1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Valuation
Discussion
Symbol
THRD
Event Date
2022-09-15
IPO Date (Actual)
2022-09-08
Sector
Health Care
Subsector
Pharmaceuticals
Offer Range
$17.00
Shares Offered
10.9M
40.32M
$657.8M
27.0%
Implied Upside vs Midpoint
Description
We are a clinical-stage biopharmaceutical company focused on the development of the next wave of medicine for the treatment of allergic and inflammatory diseases. Our lead product candidate, THB001, is a highly selective, oral small molecule inhibitor of KIT, a cell surface receptor that acts as the master survival and functional regulator of mast cells. Mast cells are a part of the immune system, and dysfunctional mast cell activity has been implicated in the pathophysiology of a broad range of allergic and other inflammatory disorders including urticaria, asthma and gastrointestinal disorders, among others. KIT inhibition has shown positive clinical responses in mast cell mediated diseases such as asthma and chronic urticaria. In our recently completed Phase 1a clinical trial, THB001 demonstrated dose-dependent reductions of serum tryptase, a key biomarker of mast cell activity which has been shown to correlate with clinical benefit in chronic urticaria patients. We submitted a clinical trial application, or CTA, in Europe for our dose escalation Phase 1b proof-of-concept trial in chronic inducible urticaria in May 2022, initiated the trial in September 2022, and expect to report initial data from this trial in the second half of 2023. We also intend to submit a CTA to support initiation of a Phase 1b trial in asthma in the first half of 2023 and expect to report initial data from this trial in the second half of 2024. We intend to submit both a CTA in Europe and an investigational new drug application, or IND, in the United States to support initiation of a Phase 2 trial in chronic spontaneous urticaria in the first half of 2024. We are also exploring development opportunities across a range of other indications where THB001 may provide benefit to patients suffering from mast cell driven inflammation to demonstrate the “pipeline-in-a-product” potential of THB001. Mast cells are a main driver of allergic inflammatory responses. They are present throughout the body in connective and vascularized tissues, most prominently along surface boundaries with exposure to the external environment: in the skin, the respiratory tract and the gastrointestinal tract. For many patients suffering from allergic conditions, inhibition of mast cell derived mediators, including histamines, leukotrienes, and prostaglandins, has demonstrated insufficient therapeutic value to-date given that many mast cell-driven disorders involve multiple pro-inflammatory mediators. As a result, we believe that targeting mast cells directly through highly selective inhibition of KIT is key to achieving the clinical efficacy needed for broad symptomatic relief across a range of allergic and other inflammatory disorders. Since KIT is a cell surface receptor that acts as the master regulator of mast cell function and survival, our approach impacts mast cells directly and provides what we believe to be a favorable point of intervention. Furthermore, significant clinical and nonclinical data has been generated internally and by third parties that demonstrate that KIT is a potential target for broad and potentially clinically differentiated inhibition of mast cells. For example, an anti-KIT antibody demonstrated compelling clinical responses in chronic inducible urticaria patients in a third-party Phase 1 trial. Our lead product candidate THB001 is a potent and highly selective, oral small molecule wild-type KIT inhibitor in development for the treatment of mast cell mediated inflammatory diseases. In nonclinical studies, THB001 demonstrated what we believe to be evidence of highly selective KIT inhibition and mast cell depletion in skin, respiratory and gastrointestinal tissues with a potent therapeutic profile. We believe that chronic inducible urticaria represents an attractive initial clinical indication for THB001 as a precursor for chronic spontaneous urticaria, given the ability to efficiently evaluate clinical activity outcomes through provocation testing, in concert with biomarker measures of mast cell activity and safety data. Our goal is to be a leader in the oral KIT inhibitor space, and we continue to invest in formulation and discovery for next generation molecules. In addition to initially developing THB001 for treatment of chronic urticaria, we are exploring THB001 as a potential treatment for other indications where mast cell dysfunction plays a key role. In our recently completed Phase 