UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 11, 2021
KYMERA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39460 | 81-2992166 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
Kymera Therapeutics, Inc.
200 Arsenal Yards Blvd., Suite 230
Watertown, Massachusetts 02472
(Address of principal executive offices, including zip code)
(857) 285-5300
(Registrant’s telephone number, including area code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trade Symbol(s) |
Name of each exchange on which registered | ||
| Common Stock, $0.0001 par value per share | KYMR | The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02 | Results of Operations and Financial Condition |
On March 11, 2021, Kymera Therapeutics, Inc. announced its financial results for the quarter ended December 31, 2020 and for the fiscal year ended December 31, 2020. A copy of the press release is being furnished as Exhibit 99.1 to this Report on Form 8-K.
The information in this Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 9.01. | Exhibits |
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press release issued by Kymera Therapeutics, Inc. on March 11, 2021, furnished herewith. | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Kymera Therapeutics, Inc. | ||||||
| Date: March 11, 2021 | By: | /s/ Nello Mainolfi | ||||
| Nello Mainolfi, Ph.D. | ||||||
| Founder, President and Chief Executive Officer | ||||||
Exhibit 99.1
Kymera Therapeutics Announces Fourth Quarter and Full Year 2020 Financial
Results and Provides a Business Update
Initiated Phase 1 first-in-human dosing of KT-474, a first-in-class oral IRAK4 degrader to treat immune-inflammatory diseases
Declared KT-333 as STAT3 development candidate for liquid and solid tumor indications and commenced IND-enabling activities
Strong financial position to support continued execution and pipeline growth; inaugural R&D Day to highlight five-year company vision
Watertown, Mass. (March 11, 2021) – Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2020.
“We continue to execute against our ambitious goal to build Kymera into a fully integrated, best-in-class degrader medicines company,” said Nello Mainolfi, PhD, Co-Founder, President and CEO, Kymera Therapeutics. “We have already achieved key milestones in 2021, a transformative year for Kymera and for the field of protein degradation, as we move our three lead degrader programs in immunology-inflammation and oncology into the clinic, expand our platform-enabled pipeline of novel degraders, and continue to grow our team and build our capabilities to deliver a new class of medicines for patients.”
Program Updates and Milestones
Kymera is discovering and developing novel small molecule therapeutics designed to selectively degrade disease-causing proteins by harnessing the body’s own natural protein degradation system, with an initial focus on immune-inflammatory diseases and oncology.
IRAK4 Degrader Program
IRAK4 is a key protein involved in inflammation mediated by the activation of toll-like receptors (TLRs) and IL-1 receptors (IL-1Rs). Aberrant activation of these pathways is the underlying cause of multiple immune-inflammatory conditions. KT-474, a potential first-in-class, highly active and selective, orally bioavailable IRAK4 degrader, is being developed for the treatment of TLR/IL-1R-driven immune-inflammatory diseases impacting millions of patients with high unmet medical need such as atopic dermatitis, hidradenitis suppurativa, and rheumatoid arthritis. KT-474 is designed to block TLR/IL-1R-mediated inflammation more broadly compared to monoclonal antibodies targeting single cytokines, and to enable pathway inhibition that is superior to IRAK4 kinase inhibitors by abolishing both the kinase and scaffolding functions of IRAK4.
