Enliven Therapeutics Inc

Previous wording

We are a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer 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 which we believe supports the development of our product candidates by increasing our probability of success. We have assembled a team of seasoned drug hunters with significant expertise in discovery and development of small molecule kinase inhibitors. Our team includes leading chemists who have been the primary or co-inventor of over 20 product candidates that have been advanced to clinical trials, including four FDA-approved products: Koselugo (selumetinib), Mektovi (binimetinib), Tukysa (tucatinib), and Retevmo (selpercatinib). We are currently advancing two parallel lead product candidates, ELVN-001 and ELVN-002, as well as pursuing several additional research stage opportunities that align with our development approach. We also nominated our third product candidate in the second quarter of 2023.

Current wording

We are a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer 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 which we believe supports the development of our product candidates by increasing our probability of success. We have assembled a team of seasoned drug hunters with significant expertise in discovery and development of small molecule kinase inhibitors. Our team includes leading chemists who have been the primary or co-inventor of over 20 product candidates that have been advanced to clinical trials, including four FDA-approved products: Koselugo (selumetinib), Mektovi (binimetinib), Tukysa (tucatinib), and Retevmo (selpercatinib). We are currently advancing two parallel lead product candidates, ELVN-001 and ELVN-002, as well as pursuing several additional research stage opportunities that align with our development approach, including a program for which we previously nominated a development candidate and completed IND-enabling studies for that candidate.

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. As of March 31, 2024, we had cash, cash equivalents and marketable securities of $320.5 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.

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 (the "Pre-Funded Warrants"), resulting in aggregate gross proceeds of $90.0 million. As of June 30, 2024, we had cash, cash equivalents and marketable securities of $312.4 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 March 31, 2024, we had an accumulated deficit of $177.2 million. We have incurred significant losses and negative cash flows from operations since inception, including net losses of $71.6 million and $37.7 million for the years ended December 31, 2023 and 2022, respectively, and $22.7 million for the three months ended March 31, 2024. 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, 2024, we had an accumulated deficit of $197.1 million. We have incurred significant losses and negative cash flows from operations since inception, including net losses of $71.6 million and $37.7 million for the years ended December 31, 2023 and 2022, respectively, and $42.7 million for the six months ended June 30, 2024. 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

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 and Israel-Hamas conflicts, and COVID-19, 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 and Israel-Hamas conflicts, COVID-19 and the upcoming U.S. presidential election, so that we may be prepared to react to new developments as they arise.

Previous wording

The extent of the impact of these developments on our business, operations and research and development timelines and plans remains uncertain and will depend on numerous factors, including the impact, if any, on our personnel, the responses of governmental entities, and the responses of third parties, such as contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”) and other third parties with whom we do business. Any prolonged material disruption to our employees or suppliers could adversely impact our development activities, financial condition and results of operations, including our ability to obtain financing. As a result of COVID-19, Pharmaron, a contract research organization that we use to conduct preclinical studies and clinical trials and provide us with active pharmaceutical ingredients (“APIs”), has previously experienced delays, which resulted in minor delays in our preclinical studies. For more information regarding the risks related to macroeconomic and geopolitical developments, see the section titled “Risk Factors” found elsewhere in this quarterly report on Form 10-Q.

Current wording

The extent of the impact of these developments on our business, operations and research and development timelines and plans remains uncertain and will depend on numerous factors, including the impact, if any, on our personnel, the responses of governmental entities, and the responses of third parties, such as contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”) and other third parties with whom we do business. Any prolonged material disruption to our employees or suppliers could adversely impact our development activities, financial condition and results of operations, including our ability to obtain financing. For more information regarding the risks related to macroeconomic and geopolitical developments, see the section titled “Risk Factors” found elsewhere in this quarterly report on Form 10-Q.

Previous wording

our ability to acquire drug supply for any combination products and the cost of such drug supply;

Current wording

our ability to acquire drug supply for any products, the cost of such drug supply, and any delays in connection with obtaining such drug supply;

Previous wording

the impact of any supply chain disruptions resulting from macroeconomic or geopolitical situations, including the COVID-19 pandemic, the Russia-Ukraine and Israel-Hamas conflicts; and

Current wording

the impact of any supply chain disruptions resulting from macroeconomic or geopolitical situations, including the COVID-19 pandemic, the Russia-Ukraine and Israel-Hamas conflicts and the upcoming U.S. presidential election; and

Previous wording

Interest income primarily consists of interest earned on our cash, cash equivalents and marketable securities.

