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) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
|
|
|
||
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s Telephone Number, Including Area Code: (
(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 November 9, 2021, Janux Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and nine months ended September 30, 2021. 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 9, 2021 |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
1
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 9, 2021 |
|
By: |
/s/ David Campbell, Ph.D. |
|
|
|
David Campbell, Ph.D. |
|
|
|
President and Chief Executive Officer |
2
|
Exhibit 99.1 |
Janux Therapeutics Reports Business Highlights and Third Quarter 2021 Financial Results
-Company remains on-track to submit IND filings for two programs in 2022-
-Board of Directors strengthened with key appointments-
-$387.5 million in cash and cash equivalents and short-term investments at end of third quarter 2021-
SAN DIEGO, November 9, 2021 – Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a 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 quarter ended September 30, 2021.
“In the third quarter, we continued to utilize our novel TRACTr and TRACIr platforms to advance our pipeline of next generation immunotherapies. We remain on-track to execute key milestones, including two IND submissions next year for our PSMA-TRACTr and EGFR-TRACTr candidates,” said David Campbell, Ph.D., President and CEO of Janux. “Further, we welcomed Dr. Ron Barrett and Alana McNulty to Janux’s Board of Directors. These two key leadership additions bring important expertise to the company as we work to advance our programs towards the clinic.”
RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:
THIRD QUARTER 2021 FINANCIAL HIGHLIGHTS:
About Janux Therapeutics
Janux Therapeutics is an innovative biopharmaceutical company developing next-generation therapeutics based on applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms to better treat patients suffering from cancer. Janux’s initial focus is on developing a novel class of T cell engagers (TCEs), and its lead product candidates are designed to target clinically validated drug targets. While TCE therapeutics have displayed potent anti-tumor activity in hematological cancers, developing TCEs to treat solid tumors have faced challenges due to the limitations of prior TCE technologies, namely (i) overactivation of the immune system leading to cytokine release syndrome, (ii) on-target, healthy tissue toxicities, and (iii) poor pharmacokinetics leading to short half-life. Janux is using its TRACTr platform technology to engineer product candidates designed to overcome these limitations. Janux is developing a broad pipeline with lead TRACTr programs targeting prostate-specific membrane antigen (PSMA), epidermal growth factor receptor (EGFR), and trophoblast cell surface antigen 2 (TROP2), and its lead TRACIr program targeting PD-L1xCD28, with all of its programs currently in the IND-enabling or discovery stage. For more info, www.januxrx.com.
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 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.
Contacts
Media:
Jessica Yingling, Ph.D.
Little Dog Communications Inc.
jessica@litldog.com
(858) 344-8091
Investors:
Christina Tartaglia
Stern Investor Relations, Inc.
christina@sternir.com
(212) 362-1200
Janux Therapeutics, Inc.
Condensed Balance Sheets
(in thousands)
|
|
September 30, 2021 |
|
|
December 31, |
|
||
Assets |
|
(unaudited) |
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
39,389 |
|
|
$ |
7,813 |
|
Short-term investments |
|
|
348,118 |
|
|
|
— |
|
Accounts receivable |
|
|
— |
|
|
|
8,000 |
|
Prepaid expenses and other current assets |
|
|
2,081 |
|
|
|
249 |
|
Total current assets |
|
|
389,588 |
|
|
|
16,062 |
|
Property and equipment, net |
|
|
1,118 |
|
|
|
155 |
|
Operating lease right-of-use assets |
|
|
238 |
|
|
|
— |
|
Other long-term assets |
|
|
140 |
|
|
|
— |
|
Total assets |
|
$ |
391,084 |
|
|
$ |
16,217 |
|
|
|
|
|
|
|
|
||
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit) |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
3,613 |
|
|
$ |
428 |
|
Accrued liabilities |
|
|
2,030 |
|
|
|
751 |
|
Current portion of deferred revenue |
|
|
5,264 |
|
|
|
1,950 |
|
Unvested stock liabilities |
|
|
1,352 |
|
|
|
52 |
|
Current portion of operating lease liabilities |
|
|
212 |
|
|
|
— |
|
Total current liabilities |
|
|
12,471 |
|
|
|
3,181 |
|
Deferred revenue, net of current portion |
|
|
1,840 |
|
|
|
6,050 |
|
Operating lease liabilities, net of current portion |
|
|
23 |
|
|
|
— |
|
Total liabilities |
|
|
14,334 |
|
|
|
9,231 |
|
Convertible preferred stock |
|
|
— |
|
|
|
21,624 |
|
Total stockholders’ equity (deficit) |
|
|
376,750 |
|
|
|
(14,638 |
) |
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) |
|
$ |
391,084 |
|
|
$ |
16,217 |
|
Janux Therapeutics, Inc.