Recent Updates:
| • | In February 2021, Kymera initiated dosing of healthy volunteers in a first-in-human Phase 1 single and multiple ascending dose trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered KT-474 in adult healthy volunteers and patients with atopic dermatitis or hidradenitis suppurativa. |
| • | Preclinical data and interim results from a Non-Interventional study evaluating IRAK4 expression in patients with atopic dermatitis or hidradenitis suppurativa were also recently presented at the 2nd Annual North American Protein Degradation Congress in February 2021. |
Expected Milestones:
| • | Presentation of final Non-Interventional trial results in HS and AD (2Q21) |
| • | Presentation of preclinical data demonstrating superiority to small molecule kinase inhibitors across a wide variety of immune-inflammatory preclinical models (2Q21) |
| • | Initiation of enrollment in multiple ascending dose portion of Phase 1 trial of KT-474 following FDA clearance, including healthy volunteers and a subsequent cohort of patients with atopic dermatitis or hidradenitis suppurativa (2H21) |
| • | Establish Phase 1 proof-of-biology in healthy volunteers (4Q21) |
IRAKIMiD Degrader Program
IRAKIMiDs are novel heterobifunctional degraders designed to degrade both IRAK4 and IMiD substrates, including Ikaros and Aiolos, with a single small molecule. IRAKIMiDs synergistically target both the MYD88-NF-kB/MAP kinase and Type 1 interferon pathways with the potential to enhance and broaden anti-tumor activity. KT-413 is being developed initially for the treatment of MYD88-mutant diffuse large B-cell lymphoma (DLBCL) with potential to expand in other MYD88-mutant indications and IL-1R/TLR/NF-kB-driven malignancies. In preclinical studies, KT-413 has demonstrated a potential first-in-class profile as a targeted therapy for MYD88-mutant DLBCL, including strong single-agent antitumor activity against MYD88-mutant lymphomas in vitro and in mouse xenograft models derived from lymphoma cell lines and patient tumors, which has led to rapid, complete, and sustained tumor regressions.
Recent Updates:
| • | A late-breaking abstract, titled “Mechanisms underlying synergistic activity in MYD88MT DLBCL of KT-413, a targeted degrader of IRAK4 and IMiD substrates,” was recently accepted for presentation at the American Association of Cancer Research (AACR) 2021 Annual Meeting, taking place April 10-15, 2021. |
Expected Milestones:
| • | Presentation of KT-413 mechanism of action at the AACR Annual Meeting (April 10-15, 2021) |
| • | Submission of KT-413 IND application, and if cleared, initiation of Phase 1 clinical trial in relapsed/refractory B cell lymphomas, including MYD88-mutant DLBCL (2H21) |
| • | Presentation of additional KT-413 preclinical data and potential indication expansion strategies (2H21) |
| • | Establish Phase 1 proof-of-biology and initial clinical proof-of-concept in patients (2022) |
STAT3 Degrader Program
Kymera is developing selective STAT3 degraders for the treatment of hematological malignancies and solid tumors, as well as autoimmune diseases and fibrosis. STAT3 is a transcription factor activated through a variety of different cytokine and growth factor receptors via Janus kinases (JAKs), as well as through oncogenic fusion proteins and mutations in STAT3 itself. Long considered an undruggable target, STAT3 hyperactivation is prominent in numerous liquid and solid tumors, including clinically aggressive lymphomas. Kymera’s potent and selective STAT3 degraders have demonstrated strong anti-tumor effects in mouse xenograft and syngeneic models of liquid and solid tumors.
Recent Updates:
| • | In February 2021, Kymera nominated KT-333 as a STAT3 development candidate for liquid and solid tumor indications and the Company has initiated IND-enabling activities. KT-333 has demonstrated high potency and selectivity in both in vitro and in vivo preclinical models, including significant and sustained anti-tumor activity in several preclinical models of liquid and solid tumors. |
| • | Kymera recently presented data showing that its STAT3 degraders demonstrate potent, highly selective, and sustained STAT3 degradation leading to cancer cell death in preclinical models of hematologic malignancies at the Oxford Global Targeted Protein Degradation & PROTAC Virtual Symposium. |
Expected Milestones:
| • | Submission of KT-333 IND application, and if cleared, initiation of Phase 1 clinical trial in relapsed/refractory liquid and solid tumors (4Q21) |
| • | Presentation of additional preclinical data in liquid and solid tumors (2H21) |
| • | Establish Phase 1 proof-of-biology and initial clinical proof-of-concept in patients (2022) |
Platform and Discovery Programs
Kymera is also actively advancing a broad pipeline of preclinical programs across a wide variety of diseases, both internally and in collaboration with existing partners Vertex Pharmaceuticals and Sanofi. The internal programs continue to be focused on undrugged or inadequately drugged nodes within highly validated pathways in immune-inflammatory and oncology indications. Kymera is also developing a new generation of tissue-selective or -restrictive degrader medicines with the goal of drugging an entirely new set of protein targets.
