8-K
Janux Therapeutics, Inc. (JANX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 7, 2023
Janux Therapeutics, Inc.
(Exact name of Registrant as Specified in Its Charter)
| Delaware | 001-40475 | 82-2289112 |
|---|---|---|
| (State or Other Jurisdiction<br><br>of Incorporation) | (Commission File Number) | (IRS Employer<br><br>Identification No.) |
| 10955 Vista Sorrento Parkway, Suite 200<br><br>San Diego, California | 92130 | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s Telephone Number, Including Area Code: (858)
751-4493
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<br><br>Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, $0.001 par value per share | JANX | Nasdaq Global Market |
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 November 7, 2023, Janux Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and nine months ended September 30, 2023. A copy of the press release is attached hereto as Exhibit 99.1.
The information in this Item and the exhibit attached hereto are being furnished and shall not be deemed “filed” for the 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 they be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, whether filed before or after the date hereof and regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release of Janux Therapeutics, Inc. dated November 7, 2023 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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 thereunto duly authorized.
| JANUX THERAPEUTICS, INC. | ||
|---|---|---|
| Date: November 7, 2023 | By: | /s/ David Campbell, Ph.D. |
| David Campbell, Ph.D. | ||
| President and Chief Executive Officer |
EX-99.1
| Exhibit 99.1 |
|---|
Janux Therapeutics Reports Third Quarter 2023 Financial Results and Business Highlights
• Enrollment ongoing for PSMA-TRACTr (JANX007) in prostate cancer
• Enrollment ongoing for EGFR-TRACTr (JANX008) in solid tumors
• Update on clinical programs expected in 2024
• $349.7 million in cash, cash equivalents, and short-term investments at end of third quarter 2023
• Cash and investments projected to support current operating plan through 2027 to generate Phase 1b data for our PSMA and EGFR-TRACTr programs
SAN DIEGO, November 7, 2023 – 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 third quarter ended September 30, 2023, and provided a business update.
“We are pleased with the enrollment in the two clinical studies for our PSMA-TRACTr JANX007 and our EGFR-TRACTr JANX008,” said David Campbell, Ph.D., President and CEO of Janux. “As we enter 2024, equipped with a strong financial foundation, we are committed to advancing these clinical programs and expanding our pipeline so that we can rapidly bring forward new meaningful therapies for cancer patients.”
RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:
• PSMA-TRACTr (JANX007) continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449).
• EGFR-TRACTr (JANX008) continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622).
• PD-L1xCD28 TRACIr (JANX009) IND-enabling studies completed.
• TROP2-TRACTr development candidate identification completed.
Janux anticipates providing an update on its clinical programs in 2024.
THIRD QUARTER 2023 FINANCIAL HIGHLIGHTS:
• Cash and cash equivalents and short-term investments: As of September 30, 2023, Janux reported cash and cash equivalents and short-term investments of $349.7 million compared to $327.0 million at December 31, 2022, which we project will be sufficient to fund our current operating plan through 2027 to generate Phase 1b data for our PSMA and EGFR-TRACTr programs.
• Research and development expenses: For the quarter ended September 30, 2023, Janux reported research and development expenses of $11.9 million compared to $13.7 million for the comparable period in 2022.
• General and administrative expenses: For the quarter ended September 30, 2023, Janux reported general and administrative expenses of $6.4 million compared to $6.1 million for the comparable period in 2022.
• Net loss: For the quarter ended September 30, 2023, Janux reported a net loss of $11.6 million compared to $16.7 million for the comparable period in 2022.
