Latest news with #TRACTr
Business Wire
15-05-2025
- Business
- Business Wire
Janux Therapeutics Appoints Janeen Doyle as Chief Corporate and Business Development Officer
SAN DIEGO--(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 announced the appointment of Janeen Doyle, MBA, as Chief Corporate and Business Development Officer. 'Janeen's unique blend of corporate development, strategic execution, and clinical insight makes her an ideal leader to help drive the next phase of growth at Janux,' said David Campbell, Ph.D., President and CEO of Janux. 'Her proven track record of building value through transformational partnerships and her ability to integrate business and science will be instrumental as we continue advancing our pipeline of tumor-activated therapeutics.' 'I'm thrilled to join Janux at such an exciting time as the company expands its clinical programs and continues to advance its pipeline,' said Ms. Doyle. 'The company's innovative TRACTr and TRACIr platforms and its commitment to delivering safer, more effective therapies to cancer patients present tremendous opportunities. I look forward to working with the team to shape and execute the company's corporate and business development strategy.' Ms. Doyle brings more than 24 years of broad and strategic experience spanning large pharmaceutical companies, mid-sized biotech, and high-growth venture-backed enterprises. She joins Janux from Flagship Pioneering, a life sciences-focused venture capital firm, where she served as a Senior Partner and Senior Vice President of Corporate Partnerships and Program Development. At Flagship, she was responsible for strategy and execution of collaborations between Flagship's portfolio companies and global pharmaceutical and technology partners. Prior to Flagship, Ms. Doyle spent over 15 years at Bristol Myers Squibb and Celgene in a breadth of cross-functional positions of increasing responsibility, starting in areas of medical affairs and program leadership, and most recently serving as Senior Vice President of Strategy & Business Development. In that role, she oversaw a portfolio of 300+ strategic collaborations and a broad equity investing portfolio, including serving as a board observer across investments. Her leadership encompassed partnerships from discovery through commercialization across multiple therapeutic areas. Previous to this, she held roles in clinical science and operations. 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 metastatic castration-resistant prostate cancer (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 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, and 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 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.
Business Wire
05-05-2025
- Business
- Business Wire
Janux Therapeutics Initiates Phase 1b Expansion Studies with JANX007 in Patients with Prostate Cancer and Provides Program Updates
SAN DIEGO--(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 announced the initiation of Phase 1b expansion studies in the ongoing ENGAGER-PSMA-01 trial. ENGAGER-PSMA-01 is a first-in-human, open-label, multicenter Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX007 administered as monotherapy or in combination in adult patients with advanced metastatic castration-resistant prostate cancer (mCRPC). In December 2024, Janux reported positive interim clinical data from the Phase 1a dose escalation portion of the trial in 16 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. In addition, Janux has selected a CRS-mitigation strategy to support the initiation of the Phase 1b expansion studies that is designed to maintain the CRS profile reported in December. The first Phase 1b expansion study will enroll taxane-naïve mCRPC patients and is designed to generate additional safety and efficacy data in this first and second line (1L/2L) patient population. This study will assess JANX007 monotherapy at two dose regimens (0.3/2/6mg and 0.3/2/9mg) with dosing administered once weekly or once every two weeks in mCRPC patients who have progressed on or after novel hormonal therapy (NHT). 'Initiation of the taxane-naïve study marks an important step as we begin to evaluate JANX007 in earlier-line mCRPC patient populations,' said Zachariah McIver, D.O., Ph.D., Chief Medical Officer of Janux. 'While therapeutic options for mCRPC have expanded, there remains a significant need for novel, non-chemotherapeutic approaches.' Janux plans to initiate three additional Phase 1b expansion studies, evaluating: JANX007 in combination with an androgen receptor inhibitor in taxane-experienced 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 'Improved efficacy and durability of responses has been observed by other prostate cancer drugs and TCEs when moving into earlier lines of therapy. There are also indications that safety with TCEs improve in earlier lines of therapy where disease burden is lower. We believe that these observations, coupled with the data seen in our Phase 1a dose escalation in later line patients, strongly support our decision to develop JANX007 in earlier lines of therapy,' said David Campbell, Ph.D., President and CEO of Janux. 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. 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 metastatic castration-resistant prostate cancer. 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 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, the timing of future data releases, and expectations regarding the use of Janux's platform technologies to generate novel product candidates. 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, the risks related to geopolitical events, including international tariffs, global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to Janux's business operations and development activities, 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 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.