Key Objectives:
| • | Plan to host inaugural R&D Day in 2H21 to unveil next pathway/programs approaching clinical development, as well as outline the Company’s vision for the next five years |
| • | Continue pipeline expansion by advancing early-stage discovery programs toward IND-enabling studies |
| • | Further expand the capabilities of Kymera’s Pegasus™ platform to identify the optimal pairing of disease-causing protein targets with E3 ligases to generate novel degrader product candidates |
| • | Leverage Kymera’s E3 Ligase Whole-Body Atlas of over 600 unique E3 ligases to identify previously unliganded E3 ligases, including tissue-restricted or -selective, to unlock new opportunities across broad therapeutic applications |
Fourth Quarter and Full Year 2020 Financial Results
Collaboration Revenues: Collaboration revenues were $12.8 million for the fourth quarter of 2020 and $34.0 million for the year ended December 31, 2020, compared to $1.8 million and $2.9 million, respectively, for the same periods of 2019. Collaboration revenues include revenue from our Sanofi and Vertex collaborations in 2020, and Vertex in 2019.
Research and Development Expenses: Research and development expenses were $20.4 million for the fourth quarter of 2020 and $62.1 million for the year ended December 31, 2020, compared to $11.1 million and $37.2 million, respectively, for the same periods of 2019. This increase was primarily due to expenses related to IND-enabling studies for our IRAK4 and IRAKIMiD programs, lead optimization activities for our STAT3 program, investments in our platform and exploratory programs, the Vertex collaboration, as well as an increase in occupancy and related costs due to continued growth in the research and development organization.
General and Administrative Expenses: General and administrative expenses were $5.2 million for the fourth quarter of 2020 and $18.2 million for the year ended December 31, 2020, compared to $2.5 million and $8.0 million, respectively, for the same periods of 2019. This increase was primarily due to increases in legal and professional service fees in support of the Company’s growth and an increase in personnel, facility, occupancy, and other expenses from an increase in headcount to support growth as a public company.
Net Loss: Net loss was $12.7 million for the fourth quarter of 2020 and $45.6 million for the year ended December 31, 2020, compared to a net loss of $11.5 million and $41.2 million, respectively, for the same periods of 2019.
Cash and Cash Equivalents: As of December 31, 2020, Kymera had approximately $458.7 million in cash, cash equivalents, and investments. Kymera expects that its cash, cash equivalents, and investments as of December 31, 2020, excluding any future potential milestones from collaborations, will enable the Company to fund its operational plans into 2025 while the Company continues to identify opportunities to accelerate growth and expand its pipeline, technologies, and clinical indications.
