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Janux TherapeuticsDDocument history
Earnings documents stored for JANX.
Investor releaseQuarter not tagged2026-08-11Janux Therapeutics (JANX) Is Up 7.1% After Reporting Narrower Net Losses And Improved Earnings Profile
Simply Wall St.
Janux Therapeutics (JANX) Is Up 7.1% After Reporting Narrower Net Losses And Improved Earnings Profile
In the past, Janux Therapeutics, Inc. reported second-quarter 2026 results showing a net loss of US$21.97 million, or US$0.35 per share, compared with a net loss of US$33.86 million, or US$0.55 per share, a year earlier. For the first half of 2026, the company also reduced its net loss to US$46.33 million, or US$0.74 per share, signaling improving cost control and operating efficiency versus the prior-year period. We will now examine how Janux Therapeutics' reduced net loss and improving earnings profile shape the company’s overall investment narrative. We've uncovered the 9 dividend fortresses yielding 5%+ that don't just survive market storms, but thrive in them. For Janux, the core belief as a shareholder is that its TRACTr and related platforms can translate into meaningful oncology drugs before the balance sheet pressure bites too hard. The latest results, with a smaller net loss and improved loss per share, help a little on that front by showing tighter cost control without obvious disruption to the pipeline. In the short term, the biggest swing factors still sit with clinical readouts for JANX007, progress on newer programs like JANX014, and execution under the Bristol Myers Squibb collaboration. The reduced loss marginally eases funding risk, but does not remove it, especially given the company’s high valuation multiples, ongoing unprofitability, recent index removals, and CMO turnover. This earnings print fits in as a supportive, but not transformative, data point. However, funding needs and dilution risk remain key issues investors should understand in detail. In light of our recent valuation report, it seems possible that Janux Therapeutics is trading beyond its estimated value. Two fair value views from the Simply Wall St Community span roughly US$36.88 to US$48, reflecting very different expectations. Set against Janux’s continuing losses and reliance on clinical catalysts, this spread underlines why you may want to compare multiple viewpoints before forming a view on the company’s trajectory. Explore 2 other fair value estimates on Janux Therapeutics - why the stock might be worth over 2x more than the current price! Disagree with this assessment? Extraordinary investment returns rarely come from following the herd, so go with your instincts. A great starting point for your Janux Therapeutics research is our analysis highlighting 1 key reward a…Read full documentShow less
In the past, Janux Therapeutics, Inc. reported second-quarter 2026 results showing a net loss of US$21.97 million, or US$0.35 per share, compared with a net loss of US$33.86 million, or US$0.55 per share, a year earlier. For the first half of 2026, the company also reduced its net loss to US$46.33 million, or US$0.74 per share, signaling improving cost control and operating efficiency versus the prior-year period. We will now examine how Janux Therapeutics' reduced net loss and improving earnings profile shape the company’s overall investment narrative. We've uncovered the 9 dividend fortresses yielding 5%+ that don't just survive market storms, but thrive in them. For Janux, the core belief as a shareholder is that its TRACTr and related platforms can translate into meaningful oncology drugs before the balance sheet pressure bites too hard. The latest results, with a smaller net loss and improved loss per share, help a little on that front by showing tighter cost control without obvious disruption to the pipeline. In the short term, the biggest swing factors still sit with clinical readouts for JANX007, progress on newer programs like JANX014, and execution under the Bristol Myers Squibb collaboration. The reduced loss marginally eases funding risk, but does not remove it, especially given the company’s high valuation multiples, ongoing unprofitability, recent index removals, and CMO turnover. This earnings print fits in as a supportive, but not transformative, data point. However, funding needs and dilution risk remain key issues investors should understand in detail. In light of our recent valuation report, it seems possible that Janux Therapeutics is trading beyond its estimated value. Two fair value views from the Simply Wall St Community span roughly US$36.88 to US$48, reflecting very different expectations. Set against Janux’s continuing losses and reliance on clinical catalysts, this spread underlines why you may want to compare multiple viewpoints before forming a view on the company’s trajectory. Explore 2 other fair value estimates on Janux Therapeutics - why the stock might be worth over 2x more than the current price! Disagree with this assessment? Extraordinary investment returns rarely come from following the herd, so go with your instincts. A great starting point for your Janux Therapeutics research is our analysis highlighting 1 key reward and 2 important warning signs that could impact your investment decision. Our free Janux Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Janux Therapeutics' overall financial health at a glance. Right now could be the best entry point. These picks are fresh from our daily scans. Don't delay: Capitalize on the AI infrastructure supercycle with our selection of the 56 best 'picks and shovels' of the AI gold rush converting record-breaking demand into massive cash flow. The future of work is here. Discover the 37 top robotics and automation stocks leading the charge in AI-driven automation and industrial transformation. Uncover the next big thing with 20 elite penny stocks that balance risk and reward. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include JANX. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2026-08-06Janux Therapeutics Reports Second Quarter 2026 Financial Results and Business Highlights
Business Wire
Janux Therapeutics Reports Second Quarter 2026 Financial Results and Business Highlights
JANX007 Phase 1b enrollment continues across taxane-naïve monotherapy and darolutamide combination cohorts JANX014 Phase 1 study continues enrolling patients with metastatic castration-resistant prostate cancer (mCRPC) JANX011 Phase 1 healthy volunteer study progressing as planned JANX013 remains on track for clinical initiation in the second half of 2026 Strong balance sheet supports advancement of multiple clinical programs with $970.9 million in cash, cash equivalents and short-term investments at end of 2Q26 SAN DIEGO, August 06, 2026--(BUSINESS WIRE)--Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, today reported financial results for the quarter ended June 30, 2026, and provided a business update. "During the second quarter we continued to execute across our clinical portfolio while preparing for multiple upcoming milestones," said David Campbell, Ph.D., President and Chief Executive Officer of Janux. "Enrollment continues across our prostate cancer programs, including JANX007 and JANX014, and we remain on track to initiate clinical development of JANX013 later this year. We also continue to make progress with JANX011 in healthy volunteers as we advance our autoimmune disease pipeline." BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS: Clinical & Pipeline Progress JANX007 (PSMA-TRACTr) continues to enroll in its Phase 1b trial in metastatic castration-resistant prostate cancer (mCRPC), with ongoing dose optimization and expansion in taxane-naïve patients. JANX014 (PSMA-TRACTr), a double-masked tumor-activated T cell engager, continues enrollment in its Phase 1 clinical study designed to evaluate safety, pharmacokinetics and preliminary antitumor activity. JANX011 (CD19-ARM) continues enrolling in its Phase 1 clinical trial in healthy volunteers. The Company continues to advance additional TRACTr, TRACIr and ARM programs for potential future development. Upcoming Milestones Initial clinical data from the Phase 1 healthy volunteer study of JANX011 expected to be announced in the second half of 2026. Clinical initiation of JANX013, a PSMA-targeted CD28 costimulatory TRACIr, expected in the second half of 2026. Additional clinical data for JANX007 expected to be announced at a future medical congress in the first half of 2027. SECOND QUARTER 2026 FINANCIAL RESULTS:…Read full documentShow less
