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 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 plan to explore 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 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.

Previous 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. 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 a private placement (the "Private Placement") common stock and pre-funded warrants to purchase shares of our common stock (the "Pre-Funded Warrants"), resulting in aggregate gross proceeds of $90.0 million. Through March 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 March 31, 2025, we had cash, cash equivalents and marketable securities of $289.6 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") of common stock and pre-funded warrants to purchase shares of our common stock, resulting in aggregate gross proceeds of $230.0 million. Through June 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 June 30, 2025, we had cash, cash equivalents and marketable securities of $490.5 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 March 31, 2025, we had an accumulated deficit of $272.0 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 $28.5 million for the three months ended March 31, 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 June 30, 2025, we had an accumulated deficit of $297.4 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 $53.9 million for the six months ended June 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.

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 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

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, 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 inflation, instability in the banking and financial sector, tightening of the credit markets, the Russia-Ukraine conflict, widening 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, including for outsourced professional scientific development services, consulting research and sponsored research.

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 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, widening 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 $24.9 million for the three months ended March 31, 2025 compared to $20.0 million for the three months ended March 31, 2024, an increase of $4.9 million. The increase was primarily due to increases in external research and development costs, consisting of $0.9 million in ELVN-002 costs and $0.3 million in ELVN-001 costs due to progression of clinical trials and an increase of $1.3 million in other external costs primarily related to higher research costs, as well as increases in internal research and development costs, consisting of $1.2 million in stock-based compensation and $1.2 million in salaries and benefits.

Current wording

Research and development expenses were $21.5 million for the three months ended June 30, 2025 compared to $18.8 million for the three months ended June 30, 2024, an increase of $2.7 million. The increase was primarily due to an increase in internal research and development costs, consisting of $1.5 million in salaries and benefits, $1.3 million in stock-based compensation and $0.1 million in other internal costs, and a net decrease in external research and development costs, consisting of a decrease of $3.2 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 $2.1 million in ELVN-001 costs due to clinical progression and $0.9 million in other external costs primarily related to higher research costs.

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 Securities and Exchange Commission (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 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, 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 March 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 March 31, 2025 and December 31, 2024, 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 March 31, 2025 and December 31, 2024, there was $160.0 million of our common stock available for sale under the Sales Agreement.

Current wording

On June 23, 2023, we filed a shelf registration statement on Form S-3 with the Securities and Exchange Commission (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, and on June 13, 2025, we filed a related registration statement on Form S-3MEF, which increased the limit of our equity and debt offerings by an additional $40.0 million. 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, 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 June 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 June 30, 2025 and December 31, 2024, there was $10.0 million and $200.0 million, respectively, 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 June 30, 2025 and December 31, 2024, there was $160.0 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 March 31, 2025, we had cash, cash equivalents and marketable securities of $289.6 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 June 30, 2025, we had cash, cash equivalents and marketable securities of $490.5 million.

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

Current wording

Net cash used in operating activities during the six months ended June 30, 2025 was $41.2 million. This consisted primarily of a net loss of $53.9 million and net cash outflows from changes in our operating assets and liabilities of $2.2 million (primarily due to a net 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 $14.5 million and other non-cash charges of $0.4 million.

Previous wording

Net cash used in operating activities during the three months ended March 31, 2024 was $23.4 million. This consisted primarily of a net loss of $22.7 million, net cash outflows from changes in our operating assets and liabilities of $4.6 million (primarily due to an increase in prepaids and other assets and a net decrease in accounts payable and accrued expenses and other liabilities) and non-cash amortization of premiums and discounts on marketable securities of $0.7 million, partially offset by non-cash charges for stock-based compensation of $4.5 million and other non-cash charges of $0.1 million.

Current wording

Net cash used in operating activities during the six months ended June 30, 2024 was $43.8 million. This consisted primarily of a net loss of $42.7 million, net cash outflows from changes in our operating assets and liabilities of $9.0 million (primarily due to an increase in prepaids and other assets and a net decrease in accounts payable and accrued expenses and other liabilities), non-cash amortization of premiums and discounts on marketable securities of $1.3 million and non-cash change in the fair value of the contingent value right liability of $0.8 million, partially offset by non-cash charges for stock-based compensation of $9.7 million and other non-cash charges of $0.3 million.

Previous wording

Net cash used in investing activities during the three months ended March 31, 2024 was $17.9 million. This consisted primarily of cash used to purchase marketable securities of $56.8 million, partially offset by proceeds from maturities of marketable securities of $38.9 million.

Current wording

Net cash used in investing activities during the six months ended June 30, 2025 was $182.2 million. This consisted primarily of cash used to purchase marketable securities of $299.4 million and purchases of property and equipment of $0.2 million, partially offset by proceeds from maturities of marketable securities of $117.4 million.

Previous wording

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

Current wording

Net cash used in investing activities during the six months ended June 30, 2024 was $51.6 million. This consisted primarily of cash used to purchase marketable securities of $177.6 million, partially offset by proceeds from maturities of marketable securities of $116.1 million and receipt of the contingent value right milestone payment of $10.0 million.

Previous wording

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

Current wording

Net cash provided by financing activities during the six months ended June 30, 2025 was $218.6 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 $216.6 million (excluding the payment of estimated accrued costs of approximately $0.4 million), proceeds from the exercise of stock options of $1.6 million and proceeds from the issuance of common stock under our employee stock purchase plan of $0.4 million.

Previous wording

Net cash provided by financing activities during the three months ended March 31, 2024 was $90.3 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 $90.0 million and proceeds from the exercise of stock options of $0.3 million.

Current wording

Net cash provided by financing activities during the six months ended June 30, 2024 was $92.1 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 $2.1 million and proceeds from the issuance of common stock under our employee stock purchase plan of $0.3 million.