Pivotal
52+ Weeks
AmylinR, GIPR,
GCGR, APJR
GSBR Oral Combinations with GSBR-1290 -1290
Aspirational Targets1
• Mid to High Teen Percent Weight Loss
• Low Adverse Events
• Long Term Usage
• Broad Accessibility
GSBR-1290 Backbone and Foundation
2024 2025 2026 2027 2028
How We Win
6.2 – 6.9%
Weight Loss
1. These selective targets are aspirational, and are based on assumptions and estimates by the Company that may prove to be wrong. In addition, the results of prior clinical trials and preclinical studies are not necessarily
predictive of future results, and any extrapolations based on past results are inherently uncertain and imprecise. Therefore, investors are cautioned to not rely on these aspirational targets. |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img030.jpg)
| 30
Strong Momentum with Multiple Potential Catalysts in 2024 – 2026
1H 2024 1H 2025
GSBR-1290
(Oral GLP-1R)
Phase 2a
Data June
Oral
GIPR
Anticipated Milestones – Entire Oral Small Molecule Portfolio
ANPA-0073
(Oral APJR)
Phase 2
Ready
LTSE-2578
(Oral LPA1R)
Phase 1 Data
2H 2025
Phase 1 Start
June 2024
Selective Weight Loss Preclinical Validation
2H 2025
Obesity
Phase 2 Initiation
2025
~$436.4 million in cash1 as of 3/31/2024 expected to fund operations through 2026
1. Cash includes cash, cash equivalents and short-term investments
Oral
AmylinR
Oral
GCGR
2H 2024 2026
Phase 3 Start
2026
Phase 1 Start
2H 2025
Phase 1 Data
2026
Phase 1 Start
1H 2026
Development
Candidate
1H 2025
Development
Candidate
1H 2026
Lead Optimization
Lead Optimization
Hits Lead Optimization
Hits
Hits
Discovery
IPF SAD/MAD
Selective Weight Loss Clinical Study
Phase 2b Data
Q4 2025
Phase 2b Obesity
Start Q4 2024
Development
Candidate
Q4 2024
IND
Submission |
![GRAPHIC](https://www.sec.gov/Archives/edgar/data/1888886/000110465924067483/tm2414821d7_ex99-2img031.jpg)
| 31
Thank you
ir@structuretx.com
www.structuretx.com |
v3.24.1.1.u2
Cover
|
Jun. 03, 2024 |
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