UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported):
(Exact Name of Registrant as Specified in its Charter)
|
|
|
|
|
|
|
(State or Other Jurisdiction of Incorporation or Organization) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(Address of Principal Executive Offices) |
|
|
|
(Zip Code) |
(
(Registrant’s Telephone Number, Including Area Code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
Title of each class |
Trading symbol(s) |
Name of each exchange on which registered |
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
|
Item 2.02 |
Results of Operations and Financial Condition. |
On July 7, 2022, Nurix Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release announcing the Company’s financial results for the fiscal quarter ended May 31, 2022. The press release is furnished as Exhibit 99.1 and is incorporated herein by reference.
The information furnished with this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
|
Item 9.01 |
Financial Statements and Exhibits. |
|
(d) |
Exhibits |
|
Exhibit No. |
|
Exhibit Title or Description |
|
|
|
|
|
99.1 |
|
|
|
|
|
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
NURIX THERAPEUTICS, INC. |
|
|
|
|
|
|
|
Date: July 7, 2022 |
|
By: |
/s/ Arthur T. Sands |
|
|
|
|
Arthur T. Sands, M.D., Ph.D. |
|
|
|
|
President and Chief Executive Officer |
3
Exhibit 99.1
Nurix Therapeutics Reports Fiscal Second Quarter 2022 Financial Results and Provides a Corporate Update
NX-2127 advanced to Phase 1b in CLL based on promising data in Phase 1a clinical trial
First patient dosed in NX-5948 Phase 1a clinical trial for certain B-cell malignancies
NX-1607 IND cleared FDA for expansion of enrollment to U.S. clinical sites for patients with solid tumors
Research engine achieved collaboration milestone for fifth consecutive quarter
Strong financial position with $348.8 million in cash and investments as of May 31, 2022
San Francisco, CA, July 7, 2022 – Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs, today reported financial results for the second quarter ended May 31, 2022 and provided a corporate update.
“In the second quarter of 2022, we reported promising data in our Phase 1 trial of NX-2127 with clinical responses in CLL patients harboring tumor mutations that confer resistance to current BTK inhibitor therapies,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “Our oncology drug discovery engine continues to hit on all cylinders. We are recruiting patients into clinical trials in all four of our wholly-owned programs, and we anticipate a data-rich second half of this year with information from each of the four clinical studies.”
Recent Business Highlights
|
|
• |
Announced Phase 1b expansion of the NX-2127 clinical trial for patients with chronic lymphocytic leukemia (CLL). Based on positive efficacy, safety, pharmacokinetic (PK), and pharmacodynamic (PD) data from the Phase 1a dose escalation portion of the trial, Nurix initiated a Phase 1b expansion cohort in patients with CLL, which represents the first of several potential expansions. Relevant clinical and biomarker data supporting the decision were presented at the company’s first R&D Day, which was held in New York on May 26th (an archived webcast of the event can be accessed via the Events and Presentations page of the Investor section of the Nurix website). The dose-finding Phase 1a stage of the clinical trial of NX-2127 continues in other non-Hodgkin lymphoma subtypes. |
|
|
• |
Provided a deep dive into Nurix’s platform and progress in its targeted protein modulation programs at the company’s first R&D Day. In addition to providing an update on each of Nurix’s four wholly owned clinical programs and highlighting the company’s DELigase R&D platform, which serves as the source of current and future programs, Nurix’s R&D Day featured a presentation by Anthony Mato M.D., MSCE, Director of the CLL program at Memorial Sloan Kettering Cancer Center. Dr. Mato outlined the unmet medical need in CLL and the growing problem of resistance and intolerance to current and next generation Bruton’s tyrosine kinase (BTK) inhibitors including the emergence of new drug resistance mutations that may be addressed by Nurix’s portfolio of BTK degraders (NX-2127 and NX-5948). An archived webcast of the event can be accessed via the Events and Presentations page of the Investor section of the Nurix website. |
|
|
• |
Announced dosing of the first patient in its Phase 1a/1b study to evaluate NX-5948 in patients with relapsed B-cell malignancies. The Phase 1 study of NX-5948, a potent and selective degrader of BTK, is a dose escalation and expansion trial at multiple clinical sites in the United Kingdom. The trial is designed to evaluate the safety and tolerability of NX‑5948 in adults with relapsed or refractory B-cell malignancies. |
|
|
• |
