Kymera Therapeutics Inc

Previous wording

Our current clinical stage programs are IRAK4, STAT3, and MDM2, which each address high impact targets within biologically-proven pathways, providing the opportunity to treat a broad range of immuno-inflammatory diseases, hematologic malignancies, and/or solid tumors. Our programs exemplify our focus on addressing high impact targets that have been elusive to conventional modalities and that drive the pathogenesis of multiple serious diseases with significant unmet medical needs. Our disclosed preclinical programs target STAT6 and TYK2, two proteins in well-validated pathways where we believe our degrader technology has the potential to offer unique advantages as compared to competing therapies. Both programs are currently in IND-enabling studies.

Current wording

Our current clinical stage programs are IRAK4, STAT3, and MDM2, which each address high impact targets within biologically-proven pathways, providing the opportunity to treat a broad range of immuno-inflammatory diseases, hematologic malignancies, and/or solid tumors. Our programs exemplify our focus on addressing high impact targets that have been elusive to conventional modalities and that drive the pathogenesis of multiple serious diseases with significant unmet medical needs. Our disclosed preclinical programs target STAT6 and TYK2, two proteins in well-validated pathways where we believe our degrader technology has the potential to offer unique advantages as compared to competing therapies. We have completed investigational new drug application, or IND-enabling studies for STAT6 and intend to initiate a Phase 1 clinical trial in the second half of 2024. IND-enabling studies for TYK2 are ongoing.

Previous wording

With respect to our IRAK4 program, we are collaborating with Sanofi S.A, or Sanofi, on the development of drug candidates targeting IRAK4 outside the oncology and immuno-oncology fields. We are developing KT-474, a highly active and selective, orally bioavailable IRAK4 degrader, for the treatment of interleukin-1 receptor/toll-like receptor or IL-1R/TLR-driven immunology-inflammation conditions and diseases with high unmet medical need, including hidradenitis suppurativa, or HS, an inflammatory skin disease, as well as atopic dermatitis, or AD, and potentially other indications. We have completed our Phase 1 trial of KT-474, which included cohorts of healthy volunteers, as well as patients with HS and AD. Phase 2 clinical trials of KT-474, conducted by Sanofi, are initially investigating its potential in HS and AD. The clinical trials for both indications have been initiated, and patient dosing is ongoing.

Current wording

With respect to our IRAK4 program, we are collaborating with Sanofi S.A, or Sanofi, on the development of drug candidates targeting IRAK4 outside the oncology and immuno-oncology fields. We are developing KT-474, a highly active and selective, orally bioavailable IRAK4 degrader, for the treatment of interleukin-1 receptor/toll-like receptor or IL-1R/TLR-driven immunology-inflammation conditions and diseases with high unmet medical need, including hidradenitis suppurativa, or HS, an inflammatory skin disease, as well as atopic dermatitis, or AD, and potentially other indications. We have completed our Phase 1 trial of KT-474, which included cohorts of healthy volunteers, as well as patients with HS and AD. Phase 2 clinical trials of KT-474, conducted by Sanofi, are initially investigating its potential in HS and AD. Sanofi has initiated clinical trials for both indications and patient dosing is ongoing.

Previous wording

With respect to our clinical oncology programs, we are evaluating KT-333, a STAT3 degrader, in a Phase 1 clinical trial. The study is evaluating the safety, tolerability, pharmacokinetics (PK)/pharmacodynamics (PD), and clinical activity of KT-333 dosed weekly in adult patients with relapsed and/or refractory lymphomas, leukemias and solid tumors. Patient enrollment and dosing are ongoing in the Phase 1a portion of the trial, and we expect to present additional clinical data in 2024. In September 2023, we announced that the FDA, granted KT-333 Fast Track Designation for the treatment of relapsed/refractory peripheral T cell lymphoma, an indication for which we have previously received Orphan Drug Designation.

Current wording

With respect to our clinical oncology programs, we are evaluating KT-333, a STAT3 degrader, in a Phase 1 clinical trial. The clinical trial is evaluating the safety, tolerability, pharmacokinetics , or PK, pharmacodynamics, or PD, and clinical activity of KT-333 dosed weekly in adult patients with relapsed and/or refractory lymphomas, leukemias and solid tumors. Patient enrollment and dosing are ongoing in the Phase 1a portion of the trial. In June 2024, we presented clinical data which demonstrated strong proof of mechanism and initial clinical proof of concept. In September 2023, we announced that the FDA, granted KT-333 Fast Track Designation for the treatment of relapsed/refractory peripheral T cell lymphoma, an indication for which we have previously received orphan drug designation.

