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. Metrics vs Peers
3. Price Chart
4. Valuation
5. Offer Terms
6. Financial Statements
Discussion
Research report, target price, DCF and forensic scores are for subscribers. View plans
Symbol
NUVL
Listed on
2021-07-29
Sector
Health Care
Subsector
Pharmaceuticals
Offer Price
$17.00
first filed $16.00–$18.00Shares Offered
9.15M
46.82M
$796.0M
19.5%
Implied Upside vs Midpoint
Description
We are a preclinical stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer. We focus our discovery efforts on small molecule inhibitors of kinases, a class of cellular targets that can play a central role in cancer growth and proliferation. In particular, we focus on “clinically proven” kinase targets, or those for which therapies have been developed by others to target those kinases, and that such drugs have demonstrated sufficient clinical efficacy and safety data to be approved by the United States Food and Drug Administration, or FDA, or similar regulatory agency and are established and used in the clinical setting. We leverage our team’s deep expertise in chemistry and structure-based drug design to develop innovative small molecules that are designed to overcome the limitations of those existing therapies. These limitations can include kinase resistance, or the emergence of new mutations in the kinase target that can enable resistance to existing therapies, kinase selectivity, or the potential for existing therapies to inhibit other structurally similar kinase targets and lead to off-target adverse events, and limited brain penetrance, or the ability for the therapy to treat disease that has spread or metastasized to the brain. By prioritizing target selectivity, we believe our drug candidates have the potential to overcome resistance, minimize adverse events, optimize brain penetrance to address brain metastases, and drive more durable responses. We are advancing a robust pipeline of product candidates with parallel lead programs in cancers driven by genomic alterations in the ROS1 and ALK kinases (i.e., ROS1-positive and ALK-positive, respectively), along with multiple discovery-stage research programs. All of our programs are currently preclinical, and we plan to initiate our first clinical trial in the second half of 2021. Our first lead product candidate, NVL-520, is a brain-penetrant ROS1-selective inhibitor, designed to inhibit ROS1 fusions that express the normal ROS1 kinase domain without any drug-resistant mutations (“wild-type ROS1”) and also remain active in the presence of mutations conferring resistance to approved and investigational ROS1 inhibitors. We have submitted an IND for NVL-520 and the FDA has confirmed that clinical investigation of NVL-520 may proceed. We plan to initiate a first-in-human clinical trial investigating NVL-520 in ROS1-positive non-small cell lung cancer (“NSCLC”) and other advanced solid tumors in the second half of 2021. We have designed our planned first-in-human trial for NVL-520 as a “Phase 1/2 trial” under a combined clinical trial protocol, which includes both a Phase 1 and Phase 2 portion. The Phase 1 dose escalation portion has the potential to transition directly into a Phase 2 multiple cohort expansion portion once a safe and tolerable dose is determined as the recommended Phase 2 dose (“RP2D”). We also plan to conduct an End of Phase 1 meeting with the FDA. The Phase 2 portion of the study is a multiple cohort study, with some cohorts designed to support potential application for registration. Our second lead product candidate, NVL-655, is a brain-penetrant ALK-selective inhibitor, designed to inhibit ALK fusions that express the normal ALK kinase domain without any drug-resistant mutations (“wild-type ALK”) and also remain active in the presence of mutations conferring resistance to first-, second-, and third-generation ALK inhibitors. IND-enabling studies are ongoing and, subject to discussions with and feedback from the FDA, initiation of a first-in-human clinical trial investigating NVL-655 in ALK-positive NSCLC and other advanced cancers is planned for the first half of 2022. Within the past decade, the increase in the utilization of cancer genomic profiling has resulted in the identification of specific genomic alterations, such as ROS1 fusions and ALK fusions, that can drive the growth and proliferation of a tumor. The successful development of targeted therapies matched to individual genomic alterations has given rise to the current era of precision oncology, where treatment decisions driven by the genomic profile of a patient’s cancer are increasingly becoming the standard of care. In particular, kinase inhibitors have fueled the targeted therapy revolution and remain at the leading edge of precision oncology. However, the clinical utility of currently approved kinase inhibitors is limited by three key challenges: kinase resistance, kinase selectivity, and, for some tumor types, limited central nervous system (“CNS”) activity. Our approach is to create innovative molecular structures and nominate product candidates that have the potential to overcome the limitations of existing therapies for clinically proven kinase targets. Our structures are designed to precisely engage the target kinase and remain active in tumors that have developed resistance, enabling our product candidates to treat both the original tumor and tumors with emergent resistance mutations. In addition, we prioritize structures that are highly selective for their target kinases in order to minimize adverse events and drive durable responses. Where appropriate, we optimize for brain penetrance to improve treatment options for patients with brain metastasis. By addressing the limitations of existing therapies, we believe our programs have the potential to drive deeper, more durable responses with minimal adverse events. We believe these potential benefits will support opportunities for clinical utility earlier in the treatment paradigm. --- Nuvalent, Inc. was incorporated under the laws of the State of Delaware on January 25, 2017 and commenced significant operations in 2018. Our principal corporate office is located at One Broadway, 14th Floor, Cambridge, MA 02142, and our telephone number is (857) 357-7000. Our website address is www.nuvalent.com.
| Metric | Value | Peer median | Among peers | |
|---|---|---|---|---|
Net cash / market cap | 1.3% | 5.0% | ||
Debt / equity | 0.00 | 0.00 | ||
Current ratio | 2.43 | 7.37 | ||
9 premium metrics: DCF value / price, Growth the price needs: how common, Last 12 months vs full year and 6 more Unlock | ||||
= Priced at $17.00, 0% above the midpoint of the first filed range ($16.00–$18.00, 2021-07-26).
Each filing is plotted ahead of the first trading day on the price chart.
| Filed | Form | Price range | Price | Shares offered | Deal size |
|---|---|---|---|---|---|
| 2021-07-26 | S-1/A | $16.00–$18.00 | — | 8,900,000 | $151.3M |
| 2021-07-30 | 424B4 | — | $17.00 | 9,750,000 | $165.8M |
Nuvalent, Inc. income statement and balance sheet, FY Dec 2022 to FY Dec 2025, as reported in SEC filings.
| Metric | FY Dec 2022after listing | FY Dec 2023after listing | FY Dec 2024after listing | FY Dec 2025after listing |
|---|---|---|---|---|
| Operating income | ($86.1M) | ($149M) | ($280M) | ($414M) |
| Net income | ($81.9M) | ($126M) | ($261M) | ($425M) |
| Metric | FY Dec 2022after listing | FY Dec 2023after listing | FY Dec 2024after listing | FY Dec 2025after listing |
|---|---|---|---|---|
| Total assets | $482M | — | $1.1B | $1.4B |
| Total liabilities | $19.5M | — | $72.0M | $164M |
| Total equity | $463M | $701M | $1.1B | $1.2B |
| Cash & equivalents | $242M | $335M | $146M | $262M |