TechandBio
1 month ago
Programs
Denifanstat – Our Lead Product Candidate in Multiple Indications
Denifanstat, our lead product candidate, is an oral, once daily pill and selective fatty acid synthase (FASN) inhibitor in development for the treatment of MASH. FASN is the key enzyme in the de novo lipogenesis (DNL) pathway that converts metabolites of dietary sugars such as fructose into palmitate, a saturated fatty acid.
Denifanstat was selected from our extensive compound library after a rigorous medicinal chemistry and preclinical development effort. We received Fast-Track designation for denifanstat from the FDA for the treatment of MASH in March 2021. In October 2024, the FDA granted Breakthrough Therapy designation to denifanstat for the treatment of noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Denifanstat has been studied in more than 740 subjects, including healthy volunteers and patients with MASH, acne and solid tumors.
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
MASH is an aggressive form of fatty liver disease characterized by an abnormal build-up of excess fat in the liver, inflammation and fibrosis along with systemic metabolic changes including dyslipidemia and insulin resistance. Left untreated, the liver becomes cirrhotic and even cancerous with time. The damage can also exacerbate a spectrum of other health problems including cardiovascular diseases, obesity, type 2 diabetes and metabolic syndrome. MASH is a growing epidemic that affected more than 265 million people worldwide in 2019. Currently, there is ! approved treatments in the United States none Europe.
We believe that denifanstat is differentiated among drug candidates in development for MASH due to its ability to directly target hepatocytes, inflammatory cells and stellate cells in the liver.
We announced positive topline results from FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, in January 2024. FASCINATE-2 was a Phase 2b clinical trial of denifanstat in biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) patients with moderate to advanced fibrosis (F2/F3) at week 52. In this trial, denifanstat, an oral, selective FASN inhibitor, showed statistically significant improvements relative to placebo on both of the primary endpoints of MASH resolution without worsening of fibrosis with =2-point reduction in NAS, and =2-point reduction in NAS without worsening of fibrosis. Denifanstat-treated patients also showed statistically significant fibrosis improvement by = 1 stage with no worsening of MASH, and a greater proportion of MRI-derived proton density fat fraction (MRI-PDFF) =33% responders relative to placebo.
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Combination Potential and Other MASH Indications/color]
Based on its proposed mechanism of action, oral administration and tolerability profile to date, we believe denifanstat has the potential to be a backbone monotherapy as well as improve clinical activity in combination with a broad set of other drugs GLP1 THR Beata . We presented clinical data at EASL in 2024 for two models of MASH, showing that the combination of a FASN inhibitor (TVB-3664, A surrogate for denifanstat) and the thyroid hormone receptor beta (THRb) agonist, resmetirom, had a synergistic effect on important liver disease markers, including improvement of NAS by histologic analysis and more robust improvement in hepatic collagen content compared to the single agents. Synergistic activity of the combination was demonstrated in the rate of histological improvement (NAS =2 points). The SGMT FASN inhibitor monotherapy showed 33% improvement,Much higher statistically compared to MDGL Resmetirom monotherapy showed 25% improvement, and the combination of the two showed an 80% improvement, a level of improvement that greatly exceeds a simple addition of the activity of the two drugs. We believe combination therapy has the potential to play a game changing role in the MASH treatment paradigm to effectively address all patient segments.
In the second half of 2025, subject to consultation with regulatory authorities, we plan to initiate a Phase 1 clinical trial to evaluate the pharmacokinetics?(PK) and tolerability of a combination of denifanstat and resmetirom with an anticipated data readout in the first half of 2026. We anticipate building on the outcome of this Phase 1 clinical PK trial, if positive, to develop a combination product for MASH patients.
Given the disease complexity as well as the heterogeneity and large size of the MASH patient population, we intend to study denifanstat in other MASH indications such as cirrhotic (F4) MASH and pediatric MASH to maximize its full clinical and commercial potential.
Acne, Many Oncology Indications-The magnitude of this oral molecule is spectacular!
Acne is the most common skin condition in the United States, affecting up to 50 million Americans annually. Acne is a promising therapeutic area for application of FASN inhibitors because FASN is required for sebum production, which is upregulated in acne and leads to exacerbation of acne lesions including development of nodules and cysts. In two Phase 1 clinical studies, denifanstat reduced overall sebum production, including palmitate and sapienic acid lipids.