Yahoo
14-03-2025
- Business
- Yahoo
Biotech Alert: Searches spiking for these stocks today
These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include: Easily identify stocks' risks and opportunities. Discover stocks' market position with detailed competitor analyses. Arvinas (ARVN), 924% surge in interest Janux Therapeutics (JANX), 479% surge in interest Fortress Biotech (FBIO), 440% surge in interest Dogwood Therapeutics (DWTX), 248% surge in interest Hepion Pharmaceuticals (HEPA), 219% surge in interest Tenaya Therapeutics (TNYA), 209% surge in interest Coherus BioSciences (CHRS), 185% surge in interest Aligos Therapeutics (ALGS), 165% surge in interest Beam Therapeutics (BEAM), 131% surge in interest NKGen Biotech (NKGN), 130% surge in interest Pipeline and key clinical candidates for these companies: Arvinas is a clinical-stage biotechnology company that says it is 'dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins.' In addition to its preclinical pipeline of PROTAC protein degraders against validated and 'undruggable' targets, the company has four investigational clinical-stage programs: vepdegestrant for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-766 and bavdegalutamide for the treatment of men with metastatic castration-resistant prostate cancer; and ARV-102 for the treatment of patients with neurodegenerative disorders. 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. Fortress Biotech is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has nine marketed prescription pharmaceutical products and over 30 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy. Dogwood Therapeutics is a development-stage biopharmaceutical company focused on developing new medicines to treat pain and fatigue-related disorders. The Dogwood research pipeline includes two separate mechanistic platforms with a non-opioid analgesic program and an antiviral program. The proprietary non-opioid, Nav 1.7 analgesic program is centered on our lead development candidate, Halneuron which is a highly specific voltage-gated sodium channel modulator, a mechanism known to be effective for reducing pain transmission. The antiviral program includes IMC-1 and IMC-2, which are novel, proprietary, fixed dose combinations of anti-herpes antivirals and the anti-inflammatory agent, celecoxib. These combination antiviral approaches are being applied to the treatment of illnesses believed to be related to reactivation of previously dormant herpesviruses, including fibromyalgia and Long-COVID. Hepion Pharmaceuticals is a clinical stage biopharmaceutical company that has been developing a treatment for non-alcoholic steatohepatitis, hepatocellular carcinoma, and other chronic liver diseases. Hepion's lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models and is currently in Phase 2 clinical development for the treatment of NASH. Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya employs a suite of integrated internal capabilities, including modality agnostic target validation, capsid engineering and manufacturing, to generate a portfolio of genetic medicines aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. Tenaya's pipeline includes TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy, TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy, TN-301, a small molecule HDAC6 inhibitor intended for heart failure with preserved ejection fraction, and multiple early-stage programs in preclinical development. Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of immunotherapies to treat cancer. Coherus' immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Aligos Therapeutics is a clinical stage biotechnology company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for high unmet medical needs such as chronic hepatitis B virus infection, metabolic dysfunction-associated steatohepatitis, and coronaviruses. Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. Recent news on these stocks: March 12 Dogwood Therapeutics entered into a securities purchase agreement with certain institutional investors to purchase 578,950 shares of common stock at an offering price of $8.26 per share, in a registered direct offering priced at-the-market under Nasdaq rules. The gross proceeds for the offering are expected to be approximately $4.8M before deducting placement agent fees and other offering expenses. This offering is expected to close on March 14, 2025, subject to customary closing conditions. Dogwood intends to use the net proceeds of this offering to further advance the clinical development of its lead development candidate, Halneuron, and for working capital and general corporate purposes. Maxim Group is acting as sole placement agent in connection with the offering. March 11 Arvinas and Pfizer (PFE) announced topline results from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative dvanced or metastatic breast cancer whose disease progressed following prior treatment with cyclin-dependent kinase 4/6 inhibitors and endocrine therapy. These are the first pivotal data for vepdegestrant, a potential first-in-class investigational oral PROteolysis TArgeting Chimera ER degrader. The trial met its primary endpoint in the estrogen receptor 1-mutant population, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared to fulvestrant. The results exceeded the pre-specified target hazard ratio of 0.60 in the ESR1m population. The trial did not reach statistical significance in improvement in PFS in the intent-to-treat population. Overall survival was not mature at the time of the analysis, with less than a quarter of the required number of events having occurred. The trial will continue to assess overall survival as a key secondary endpoint. In the