Skip to main content

Enliven Therapeutics, Inc.

For the period ended Mar 31, 2026. Filed May 7, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2026 · Filed May 7, 2026

ELVN$49.43+10.4%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-09-30; filed 2025-11-12.

0001193125-25-277619

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

Current report: 10-Q

Period ended 2026-03-31; filed 2026-05-07.

0001193125-26-211982

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

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 163 previous paragraphs and 158 current paragraphs.

126 unchanged; 24 reworded; 7 added; 10 removed; 3 previous and 1 current paragraphs rearranged.

Tables are not compared: 6 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (7)

Current report

General and administrative expenses were $7.1 million for the three months ended March 31, 2026 compared to $6.8 million for the three months ended March 31, 2025, an increase of $0.3 million. The increase was driven by higher salaries and benefits of $0.8 million, partially offset by lower consulting costs of $0.3 million and lower other costs of $0.2 million.

Current report

the cost of patient enrollment and recruitment for existing clinical trials and any additional clinical trials;

Current report

In April 2026, we entered into a non-cancellable operating lease (the “Bay Area Lease”) with JSR Karp 7, LP for our new headquarters in Burlingame, California. The Bay Area Lease provides for approximately 7,200 square feet of office space with a lease term from June 1, 2026 through May 31, 2029. Because the Bay Area Lease was entered into after March 31, 2026, the associated future lease payments are not included in the contractual obligations table as of that date.
Removed paragraphs (10)

Previous report

The following table summarizes our ELVN-001 and ELVN-002 programs:

Previous report

General and administrative expenses were $6.9 million for the three months ended September 30, 2025 compared to $5.8 million for the three months ended September 30, 2024, an increase of $1.1 million. The increase was primarily due to an increase in stock-based compensation.

Previous report

Comparison of the nine months ended September 30, 2025 and 2024

Previous report

Research and development expenses were $64.6 million for the nine months ended September 30, 2025 compared to $60.1 million for the nine months ended September 30, 2024, an increase of $4.5 million. The increase was primarily due to an increase in internal research and development costs, consisting of $3.6 million in stock-based compensation, $3.3 million in salaries and benefits and $0.2 million in other internal costs, partially offset by a net decrease in external research and development costs, consisting of a decrease of $8.5 million in ELVN-002 costs due to our intention not to pursue development beyond 2025 as we explore strategic alternatives for the program, partially offset by increases of $3.9 million in ELVN-001 costs due to clinical progression and $2.0 million in other external costs primarily related to higher research costs.

Previous report

General and administrative expenses were $20.8 million for the nine months ended September 30, 2025 compared to $17.6 million for the nine months ended September 30, 2024, an increase of $3.2 million. The increase was primarily due to an increase of $3.2 million in stock-based compensation, $0.5 million in salaries and benefits and $0.2 million in other costs, partially offset by a decrease of $0.7 million in consulting costs.

Previous report

Other income was $11.3 million for the nine months ended September 30, 2025 compared to $11.8 million for the nine months ended September 30, 2024, a decrease of $0.5 million. The decrease was primarily related to a lower gain of $0.9 million related to the change in fair value of the CVR liability upon remeasurement in 2024, partially offset by higher interest income of $0.2 million due to a higher investment balance net of lower interest rates and lower income tax expense of $0.2 million related to the CVR milestone payment in 2024.

Previous report

Net cash provided by financing activities during the nine months ended September 30, 2024 was $93.2 million. This consisted primarily of net proceeds from the sale of shares of our common stock and pre-funded warrants in the Private Placement of $89.7 million, proceeds from the exercise of stock options of $3.2 million and proceeds from the issuance of common stock under our employee stock purchase plan of $0.3 million.
Reworded paragraphs (24)

Previous wording

We are a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. We aim to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Our discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs. By combining clinically validated targets and specific target product profiles with disciplined clinical trial design and regulatory strategy, we aim to develop drugs with an increased probability of clinical and commercial success. Clinically validated targets refers to biological targets that have demonstrated statistical significance on efficacy endpoints in published third-party clinical trials. We have assembled a team of seasoned drug hunters with significant expertise in discovery and development of small molecule therapeutics. Our team includes leading chemists who have been the primary or co-inventors of over 20 product candidates that have been advanced to clinical trials, including four FDA-approved products at their prior companies: Koselugo (selumetinib), Mektovi (binimetinib), Tukysa (tucatinib), and Retevmo (selpercatinib). We are currently advancing ELVN-001, as well as pursuing several additional research stage opportunities that align with our development approach. To prioritize the advancement of ELVN-001 and its upcoming pivotal trial, we are exploring strategic alternatives for the ELVN-002 program, and we do not intend to pursue its development beyond 2025.

