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 May 31, 2023, and provided a corporate update.
“The expansion of our NX-2127 clinical trial in non-Hodgkin’s
lymphomas provides an opportunity to identify clinical benefit in a
significant patient population,” said Arthur T. Sands, M.D., Ph.D.,
president and chief executive officer of Nurix. “In the second half
of 2023, we expect to generate clinical data that will provide
additional insight into the potential specific applications of both
the NX-5948 and NX-2127 BTK degrader programs while we continue to
advance our internal and partnered programs.”
Recent Business Highlights
- Nurix announced the
initiation of two additional Phase 1b expansion cohorts in the
ongoing Phase 1a/1b trial of NX-2127: In June, Nurix
announced the initiation of expansion cohorts in patients with
diffuse large B cell lymphoma (DLBCL) and mantle cell lymphoma
(MCL). The decision to expand was informed by evolving data from
the Phase 1a portion of the trial including a rapid and sustained
complete response in a patient with DLBCL, as previously
reported.
- Nurix enhanced its cash
position with the receipt of $20 million from Gilead: In
April, Gilead exercised its option to exclusively license Nurix’s
oral IRAK4 degrader, which has potential applications in the
treatment of rheumatoid arthritis and other inflammatory diseases.
GS-6791/NX-0479 is the first development candidate resulting from
the 2019 Nurix-Gilead collaboration to discover, develop and
commercialize a pipeline of innovative targeted protein degradation
therapies. In addition to the $20 million license fee, Nurix could
potentially receive up to an additional $425 million in clinical,
regulatory and commercial milestone payments, as well as up to low
double-digit tiered royalties on product net sales.
- Nurix presented data at the
American Association for Cancer Research (AACR) Annual Meeting for
its Bruton’s tyrosine kinase (BTK) Targeted Protein Degraders,
NX-5948 and NX-2127: In April, Nurix presented preclinical
data demonstrating the potent tumor cell-killing activity of
Nurix’s BTK degraders, NX-5948 and NX-2127, against a broad range
of acquired BTK inhibitor resistance mutations and their
superiority compared with other reported BTK degraders. For
NX-2127, the structure was disclosed to the broader oncology
audience following its initial disclosure in an oral presentation
at the American Chemical Society Spring 2023 meeting in March.
- Nurix presented additional
data for NX-5948 and NX-2127 at the International Conference on
Malignant Lymphoma (ICML): In June, Nurix presented early
clinical PK/PD data from the Phase 1a trial of NX-5948
demonstrating rapid, robust and sustained BTK degradation and
supporting ongoing investigation in B-cell malignancies and
continuing dose escalation. Nurix also presented preclinical data
demonstrating the potential utility of NX-5948 in addressing the
unmet need in patients with central nervous system (CNS) lymphoma.
For NX-2127, early clinical data, including a rapid and sustained
complete response, informed Nurix’s Phase 1b dose expansion plans
in that trial in patients with DLBCL and MCL.
Upcoming Program Highlights*
- NX-2127: Nurix’s
lead drug candidate from its protein degradation portfolio,
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 now includes three Phase
1b expansion cohorts in patients with chronic lymphocytic leukemia
(CLL), DLBCL and MCL. 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-5948: Nurix’s
second drug candidate from its protein degradation portfolio,
NX-5948, is an orally bioavailable degrader of 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 Phase 1b cohort
expansion. Additional information on the clinical trial can be
accessed at www.clinicaltrials.gov (NCT05131022).
- 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
and 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, is responsible for
conducting IND-enabling studies and advancing this program to
clinical development.
- Continued advancement of strategic collaborations with
Gilead Sciences and Sanofi: Nurix expects to continue to
achieve substantial research collaboration milestones throughout
2023 from its collaborations with Gilead Sciences and Sanofi.
* Expected timing of events throughout this press
release is based on calendar year quarters.
Fiscal Second Quarter 2023 Financial Results
Revenue for the three months ended May 31,
2023, was $30.7 million compared to $11.4 million for the three
months ended May 31, 2022. The increase was primarily due to the
receipt of $20 million related to the license option exercise
payment from Gilead.
Research and development expenses for the three
months ended May 31, 2023, were $45.8 million compared to $47.5
million for the three months ended May 31, 2022. The decrease was
primarily related to a decrease in research related costs as we
concluded certain studies and sponsored research agreements and a
decrease in contract manufacturing as we stabilize the supply
needed for our clinical trials, offset by an increase in
compensation and related personnel costs and in non-cash
stock-based compensation expense. There was also an increase in
facility and other costs primarily driven by additional investments
in information technology and expenses related to our leases of
office and laboratory space.
General and administrative expenses for the
three months ended May 31, 2023, were $11.7 million compared to
$9.7 million for the three months ended May 31, 2022. The increase
was primarily related to an increase in compensation related
expenses and non-cash stock-based compensation expense and an
increase in outside consulting and professional service costs.