Previous wording

Our Phase 1 clinical trial of KT-253, a MDM2 degrader is evaluating the safety, tolerability, PK/PD, and clinical activity of ascending doses of KT-253 in adult patients with relapsed or refractory high grade myeloid malignancies, acute lymphocytic leukemia, or ALL, lymphomas, and solid tumors. Patient enrollment and dosing are ongoing in the Phase 1a portion of the trial, and we expect to present additional clinical data in 2024. In November, 2023 we provided initial safety, proof-of-mechanism and proof-of-concept data . In June 2023, KT-253 was granted orphan drug designation by the FDA for the treatment of acute myeloid leukemia.

Current wording

Our Phase 1 clinical trial of KT-253, a MDM2 degrader, is evaluating the safety, tolerability, PK, PD, and clinical activity of ascending doses of KT-253 in adult patients with relapsed or refractory high grade myeloid malignancies, acute lymphocytic leukemia, or ALL, lymphomas, and solid tumors. Patient enrollment and dosing are ongoing in the Phase 1a portion of the trial. In June 2024, we presented clinical data which demonstrated strong proof of mechanism and initial clinical proof of concept. In June 2023, KT-253 was granted orphan drug designation by the FDA for the treatment of acute myeloid leukemia.

Previous wording

We have incurred significant operating losses since inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current product candidates or any future product candidates. Our net losses were $147.0 million and $154.8 million for the years ended December 31, 2023 and 2022, respectively. We reported net losses of $48.6 million and $40.9 million for the three months ended March 31, 2024 and 2023, respectively. In addition, as of March 31, 2024 and December 31, 2023 we had an accumulated deficit of $579.3 million and $530.8 million, respectively. We expect that our expense and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

Current wording

We have incurred significant operating losses since inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our current product candidates or any future product candidates. Our net losses were $147.0 million and $154.8 million for the years ended December 31, 2023 and 2022, respectively. We reported net losses of $42.1 million and $38.8 million for the three months ended June 30, 2024 and 2023, respectively and $90.6 million and $79.7 million for the six months ended June 30, 2024 and 2023, respectively. In addition, as of June 30, 2024 and December 31, 2023 we had an accumulated deficit of $621.4 million and $530.8 million, respectively. We expect that our expense and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

Previous wording

As of March 31, 2024, we had cash, cash equivalents and marketable securities of $744.9 million. We believe the existing cash, cash equivalents and marketable securities on hand will be sufficient to fund our operations into the first half of 2027, which is expected to take us beyond the Phase 2 data for KT-474, as well as additional proof-of-concept data for KT-253 and KT-333, and several clinical inflection points for our STAT6 and TYK2 programs. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and capital resources.”

Current wording

As of June 30, 2024, we had cash, cash equivalents and marketable securities of $702.4 million. We believe the existing cash, cash equivalents and marketable securities on hand will be sufficient to fund our operations into the first half of 2027, which is expected to take us beyond the Phase 2 data for KT-474, as well as additional proof-of-concept data for KT-253 and KT-333, and several clinical inflection points for our STAT6 and TYK2 programs. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and capital resources.”

Previous wording

Collaboration revenues were $10.3 million for the three months ended March 31, 2024, the entirety of which is attributable to our collaboration agreement with Sanofi. Collaboration revenues were $9.5 million for the three months ended March 31, 2023, of which $7.7 million and $1.8 million were attributable to our collaboration agreements with Sanofi and Vertex, respectively.

Current wording

Collaboration revenues were $25.7 million for the three months ended June 30, 2024, the entirety of which is attributable to our collaboration agreement with Sanofi. Collaboration revenues were $16.5 million for the three months ended June 30, 2023, of which $9.9 million and $6.6 million were attributable to our collaboration agreements with Sanofi and Vertex, respectively.

Previous wording

Research and development expenses were $48.8 million for the three months ended March 31, 2024, compared to $42.2 million for the three months ended March 31, 2023. The increase of $6.6 million was primarily due to a $5.5 million increase in personnel, stock-based compensation, and occupancy related costs due to increases in employee headcount in the research and development functions and a $2.6 million increase in costs related to our STAT6 and discovery programs. These increases were partially offset by a $1.5 million reduction in activities related to our IRAK4, STAT3 and MDM2 programs.

Current wording

Research and development expenses were $59.2 million for the three months ended June 30, 2024, compared to $45.8 million for the three months ended June 30, 2023. The increase of $13.4 million was primarily due to a $5.5 million increase in personnel, stock-based compensation, occupancy, and other internal costs due to increase investment in employee talent and facilities in the research and development functions and a $12.1 million increase in costs related to our STAT6 and MDM2. These increases were partially offset by a $4.2 million reduction in activities related to our IRAK4, STAT3 and discovery programs.