Unaudited Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
Collaboration revenue |
|
$ |
1,159 |
|
|
$ |
— |
|
|
$ |
2,021 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
8,406 |
|
|
|
834 |
|
|
|
15,068 |
|
|
|
2,056 |
|
General and administrative |
|
|
3,656 |
|
|
|
422 |
|
|
|
6,392 |
|
|
|
1,132 |
|
Total operating expenses |
|
|
12,062 |
|
|
|
1,256 |
|
|
|
21,460 |
|
|
|
3,188 |
|
Loss from operations |
|
|
(10,903 |
) |
|
|
(1,256 |
) |
|
|
(19,439 |
) |
|
|
(3,188 |
) |
Total other income (expense) |
|
|
137 |
|
|
|
— |
|
|
|
183 |
|
|
|
(1,941 |
) |
Net loss |
|
$ |
(10,766 |
) |
|
$ |
(1,256 |
) |
|
$ |
(19,256 |
) |
|
$ |
(5,129 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized gain (loss) on available-for-sale securities, net |
|
|
7 |
|
|
|
— |
|
|
|
24 |
|
|
|
— |
|
Comprehensive loss |
|
$ |
(10,759 |
) |
|
$ |
(1,256 |
) |
|
$ |
(19,232 |
) |
|
$ |
(5,129 |
) |
Net loss per common share, basic and diluted |
|
$ |
(0.26 |
) |
|
$ |
(1.33 |
) |
|
$ |
(1.10 |
) |
|
$ |
(5.79 |
) |
Weighted-average shares of common stock outstanding, basic and diluted |
|
|
41,134,102 |
|
|
|
943,634 |
|
|
|
17,572,807 |
|
|
|
885,486 |
|
Document and Entity Information |
Nov. 09, 2021 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Nov. 09, 2021 |
Trading Symbol | JANX |
Security12b Title | Common Stock, $0.001 par value per share |
Security Exchange Name | NASDAQ |
Entity Registrant Name | Janux Therapeutics, Inc. |
Entity Central Index Key | 0001817713 |
Entity Emerging Growth Company | true |
Entity Ex Transition Period | true |
Entity File Number | 001-40475 |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 82-2289112 |
Entity Address, Address Line One | 11099 N. Torrey Pines Road |
Entity Address, Address Line Two | Suite 290 |
Entity Address, City or Town | La Jolla |
Entity Address, State or Province | CA |
Entity Address, Postal Zip Code | 92037 |
City Area Code | 858 |
Local Phone Number | 750-4700 |
Entity Information, Former Legal or Registered Name | N/A |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
M-8?20$3;8T.P6BP^0"X99K>]9!:G
PG1&H-X)*DA'7K^8\W:V8*+N*F>M
MK>V 24IF=!I9Z5^<;\B5G4*$I^\=O.L)KGWV8 "TR,#(Q,3$P.2YX M_/"JE?@2/ QGW@_V8M<+O*P3OY>VD!43!H--%H[GVXA(FBS=PQU40?
MWB5I8#O1NLFG@>3C)?DT:HU-'@N$Q.*H*=N]6G"T?BY(QGGKYWA3GW>B1>N'
MU@^MGR_6#WT_M'YH_=#ZO4WKA[Z?3]8/NV>]Z8(XU153L.)->1W)V(0E.6
M5[=\A=U%UAU%V'P[$/;XK-#C$]3;1ZA,.V.F_-,%C\%V"%KD!-_UP!UIX2'M
M2 M;5P>/P78(6J0%W_7 '6DU@J63)[NK3!Z;*?]TP6.P'8(6.<%W/7!'6A@J
MX.M G +>'=4HSEI(AH3=IOHP!MG#.OV=J5;PCS2V[3PAS BS5S"C <&5C3 C
MS&A _($<84:8=P=F-""XLG<.YK75-,]#6=QIJ5VM^4,8ZW.(N;6#XLY&UV@JR.^=84.*^HF([/Y-HS'F8\?YBS3Z
MV6 C!BU@N"J:MR:S+Z3;\[)P>\;^X\Y;)MTL][V]4\:GM;!_#\*>*'HMZ[^?WB(K@JFB%A'M
5&Y[@=_;T
M4HBQ1UQ7/^FT\(3RV$P:5KB+ ;)D874H)GX$Q\_Z)QKR8A\#S'!L>N2*]6$:
MG.&'J;EH#"QN35M1)29EKA^7"."RN#ARRAR?F]K.:.UD/?E<+7%FEHO)OUNF
MM^?4W9C-$9BMK4$H'#4P+HFZ4XX;L Y5)X(.KU(=I]I+#WUZ.8\KR.F8[%<6
M<>I1YXT[=N@?NH(GI.0_8 5BXX.9EN7_T?]#/%^/YT>N%##DF1@:%LV3TH\W
M;U_X'T]P=8'1_[ K\^\08\>1&"[8]G87/_?6Y7ZWW3T@S5:KTJT=U?U!<,