Current wording

We are a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. We aim to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Our discovery process combines deep insights into clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs. By combining clinically validated targets and specific target product profiles with disciplined clinical trial design and regulatory strategy, we aim to develop drugs that address unmet needs with an increased probability of clinical and commercial success. Validated targets are those whose role in disease pathology have been demonstrated by mechanistic and clinical studies. We are currently advancing ELVN-001, as well as pursuing multiple additional research-stage opportunities that align with our small molecule development approach. To prioritize the advancement of ELVN-001 and its upcoming pivotal trial, we are exploring strategic alternatives for the ELVN-002 program and are no longer pursuing its development.

Previous wording

Enliven Inc. (formerly, Enliven Therapeutics, Inc.) (“Former Enliven”) was incorporated in the State of Delaware in June 2019, and we are headquartered in Boulder, Colorado. Since its inception, Former Enliven has devoted substantially all of its resources to research and development activities, including with respect to our breakpoint cluster region – Abelson (“BCR-ABL”) and human epidermal growth factor receptor 2 (“HER2”) programs and our other programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these activities.

Current wording

Enliven Inc. (formerly, Enliven Therapeutics, Inc.) (“Former Enliven”) was incorporated in the State of Delaware in June 2019, and we are headquartered in Boulder, Colorado. We devote substantially all of our resources to research and development activities of our breakpoint cluster region – Abelson (“BCR-ABL”) program and our other programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these activities.

Previous wording

Former Enliven funded its operations primarily through private placements of its convertible preferred stock and sale of common stock, raising aggregate gross proceeds of $140.5 million from these private placements and an aggregate of $164.5 million in gross proceeds from the sale of common stock in the Former Enliven pre-closing financing (the “Financing Transaction”). In March 2024, we sold in a private placement (the "Private Placement") common stock and pre-funded warrants to purchase shares of our common stock, resulting in aggregate gross proceeds of $90.0 million, and in June 2025, we completed an underwritten public offering (the "Public Offering") of common stock and pre-funded warrants to purchase shares of our common stock, resulting in aggregate gross proceeds of $230.0 million. Through September 30, 2025, we have sold shares of our common stock pursuant to the Sales Agreement (as defined below) and received gross proceeds of $40.0 million. As of September 30, 2025, we had cash, cash equivalents and marketable securities of $477.6 million. Based on our current operating plan, our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operating expenses and capital expenditure requirements for at least the next 12 months from the date of the filing of this Form 10-Q.

Current wording

Former Enliven funded its operations primarily through private placements of its convertible preferred stock and sale of common stock, raising aggregate gross proceeds of $140.5 million from these private placements and an aggregate of $164.5 million in gross proceeds from the sale of common stock in the Former Enliven pre-closing financing (the “Financing Transaction”). In March 2024, we sold in a private placement (the "Private Placement") common stock and pre-funded warrants to purchase shares of our common stock, resulting in aggregate gross proceeds of $90.0 million, and in June 2025, we completed an underwritten public offering (the "Public Offering") where we sold common stock and pre-funded warrants to purchase shares of our common stock, resulting in aggregate gross proceeds of $230.0 million. Through March 31, 2026, we have sold shares of our common stock pursuant to the Sales Agreement (as defined below) and received gross proceeds of $40.0 million. As of March 31, 2026, we had cash, cash equivalents and marketable securities of $452.4 million. Based on our current operating plan, our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operating expenses and capital expenditure requirements for at least the next 12 months from the date of the filing of this Form 10-Q.

Previous wording

As of September 30, 2025, we had an accumulated deficit of $317.5 million. We have incurred significant losses and negative cash flows from operations since inception, including net losses of $89.0 million and $71.6 million for the years ended December 31, 2024 and 2023, respectively, and $74.0 million for the nine months ended September 30, 2025. We expect that our operating losses and negative operating cash flows will continue for the foreseeable future as we continue to develop our product candidates.

Current wording

As of March 31, 2026, we had an accumulated deficit of $370.8 million. We have incurred significant losses and negative cash flows from operations since inception, including net losses of $103.7 million and $89.0 million for the years ended December 31, 2025 and 2024, respectively, and $23.6 million for the three months ended March 31, 2026. We expect that our operating losses and negative operating cash flows will continue for the foreseeable future as we continue to develop our product candidates.