Net loss for the three months ended May 31,
2023, was $24.3 million, or ($0.45) per share, compared to a net
loss of $45.4 million for the three months ended May 31, 2022, or
($1.01) per share.
Cash, cash equivalents and marketable
securities was $308.6 million as of May 31, 2023, compared
to $325.6 million as of February 28, 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 clinical
updates and findings from Nurix’s clinical studies; the potential
advantages of Nurix’s DELigase™ platform and drug candidates; and
the extent to which Nurix’s scientific approach and DELigase™
platform may potentially address a broad range of diseases.
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 impact of macroeconomic conditions,
including inflation, increasing interest rates, volatile market
conditions, instability in the global banking system, and global
events, including the ongoing war in Ukraine, on Nurix’s business,
clinical trials, financial condition, liquidity and results of
operations; (v) Nurix’s ability to protect intellectual property
and (vi) 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, 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 May 31, |
|
Six Months Ended May 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
Collaboration revenue |
$ |
10,676 |
|
|
$ |
11,432 |
|
|
$ |
23,361 |
|
|
$ |
21,053 |
|
License revenue |
|
20,000 |
|
|
|
— |
|
|
|
20,000 |
|
|
|
— |
|
Total revenue |
|
30,676 |
|
|
|
11,432 |
|
|
|
43,361 |
|
|
|
21,053 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
45,763 |
|
|
|
47,493 |
|
|
|
91,579 |
|
|
|
90,630 |
|
General and administrative |
|
11,678 |
|
|
|
9,654 |
|
|
|
21,499 |
|
|
|
18,882 |
|
Total operating expenses |
|
57,441 |
|
|
|
57,147 |
|
|
|
113,078 |
|
|
|
109,512 |
|
Loss from operations |
|
(26,765 |
) |
|
|
(45,715 |
) |
|
|
(69,717 |
) |
|
|
(88,459 |
) |
Interest and other income,
net |
|
2,488 |
|
|
|
314 |
|
|
|
4,707 |
|
|
|
525 |
|
Net loss |
$ |
(24,277 |
) |
|
$ |
(45,401 |
) |
|
$ |
(65,010 |
) |
|
$ |
(87,934 |
) |
Net loss per share, basic and
diluted |
$ |
(0.45 |
) |
|
$ |
(1.01 |
) |
|
$ |
(1.20 |
) |
|
$ |
(1.96 |
) |
Weighted-average number of
shares outstanding, basic and diluted |
|
54,259,045 |
|
|
|
44,898,409 |
|
|
|
54,144,909 |
|
|
|
44,797,235 |
|
Nurix Therapeutics, Inc.Condensed Consolidated
Balance Sheets(in
thousands)(unaudited) |
|
|
May 31,2023 |
|
November 30,2022 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
58,958 |
|
|
$ |
64,474 |
|
Marketable securities, current |
|
222,219 |
|
|
|
244,667 |
|
Prepaid expenses and other current assets |
|
8,837 |
|
|
|
9,308 |
|
Total current assets |
|
290,014 |
|
|
|
318,449 |
|
Marketable securities, non-current |
|
27,463 |
|
|
|
63,879 |
|
Operating lease right-of-use assets |
|
9,941 |
|
|
|
12,345 |
|
Property and equipment, net |
|
18,495 |
|
|
|
17,163 |
|
Restricted cash |
|
901 |
|
|
|
901 |
|
Other assets |
|
3,810 |
|
|
|
4,022 |
|
Total assets |
$ |
350,624 |
|
|
$ |
416,759 |
|
Liabilities and
stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
4,525 |
|
|
$ |
5,064 |
|
Accrued expenses and other current liabilities |
|
18,091 |
|
|
|
22,428 |
|
Operating lease liabilities, current |
|
5,583 |
|
|
|
5,530 |
|
Deferred revenue, current |
|
44,063 |
|
|
|
37,633 |
|
Total current liabilities |
|
72,262 |
|
|
|
70,655 |
|
Operating lease liabilities, net of current portion |
|
3,758 |
|
|
|
6,434 |
|
Deferred revenue, net of current portion |
|
14,683 |
|
|
|
35,974 |
|
Total liabilities |
|
90,703 |
|
|
|
113,063 |
|
Stockholders’ equity: |
|
|
|
Common stock |
|
48 |
|
|
|
47 |
|
Additional paid-in-capital |
|
728,038 |
|
|
|
709,220 |
|
Accumulated other comprehensive loss |
|
(1,903 |
) |
|
|
(4,319 |
) |
Accumulated deficit |
|
(466,262 |
) |
|
|
(401,252 |
) |
Total stockholders’ equity |
|
259,921 |
|
|
|
303,696 |
|
Total liabilities and stockholders’ equity |
$ |
350,624 |
|
|
$ |
416,759 |
|
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