JANX007 Phase 1b enrollment continues across taxane-naïve monotherapy and darolutamide combination cohorts JANX014 Phase 1 study continues enrolling patients with metastatic castration-resistant prostate cancer (mCRPC) JANX011 Phase 1 healthy volunteer study progressing as planned JANX013 remains on track for clinical initiation in the second half of 2026 Strong balance sheet supports advancement of multiple clinical programs with $970.9 million in cash, cash equivalents and short-term investments at end of 2Q26 SAN DIEGO, August 06, 2026--(BUSINESS WIRE)--Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, today reported financial results for the quarter ended June 30, 2026, and provided a business update. "During the second quarter we continued to execute across our clinical portfolio while preparing for multiple upcoming milestones," said David Campbell, Ph.D., President and Chief Executive Officer of Janux. "Enrollment continues across our prostate cancer programs, including JANX007 and JANX014, and we remain on track to initiate clinical development of JANX013 later this year. We also continue to make progress with JANX011 in healthy volunteers as we advance our autoimmune disease pipeline." BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS: Clinical & Pipeline Progress JANX007 (PSMA-TRACTr) continues to enroll in its Phase 1b trial in metastatic castration-resistant prostate cancer (mCRPC), with ongoing dose optimization and expansion in taxane-naïve patients. JANX014 (PSMA-TRACTr), a double-masked tumor-activated T cell engager, continues enrollment in its Phase 1 clinical study designed to evaluate safety, pharmacokinetics and preliminary antitumor activity. JANX011 (CD19-ARM) continues enrolling in its Phase 1 clinical trial in healthy volunteers. The Company continues to advance additional TRACTr, TRACIr and ARM programs for potential future development. Upcoming Milestones Initial clinical data from the Phase 1 healthy volunteer study of JANX011 expected to be announced in the second half of 2026. Clinical initiation of JANX013, a PSMA-targeted CD28 costimulatory TRACIr, expected in the second half of 2026. Additional clinical data for JANX007 expected to be announced at a future medical congress in the first half of 2027. SECOND QUARTER 2026 FINANCIAL RESULTS: Cash and cash equivalents and short-term investments: As of June 30, 2026, Janux reported cash and cash equivalents and short-term investments of $970.9 million, compared to $966.6 million on December 31, 2025. Research and development expenses: Research and development expenses were $31.0 million for the quarter ended June 30, 2026, compared to $34.7 million for the comparable period in 2025. General and administrative expenses: General and administrative expenses were $11.0 million for the quarter ended June 30, 2026, compared to $10.5 million for the comparable period in 2025. Net loss: Net loss was $22.0 million for the quarter ended June 30, 2026, compared to $33.9 million for the comparable period in 2025. About Janux Therapeutics Janux is 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), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms. Janux’s lead clinical candidate, JANX007, is a PSMA-targeted TRACTr being investigated in a Phase 1 clinical trial in patients with metastatic castration-resistant prostate cancer (mCRPC). The Company is also advancing additional PSMA-targeted programs, including JANX014, a double-masked PSMA TRACTr being evaluated in a Phase 1 clinical trial, and JANX013, a CD28 co-stimulatory TRACIr designed for combination with JANX007. Beyond its prostate cancer programs, Janux’s pipeline includes JANX011, a CD19-targeted ARM being evaluated in a Phase 1 clinical trial in healthy adult volunteers for potential treatment of autoimmune diseases. Janux continues to generate additional TRACTr, TRACIr, and ARM programs for potential future development. 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, and 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 interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations, 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. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. View source version on businesswire.com: https://www.businesswire.com/news/home/20260806111340/en/ Contacts Investors: Chad RubinEndurance [email protected] 646.319.3261 Media: Jessica Yingling, Ph.D.Little Dog Communications [email protected] 858.344.8091
Investor releaseQuarter not tagged2026-05-08Janux Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights
Business Wire
Janux Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights
JANX007 continues to enroll in its Phase 1b taxane-naïve patient population, including combination cohorts with darolutamide Initiated clinical evaluation of JANX014, a double-masked PSMA-TRACTr candidate JANX011 Phase 1 study ongoing in healthy volunteers Discontinued development of JANX008 following completion of Phase 1a Achieved development candidate nomination under Bristol Myers Squibb collaboration, triggering milestone payment Strong cash position supporting continued pipeline execution SAN DIEGO, May 07, 2026--(BUSINESS WIRE)--Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, today reported financial results for the quarter ended March 31, 2026, and provided a business update. "Our commitment to advancing a prostate cancer franchise is demonstrated by our continued progress with JANX007, clinical initiation of JANX014, and advancement of JANX013 toward the clinic," said David Campbell, Ph.D., President and CEO of Janux. "Our ongoing clinical study with JANX011 has been designed to support our emerging autoimmune disease opportunity." BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS: Clinical & Pipeline Progress JANX007 (PSMA-TRACTr) continues to enroll in its Phase 1b trial in metastatic castration-resistant prostate cancer (mCRPC), with ongoing dose optimization and expansion in taxane-naïve patients. An expansion cohort evaluating JANX007 in combination with darolutamide, an androgen receptor pathway inhibitor, is actively enrolling in taxane-naïve mCRPC. JANX014 (PSMA-TRACTr), a double masked tumor-activated T cell engager, has initiated clinical evaluation. Following the completion of the Phase 1a portion of the study and internal review of the data, the Company has discontinued further clinical development of JANX008 (EGFR-TRACTr) and is prioritizing resources toward other pipeline opportunities. JANX011 (CD19-ARM) is actively enrolling in its Phase 1 clinical trial in healthy volunteers. The Company continues to advance additional TRACTr, TRACIr and ARM programs for potential future development. Strategic Collaborations Janux announced a collaboration and exclusive worldwide license agreement with Bristol Myers Squibb to develop a novel tumor-activated therapeutic targeting a validated solid tumor antigen, utilizing Janux’s TRACTr platform. Recently anno…Read full documentShow less
JANX007 continues to enroll in its Phase 1b taxane-naïve patient population, including combination cohorts with darolutamide Initiated clinical evaluation of JANX014, a double-masked PSMA-TRACTr candidate JANX011 Phase 1 study ongoing in healthy volunteers Discontinued development of JANX008 following completion of Phase 1a Achieved development candidate nomination under Bristol Myers Squibb collaboration, triggering milestone payment Strong cash position supporting continued pipeline execution SAN DIEGO, May 07, 2026--(BUSINESS WIRE)--Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, today reported financial results for the quarter ended March 31, 2026, and provided a business update. "Our commitment to advancing a prostate cancer franchise is demonstrated by our continued progress with JANX007, clinical initiation of JANX014, and advancement of JANX013 toward the clinic," said David Campbell, Ph.D., President and CEO of Janux. "Our ongoing clinical study with JANX011 has been designed to support our emerging autoimmune disease opportunity." BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS: Clinical & Pipeline Progress JANX007 (PSMA-TRACTr) continues to enroll in its Phase 1b trial in metastatic castration-resistant prostate cancer (mCRPC), with ongoing dose optimization and expansion in taxane-naïve patients. An expansion cohort evaluating JANX007 in combination with darolutamide, an androgen receptor pathway inhibitor, is actively enrolling in taxane-naïve mCRPC. JANX014 (PSMA-TRACTr), a double masked tumor-activated T cell engager, has initiated clinical evaluation. Following the completion of the Phase 1a portion of the study and internal review of the data, the Company has discontinued further clinical development of JANX008 (EGFR-TRACTr) and is prioritizing resources toward other pipeline opportunities. JANX011 (CD19-ARM) is actively enrolling in its Phase 1 clinical trial in healthy volunteers. The Company continues to advance additional TRACTr, TRACIr and ARM programs for potential future development. Strategic Collaborations Janux announced a collaboration and exclusive worldwide license agreement with Bristol Myers Squibb to develop a novel tumor-activated therapeutic targeting a validated solid tumor antigen, utilizing Janux’s TRACTr platform. Recently announced development candidate nomination, triggering a $35 million milestone payment. Corporate & Leadership Janux announced the appointment of William Go, M.D., Ph.D. as Chief Medical Officer, supporting the