Janux’s TRACTr and TRACIr Pipeline
Janux’s first clinical candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). Janux’s second clinical candidate, JANX008, is a TRACTr that targets EGFR and is being studied in a Phase 1 clinical 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 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. 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 for the treatment of solid tumors. 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 tumor-activated immunotherapies for cancer. Janux’s proprietary technology enabled the development of two distinct bispecific platforms: Tumor Activated T Cell Engagers (TRACTr) and Tumor Activated Immunomodulators (TRACIr). The goal of both platforms is to provide cancer patients with safe and effective therapeutics that direct and guide their immune system to eradicate tumors while minimizing safety concerns. Janux is currently developing a broad pipeline of TRACTr and TRACIr therapeutics directed at several targets to treat solid tumors. Janux has two TRACTr therapeutic candidates in clinical trials, the first targeting PSMA is in development for prostate cancer, and the second targeting EGFR is being developed for colorectal, lung, head and neck, and renal cancers. 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 preclinical studies and 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 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.
Janux Therapeutics, Inc.
Condensed Balance Sheets
(in thousands)
| September 30,<br>2023 | December 31,<br>2022 | |||
|---|---|---|---|---|
| Assets | (unaudited) | |||
| Current assets: | ||||
| Cash and cash equivalents | $ | 17,152 | $ | 51,426 |
| Short-term investments | 332,560 | 275,590 | ||
| Prepaid expenses and other current assets | 5,483 | 5,423 | ||
| Total current assets | 355,195 | 332,439 | ||
| Restricted cash | 816 | 816 | ||
| Property and equipment, net | 7,317 | 7,086 | ||
| Operating lease right-of-use assets | 21,208 | 22,279 | ||
| Other long-term assets | 2,314 | 1,390 | ||
| Total assets | $ | 386,850 | $ | 364,010 |
| Liabilities and Stockholders’ Equity | ||||
| Current liabilities: | ||||
| Accounts payable | $ | 2,505 | $ | 2,159 |
| Accrued liabilities | 6,831 | 8,010 | ||
| Current portion of deferred revenue | 3,648 | 5,406 | ||
| Unvested stock liabilities | 25 | 169 | ||
| Current portion of operating lease liabilities | 1,462 | 763 | ||
| Total current liabilities | 14,471 | 16,507 | ||
| Deferred revenue, net of current portion | — | 2,221 | ||
| Operating lease liabilities, net of current portion | 23,431 | 24,542 | ||
| Total liabilities | 37,902 | 43,270 | ||
| Total stockholders’ equity | 348,948 | 320,740 | ||
| Total liabilities and stockholders’ equity | $ | 386,850 | $ | 364,010 |
Janux Therapeutics, Inc.
Unaudited Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
| Three Months Ended<br>September 30, | Nine Months Ended<br>September 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2023 | 2022 | |||||||||
| Collaboration revenue | $ | 2,517 | $ | 1,813 | $ | 5,622 | $ | 5,767 | ||||
| Operating expenses: | ||||||||||||
| Research and development | 11,892 | 13,737 | 42,681 | 38,007 | ||||||||
| General and administrative | 6,438 | 6,098 | 19,783 | 16,585 | ||||||||
| Total operating expenses | 18,330 | 19,835 | 62,464 | 54,592 | ||||||||
| Loss from operations | (15,813 | ) | (18,022 | ) | (56,842 | ) | (48,825 | ) | ||||
| Total other income | 4,245 | 1,326 | 10,307 | 1,831 | ||||||||
| Net loss | $ | (11,568 | ) | $ | (16,696 | ) | $ | (46,535 | ) | $ | (46,994 | ) |
| Other comprehensive loss: | ||||||||||||
| Unrealized gain (loss) on available-for-sale securities, net | (115 | ) | (370 | ) | 360 | (2,007 | ) | |||||
| Comprehensive loss | $ | (11,683 | ) | $ | (17,066 | ) | $ | (46,175 | ) | $ | (49,001 | ) |
| Net loss per common share, basic and diluted | $ | (0.25 | ) | $ | (0.40 | ) | $ | (1.08 | ) | $ | (1.13 | ) |
| Weighted-average shares of common stock outstanding, basic and diluted | 45,708,649 | 41,526,524 | 43,117,403 | 41,431,023 |
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