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)
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address, including zip code, of Registrant’s principal executive offices)
(858 ) 299-4699
(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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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.
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The information set forth in Item 8.01 is hereby incorporated by reference.
| Item 8.01 |
Other Events.
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On April 17, 2023, Kinnate Biopharma Inc. issued a press release
announcing monotherapy dose escalation data from its ongoing, global Phase 1 KN-8701 trial evaluating exarafenib, an update on its
monotherapy dose expansion strategy and preliminary findings from the combination arm of KN-8701. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
On April 17, 2023, Kinnate Biopharma Inc. issued a press release announcing it is advancing other small molecule research programs and providing cash runway guidance. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
| Item 9.01 |
Financial Statements and Exhibits.
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(d)
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Exhibits.
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Exhibit
No.
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Description
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Press Release dated April 17, 2023.
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Press Release dated April 17, 2023.
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104
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Cover page interactive data file (embedded within the inline XBRL document).
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SIGNATURES
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.
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KINNATE BIOPHARMA INC.
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By:
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/s/ Nima Farzan
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Nima Farzan
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President and Chief Executive Officer
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Date: April 17, 2023
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Exhibit 99.1
First Report of Positive Dose Escalation Data Supports Best-in-Class Profile for Investigational Exarafenib as a Single Agent and in Combination with
Binimetinib in BRAF-altered Cancers and NRAS Mutant Melanoma
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Exarafenib was well-tolerated at substantial monotherapy exposures; only 3% (n=2/60) of patients discontinued therapy due to treatment-related adverse events
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Breadth of responses observed across tumor types and BRAF or NRAS alterations with a total of 8 partial responses in the monotherapy and combination arms
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Monotherapy dose expansion ongoing at 300 mg bid; data-informed strategy prioritizes enrollment in BRAF Class II-driven melanoma and lung cancer (33% ORR);
initial data expected in the first half of 2024
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Well-tolerated monotherapy backbone enables multiple development approaches, including the ongoing exarafenib combination arm in NRAS mutant melanoma; dose
selection expected in the second half of 2023
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SAN FRANCISCO and SAN DIEGO – April 17, 2023 – Kinnate
Biopharma Inc. (Nasdaq: KNTE) (Kinnate), a clinical-stage precision oncology company, today announced positive monotherapy dose escalation
data for its investigational, highly selective and potent pan-RAF inhibitor, exarafenib, from Part A1 of its ongoing global Phase 1 KN-8701 clinical trial. These results
will be featured in an oral presentation today at 3:35 p.m. ET during the Clinical Trials Mini Symposium Session at the American Association for Cancer Research (AACR) 2023 Annual Meeting. (Abstract #CT032)
The company today also provided details around its monotherapy dose expansion strategy (Part B) and a preliminary update on the combination arm (Part A2) evaluating
exarafenib with binimetinib, a MEK inhibitor, in patients with BRAF-altered solid tumors and/or who have NRAS mutant melanoma.
Kinnate will host a virtual investor webcast today at 5:30 p.m. ET to discuss these updates, along with the expansion of its early development pipeline announced
separately.
“The exarafenib dose escalation data provide striking proof of concept for a monotherapy pan-RAF inhibitor,” said Alexander Spira, MD, PhD, FACP,
co-director, Virginia Cancer Specialists Research Institute. “For the first time, a pan-RAF inhibitor has shown both promising tolerability as a single agent and has achieved compelling breadth of activity with durable responses in targetable
mutations. Responses in patients with BRAF Class II or NRAS alterations is meaningful because no approved targeted therapy is available today, and physicians are left with limited treatment options for advanced cancers, which means patients often
have poor survival outcomes. I look forward to the further study of exarafenib’s therapeutic potential to address these patients who are currently medically underserved.”