Company’s continued clinical advancement as additional programs enter the clinic in 2026. Upcoming Milestones Janux expects to provide additional clinical data for JANX007 at a future medical congress in the first half of 2027. Janux plans to announce an initial clinical update from the Phase 1 study of JANX011 in healthy volunteers in the second half of 2026. Janux plans to initiate clinical development of JANX013, a PSMA-targeted CD28 costimulatory TRACIr, in the second half of 2026. FIRST QUARTER 2026 FINANCIAL RESULTS: Cash and cash equivalents and short-term investments: As of March 31, 2026, Janux reported cash and cash equivalents and short-term investments of $956.4 million, compared to $966.6 million on December 31, 2025. Research and development expenses: Research and development expenses were $26.8 million for the quarter ended March 31, 2026, compared to $25.1 million for the comparable period in 2025. The change was primarily driven by manufacturing. General and administrative expenses: General and administrative expenses were $11.1 million for the quarter ended March 31, 2026, compared to $9.8 million for the comparable period in 2025. Net loss: Net loss was $24.4 million for the quarter ended March 31, 2026, compared to $23.5 million for the comparable period in 2025. About Janux Therapeutics Janux is 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), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms. Janux’s lead clinical candidate, JANX007, is a PSMA-targeted TRACTr being investigated in a Phase 1 clinical trial in patients with metastatic castration-resistant prostate cancer (mCRPC). The Company is also advancing additional PSMA-targeted programs, including JANX014, a double-masked PSMA TRACTr being evaluated in a Phase 1 clinical trial, and JANX013, a CD28 co-stimulatory TRACIr designed for combination with JANX007. Beyond its prostate cancer programs, Janux’s pipeline includes JANX011, a CD19-targeted ARM being evaluated in a Phase 1 clinical trial in healthy adult volunteers for potential treatment of autoimmune diseases. Janux continues to generate additional TRACTr, TRACIr, and ARM programs for potential future development. 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, and 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 interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations, 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. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. View source version on businesswire.com: https://www.businesswire.com/news/home/20260507597234/en/ Contacts Investors: Chad Rubin Endurance Advisors [email protected] 646.319.3261 Media: Jessica Yingling, Ph.D. Little Dog Communications Inc. [email protected] 858.344.8091
Investor releaseQuarter not tagged2026-04-28FDA claims Amgen drug data were ‘manipulated’; Erasca slides despite ‘home run’ results
BioPharma Dive
FDA claims Amgen drug data were ‘manipulated’; Erasca slides despite ‘home run’ results
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news involving Amgen and Erasca, as well as updates from Rocket Pharma and Janux Therapeutics that you may have missed. The Food and Drug Administration has officially proposed that Amgen withdraw from market Tavneos, a drug the company acquired in a nearly $4 billion deal in 2022. Amgen disclosed in February that it intended to keep selling Tavneos despite FDA concerns about the drug's clinical results and safety. The FDA stepped up its campaign Monday, publishing a letter to Amgen arguing Tavneos should be pulled because of "new information" showing the drug's approval submissions from former developer ChemoCentryx "contained untrue statements of material fact." According to the agency, "unblinded study personnel manipulated [Tavneos'] results" to make the drug look effective when the original analysis "did not support that conclusion." That initial analysis wasn't disclosed, violating agency regulations, the FDA claimed. Tavneos will remain on the market until Amgen chooses to remove it or is forced to do so by Commissioner Martin Makary. Amgen could also request a public hearing, the FDA said. Shares of Erasca lost nearly half their value despite early clinical data for a drug that, to multiple Wall Street analysts, may be competitive with Revolution Medicines' closely watched pancreatic cancer medicine. Erasca's therapy ERAS-0015 targets "RAS" mutations, as Revolution's does, but was designed to have potentially superior characteristics. Data disclosed Monday showed a 62% unconfirmed response rate in people with second-line, non-small cell lung cancer and a 40% response rate in previously treated pancreatic cancer patients. Erasca said both figures were double-digit percentage points higher than previously reported results from Revolution, and analysts at Evercore ISI and Stifel described the findings as a "home run" and "promising signals of differentiation." Yet Erasca also disclosed that Revolution has accused it of patent infringement and, in a slide presentation, revealed that a treatment recipient who'd experienced a kind of lung tissue inflammation voluntarily withdrew from supportive care and later died. Stifel's Laura Prendergast claimed in a Tuesday note that those factors w…Read full documentShow less
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news involving Amgen and Erasca, as well as updates from Rocket Pharma and Janux Therapeutics that you may have missed. The Food and Drug Administration has officially proposed that Amgen withdraw from market Tavneos, a drug the company acquired in a nearly $4 billion deal in 2022. Amgen disclosed in February that it intended to keep selling Tavneos despite FDA concerns about the drug's clinical results and safety. The FDA stepped up its campaign Monday, publishing a letter to Amgen arguing Tavneos should be pulled because of "new information" showing the drug's approval submissions from former developer ChemoCentryx "contained untrue statements of material fact." According to the agency, "unblinded study personnel manipulated [Tavneos'] results" to make the drug look effective when the original analysis "did not support that conclusion." That initial analysis wasn't disclosed, violating agency regulations, the FDA claimed. Tavneos will remain on the market until Amgen chooses to remove it or is forced to do so by Commissioner Martin Makary. Amgen could also request a public hearing, the FDA said. Shares of Erasca lost nearly half their value despite early clinical data for a drug that, to multiple Wall Street analysts, may be competitive with Revolution Medicines' closely watched pancreatic cancer medicine. Erasca's therapy ERAS-0015 targets "RAS" mutations, as Revolution's does, but was designed to have potentially superior characteristics. Data disclosed Monday showed a 62% unconfirmed response rate in people with second-line, non-small cell lung cancer and a 40% response rate in previously treated pancreatic cancer patients. Erasca said both figures were double-digit percentage points higher than previously reported results from Revolution, and analysts at Evercore ISI and Stifel described the findings as a "home run" and "promising signals of differentiation." Yet Erasca also disclosed that Revolution has accused it of patent infringement and, in a slide presentation, revealed that a treatment recipient who'd experienced a kind of lung tissue inflammation voluntarily withdrew from supportive care and later died. Stifel's Laura Prendergast claimed in a Tuesday note that those factors weighed down shares, as did sky-high expectations and findings that were "sliced in many different ways” — a "red flag for investors." Rocket Pharmaceuticals has sold for $180 million a regulatory fast pass it received upon winning U.S. approval of a gene therapy for a rare immune disorder. Rocket didn't reveal which firm had agreed to acquire the "priority review voucher" it was awarded in May, but said Tuesday the sale proceeds will help progress its pipeline of gene therapies for heart conditions, among them a program for Danon disease that's currently in advanced testing. Rocket now expects to be able to operate into the second quarter of 2028, compared to mid-2027 previously. Janux Therapeutics has trimmed its pipeline, announcing Monday it scrapped an experimental cancer drug called JANX008 that targets the well-known cancer-driving protein EGFR. Janux said that, while “durable responses” were observed in early clinical testing, the “overall magnitude and consistency of activity” for JANX008 didn’t warrant further development. Janux shares have lost more than half their value since late last year, following the release of prostate cancer drug results that disappointed investors. The latest update will “raise more questions,” wrote Stifel’s Stephen Wiley, though the company claimed JANX008’s issues were “program-specific” and don’t impact its broader pipeline.
Investor releaseQuarter not tagged2026-04-17Will Health Benefits Weakness Drag Elevance's Q1 Earnings?