Previous wording

establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates;

Current wording

establish a sales, marketing, medical and distribution infrastructure to commercialize any approved product candidates;

Previous wording

contract to manufacture any clinical product candidates as well as approved product candidates; for example, we expect to manufacture certain of our product candidates in additional countries including countries in Europe, which we expect to increase the cost of manufacturing our product candidates;

Current wording

contract to manufacture any clinical product candidates as well as approved product candidates; for example, we expect to manufacture certain of our product candidates in additional countries including countries in Europe, which may increase the cost of manufacturing our product candidates;

Previous wording

We are monitoring macroeconomic and geopolitical developments, such as the government shutdown, inflation, instability in the banking and financial sector, tightening of the credit markets, the Russia-Ukraine conflict, conflict in the Middle East, including the Israel-Iran conflict, the imposition of various sanctions and tariffs by the United States and in other countries, public health emergencies/epidemics and the changes in government administration policy positions as a result of the current presidential administration, so that we may be prepared to react to new developments as they arise.

Current wording

We are monitoring macroeconomic and geopolitical developments, such as conditions and risks related to government shutdowns, inflation, instability in the banking and financial sector, tightening of the credit markets, the Russia-Ukraine conflict, conflicts in the Middle East (including the Iran conflict), the imposition of various sanctions and tariffs by the United States or other countries, public health emergencies/epidemics, and changes in government administration policy positions, so that we may be prepared to react to new developments as they arise.

Previous wording

successful patient enrollment in, and the initiation and completion of, clinical trials;

Current wording

successful patient recruitment, enrollment in, and the initiation and completion of, clinical trials;

Previous wording

patient enrollment, which could be delayed due to the approval of new drugs for the same indications that may compete with our product candidates during clinical trials, for example, Scemblix (asciminib), which may lead to reduced market acceptance of our product candidates if our product candidates are approved;

Current wording

patient recruitment and enrollment, which could be delayed due to the approval of new drugs for the same indications that may compete with our product candidates during clinical trials, for example, Scemblix (asciminib), which may lead to reduced market acceptance of our product candidates if our product candidates are approved;

Previous wording

the impact of any supply chain disruptions resulting from macroeconomic or geopolitical situations, including due to any public health emergency, health epidemic (including COVID-19) or other outbreaks, the Russia-Ukraine conflict, conflict in the Middle East, including the Israel-Iran conflict, national security concerns and related legislation related to business operations in China and other countries and changes in government administration policy positions as a result of the current presidential administration; and

Current wording

the impact of any supply chain disruptions resulting from macroeconomic or geopolitical situations, including due to any public health emergency, health epidemic (including COVID-19) or other outbreaks, the Russia-Ukraine conflict, conflicts in the Middle East (including the Iran conflict), national security concerns and related legislation related to business operations in China and other countries and changes in government administration policy positions as a result of the current presidential administration; and

Previous wording

Other income (expense), net primarily consists of interest earned on our cash, cash equivalents and marketable securities, as well as gains and losses related to the change in fair value of the contingent value right ("CVR") liability and income tax expense.

Current wording

Other income (expense), net primarily consists of interest earned on our cash, cash equivalents and marketable securities.

Previous wording

Research and development expenses were $18.2 million for the three months ended September 30, 2025 compared to $21.3 million for the three months ended September 30, 2024, a decrease of $3.1 million. The decrease was primarily due to a net decrease in external research and development costs, consisting of decreases of $6.1 million in ELVN-002 costs due to our intention not to pursue development beyond 2025 as we explore strategic alternatives for the program and $0.3 million in other external costs, partially offset by an increase of $1.5 million in ELVN-001 costs due to clinical progression, partially offset by an increase in internal research and development costs, consisting of $1.1 million in stock-based compensation and $0.7 million in salaries and benefits.

Current wording

Research and development expenses were $20.7 million for the three months ended March 31, 2026 compared to $24.9 million for the three months ended March 31, 2025, a decrease of $4.2 million. The decrease was due to lower external research and development costs, driven by a decrease of $7.0 million in ELVN-002 costs due to our decision not to pursue further development of the program and $0.7 million in other external costs mainly related to lower research costs, partially offset by an increase of $2.8 million in ELVN-001 costs due to clinical progression. This decrease was partially offset by higher internal research and development costs, consisting of $0.7 million in stock-based compensation.