Page 1of 6
Key Exarafenib Monotherapy Data Presented at AACR 2023
The data at AACR were based on a February 28, 2023 data cutoff. Sixty patients with a median of three prior therapies had been enrolled into six
monotherapy dose escalation cohorts: 25 mg bid (dose level; DL 1), 50 mg bid (DL 2), 100 mg bid (DL 3), 200 mg bid (DL 4), 300 mg bid (DL 5) and 400 mg bid
(DL 6). Treated patients included those with solid tumors driven by BRAF Class I (41.7%), Class II (13.3%) and Class III (30%) alterations or
melanoma with NRAS mutations (15%). BRAF and NRAS alterations were identified by local laboratories either in tumor or plasma. As of the data cutoff, all 60 patients enrolled were part of the safety analysis population, of which 49
patients were efficacy evaluable.1
Favorable Tolerability Profile; Only 3% (n=2/60) of Patients Discontinued Therapy Due to Treatment-Related Adverse Events
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The maximum tolerated dose (MTD) was determined to be 300 mg bid (n=29). At therapeutically relevant exposures, there was no cutaneous (skin) evidence of paradoxical activation.
Dose limiting toxicities observed at the highest dose level (400 mg bid) were Grade 3 acneiform rash (n=1) and Grade 3 macular rash (n=1).
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Treatment-related adverse events (TRAEs) reported by investigators at any Grade occurred in 73.3% (n=44) of patients, with 18.3% of TRAEs reported as Grade 3 or higher (n=11).
There were no Grade 5 TRAEs reported as of the data cutoff.
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The most common TRAEs of any Grade were skin related (21.7%; n=13), with 3.3% (n=2) of patients having skin events that were Grade 3 or greater.
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Grade 2 gastrointestinal (GI) TRAEs occurred in 3.3% of patients (n=2). No Grade 3 GI TRAEs were observed.
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Reversible, asymptomatic increased alanine transaminase and/or increased aspartate aminotransferase TRAEs were reported at Grade 3 (n=4; 6.7%) and Grade 4 (n=1; 1.7%).
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In all patients (n=60) treated with exarafenib, the overall relative mean dose intensity was 97% and was 95% in patients treated at 300 mg bid (n=29). The median for both patient
sets was 100%.2
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Dose Dependent and Steady State Unbound Exposures with Exarafenib Treatment
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Pharmacokinetic analyses demonstrated dose-dependent increases in exarafenib exposure (Cmax; peak plasma concentration and area under the curve) with increasing dose.
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Exarafenib had a half-life of eight hours in patients, which is a longer duration range than the predicted half-life preclinically, supporting a bid dosing strategy.
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At 300 mg bid, exarafenib delivered high target coverage in patients. Unbound exposures exceeded the IC50 values across BRAF and NRAS cell lines by two-to-ten-fold,
while remaining below the wild type cells IC50. We believe multiple fold target coverage is ultimately necessary for meaningful outcomes in these patient subtypes.
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Page 2of 6
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Treatment with exarafenib also led to significant reductions in circulating tumor DNA across BRAF and NRAS-altered tumor types.
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Promising Early Efficacy, Including RECIST Responses in Priority BRAF Class II and NRAS Subtypes
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In total, 6 patients achieved a partial response (PR) with exarafenib monotherapy treatment during dose escalation, including five confirmed PRs as evaluated by Response
Evaluation Criteria in Solid Tumors (RECIST). For responders, the average tumor reduction was 61% and treatment duration was 7 months. Four of the 6 responders continue exarafenib therapy.
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Treatment with exarafenib at 300 mg bid, the MTD, in patients with BRAF Class II or NRAS alterations led to a 30% (3 of 10) overall response rate (ORR).
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The ORR in patients with BRAF Class II alterations was 33% (1 of 3) at 300 mg bid, which included a patient with non-small cell lung cancer (NSCLC) harboring a BRAF Class II
fusion.
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In addition, 71% (5 of 7) of patients with BRAF Class II alterations achieved an objective tumor reduction. In all treated patients with Class II alterations, the disease control
rate was 86% (6 of 7).
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The ORR in patients with NRAS alterations was 29% (2 of 7) at 300 mg bid and included patients with NRAS mutant melanoma and a patient with colorectal cancer harboring an NRAS
alteration co-occurring with a BRAF Class III alteration.
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The two additional subtypes with confirmed PRs included RAF inhibitor naïve patients with BRAF Class I (V600E) papillary thyroid cancer and squamous cell carcinoma. One
unconfirmed PR was reported in a RAF pretreated patient with BRAF Class I melanoma.