TVB-3567
Our second FASN inhibitor, TVB-3567, is a potent and selective small molecule FASN inhibitor, planned to enter clinical development for the treatment of acne. TVB-3567 showed potent FASN inhibitory activity based on inhibition of palmitate synthesis in human, rat, mouse, and dog cell lines; a single dose of TVB-3567 inhibited palmitate synthesis in a rat model. These studies include the standard suite of IND-enabling, GLP-compliant safety pharmacology and genotoxicity studies, and GLP-compliant general toxicology studies of up to four weeks treatment duration Trialed with Novo Ozempic
In March 2025, we announced the clearance of our Investigational New Drug (IND) application for a first-in-human Phase 1 clinical trial of TVB-3567. The IND clearance allows us to initiate a first-in-human Phase 1 clinical trial of TVB-3567 for development of an acne indication, which we expect to initiate in the second half of 2025. The planned Phase 1 clinical trial will be a randomized double-blind placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TVB-3567 in healthy participants with or without acne. The trial is expected to be comprised of several parts, including single ascending dose cohorts and multiple ascending dose cohorts in participants without acne, followed by testing in participants with acne including evaluation of pharmacodynamic biomarkers.
Ongoing Phase 3 Clinical Trial in Acne
In May 2023, our license partner, Ascletis, announced positive topline results with the achievement of primary and key secondary endpoints in a Phase 2 randomized, double-blind, placebo-controlled clinical trial in 179 patients with moderate to severe acne vulgaris in China. Denifanstat is currently being tested by Ascletis in a Phase 3 clinical trial in China for moderate to severe acne vulgaris. In November 2024, Ascletis announced completion of enrollment of 480 patients in its acne Phase 3 clinical trial and that it expects to announce topline results in the second quarter of 2025.
Vast Oncology Pipeline
Dysregulation of lipid metabolism is a hallmark of certain cancers. Increased expression of FASN has been associated with poor prognosis and reduced survival in tumor cell types. Several cancer types have been shown to upregulate FASN to rewire lipid metabolism and change the nature of the tumor cell membrane making these cells resistant to traditional cancer drugs. FASN inhibition can also potentially address the enormous challenge of resistance to cancer therapies.
We completed a Phase 1 clinical trial with denifanstat in 136 patients with advanced, heavily pretreated and mostly metastatic solid tumors, which demonstrated clinical activity in defined patient populations and provides the foundation for future clinical development.
Our strategy is to evaluate denifanstat either alone or in combination with other classes of oncology drugs in specific subsets of solid tumors that are FASN-dependent.
These include:
Glioblastoma – Denifanstat is currently being tested in a Phase 3 clinical trial in glioblastoma (GBM), by Ascletis, our license partner in China. In September 2023, Ascletis announced the enrollment of 120 recurrent GBM patients in its Phase 3 GBM trial, which it expects will provide a sufficient basis for its planned interim analysis of the Phase 3 trial.
Metastatic castration resistant prostate cancer, FASN-dependent –– Investigator-sponsored Phase 1 clinical trial of denifanstat in combination with enzautamide therapy ongoing.
Hepatocellular carcinoma FASN-dependent – Positive preclinical combination with kinase inhibitors, supported by translational bioinformatics.
Non-small cell lung cancer/KRAS mutation – Positive preclinical combination results with KRAS inhibitor, encouraging results observed in patients with NSCLC KRASM tumors enrolled in a Phase 1 clinical trial in patients with solid tumors.
Pediatric Mash Nearing Phase 2 Ready.
MDGL 6.5 Billion Market cap molecule is no where is effective or as versatile as SGMT
AKRO 3.5 Billion IV route again no where is versatile more side effects and SGMT is oral and the data is showing more effectiveness as the Data matures for SGMT
SGMT market cap 110 Million 150 Million in cash small burn rate and 15 employees and one of the best Board of directors for a company its size including Tim Walbert founder of Horizon which sold to AMGN for 28 Billion and Horizon CFO Paul Hoelscher
Multiple Partnerships and other catalysts near term!
