Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage
biopharmaceutical company developing targeted protein modulation
drugs designed to treat patients with hematologic malignancies and
solid tumors, today reported financial results for the fiscal
quarter ended August 31, 2023, and provided a corporate update.
“As our drug development pipeline continues to advance in the
clinic, we are excited to add to our pipeline with Seagen to
advance a portfolio of Degrader-Antibody Conjugates, or DACs, a new
class of highly selective cancer therapeutics,” said Arthur T.
Sands, M.D., Ph.D., president and chief executive officer of Nurix.
“Nurix enters the fourth quarter of 2023 in a strong financial
position due to our ability to access significant revenue from
corporate partners including our recently announced agreement with
Seagen and ongoing strategic collaborations with Gilead and
Sanofi.”
Recent Business Highlights
- Nurix announced a first of
its kind strategic collaboration with Seagen: In
September, Nurix entered a collaboration with Seagen to develop a
portfolio of Degrader-Antibody Conjugates (DACs): antibodies that
deliver a targeted protein degrader payload to selectively kill
cancer cells. Nurix received a $60 million upfront payment and has
the potential to receive approximately $3.4 billion in milestone
payments plus future royalties. Nurix also retains an option for
U.S. profit sharing and co-promotion on two products arising from
the collaboration. In addition, Nurix announced that with the
receipt of the $60 million upfront payment, Nurix expects that its
existing cash, cash equivalents and marketable securities,
excluding any future potential milestones from collaborations, will
be sufficient to fund its operating activities into the second
quarter of 2025.
- Nurix expanded its Phase 1a
trial of NX-1607 to include a combination with paclitaxel:
In August, Nurix treated the first patient with NX-1607 in
combination with paclitaxel. The decision to initiate combination
trials was informed by the evolving safety and activity data from
Phase 1a.
Upcoming Program Highlights*
- NX-5948: NX-5948 is
an orally bioavailable degrader of Bruton’s tyrosine kinase (BTK)
designed without immunomodulatory activity. Nurix is evaluating
NX-5948 in a Phase 1 clinical trial in adults with relapsed or
refractory B-cell malignancies and expects to present initial
clinical data from the Phase 1a portion of the study in the second
half of 2023. In addition, Nurix expects to define a dose for the
Phase 1b cohort expansion in the second half of 2023. 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 1 clinical trial
of NX-2127, which includes three Phase 1b expansion cohorts in
patients with diffuse large B cell lymphoma (DLBCL), mantle cell
lymphoma (MCL) and chronic lymphocytic leukemia (CLL). Nurix
anticipates presenting additional clinical results from this
ongoing trial in the second half of 2023. Nurix also anticipates
defining a regulatory strategy for NX-2127 in the second half of
2023 based on emerging clinical data and feedback from the FDA.
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 1a
dose escalation trial in monotherapy and in a combination cohort
utilizing paclitaxel in adults in a range of oncology indications.
Nurix expects to present clinical data from the Phase 1a portion of
the study and to define a dose for Phase 1b cohort expansion in the
second half of 2023. 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 Sciences, is
responsible for conducting IND-enabling studies and advancing this
program to clinical development.
- Continued advancement of strategic collaborations with
Gilead and Sanofi: Nurix expects to continue to achieve
substantial research collaboration milestones throughout the terms
of its collaborations with Gilead and Sanofi.
* Expected timing of events throughout this press
release is based on calendar year quarters.
Fiscal Third Quarter 2023 Financial Results
Revenue for the three months ended August 31,
2023, was $18.5 million compared to $10.8 million for the three
months ended August 31, 2022. The increase 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.
During the three months ended August 31, 2023, Nurix achieved
research milestones under its collaborations with Gilead and Sanofi
totaling $6.0 million and $2.0 million, respectively.
Research and development expenses for the three
months ended August 31, 2023, were $47.9 million compared to $47.8
million for the three months ended August 31, 2022. There was an
increase in clinical costs as Nurix continued its clinical trial
programs and ongoing patient enrollment, primarily offset by a
decrease in research related costs and in contract manufacturing.
There was also an increase in facility and other costs primarily
driven by additional investments in information technology and
lease related expenses.
General and administrative expenses for the
three months ended August 31, 2023, were $10.6 million compared to
$9.7 million for the three months ended August 31, 2022. The
increase was primarily related to an increase in non-cash
stock-based compensation expense and an increase in professional
service costs related to the Seagen collaboration agreement, offset
by a decrease in outside consulting costs.
Net loss for the three months ended August 31,
2023, was $37.0 million, or ($0.68) per share, compared to a net
loss of $45.7 million for the three months ended August 31, 2022,
or ($0.90) per share.
Cash, cash equivalents and marketable
securities was $268.7 million as of August 31, 2023,
compared to $308.6 million as of May 31, 2023.
About Nurix Therapeutics, Inc.