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Twenty-two patients achieved stable disease (SD) across dose levels, including 10 patients with objective tumor shrinkage (up to 20%), showing encouraging breadth of activity and
prolonged disease control in a broad range of alterations and tumor types.
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1Efficacy evaluable set includes all participants with documented BRAF (or melanoma with NRAS) genomic alterations (as specified for each
study Part) who received at least 1 dose of exarafenib and have >= 1 measurable lesion at baseline for disease response assessment and at least 1 post-baseline efficacy assessment per RECIST Version 1.1 criteria. Response assessments performed
by each respective clinical trial site (local, investigator-assessed radiology). Disease control rate is defined as the percent of participants who achieved a complete response, PR or SD as their best overall response in accordance with RECIST
v1.1.
2Overall relative dose intensity based on assigned dose will use the full course of dose received (including intrapatient dose escalation
or de-escalation) divided by the total planned dose as per the originally assigned.
Exarafenib Monotherapy Dose Expansion Strategy Optimized for Probability of Success
The expansion cohorts of the KN-8701 clinical trial opened year-end 2022 and are
currently enrolling patients at the 300 mg bid dose.
Page 3of 6
Kinnate refined its dose expansion strategy to include greater enrichment of more sensitive tumor and alteration types based on the emerging profile and clinical signals
observed during dose escalation.
The priority cohorts will enroll patients with BRAF Class II alterations, including BRAF fusions, across solid tumors, primarily melanoma and NSCLC. These cohorts are
expected to enroll approximately 55 patients.
The company expects to provide initial monotherapy dose expansion data in the first half of 2024.
Exarafenib + Binimetinib Dose Escalation Ongoing; Early Clinical Activity Observed
Key combination updates as of March 31, 2023 include:
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Enrolled 12 patients primarily with NRAS mutant melanoma into 3 combination dose cohorts: (1) exarafenib 100 mg bid and binimetinib 45 mg bid, (2) exarafenib 100 mg bid and
binimetinib 15 mg bid, and (3) exarafenib 200 mg bid and binimetinib 15 mg bid.
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Enrollment continues at exarafenib 200 mg bid dose and binimetinib 15 mg bid, with safety evaluation ongoing.
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Two of the 7 efficacy evaluable patients achieved RECIST PRs, including an unconfirmed PR in a patient with NRAS mutant melanoma and a confirmed PR in a patient with BRAF Class II
pancreatic cancer. One additional patient with NRAS mutant melanoma experienced a 25% reduction in their target lesions. Patients who responded continue combination therapy.
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Kinnate will prioritize development of the exarafenib combination in patients with NRAS mutant melanoma. The trial will also enroll RAF pre-treated patients with a BRAF Class I
alteration.
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The company expects to provide an update in the second half of 2023 on the combination dose that will be taken into dose expansion.
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"With the selection of the maximum tolerated dose for exarafenib, we initiated
monotherapy dose expansion with enrollment ongoing in patients with a meaningful unmet medical need and where we believe we have the highest probability of success with a single-agent pan-RAF, including in patients with advanced lung cancer and
melanoma that harbor a BRAF Class II alteration,” said Richard Williams, MBBS, PhD, chief medical officer, Kinnate Biopharma Inc. “In addition, with a well-tolerated monotherapy profile, compelling PK/PD and responses as the backbone, we continue to pursue priority pan-RAF combination
approaches, such as with a MEK inhibitor in NRAS mutant melanoma, where a combination may offer additive benefit to patients.”
Nima Farzan, Kinnate Biopharma Inc. chief executive officer, commented, “Kinnate was formed just five years ago, and in that time, we have evolved from a start up to a global, precision oncology company with two programs in
the clinic and a growing pipeline of targeted therapy candidates developed by our own scientists. Today, we are proud to share the first clinical data from the company on exarafenib, showing early efficacy both as a monotherapy and as a
combination regimen in BRAF and NRAS-altered cancers. This potential best-in-class pan-RAF inhibitor anchors our growing pipeline and positions the company for future growth.”