1a trial in healthy volunteers, we have observed dose dependent increases in THB001 serum concentration levels above the protein binding adjusted KIT cellular IC50 value. As signs of the potential efficacy of THB001, we observed that dose levels of 200 mg once daily, or QD, 200 mg twice daily, or BID, and 400 mg BID resulted in dose dependent declines in serum tryptase. The twice daily dose at the 400 mg level of THB001 resulted in a decreased mean serum tryptase level that was at the lower limit of quantification. Reductions in serum tryptase have been associated with a robust clinical response in a clinical trial of an anti-KIT antibody in chronic inducible urticaria patients conducted by a third party. Furthermore, THB001 was well-tolerated, with no serious adverse events, or SAEs, in the trial to-date. We submitted a CTA in Europe for our dose escalation Phase 1b proof-of-concept trial in chronic inducible urticaria in May 2022, which has been cleared in the Netherlands and Germany. We initiated the trial in September 2022, and expect to report initial data from this trial in the second half of 2023. We also intend to submit a CTA to support initiation of a Phase 1b trial in asthma in the first half of 2023 and expect to report initial data from this trial in the second half of 2024. We intend to submit both a CTA in Europe and an IND in the United States to support initiation of a Phase 2 trial in chronic spontaneous urticaria in the first half of 2024. There remains a large unmet need in chronic urticaria. Epidemiological studies indicate that up to 25% of the population suffers from urticaria at some point in their lifetime, with 0.5-1% of the population suffering from the disease at any point in time, suggesting a point prevalence of over 1.5 million patients in the United States. Approximately 70% to 80% of patients with urticaria are women. Many patients are first provided H1 antihistamine therapy when diagnosed with urticaria; however, there remains a large unmet need. Approximately 50% of chronic spontaneous urticaria patients continue to experience itch and hives despite H1 antihistamine treatment at FDA-approved doses. There have been no new approved therapies to treat chronic urticaria in eight years, and the most recently approved treatment, the injectable biologic Xolair, provided complete hive and itch symptom relief to approximately 36% of patients in clinical trials. We believe Xolair is currently addressing less than 20% of eligible patients whose symptoms have failed to be controlled by H1 antihistamine therapy. There is a clear unmet need for chronic urticaria treatments that provide higher levels of complete hive and itch symptom relief, while also providing improved patient comfort and convenience via an oral route of administration. We believe an oral therapy offers clear advantages over an injectable therapy, and an oral therapy with the potential to improve upon the results of the existing standard of care offers a significant opportunity to address a large unmet need. While the potential market opportunity within urticaria alone is vast, dysfunctional mast cell activity has also been implicated in the pathophysiology of a broad range of allergic and other inflammatory disorders, including respiratory and gastrointestinal disorders. Furthermore, in nonclinical studies, THB001 has demonstrated the ability to deplete mast cells across different tissue types, which we believe supports its ability to potentially treat a range of mast cell mediated skin, respiratory and gastrointestinal conditions supporting our ultimate goal of THB001 achieving its potential as a “pipeline-in-a-product.” The table below reflects our initial targeted indications for THB001. --- We were incorporated under the laws of the State of Delaware on April 25, 2019, originally under the name Project Ige, Inc. We changed our name on June 28, 2019 to Third Harmonic Bio, Inc. Our principal executive offices are located at 300 Technology Square, 8th Floor, Cambridge, Massachusetts 02139, and our telephone number is (617) 915-6680. Our website address is www.thirdharmonicbio.com.
Third Harmonic Bio, Inc. annual income statement and balance sheet, FY 2021 to FY 2024, as reported in SEC filings.
| Metric | FY 2021 | FY 2022 | FY 2023 | FY 2024 |
|---|---|---|---|---|
| Operating income | ($19.0M) | ($37.7M) | ($44.0M) | ($58.9M) |
| Net income | ($29.6M) | ($35.2M) | ($30.8M) | ($45.5M) |
| Metric | FY 2021 | FY 2022 | FY 2023 | FY 2024 |
|---|---|---|---|---|
| Total assets | $129M | $299M | $278M | — |
| Total liabilities | $5.7M | $9.6M | $8.6M | — |
| Total equity | ($46.7M) | $289M | $269M | — |
| Cash & equivalents | $128M | $289M | $269M | — |