-Interim clinical update from Phase 1 trial of JANX007 expected in 2H 2023-
-FDA clearance granted for Investigational New Drug (IND) application for EGFR-TRACTr (JANX008)-
-$327.0 million in year-end cash and cash equivalents and short-term investments-
SAN DIEGO–(BUSINESS WIRE)–$JANX—Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.
“Janux made great strides in 2022 as we transitioned to a clinical-stage company by dosing the first patient with our PSMA-TRACTr and advancing our pipeline utilizing our novel TRACTr and TRACIr platforms. We recently received IND clearance from the FDA for our EGFR-TRACTr, keeping us on track to enter a second program into the clinic. Importantly, this milestone underscores our ability to reproducibly bring novel immunotherapies through development and deliver them to patients. Two of our core values at Janux are ‘collaboration’ and ‘urgency,’ and both were on display in connection with hitting these milestones,” said David Campbell, Ph.D., President and CEO of Janux.
RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:
Janux has prioritized its programs to enable sufficient funding to provide key clinical data assessments for its lead programs. Janux is aware of recent media reports related to the closure of Silicon Valley Bank (“SVB”). Janux considers its exposure to any liquidity concern at SVB as immaterial and will have no impact on its short- or long-term objectives. In addition, none of Janux’s investment portfolio contains direct exposure to SVB.
- Lead program PSMA-TRACTr (JANX007) continues to enroll in first-in-human Phase 1 clinical trial in prostate cancer patients.
- Janux received U.S. Food and Drug Administration (FDA) clearance for an IND application for EGFR-TRACTr (JANX008).
- PD-L1xCD28 TRACIr (JANX009) on-track for an IND submission in 2023.
- TROP2-TRACTr evaluations to support development candidate selection are ongoing.
Janux anticipates providing an interim clinical update from the PSMA-TRACTr (JANX007) trial in the second half of 2023. In addition, Janux expects to select a development candidate for its TROP2-TRACTr in 2023.
FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS:
- Cash and cash equivalents and short-term investments: As of December 31, 2022, Janux reported cash and cash equivalents and short-term investments of $327.0 million, compared to $375.0 million at December 31, 2021.
- Research and development expenses: Research and development expenses were $15.4 million for the quarter and $53.4 million for the year ended December 31, 2022, compared to $11.2 million and $26.2 million for the same quarter and year in 2021.
- General and administrative expenses: General and administrative expenses were $5.7 million for the quarter and $22.3 million for the year ended December 31, 2022, compared to $3.9 million and $10.3 million for the same quarter and year in 2021.
- Net loss: Net loss was $16.1 million for the quarter and $63.1 million for the year ended December 31, 2022, compared to $13.4 million and $32.7 million for the same quarter and year in 2021.
Janux’s TRACTr and TRACIr Pipeline
Janux’s lead candidate, JANX007, is being investigated in a phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). JANX007 is a TRACTr that targets PSMA, a protein expressed in prostate cancer tumors and the vasculature of tumors, and a validated target for treating mCRPC. Similarly, JANX008 is a TRACTr that targets EGFR and is being studied in a phase 1 trial for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. Janux’s TRACIr drug candidate JANX009 is designed for targeting both the programmed death-ligand 1 (PD-L1) receptor as well as the costimulatory CD28 receptor on T cells and is being investigated in preclinical studies for the treatment of solid tumors. Janux is also applying its proprietary technology to develop a TRACTr designed to target TROP2, a clinically validated anti-tumor target that is overexpressed in various cancer types, such as breast, lung, urothelial, endometrial, ovarian, prostate, pancreatic, gastric, colon, head and neck, and glioma. In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.
