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 second quarter
ended May 31, 2024, and provided a corporate update.
“Our second quarter was one of significant advancements on a
number of fronts, led by our positive clinical data for NX-5948
presented at EHA2024 in June and reinforced with the strengthening
of our balance sheet to accelerate the development of this
program,” said Arthur T. Sands, M.D., Ph.D., president and chief
executive officer of Nurix. “The data presented at EHA2024,
reaffirm the best-in-class potential of our protein degradation
platform to address the limitations of current inhibitors against
challenging targets such as Bruton’s tyrosine kinase. We enter the
second half of 2024 well positioned to develop our lead clinical
program, NX-5948, into pivotal clinical trials in CLL in 2025 and
to continue to advance our wholly owned pipeline of clinical
assets, preclinical programs and strategic collaboration programs
with Gilead, Sanofi and Pfizer.”
Recent Business Highlights
- Presentation of positive
clinical data from ongoing Phase1a/b trial of NX-5948, Nurix’s
orally bioavailable degrader of Bruton’s tyrosine kinase
(BTK): On June 16, 2024, Kim Linton, M.B.Ch.B, MRCP,
Ph.D., FRCP, senior lecturer at the University of Manchester, a
consultant at The Christie NHS Foundation Trust and an investigator
on the clinical trial, presented data from the ongoing Phase 1a/b
clinical trial of NX-5948 in adults with relapsed or refractory
B-cell malignancies in an oral session at the European Hematology
Association Congress (EHA2024). NX-5948 demonstrated an objective
response rate (ORR) of 69.2% in heavily pretreated chronic
lymphocytic leukemia (CLL) patients, including in patients with
Bruton’s tyrosine kinase (BTK) inhibitor resistance mutations and
patients with central nervous system (CNS) involvement. Clinical
responses were rapid and deepening with longer time on treatment,
and NX-5948 was well tolerated with extended treatment durations in
many patients. Nurix also highlighted its plans for expansion to
Phase 1b in CLL and its goal of initiating pivotal development in
2025. The Company hosted a webcast to discuss the presented data
and its plans for development of NX-5948, a recording of which is
accessible under the Events and Presentations page in the Investors
section of the company’s website here.
- Strengthened balance
sheet: On April 16, 2024, Nurix announced the closing of
its underwritten public offering of 11,916,667 shares of its common
stock at a public offering price of $15.00 per share, which
includes 1,750,000 shares issued upon the exercise in full by the
underwriters of their option to purchase additional shares of
common stock. In addition, and in lieu of common stock, Nurix sold
to certain investors pre-funded warrants to purchase 1,500,100
shares of common stock at a purchase price of $14.999 per
pre-funded warrant, which represents the per share public offering
price for the common stock less the $0.001 per share exercise price
for each such pre-funded warrant. The net proceeds from the
offering were approximately $188.7 million after deducting
underwriting discounts and commissions and other offering
expenses.
- Strengthened leadership
with C-suite appointments: On May 28, 2024, Nurix
announced the appointments of Paula G. O’Connor, M.D., as chief
medical officer and Pasit Phiasivongsa, Ph.D., as chief technical
officer of Nurix. Dr. O’Connor joined Nurix in September 2022 and
most recently served as executive vice president and head of
clinical development. Dr. Phiasivongsa joined Nurix in August 2022
and most recently served as executive vice president of technical
operations. These appointments strengthen leadership in clinical
operations and CMC ahead of planned pivotal studies for NX-5948 in
2025.
- Election of new board
chair: Nurix’s board of directors unanimously elected
board member Julia P. Gregory as its new board chair, and Judith A.
Reinsdorf, J.D., as its new Nominating and Corporate Governance
Committee chair, effective as of May 20, 2024. Ms. Gregory joined
the Nurix board in 2019 and currently also serves as the chair of
its Audit Committee and as a member of its Nominating and Corporate
Governance Committee. Ms. Reinsdorf joined the Nurix board in 2021
and currently also serves as a member of its Audit Committee. David
L. Lacey, M.D., stepped down as board chair and remains on the
Nurix board serving as chair of its Compensation Committee and a
member of its Development Advisory Committee.
Upcoming Program Highlights*
NX-5948: NX-5948 is an investigational, orally
bioavailable 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 the second half of 2024, Nurix
plans to present additional clinical data from this study for
patients with CLL and non-Hodgkin lymphoma (NHL). In addition, in
2024, Nurix plans to define doses for Phase 1b cohort expansion in
CLL to enable pivotal trial initiation in 2025. Nurix also plans to
complete preclinical studies to enable an investigational new drug
(IND) application for NX-5948 in autoimmune indications. Additional
information on the Phase 1a/b 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
Phase 1b expansion cohorts focused on patients with diffuse large
B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). As
previously announced, in March 2024, the FDA lifted a
manufacturing-related, partial clinical hold on the NX-2127
clinical trial. Nurix plans to reinitiate enrollment with the new
chirally controlled drug product in a standard dose escalation
study within the current Phase 1a/1b trial in the second half of
2024. 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 the second half of 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).
GS-6791 (previously NX-0479): GS-6791 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.
STAT6 degrader: In April 2024, Nurix announced
an extension of the ongoing research program with Sanofi for STAT6
(signal transducer and activator of transcription 6), a key drug
target in type 2 inflammation, with the goal of nominating a
development candidate in the first year of the extended term. Nurix
remains on track for this goal.
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 Second Quarter 2024 Financial Results
Collaboration revenue for the three months
ended May 31, 2024, was $12.1 million compared with $10.7 million
for the three months ended May 31, 2023. The increase was primarily
due to the recognition of revenue from the collaboration with
Pfizer that was entered into in the fourth quarter of fiscal year
2023. During the three months ended May 31, 2024, Nurix achieved a
research milestone under its collaboration with Pfizer totaling
$5.0 million.