Zacks
Will Health Benefits Weakness Drag Elevance's Q1 Earnings?
Elevance Health, Inc. ELV is set to report its first-quarter 2026 results on April 22, 2026, before the opening bell. The Zacks Consensus Estimate for the to-be-reported quarter’s earnings is currently pegged at $10.61 per shareon revenues of $48.37 billion. The first-quarter earnings estimate witnessed one downward revision and three upward revisions over the past 60 days. The bottom-line projection indicates a year-over-year decline of 11.4%. Also, the Zacks Consensus Estimate for quarterly revenues implies a year-over-year decrease of 0.8%. Image Source: Zacks Investment Research For 2026, the Zacks Consensus Estimate for Elevance’s revenues is pegged at $194.76 billion, implying a fall of 1.4% year over year. The consensus mark for 2026 EPS is pegged at $25.92, indicating a 14.4% year-over-year decrease. Elevance’s earnings beat the consensus estimate in three of the trailing four quarters and missed once, with the average surprise being 7.9%. This is depicted in the figure below. Elevance Health, Inc. price-eps-surprise | Elevance Health, Inc. Quote Our proven model does not conclusively predict an earnings beat for the company this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here. ELV currently has an Earnings ESP of 0.00% and a Zacks Rank #4 (Sell). You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter. The Zacks Consensus Estimate for product revenues indicates 4.9% growth from the year-ago period’s $5.8 billion. The consensus estimate for premiums indicates a 1.8% decrease from the year-ago period. The consensus mark for Commercial Individual membership implies 25.7% fall from a year ago, while our model estimate indicates a 23.7% decline. Also, declining memberships in Medicaid (-8.4%) are likely to have kept first-quarter performance in check. However, the consensus estimate for Commercial Fee-based memberships indicates 0.6% year-over-year growth. Meanwhile, the Zacks Consensus Estimate for Carelon brand’s operating income for the first quarter indicates a 1.7% year-over-year decrease. The consensus estimate for the Health Benefits segment’s operating income for the first quarter indicates a 13.7% year-over-year plunge, making an earnings beat uncertain. The Zacks Consensus Es…Read full documentShow less
Elevance Health, Inc. ELV is set to report its first-quarter 2026 results on April 22, 2026, before the opening bell. The Zacks Consensus Estimate for the to-be-reported quarter’s earnings is currently pegged at $10.61 per shareon revenues of $48.37 billion. The first-quarter earnings estimate witnessed one downward revision and three upward revisions over the past 60 days. The bottom-line projection indicates a year-over-year decline of 11.4%. Also, the Zacks Consensus Estimate for quarterly revenues implies a year-over-year decrease of 0.8%. Image Source: Zacks Investment Research For 2026, the Zacks Consensus Estimate for Elevance’s revenues is pegged at $194.76 billion, implying a fall of 1.4% year over year. The consensus mark for 2026 EPS is pegged at $25.92, indicating a 14.4% year-over-year decrease. Elevance’s earnings beat the consensus estimate in three of the trailing four quarters and missed once, with the average surprise being 7.9%. This is depicted in the figure below. Elevance Health, Inc. price-eps-surprise | Elevance Health, Inc. Quote Our proven model does not conclusively predict an earnings beat for the company this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here. ELV currently has an Earnings ESP of 0.00% and a Zacks Rank #4 (Sell). You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter. The Zacks Consensus Estimate for product revenues indicates 4.9% growth from the year-ago period’s $5.8 billion. The consensus estimate for premiums indicates a 1.8% decrease from the year-ago period. The consensus mark for Commercial Individual membership implies 25.7% fall from a year ago, while our model estimate indicates a 23.7% decline. Also, declining memberships in Medicaid (-8.4%) are likely to have kept first-quarter performance in check. However, the consensus estimate for Commercial Fee-based memberships indicates 0.6% year-over-year growth. Meanwhile, the Zacks Consensus Estimate for Carelon brand’s operating income for the first quarter indicates a 1.7% year-over-year decrease. The consensus estimate for the Health Benefits segment’s operating income for the first quarter indicates a 13.7% year-over-year plunge, making an earnings beat uncertain. The Zacks Consensus Estimate for the benefit expense ratio is pegged at 87.5, higher than the year-ago level of 86.4. While an earnings beat looks uncertain for Elevance, here are some companies from the broader Medical space that you may want to consider, as our model shows that these have the right combination of elements to post an earnings beat this time around: The Ensign Group, Inc. ENSG has an Earnings ESP of +1.12% and a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here. The Zacks Consensus Estimate for Ensign’s bottom line for the to-be-reported quarter of $1.79 indicates 17.8% year-over-year growth. It has witnessed one upward revision against no downward movement over the past 60 days. The consensus mark for Ensign’s revenues is pegged at $1.39 billion, an 18.5% increase from a year ago. Janux Therapeutics, Inc. JANX has an Earnings ESP of +26.03% and a Zacks Rank of 3. The Zacks Consensus Estimate for Janux Therapeutics’ bottom line for the to-be-reported quarter has improved by 3 cents over the past month. The company’s earnings beat estimates in three of the trailing four quarters and missed once, with an average surprise of 13.4%. The consensus estimate for JANX’s revenues is pegged at $15 million. Cullinan Therapeutics, Inc. CGEM has an Earnings ESP of +28.36% and a Zacks Rank of 3. The Zacks Consensus Estimate for Cullinan Therapeutics’ bottom line for the to-be-reported quarter improved by 11 cents over the past 60 days. Its earnings beat estimates in three of the past four quarters and missed once. Cullinan Therapeutics’ revenues for the to be reported quarter are pegged at $17.34 million. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report The Ensign Group, Inc. (ENSG) : Free Stock Analysis Report Cullinan Therapeutics, Inc. (CGEM) : Free Stock Analysis Report Janux Therapeutics, Inc. (JANX) : Free Stock Analysis Report Elevance Health, Inc. (ELV) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-02-27Janux Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights
Business Wire
Janux Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights
Continued clinical execution across TRACTr programs JANX007 and JANX008 JANX007 enrolling in Phase 1b Taxane-naïve patient population in metastatic castration-resistant prostate cancer (mCRPC) JANX008 enrolling expansion cohorts in defined tumor settings Initiated Phase 1 study of JANX011 in healthy volunteers Entered collaboration and exclusive worldwide license agreement with Bristol Myers Squibb to develop a novel tumor-activated therapeutic for solid tumors Appointment of William Go, M.D., Ph.D., as Chief Medical Officer Strong year-end cash position supporting continued pipeline execution SAN DIEGO, February 26, 2026--(BUSINESS WIRE)--Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. "The past year marked a period of significant execution and progress for Janux as we continued to translate the promise of our tumor-activated platform into meaningful clinical and strategic advances. Recent JANX007 clinical results demonstrate clinical activity and a consistent and predictable safety profile in mCRPC and support continued advancement in taxane-naïve patients as well as other expansion cohorts," said David Campbell, Ph.D., President and CEO of Janux. "In early 2026, we announced a collaboration with Bristol Myers Squibb that provides near-term capital and further validates the potential of our platform. We also continue to strengthen our team to support the next phase of clinical and pipeline growth. With additional product candidates entering the clinic in 2026, we believe Janux is well positioned to execute on our clinical strategy and continue to build long-term value for patients and shareholders." BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS: Clinical & Pipeline Progress Janux presented updated interim Phase 1 data for JANX007 (PSMA-TRACTr) in December 2025. As of the October 15, 2025 data cutoff, 109 patients had been treated across Phase 1 cohorts: Durable clinical activity was observed across both once-weekly (QW) and every-two-week (Q2W) cohorts, with median radiographic progression-free survival (rPFS) ranging from 7.9 to 8.9 months. The rPFS in the Q2W cohort compared favorably to the QW expansion group. Data demonstrated high p…Read full documentShow less
