# Cullinan Therapeutics, Inc. (CGEM)

Informational only - not investment advice.

CIK: 0001789972
SIC: 2836 Biological Products, (No Diagnostic Substances)
SIC breadcrumb: [Manufacturing](/division/D/) > [Chemicals And Allied Products](/major-group/28/) > [SIC 2836 Biological Products, (No Diagnostic Substances)](/industry/2836/)
Latest 10-K filed: 2026-03-10
SEC page: https://www.sec.gov/edgar/browse/?CIK=1789972
Filing source: https://www.sec.gov/Archives/edgar/data/1789972/000119312526099362/cgem-20251231.htm

## At a glance

No standardized annual SEC companyfacts metrics were extracted for this company; the at-a-glance panel is omitted rather than estimated.

No market price, no rating, no forecast on this site. Not investment advice.

### Peer percentile fingerprint

| Ratio | CGEM | Peer median | Percentile | N |
| --- | ---: | ---: | ---: | ---: |
| ROE | -53.8% | -38.7% | 41 | 60 |
| ROA | -49.0% | -30.4% | 22 | 66 |
| Liabilities / equity | 0.10 | 0.38 | 15 | 62 |
| Current ratio | 10.25 | 5.52 | 77 | 66 |

Percentile = share of the N covered peers reporting that ratio whose value is lower (ties counted half); computed among grepcent-covered companies in SIC industry 2836 Biological Products, (No Diagnostic Substances), not the whole market. A higher percentile means a higher value of the ratio, not a better company. Ratios with fewer than 8 reporting peers are omitted. Latest reported values per company; fiscal periods may differ. Descriptive arithmetic - not a score, rating, or ranking.

## Selected Fundamentals
| Metric | Value | Unit | FY | Filed |
| --- | ---: | --- | ---: | --- |
| Net income | -219879000 | USD | 2025 | 2026-03-10 |
| Assets | 448374000 | USD | 2025 | 2026-03-10 |

## Financials

Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-03-10. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001789972.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.

| Metric | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Net income |  | -51,799,000 | -65,570,000 | 111,214,000 | -153,162,000 | -167,383,000 | -219,879,000 |
| Operating income |  | -60,335,000 | -67,954,000 | 144,648,000 | -191,089,000 | -196,919,000 | -241,648,000 |
| Operating cash flow |  | -29,772,000 | -43,433,000 | -126,664,000 | -134,275,000 | -145,303,000 | -175,750,000 |
| Capital expenditures |  | 10,000 | 0.00 | 1,133,000 | 208,000 | 0.00 | 49,000 |
| Assets |  | 214,708,000 | 437,185,000 | 561,117,000 | 484,182,000 | 621,824,000 | 448,374,000 |
| Liabilities |  | 14,394,000 | 11,811,000 | 26,088,000 | 30,287,000 | 31,496,000 | 39,644,000 |
| Stockholders' equity | 97,001,000 | 199,010,000 | 424,971,000 | 535,029,000 | 453,703,000 | 590,328,000 | 408,730,000 |
| Cash and cash equivalents |  | 168,198,000 | 59,774,000 | 156,152,000 | 98,434,000 | 83,005,000 | 88,332,000 |
| Free cash flow |  | -29,782,000 | -43,433,000 | -127,797,000 | -134,483,000 | -145,303,000 | -175,799,000 |

### Ratios

ROE and ROA use period-end equity/assets. Liabilities / equity uses total liabilities divided by stockholders' equity. Current ratio uses current assets divided by current liabilities when both are reported.

| Metric | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Return on equity |  | -26.03% | -15.43% | 20.79% | -33.76% | -28.35% | -53.80% |
| Return on assets |  | -24.13% | -15.00% | 19.82% | -31.63% | -26.92% | -49.04% |
| Liabilities / equity |  | 0.07 | 0.03 | 0.05 | 0.07 | 0.05 | 0.10 |
| Current ratio |  | 14.82 | 25.25 | 21.09 | 17.07 | 13.53 | 10.25 |

## As-reported value updates

No tracked differences above grepcent's stated thresholds and capped precision rule were found between the earliest XBRL-filed value and the value currently on file for the standardized annual metrics grepcent tracks.


## Quarterly

Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-08-06. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001789972.json.