Presented data and clinical trial information at key oncology meetings. Data and clinical trial design presentations for each of Nurix’s wholly owned programs were made at major oncology clinical and scientific meetings including the annual meetings of the American Academy of Cancer Research (AACR) in April, the American Society of Clinical Oncology (ASCO) in June, the European Hematology Association (EHA) in June, and the Translational Research Cancer Centers Consortium (TRCCC) in June. The presentations can be found in the Scientific Presentations section of the Events and Presentations page of the Investor section of the Nurix website. |
Upcoming Program Highlights*
|
|
|
|
• |
NX-5948: Nurix’s second drug candidate from its protein degradation portfolio, NX-5948, is an orally bioavailable BTK degrader designed without immunomodulatory activity for certain B-cell malignancies and autoimmune diseases. Nurix is evaluating NX-5948 in a Phase 1 clinical trial in adults with relapsed or refractory B-cell malignancies and expects to have initial safety and PK/PD data from the Phase 1a portion of the study in the second half of 2022. Additional information on the clinical trial can be accessed at 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 CBL-B for immuno-oncology indications including a range of solid tumor types. Nurix is evaluating NX-1607 in an ongoing, Phase 1 dose escalation and expansion trial in adults with a variety of oncology indications at multiple clinical sites in the United Kingdom and expects to have initial PK/PD data from the Phase 1a stage of the study, including biomarker and safety data, in the second half of 2022. Additional information on the clinical trial can be accessed at clinicaltrials.gov (NCT05107674). |
|
|
• |
DeTIL-0255: Nurix’s lead candidate in its cellular therapy portfolio, DeTIL-0255, is a drug-enhanced adoptive cellular therapy. Nurix is evaluating DeTIL-0255 in a Phase 1 trial in adults with gynecological malignancies including ovarian cancer, cervical cancer, and endometrial cancer. Nurix anticipates providing a clinical update from the run-in portion of the DeTIL-0255 Phase 1 study in the second half of 2022. Additional information on the clinical trial can be accessed at clinicaltrials.gov (NCT05107739). |
* Expected timing of events throughout the press release are based on calendar year quarters.
Fiscal Second Quarter 2022 Financial Highlights
Collaboration revenue for the three months ended May 31, 2022, was $11.4 million compared to $7.1 million for the three months ended May 31, 2021. The increase was primarily due to increased effort resulting in a higher percentage of completion of performance obligations under Nurix’s collaborations with Gilead and Sanofi in the current period. The increase was also due to changes in transaction price that resulted in higher revenue recognized in each period and impacted the cumulative catch up in revenue for activities satisfied in previous periods. In the three months ended May 31, 2022, Nurix achieved a research milestone under its collaboration with Gilead and anticipates a payment of $1.5 million in the third fiscal quarter of 2022.
Research and development expenses for the three months ended May 31, 2022, were $47.5 million compared to $26.0 million for the three months ended May 31, 2021. The increase was primarily related to an increase of $7.2 million in compensation and related personnel costs and an increase of $2.0 million in non-cash stock-based compensation expense attributable to higher headcount. The increase in non-cash stock-based compensation expense was also attributable to the issuance of restricted stock units. There was also an increase of $10.0 million in supplies, contract research, contract manufacturing and clinical trial costs.
General and administrative expenses for the three months ended May 31, 2022, were $9.7 million compared to $7.5 million for the three months ended May 31, 2021. The increase was primarily related to an increase of $0.6 million in compensation-related expenses and an increase of $0.9 million in non-cash stock-based compensation expense, both of which were primarily attributable to higher headcount. There was also an increase of $0.6 million in professional service expenses, including legal and accounting expenses related to infrastructure improvements.
Net loss for the three months ended May 31, 2022, was $45.4 million, or ($1.01) per share, compared to a net loss of $26.4 million, or ($0.60) per share for the three months ended May 31, 2021.
Cash, cash equivalents and investments: As of May 31, 2022, Nurix had cash, cash equivalents and investments of $348.8 million compared to $385.7 million as of February 28, 2022.
About Nurix Therapeutics, Inc.
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of small molecule and cell therapies based on the modulation of cellular protein levels as a novel treatment approach for cancer and other challenging diseases. Leveraging Nurix’s extensive expertise in E3 ligases together with its 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 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 T cell activation. Nurix is headquartered in San Francisco, California. For more information, please visit http://www.nurixtx.com/.
