Kinnate Biopharma Inc. Reports First Quarter 2023 Financial Results and Recent Corporate Updates
11 Mai 2023 - 10:05PM
Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate”), a clinical-stage
precision oncology company, today announced financial results for
the first quarter of 2023 and recent corporate updates.
“Kinnate continues to make demonstrable progress with its
pipeline of highly selective compounds designed with optimized drug
properties and the ability to address a broad set of alterations,
overcome resistance mechanisms and/or achieve brain penetrance,”
said Nima Farzan, chief executive officer, Kinnate Biopharma Inc.
“At AACR this year, we presented the first clinical data for the
company from our RAF program, showing exarafenib, the lead product
candidate, was well-tolerated, achieved substantial, dose
proportional and therapeutically meaningful exposures with
objective measures of response supporting its best-in-class
profile. Building on this momentum, we look forward to several
additional catalysts in the second half of the year, including dose
selection for the exarafenib and binimetinib combination where
we’ve also observed early responses, initial dose escalation data
for KIN-3248, our investigational pan-FGFR inhibitor, and entering
the clinic with our third internally developed product candidate, a
brain-penetrant MEK inhibitor. With a strong balance sheet, we
believe our current capital will fund operations into early 2025,
enabling our continued growth as a global company.”
Pipeline Updates
- The company will have a poster presentation at the 2023
American Society of Clinical Oncology Annual Meeting on circulating
tumor DNA-based genomic landscape analysis to evaluate molecular
brake and gatekeeper mutations in FGFR2. (View Poster Details)
Initial dose escalation data from the ongoing global Phase 1
clinical trial, KN-4802, evaluating the pan-FGFR inhibitor,
KIN-3248, in patients with FGFR2/3 alterations is expected in the
second half of 2023.
- Presented exarafenib monotherapy dose escalation data from
KN-8701, a global Phase 1 clinical trial, during an oral
presentation at the American Association for Cancer Research (AACR)
2023 Annual Meeting. In addition, the company provided an update on
the monotherapy dose expansion strategy and announced preliminary
findings from the combination arm of KN-8701, evaluating exarafenib
plus binimetinib. The company expects to provide an update in the
second half of 2023 on the dose selection and additional escalation
data for exarafenib plus binimetinib, and initial exarafenib
monotherapy dose expansion data in the first half of 2024. (View
Release)
- Presented preclinical data for exarafenib monotherapy and in
combination with a MEK inhibitor in human NRAS mutant melanoma
models in a poster session at the AACR 2023 Annual Meeting. (View
Poster)
- Announced the addition of two next-generation development
candidates to the pipeline – a brain penetrant mitogen-activated
protein kinase (MEK) inhibitor (KIN-7136), expected to enter the
clinic in the second half of 2023, and a highly selective
mesenchymal epithelial transition (c-MET) inhibitor (KIN-8741),
expected to enter the clinic in the first half of 2024. (View
Release)
- Announced the company will evaluate strategic alternatives for
its Cyclin-Dependent Kinase (CDK12) program. (View Release)
Financial Results
- As of March 31, 2023, total cash, cash equivalents and
investments were $231.2 million, which is expected to fund current
operations into early 2025.
- First quarter research and development expenses for 2023 were
$26.5 million, compared to $19.6 million for the same period in
2022.
- First quarter general and administrative expenses for 2023 were
$8.1 million, compared to $7.4 million for the same period in
2022.
- First quarter net loss for 2023 was $32.9 million, compared to
$26.9 million for the same period in 2022.