Flow metrics use discrete quarter-length periods from 10-Q/10-Q/A filings. Q4 revenue and net income are derived only when annual FY and nine-month YTD facts exist for the same fiscal year; derived Q4 values are labeled. EPS Q4 is not derived.

| Quarter | End date | Revenue | Net income | Diluted EPS | Method |
| --- | --- | ---: | ---: | ---: | --- |
| 2021-Q1 | 2021-03-31 | 18,943,000 |  |  | reported discrete quarter |
| 2021-Q4 | 2021-12-31 | 0.00 |  |  | derived Q4 = FY annual - nine-month YTD |
| 2022-Q1 | 2022-03-31 | 0.00 |  |  | reported discrete quarter |
| 2022-Q2 | 2022-06-30 | 0.00 |  | 3.77 | reported discrete quarter |
| 2022-Q3 | 2022-09-30 | 0.00 |  | -0.54 | reported discrete quarter |
| 2022-Q4 | 2022-12-31 | 0.00 |  |  | derived Q4 = FY annual - nine-month YTD |
| 2023-Q1 | 2023-03-31 |  |  | -1.42 | reported discrete quarter |
| 2023-Q2 | 2023-06-30 |  |  | -0.82 | reported discrete quarter |
| 2023-Q3 | 2023-06-30 |  | -32,214,000 |  | reported discrete quarter |
| 2023-Q3 | 2023-09-30 |  |  | -0.91 | reported discrete quarter |
| 2023-Q4 | 2023-12-31 |  | -25,563,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2024-Q1 | 2024-03-31 |  | -37,340,000 | -0.86 | reported discrete quarter |
| 2024-Q2 | 2024-03-31 |  | -37,340,000 |  | reported discrete quarter |
| 2024-Q2 | 2024-06-30 |  |  | -0.75 | reported discrete quarter |
| 2024-Q3 | 2024-06-30 |  | -42,028,000 |  | reported discrete quarter |
| 2024-Q3 | 2024-09-30 |  |  | -0.69 | reported discrete quarter |
| 2024-Q4 | 2024-12-31 |  | -47,647,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2025-Q1 | 2025-03-31 |  | -48,501,000 |  | reported discrete quarter |
| 2025-Q2 | 2025-03-31 |  | -48,501,000 |  | reported discrete quarter |
| 2025-Q3 | 2025-06-30 |  | -70,055,000 |  | reported discrete quarter |
| 2025-Q4 | 2025-12-31 |  | -50,713,000 |  | derived Q4 = FY annual - nine-month YTD |
| 2026-Q1 | 2026-03-31 |  | -49,661,000 |  | reported discrete quarter |
| 2026-Q2 | 2026-03-31 |  | -49,661,000 |  | reported discrete quarter |

## Filed narrative (10-K & 10-Q)

## Business

Verbatim Item 1 Business section from CGEM's latest 10-K: [/company/CGEM/business/](/company/CGEM/business/).

## Risk Factors

Verbatim Item 1A Risk Factors from CGEM's latest 10-K: [/company/CGEM/risk-factors/](/company/CGEM/risk-factors/).

## Latest quarter (10-Q)

Latest 10-Q source: https://www.sec.gov/Archives/edgar/data/1789972/000119312526336717/cgem-20260630.htm

Extracted structurally from real Item 2 body heading to real Item 3/4 boundary. Published MD&A gate trimmed front/tail over-capture.
Confidence: high
Filing date: 2026-08-06
Report date: 2026-06-30

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025 (the “2025 10-K”), filed with the Securities and Exchange Commission (the “SEC”) on March 10, 2026. This discussion and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements that involve risks and uncertainties, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results could differ materially from those discussed in these forward-looking statements. Please also refer to those factors described in “Part I, Item 1A. Risk Factors” of our 2025 10-K and "Part II, Item 1A. Risk Factors" in this Quarterly Report on Form 10-Q for important factors that we believe could cause actual results to differ materially from those in our forward-looking statements.

Overview

We are a biopharmaceutical company developing potential first- or best-in-class, disease-modifying T cell engagers for autoimmune diseases and cancer. We pursue promising therapeutic targets while leveraging our core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, we are advancing our mission to deliver new standards of care for patients.

