Enliven Therapeutics, Inc.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
View on SEC.govAbout 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.
Sep 30, 2026 · Filed Nov 5, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-05.
0001193125-26-335155
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001193125-26-449870
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 165 previous paragraphs and 164 current paragraphs.
145 unchanged; 18 reworded; 1 added; 1 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 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 (1)
Current report
Comparison of the nine months ended September 30, 2026 and 2025
Removed paragraphs (1)
Previous report
Comparison of the six months ended June 30, 2026 and 2025
Reworded paragraphs (18)
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 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, including preparations for our planned ELVN-001 pivotal trial, as well as pursuing 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.
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 relcobatinib, including preparations for our planned ENABLE-2 Phase 3 pivotal trial, as well as pursuing additional research-stage opportunities that align with our small molecule development approach.
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. In June 2025, we completed an underwritten public offering (the "2025 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. In June 2026, we completed an underwritten public offering (the "2026 Public Offering") where we sold common stock and pre-funded warrants to purchase shares of our common stock, resulting in aggregate gross proceeds of $460.0 million. Through June 30, 2026, we have sold shares of our common stock pursuant to the Sales
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. In June 2025, we completed an underwritten public offering (the "2025 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. In June 2026, we completed an underwritten public offering (the "2026 Public Offering") where we sold common stock and pre-funded warrants to purchase shares of our common stock, resulting in aggregate gross proceeds of $460.0 million. Through September 30, 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 September 30, 2026, we had cash, cash equivalents and marketable securities of $884.4 million. Based on our current operating plan, which includes the continued advancement of relcobatinib and preparations for our planned pivotal trial, 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 June 30, 2026, we had an accumulated deficit of $403.3 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 $56.1 million for the six months ended June 30, 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.
Current wording
As of September 30, 2026, we had an accumulated deficit of $431.0 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 $83.8 million for the nine months ended September 30, 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
make changes to our clinical development plan for ELVN-001;
Current wording
make changes to our clinical development plan for relcobatinib;
Previous wording
Research and development expenses were $29.0 million for the three months ended June 30, 2026 compared to $21.5 million for the three months ended June 30, 2025, an increase of $7.5 million. The increase was due to higher internal research and development costs, consisting of $5.5 million in stock-based compensation, largely attributable to modifications to certain equity awards and higher valuations on equity grants, and $1.1 million in salaries and benefits, and higher external research and development costs, driven by an increase of $2.3 million in ELVN-001 costs due to clinical progression and $0.9 million in other external costs mainly related to higher consulting costs, partially offset by a decrease of $2.3 million in ELVN-002 costs due to our decision not to pursue further development of the program.
Current wording
Research and development expenses were $28.0 million for the three months ended September 30, 2026 compared to $18.2 million for the three months ended September 30, 2025, an increase of $9.8 million. The increase was due to higher external research and development costs, driven by an increase of $7.3 million in relcobatinib costs due to clinical progression and $1.3 million in other external costs, partially offset by a decrease of $1.3 million in ELVN-002 costs due to our decision not to pursue further development of the program, and higher internal research and development costs, consisting of $1.4 million in salaries and benefits and $1.1 million in stock-based compensation.
Previous wording
General and administrative expenses were $8.2 million for the three months ended June 30, 2026 compared to $7.1 million for the three months ended June 30, 2025, an increase of $1.1 million. The increase was driven by higher stock-based compensation of $0.7 million and salaries and benefits of $0.5 million, partially offset by lower other costs of $0.1 million.
Current wording
General and administrative expenses were $8.0 million for the three months ended September 30, 2026 compared to $6.9 million for the three months ended September 30, 2025, an increase of $1.1 million. The increase was driven by higher professional fees of $0.8 million and other costs of $0.3 million.
Previous wording
Other income was $4.7 million for the three months ended June 30, 2026 compared to $3.2 million for the three months ended June 30, 2025, an increase of $1.5 million. The increase was driven by higher interest income due to a higher investment balance net of lower interest rates.
Current wording
Other income was $8.3 million for the three months ended September 30, 2026 compared to $4.9 million for the three months ended September 30, 2025, an increase of $3.4 million. The increase was driven by higher interest income due to a higher investment balance net of lower interest rates.
Previous wording
Research and development expenses were $49.7 million for the six months ended June 30, 2026 compared to $46.4 million for the six months ended June 30, 2025, an increase of $3.3 million. The increase was due to higher internal research and development costs, consisting of $6.2 million in stock-based compensation, largely attributable to modifications to certain equity awards and higher valuations on equity grants, and $1.4 million in salaries and benefits, partially offset by a decrease of $0.3 million in other internal costs. This increase was partially offset by lower external research and development costs, driven by a decrease of $9.3 million in ELVN-002 costs due to our decision not to pursue further development of the program, partially offset by an increase of $5.1 million in ELVN-001 costs due to clinical progression and $0.2 million in other external costs.
