Enliven Therapeutics, Inc.

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 two product candidates, ELVN-001 and ELVN-002, as well as pursuing several additional research stage opportunities that align with our development approach.

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. 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 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.

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 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

We also do not own or operate, and currently have no plans to establish, any manufacturing facilities. We rely, and expect to continue to rely, on third parties for the manufacture of our product candidates for clinical and preclinical testing, as well as for commercial manufacturing, should any of our product candidates obtain marketing approval. We believe that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment and personnel, while also enabling us to focus our expertise and resources on the development of our product candidates. In addition, we generally expect to rely on third parties for the manufacture of any companion diagnostics we may develop.

Current wording

We do not own or operate, and currently have no plans to establish, any manufacturing facilities. We rely, and expect to continue to rely, on third parties for the manufacture of our product candidates for clinical and preclinical testing, as well as for commercial manufacturing, should any of our product candidates obtain marketing approval. We believe that this strategy allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment and personnel, while also enabling us to focus our expertise and resources on the development of our product candidates.

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 the Private Placement common stock and Pre-Funded Warrants, resulting in aggregate gross proceeds of $90.0 million. Through December 31, 2024, we have sold shares of our common stock pursuant to the Sales Agreement and received gross proceeds of $40.0 million. As of December 31, 2024, we had cash, cash equivalents and marketable securities of $313.4 million.

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 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 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 December 31, 2025, we have sold shares of our common stock pursuant to the Sales Agreement and received gross proceeds of $40.0 million. As of December 31, 2025, we had cash, cash equivalents and marketable securities of $462.6 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-K.

Previous wording

As of December 31, 2024, we had an accumulated deficit of $243.5 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. 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 December 31, 2025, we had an accumulated deficit of $347.2 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. 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

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

contract for supplies and drug product for use in potential combination studies;

Current wording

contract for supplies and drug product for use in potential combination studies or in comparator arms of clinical trials;

Previous wording

We do not have any products approved for commercial sale, and we have not generated any revenue from product sales or other sources. Our ability to generate product revenue sufficient to achieve and maintain profitability will depend upon the successful development and eventual commercialization of one or more of our product candidates, which we expect, if it ever occurs, will take many years. We will therefore require substantial additional capital to develop our product candidates and support our continuing operations. Accordingly, until such time that we can generate a sufficient amount of revenue from product sales, combination drug products, companion diagnostics or other sources, if ever, we expect to finance our operations through equity or debt financings, loans or other capital sources, which could include income from collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. However, we may be unable to raise additional capital from these sources on favorable terms, or at all. Our failure to obtain sufficient capital on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to delay, reduce or curtail our research, product development or future commercialization efforts. We may also be required to license rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. We cannot provide assurance that we will ever generate positive cash flow from operating activities.

Current wording

We do not have any products approved for commercial sale, and we have not generated any revenue from product sales or other sources. Our ability to generate product revenue sufficient to achieve and maintain profitability will depend upon the successful development and eventual commercialization of one or more of our product candidates, which we expect, if it ever occurs, will take many years. We will therefore require substantial additional capital to develop our product candidates and support our continuing operations. Accordingly, until such time that we can generate a sufficient amount of revenue from product sales, companion diagnostics or other sources, if ever, we expect to finance our operations through equity or debt financings, loans or other capital sources, which could include income from collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants. However, we may be unable to raise additional capital from these sources on favorable terms, or at all. Our failure to obtain sufficient capital on acceptable terms when needed could have a material adverse effect on our business, results of operations or financial condition, including requiring us to delay, reduce or curtail our research, product development or future commercialization efforts. We may also be required to license rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose. We cannot provide assurance that we will ever generate positive cash flow from operating activities.

Previous wording

On October 13, 2022, we entered into the Merger Agreement with Former Enliven and Merger Sub. Pursuant to the Merger Agreement, Merger Sub merged with and into Former Enliven, with Former Enliven continuing as our wholly owned subsidiary and the surviving corporation of the Merger. The Merger was intended to qualify for U.S. federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the IRC. In the event that Former Enliven stockholders, including stockholders that participated in the Financing Transaction where an aggregate of $164.5 million of common stock of Former Enliven was purchased, were in “control” of us immediately after the Merger (within the meaning of Section 368(c) of the IRC), the Merger was also intended to qualify as a non-taxable exchange of shares of Former Enliven common stock for shares of our common stock within the meaning of Section 351(a) of the IRC.

Current wording

On October 13, 2022, we entered into the Merger Agreement with Former Enliven and Merger Sub. Pursuant to the Merger Agreement, Merger Sub merged with and into Former Enliven, with Former Enliven continuing as our wholly owned subsidiary and the surviving corporation of the Merger. Immediately following the Merger, we changed our name to Enliven Therapeutics, Inc.