Previous wording

General and administrative expenses were $14.4 million for the three months ended March 31, 2024, compared to $12.6 million for the three months ended March 31, 2023. This increase was primarily due to an increase in legal and professional service fees, personnel, facility, occupancy, and other expenses to support our growth. Stock based compensation expenses included in general and administrative expenses were $5.8 million and $4.7 million for the three months ended March 31, 2024 and March 31, 2023, respectively.

Current wording

General and administrative expenses were $17.4 million for the three months ended June 30, 2024, compared to $14.1 million for the three months ended June 30, 2023. This increase was primarily due to an increase in legal and professional service fees, personnel, facility, occupancy, and other expenses to support our growth. Stock based compensation expenses included in general and administrative expenses were $7.1 million and $5.5 million for the three months ended June 30, 2024 and June 30, 2023, respectively.

Previous wording

Other income, net was $9.3 million for the three months ended March 31, 2024, compared to $4.4 million for the three months ended March 31, 2023. The $4.9 million increase was primarily due to the increase in our investments balance as a result of the 2024 financing activities as well as prevailing interest rates in the respective periods.

Current wording

Other income, net was $8.9 million for the three months ended June 30, 2024, compared to $4.6 million for the three months ended June 30, 2023. The $4.3 million increase was primarily due to the increase in our investments balance as a result of the 2024 financing activities as well as prevailing interest rates in the respective periods.

Previous wording

Impairment on long-lived assets was $4.9 million for the three months ended March 31, 2024, compared to $0 for three months ended March 31, 2023. The increase of $4.9 million was as a result of the occupancy of the 2021 Lease facility in February of 2024 and the corresponding exit of the 2019 Lease facility, resulting in an impairment charge of $4.9 million in the three months ended March 31, 2024.

Current wording

Impairment on long-lived assets was $4.9 million for the six months ended June 30, 2024, compared to $0 for six months ended June 30, 2023. The increase of $4.9 million was as a result of the occupancy of the 2021 Lease facility in February of 2024 and the corresponding exit of the 2019 Lease facility, resulting in an impairment charge of $4.9 million in the six months ended June 30, 2024.

Previous wording

We have not yet generated any revenue from any product sales, and we have incurred significant operating losses since our inception. We have not yet commercialized any products and we do not expect to generate revenue from sales of products for several years, if at all. To date, we have received gross proceeds of $1.45 billion from sales of our convertible preferred stock, the sale of common stock including our August 2020 IPO and concurrent private placement, our July 2021 follow-on offering and concurrent private placement, our August 2022 PIPE offering, January 2024 follow-on offering, our sales agreement with Cowen and Company, LLC., and through our corporate collaborations. As of March 31, 2024 we had cash and cash equivalents and marketable securities of $744.9 million.

Current wording

We have not yet generated any revenue from any product sales, and we have incurred significant operating losses since our inception. We have not yet commercialized any products and we do not expect to generate revenue from sales of products for several years, if at all. To date, we have received gross proceeds of $1.45 billion from sales of our convertible preferred stock, the sale of common stock including our August 2020 IPO and concurrent private placement, our July 2021 follow-on offering and concurrent private placement, our August 2022 PIPE offering, January 2024 follow-on offering, our Sales Agreement with Cowen and Company, LLC., and through our corporate collaborations. As of June 30, 2024 we had cash and cash equivalents and marketable securities of $702.4 million.

Previous wording

During the three months ended March 31, 2024, cash used in operating activities was $39.6 million, primarily resulting from our net loss of $48.6 million during the period and the $8.3 million change in deferred revenue related to our collaboration agreements. These were offset by a $2.0 million net decrease in other operating assets and liabilities primarily driven by changes in accounts receivable, accounts payable, accrued expenses and operating lease liabilities. and adjustments for non-cash items of $15.3 million (primarily consisting of stock-based compensation, lease impairment charge, depreciation & amortization and premiums & discounts on available-sale-securities).

Current wording

During the six months ended June 30, 2024, cash used in operating activities was $82.5 million, primarily resulting from our net loss of $90.6 million during the period and the $32.2 million change in deferred revenue related to our collaboration agreements. These were offset by a $12.8 million net decrease in other operating assets and liabilities primarily driven by changes in accounts receivable, accounts payable, accrued expenses and operating lease liabilities and adjustments for non-cash items of $27.5 million (primarily consisting of stock-based compensation, lease impairment charge, depreciation & amortization and premiums & discounts on available-sale-securities).