Research and development expenses for the three
months ended May 31, 2024, was $48.9 million compared with $45.8
million for the three months ended May 31, 2023. The increase was
primarily due to clinical costs and contract manufacturing costs as
Nurix continues to progress its clinical trial programs and ongoing
patient enrollment.
General and administrative expenses for the
three months ended May 31, 2024 and May 31, 2023 were both $11.7
million.
Net loss for the three months ended May 31,
2024, was $44.5 million, or ($0.71) per share, compared with $24.3
million, or ($0.45) per share, for the three months ended May 31,
2023.
Cash, cash equivalents and marketable
securities was $452.5 million as of May 31, 2024,
compared to $254.3 million as of February 29, 2024.
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; the tolerability, safety profile,
therapeutic potential and other advantages of Nurix’s drug
candidates; the potential of Nurix’s protein degradation platform
to address the limitations of current protein inhibitors; 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;
and the potential advantages of Nurix’s scientific approach and
DELigase™ platform. 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 Quarterly Report on Form 10-Q
for the fiscal quarter ended May 31, 2024, 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 |
|
Six Months Ended |
|
May 31, |
May 31, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Revenue: |
|
|
|
|
|
|
|
Collaboration revenue |
$ |
12,092 |
|
|
$ |
10,676 |
|
|
$ |
28,677 |
|
|
$ |
23,361 |
|
License revenue |
|
— |
|
|
|
20,000 |
|
|
|
— |
|
|
|
20,000 |
|
Total
revenue |
|
12,092 |
|
|
|
30,676 |
|
|
|
28,677 |
|
|
|
43,361 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
48,922 |
|
|
|
45,763 |
|
|
|
98,927 |
|
|
|
91,579 |
|
General and administrative |
|
11,710 |
|
|
|
11,678 |
|
|
|
23,509 |
|
|
|
21,499 |
|
Total
operating expenses |
|
60,632 |
|
|
|
57,441 |
|
|
|
122,436 |
|
|
|
113,078 |
|
Loss from
operations |
|
(48,540 |
) |
|
|
(26,765 |
) |
|
|
(93,759 |
) |
|
|
(69,717 |
) |
Interest and
other income, net |
|
4,084 |
|
|
|
2,488 |
|
|
|
7,875 |
|
|
|
4,707 |
|
Loss before
income taxes |
|
(44,456 |
) |
|
|
(24,277 |
) |
|
|
(85,884 |
) |
|
|
(65,010 |
) |
Provision
for income taxes |
|
90 |
|
|
|
— |
|
|
|
180 |
|
|
|
— |
|
Net
loss |
$ |
(44,546 |
) |
|
$ |
(24,277 |
) |
|
$ |
(86,064 |
) |
|
$ |
(65,010 |
) |
Net loss per
share, basic and diluted |
$ |
(0.71 |
) |
|
$ |
(0.45 |
) |
|
$ |
(1.47 |
) |
|
$ |
(1.20 |
) |
Weighted-average number of shares outstanding, basic and
diluted |
|
62,377,551 |
|
|
|
54,259,045 |
|
|
|
58,660,900 |
|
|
|
54,144,909 |
|
|
|
|
|
|
|
|
|
|
Nurix
Therapeutics, Inc.Condensed Consolidated Balance
Sheets(in
thousands)(unaudited) |
|
|
|
|
|
May 31, |
|
November 30, |
|
2024 |
|
2023 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
116,790 |
|
|
$ |
54,627 |
|
Marketable securities, current |
|
326,349 |
|
|
|
233,281 |
|
Prepaid expenses and other current assets |
|
7,078 |
|
|
|
7,595 |
|
Total current assets |
|
450,217 |
|
|
|
295,503 |
|
Marketable securities, non-current |
|
9,380 |
|
|
|
7,421 |
|
Operating lease right-of-use assets |
|
28,835 |
|
|
|
31,142 |
|
Property and equipment, net |
|
18,557 |
|
|
|
16,808 |
|
Restricted cash |
|
901 |
|
|
|
901 |
|
Other assets |
|
3,141 |
|
|
|
3,823 |
|
Total assets |
$ |
511,031 |
|
|
$ |
355,598 |
|
Liabilities and stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,813 |
|
|
$ |
6,401 |
|
Accrued expenses and other current liabilities |
|
23,263 |
|
|
|
24,970 |
|
Operating lease liabilities, current |
|
7,934 |
|
|
|
7,489 |
|
Deferred revenue, current |
|
46,769 |
|
|
|
48,098 |
|
Total current liabilities |
|
80,779 |
|
|
|
86,958 |
|
Operating lease liabilities, net of current portion |
|
20,885 |
|
|
|
23,125 |
|
Deferred revenue, net of current portion |
|
38,674 |
|
|
|
45,022 |
|
Total liabilities |
|
140,338 |
|
|
|
155,105 |
|
Stockholders’ equity: |
|
|
|
Common stock |
|
64 |
|
|
|
49 |
|
Additional paid-in-capital |
|
1,002,028 |
|
|
|
746,299 |
|
Accumulated other comprehensive loss |
|
(135 |
) |
|
|
(655 |
) |
Accumulated deficit |
|
(631,264 |
) |
|
|
(545,200 |
) |
Total stockholders’ equity |
|
370,693 |
|
|
|
200,493 |
|
Total liabilities and stockholders’ equity |
$ |
511,031 |
|
|
$ |
355,598 |
|
|
|
|
|
Nurix Therapeutics (NASDAQ:NRIX)
Gráfica de Acción Histórica
De Jun 2024 a Jul 2024
Nurix Therapeutics (NASDAQ:NRIX)
Gráfica de Acción Histórica
De Jul 2023 a Jul 2024