CFO for SGMT:
Mr.Thierry Chauche brings to Sagimet more than twenty years of financial, strategic planning, and corporate leadership experience in finance and biopharma companies. Most recently he served as Chief Financial Officer of Provention Bio, a publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including Type 1 Diabetes, where he built up and led finance, investor relations, and information technology teams supporting market creation and a transformational therapeutic launch and commercialization. At Provention, he also focused on the successful execution of several financings, and an M&A strategy leading to a $2.9B Billion acquisition of the company by Sanofi. Before Provention Bio, Mr. Chauche was the Vice President and Head of Strategic Financial Planning & Analysis at Alexion Pharmaceuticals. Prior to Alexion Pharmaceuticals, he served in roles of increasing responsibility at Novartis, and Rothschild & Cie. Mr. Chauche holds an MBA from the Wharton School at the University of Pennsylvania, and a MS in engineering from Ecole des Ponts ParisTech in Paris, France. Provention Bio was the Highest Premium in Biotech history for a company just north of Billion dollars when it was sold to Sanofi
GSK just bought Boston Pharma for 1.2 Billion in cash and another 800 million in milestone payments for a Mash asset that did not have a FDA Break through designation like SGMT for their Phase 3 ready asset.
Strong IP, Cash Position, and Collaboration Potential.
$SGMT
TechandBio
1 month ago
SGMT CFO last gig Provention Bio stock ascended mid $3.00's to the $25.00= 2.9 Billions sale to Sanofi within a few years of Thierry joining Provention Bio he has been at SGMT about year. Deals take some time. The timing of signaling from the company less than 24 hours of the announcement of GSK buying MASH 2A asset for 2 Billion without Break through designation is telling.
There is one drug Madrigals resmetirom shows 25% improvement alone
SGMT shows 33% improvement combined and now that SGMT has the IP through 2048 for the combo tablet
SGMT FASN inhibitor the only fat synthesis monotherapy showed 33% improvement, resmetirom monotherapy showed 25% improvement, and the combination of the two showed an 80% improvement, a level of improvement that greatly exceeds a simple addition of the activity of the two drugs. Building on this combination data, subject to consultation with regulatory authorities, Sagimet plans to initiate a Phase 1 clinical trial to evaluate the PK of a combination of denifanstat and resmetirom in the second half of 2025, with an anticipated data readout in the first half of 2026. If the outcome of this Phase 1 clinical PK trial is positive, Sagimet anticipates exploring the development of a combination product for MASH patients.
Denifanstat:
• Method of use patent—2036; potential PTE to 2041
• Combination of denifanstat and resmetirom (Madrigal)
• Application filed 2024; if granted—2044; potential PTE to 2048
• TVB-3567:
• Method of use application for TVB-3567 for acne filed 2025; if granted—2046
Biotech
GSK pays $1.2B upfront for Boston Pharmaceuticals' lead MASH liver disease drug.
By Ben Adams
May 14, 2025 2:53am
Treatments that receive Breakthrough Therapy designation must target a serious or life-threatening disease and preliminary clinical evidence must indicate that the drug may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints.
“The FDA’s Breakthrough Therapy designation for denifanstat underscores the global incidence of MASH and the continuing need for new therapies,” said David Happel, Chief Executive Officer of Sagimet. “As the only fat synthesis inhibitor that directly targets the three main drivers of MASH— fat accumulation, inflammation, and fibrosis— we believe denifanstat is well-positioned to offer a leading treatment option for patients living with MASH.”
Treatments that receive Breakthrough Therapy designation must target a serious or life-threatening disease and preliminary clinical evidence must indicate that the drug may demonstrate a substantial improvement over existing therapies on one or more clinically significant endpoints. Drugs that receive Breakthrough Therapy designation are eligible for all the benefits of Fast Track designation, as well as intensive guidance by FDA on an efficient drug development program and organizational commitment involving FDA senior managers.
$SGMT
TechandBio
1 month ago
I keep adding shares 19,759 Friday.
GSK pays $1.2B upfront for Boston Pharmaceuticals' lead liver disease drug
By Ben Adams May 14, 2025 2:53am
https://www.fiercebiotech.com/biotech/gsk-pays-12b-upfront-boston-pharmaceuticals-lead-liver-disease-drug
Phase 2A sells for 1.2 Billion in cash with 800 million in milestones. GSK for Boston Mash asset GSK pays $1.2B upfront for Boston Pharmaceuticals' lead liver disease drug Phase 2A Injectable no break through designation.
SGMT has oral drug 3100 patient two phase 3's with break through designation. where the data is much better than MDGL current approved drug
I think blockbuster comes from MASH stand alone & or GLP1/Mash combos will be the future treatments with Fasn/obesity
The oncology platform is being overlooked as well. Also Acne where milestone payment comes in soon.