Immunology Pipeline

•
CLN-978 is a CD19xCD3 T cell engager that we are developing for rheumatic diseases driven by pathogenic B cells. In the Phase 1 OUTRACE Program, CLN-978 is being evaluated in patients with systemic lupus erythematosus (“SLE”), rheumatoid arthritis (“RA”), and Sjögren’s disease (“SjD”). The OUTRACE SLE Study is an ongoing global Phase 1 clinical trial in patients with treatment-refractory moderate to severe SLE. The OUTRACE RA Study is a Phase 1 clinical trial in patients with difficult-to-treat RA, which is ongoing in Europe. We shared initial clinical data in patients with SLE and RA in a poster presentation at the European Alliance of Associations for Rheumatology (“EULAR”) European Congress of Rheumatology and additional clinical data, including initial multi-dose regimen data in patients with RA, at an investor event in June 2026. We also plan to share additional multi-dose regimen data in patients with RA and SLE in the third and fourth quarters of 2026, respectively, and expect to begin Phase 2 expansion in both disease areas by early 2027. The OUTRACE SjD Study is an ongoing global Phase 1 clinical trial in patients with treatment-refractory moderate to severe Sjögren’s disease. We plan to share initial clinical data in patients with Sjögren’s disease in the fourth quarter of 2026.

•
Velinotamig is a BCMAxCD3 T cell engager that we are developing for autoimmune diseases driven by pathogenic autoantibodies produced by long-lived plasma cells. Chongqing Genrix Biopharmaceutical Co., Ltd. ("Genrix"), from which we licensed velinotamig, is enrolling a Phase 1/2 clinical trial in China in patients with treatment-refractory autoimmune diseases, initially in patients with moderate to severe SLE. In June 2026, we shared initial clinical observations from two SLE patients with nephritis from the trial. Additional multi-dose regimen data from the trial are expected to be shared in the fourth quarter of 2026. In early 2027, we plan to initiate a global Phase 1/2 basket clinical trial in patients with autoimmune cytopenias, including immune thrombocytopenia and autoimmune hemolytic anemia.

Oncology Pipeline

•
CLN-049 is a FLT3xCD3 T cell engager that we are developing for blood cancers. CLN-049 is being evaluated in an ongoing Phase 1 clinical trial in patients with relapsed/refractory acute myeloid leukemia ("AML") or myelodysplastic syndrome (“MDS”). We plan to share a clinical data update from the dose escalation portion of the trial in the fourth quarter of 2026. Following a positive End-of-Phase 1 meeting with the U.S. Food and Drug Administration (“U.S. FDA”) in July 2026, we will initiate a potentially registrational Phase 2 trial in patients with relapsed/refractory AML in the third quarter of 2026. The study will begin with a dose-optimization phase with seamless progression to a single-arm expansion cohort at the recommended Phase 2 dose. Phase 2 expansion will include a parallel exploratory cohort enrolling previously untreated TP53-mutated AML patients. In the fourth quarter of 2026, we also will initiate a Phase 1/2 clinical trial evaluating the combination of CLN-049, venetoclax, and azacitidine as a potential frontline treatment for patients with previously untreated AML.

13

•
Zipalertinib (CLN-081/TAS6417), on which we are collaborating with an affiliate of Taiho Pharmaceutical Co., Ltd. ("Taiho"), is an orally-available small-molecule, irreversible epidermal growth factor receptor ("EGFR") inhibitor that is designed to selectively target cells expressing EGFR exon 20 insertion mutations (“EGFR ex20ins”) with relative sparing of cells expressing wild-type EGFR. In April 2026, the U.S. FDA accepted for review a new drug application (“NDA”) for zipalertinib, supported by data from the pivotal Phase 2b portion of the REZILIENT1 clinical trial, for the treatment of patients with locally advanced or metastatic EGFR ex20ins non-small cell lung cancer (“NSCLC”) whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The U.S. FDA assigned a Prescription Drug User Fee Act target action date of February 27, 2027. Taiho is also evaluating zipalertinib in a Phase 2 parallel cohort trial (“REZILIENT2”) and a global Phase 3 clinical trial (“REZILIENT3”) in combination with chemotherapy as a potential first-line treatment for locally advanced or metastatic EGFR ex20ins NSCLC adult patients, for which Taiho completed enrollment in February 2026 and expects top-line results by the end of 2026.

Preclinical Programs

In addition to the product candidates described above, we are actively developing several preclinical programs.

