FDA grants Terns (NASDAQ: TERN) Breakthrough status for CML drug TERN-701

Rhea-AI Filing Summary

Terns Pharmaceuticals reports that the FDA granted Breakthrough Therapy Designation to TERN-701, an oral allosteric BCR:ABL1 inhibitor for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase without the T315I mutation who were previously treated with at least two tyrosine kinase inhibitors.

The designation is based on preliminary data from the ongoing Phase 1/2 CARDINAL trial, where TERN-701 showed promising activity with encouraging major and deep molecular responses by week 24 and mostly low-grade side effects, with few severe events or discontinuations.

Terns highlights that Breakthrough Therapy Designation is intended to speed development and review of therapies for serious conditions and notes that this milestone, together with a recent agreement for Merck to acquire Terns, may help advance TERN-701 toward pivotal studies, though all future outcomes remain subject to clinical and regulatory risk.

Positive

• FDA Breakthrough Therapy Designation granted to TERN-701 for certain heavily pretreated Ph+ CML patients, based on early CARDINAL trial data showing encouraging molecular responses and a largely low-grade safety profile.
• Strategic backdrop with Merck: the designation is announced alongside reference to a recent agreement for Merck to acquire Terns, which could support advancing TERN-701 toward pivotal development if the deal is completed.

Negative

• None.

Insights

Biotech and regulatory analyst

FDA Breakthrough status for TERN-701 is a major validation but not yet approval.

The FDA’s Breakthrough Therapy Designation for TERN-701 in heavily pretreated Ph+ CML signals that early Phase 1/2 data from the CARDINAL trial look encouraging on both efficacy and safety. This status can provide more FDA interaction and an expedited review path if later data remain supportive.

The company reports encouraging major and deep molecular responses at week 24, including in patients with high baseline disease burden and prior allosteric TKI exposure, while most side effects were low grade with few severe events or discontinuations. That combination is particularly important in a chronic leukemia setting.

Management links this designation with a recent agreement for Merck to acquire Terns, suggesting a potentially stronger development and commercialization platform for TERN-701 if the transaction closes. However, the therapy remains in clinical testing, and ultimate approval and commercial impact will depend on future trial outcomes and regulatory decisions.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Breakthrough Therapy Designation date: April 27, 2026 Prior TKI treatments: Two or more TKIs Trial phase: Phase 1/2 +1 more

4 metrics

Breakthrough Therapy Designation date April 27, 2026 FDA designation for TERN-701 disclosed on this date

Prior TKI treatments Two or more TKIs Minimum number of tyrosine kinase inhibitors previously received by eligible patients

Trial phase Phase 1/2 Development stage of the CARDINAL clinical trial for TERN-701

Response assessment timepoint Week 24 Timepoint at which major and deep molecular responses were highlighted

Key Terms

Breakthrough Therapy Designation, allosteric BCR:ABL1 inhibitor, Phase 1/2 CARDINAL clinical trial, major molecular response, +2 more

6 terms

Breakthrough Therapy Designation regulatory

"FDA granted Breakthrough Therapy Designation to TERN-701, a novel, oral allosteric BCR:ABL1 inhibitor"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

allosteric BCR:ABL1 inhibitor medical

"TERN-701, a novel, oral allosteric BCR:ABL1 inhibitor, for the treatment of adult patients"

Phase 1/2 CARDINAL clinical trial medical

"TERN-701 BTD is based on data from the ongoing Phase 1/2 CARDINAL clinical trial of TERN-701"

major molecular response medical

"TERN-701 has shown promising activity, with encouraging rates of major molecular response and deep molecular response"

Major molecular response is a clinical milestone in treating certain blood cancers that means the amount of disease-specific genetic material in a patient’s blood has dropped by about 99.9% from a standardized baseline. Investors care because MMR is a clear, measurable sign that a therapy is working; it influences regulatory decisions, physician adoption and sales prospects, so it functions like a performance score that can change a drug’s commercial value.