Current 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 liability and income tax expense.

Previous wording

Research and development expenses were $20.0 million for the three months ended March 31, 2024 compared to $11.9 million for the three months ended March 31, 2023, an increase of $8.1 million. This increase was primarily due to increases in external research and development costs, consisting primarily of $3.4 million in clinical trial expenses, $1.9 million in contract manufacturing expenses and $0.6 million in consulting costs, partially offset by a decrease of $0.4 million in preclinical costs, as well as increases in internal research and development costs, consisting of $1.7 million in stock-based compensation and $0.9 million in salaries and benefits.

Current wording

Research and development expenses were $18.8 million for the three months ended June 30, 2024 compared to $15.2 million for the three months ended June 30, 2023, an increase of $3.6 million. The increase was primarily due to increases in external research and development costs, consisting primarily of $2.1 million in clinical trial expenses, $0.8 million in contract manufacturing expenses and $0.6 million in consulting costs, partially offset by a decrease of $0.4 million in preclinical costs, as well as increases in internal research and development costs, consisting of $0.3 million in stock-based compensation and $0.2 million in salaries and benefits.

Previous wording

Other income was $3.2 million for the three months ended March 31, 2024 compared to $1.7 million for the three months ended March 31, 2023. The increase was primarily related to higher interest income due to higher interest rates and higher investment balances.

Current wording

Other income was $4.7 million for the three months ended June 30, 2024 compared to $3.4 million for the three months ended June 30, 2023, an increase of $1.3 million. The increase was primarily related to a gain of $0.8 million related to the change in fair value of the contingent value right liability upon remeasurement in June 2024 and higher interest income of $0.7 million due to higher interest rates and higher investment balances, partially offset by the accrual of income taxes payable of $0.2 million related to the contingent value right milestone payment.

Previous wording

General and administrative expenses were $6.0 million for the three months ended March 31, 2024 compared to $4.5 million for the three months ended March 31, 2023, an increase of $1.5 million. The increase was primarily due to an increase of $1.8 million in stock-based compensation primarily related to higher valuations on equity grants, $0.7 million in salaries and benefits and $0.3 million in other expenses, 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.

Current wording

General and administrative expenses were $11.8 million for the six months ended June 30, 2024 compared to $9.5 million for the six months ended June 30, 2023, an increase of $2.3 million. The increase was primarily due to an increase of $2.4 million in stock-based compensation primarily related to higher valuations on equity grants and $1.2 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.

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. As of March 31, 2024, we had cash, cash equivalents and marketable securities of $320.5 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. As of June 30, 2024, we had cash, cash equivalents and marketable securities of $312.4 million.

Previous wording

Net cash used in operating activities during the three months ended March 31, 2023 was $20.8 million. This consisted primarily of a net loss of $14.7 million and net cash outflows from changes in our operating assets and liabilities of $8.4 million (primarily due to an increase in prepaids and other assets and a net decrease in accounts payable and accrued expenses and other liabilities), partially offset by non-cash charges for stock-based compensation of $2.3 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 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, 2023 was $32.9 million. This consisted primarily of a net loss of $31.4 million, net cash outflows from changes in our operating assets and liabilities of $7.2 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 $0.8 million, partially offset by non-cash charges for stock-based compensation of $6.5 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, 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 used in investing activities during the three months ended March 31, 2023 was $31,000. This consisted primarily of cash used to purchase property and equipment.

Current wording

Net cash used in investing activities during the six months ended June 30, 2023 was $151.5 million. This consisted primarily of cash used to purchase marketable securities.

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.

Previous wording

Net cash provided by financing activities during the three months ended March 31, 2023 was $237.4 million. This consisted primarily of net proceeds from the sale of shares of our common stock in the Financing Transaction of $162.9 million, net cash acquired in connection with the reverse recapitalization of $74.4 million, and proceeds from the exercise of stock options of $0.1 million.

Current wording

Net cash provided by financing activities during the six months ended June 30, 2023 was $234.6 million. This consisted primarily of net proceeds from the sale of shares of our common stock in the Financing Transaction of $161.4 million and net cash acquired in connection with the reverse recapitalization of $73.1 million.