Recently Discontinued Programs

CLN-619 is a MICA/B monoclonal antibody that we were previously evaluating in Phase 1 clinical trials. In May 2025, following a review of the CLN-619 data from the disease-specific expansion cohorts for endometrial and cervical cancers, we announced discontinuation of further development of CLN-619 in patients with gynecological cancers as preliminary results did not meet our internal threshold for advancement. In November 2025, after a review of the emerging clinical data in patients with NSCLC and multiple myeloma, we discontinued further development of CLN-619.

CLN-617 is an interleukin-2 and interleukin-12 fusion protein that we were previously evaluating in a Phase 1 clinical trial. In November 2025, after a review of the emerging clinical data in patients with advanced solid tumors, we discontinued further development of CLN-617.

Intellectual Property

We hold worldwide intellectual property rights for CLN-978. We hold worldwide, excluding mainland China, Hong Kong, Macau and Taiwan (collectively referred to as “greater China”), intellectual property rights for velinotamig. We hold worldwide intellectual property rights for CLN-049 through a development subsidiary in which we had a 98% ownership interest as of June 30, 2026. We are co-developing zipalertinib, for which Taiho holds intellectual property rights, with an affiliate of Taiho.

Financing and Business Operations

Since our inception in 2016, we have focused all of our efforts and financial resources on raising capital, organizing and staffing our company, identifying, acquiring or in-licensing and developing product and technology rights, establishing and protecting our intellectual property portfolio, and developing and advancing our programs. We do not have any products approved for sale and have not generated any revenue from product sales.

We have funded our operations primarily through the sale of equity securities and from licensing or selling the rights to our product candidates. As of June 30, 2026, we have received net proceeds of $842.2 million from equity financings. We have received $18.9 million in revenue from a previous license agreement and cash proceeds of $275.0 million from the sale of our equity interest in our former zipalertinib development subsidiary to Taiho.

In April 2026, we entered into a sales agreement with TD Securities (USA) LLC (“TD Cowen”) to continue our at-the-market equity offering program (“ATM”), pursuant to which we can offer and sell up to $200.0 million of our common stock through TD Cowen at prevailing market prices from time to time. We made no sales under the ATM through June 30, 2026.

As of June 30, 2026, we had cash, cash equivalents, and short-term investments of $334.5 million, and long-term investments and interest receivable of $21.4 million. Interest receivable is included in prepaid expenses and other current assets on the consolidated balance sheets and represents accrued and unpaid interest on our marketable securities. We have a history of significant operating losses and have had negative cash flows from operations since our inception. As of June 30, 2026, we had an accumulated deficit of $691.5 million. We expect to continue to generate operating losses for the foreseeable future. Our future viability is dependent on the success of our research and development and our ability to access additional capital to fund our operations. There can be no assurance that our current operating plan will be achieved or that additional funding will be available on terms acceptable to us, or at all.

14

We are subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, reliance on third parties, compliance with government regulations and the ability to obtain additional capital to fund operations. Our current and future product candidates will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require additional capital, adequate personnel and extensive compliance-reporting capabilities. There can be no assurance that our research and development will be successfully completed, that adequate protection for our intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable.

Global Economic Conditions

As we continue to pursue commercial opportunities in both U.S. and international markets, we remain attentive to evolving global economic conditions, including uncertainties related to international trade policies, tariffs, and supply chain dynamics. Although these factors have not had a material impact on our business to date, future changes in trade regulations or tariff structures could have an impact on our business and operations, including our expenses, supply chain, manufacturing processes, preclinical studies and clinical trials. We continue to monitor these developments closely.

Components of Our Results of Operations

Revenue

We have not generated any revenue from the sale of products since our inception.

Research and Development Expenses

Research and development expenses consist primarily of costs incurred in connection with the research and development of our product candidates and programs. These expenses include:

•
compensation costs for emplo

[Excerpt truncated for page length; source filing is linked above.]

## Latest 10-K MD&A (excerpt)

Latest 10-K Item 7 source: https://www.sec.gov/Archives/edgar/data/1789972/000119312526099362/cgem-20251231.htm
Complete FY 2025 MD&A: /company/CGEM/mda/fy2025/

Extracted from a substantive MD&A body after the formal Item 7 span was a TOC or reference stub.
Confidence: high
Filing date: 2026-03-10
Report date: 2025-12-31

Overview

We are a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for autoimmune diseases and cancer. We pursue promising therapeutic targets while leveraging core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, we are advancing our mission to deliver new standards of care for patients.