Previous wording

Other income was $4.9 million for the three months ended September 30, 2025 compared to $3.9 million for the three months ended September 30, 2024, an increase of $1.0 million. The increase was primarily related to higher interest income of $1.1 million due to a higher investment balance net of lower interest rates, partially offset by a lower gain of $0.1 million related to the change in fair value of the CVR liability upon remeasurement in 2024.

Current wording

Other income was $4.2 million for the three months ended March 31, 2026 compared to $3.1 million for the three months ended March 31, 2025, an increase of $1.1 million. The increase was driven by higher interest income due to a higher investment balance net of lower interest rates.

Previous wording

On June 23, 2023, we entered into an Open Market Sale Agreement SM (the “Sales Agreement”) with Jefferies LLC (the "Sales Agent”), pursuant to which we may offer and sell shares of our common stock, from time to time, through the Sales Agent, in such share amounts as we may specify by notice to the Sales Agent, in accordance with the terms and conditions set forth in the Sales Agreement. On August 13, 2025, we filed an automatic shelf registration statement on Form S-3ASR (the “Automatic Shelf Registration Statement”) with the Securities and Exchange Commission (the “SEC”) that allows us to undertake an indeterminate amount of equity and debt offerings. Concurrently with the filing of the Automatic Shelf Registration Statement, our prior shelf registration statement and prior prospectus supplement, which registered $200.0 million of common stock under our at-the-market program, were terminated, and we no longer had any common stock available for sale under the prior prospectus supplement.

Current wording

On June 23, 2023, we entered into an Open Market Sale Agreement SM (the “Sales Agreement”) with Jefferies LLC (the "Sales Agent”), pursuant to which we may offer and sell shares of our common stock, from time to time, through the Sales Agent, in such share amounts as we may specify by notice to the Sales Agent, in accordance with the terms and conditions set forth in the Sales Agreement. On August 13, 2025, we filed an automatic shelf registration statement on Form S-3ASR (the “Automatic Shelf Registration Statement”) with the Securities and Exchange Commission (the “SEC”) that allows us to undertake an indeterminate amount of equity and debt offerings. On August 13, 2025, we also filed a prospectus supplement to the Automatic Shelf Registration Statement that covers the offering, issuance and sale of up to $200.0 million of our common stock under the Sales Agreement. Through March 31, 2026, we have sold shares of our common stock pursuant to the Sales Agreement and received gross proceeds of

Previous wording

Through September 30, 2025, we have sold shares of our common stock pursuant to the Sales Agreement and received gross proceeds of $40.0 million. As of September 30, 2025 and December 31, 2024, there was $200.0 million and $160.0 million, respectively, of our common stock available for sale under the Sales Agreement.

Current wording

$40.0 million. As of March 31, 2026 and December 31, 2025, there was $200.0 million of our common stock available for sale under the Sales Agreement.

Previous wording

Our primary uses of cash to date have been to fund our research and development activities, including with respect to our BCR-ABL and HER2 programs and our other programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these activities. As of September 30, 2025, we had cash, cash equivalents and marketable securities of $477.6 million.

Current wording

Our primary uses of cash to date have been to fund our research and development activities, including with respect to our BCR-ABL and HER2 programs and our other programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these activities. As of March 31, 2026, we had cash, cash equivalents and marketable securities of $452.4 million.

Previous wording

establish a sales, marketing and distribution infrastructure to commercialize any approved product candidates;

Current wording

establish a sales, marketing, medical and distribution infrastructure to commercialize any approved product candidates;

Previous wording

contract to manufacture any clinical product candidates or approved product candidates; for example, we expect to manufacture certain of our product candidates in additional countries, including countries in Europe, which we expect to increase the cost of manufacturing our product candidates;

Current wording

contract to manufacture any clinical product candidates or approved product candidates; for example, we expect to manufacture certain of our product candidates in additional countries, including countries in Europe, which may increase the cost of manufacturing our product candidates;

Previous wording

Net cash used in operating activities during the nine months ended September 30, 2025 was $54.5 million. This consisted primarily of a net loss of $74.0 million and net cash outflows from changes in our operating assets and liabilities of $2.3 million (primarily due to a decrease in accounts payable and accrued expenses and other liabilities and an increase in prepaids and other assets), partially offset by non-cash charges for stock-based compensation of $21.7 million and other non-cash charges of $0.1 million.