My guess Thierry the CFO came on last year with laser like focus to negotiate a deal sure multiple parties are interested in the single asset and the whole company. I hope they sell it to large pharma with deep pockets. or Merge with Madrigal & pay SGMT shareholders 30.00-40.00 =roughly a billion too SGMT shareholders probably get MDGL shares in exchange. The SGMT platform is vast maybe AMGN with Walbert and Beth Link come in and scoop up the monotherapy Mash including pediatric indications or the whole company. Time will tell. LLY or NOVO, Gilead are great suitors as well.
the 2048 patent for the single combo tablet of Deny/Resmetirom is worth Billions the data is off the charts. 80% efficacy much higher in combo then either drug alone.
The other option is MDGL & SGMT both get bought soon possibly to the same suitor.
I wonder if we get toxicology studies on Pedatric Mash soon that is phase 2 Ready after the tox studies are validated that also seemed to disappear off the SGMT website lots of moving parts here. did a negotiating party insists in good faith to withdraw the Mash Phase 3 Trial so another company takes it over with Pediatric Mash children Mash market has to be enormous 20% of the kids today are obese.
Website now has a focus of a full biotech pharmaceutical company vast array of tumors Mash Obesity & Acne their looking to bringing the first Acne oral medication to market in the last 50 years. The combo markets have unlimited potential.
The acne therapeutics market in China is a significant and growing market, with projections indicating substantial growth in the coming years. China's acne market is the largest in the Asia-Pacific region and is experiencing growth driven by factors such as increasing healthcare expenditure, rising awareness about skin health, and the adoption of advanced acne treatments.
Market Growth and Trends:
Projected Growth:
The China acne therapeutics market is projected to grow from $806 million in 2022 to $1.5 Billion by 2030,
2048 patent for the single combo tablet of Deny/Resmetirom is worth Billions the data is off the charts. 80% efficacy much higher in combo then either drug alone.
The other option is MDGL & SGMT both get bought soon possibly to the same suitor.
Website has a focus of a full biotech pharmaceutical company vast array of tumors Mash Obesity & Acne their looking to bringing the first Acne oral medication to market in the last 50 years. The combo markets have unlimited potential.
Nice Milestone payments will start to come in for SGMT making it a revenue generating company and proving the versatility of the molecule you will also see approval for the GBM cancer indication which will again prove validity of the cancer platform beyond liver cancer making this a sought after company as its tentacles start to envelope a vast platform of a Ketyruda & or ivonescimab from Summit Therapeurics which is a 18 Billion dollar company and Merck market cap 190 Billion.
Sagimet's lead drug candidate, which is under development, is called denifanstat. It is an oral, once-daily pill and selective FASN (fatty acid synthase) inhibitor. Denifanstat is being developed for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Additionally, Sagimet is developing another FASN inhibitor, TVB-3567, for the treatment of acne & myriad of cancer indications that will include dozens of cancer indications and will become a blue chip combo for oncology and stand alone first level treatment potential with Mash & Acne the Trillion dollar market that will show the greatest efficacy and safety will be the Obesity Combo drug with SGMT denifanstat which has already been validated with their GLP1/ FASN data with Novo Nordisk Semaglutide is an FDA-approved medication used to treat type 2 diabetes and obesity. It is marketed under the brand names Ozempic (for diabetes) and Wegovy (for obesity)
They Key is the CFO Thierry Chauche who has a proven track record of record breaking success inking the highest premium for a Billion dollar market cap from last day before the deal announced with GSK for provention Bio for 2.9 Billion in 2023 and then leading ALXN a 40 Billion biotech for many years. Things are getting very interesting with a lot moving pieces on Phase 3's and pediatric Mash signals some sort of agreement was made with another company to make some moves before the I's get dotted and T's get get crossed on a some type of deal for Mash assets or the whole company break through designation oral pill that showed results in another league compared to MDGL drug breakthrough means that the drug can be approved after 52 weeks 1 year even though the data will continue to mature for 2 more years validating the molecule even more as they believe it will show more efficacy than other Mash drug in the clinic or on the market.
Recap GSK pays $1.2B upfront for Boston Pharmaceuticals phase 2A' lead liver disease drug that sold that is an injection earlier this week.
we know what phase 3 ready trial with 3100 Patients for f-2 f3 patients is worth with break through designation is worth now!