Continued clinical execution across TRACTr programs JANX007 and JANX008 JANX007 enrolling in Phase 1b Taxane-naïve patient population in metastatic castration-resistant prostate cancer (mCRPC) JANX008 enrolling expansion cohorts in defined tumor settings Initiated Phase 1 study of JANX011 in healthy volunteers Entered collaboration and exclusive worldwide license agreement with Bristol Myers Squibb to develop a novel tumor-activated therapeutic for solid tumors Appointment of William Go, M.D., Ph.D., as Chief Medical Officer Strong year-end cash position supporting continued pipeline execution SAN DIEGO, February 26, 2026--(BUSINESS WIRE)--Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. "The past year marked a period of significant execution and progress for Janux as we continued to translate the promise of our tumor-activated platform into meaningful clinical and strategic advances. Recent JANX007 clinical results demonstrate clinical activity and a consistent and predictable safety profile in mCRPC and support continued advancement in taxane-naïve patients as well as other expansion cohorts," said David Campbell, Ph.D., President and CEO of Janux. "In early 2026, we announced a collaboration with Bristol Myers Squibb that provides near-term capital and further validates the potential of our platform. We also continue to strengthen our team to support the next phase of clinical and pipeline growth. With additional product candidates entering the clinic in 2026, we believe Janux is well positioned to execute on our clinical strategy and continue to build long-term value for patients and shareholders." BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS: Clinical & Pipeline Progress Janux presented updated interim Phase 1 data for JANX007 (PSMA-TRACTr) in December 2025. As of the October 15, 2025 data cutoff, 109 patients had been treated across Phase 1 cohorts: Durable clinical activity was observed across both once-weekly (QW) and every-two-week (Q2W) cohorts, with median radiographic progression-free survival (rPFS) ranging from 7.9 to 8.9 months. The rPFS in the Q2W cohort compared favorably to the QW expansion group. Data demonstrated high prostate-specific antigen (PSA) response rates including deep PSA declines. Anti-tumor activity was observed, with confirmed and unconfirmed partial responses in 30% (8/27) of RECIST-evaluable patients. Ongoing dose optimization of JANX007 monotherapy is focused on taxane-naïve mCRPC. The Phase 1 study also includes expansion cohorts evaluating JANX007 in combination with darolutamide, an androgen receptor pathway inhibitor, to further characterize safety and clinical activity in taxane-naïve mCRPC. Additional expansion cohorts are evaluating JANX007 monotherapy in patients with PARP inhibitor-refractory mCRPC, supporting assessment of activity in a high-unmet-need population. JANX008 (EGFR-TRACTr) continues to enroll in its Phase 1 clinical trial in a defined group of solid tumors, with expansion cohorts underway to further characterize safety and clinical activity. JANX011 (CD19-ARM) is actively enrolling its Phase 1 clinical trial in healthy volunteers. Strategic Collaboration In January 2026, Janux announced a collaboration and exclusive worldwide license agreement with Bristol Myers Squibb to develop a novel tumor-activated therapeutic targeting a validated solid tumor antigen. Under the terms of the agreement, Janux is eligible to receive $50 million in upfront and near-term milestone payments, with the potential for additional development, regulatory and commercial milestones totaling approximately $800 million, as well as tiered royalties on global product sales, if successful. Janux will lead preclinical development through IND submission, with Bristol Myers Squibb assuming responsibility for subsequent clinical development and global commercialization. Corporate & Leadership Janux recently announced the appointment of William Go, M.D., Ph.D. as Chief Medical Officer, strengthening the Company’s clinical leadership as additional programs enter the clinic in 2026 and progress toward later-stage development. Upcoming Milestones The Company expects to provide additional clinical data for JANX007 in 2026 or present these data at a future medical meeting. The Company expects to provide an additional clinical update for JANX008 in 2026. The Company expects to announce an initial clinical update from the Phase 1 study of JANX011 in healthy volunteers by year-end 2026. FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS: Cash and cash equivalents and short-term investments: As of December 31, 2025, Janux reported cash and cash equivalents and short-term investments of $966.6 million, compared to $1.03 billion on December 31, 2024. Research and development expenses: Research and development expenses were $31.5 million for the quarter and $125.9 million for the year ended December 31, 2025, compared to $20.8 million and $68.4 million for the same quarter and year in 2024. General and administrative expenses: General and administrative expenses were $10.9 million for the quarter and $41.8 million for the year ended December 31, 2025, compared to $8.2 million and $41.0 million for the same quarter and year in 2024. Net loss: Net loss was $31.9 million for the quarter and $113.6 million for the year ended December 31, 2025, compared to $20.2 million and $69.0 million for the same quarter and year in 2024. About Janux Therapeutics Janux is 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), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms. Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid tumors. Janux is also advancing its first ARM platform clinical candidate, JANX011, a CD19-ARM for the potential treatment of autoimmune diseases in a Phase 1 study in healthy adult volunteers. Janux continues to generate a number of additional TRACTr, TRACIr, and ARM programs for potential future development. 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, and 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 interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations, 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. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. View source version on businesswire.com: https://www.businesswire.com/news/home/20260226553379/en/ Contacts Investors: Chad Rubin Endurance Advisors [email protected] 646.319.3261 Media: Jessica Yingling, Ph.D. Little Dog Communications Inc. [email protected] 858.344.8091
Investor releaseQuarter not tagged2026-01-23A Look At Bristol Myers Squibb (BMY) Valuation After New Microsoft AI Pact And Camzyos Trial Results
Simply Wall St.