Current wording

Net cash used in operating activities during the three months ended March 31, 2026 was $19.3 million. This consisted of a net loss of $23.6 million and net cash outflows from changes in our operating assets and liabilities of $3.4 million (mainly due to a decrease in accounts payable and accrued expenses and other liabilities and an increase in prepaids and other assets), partially offset by noncash charges for stock-based compensation of $7.4 million and other noncash charges of $0.3 million.

Previous wording

Net cash used in operating activities during the nine months ended September 30, 2024 was $56.0 million. This consisted primarily of a net loss of $65.8 million, net cash outflows from changes in our operating assets and liabilities of $4.0 million (primarily due to an increase in prepaids and other assets, partially offset by an increase in accounts payable and accrued expenses and other liabilities), non-cash change in the fair value of the CVR liability of $0.9 million and non-cash amortization of premiums and discounts on marketable securities of $0.6 million, partially offset by non-cash charges for stock-based compensation of $14.8 million and other non-cash charges of $0.5 million.

Current wording

Net cash used in operating activities during the three months ended March 31, 2025 was $24.1 million. This consisted of a net loss of $28.5 million and net cash outflows from changes in our operating assets and liabilities of $2.5 million (mainly due to a net decrease in accounts payable and accrued expenses and other liabilities), partially offset by noncash charges for stock-based compensation of $6.8 million and other noncash charges of $0.1 million.

Previous wording

Net cash used in investing activities during the nine months ended September 30, 2025 was $186.2 million. This consisted primarily of cash used to purchase marketable securities of $371.3 million and purchases of property and equipment of $0.2 million, partially offset by proceeds from maturities of marketable securities of $185.2 million.

Current wording

Net cash provided by investing activities during the three months ended March 31, 2026 was $42.5 million. This consisted of proceeds from maturities of marketable securities of $108.4 million, partially offset by cash used to purchase marketable securities of $65.8 million.

Previous wording

Net cash used in investing activities during the nine months ended September 30, 2024 was $36.7 million. This consisted primarily of cash used to purchase marketable securities of $234.2 million and payment of the CVR milestone (net of permitted deductions) of $9.1 million, partially offset by proceeds from maturities of marketable securities of $196.7 million and receipt of the CVR milestone of $10.0 million.

Current wording

Net cash provided by investing activities during the three months ended March 31, 2025 was $1.4 million. This consisted of proceeds from maturities of marketable securities of $60.7 million, partially offset by cash used to purchase marketable securities of $59.2 million.

Previous wording

Net cash provided by financing activities during the nine months ended September 30, 2025 was $218.2 million. This consisted primarily of net proceeds from the sale of shares of our common stock and pre-funded warrants in the Public Offering of $216.2 million, proceeds from the exercise of stock options of $1.8 million and proceeds from the issuance of common stock under our employee stock purchase plan of $0.4 million, partially offset by the payment of deferred offering costs of $0.1 million.

Current wording

Net cash provided by financing activities during the three months ended March 31, 2026 was $10.1 million. This consisted of proceeds from the exercise of stock options.

Previous wording

In September 2024, we entered into a non-cancellable operating lease (the "Lease") with Crestview, LLC. Under the terms of the Lease, we will lease approximately 20,011 rentable square feet of office and laboratory space from January 1, 2025 through December 31, 2026, with a renewal option for an additional term of five years.

Current wording

In September 2024, we entered into a non-cancellable operating lease (the "Boulder Lease") with Crestview, LLC in Boulder, Colorado. Under the terms of the Boulder Lease, we will lease approximately 20,011 rentable square feet of office and laboratory space from January 1, 2025 through December 31, 2026, with a renewal option for an additional term of five years.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

Net cash provided by financing activities during the three months ended March 31, 2025 was $0.2 million. This consisted of proceeds from the exercise of stock options.
Rearranged previous paragraphs (3)

Previous report — wording carried elsewhere

The following table summarizes our results of operations for the periods indicated:

Previous report — wording carried elsewhere

The following table summarizes our research and development expenses for the periods indicated:

Previous report — wording carried elsewhere

On August 13, 2025, we filed a prospectus supplement to the Automatic Shelf Registration Statement that covers the offering, issuance and sale of up to $200.0 million of our common stock under the Sales Agreement. Following the filing of such prospectus supplement and the termination of our prior shelf registration statement and prior prospectus supplement, there was $200.0 million of common stock available for sale under the Sales Agreement.