About Kymera Therapeutics
Kymera Therapeutics is a biopharmaceutical company focused on advancing the field of targeted protein degradation, a transformative new approach to address previously intractable disease targets. Kymera’s Pegasus™ targeted protein degradation platform harnesses the body’s natural protein recycling machinery to degrade disease-causing proteins, with a focus on undrugged nodes in validated pathways currently inaccessible with conventional therapeutics. Kymera is accelerating drug discovery with an unmatched ability to target and degrade the most intractable of proteins, and advance new treatment options for patients. Kymera’s initial programs are IRAK4, IRAKIMiD, and STAT3, which each address high impact targets within the IL-1R/TLR or JAK/STAT pathways, providing the opportunity to treat a broad range of immune-inflammatory diseases, hematologic malignancies, and solid tumors. For more information, visit www.kymeratx.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding its: strategy, business plans and objectives for the IRAK4, IRAKIMiD and STAT3 degrader programs; and plans and timelines for the clinical development of Kymera Therapeutics’ product candidates, including the therapeutic potential and clinical benefits thereof. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on countries or regions in which we have operations or do business, as well as on the timing and anticipated results of our current preclinical studies and future clinical trials, strategy and future operations; the delay of any current preclinical studies or future clinical trials or the development of Kymera Therapeutics’ drug candidates; the risk that the results of current preclinical studies may not be predictive of future results in connection with future clinical trials; Kymera Therapeutics’ ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Company’s planned interactions with regulatory authorities, including the resolution of the current partial clinical hold for KT-474; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in the Annual Report on Form 10-K for the period ended December 31, 2020, expected to be filed on or about March 11, 2021, as well as discussions of potential risks, uncertainties, and other important factors in Kymera Therapeutics’ subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Kymera Therapeutics’ views only as of today and should not be relied upon as representing its views as of any subsequent date. Kymera Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Investors:
Paul Cox
VP, Investor Relations and Communications
pcox@kymeratx.com
917-754-0207
Media:
Lissette L. Steele
Verge Scientific Communications for Kymera Therapeutics
lsteele@vergescientific.com
202-930-4762
KYMERA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
| December 31, 2020 |
December 31, 2019 |
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| Assets |
||||||||
| Cash, cash equivalents and marketable securities |
$ | 458,733 | 91,957 | |||||
| Property and equipment, net |
10,841 | 3,794 | ||||||
| Other assets |
17,601 | 20,951 | ||||||
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| Total assets |
$ | 487,175 | $ | 116,702 | ||||
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| Liabilities and Stockholders’ Equity (Deficit) |
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| Deferred revenue |
$ | 170,390 | $ | 52,991 | ||||
| Other liabilities |
32,897 | 29,037 | ||||||
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| Total liabilities |
203,287 | 82,028 | ||||||
| Preferred stock |
— | 109,080 | ||||||
| Total stockholders’ equity (deficit) |
283,888 | (74,406 | ) | |||||
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| Total liabilities, preferred stock and stockholders’ equity (deficit) |
$ | 487,175 | $ | 116,702 | ||||
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KYMERA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except for share and per share amounts)
(Unaudited)
| Three Months Ended December 31, |
Year Ended December 31, |
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| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Collaboration Revenue—from related parties |
$ | 12,785 | $ | 1,833 | $ | 34,034 | $ | 2,934 | ||||||||
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| Operating expenses: |
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| Research and development |
$ | 20,392 | $ | 11,087 | $ | 62,105 | $ | 37,158 | ||||||||
| General and administrative |
5,175 | 2,530 | 18,233 | 7,981 | ||||||||||||
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| Total operating expenses |
25,567 | 13,617 | 80,338 | 45,139 | ||||||||||||
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| Loss from operations |
(12,782 | ) | (11,784 | ) | (46,304 | ) | (42,205 | ) | ||||||||
| Other income (expense): |
||||||||||||||||
| Interest Income |
124 | 300 | 826 | 1,005 | ||||||||||||
| Interest Expense |
(27 | ) | (29 | ) | (115 | ) | (46 | ) | ||||||||
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| Total other income: |
97 | 271 | 711 | 959 | ||||||||||||
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| Net loss |
$ | (12,685 | ) | $ | (11,513 | ) | $ | (45,593 | ) | $ | (41,246 | ) | ||||
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| Deemed dividend from exchange of convertible preferred stock |
— | — | (9,050 | ) | — | |||||||||||
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| Net loss attributable to common stockholders |
$ | (12,685 | ) | $ | (11,513 | ) | $ | (54,643 | ) | $ | (41,246 | ) | ||||
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| Net loss per share attributable to common stockholders, basic and diluted |
$ | (0.29 | ) | $ | (6.06 | ) | $ | (3.15 | ) | $ | (24.28 | ) | ||||
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| Weighted average common stocks outstanding, basic and diluted |
44,467,228 | 1,900,813 | 17,349,582 | 1,698,522 | ||||||||||||
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