Immunology

•
CLN-978 is a CD19xCD3 bispecific T cell engager that we are developing for autoimmune diseases. In the Phase 1 OUTRACE Program, CLN-978 is being evaluated in patients with systemic lupus erythematosus (“SLE”), rheumatoid arthritis (“RA”), and Sjögren’s disease (“SjD”). The OUTRACE SLE Study is an ongoing global Phase 1 clinical trial in patients with moderate to severe SLE. The OUTRACE RA Study is a Phase 1 clinical trial in patients with active, difficult-to-treat RA, which is ongoing in Europe. We plan to share initial clinical data in SLE RA in the second quarter of 2026 and repeat dosing data in RA in the third quarter of 2026. The OUTRACE SjD Study is an ongoing global Phase 1 clinical trial in patients with active, moderate to severe Sjögren’s disease. We plan to share initial clinical data in Sjögren’s disease in the fourth quarter of 2026.

•
Velinotamig is a BCMAxCD3 bispecific T cell engager that we are developing for autoimmune diseases. Chongqing Genrix Biopharmaceutical Co., Ltd. ("Genrix"), from which we licensed velinotamig, is enrolling a Phase 1 clinical trial in China in patients with autoimmune diseases, initially in patients with SLE, followed by planned future expansion into other indications, and initial clinical data will be shared in the fourth quarter of 2026. We intend to use the data generated from this Phase 1 clinical trial to accelerate global clinical development. Following the completion of the Genrix Phase 1 clinical trial, we will conduct all further development of velinotamig in autoimmune diseases.

Oncology

•
CLN-049 is a FLT3xCD3 bispecific T cell engager. CLN-049 is being evaluated in an ongoing Phase 1 clinical trial in patients with relapsed/refractory acute myeloid leukemia ("AML") or myelodysplastic syndrome (“MDS”). At the 2025 American Society for Hematology (“ASH”) Annual Meeting, we shared monotherapy efficacy data from the ongoing dose escalation portion of the trial in a heavily pretreated all-comer population of patients with relapsed/refractory AML. We plan to share a clinical data update from the dose escalation portion of the trial in the second half of 2026. We also plan to begin enrolling dose expansion cohorts in the second quarter of 2026 and expect to complete enrollment in the fourth quarter of 2026 to determine the recommended Phase 2 dose for an expected single-arm pivotal registrational trial.

•
Zipalertinib (CLN-081/TAS6417), on which we are collaborating with an affiliate of Taiho Pharmaceutical Co., Ltd. ("Taiho"), is an orally-available small-molecule, irreversible epidermal growth factor receptor ("EGFR") inhibitor that is designed to selectively target cells expressing EGFR exon 20 insertion mutations (“EGFR ex20ins”) with relative sparing of cells expressing wild-type EGFR.

o
We are evaluating zipalertinib in the pivotal Phase 2b portion of the REZILIENT1 clinical trial in patients with EGFR ex20ins non-small cell lung cancer ("NSCLC") who progressed after prior systemic therapy. In February 2026, based on the primary efficacy data from REZILIENT1, Taiho completed a rolling submission of a new drug application (“NDA”) seeking accelerated approval of zipalertinib for the treatment of patients with locally advanced or metastatic EGFR ex20ins NSCLC who have previously received platinum-based systemic chemotherapy.

o
Taiho is evaluating zipalertinib in a global Phase 3 clinical trial (“REZILIENT3”) in combination with chemotherapy as a potential first-line treatment for locally advanced or metastatic EGFR ex20ins NSCLC adult patients. Taiho completed enrollment of the trial in February 2026 and expects to obtain top-line results by the end of 2026.

87

o
Taiho is also evaluating zipalertinib in a Phase 2 parallel cohort trial (“REZILIENT2”). Taiho shared emerging data from certain REZILIENT2 cohorts at the International Association for the Study of Lung Cancer (“IASLC”) 2025 World Conference on Lung Cancer (“WCLC”) and European Society for Medical Oncology (“ESMO”) Congress 2025.

Preclinical Programs

In addition to the product candidates described above, we are actively developing several preclinical programs in autoimmune diseases and oncology.