A Look At Bristol Myers Squibb (BMY) Valuation After New Microsoft AI Pact And Camzyos Trial Results
Track your investments for FREE with Simply Wall St, the portfolio command center trusted by over 7 million individual investors worldwide. Bristol Myers Squibb (BMY) is back in focus after two key updates: a new AI lung cancer screening agreement with Microsoft, and positive Phase 3 data for Camzyos in adolescents with obstructive hypertrophic cardiomyopathy. See our latest analysis for Bristol-Myers Squibb. Those AI and cardiology updates come after a busy start to 2026, including oncology focused deals like the new Janux Therapeutics agreement. They follow a 90 day share price return of 25.35% against a weaker 1 year total shareholder return of a 2.41% decline, suggesting recent momentum has picked up after a tougher stretch. If news around AI in healthcare and rare disease pipelines has your attention, it could be a good moment to scan healthcare stocks for other ideas in the sector. With Bristol Myers Squibb trading at $54.94 and carrying a value score of 5 alongside an indicated intrinsic discount of 56.70%, the key question is whether this reflects genuine undervaluation or whether the market is already incorporating expectations for future growth in the price. The most followed narrative puts Bristol Myers Squibb’s fair value at $56.26, just above the recent $54.94 close, and anchors that view in detailed forecasts. Read the complete narrative. Want to understand why a company with expected revenue declines still lands near this fair value mark? The narrative leans heavily on a rebuild in profitability and a future earnings profile that hinges on higher margins and a different earnings mix. Curious which specific earnings and margin paths sit behind that conclusion and how they tie back to today’s price? Result: Fair Value of $56.26 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this hinges on Bristol Myers Squibb managing patent cliffs around key drugs and avoiding setbacks in late stage trials, which could weaken the earnings rebuild story. Find out about the key risks to this Bristol-Myers Squibb narrative. If you are not fully on board with this storyline or prefer to test the assumptions yourself, you can build a custom view in minutes, starting with Do it your way. A great starting point for your Bristol-Myers Squibb research is our analysis highlighting 4 key rewards and 2 important warn…Read full documentShow less
Track your investments for FREE with Simply Wall St, the portfolio command center trusted by over 7 million individual investors worldwide. Bristol Myers Squibb (BMY) is back in focus after two key updates: a new AI lung cancer screening agreement with Microsoft, and positive Phase 3 data for Camzyos in adolescents with obstructive hypertrophic cardiomyopathy. See our latest analysis for Bristol-Myers Squibb. Those AI and cardiology updates come after a busy start to 2026, including oncology focused deals like the new Janux Therapeutics agreement. They follow a 90 day share price return of 25.35% against a weaker 1 year total shareholder return of a 2.41% decline, suggesting recent momentum has picked up after a tougher stretch. If news around AI in healthcare and rare disease pipelines has your attention, it could be a good moment to scan healthcare stocks for other ideas in the sector. With Bristol Myers Squibb trading at $54.94 and carrying a value score of 5 alongside an indicated intrinsic discount of 56.70%, the key question is whether this reflects genuine undervaluation or whether the market is already incorporating expectations for future growth in the price. The most followed narrative puts Bristol Myers Squibb’s fair value at $56.26, just above the recent $54.94 close, and anchors that view in detailed forecasts. Read the complete narrative. Want to understand why a company with expected revenue declines still lands near this fair value mark? The narrative leans heavily on a rebuild in profitability and a future earnings profile that hinges on higher margins and a different earnings mix. Curious which specific earnings and margin paths sit behind that conclusion and how they tie back to today’s price? Result: Fair Value of $56.26 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, this hinges on Bristol Myers Squibb managing patent cliffs around key drugs and avoiding setbacks in late stage trials, which could weaken the earnings rebuild story. Find out about the key risks to this Bristol-Myers Squibb narrative. If you are not fully on board with this storyline or prefer to test the assumptions yourself, you can build a custom view in minutes, starting with Do it your way. A great starting point for your Bristol-Myers Squibb research is our analysis highlighting 4 key rewards and 2 important warning signs that could impact your investment decision. If you are serious about putting your research to work, do not stop at one company when the Simply Wall Street Screener can surface fresh ideas in minutes. Spot potential mispricing by reviewing these 880 undervalued stocks based on cash flows that line up with your own expectations on cash flows and quality. Tap into long term themes by checking out these 24 AI penny stocks that tie artificial intelligence to real business models and financials. Strengthen your income watchlist by scanning these 12 dividend stocks with yields > 3% that might suit a portfolio focused on regular cash returns. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include BMY. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2025-12-06Do JANX007’s Interim Results Put Janux Therapeutics’ (JANX) TRACTr Platform Competitiveness to the Test?
Simply Wall St.
Do JANX007’s Interim Results Put Janux Therapeutics’ (JANX) TRACTr Platform Competitiveness to the Test?
In early December 2025, Janux Therapeutics reported updated interim Phase 1 data for JANX007 in metastatic castration-resistant prostate cancer, showing anti-tumor activity with partial responses in 30% of evaluable patients and radiographic progression-free survival of 7.9 to 8.9 months. Despite Janux characterizing the results as positive, investors questioned whether JANX007 can compete with established options such as Novartis’s Pluvicto, putting the company’s broader TRACTr platform under closer scrutiny. Next, we’ll examine how concerns about JANX007’s competitive profile in metastatic castration-resistant prostate cancer shape Janux Therapeutics’ investment narrative. We've found 15 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. To own Janux Therapeutics after the JANX007 update, you have to believe the TRACTr platform can still turn early pharmacology into clinically and commercially relevant drugs, despite a painful reset in expectations. The Phase 1 data showed real anti-tumor activity, but the market’s 40%+ selloff and analyst target cuts suggest JANX007 may no longer be viewed as a clear contender against options like Pluvicto, at least near term. That likely shifts the key catalysts from “how fast can JANX007 scale” to more proof-of-concept questions around dosing, combinations in taxane-naïve and PARP inhibitor–refractory settings, and follow‑on assets such as JANX008 and the CD19-ARM program. At the same time, rising losses, a young management team and reliance on equity markets remain front‑of‑mind risks. However, one emerging risk now goes beyond science and into competitive positioning that investors should not ignore. According our valuation report, there's an indication that Janux Therapeutics' share price might be on the expensive side. Three Simply Wall St Community fair value views span roughly US$48 to US$150 per share, but the recent JANX007 data debate and sharp price reaction show why you may want to compare several such viewpoints. Explore 3 other fair value estimates on Janux Therapeutics - why the stock might be worth over 9x more than the current price! Disagree with this assessment? Create your own narrative in under 3 minutes - extraordinary investment returns rarely come from following the herd. A great starting point for your Janux Therapeutics research is our analysis…Read full documentShow less
In early December 2025, Janux Therapeutics reported updated interim Phase 1 data for JANX007 in metastatic castration-resistant prostate cancer, showing anti-tumor activity with partial responses in 30% of evaluable patients and radiographic progression-free survival of 7.9 to 8.9 months. Despite Janux characterizing the results as positive, investors questioned whether JANX007 can compete with established options such as Novartis’s Pluvicto, putting the company’s broader TRACTr platform under closer scrutiny. Next, we’ll examine how concerns about JANX007’s competitive profile in metastatic castration-resistant prostate cancer shape Janux Therapeutics’ investment narrative. We've found 15 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. To own Janux Therapeutics after the JANX007 update, you have to believe the TRACTr platform can still turn early pharmacology into clinically and commercially relevant drugs, despite a painful reset in expectations. The Phase 1 data showed real anti-tumor activity, but the market’s 40%+ selloff and analyst target cuts suggest JANX007 may no longer be viewed as a clear contender against options like Pluvicto, at least near term. That likely shifts the key catalysts from “how fast can JANX007 scale” to more proof-of-concept questions around dosing, combinations in taxane-naïve and PARP inhibitor–refractory settings, and follow‑on assets such as JANX008 and the CD19-ARM program. At the same time, rising losses, a young management team and reliance on equity markets remain front‑of‑mind risks. However, one emerging risk now goes beyond science and into competitive positioning that investors should not ignore. According our valuation report, there's an indication that Janux Therapeutics' share price might be on the expensive side. Three Simply Wall St Community fair value views span roughly US$48 to US$150 per share, but the recent JANX007 data debate and sharp price reaction show why you may want to compare several such viewpoints. Explore 3 other fair value estimates on Janux Therapeutics - why the stock might be worth over 9x more than the current price! Disagree with this assessment? Create your own narrative in under 3 minutes - extraordinary investment returns rarely come from following the herd. A great starting point for your Janux Therapeutics research is our analysis highlighting 1 key reward and 3 important warning signs that could impact your investment decision. Our free Janux Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Janux Therapeutics' overall financial health at a glance. Don't miss your shot at the next 10-bagger. Our latest stock picks just dropped: Find companies with promising cash flow potential yet trading below their fair value. The end of cancer? These 29 emerging AI stocks are developing tech that will allow early identification of life changing diseases like cancer and Alzheimer's. The best AI stocks today may lie beyond giants like Nvidia and Microsoft. Find the next big opportunity with these 26 smaller AI-focused companies with strong growth potential through early-stage innovation in machine learning, automation, and data intelligence that could fund your retirement. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include JANX. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2025-11-07Janux Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights
Business Wire
Janux Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights
Enrollment ongoing for JANX007 and JANX008 Updates on JANX007 and JANX008 expected in the fourth quarter of 2025 $989.0 million in cash, cash equivalents, and short-term investments at end of third quarter 2025 SAN DIEGO, November 06, 2025--(BUSINESS WIRE)--Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, today reported financial results for the third quarter ended September 30, 2025, and provided a business update. "With enrollment ongoing in the JANX007 and JANX008 clinical trials and multiple new drug candidates expected to enter the clinic next year, we remain confident in our ability to advance these programs, supported by a strong balance sheet that enables continued execution," said David Campbell, Ph.D., President and CEO of Janux. RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES: JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449). JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622). Additional data from JANX007 and JANX008 will be presented at future Janux events in the fourth quarter of 2025. THIRD QUARTER 2025 FINANCIAL RESULTS: Cash and cash equivalents and short-term investments: As of September 30, 2025, Janux reported cash and cash equivalents and short-term investments of $989.0 million, compared to $1.03 billion at December 31, 2024. Research and development expenses: Research and development expenses for the quarter ended September 30, 2025 were $34.6 million, compared to $18.6 million for the comparable period in 2024. General and administrative expenses: General and administrative expenses for the quarter ended September 30, 2025 were $10.6 million, compared to $17.7 million for the comparable period in 2024. With respect to the quarter ended September 30, 2024, $9.5 million of the general and administrative expense incurred was due to stock-based compensation expense associated with equity modifications. Net loss: For the quarter ended September 30, 2025, Janux reported a net loss of $24.3 million, compared to a net loss of $28.1 million for t…Read full documentShow less
Enrollment ongoing for JANX007 and JANX008 Updates on JANX007 and JANX008 expected in the fourth quarter of 2025 $989.0 million in cash, cash equivalents, and short-term investments at end of third quarter 2025 SAN DIEGO, November 06, 2025--(BUSINESS WIRE)--Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, today reported financial results for the third quarter ended September 30, 2025, and provided a business update. "With enrollment ongoing in the JANX007 and JANX008 clinical trials and multiple new drug candidates expected to enter the clinic next year, we remain confident in our ability to advance these programs, supported by a strong balance sheet that enables continued execution," said David Campbell, Ph.D., President and CEO of Janux. RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES: JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449). JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622). Additional data from JANX007 and JANX008 will be presented at future Janux events in the fourth quarter of 2025. THIRD QUARTER 2025 FINANCIAL RESULTS: Cash and cash equivalents and short-term investments: As of September 30, 2025, Janux reported cash and cash equivalents and short-term investments of $989.0 million, compared to $1.03 billion at December 31, 2024. Research and development expenses: Research and development expenses for the quarter ended September 30, 2025 were $34.6 million, compared to $18.6 million for the comparable period in 2024. General and administrative expenses: General and administrative expenses for the quarter ended September 30, 2025 were $10.6 million, compared to $17.7 million for the comparable period in 2024. With respect to the quarter ended September 30, 2024, $9.5 million of the general and administrative expense incurred was due to stock-based compensation expense associated with equity modifications. Net loss: For the quarter ended September 30, 2025, Janux reported a net loss of $24.3 million, compared to a net loss of $28.1 million for the comparable period in 2024. Janux’s TRACTr, TRACIr and ARM Pipeline Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials. Janux is also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development. About Janux Therapeutics Janux is 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), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms. 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 carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. 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, and 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 interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations, 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. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. View source version on businesswire.com: https://www.businesswire.com/news/home/20251106163122/en/ Contacts Investors: Andy Meyer Janux Therapeutics [email protected] (202) 215-2579 Media: Jessica Yingling, Ph.D. Little Dog Communications Inc. [email protected] (858) 344-8091
Investor releaseQuarter not tagged2025-08-10Janux Therapeutics First Half 2025 Earnings: US$0.93 loss per share (vs US$0.41 loss in 1H 2024)
Simply Wall St.
Janux Therapeutics First Half 2025 Earnings: US$0.93 loss per share (vs US$0.41 loss in 1H 2024)
Net loss: US$57.4m (loss widened by 177% from 1H 2024). US$0.93 loss per share (further deteriorated from US$0.41 loss in 1H 2024). AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Looking ahead, revenue is forecast to grow 74% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 3.1% from a week ago. We don't want to rain on the parade too much, but we did also find 4 warning signs for Janux Therapeutics (2 are a bit unpleasant!) that you need to be mindful of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-08-08Janux Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights
Business Wire
Janux Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights
R&D Day highlighted TRACTr, TRACIr, and ARM pipeline progress and best-in-class potential of novel bispecific ARM platform for autoimmune diseases Enrollment ongoing for JANX007 and JANX008 Updates on JANX007 and JANX008 expected in the second half of 2025 First patient dosed in lead collaboration program triggers $10 million milestone payment from Merck $996.0 million in cash, cash equivalents, and short-term investments at end of second quarter 2025 SAN DIEGO, August 07, 2025--(BUSINESS WIRE)--Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, today reported financial results for the second quarter ended June 30, 2025, and provided a business update. "The recent expansion of our TRACTr, TRACIr, and ARM development programs displays our ability to enact a strategy that attempts to both maximize the benefit and value of our current clinical programs, including JANX007, while continuing to advance other differentiated candidates in oncology and autoimmune disease," said David Campbell, Ph.D., President and CEO of Janux. "We look forward to additional clinical data from JANX007 and JANX008 expected in the second half of 2025." RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES: R&D Day highlighted pipeline progress and novel bispecific platform in autoimmune disease. In July 2025, Janux management presented multiple product candidates identified from its preclinical pipeline to move towards clinical trials. A PSMA-TRACIr designed to be combined with potentially best-in-treatment asset, JANX007, and provide CD28 co-stimulation to further differentiate depth and durability of patient responses. A TROP2-TRACTr added a first-in-class opportunity targeting multiple solid tumors with preclinical data supporting differentiated safety and efficacy potential. A CD19-ARM displayed rapid, deep and durable B-cell depletion in periphery and tissues with a prolonged memory B cell reset while maintaining a large safety window in non-human primates. JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449). JANX008 continues to enroll in the first-in-human Phase 1…Read full documentShow less
