Janux Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2021 Financial Results
Janux Therapeutics (Nasdaq: JANX) reported financial results for Q4 and the full year ending December 31, 2021. The company's cash resources surged to $375.0 million from $7.8 million a year earlier, aiding ongoing development of its immunotherapy pipeline. Notably, Janux nominated its first TRACIr candidate for solid tumors and remains on track for IND submissions for two TRACTr candidates in 2022. However, it reported a net loss of $32.7 million for the year, up from $6.8 million in 2020, indicating increased expenditures related to R&D and operational activities.
- Cash reserves reached $375.0 million, significantly up from $7.8 million in 2020.
- Nominated first TRACIr development candidate for solid tumors.
- On track to submit IND applications for PSMA-TRACTr and EGFR-TRACTr in 2022.
- Net loss increased to $32.7 million from $6.8 million in 2020.
- R&D expenses rose to $26.2 million for the year, up from $3.0 million in 2020.
–Company remains on-track to submit IND filings for two programs in 2022–
–Company nominated its first TRACIr development candidate, a PD-L1 x CD28 costimulatory bispecific–
–Management team strengthened with key appointment–
–
“Janux made great strides in 2021 as we transitioned to a public company and advanced our pipeline of next generation immunotherapies utilizing our novel TRACTr and TRACIr platforms. We continue to build on this momentum by nominating a development candidate for our costimulatory bispecific program, the first development candidate discovered using our TRACIr platform,” said
RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:
-
TRACTr product candidates advancing as planned. Janux’s lead TRACTr programs of next-generation T cell engagers remain on-track, with two Investigational New Drug (IND) applications expected in 2022.
- In the first half of 2022, Janux expects to submit an IND for its PSMA-TRACTr candidate, targeting prostate-specific membrane antigen (PSMA), for the treatment of metastatic castration-resistant prostate cancer (mCPRC). cGMP manufacturing of drug substance and drug product has been completed.
- In the second half of 2022, Janux expects to submit an IND application for its EGFR-TRACTr candidate, targeting epidermal growth factor receptor (EGFR), for the treatment of metastatic colorectal cancer (mCRC), squamous cell carcinoma of the head and neck (SCCHN) and non-small cell lung cancer (NSCLC). cGMP manufacturing of drug substance has been completed.
- In 2023, Janux expects to submit an IND application for its TROP2-TRACTr, targeting trophoblast cell surface antigen 2 (TROP2).
- Nominated first TRACIr development candidate, a PD-L1xCD28 costimulatory bispecific for the treatment of solid tumors. Janux has successfully applied its TRACIr platform to develop a costimulatory bispecific product candidate against programmed death-ligand 1 (PD-L1) and Cluster of Differentiation 28 (CD28) to further enhance the anti-tumor activity of T cells, which we believe has the potential to be used as a single-agent or in combination with our current TRACTr pipeline and other modalities. This is Janux’s first program derived from its TRACIr platform. In 2023, Janux expects to submit an IND application for this program.
-
Strengthened management team with appointment of
Byron Robinson , Ph.D., J.D., as Chief Strategy Officer.Dr. Robinson brings 30 years of industry expertise and experience from key strategy roles at large pharma companies. Prior to joining Janux,Dr. Robinson served as Senior Vice President of Clinical Development Strategy and Innovation at Merck KGaA. In this role, he was responsible for generating strategic insights for internal and external innovation for the generation of the Clinical Oncology Franchise Strategy for all Merck KGaA oncology assets. In addition, he also served as the Senior Vice President Global Program Leader for the avelumab program, where he advanced BAVENCIO® through late-stage development, including 11 registrational Phase 3 trials and more than 240 clinical trials.
FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS:
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Cash and cash equivalents and short-term investments: As of
December 31, 2021 , Janux reported cash, cash equivalents and short-term investments of , compared to$375.0 million at$7.8 million December 31, 2020 .
-
Research and development expenses: Research and development expenses were
for the quarter and$11.2 million for the year ended$26.2 million December 31, 2021 , compared to and$1.0 million for the same quarter and year in 2020.$3.0 million
-
General and administrative expenses: General and administrative expenses were
for the quarter and$3.9 million for the year ended$10.3 million December 31, 2021 , compared to and$0.7 million for the same quarter and year in 2020.$1.8 million
-
Net loss: Net loss was
for the quarter and$13.4 million for the year ended$32.7 million December 31, 2021 , compared to and$1.7 million for the same quarter and year in 2020.$6.8 million
About
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, the progress and expected timing of Janux’s drug development programs, 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
Condensed Balance Sheets (in thousands) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
35,582 |
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$ |
7,813 |
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Accounts receivable |
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— |
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8,000 |
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Short-term investments |
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339,383 |
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— |
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Prepaid expenses and other current assets |
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2,054 |
|
|
|
249 |
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Total current assets |
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377,019 |
|
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|
16,062 |
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Restricted cash |
|
|
816 |
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— |
|
Property and equipment, net |
|
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1,412 |
|
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|
155 |
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Operating lease right-of-use assets |
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185 |
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— |
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Other long-term assets |
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392 |
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— |
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Total assets |
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$ |
379,824 |
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$ |
16,217 |
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Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit) |
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Current liabilities: |
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Accounts payable |
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$ |
2,458 |
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$ |
428 |
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Accrued liabilities |
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3,779 |
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|
751 |
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Current portion of deferred revenue |
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5,163 |
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1,950 |
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Unvested stock liabilities |
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1,203 |
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52 |
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Current portion of operating lease liabilities |
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194 |
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— |
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Total current liabilities |
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12,797 |
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3,181 |
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Deferred revenue, net of current portion |
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|
700 |
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6,050 |
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Total liabilities |
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13,497 |
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9,231 |
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Convertible preferred stock |
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— |
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21,624 |
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Total stockholders’ equity (deficit) |
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366,327 |
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(14,638 |
) |
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) |
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$ |
379,824 |
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$ |
16,217 |
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Condensed Statements of Operations and Comprehensive Loss (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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2021 |
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2020 |
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2021 |
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2020 |
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Collaboration revenue |
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$ |
1,616 |
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$ |
— |
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$ |
3,637 |
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$ |
— |
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Operating expenses: |
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Research and development |
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11,169 |
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985 |
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26,237 |
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3,041 |
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General and administrative |
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3,937 |
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670 |
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10,329 |
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1,802 |
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Total operating expenses |
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15,106 |
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1,655 |
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36,566 |
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4,843 |
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Loss from operations |
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(13,490 |
) |
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(1,655 |
) |
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(32,929 |
) |
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(4,843 |
) |
Total other income (expense) |
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74 |
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— |
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257 |
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(1,941 |
) |
Net loss |
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$ |
(13,416 |
) |
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$ |
(1,655 |
) |
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$ |
(32,672 |
) |
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$ |
(6,784 |
) |
Other comprehensive loss: |
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Unrealized gain (loss) on available-for-sale securities, net |
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(294 |
) |
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— |
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(270 |
) |
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— |
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Comprehensive loss |
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$ |
(13,710 |
) |
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$ |
(1,655 |
) |
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$ |
(32,942 |
) |
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$ |
(6,784 |
) |
Net loss per common share, basic and diluted |
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$ |
(0.33 |
) |
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$ |
(1.65 |
) |
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$ |
(1.39 |
) |
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$ |
(7.41 |
) |
Weighted-average shares of common stock outstanding, basic and diluted |
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41,208,323 |
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1,003,482 |
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23,530,252 |
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915,146 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20220318005283/en/
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Source:
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