Recently Discontinued Program

CLN-619 is a MICA/B monoclonal antibody that we were previously evaluating in Phase 1 clinical trials. In May 2025, following a review of the CLN-619 data from the disease-specific expansion cohorts for endometrial and cervical cancers, we announced discontinuation of further development of CLN-619 in patients with gynecological cancers as preliminary results did not meet our internal threshold for advancement. In November 2025, after a review of the emerging clinical data in patients with NSCLC and multiple myeloma, we discontinued further development of CLN-619.

CLN-617 is an interleukin-2 and interleukin-12 fusion protein that we were previously evaluating in a Phase 1 clinical trial. In November 2025, after a review of the emerging clinical data in patients with advanced solid tumors, we discontinued further development of CLN-617.

CLN-418 is a B7H4x4-1BB bispecific antibody that we licensed from Harbour BioMed US Inc. (“Harbour”) and were previously evaluating in a Phase 1 clinical trial. In August 2024, following a review of the data from the Phase 1 clinical trial in solid tumors, we notified Harbour of our decision to terminate the license and collaboration agreement for CLN-418 (the “Harbour License Agreement”), effective November 2024. In connection with the termination of the Harbour License Agreement, we discontinued development of CLN-418 and returned development and commercial rights for CLN-418 to Harbour.

Intellectual Property

We directly hold the worldwide intellectual property rights for CLN-978. We hold the worldwide, excluding mainland China, Hong Kong, Macau and Taiwan (collectively referred to as “greater China”), intellectual property rights for velinotamig. We hold the worldwide intellectual property rights for CLN-049 through a development subsidiary that we had a 98% ownership interest in as of December 31, 2025. We are co-developing zipalertinib, for which Taiho holds the intellectual property rights, with an affiliate of Taiho. We hold the worldwide intellectual property rights or exclusive options for worldwide intellectual property for our early-stage programs.

Financing and Business Operations

Since our inception in 2016, we have focused all of our efforts and financial resources on raising capital, organizing and staffing our company, identifying, acquiring or in-licensing and developing product and technology rights, establishing and protecting our intellectual property portfolio, and developing and advancing our programs. We do not have any products approved for sale and have not generated any revenue from product sales.

We have funded our operations primarily through the sale of equity securities and from licensing or selling the rights to our product candidates. As of December 31, 2025, we have received net proceeds of $842.2 million from equity financings, $275.0 million from the sale of our equity interest in our zipalertinib development subsidiary to Taiho, and $18.9 million in revenue from a previous license agreement.

As of December 31, 2025, we had cash, cash equivalents, and short-term investments of $377.9 million, and long-term investments and interest receivable of $61.1 million. Interest receivable is included in prepaid expenses and other current assets on the consolidated balance sheets and represents accrued and unpaid interest on our marketable securities. We have a history of significant operating losses and have had negative cash flows from operations since our inception. As of December 31, 2025, we had an accumulated deficit of $588.1 million. We expect to continue to generate operating losses for the foreseeable future. Our future viability is dependent on the success of our research and development and our ability to access additional capital to fund our operations. There can be no assurance that our current operating plan will be achieved or that additional funding will be available on terms acceptable to us, or at all.

88

We are subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the ability to obtain additional capital to fund operations. Our current and future product candidates will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require additional capital, adequate personnel and extensive compliance-reporting capabilities. There can be no assurance that our research and development will be successfully completed, that adequate protection for our intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable.

Components of Our Results of Operations

Revenue

We have not generated any revenue from the sale of products since our inception.

Research and Development Expenses

Research and development expenses consist primarily of costs incurred in connection with the research and development of our product candidates and programs. These expenses include:

•
compensation costs for employees engaged in research and development functions;

•
expenses incurred under agreements with organizations that support our drug discovery and development activities;

•
expenses incurred in connection with the preclinical and clinical development of our product candidates and programs, including under agreements with contract research organizations ("CROs");

•
costs related to contract manufacturing organizations that are primarily engaged to provide drug substance, raw materials, and drug product for our clinical trials, research and development programs, as well as investigative sites and consultants that conduct our clinical trials, nonclinical studies, and other scientific development services;

•
the costs of acquiring and manufacturing nonclinical and clinical trial materials, including manufacturing registration and validation batches;

•
costs related to compliance with quality and regulatory requirements;

•
payments made under third-party licensing agreements; and

•
direct and allocated costs related to facilities, information technology, personnel and other overhead.