deep molecular response medical

"encouraging rates of major molecular response and deep molecular response observed at week 24"

A deep molecular response is when a highly sensitive blood test can no longer detect or finds only trace amounts of disease-causing genetic material after treatment, indicating the illness has been driven down to very low levels. For investors, it signals a therapy’s strong effectiveness and durability, can support regulatory approvals or premium pricing, and may increase the likelihood of patients safely stopping treatment — similar to showing a factory has reduced its defect rate from common to nearly zero.

treatment-emergent adverse events medical

"The majority of treatment-emergent adverse events were reported as low grade with a low incidence of severe adverse events"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

Understanding 8-K Material Events →

false 0001831363 0001831363 2026-04-27 2026-04-27

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): April 27, 2026

Terns Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware		001-39926		98-1448275
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

1065 East Hillsdale Blvd. Suite 100
Foster City, California		94404
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (650) 525-5535

N/A

(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:

☐ 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:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		TERN		Nasdaq Global Select Market

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 ☒

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 April 27, 2026, Terns Pharmaceuticals, Inc. (the “Company” or “Terns”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) granted Breakthrough Therapy Designation to TERN-701, a novel, oral allosteric BCR::ABL1 inhibitor, for the treatment of adult patients with chromosome-positive chronic myeloid leukemia (“Ph+CML”) in the chronic phase without the T315I mutation previously treated with two or more tyrosine kinase inhibitors (“TKIs”). A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

On April 27, 2026, Terns announced that the FDA granted Breakthrough Therapy Designation to TERN-701, a novel, oral allosteric BCR::ABL1 inhibitor, for the treatment of adult patients with Ph+CML in the chronic phase without the T315I mutation previously treated with two or more TKIs.

Breakthrough Therapy Designation (“BTD”) is intended to expedite the development and review of potential new medicines designed to treat serious conditions or address significant unmet medical needs. Based on FDA guidelines, the medicine needs to have shown encouraging preliminary clinical evidence that demonstrates potential for substantial improvement over available medicines.

TERN-701 BTD is based on data from the ongoing Phase 1/2 CARDINAL clinical trial of TERN-701 in patients with chronic myeloid leukemia previously treated with at least one prior TKI and who experienced treatment failure, suboptimal response or treatment intolerance. TERN-701 has shown promising activity, with encouraging rates of major molecular response and deep molecular response observed at week 24. Importantly, this includes responses in patients with high baseline disease burden who previously received multiple lines of therapy, including many who were treated with an allosteric TKI. The majority of treatment-emergent adverse events were reported as low grade with a low incidence of severe adverse events and discontinuations.

Cautionary Note Regarding Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements about the Company within the meaning of the federal securities laws that involve substantial risks and uncertainties. Forward-looking statements include statements related to or in connection with expectations, timing and potential results of clinical trials and other development activities, including with respect to the CARDINAL trial; the potential indications to be targeted by the Company with its product candidates; the therapeutic potential of the Company’s product candidates; the potential for the mechanisms of action of the Company’s product candidates to be therapeutic targets for their targeted