Today’s AACR presentation is available on the company’s website at Kinnate.com.
Page 4of 6
Virtual Investor Webcast Information
Kinnate will host a webcast today, Monday, April 17, 2023, at 5:30 p.m. ET. Investors and
the general public are invited to listen to a live webcast of the session through the "Investors and Media" section on Kinnate.com or by dialing the U.S. toll free number +1-888-256-1007 and entering confirmation code: 7465233. An archived edition of the session will be available following the event.
About Exarafenib
Exarafenib is an orally administered, potent and selective investigational small molecule
pan-RAF inhibitor. Unlike currently available treatments that target only Class I BRAF kinase mutations, exarafenib is designed to target BRAF Class II
and Class III alterations, where it has the potential to be a first-line targeted therapy, in addition to covering BRAF Class I alterations, and as a potential treatment for NRAS mutation-positive melanoma.
KN-8701 Clinical Trial Background
KN-8701 is an ongoing, global Phase 1 clinical trial (NCT04913285) evaluating
exarafenib in patients with advanced solid tumors harboring BRAF Class I, II and III alterations, and/or who have NRAS mutant melanoma. KN-8701 contains
a two-part dose escalation: Part A1 is evaluating exarafenib as a monotherapy across BRAF alterations and tumor types, and Part A2 is evaluating exarafenib in combination with binimetinib, a MEK inhibitor. Part B, dose expansion, is evaluating
exarafenib at the recommended dose and schedule in patients with BRAF-altered cancers including lung cancer, melanoma and other solid tumors.
About Kinnate Biopharma Inc.
Kinnate Biopharma Inc. is a clinical-stage precision oncology company focused on expanding on the promise of targeted therapies for those battling cancer. The company is developing medicines for known oncogenic drivers where there are no approved targeted drugs and to overcome the limitations of marketed cancer therapies, such as
non-responsiveness or acquired and intrinsic resistance. Kinnate has two lead clinical programs being studied in solid tumors with RAF, NRAS and FGFR-driven alterations, and is rapidly progressing a pipeline of additional small molecule
drug candidates as part of the Kinnate Discovery Engine. The company is driven by the urgency and knowledge that patients are waiting for new, effective cancer medicines. For more information, visit Kinnate.com and follow us on LinkedIn.
Page 5of 6
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. These forward-looking statements include, without limitation,
statements regarding the therapeutic potential, efficacy and clinical benefits of exarafenib; the safety and tolerability profile of exarafenib; the future conduct of the monotherapy and combination arms of KN-8701; the size and makeup of KN-8701
priority and dose-expansion cohorts; plans for KN-8701 patient enrollment; development priorities; the timing and presentation of clinical data from KN-8701 for exarafenib monotherapy and of dose selection for the exarafenib and binimetinib
combination; the relationship between the results from the positive dose escalation data and results of future clinical trials; the company’s intention to hold a webcast; and statements by the company’s chief executive officer and others. Words
such as “believes,” “anticipates,” “plans,” “expects,” “will,” “potential” and similar expressions are also intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and
projections about future events and trends. Such expectations and projections may never materialize or may prove to be incorrect. These forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors,
including recently transitioning to operating as a clinical-stage biopharmaceutical company with a limited operating history; the timing, progress and results of ongoing and planned preclinical studies and clinical trials for our current product
candidates; that continued dose escalation in our clinical trials could increase the risk of the occurrence of adverse events; the potential for future clinical trial
results to differ from initial results or from our preclinical studies; our ability to timely enroll a sufficient number of patients in our clinical trials; our ability to raise additional capital to finance our operations; our ability to
discover, advance through the preclinical and clinical development of, obtain regulatory approval for and commercialize our product candidates; the novel approach we are taking to discover and develop drugs; our ability to timely file and obtain
approval of investigational new drug applications for our planned clinical trials; negative impacts of the COVID-19 pandemic on our business, including ongoing and planned clinical trials and preclinical studies; competition in our industry;
regulatory developments in the United States and other countries; our ability to attract, hire and retain highly skilled executive officers and employees; difficulties in managing our growth; our ability to protect our intellectual property;
reliance on third parties to conduct our ongoing and planned preclinical studies and clinical trials, and to manufacture our product candidates; general economic and market conditions; and other risks. These and other risks, uncertainties,
assumptions and other factors are further described under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 that we have filed with the Securities and Exchange Commission (“SEC”), as well as in
our subsequent filings we make with the SEC. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any
factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. Investors should not rely upon forward-looking statements as predictions of future events.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Our forward-looking statements speak only as of the date of
this release, and except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason in the future.