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, the timing and presentation
of clinical data and dose selection; statements regarding the
potential benefits and properties of the company’s product
candidates; the timing for initiation of clinical trials for
KIN-7136 and KIN-8741; the sufficiency of our funding to continue
to operate, support long term growth and progress our pipeline; our
anticipated cash runway; and statements by our Chief Executive
Officer. 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, among other things: 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 Quarterly Report on Form
10-Q for the quarter ended March 31, 2023 that we are concurrently
filing 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
Kinnate
Biopharma Inc. |
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|
Condensed
Consolidated Balance Sheets |
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|
(in
thousands, except share and par value amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2023 |
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
73,570 |
|
|
$ |
29,261 |
|
|
|
Cash at consolidated joint venture |
|
|
- |
|
|
|
25,725 |
|
|
|
Short-term investments |
|
|
127,411 |
|
|
|
172,214 |
|
|
|
Prepaid expenses and other current assets |
|
|
4,307 |
|
|
|
3,637 |
|
|
|
Total current assets |
|
|
205,288 |
|
|
|
230,837 |
|
|
|
Property and
equipment, net |
|
|
2,877 |
|
|
|
3,071 |
|
|
|
Right-of-use
lease assets |
|
|
3,170 |
|
|
|
3,377 |
|
|
|
Long-term
investments |
|
|
30,203 |
|
|
|
39,139 |
|
|
|
Restricted
cash |
|
|
371 |
|
|
|
371 |
|
|
|
Other
non-current assets |
|
|
1,971 |
|
|
|
2,031 |
|
|
|
Total assets |
|
$ |
243,880 |
|
|
$ |
278,826 |
|
|
|
|
|
|
|
|
|
|
Liabilities, Redeemable Convertible Noncontrolling
Interests and Stockholders' Equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,451 |
|
|
$ |
2,970 |
|
|
|
Accrued expenses |
|
|
12,721 |
|
|
|
13,206 |
|
|
|
Current portion of operating lease liabilities |
|
|
983 |
|
|
|
991 |
|
|
|
Total current liabilities |
|
|
18,155 |
|
|
|
17,167 |
|
|
|
Operating
lease liabilities, long-term |
|
|
2,963 |
|
|
|
3,191 |
|
|
|
Total liabilities |
|
|
21,118 |
|
|
|
20,358 |
|
|
|
Redeemable
convertible noncontrolling interests |
|
|
- |
|
|
|
35,000 |
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.0001 par value; 200,000,000 shares authorized
at |
|
|
|
|
|
|
March 31, 2023 and December 31, 2022; 0
shares outstanding at |
|
|
|
|
|
|
March 31, 2023 and December 31, 2022 |
|
|
- |
|
|
|
- |
|
|
|
Common stock, $0.0001 par value; 1,000,000,000 shares authorized
at |
|
|
|
|
|
|
March 31, 2023 and December 31, 2022;
46,569,648 and 44,342,292 shares |
|
|
|
|
|
|
issued and outstanding at March 31, 2023
and December 31, 2022 , respectively |
|
|
5 |
|
|
|
4 |
|
|
|
Additional paid-in capital |
|
|
515,524 |
|
|
|
484,237 |
|
|
|
Accumulated other comprehensive loss |
|
|
(464 |
) |
|
|
(1,410 |
) |
|
|
Accumulated deficit |
|
|
(292,303 |
) |
|
|
(259,363 |
) |
|
|
Total stockholders’ equity |
|
|
222,762 |
|
|
|
223,468 |
|
|
|
Total
liabilities, redeemable convertible noncontrolling interests and
stockholders' equity |
|
$ |
243,880 |
|
|
$ |
278,826 |
|
|
|
|
|
|
|
|
|
|
Kinnate
Biopharma Inc. |
Condensed
Consolidated Statements of Operations and Comprehensive
Loss |
(in
thousands, except share and per share amounts) |
|
|
|
|
|
|
|
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|
|
Three Months Ended March 31, |
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
|
$ |
26,559 |
|
|
$ |
19,647 |
|
|
General and administrative |
|
|
|
8,094 |
|
|
|
7,412 |
|
|
Total operating expenses |
|
|
|
34,653 |
|
|
|
27,059 |
|
|
Loss from
operations |
|
|
|
(34,653 |
) |
|
|
(27,059 |
) |
|
Other
income, net |
|
|
|
1,713 |
|
|
|
157 |
|
|
Net
loss |
|
|
$ |
(32,940 |
) |
|
$ |
(26,902 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares outstanding, basic and diluted |
|
|
|
45,409,572 |
|
|
|
43,882,920 |
|
|
Net loss per
share, basic and diluted |
|
|
$ |
(0.73 |
) |
|
$ |
(0.61 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
Net
loss |
|
|
$ |
(32,940 |
) |
|
$ |
(26,902 |
) |
|
Other
comprehensive loss: |
|
|
|
|
|
|
Unrealized gain (loss) on investments |
|
|
|
946 |
|
|
|
(1,656 |
) |
|
Total
comprehensive loss |
|
|
$ |
(31,994 |
) |
|
$ |
(28,558 |
) |
|
|
|
|
|
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Kinnate Biopharma (NASDAQ:KNTE)
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