Previous wording

We are monitoring macroeconomic and geopolitical developments, such as inflation, instability in the banking and financial sector, tightening of the credit markets, the Russia-Ukraine conflict, widening conflict in the Middle East, public health emergencies/epidemics and the new 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 a potential 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.

Previous wording

the cost to acquire drug product for use in combination studies; and

Current wording

the cost to acquire drug product for use in combination studies and for comparator arms of clinical trials; and

Previous wording

payments to third parties in connection with the preclinical development of our product candidates and any required companion diagnostics, including for outsourced professional scientific development services, consulting research and sponsored research.

Current wording

payments to third parties in connection with the preclinical development of our product candidates and any required companion diagnostic, including for outsourced professional scientific development services, consulting research and sponsored research.

Previous wording

the impact of any business interruptions to our operations or to those of the third parties with whom we work, including due to any public health emergency, health epidemic (including COVID-19) or other outbreaks, natural disasters, or other disruptions;

Current wording

the impact of any business interruptions to our operations or to those of the third parties with whom we work, including due to any government shutdowns, public health emergency, health epidemic (including COVID-19) or other outbreaks, natural disasters, or other disruptions;

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, widening conflict in the Middle East, national security concerns and related legislation related to business operations in China and other countries and the new 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, 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

Previous wording

Research and development expenses were $80.8 million for the year ended December 31, 2024 compared to $64.6 million for the year ended December 31, 2023, an increase of $16.2 million. This increase was primarily due to increases in external research and development costs, consisting of $10.0 million in ELVN-002 costs and $1.8 million in ELVN-001 costs due to progression of clinical trials, partially offset by a decrease of $3.0 million in other external costs primarily related to lower research costs net of higher consulting costs, as well as increases in internal research and development costs, consisting of $4.0 million in stock-based compensation and $3.4 million in salaries and benefits.

Current wording

Research and development expenses were $85.9 million for the year ended December 31, 2025 compared to $80.8 million for the year ended December 31, 2024, an increase of $5.1 million. The increase was primarily due to higher internal research and development costs, consisting of $4.3 million in stock-based compensation, $3.6 million in salaries and benefits, and $0.3 million in other internal costs. This increase was partially offset by lower external research and development costs, driven by a decrease of $12.8 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 $7.8 million in ELVN-001 costs due to clinical progression and $1.9 million in other external costs primarily related to higher research costs.

Previous wording

General and administrative expenses were $23.8 million for the year ended December 31, 2024 compared to $19.0 million for the year ended December 31, 2023, an increase of $4.8 million. The increase was primarily due to an increase of $4.5 million in stock-based compensation primarily related to higher valuations on equity grants and $2.1 million in salaries and benefits, partially offset by a decrease of $1.3 million in stock-based compensation as a result of the acceleration of stock option vesting in connection with the Merger in February 2023 and $0.5 million in other costs.

Current wording

General and administrative expenses were $33.8 million for the year ended December 31, 2025 compared to $23.8 million for the year ended December 31, 2024, an increase of $10.0 million. The increase was primarily due to an increase of $9.6 million in stock-based compensation, largely attributable to modifications to certain equity awards and higher valuations on equity grants, as well as an increase of $0.4 million in professional fees and other costs.

Previous wording

Other income was $15.5 million for the year ended December 31, 2024 compared to $11.9 million for the year ended December 31, 2023, an increase of $3.6 million. The increase was primarily related to higher interest income of $2.9 million due to higher interest rates and higher investment balances and a gain of $0.9 million related to the change in fair value of the CVR liability upon remeasurement, partially offset by income tax expense of $0.2 million related to the CVR milestone payment.

Current wording

Other income was $16.0 million for the year ended December 31, 2025 compared to $15.5 million for the year ended December 31, 2024, an increase of $0.5 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 and lower income tax expense of $0.2 million related to the CVR milestone payment in 2024, partially offset by a lower gain of $0.9 million related to the change in fair value of the CVR liability upon remeasurement in 2024.

Previous wording

Since our inception, we have not generated any revenue from product sales or other sources and have incurred significant operating losses and negative cash flows from our operations. Former Enliven funded its operations primarily through private placements of its convertible preferred stock for gross proceeds of $140.5 million and sale of common stock in the Financing Transaction in February 2023 for gross proceeds of $164.5 million. In March 2024, we sold common stock and Pre-Funded Warrants in the Private Placement and received aggregate gross proceeds of $90.0 million.