Pursuant to a co-development agreement, we are collaborating with a Taiho affiliate to develop zipalertinib for the treatment of a genetically defined subset of patients with NSCLC, and Taiho will commercialize zipalertinib. For the agreed-upon indication, we and Taiho share development costs equally, and each party will receive 50% of any future potential pre-tax profits from U.S. sales of zipalertinib. For any additional indications that Taiho chooses to develop independently, Taiho will bear all development costs until they have sufficient data from such indication to support a commercial purpose or submission of zipalertinib for the additional indication. At such time, 50% of Taiho’s independent development costs, subject to certain adjustments, will be deducted from future pre-tax profits for potential U.S. sales of zipalertinib. In November

[Excerpt truncated for page length; the complete text is on the linked full-MD&A page.]

Read the full FY 2025 MD&A: /company/CGEM/mda/fy2025/
All MD&A years: /company/CGEM/mda/


## MD&A history

Prior-year 10-K MD&A spans are extracted from SEC filings with the same bounded parser used for the latest filing. Each year's full verbatim text is on its own sub-page.

- [FY 2024 MD&A](/company/CGEM/mda/fy2024/): filed 2025-02-27; accession 0000950170-25-028346 (https://www.sec.gov/Archives/edgar/data/1789972/000095017025028346/cgem-20241231.htm)
- [FY 2023 MD&A](/company/CGEM/mda/fy2023/): filed 2024-03-14; accession 0000950170-24-031143 (https://www.sec.gov/Archives/edgar/data/1789972/000095017024031143/cgem-20231231.htm)
- [FY 2022 MD&A](/company/CGEM/mda/fy2022/): filed 2023-03-09; accession 0000950170-23-006839 (https://www.sec.gov/Archives/edgar/data/1789972/000095017023006839/cgem-20221231.htm)
- [FY 2021 MD&A](/company/CGEM/mda/fy2021/): filed 2022-03-17; accession 0000950170-22-004002 (https://www.sec.gov/Archives/edgar/data/1789972/000095017022004002/cgem-20211231.htm)


## FDA-approved drug applications

Applications listed under this company's exact-matched sponsor name. Approved applications only.

No resolved FDA applications were found for this company under the exact-unique, approved-only publish rule.

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

This list covers FDA applications whose listed sponsor name maps to this company by an exact-unique match; applications listed under sponsor names not mapped to this company (subsidiaries, name variants, joint ventures) are absent.


## Macro cross-references

Indicators mapped to this company's SIC classification (industry 2836 Biological Products, (No Diagnostic Substances)) by grepcent's deterministic macro-sector crosswalk. A navigational mapping, not a statistical or causal claim.

- [INDPRO](/indicator/INDPRO/): Industrial Production: Total Index
- [TCU](/indicator/TCU/): Capacity Utilization: Total Index
- [PPIACO](/indicator/PPIACO/): Producer Price Index by Commodity: All Commodities
- [GDPC1](/indicator/GDPC1/): Real Gross Domestic Product
- [DGS10](/indicator/DGS10/): Market Yield on U.S. Treasury Securities at 10-Year Constant Maturity
- [FEDFUNDS](/indicator/FEDFUNDS/): Federal Funds Effective Rate
- [CES0500000003](/indicator/CES0500000003/): Average Hourly Earnings of All Employees, Total Private
- [PAYEMS](/indicator/PAYEMS/): All Employees, Total Nonfarm

Macro-to-micro threads including this sector: [Inflation (CPI / PCE / PPI)](/thread/inflation-cpi-pce-ppi/), [US labor market](/thread/us-labor-market/), [Growth & output](/thread/growth-output/), [Money & trade](/thread/money-trade/), [Government finances](/thread/government-finances/), [Sector employment](/thread/sector-employment/), [Industrial orders & inventories](/thread/industrial-orders/), [Trade & external](/thread/trade-external/).

All macro indicators: /indicators/


## For LLMs & downloads

Markdown twin: /company/CGEM.md · JSON record: /company/CGEM.json · verified financials: /company/CGEM/financials.json / /company/CGEM/financials.csv · machine TOC for the whole site: /llms.txt