Nurix Therapeutics is a clinical stage biopharmaceutical company
focused on the discovery, development and commercialization of
medicines based on the modulation of cellular protein levels as a
novel treatment approach for cancer 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 current and prospective drug candidates; the planned timing
and conduct of Nurix’s clinical trial programs for our drug
candidates; the planned timing for the provision of updates and
findings from Nurix’s clinical studies; the potential benefits of
the Nurix-Seagen collaboration, including potential milestone and
sales-related payments; the potential advantages and therapeutic
benefits of Degrader-Antibody Conjugates; the potential advantages
of Nurix’s DELigase™ platform and drug candidates; the extent to
which Nurix’s scientific approach, Nurix’s DELigase™ platform and
Degrader-Antibody Conjugates may potentially address a broad range
of diseases; and Nurix’s ability to fund it operating activities
into the second quarter of 2025. 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) risks and
uncertainties related to Nurix’s ability to advance its drug
candidates, obtain regulatory approval of and ultimately
commercialize its drug candidates; (ii) the timing and results of
preclinical studies and clinical trials; (iii) Nurix’s ability to
fund development activities and achieve development goals; (iv) the
timing and receipt of payments from Nurix’s collaboration partners,
including milestone payments and royalties on future potential
product sales; (v) the impact of macroeconomic conditions,
including inflation, increasing interest rates, volatile market
conditions, instability in the global banking system, uncertainty
with respect to the federal budget and debt ceiling, and global
events, including regional conflicts around the world, on Nurix’s
business, clinical trials, financial condition, liquidity and
results of operations; (vi) Nurix’s ability 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 August 31, 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:
InvestorsSilinda NeouNurix
Therapeuticsir@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 August 31, |
|
Nine Months Ended August 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
Collaboration revenue |
$ |
18,467 |
|
|
$ |
10,791 |
|
|
$ |
41,828 |
|
|
$ |
31,844 |
|
License revenue |
|
— |
|
|
|
— |
|
|
|
20,000 |
|
|
|
— |
|
Total revenue |
|
18,467 |
|
|
|
10,791 |
|
|
|
61,828 |
|
|
|
31,844 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
47,856 |
|
|
|
47,761 |
|
|
|
139,435 |
|
|
|
138,391 |
|
General and administrative |
|
10,623 |
|
|
|
9,748 |
|
|
|
32,122 |
|
|
|
28,630 |
|
Total operating expenses |
|
58,479 |
|
|
|
57,509 |
|
|
|
171,557 |
|
|
|
167,021 |
|
Loss from operations |
|
(40,012 |
) |
|
|
(46,718 |
) |
|
|
(109,729 |
) |
|
|
(135,177 |
) |
Interest and other income,
net |
|
3,030 |
|
|
|
1,009 |
|
|
|
7,737 |
|
|
|
1,534 |
|
Net loss |
$ |
(36,982 |
) |
|
$ |
(45,709 |
) |
|
$ |
(101,992 |
) |
|
$ |
(133,643 |
) |
Net loss per share, basic and
diluted |
$ |
(0.68 |
) |
|
$ |
(0.90 |
) |
|
$ |
(1.88 |
) |
|
$ |
(2.85 |
) |
Weighted-average number of
shares outstanding, basic and diluted |
|
54,390,859 |
|
|
|
50,868,542 |
|
|
|
54,227,491 |
|
|
|
46,835,776 |
|
Nurix Therapeutics,
Inc.Condensed Consolidated Balance
Sheets(in
thousands)(unaudited)
|
August 31,2023 |
|
November 30,2022 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
42,304 |
|
|
$ |
64,474 |
|
Marketable securities, current |
|
216,548 |
|
|
|
244,667 |
|
Accounts receivable |
|
2,000 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
7,097 |
|
|
|
9,308 |
|
Total current assets |
|
267,949 |
|
|
|
318,449 |
|
Marketable securities, non-current |
|
9,882 |
|
|
|
63,879 |
|
Operating lease right-of-use assets |
|
9,027 |
|
|
|
12,345 |
|
Property and equipment, net |
|
16,581 |
|
|
|
17,163 |
|
Restricted cash |
|
901 |
|
|
|
901 |
|
Other assets |
|
3,855 |
|
|
|
4,022 |
|
Total assets |
$ |
308,195 |
|
|
$ |
416,759 |
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,187 |
|
|
$ |
5,064 |
|
Accrued expenses and other current liabilities |
|
21,907 |
|
|
|
22,428 |
|
Operating lease liabilities, current |
|
5,362 |
|
|
|
5,530 |
|
Deferred revenue, current |
|
32,037 |
|
|
|
37,633 |
|
Total current liabilities |
|
61,493 |
|
|
|
70,655 |
|
Operating lease liabilities, net of current portion |
|
2,642 |
|
|
|
6,434 |
|
Deferred revenue, net of current portion |
|
10,243 |
|
|
|
35,974 |
|
Total liabilities |
|
74,378 |
|
|
|
113,063 |
|
Stockholders’ equity: |
|
|
|
Common stock |
|
49 |
|
|
|
47 |
|
Additional paid-in-capital |
|
738,240 |
|
|
|
709,220 |
|
Accumulated other comprehensive loss |
|
(1,228 |
) |
|
|
(4,319 |
) |
Accumulated deficit |
|
(503,244 |
) |
|
|
(401,252 |
) |
Total stockholders’ equity |
|
233,817 |
|
|
|
303,696 |
|
Total liabilities and stockholders’ equity |
$ |
308,195 |
|
|
$ |
416,759 |
|
Nurix Therapeutics (NASDAQ:NRIX)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Nurix Therapeutics (NASDAQ:NRIX)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024