Current wording

Since our inception, we have not generated any revenue from product sales or other sources and have incurred significant operating losses and negative cash flows from our operations. Former Enliven funded its operations primarily through private placements of its convertible preferred stock for gross proceeds of $140.5 million and sale of common stock in the Financing Transaction in February 2023 for gross proceeds of $164.5 million. In March 2024, we sold common stock and pre-funded warrants in the Private Placement and received aggregate gross proceeds of $90.0 million, and in June 2025, we completed the Public Offering where we sold common stock and pre-funded warrants, resulting in aggregate gross proceeds of $230.0 million.

Previous wording

On June 23, 2023, we filed a shelf registration statement on Form S-3 with the SEC, which was declared effective by the SEC on July 3, 2023, which allows us to undertake various equity and debt offerings up to $400.0 million. On June 23, 2023, we also entered into the Sales Agreement with the Sales Agent, pursuant to which we may offer and sell shares of our common stock, from time to time, having an aggregate offering price of up to $200.0 million 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. Sales of our common stock made pursuant to the Sales Agreement are made under our shelf registration statement on Form S-3. Through December 31, 2024, we have sold shares of our common stock pursuant to the Sales Agreement and received gross proceeds of $40.0 million. As of December 31, 2024 and 2023, there was $200.0 million available for use under the shelf registration statement on Form S-3, excluding our common stock that may be offered under the Sales Agreement. As of December 31, 2024 and 2023, there was $160.0 million and $200.0 million, respectively, of our common stock available for sale under the Sales Agreement.

Current wording

On June 23, 2023, we entered into the Sales Agreement with 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 the Automatic Shelf Registration Statement with 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.

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 December 31, 2024, we had cash, cash equivalents and marketable securities of $313.4 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 December 31, 2025, we had cash, cash equivalents and marketable securities of $462.6 million.

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

the cost of developing a companion diagnostic;

Current wording

the cost of developing a companion diagnostic, if required for regulatory approval of any product;

Previous wording

the cost of acquiring drug product for any combination studies;

Current wording

the cost of acquiring drug product for any combination studies or comparator arms of clinical trials;

Previous wording

Net cash used in operating activities during the year ended December 31, 2023 was $61.3 million. This consisted primarily of a net loss of $71.6 million and non-cash amortization of premiums and discounts on marketable securities of $4.6 million, partially offset by non-cash charges for stock-based compensation of $12.9 million, net cash inflows from changes in our operating assets and liabilities of $1.4 million (primarily due to a net increase in accounts payable and accrued expenses and other liabilities, partially offset by an increase in prepaids and other assets) and other non-cash charges of $0.6 million.

Current wording

Net cash used in operating activities during the year ended December 31, 2025 was $70.3 million. This consisted primarily of a net loss of $103.7 million and net cash outflows from changes in our operating assets and liabilities of $1.1 million (primarily due to an increase in prepaids and other assets), partially offset by non-cash charges for stock-based compensation of $34.0 million and other non-cash charges of $0.5 million.

Previous wording

Net cash used in investing activities during the year ended December 31, 2023 was $148.4 million. This consisted primarily of cash used to purchase marketable securities of $268.3 million, partially offset by proceeds from maturities of marketable securities of $120.0 million.

Current wording

Net cash used in investing activities during the year ended December 31, 2025 was $173.8 million. This consisted primarily of cash used to purchase marketable securities of $446.8 million, partially offset by proceeds from maturities of marketable securities of $272.9 million.

Previous wording

Net cash used in financing activities during the year ended December 31, 2023 was $234.3 million. This consisted primarily of net proceeds of $161.4 million resulting from the sale of shares of our common stock in the Financing Transaction, net cash acquired in connection with the reverse recapitalization of $73.1 million, and proceeds from the exercise of stock options of $0.4 million, partially offset by deferred offering costs related to the Sales Agreement of $0.6 million.

Current wording

Net cash provided by financing activities during the year ended December 31, 2025 was $218.9 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 $2.3 million and proceeds from the issuance of common stock under our employee stock purchase plan of $0.6 million, partially offset by the payment of deferred offering costs of $0.2 million.

Previous wording

Net cash provided by financing activities during the year ended December 31, 2024 was $133.2 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, net proceeds from the sale of shares of our common stock pursuant to the Sales Agreement of $39.2 million, proceeds from the exercise of stock options of $3.6 million and proceeds from the issuance of common stock under our employee stock purchase plan of $0.7 million.

Current wording

Net cash used in financing activities during the year ended December 31, 2024 was $133.2 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, net proceeds from the sale of shares of our common stock pursuant to the Sales Agreement of $39.2 million, proceeds from the exercise of stock options of $3.6 million and proceeds from the issuance of common stock under our employee stock purchase plan of $0.7 million.

Previous wording

In September 2024, we entered into the Lease, which is a non-cancellable operating lease. 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. The Lease replaces our previous sublease for more space in the same location.

Current wording

In September 2024, we entered into the Lease, which is a non-cancellable operating lease. 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.