Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage
biopharmaceutical company developing targeted protein modulation
drugs designed to treat patients with cancer and inflammatory
diseases, today reported financial results for the fiscal quarter
and fiscal year ended November 30, 2023, and provided a corporate
update.
“Building on a very successful 2023, marked by impressive
clinical data for both NX-5948 and NX-2127, Nurix has hit the
ground running in 2024, with plans to accelerate enrollment in the
NX-5948 leukemia and lymphoma program and enable development in
inflammatory diseases,” said Arthur T. Sands, M.D., Ph.D.,
president and chief executive officer of Nurix. “2023 was also a
great year for our partnerships, generating significant
non-dilutive funding and expanding our pipeline in both oncology
and inflammation with our IRAK-4 degrader. We anticipate continued
success with our partners Gilead, Sanofi, and Pfizer in the coming
year.”
Recent Business Highlights
- Nurix presented clinical
data for Bruton’s tyrosine kinase (BTK) degrader NX-5948 at the
American Society of Hematology (ASH) Annual Meeting: In
December 2023, Nurix reported data from the dose escalation stage
of the Phase 1 trial demonstrating dose-dependent pharmacokinetics
(PK), resulting in rapid, robust, and sustained BTK degradation in
all patients treated. NX-5948 was well-tolerated across all doses.
Preliminary efficacy data demonstrated clinical benefit in six of
seven patients with chronic lymphocytic leukemia (CLL). Durable
responses were seen across indications in non-Hodgkin lymphoma
(NHL) patients, with almost half the patients continuing to receive
treatment as of the data cut-off date. Dose escalation in the
NX-5948 trial continues across all indications and the study is
actively enrolling patients in the United States, the United
Kingdom, and the Netherlands.
- NX-5948 received U.S. FDA
Fast Track designation: In January 2024, the FDA granted
Fast Track designation for NX-5948 for the treatment of adult
patients with relapsed or refractory CLL or small lymphocytic
lymphoma after at least two lines of therapy, including a BTK
inhibitor (BTKi) and a B-cell lymphoma 2 (BCL2) inhibitor. The
FDA’s Fast Track designation is intended to facilitate and expedite
the development and review of drug candidates to treat serious
conditions and fulfill an unmet medical need. A therapeutic
candidate that receives Fast Track designation may be eligible for
more frequent interactions with the FDA to discuss the candidate’s
development plan and, if relevant criteria are met, eligibility for
Accelerated Approval and Priority Review.
- Nurix presented clinical
data for NX-2127, a dual BTK and IKZF1/3 degrader, at the ASH
Annual Meeting: In December 2023, Nurix reported data from
its Phase 1a dose escalation and Phase 1b dose expansion cohorts in
CLL, mantle cell lymphoma (MCL) and diffuse large B-cell lymphoma
(DLBCL). NX-2127 exhibited dose-dependent PK, leading to robust and
sustained degradation of BTK and biologically relevant degradation
of IKZF1 (Ikaros). Treatment with NX-2127 resulted in encouraging
rapid and durable responses in the heavily pre-treated patient
population including patients with BTK inhibitor resistance
mutations. Durable complete responses were reported in two patients
with MCL and DLBCL which remained ongoing for over one year.
NX-2127 had a manageable safety profile that was consistent with
previous reports for BTK-targeted and immunomodulatory
therapies.
- High profile publications
provide scientific basis for BTK scaffold function and degrader
mechanism: In February 2024, Nurix announced the
publication of a manuscript in the journal Science titled: “Kinase
Impaired BTK Mutations Are Susceptible to Clinical Stage BTK and
IKZF1/3 Degrader NX-2127” that elucidates a previously
unappreciated oncogenic scaffold function of BTK responsible for
clinical resistance to enzymatic inhibitors and shows that NX-2127
can overcome this resistance across a broad range of acquired
mutations. A second manuscript was published contemporaneously in
The Journal of Medicinal Chemistry entitled “Discovery and
Preclinical Pharmacology of NX-2127, an Orally Bioavailable
Degrader of Bruton’s Tyrosine Kinase with Immunomodulatory Activity
for the Treatment of Patients with B Cell Malignancies,” which
details the discovery and optimization of NX-2127.