indications; the potential utility and progress of the Company’s product candidates in their targeted indications, including the clinical utility of the data from and the endpoints used in the Company’s clinical trials; the applicability of expected parameters and benchmarks on which to assess clinical trial results; the Company’s clinical development plans and activities, including potential future dosing regimens and trial designs, milestones and results of any interactions with regulatory authorities on its programs; the Company’s expectations regarding the profile and potential beneficial characteristics and therapeutic effects of its product candidates, including with respect to efficacy, tolerability, safety, convenience and pharmacokinetic profile; the potential differentiation of the Company’s product candidates compared to similar, competitive or other products or product candidates; the best-in-disease potential for TERN-701; the Company’s plans for and ability to continue to execute on its current development strategy; the process, timing or potential to establish a strategic partnership or similar arrangement for future development and/or potential commercialization of any of its product candidates; the potential approval and commercialization of the Company’s product candidates; and the Company’s expectations with regard to its cash runway and sufficiency of its cash resources. All statements other than statements of historical facts contained in this Form 8-K, including statements regarding the Company’s strategy, future financial condition, future operations, future trial results, future approvals, future commercial launches, projected costs, prospects, plans, objectives of management and expected industry and market trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “develop,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company’s plans to vary materially, including the risks associated with the initiation, cost, timing, progress, results and utility of the Company’s current and future research and development activities and preclinical studies and clinical trials. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s reports filed with the Securities and Exchange Commission, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2025. New risk factors emerge from time to time and it is not possible for Company management to predict all risk factors, nor can the Company assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release issued by Terns Pharmaceuticals, Inc. on April 27, 2026.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

						TERNS PHARMACEUTICALS, INC.
Date: April 27, 2026				By:		/s/ Caryn McDowell
						Caryn McDowell
						Chief Legal Officer and Corporate Secretary

Exhibit 99.1

Terns Pharmaceuticals Announces FDA Breakthrough Therapy Designation Granted to

TERN-701 for Certain Patients with Chronic Myeloid Leukemia

Designation for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP) without the T315I mutation previously treated with two or more tyrosine kinase inhibitors (TKIs)

FOSTER CITY, Calif., Apr. 27, 2026 (GLOBE NEWSWIRE) — Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to TERN-701, a novel, oral allosteric BCR::ABL1 inhibitor, for the treatment of adult patients with Ph+ CML in the chronic phase without the T315I mutation previously treated with two or more TKIs.

“There remains an urgent need for CML treatments that offer improved efficacy, safety, and tolerability over current therapies,” said Scott Harris, chief development and operations officer at Terns. “This designation from the FDA supports the significant potential of TERN-701 to be a best-in-disease therapy for CML patients and offer substantial improvement based on the faster, deeper responses compared to prior TKIs and encouraging safety and tolerability profile observed to date.”

“This Breakthrough Therapy Designation, along with the recent agreement for Merck to acquire Terns, has the potential to accelerate efforts to advance TERN-701 to a pivotal trial and to patients,” said Amy Burroughs, chief executive officer of Terns. “This is an exciting time for everyone involved in the TERN-701 program. We are grateful to the investigators, patients and community advocates whose dedication and support have made these advancements possible.”

Breakthrough Therapy Designation (BTD) is intended to expedite the development and review of potential new medicines designed to treat serious conditions or address significant unmet medical needs. Based on FDA guidelines, the medicine needs to have shown encouraging preliminary clinical evidence that demonstrates potential for substantial improvement over available medicines.

TERN-701 BTD is based on data from the ongoing Phase 1/2 CARDINAL clinical trial of TERN-701 in patients with CML previously treated with at least one prior TKI and who experienced treatment failure, suboptimal response or treatment intolerance. TERN-701 has shown promising activity, with encouraging rates of major molecular response and deep molecular response observed at week 24. Importantly, this includes responses in patients with high baseline disease burden who previously received multiple lines of therapy, including many who were treated with an allosteric TKI. The majority of treatment-emergent adverse events were reported as low grade with a low incidence of severe adverse events and discontinuations.