Previous wording

During the three months ended March 31, 2023, cash used in operating activities was $44.0 million, primarily resulting from our net loss of $40.9 million during the period, the $6.1 million change in deferred revenue under our collaboration agreements, and a $5.9 million net decrease in other operating assets and liabilities primarily driven by changes in accounts receivable, accounts payable, accrued expenses and operating lease liabilities. These were offset by adjustments for non-cash items of $8.9 million (primarily consisting of stock-based compensation, depreciation & amortization and premiums & discounts on available-sale-securities).

Current wording

During the six months ended June 30, 2023, cash used in operating activities was $79.2 million, primarily resulting from our net loss of $79.7 million during the period, the $18.5 million change in deferred revenue under our Sanofi and Vertex collaboration agreements, and a $0.6 million net decrease in other operating assets and liabilities primarily driven by changes in accounts receivable, accounts payable, accrued expenses and operating lease liabilities. These were offset by adjustments for non-cash items of $19.6 million (primarily consisting of stock-based compensation, depreciation & amortization and premiums & discounts on available-sale-securities).

Previous wording

During the three months ended March 31, 2024, cash used in investing activities was $330.6 million comprised of purchases of marketable securities of $422.7 million and purchases of property and equipment of $7.4 million, partially offset by maturities of marketable securities of $99.5 million

Current wording

During the six months ended June 30, 2024, cash used in investing activities was $315.0 million comprised of purchases of marketable securities of $526.9 million and purchases of property and equipment of $12.1 million, partially offset by maturities of marketable securities of $224.0 million.

Previous wording

During the three months ended March 31, 2023, cash provided by investing activities was $24.6 million comprised of maturities of marketable securities of $90.4 million, partially offset by purchases of marketable securities of $61.8 million and purchases of property and equipment of $4.0 million.

Current wording

During the six months ended June 30, 2023, cash provided by investing activities was $60.4 million comprised of maturities of marketable securities of $189.7 million, partially offset by purchases of marketable securities of $114.5 million and purchases of property and equipment of $14.8 million.

Previous wording

During the three months ended March 31, 2024, net cash provided by financing activities was $353.8 million, consisting of $301.4 million in proceeds from issuance of common stock and accompanying pre-funded warrants, net of offering costs, $48.7 million in proceeds from the issuance of common stock through an at-the-market sales agreement, net of issuance costs, $3.9 million in proceeds from the exercise of employee stock options, partially offset by finance lease payments of $0.3 million.

Current wording

During the six months ended June 30, 2024, net cash provided by financing activities was $355.2 million, consisting of $301.4 million in proceeds from issuance of common stock and accompanying pre-funded warrants, net of offering costs, $48.7 million in proceeds from the issuance of common stock through an Sales Agreement, net of issuance costs, $4.6 million in proceeds from the exercise of employee stock options, $1.1 million from proceeds from the employee stock purchase plan, partially offset by finance lease payments of $0.6 million.

Previous wording

During the three months ended March 31, 2023, net cash provided by financing activities was $1.2 million, consisting of $1.5 in proceeds from the exercise of employee stock options, partially offset by finance lease payments of $0.3 million.

Current wording

During the six months ended June 30, 2023, net cash provided by financing activities was $2.5 million, consisting of $2.1 million in proceeds from the exercise of employee stock options and $1.0 million in proceeds from the employee stock purchase plan, partially offset by finance lease payments of $0.6 million.

Previous wording

We believe the existing cash, cash equivalents and marketable securities of $744.9 million as of March 31, 2024, will enable us to fund our operating expenses and capital expenditure requirements into the first half of 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. We expect that we will require additional funding to continue the clinical development of our clinical programs, commercialize our product candidates if we receive regulatory approval, and pursue in-licenses or acquisitions of other product candidates. If we receive regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize our product candidates.

Current wording

We believe the existing cash, cash equivalents and marketable securities of $702.4 million as of June 30, 2024, will enable us to fund our operating expenses and capital expenditure requirements into the first half of 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. We expect that we will require additional funding to continue the clinical development of our clinical programs, commercialize our product candidates if we receive regulatory approval, and pursue in-licenses or acquisitions of other product candidates. If we receive regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize our product candidates.

Previous wording

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. During the three months ended March 31, 2024, there were no material changes to our critical accounting policies from those described in our Annual Report Form 10-K filed with the SEC on February 22, 2024.

Current wording

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. During the six months ended June 30, 2024, there were no material changes to our critical accounting policies from those described in our Annual Report Form 10-K filed with the SEC on February 22, 2024.