MDGL market cap 6.5 Billion
AKRO market cap 3.1 Billion
SGMT market cap 105 Million (superior drug that is much more versatile than Madrigal & Akeros pipelines!
$SGMT
TechandBio
1 month ago
Think Keytruda 2.0 Ivonescimab in Oral form it will be a blockbuster stand alone + blockbuster combo oral drug for a myriad of applications in oncology obesity + more. 10-20 Billion market cap potential and potential unicorn status 100 Billion dollar plus conglomerate in the making!
The size of the market cap today you potentially can see a this stock grow 10,000%- upside from these levels.
Combination of denifanstat and resmetirom:
• Application filed 2024; if granted—2044; potential PTE to 2048
This can go straight to registartional trial or pivotal trial after a phase 1 with FDA approved drug and & drug that has been tested with biopsy on nearly 800 patients in a phase 2B
Remember RGLS just got bought after phase 1 data the data is so compelling it works 200% more effective in combo than madrigals drug alone also the combo with sgmt drug with GLP1 has similar synergistic effects with a market size much bigger.
Semaglutide is a medication that belongs to a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists
. It's available under different brand names, including Ozempic (for type 2 diabetes) and Wegovy (for weight loss)
This is combo sgmt fat synthesis & fat burner GLP1 is ready also ready for human trial I would think Madrigal wants in on the obesity game as well but logic tells me a company with deeper pockets will want the asset. Remember SGMT has one of the best CFO Thierry who inked provention bio deal for 2.9 Billion and was CFO at ALXN 40 billion dollar blue chip biotech co in the biotech industry to get a deal done with multiple suitors lets see how this plays out!
What makes SGMT invaluable is that they have the only fat synthesis oral molecule in the clinic with a deep vast pipeline.
https://ir.sagimet.com/events-and-presentations
Our strategy is to evaluate denifanstat either alone or in combination with other classes of oncology drugs in specific subsets of solid tumors that are FASN-dependent.
These include:
Glioblastoma – Denifanstat is currently being tested in a Phase 3 clinical trial in glioblastoma (GBM), by Ascletis, our license partner in China. In September 2023, Ascletis announced the enrollment of 120 recurrent GBM patients in its Phase 3 GBM trial, which it expects will provide a sufficient basis for its planned interim analysis of the Phase 3 trial.
Phase 3 ongoing
In China by Ascletis, denifanstat combination with bevacizumab
Positive investigator sponsored Phase 2 results*
Phase 3 enrollment of 120 patients achieved in 3Q2023
Type Status
Phase 1 ongoing
Investigator Sponsored at Weill Cornell, denifanstat combination with enzalutamide
Phase 1 results expected 4Q2025
Translational work ongoing
Patient selection strategy by bioinformatics on primary samples
Positive preclinical combination results**
Phase 2-ready
Preclinical and clinical evidence
Positive preclinical combination with KRAS inhibitor***
Encouraging monotherapy Phase 1 results with denifanstat
Phase 2-ready
Metastatic castration resistant prostate cancer, FASN-dependent –– Investigator-sponsored Phase 1 clinical trial of denifanstat in combination with enzautamide therapy ongoing.
Pediatric Nash Phase 2 Ready:
Hepatocellular carcinoma FASN-dependent – Positive preclinical combination with kinase inhibitors, supported by translational bioinformatics.
Non-small cell lung cancer/KRAS mutation – Positive preclinical combination results with KRAS inhibitor, encouraging results observed in patients with NSCLC KRASM tumors enrolled in a Phase 1 clinical trial in patients with solid tumors.
Evaluation of FASN inhibitor & GLP-1 Combination in Obesity 100x larger than Mash
clinical NASH Mouse Model
Wen-Wei Tsai
Director, R&D
Nov. 28, 2023
7th Obesity and NASH Drug Development Summit
who ever they where in talks with probably wants to take full control of the trial for phase 3's its very valuable with a break through designation GSK paid 1.2 Billion and 800 Million in milestone for a phase 3 ready Mash asset injection with no break through designation.like SGMT has from the FDA
Deal Implications:
Companies might remove a trial listing if they've entered into a deal with another company that involves transferring the trial
AI Overview
Yes, the removal of a Phase 3 trial from the FDA website could potentially indicate that a deal or a change in the trial's status.
$SMMT
$SGMT
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