About Terns Pharmaceuticals

Terns Pharmaceuticals is a clinical-stage oncology company reimagining known biology to deliver high impact medicines. Our lead program, TERN-701, is a highly selective, oral, allosteric BCR::ABL1 inhibitor with a potentially best-in-disease profile that could meaningfully improve upon the efficacy, safety and convenience of existing treatments for chronic myeloid leukemia. For more information, please visit: www.ternspharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements about the Company within the meaning of the federal securities laws that involve substantial risks and uncertainties. Forward-looking statements include statements related to or in connection with, expectations, timing and potential results of clinical trials and other development activities, including with respect to the CARDINAL trial; the potential indications to be targeted by the Company with its product candidates; the therapeutic potential of the Company’s product candidates; the potential for the mechanisms of action of the Company’s product candidates to be therapeutic targets for their targeted indications; the potential utility and progress of the Company’s product candidates in their targeted indications, including the clinical utility of the data from and the endpoints used in the Company’s clinical trials; the applicability of expected parameters and benchmarks on which to assess clinical trial results; the Company’s clinical development plans and activities, including potential future dosing regimens and trial designs, milestones and results of any interactions with regulatory authorities on its programs; the Company’s expectations regarding the profile and potential benefit characteristics and therapeutic effects of its product candidates, including with respect to efficacy, tolerability, safety, convenience and pharmacokinetic profile; the potential differentiation of the Company’s product candidates compared to similar, competitive or other products or product candidates; the best in disease potential for TERN-701; the Company’s plans for and ability to continue to execute on its current development strategy, the process, timing or potential to establish a strategic partnership or similar arrangement for future development and/or potential commercialization of any of its product candidates, the potential approval and commercialization of the Company’s product candidates and the Company’s expectations with regard to its cash runway and sufficiency of its cash resources. All statements other than statements of historical facts contained in this press release, including statements regarding the Company’s strategy, future financial condition, future operations, future trial results, future approvals, future commercial launches, projected costs, prospects, plans, objectives of management and expected industry and market trends, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “develop,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar

expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company’s plans to vary materially, including the risks associated with the initiation, cost, timing, progress, results and utility of the Company’s current and future research and development activities and preclinical studies and clinical trials. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s reports filed with the Securities and Exchange Commission, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2025. New risk factors emerge from time to time and it is not possible for Company management to predict all risk factors, nor can the Company assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

Contacts for Terns

Investors

Justin Ng

investors@ternspharma.com

Media

Jenna Urban

CG Life

media@ternspharma.com

FAQ

What did Terns Pharmaceuticals (TERN) announce regarding TERN-701?

Terns announced that the FDA granted Breakthrough Therapy Designation to its investigational drug TERN-701. The designation covers certain adult patients with Philadelphia chromosome‑positive chronic myeloid leukemia in chronic phase, without the T315I mutation, after treatment with at least two tyrosine kinase inhibitors.

Which chronic myeloid leukemia patients could be treated by TERN-701 according to the 8-K?

TERN-701’s designation covers adult Ph+ CML patients in chronic phase lacking the T315I mutation who were previously treated with two or more TKIs. These are typically individuals whose disease was resistant, suboptimal, or intolerant to prior tyrosine kinase inhibitor therapies.

What trial data supported the Breakthrough Therapy Designation for TERN-701?

The designation is based on data from the ongoing Phase 1/2 CARDINAL trial of TERN-701. Terns reports promising activity, including encouraging major and deep molecular responses at week 24 and mostly low‑grade treatment‑emergent adverse events with few severe events or treatment discontinuations.

How does the FDA define Breakthrough Therapy Designation mentioned for TERN-701?

Breakthrough Therapy Designation is intended to expedite development and review of potential new medicines for serious conditions or significant unmet needs. The FDA requires encouraging preliminary clinical evidence suggesting a substantial improvement over available therapies before granting this status.

What safety profile for TERN-701 is described in the Terns (TERN) filing?

In the CARDINAL trial, TERN-701 showed a favorable early safety profile, with the majority of treatment‑emergent adverse events reported as low grade. The company notes a low incidence of severe adverse events and discontinuations among treated chronic myeloid leukemia patients.

How does the Merck acquisition agreement relate to TERN-701 in this disclosure?

Terns states that the Breakthrough Therapy Designation, together with a recent agreement for Merck to acquire Terns, has the potential to accelerate efforts to advance TERN-701 toward a pivotal trial and ultimately to patients, subject to clinical and regulatory outcomes.

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 11.9 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.1 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 18.3 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.4 KB