R&D Day highlighted TRACTr, TRACIr, and ARM pipeline progress and best-in-class potential of novel bispecific ARM platform for autoimmune diseases Enrollment ongoing for JANX007 and JANX008 Updates on JANX007 and JANX008 expected in the second half of 2025 First patient dosed in lead collaboration program triggers $10 million milestone payment from Merck $996.0 million in cash, cash equivalents, and short-term investments at end of second quarter 2025 SAN DIEGO, August 07, 2025--(BUSINESS WIRE)--Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, today reported financial results for the second quarter ended June 30, 2025, and provided a business update. "The recent expansion of our TRACTr, TRACIr, and ARM development programs displays our ability to enact a strategy that attempts to both maximize the benefit and value of our current clinical programs, including JANX007, while continuing to advance other differentiated candidates in oncology and autoimmune disease," said David Campbell, Ph.D., President and CEO of Janux. "We look forward to additional clinical data from JANX007 and JANX008 expected in the second half of 2025." RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES: R&D Day highlighted pipeline progress and novel bispecific platform in autoimmune disease. In July 2025, Janux management presented multiple product candidates identified from its preclinical pipeline to move towards clinical trials. A PSMA-TRACIr designed to be combined with potentially best-in-treatment asset, JANX007, and provide CD28 co-stimulation to further differentiate depth and durability of patient responses. A TROP2-TRACTr added a first-in-class opportunity targeting multiple solid tumors with preclinical data supporting differentiated safety and efficacy potential. A CD19-ARM displayed rapid, deep and durable B-cell depletion in periphery and tissues with a prolonged memory B cell reset while maintaining a large safety window in non-human primates. JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449). JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622). Clinical milestone payment of $10 million from Merck recently triggered by first patient dosed in the lead collaboration program under the companies’ 2020 Research Collaboration and Exclusive License Agreement. Additional data from JANX007 and JANX008 will be presented at future Janux events in the second half of 2025. SECOND QUARTER 2025 FINANCIAL RESULTS: Cash and cash equivalents and short-term investments: As of June 30, 2025, Janux reported cash and cash equivalents and short-term investments of $996.0 million, compared to $1.03 billion at December 31, 2024. Research and development expenses: Research and development expenses for the quarter ended June 30, 2025 were $34.7 million, compared to $14.9 million for the comparable period in 2024. General and administrative expenses: General and administrative expenses for the quarter ended June 30, 2025 were $10.5 million, compared to $7.8 million for the comparable period in 2024. Net loss: For the quarter ended June 30, 2025, Janux reported a net loss of $33.9 million, compared to a net loss of $6.0 million for the comparable period in 2024. Janux’s TRACTr, TRACIr and ARM Pipeline Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials. Janux is also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development. About Janux Therapeutics Janux is 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), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms. 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 carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. 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, and 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 interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations, 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. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. View source version on businesswire.com: https://www.businesswire.com/news/home/20250807931875/en/ Contacts Investors: Andy Meyer Janux Therapeutics [email protected] (202) 215-2579 Media: Jessica Yingling, Ph.D. Little Dog Communications Inc. [email protected] (858) 344-8091
Investor releaseQuarter not tagged2025-05-09Janux Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights
Business Wire
Janux Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights
Phase 1b expansion study initiated with JANX007 in taxane-naïve mCRPC patients Updated JANX007 data from Phase 1a dose escalation support initiation of Phase 1b dose expansion Enrollment ongoing for JANX007 and JANX008 Updates on JANX007 and JANX008 expected in the second half of 2025 $1.01 billion in cash, cash equivalents, and short-term investments at end of first quarter 2025 SAN DIEGO, May 08, 2025--(BUSINESS WIRE)--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 first quarter ended March 31, 2025, and provided a business update. "We are proud to advance into the next phase of our clinical journey for JANX007 and begin treating patients in our Phase 1b expansion studies," said David Campbell, Ph.D., President and CEO of Janux. "We also look forward to our first R&D Day where we will unveil previously undisclosed preclinical programs that utilize our expertise and platform technologies to address significant unmet medical needs." RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES: Initiated first Phase 1b expansion study with JANX007 in taxane-naïve mCRPC patients. In December 2024, Janux reported positive interim clinical data from the Phase 1a dose escalation portion of the trial in 16 metastatic castration-resistant prostate cancer (mCRPC) patients with a median of four prior lines of therapy. At that time, the median radiographic progression-free survival (rPFS) reported was 7.4 months for all 16 patients.* As of April 21, 2025, updated results** have been achieved in the same 16 patients supporting the initiation of the Phase 1b expansion studies: Median rPFS of 7.5 months (n=16) Median rPFS of 7.9 months for patients treated at 6mg and 9mg target doses (n=9) 6-month rPFS of 65% (n=16) 6-month rPFS of 78% for patients treated at 6mg and 9mg target doses (n=9) Safety data remained consistent with the December 2024 data disclosure (n=16) *8/16 patients were noted as in-progress in the December 2024 reported results. **rPFS results based upon Kaplan-Meier estimate. Janux selected 0.3/2/6mg and 0.3/2/9mg with dosing administered once weekly or once every two weeks as the two dose…Read full documentShow less
Phase 1b expansion study initiated with JANX007 in taxane-naïve mCRPC patients Updated JANX007 data from Phase 1a dose escalation support initiation of Phase 1b dose expansion Enrollment ongoing for JANX007 and JANX008 Updates on JANX007 and JANX008 expected in the second half of 2025 $1.01 billion in cash, cash equivalents, and short-term investments at end of first quarter 2025 SAN DIEGO, May 08, 2025--(BUSINESS WIRE)--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 first quarter ended March 31, 2025, and provided a business update. "We are proud to advance into the next phase of our clinical journey for JANX007 and begin treating patients in our Phase 1b expansion studies," said David Campbell, Ph.D., President and CEO of Janux. "We also look forward to our first R&D Day where we will unveil previously undisclosed preclinical programs that utilize our expertise and platform technologies to address significant unmet medical needs." RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES: Initiated first Phase 1b expansion study with JANX007 in taxane-naïve mCRPC patients. In December 2024, Janux reported positive interim clinical data from the Phase 1a dose escalation portion of the trial in 16 metastatic castration-resistant prostate cancer (mCRPC) patients with a median of four prior lines of therapy. At that time, the median radiographic progression-free survival (rPFS) reported was 7.4 months for all 16 patients.* As of April 21, 2025, updated results** have been achieved in the same 16 patients supporting the initiation of the Phase 1b expansion studies: Median rPFS of 7.5 months (n=16) Median rPFS of 7.9 months for patients treated at 6mg and 9mg target doses (n=9) 6-month rPFS of 65% (n=16) 6-month rPFS of 78% for patients treated at 6mg and 9mg target doses (n=9) Safety data remained consistent with the December 2024 data disclosure (n=16) *8/16 patients were noted as in-progress in the December 2024 reported results. **rPFS results based upon Kaplan-Meier estimate. Janux selected 0.3/2/6mg and 0.3/2/9mg with dosing administered once weekly or once every two weeks as the two dose regimens for the Phase 1b expansion studies. In addition, Janux has selected a CRS-mitigation strategy to support the initiation of the Phase 1b expansion studies that is designed to reduce the risk of overuse of steroids while maintaining the early cycle grades 1 and 2 CRS profile reported in December. Janux plans to initiate three additional Phase 1b expansion studies with JANX007, evaluating: JANX007 in combination with an androgen receptor inhibitor (ARi) in taxane-experienced, ARi-naïve mCRPC patients JANX007 monotherapy in PARP inhibitor-resistant mCRPC patients JANX007 monotherapy in NHT- and taxane-experienced mCRPC patients designed to support OPTIMUS dose selection for registrational studies JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449). JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622). Additional data from JANX007 and JANX008 will be presented at future Janux events in the second half of 2025. Separately, Janux will host an R&D Day in mid-2025 highlighting product candidates identified from its preclinical pipeline to move into clinical trials. FIRST QUARTER 2025 FINANCIAL RESULTS: Cash and cash equivalents and short-term investments: As of March 31, 2025, Janux reported cash and cash equivalents and short-term investments of $1.01 billion compared to $1.03 billion at December 31, 2024. Research and development expenses: Research and development expenses for the quarter ended March 31, 2025, were $25.1 million compared to $14.1 million for the comparable period in 2024. General and administrative expenses: General and administrative expenses for the quarter ended March 31, 2025, were $9.8 million compared to $7.3 million for the comparable period in 2024. Net loss: For the quarter ended March 31, 2025, Janux reported a net loss of $23.5 million compared to a net loss of $14.8 million for the comparable period in 2024. Janux’s TRACTr and TRACIr Pipeline Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. We are also generating a number of additional TRACTr and TRACIr programs for potential future development, some of which are at development candidate stage or later. We are currently assessing priorities in our preclinical pipeline. 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: TRACTr and 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 carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20250508726966/en/ Contacts Investors: Andy Meyer Janux Therapeutics [email protected] (202) 215-2579 Media: Jessica Yingling, Ph.D. Little Dog Communications Inc. [email protected] (858) 344-8091