Investor & Media Contact:
Priyanka Shah | Priyanka.Shah@kinnate.com | +1-908-447-6134
Exhibit 99.2
Kinnate Biopharma Inc. Adds Two New Drug Candidates to Its Growing Targeted Oncology Pipeline and Provides Cash Runway Guidance
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KIN-7136, a next generation brain-penetrant MEK inhibitor for MAPK-driven advanced adult solid tumors, is expected to enter the clinic in
the second half of 2023
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KIN-8741, a highly selective c-MET inhibitor designed to cover acquired resistance in non-small cell lung cancer and other advanced adult
solid tumors, is expected to enter the clinic in the first half of 2024
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Kinnate to evaluate strategic alternatives for its CDK12 program
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~$231 million of cash, cash equivalents and investments as of March 31, 2023 is anticipated to fund planned operations into early 2025
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Kinnate to host virtual investor webcast today, April 17, 2023, at 5:30 pm ET
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SAN FRANCISCO and SAN DIEGO – April 17 2023 – Kinnate
Biopharma Inc. (Nasdaq: KNTE) (Kinnate), a clinical-stage precision oncology company, today announced the addition of two new internally
developed next generation development candidates to its targeted oncology pipeline – a brain penetrant mitogen-activated protein kinase (MEK) inhibitor and a highly selective mesenchymal-epithelial transition factor gene (c-MET) inhibitor.
The company also announced that it had approximately $231 million of cash, cash equivalents and investments as of March 31, 2023, which is anticipated to fund planned
operations into early 2025.
“We are proud of our growing portfolio of precision oncology programs comprised of highly selective therapeutics with optimized drug properties designed to address broad
alteration coverage, resistance mechanisms and now brain penetrance,” said Robert Kania, Ph.D., senior vice president, drug discovery, Kinnate Biopharma Inc. “The
addition of Kinnate’s next generation MEK and c-MET research programs to our development pipeline illustrates the productivity of our capability-based discovery
engine, which is delivering on our goal of bringing forward one new IND a year. Targeted therapies have tremendous potential to help patients, but only about ten percent of patients with advanced or metastatic cancer are eligible for currently
approved targeted therapies. We look forward to continued progress powered by our Kinnate Discovery Engine and the impact we can have on the lives of those battling cancer.”
In-House Brain-Penetrant MEK Inhibitor Designed for Optimal Control in Potential Commercial Opportunities
KIN-7136 is designed to be a next generation brain-penetrant MEK inhibitor for investigation in advanced adult solid tumors, primarily non-small cell lung cancer (NSCLC),
that are MAPK pathway-driven, including those with brain metastases.
Kinnate expects to enter the clinic with KIN-7136 in the second half of 2023, pending U.S. Food and Drug Administration (FDA) clearance on its investigational new drug
(IND) application. The goal of the Phase 1 clinical trial will be to establish safety and tolerability, and generate understanding of the pharmacokinetics, pharmacodynamics and early clinical activity of KIN-7136 as a monotherapy.
In parallel, the company intends to evaluate KIN-7136 combined with exarafenib, Kinnate’s investigational pan-RAF inhibitor. Kinnate plans to prioritize exploring the
KIN-7136 and exarafenib combination in BRAF Class I patients with NSCLC that have been previously treated with a RAF inhibitor and patients with NRAS mutant melanoma. This approach enables access to a potentially broader patient population to be
evaluated with exarafenib, including those with brain metastases. KIN-7136 may serve as part of the company’s long-term RAF combination strategy.
Today, the company separately provided a preliminary update on the combination arm of the ongoing Phase 1 KN-8701 clinical trial evaluating exarafenib with binimetinib, a
first generation MEK inhibitor with minimal brain penetrant properties, in patients primarily with NRAS mutant melanoma.