Upcoming Program Highlights*
- NX-5948: NX-5948 is
an investigational, orally bioavailable, small molecule degrader of
BTK. NX-5948 is currently being evaluated in a Phase 1a/b clinical
trial in adults with relapsed or refractory B-cell malignancies. In
2024, Nurix expects to define doses for Phase 1b cohort expansion
in CLL and NHL and accelerate Phase 1 clinical trial enrollment to
enable pivotal trials. Nurix plans to present additional clinical
data with higher dose levels and longer treatment duration in
mid-2024. In addition, Nurix expects to complete ongoing
preclinical studies that can enable an investigational new drug
(IND) application for NX-5948 in autoimmune indications. Additional
information on the clinical trial can be accessed at
www.clinicaltrials.gov (NCT05131022).
- NX-2127: NX-2127 is
an orally bioavailable degrader of BTK with immunomodulatory
activity for the treatment of patients with relapsed or refractory
B-cell malignancies. Nurix is conducting a Phase 1a/b clinical
trial of NX-2127, which includes three Phase 1b expansion cohorts
in patients with DLBCL, MCL and CLL. Screening and enrollment of
new study participants have been paused due to a partial clinical
hold placed on the study by the FDA. Patients currently enrolled in
the clinical study who are deriving clinical benefit may continue
to receive treatment in accordance with the ongoing study protocol.
In 2024, Nurix expects to resolve the partial clinical hold to
enable the introduction of newly manufactured drug product into the
ongoing Phase 1 clinical trial. Additional information on the
clinical trial can be accessed at www.clinicaltrials.gov
(NCT04830137).
- NX-1607: Nurix’s
lead drug candidate from its targeted protein elevation portfolio,
NX-1607, is an orally bioavailable inhibitor of the E3 ligase
Casitas B-lineage lymphoma proto-oncogene B (CBL-B) for
immuno-oncology indications including a range of solid tumor types
and lymphoma. Nurix is evaluating NX-1607 in an ongoing, Phase 1
trial in monotherapy and in a combination cohort utilizing
paclitaxel in adults in a range of oncology indications. In 2024,
Nurix expects to present data from the Phase 1a dose-escalation
portion of the trial of NX-1607 and to define dose(s) to enable
Phase 1b cohort expansion. Additional information on the clinical
trial can be accessed at www.clinicaltrials.gov (NCT05107674).
- NX-0479/GS-6791:
GS-6791 (previously NX-0479) is a potent, selective, oral IRAK4
degrader. Degradation of IRAK4 by GS-6791 has potential
applications in the treatment of rheumatoid arthritis and other
inflammatory diseases. Nurix’s partner, Gilead, is responsible for
conducting IND-enabling studies and advancing this program to
clinical development.
- Selection of new drug
candidate: Nurix expects to select a new targeted protein
degrader development candidate in 2024.
- Continued pipeline advancement of strategic
collaborations with Gilead, Sanofi and Pfizer: Nurix
expects to continue to achieve substantial research collaboration
milestones throughout the terms of its collaborations with Gilead,
Sanofi and Pfizer.
* Expected timing of events throughout this
press release is based on calendar year quarters.
Fiscal Fourth Quarter and Full Year 2023 Financial Results
Revenue for the three months and twelve months
ended November 30, 2023, was $15.2 million and $77.0 million,
respectively, compared with $6.8 million and $38.6 million for the
three and twelve months ended November 30, 2022, respectively. The
increase for the twelve-month period was primarily due to a higher
percentage of completion of performance obligations and an increase
in the value of milestones achieved in the current period. The
increase was also due to the receipt of $20.0 million related
to the license option exercise payment from Gilead. During the year
ended November 30, 2023, Nurix achieved research milestones under
its collaborations with Gilead and Sanofi totaling $12.5 million
and $7.0 million, respectively.
Research and development expenses for the three
months and twelve months ended November 30, 2023, were
$49.7 million and $189.1 million, respectively, compared to
$46.1 million and $184.5 million for the three and twelve
months ended November 30, 2022, respectively. For the twelve-month
period, there was an increase in compensation and related personnel
costs and an increase in clinical costs as Nurix continued its
clinical trial programs and ongoing patient enrollment, offset by a
decrease in research related costs and in contract
manufacturing.
General and administrative expenses for the
three months and twelve months ended November 30, 2023, were
$10.8 million and $42.9 million, respectively, compared to
$9.4 million and $38.0 million for the three and twelve months
ended November 30, 2022, respectively. The increase for the
twelve-month period was primarily related to an increase in
non-cash stock-based compensation expense and an increase in
professional service costs related to the Pfizer collaboration
agreement, offset by a decrease in outside consulting costs.
Net loss for the three months and twelve months
ended November 30, 2023, was $42.0 million or ($0.77) per share and
$143.9 million or ($2.65) per share, respectively, compared with
$46.7 million or ($0.87) per share and $180.4 million or ($3.71)
per share for the three and twelve months ended November 30, 2022,
respectively.