About Janux Therapeutics
Janux is a clinical-stage biopharmaceutical company developing next-generation bispecific immunotherapies with the goal of fighting cancers by killing tumor cells while allowing healthy tissues to remain unharmed. Janux’s proprietary platforms develop unique Tumor Activated T Cell Engagers (TRACTr) and Tumor Activated Immunomodulators (TRACIr) and support the building of a broad pipeline of drugs designed to direct and guide the patient’s immune system to eradicate tumors while minimizing safety concerns. The company’s innovative technology currently focuses on the engineering of bispecific antibodies functional only in the tumor, providing safety advantages compared to earlier generations of bispecific immunotherapies. For more information, please visit www.januxrx.com and follow us on LinkedIn.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Janux’s ability to bring new treatments to cancer patients in need, expectations regarding the timing, scope and results of Janux’s development activities, including its ongoing and planned clinical trials, the timing of and plans for regulatory filings, the potential benefits of Janux’s product candidates and platform technologies, expectations regarding the use of Janux’s platform technologies to generate novel product candidates, the expected timing for announcing interim clinical updates and the strength of Janux’s balance sheet and the adequacy of cash on hand. Factors that may cause actual results to differ materially include the risk that compounds that appear promising in early research do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Janux may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Janux faces, please refer to Janux’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Janux assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
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Janux Therapeutics, Inc. |
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Condensed Balance Sheets |
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(in thousands) |
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December 31, |
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Assets |
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2022 |
|
|
2021 |
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Current assets: |
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|
|
|
|
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||
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Cash and cash equivalents |
|
$ |
51,426 |
|
|
$ |
35,582 |
|
|
Short-term investments |
|
|
275,590 |
|
|
|
339,383 |
|
|
Prepaid expenses and other current assets |
|
|
5,423 |
|
|
|
2,054 |
|
|
Total current assets |
|
|
332,439 |
|
|
|
377,019 |
|
|
Restricted cash |
|
|
816 |
|
|
|
816 |
|
|
Property and equipment, net |
|
|
7,086 |
|
|
|
1,412 |
|
|
Operating lease right-of-use assets |
|
|
22,279 |
|
|
|
185 |
|
|
Other long-term assets |
|
|
1,390 |
|
|
|
392 |
|
|
Total assets |
|
$ |
364,010 |
|
|
$ |
379,824 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
|
$ |
2,159 |
|
|
$ |
2,458 |
|
|
Accrued liabilities |
|
|
8,010 |
|
|
|
3,779 |
|
|
Current portion of deferred revenue |
|
|
5,406 |
|
|
|
5,163 |
|
|
Unvested stock liabilities |
|
|
169 |
|
|
|
1,203 |
|
|
Current portion of operating lease liabilities |
|
|
763 |
|
|
|
194 |
|
|
Total current liabilities |
|
|
16,507 |
|
|
|
12,797 |
|
|
Deferred revenue, net of current portion |
|
|
2,221 |
|
|
|
700 |
|
|
Operating lease liabilities, net of current portion |
|
|
24,542 |
|
|
|
— |
|
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Total liabilities |
|
|
43,270 |
|
|
|
13,497 |
|
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Total stockholders’ equity |
|
|
320,740 |
|
|
|
366,327 |
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|
Total liabilities and stockholders’ equity |
|
$ |
364,010 |
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|
$ |
379,824 |
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Janux Therapeutics, Inc. |
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Condensed Statements of Operations and Comprehensive Loss |
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(in thousands, except share and per share data) |
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Three Months Ended |
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Year Ended |
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2022 |
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2021 |
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2022 |
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2021 |
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Collaboration revenue |
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$ |
2,845 |
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$ |
1,616 |
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$ |
8,612 |
|
|
$ |
3,637 |
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Operating expenses: |
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|
|
|
|
|
|
|
|
|
|
|
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Research and development |
|
|
15,434 |
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|
|
11,169 |
|
|
|
53,441 |
|
|
|
26,237 |
|
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General and administrative |
|
|
5,677 |
|
|
|
3,937 |
|
|
|
22,262 |
|
|
|
10,329 |
|
|
Total operating expenses |
|
|
21,111 |
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|
|
15,106 |
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|
|
75,703 |
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|
|
36,566 |
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|
Loss from operations |
|
|
(18,266 |
) |
|
|
(13,490 |
) |
|
|
(67,091 |
) |
|
|
(32,929 |
) |
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Total other income |
|
|
2,201 |
|
|
|
74 |
|
|
|
4,032 |
|
|
|
257 |
|
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Net loss |
|
$ |
(16,065 |
) |
|
$ |
(13,416 |
) |
|
$ |
(63,059 |
) |
|
$ |
(32,672 |
) |
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Other comprehensive loss: |
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|
|
|
|
|
|
|
|
|
|
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Unrealized gain (loss) on available-for-sale securities, net |
|
|
742 |
|
|
|
(294 |
) |
|
|
(1,265 |
) |
|
|
(270 |
) |
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Comprehensive loss |
|
$ |
(15,323 |
) |
|
$ |
(13,710 |
) |
|
$ |
(64,324 |
) |
|
$ |
(32,942 |
) |
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Net loss per common share, basic and diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.33 |
) |
|
$ |
(1.52 |
) |
|
$ |
(1.39 |
) |
|
Weighted-average shares of common stock outstanding, basic and diluted |
|
|
41,584,195 |
|
|
|
41,208,323 |
|
|
|
41,469,631 |
|
|
|
23,530,252 |
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Contacts
Investors:
Andy Meyer
Janux Therapeutics
ameyer@januxrx.com
(202) 215-2579
Media:
Jessica Yingling, Ph.D.
Little Dog Communications Inc.
jessica@litldog.com
(858) 344-8091