Forward Looking Statement
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 our future financial or business performance; our future plans, prospects and strategies and our cash position; our current and prospective drug candidates; the planned timing and conduct of the clinical trials for our drug candidates; the planned timing for the provision of updates and findings from our clinical trials; the potential advantages of our DELigase™ platform and drug candidates; and the extent to which our scientific approach and DELigase™ platform may potentially address a broad range of diseases. Forward-looking statements reflect Nurix’s current beliefs, expectations, and assumptions. 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 clinical trials; (iii) Nurix’s ability to fund development activities and achieve development goals; (iv) the impact of the COVID-19 pandemic on Nurix’s business, clinical trials, financial condition, liquidity and results of operations; (v) Nurix’s ability to protect its 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, 2022, 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:
|
Investors: |
Media: |
|
Elizabeth Wolffe, Ph.D. |
Brett Whelan |
|
Wheelhouse Life Science Advisors |
LifeSci Communications |
|
lwolffe@wheelhouselsa.com |
bwhelan@lifescicomms.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, |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|||||
|
Collaboration revenue |
|
$ |
11,432 |
|
|
$ |
7,091 |
|
|
$ |
21,053 |
|
|
$ |
12,102 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
47,493 |
|
|
|
25,994 |
|
|
|
90,630 |
|
|
|
48,997 |
|
|
General and administrative |
|
|
9,654 |
|
|
|
7,511 |
|
|
|
18,882 |
|
|
|
14,041 |
|
|
Total operating expenses |
|
|
57,147 |
|
|
|
33,505 |
|
|
|
109,512 |
|
|
|
63,038 |
|
|
Loss from operations |
|
|
(45,715 |
) |
|
|
(26,414 |
) |
|
|
(88,459 |
) |
|
|
(50,936 |
) |
|
Interest and other income, net |
|
|
314 |
|
|
|
171 |
|
|
|
525 |
|
|
|
489 |
|
|
Loss before income taxes |
|
|
(45,401 |
) |
|
|
(26,243 |
) |
|
|
(87,934 |
) |
|
|
(50,447 |
) |
|
Provision for income taxes |
|
|
— |
|
|
|
139 |
|
|
|
— |
|
|
|
210 |
|
|
Net loss |
|
$ |
(45,401 |
) |
|
$ |
(26,382 |
) |
|
$ |
(87,934 |
) |
|
$ |
(50,657 |
) |
|
Net loss per share, basic and diluted |
|
$ |
(1.01 |
) |
|
$ |
(0.60 |
) |
|
$ |
(1.96 |
) |
|
$ |
(1.23 |
) |
|
Weighted-average number of shares outstanding, basic and diluted |
|
|
44,898,409 |
|
|
|
43,804,066 |
|
|
|
44,797,235 |
|
|
|
41,318,281 |
|
Nurix Therapeutics, Inc.
Condensed consolidated balance sheets
(in thousands)
(unaudited)
|
|
|
May 31, 2022 |
|
|
November 30, 2021 |
|
||
|
Assets |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
41,533 |
|
|
$ |
80,506 |
|
|
Short-term investments |
|
|
255,746 |
|
|
|
215,214 |
|
|
Accounts receivable |
|
|
— |
|
|
|
6,000 |
|
|
Income tax receivable |
|
|
— |
|
|
|
204 |
|
|
Prepaid expenses and other current assets |
|
|
9,510 |
|
|
|
9,194 |
|
|
Total current assets |
|
|
306,789 |
|
|
|
311,118 |
|
|
Long-term investments |
|
|
51,538 |
|
|
|
137,189 |
|
|
Operating lease right-of-use assets |
|
|
15,418 |
|
|
|
14,005 |
|
|
Property and equipment, net |
|
|
15,507 |
|
|
|
11,340 |
|
|
Restricted cash |
|
|
901 |
|
|
|
286 |
|
|
Other assets |
|
|
4,157 |
|
|
|
2,833 |
|
|
Total assets |
|
$ |
394,310 |
|
|
$ |
476,771 |
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
6,142 |
|
|
$ |
6,650 |
|
|
Accrued expenses and other current liabilities |
|
|
19,734 |
|
|
|
14,549 |
|
|
Operating lease current liabilities |
|
|
5,470 |
|
|
|
3,847 |
|
|
Deferred revenue, current |
|
|
41,319 |
|
|
|
41,212 |
|
|
Total current liabilities |
|
|
72,665 |
|
|
|
66,258 |
|
|
Operating lease long-term liabilities |
|
|
9,043 |
|
|
|
9,189 |
|
|
Deferred revenue, net of current portion |
|
|
45,863 |
|
|
|
59,022 |
|
|
Total liabilities |
|
|
127,571 |
|
|
|
134,469 |
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
|
Common stock |
|
|
45 |
|
|
|
45 |
|
|
Additional paid-in-capital |
|
|
578,605 |
|
|
|
563,757 |
|
|
Accumulated other comprehensive loss |
|
|
(3,085 |
) |
|
|
(608 |
) |
|
Accumulated deficit |
|
|
(308,826 |
) |
|
|
(220,892 |
) |
|
Total stockholders’ equity |
|
|
266,739 |
|
|
|
342,302 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
394,310 |
|
|
$ |
476,771 |
|