In-House, Highly Selective c-MET Inhibitor Designed for Broad Mutational Coverage
Research has shown that acquired resistance to approved and in-development c-MET inhibitors limits clinical benefit. Up to 35% of patients treated with approved c-MET
inhibitors develop on-target resistance mutations, leaving them with limited treatment options and a poor prognosis. In patients with NSCLC, about 3-4% of patients present with actionable MET exon 14 alterations.
KIN-8741 is designed to be a highly selective c-MET inhibitor with broad mutational coverage, including acquired resistance mutations, across a variety of solid tumors in
which c-MET is overexpressed, such as NSCLC.
Kinnate expects to enter the clinic with KIN-8741 in the first half of 2024, pending FDA clearance on its IND application.
CDK12 Program Update
The company will deprioritize development for its CDK12 program and evaluate strategic alternatives as it deepens focus on its two clinical-stage assets and advances
development of its MEK and c-MET programs.
Virtual Investor Webcast Information
Kinnate will host a webcast today, April 17, 2023, at 5:30 p.m. ET. Investors and the
general public are invited to listen to a live webcast of the session through the "Investors and Media" section on Kinnate.com or by dialing the U.S. toll free number +1-888-256-1007 and entering confirmation code: 7465233. An archived edition of the session will be available following the event.
About Kinnate Biopharma Inc.
Kinnate Biopharma Inc. is a clinical-stage precision oncology company focused on expanding on the promise of targeted therapies for those battling cancer. The company is developing medicines for known oncogenic drivers where there are no approved targeted drugs and to overcome the limitations of marketed cancer therapies, such as
non-responsiveness or acquired and intrinsic resistance. Kinnate has two lead clinical programs being studied in solid tumors with RAF, NRAS and FGFR-driven alterations, and is rapidly progressing a pipeline of additional small molecule
drug candidates as part of the Kinnate Discovery Engine. The company is driven by the urgency and knowledge that patients are waiting for new, effective cancer medicines. For more information, visit Kinnate.com and follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. These forward-looking statements include, without limitation,
statements regarding the potential benefits of the company’s product candidates, including KIN-7136 and KIN-8741; the timing for initiation, conduct of and goals for clinical trials for KIN-7136 and KIN-8741; development priorities and portfolio
strategy; preliminary and unaudited financial results and anticipated cash runway; the company’s intention to hold a webcast; and statements by the company’s senior vice president, drug discovery. Words such as “believes,” “anticipates,” “plans,”
“expects,” “will,” “potential” and similar expressions are also intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends. Such
expectations and projections may never materialize or may prove to be incorrect. These forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors, including recently transitioning to operating as a
clinical-stage biopharmaceutical company with a limited operating history; the timing, progress and results of ongoing and planned preclinical studies and clinical trials for our current product candidates; the potential for future clinical trial results to differ from our preclinical studies; our ability to timely enroll a sufficient number of patients in our clinical trials; our ability to
raise additional capital to finance our operations; our ability to discover, advance through the preclinical and clinical development of, obtain regulatory approval for and commercialize our product candidates; the novel approach we are taking to
discover and develop drugs; our ability to timely file and obtain approval of investigational new drug applications for our planned clinical trials; negative impacts of the COVID-19 pandemic on our business, including ongoing and planned clinical
trials and preclinical studies; competition in our industry; regulatory developments in the United States and other countries; our ability to attract, hire and retain highly skilled executive officers and employees; difficulties in managing our
growth; our ability to protect our intellectual property; reliance on third parties to conduct our ongoing and planned preclinical studies and clinical trials, and to manufacture our product candidates; general economic and market conditions; and
other risks. These and other risks, uncertainties, assumptions and other factors are further described under the heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 that we have filed with the
Securities and Exchange Commission (“SEC”), as well as in our subsequent filings we make with the SEC. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of
all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. Investors should not rely upon
forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
Our forward-looking statements speak only as of the date of this release, and except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason in the future.
Investor & Media Contact:
Priyanka Shah | Priyanka.Shah@kinnate.com | +1-908-447-6134