Cash, cash equivalents and marketable
securities was $295.3 million as of November 30, 2023,
compared to $268.7 million as of August 31, 2023.
About Nurix Therapeutics, Inc.
Nurix Therapeutics is a clinical stage biopharmaceutical company
focused on the discovery, development and commercialization of
innovative small molecules and antibody therapies based on the
modulation of cellular protein levels as a novel treatment approach
for cancer, inflammatory conditions, and other challenging
diseases. Leveraging extensive expertise in E3 ligases together
with proprietary DNA-encoded libraries, Nurix has built DELigase,
an integrated discovery platform, to identify and advance novel
drug candidates targeting E3 ligases, a broad class of enzymes that
can modulate proteins within the cell. Nurix’s drug discovery
approach is to either harness or inhibit the natural function of E3
ligases within the ubiquitin-proteasome system to selectively
decrease or increase cellular protein levels. Nurix’s wholly owned,
clinical stage pipeline includes targeted protein degraders of
Bruton’s tyrosine kinase, a B-cell signaling protein, and
inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3
ligase that regulates activation of multiple immune cell types
including T cell and NK cells. Nurix is headquartered in San
Francisco, California. For additional information visit
http://www.nurixtx.com.
Forward-Looking Statements
This press release contains statements that relate to future
events and expectations and as such constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. When or if used in this press release, the
words “anticipate,” “believe,” “could,” “estimate,” “expect,”
“intend,” “may,” “outlook,” “plan,” “predict,” “should,” “will,”
and similar expressions and their variants, as they relate to
Nurix, may identify forward-looking statements. All statements that
reflect Nurix’s expectations, assumptions or projections about the
future, other than statements of historical fact, are
forward-looking statements, including, without limitation,
statements regarding: Nurix’s future financial or business
performance; Nurix’s future plans, prospects and strategies;
Nurix’s plans and expectations with respect to its current and
prospective drug candidates, including its plans to accelerate
enrollment in the NX-5948 clinical trial and its expectations with
respect to the partial clinical hold on the NX-2127 clinical trial;
the tolerability, safety profile, therapeutic potential and other
advantages of Nurix’s drug candidates, including their potential to
address a range of acquired mutations; the planned timing and
conduct of Nurix’s clinical trials; the planned timing for the
provision of updates and findings from Nurix’s preclinical studies
and clinical trials; the potential benefits of and Nurix’s
expectations with respect to its strategic collaborations,
including the achievement of research milestones; the potential
advantages of Nurix’s scientific approach and DELigase™ platform;
and the potential benefits of Fast Track designation.
Forward-looking statements reflect Nurix’s current beliefs,
expectations, and assumptions regarding the future of Nurix’s
business, its future plans and strategies, its development plans,
its preclinical and clinical results, future conditions and other
factors Nurix believes are appropriate in the circumstances.
Although Nurix believes the expectations and assumptions reflected
in such forward-looking statements are reasonable, Nurix can give
no assurance that they will prove to be correct. Forward-looking
statements are not guarantees of future performance and are subject
to risks, uncertainties and changes in circumstances that are
difficult to predict, which could cause Nurix’s actual activities
and results to differ materially from those expressed in any
forward-looking statement. Such risks and uncertainties include,
but are not limited to: (i) whether Nurix will be able to advance
its drug candidates, obtain regulatory approval of and ultimately
commercialize its drug candidates; (ii) uncertainties related to
the timing and results of preclinical studies and clinical trials;
(iii) whether Nurix will be able to fund development activities and
achieve development goals; (iv) uncertainties related to the timing
and receipt of payments from Nurix’s collaboration partners,
including milestone payments and royalties on future product sales;
(v) the impact of global business, political and macroeconomic
conditions, cybersecurity events, instability in the banking
system, and global events, including regional conflicts around the
world, on Nurix’s business, clinical trials, financial condition,
liquidity and results of operations; (vi) whether Nurix will be
able to protect intellectual property and (vii) other risks and
uncertainties described under the heading “Risk Factors” in Nurix’s
Annual Report on Form 10-K for the fiscal year ended November 30,
2023, and other SEC filings. Accordingly, readers are cautioned not
to place undue reliance on these forward-looking statements. The
statements in this press release speak only as of the date of this
press release, even if subsequently made available by Nurix on its
website or otherwise. Nurix disclaims any intention or obligation
to update publicly any forward-looking statements, whether in
response to new information, future events, or otherwise, except as
required by applicable law.