Current wording
Research and development expenses were $77.7 million for the nine months ended September 30, 2026 compared to $64.6 million for the nine months ended September 30, 2025, an increase of $13.1 million. The increase was due to higher internal research and development costs, consisting of $7.3 million in stock-based compensation, largely attributable to modifications to certain equity awards and higher valuations on equity grants, and $2.7 million in salaries and benefits, partially offset by a decrease of $0.2 million in other internal costs, and higher external research and development costs, driven by an increase of $12.4 million in relcobatinib costs due to clinical progression and $1.5 million in other external costs, partially offset by a decrease of $10.6 million in ELVN-002 costs due to our decision not to pursue further development of the program.
Previous wording
General and administrative expenses were $15.3 million for the six months ended June 30, 2026 compared to $13.9 million for the six months ended June 30, 2025, an increase of $1.4 million. The increase was driven by higher salaries and benefits of $1.3 million and stock-based compensation of $0.5 million, partially offset by lower consulting costs of $0.4 million.
Current wording
General and administrative expenses were $23.4 million for the nine months ended September 30, 2026 compared to $20.8 million for the nine months ended September 30, 2025, an increase of $2.6 million. The increase was driven by higher salaries and benefits of $1.6 million, professional fees of $0.4 million, stock-based compensation of $0.3 million and other costs of $0.3 million.
Previous wording
Other income was $8.9 million for the six months ended June 30, 2026 compared to $6.4 million for the six months ended June 30, 2025, an increase of $2.5 million. The increase was driven by higher interest income due to a higher investment balance net of lower interest rates.
Current wording
Other income was $17.3 million for the nine months ended September 30, 2026 compared to $11.3 million for the nine months ended September 30, 2025, an increase of $6.0 million. The increase was driven by higher interest income due to a higher investment balance net of lower interest rates.
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 June 30, 2026, we had cash, cash equivalents and marketable securities of $895.2 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 (relcobatinib) and HER2 (ELVN-002) 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, 2026, we had cash, cash equivalents and marketable securities of $884.4 million.
Previous wording
Net cash used in operating activities during the six months ended June 30, 2025 was $41.2 million. This consisted of a net loss of $53.9 million and net cash outflows from changes in our operating assets and liabilities of $2.2 million (mainly 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 noncash charges for stock-based compensation of $14.5 million and other noncash charges of $0.4 million.
Current wording
Net cash used in operating activities during the nine months ended September 30, 2026 was $50.4 million. This consisted of a net loss of $83.8 million, partially offset by noncash charges for stock-based compensation of $29.4 million, net cash inflows from changes in our operating assets and liabilities of $3.9 million (mainly due to an increase in accounts payable and accrued expenses and other liabilities and a decrease in prepaids and other assets), and other noncash charges of $0.1 million.
Previous wording
Net cash used in operating activities during the six months ended June 30, 2026 was $37.8 million. This consisted of a net loss of $56.1 million and net cash outflows from changes in our operating assets and liabilities of $4.0 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 $21.3 million and other noncash charges of $1.0 million.
Current wording
Net cash used in operating activities during the nine months ended September 30, 2025 was $54.5 million. This consisted of a net loss of $74.0 million and net cash outflows from changes in our operating assets and liabilities of $2.3 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 $21.7 million and other noncash charges of $0.1 million.
Previous wording
Net cash used in investing activities during the six months ended June 30, 2025 was $182.2 million. This consisted 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.
Current wording
Net cash used in investing activities during the nine months ended September 30, 2026 was $372.7 million. This consisted of cash used to purchase marketable securities of $672.0 million and purchases of property and equipment of $0.2 million, partially offset by proceeds from maturities of marketable securities of $299.5 million.
Previous wording
Net cash used in investing activities during the six months ended June 30, 2026 was $399.0 million. This consisted of cash used to purchase marketable securities of $626.0 million and purchases of property and equipment of $0.1 million, partially offset by proceeds from maturities of marketable securities of $227.1 million.
Current wording
Net cash used in investing activities during the nine months ended September 30, 2025 was $186.2 million. This consisted 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.
Previous wording
Net cash provided by financing activities during the six months ended June 30, 2025 was $218.6 million. This consisted of net proceeds from the sale of shares of our common stock and pre-funded warrants in the 2025 Public Offering of $216.6 million (excluding the payment of 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.
Current wording
Net cash provided by financing activities during the nine months ended September 30, 2026 was $475.9 million. This consisted of net proceeds from the sale of shares of our common stock and pre-funded warrants in the 2026 Public Offering of $432.8 million, proceeds from the exercise of stock options of $42.7 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 six months ended June 30, 2026 was $473.5 million. This consisted of net proceeds from the sale of shares of our common stock and pre-funded warrants in the 2026 Public Offering of $433.5 million (excluding the payment of accrued costs of approximately $0.7 million), proceeds from the exercise of stock options of $39.6 million and proceeds from the issuance of common stock under our employee stock purchase plan of $0.4 million.
Current wording
Net cash provided by financing activities during the nine months ended September 30, 2025 was $218.2 million. This consisted of net proceeds from the sale of shares of our common stock and pre-funded warrants in the 2025 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.
Previous 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.
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. We do not intend to exercise the renewal option, and the Boulder Lease is expected to expire on December 31, 2026.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Agreement (as defined below) and received gross proceeds of $40.0 million. As of June 30, 2026, we had cash, cash equivalents and marketable securities of $895.2 million. Based on our current operating plan, which includes the continued advancement of ELVN-001 and preparations for our planned pivotal trial, 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.