Contacts:
InvestorsJason Kantor, Ph.D.Nurix Therapeutics,
Inc.ir@nurixtx.com
Elizabeth Wolffe, Ph.D.Wheelhouse Life Science
Advisorslwolffe@wheelhouselsa.com
MediaAljanae ReynoldsWheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
|
Nurix Therapeutics, Inc.Condensed
Consolidated Statements of Operations(in
thousands, except share and per share
amounts)(unaudited) |
|
|
|
|
|
Three Months Ended November 30, |
|
Year Ended November 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenue: |
|
|
|
|
|
|
|
Collaboration revenue |
$ |
15,159 |
|
|
$ |
6,783 |
|
|
$ |
56,987 |
|
|
$ |
38,627 |
|
License revenue |
|
— |
|
|
|
— |
|
|
|
20,000 |
|
|
|
— |
|
Total revenue |
|
15,159 |
|
|
|
6,783 |
|
|
|
76,987 |
|
|
|
38,627 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
49,713 |
|
|
|
46,106 |
|
|
|
189,148 |
|
|
|
184,497 |
|
General and administrative |
|
10,780 |
|
|
|
9,367 |
|
|
|
42,902 |
|
|
|
37,997 |
|
Total operating expenses |
|
60,493 |
|
|
|
55,473 |
|
|
|
232,050 |
|
|
|
222,494 |
|
Loss from operations |
|
(45,334 |
) |
|
|
(48,690 |
) |
|
|
(155,063 |
) |
|
|
(183,867 |
) |
Interest and other income,
net |
|
3,378 |
|
|
|
1,973 |
|
|
|
11,115 |
|
|
|
3,507 |
|
Net loss |
$ |
(41,956 |
) |
|
$ |
(46,717 |
) |
|
$ |
(143,948 |
) |
|
$ |
(180,360 |
) |
Net loss per share, basic and
diluted |
$ |
(0.77 |
) |
|
$ |
(0.87 |
) |
|
$ |
(2.65 |
) |
|
$ |
(3.71 |
) |
Weighted-average number of
shares outstanding, basic and diluted |
|
54,670,342 |
|
|
|
53,944,109 |
|
|
|
54,337,901 |
|
|
|
48,607,990 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nurix Therapeutics, Inc.Condensed
Consolidated Balance Sheets(in
thousands)(unaudited) |
|
|
|
November 30, |
|
2023 |
|
2022 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
54,627 |
|
|
$ |
64,474 |
|
Marketable securities, current |
|
233,281 |
|
|
|
244,667 |
|
Prepaid expenses and other current assets |
|
7,595 |
|
|
|
9,308 |
|
Total current assets |
|
295,503 |
|
|
|
318,449 |
|
Marketable securities, non-current |
|
7,421 |
|
|
|
63,879 |
|
Operating lease right-of-use assets |
|
31,142 |
|
|
|
12,345 |
|
Property and equipment, net |
|
16,808 |
|
|
|
17,163 |
|
Restricted cash |
|
901 |
|
|
|
901 |
|
Other assets |
|
3,823 |
|
|
|
4,022 |
|
Total assets |
$ |
355,598 |
|
|
$ |
416,759 |
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
6,401 |
|
|
$ |
5,064 |
|
Accrued expenses and other current liabilities |
|
24,970 |
|
|
|
22,428 |
|
Operating lease liabilities, current |
|
7,489 |
|
|
|
5,530 |
|
Deferred revenue, current |
|
48,098 |
|
|
|
37,633 |
|
Total current liabilities |
|
86,958 |
|
|
|
70,655 |
|
Operating lease liabilities, net of current portion |
|
23,125 |
|
|
|
6,434 |
|
Deferred revenue, net of current portion |
|
45,022 |
|
|
|
35,974 |
|
Total liabilities |
|
155,105 |
|
|
|
113,063 |
|
Stockholders’ equity: |
|
|
|
Common stock |
|
49 |
|
|
|
47 |
|
Additional paid-in-capital |
|
746,299 |
|
|
|
709,220 |
|
Accumulated other comprehensive loss |
|
(655 |
) |
|
|
(4,319 |
) |
Accumulated deficit |
|
(545,200 |
) |
|
|
(401,252 |
) |
Total stockholders’ equity |
|
200,493 |
|
|
|
303,696 |
|
Total liabilities and stockholders’ equity |
$ |
355,598 |
|
|
$ |
416,759 |
|
|
|
|
|
|
|
|
|
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