trial, vepdegestrant was generally well tolerated and its safety profile was consistent with what has been observed in previous studies. March 10 Checkpoint Therapeutics and Sun Pharmaceutical Industries announced on March 9 that they have entered into an agreement by which Sun Pharma will acquire the immunotherapy and targeted oncology company. Upon completion of the transaction, Sun Pharma will acquire all outstanding shares of Checkpoint and Checkpoint stockholders will receive, for each share of common stock they hold, an upfront cash payment of $4.10, without interest, and a non-transferable contingent value right, or CVR, entitling the stockholder to receive up to an additional 70c in cash, without interest, if cosibelimab is approved prior to certain deadlines in the European Union pursuant to the centralized approval procedure or in Germany, France, Italy, Spain or the United Kingdom, subject to the terms and conditions in the contingent value rights agreement. Tenaya reported better-than-expected Q4 earnings per share. 'Throughout 2024, Tenaya made important advances across our cardiovascular gene therapy development pipeline that have positioned us for a data-rich 2025. We look forward to sharing data from both the TN-201 MyPEAK-1 clinical trial for MYBPC3-associated HCM and the RIDGE-1 clinical trial of TN-401 for PKP2-associated ARVC in the months ahead,' said Faraz Ali, Chief Executive Officer of Tenaya. 'The recent financing with support from existing and new shareholders allows us to maintain our focus on driving our gene therapy programs for cardiomyopathies toward later-stage development. In the first half of next year, we expect to have greater than one-year of follow-up in the high-dose cohort of MyPEAK-1, as well as one-year follow-up for the first few patients enrolled in the RIDGE-1 clinical trial.' Coherus Biosciences reportetd mixed Q4 results and announced it would reduce its headcount by 30%. The company said, 'Coherus projects post-UDENYCA-close cash of approximately $250 million and cash runway projections exceeding two years, past key data readouts expected in 2026. Approximately 50 employees associated with UDENYCA are expected to transfer to Accord BioPharma, Inc. as part of the asset purchase agreement and Coherus' headcount will be reduced by approximately 30% following the transaction to approximately 155.' Aligos reported a year-over-year decline in Q4 earnings per share, thtough revenue was higher year-over-year. '2024 was a pivotal year for the company, paving the way for the future of Aligos,' stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. 'That future looks bright as we move ALG-000184 closer towards a Phase 2 clinical study, which is expected to begin in mid-2025. We continue to believe our CAM-E has the potential to be a first- and best-in-class candidate, by acting as a disease modifying agent for patients in need of better outcomes. Our recent fundraising is backed by investors supportive of our vision for ALG-000184, which has the potential to replace standard of care and become the backbone of treatment for next-generation therapies for chronic hepatitis B virus infection.' Beam Therapeutics announced initial safety and efficacy data from its Phase 1/2 trial of BEAM-302, establishing clinical proof-of-concept as a potential treatment for alpha-1 antitrypsin deficiency and for in vivo base editing. Preliminary results from the first three single-ascending dose cohorts demonstrated that BEAM-302 was well tolerated, with single doses of BEAM-302 leading to durable dose-dependent correction of the disease-causing mutation. Treatment with BEAM-302 was well tolerated with an acceptable safety profile at all dose levels explored to date. All adverse events were mild to moderate, with no serious AEs reported and no dose-limiting toxicities as of the data cutoff. Grade 1 asymptomatic alanine transaminase and aspartate aminotransferase elevations and transient Grade 1 infusion-related reactions were observed in some patients and did not require treatment. Following a single infusion of BEAM-302, rapid, durable, and dose-dependent increases in total AAT, new production of corrected M-AAT, and decreases in mutant Z-AAT were observed in circulation. Changes in total AAT were observed by turbidimetry assays as early as Day 7, plateaued around Day 21 and were maintained for the duration of follow-up. Increased total AAT was functional as determined by both neutrophil elastase inhibition and neutrophil elastase binding assays. Hear more from InvestingChannel by signing up for The Spill. About 'Biotech Alert' The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel. This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 20-plus million retail and financial professional investors through InvestingChannel's online financial news media ecosystem. This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on PFE: Questions or Comments about the article? Write to editor@ Arvinas price target lowered to $12 from $48 at Morgan Stanley ViiV announces new study data showing zero HIV cases with Apretude ViiV Healthcare announces data from EMBRACE Phase IIb study Arvinas, Pfizer announce VERITAC-2 achieved primary endpoint in Phase 3 trial Pfizer, Walmart, Super Micro, Salesforce, AbbVie: Insider Moves Unveiled! Sign in to access your portfolio
Yahoo
27-02-2025
- Business
- Yahoo
Janux Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights
Recently presented positive Phase 1 clinical trial data for PSMA-TRACTr JANX007 in mCRPC Enrollment ongoing for JANX007 and JANX008 Update on JANX007 and JANX008 data is anticipated in 2025 R&D Day is anticipated in 2025 to disclose new programs moving toward the clinic $1.03 billion in year-end cash, cash equivalents, and short-term investments SAN DIEGO, February 27, 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 fourth quarter and full year ended December 31, 2024, and provided a business update. "2024 was an exceptional year for Janux as we displayed the potential power of our TRACTr platform in the clinic. We believe the data recently presented from JANX007 demonstrated substantial clinical activity in late line mCRPC patients, supporting our future clinical development plans directed at earlier line patients. With our substantial cash runway, we feel well-positioned to execute on our clinical plans, as well as bring new programs towards the clinic that could provide substantial value to both Janux, and more importantly, the patients we serve," said David Campbell, Ph.D., President and CEO of Janux. RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES: Presented positive updated interim Phase 1 clinical trial data for PSMA-TRACTr JANX007 in prostate cancer in December 2024. As of the November 15, 2024, data cutoff in 16 patients JANX007 displayed: High prostate-specific antigen (PSA) response rates: 100% achieved best PSA50 declines. Deep PSA declines: 63% achieved best PSA90 declines; 31% achieved best PSA99 declines. Durable PSA declines maintained at ≥ 12 weeks: 75% maintained PSA 50 declines; 50% maintained PSA90 declines. Encouraging anti-tumor activity: 50% ORR (4/8) and 63% DCR (5/8) (including confirmed and unconfirmed). Well-tolerated safety profile: CRS and TRAEs primarily limited to cycle 1 and lower grades. Gross proceeds of approximately $402.5 million (before deducting underwriting discounts and commissions and other estimated offering expenses) raised in an underwritten offering of common stock and pre-funded warrants in December 2024. Janux to host R&D Day in 2025. Janux plans to provide an update on pipeline programs selected for clinical development. 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). Zachariah McIver, D.O., Ph.D. promoted to Chief Medical Officer. Dr. McIver has been instrumental in executing on Janux's clinical programs. Dr. McIver continues to lead cross-functional teams in the design, implementation, and execution of clinical and correlative study strategies. An accomplished physician-scientist with over 15-years of experience in clinical research, Dr. McIver joined Janux after serving as Amgen's Executive Medical Director for over 4 years. An update on JANX007 and JANX008 data is anticipated in 2025. Janux will also be hosting an R&D Day in 2025. FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS: Cash and cash equivalents and short-term investments: As of December 31, 2024, Janux reported cash and cash equivalents and short-term investments of $1.03 billion compared to $344.0 million at December 31, 2023. Research and development expenses: Research and development expenses were $20.8 million for the quarter and $68.4 million for the year ended December 31, 2024, compared to $12.2 million and $54.9 million for the same quarter and year in 2023. General and administrative expenses: General and administrative expenses were $8.2 million for the quarter and $41.0 million for the year ended December 31, 2024, compared to $6.4 million and $26.1 million for the same quarter and year in 2023. Net loss: Net loss was $20.2 million for the quarter and $69.0 million for the year ended December 31, 2024, compared to $11.8 million and $58.3 million for the same quarter and year in 2023. 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 metastatic castration-resistant prostate cancer (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 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 Such forward-looking statements are current only as of the date they are made, and Janux assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Janux Therapeutics, Balance Sheets(in thousands) December 31, Assets 2024 2023 Current assets: Cash and cash equivalents $ 430,605 $ 19,205 Short-term investments 594,568 324,823 Prepaid expenses and other current assets 8,493 5,213 Total current assets 1,033,666 349,241 Restricted cash 816 816 Property and equipment, net 4,864 7,003 Operating lease right-of-use assets 19,286 20,838 Other long-term assets 2,884 2,509 Total assets $ 1,061,516 $ 380,407 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 4,026 $ 2,424 Accrued expenses 11,684 7,387 Current portion of deferred revenue — 1,705 Current portion of operating lease liabilities 1,749 1,517 Total current liabilities 17,459 13,033 Operating lease liabilities, net of current portion 21,276 23,025 Total liabilities 38,735 36,058 Total stockholders' equity 1,022,781 344,349 Total liabilities and stockholders' equity $ 1,061,516 $ 380,407 Janux Therapeutics, Statements of Operations and Comprehensive Loss(in thousands, except share and per share data) Three Months EndedDecember 31, Year EndedDecember 31, 2024 2023 2024 2023 Collaboration revenue $ — $ 2,461 $ 10,588 $ 8,083 Operating expenses: Research and development 20,806 12,241 68,388 54,922 General and administrative 8,216 6,357 41,047 26,140 Total operating expenses 29,022 18,598 109,435 81,062 Loss from operations (29,022 ) (16,137 ) (98,847 ) (72,979 ) Total other income 8,806 4,379 29,853 14,686 Net loss $ (20,216 ) $ (11,758 ) $ (68,994 ) $ (58,293 ) Other comprehensive gain (loss): Unrealized gain (loss) on available-for-sale securities, net (5,668 ) 1,840 1,498 2,200 Comprehensive loss $ (25,884 ) $ (9,918 ) $ (67,496 ) $ (56,093 ) Net loss per common share, basic and diluted $ (0.36 ) $ (0.25 ) $ (1.28 ) $ (1.32 ) Weighted-average shares of common stock outstanding, basic and diluted 56,832,374 46,683,613 53,751,480 44,016,283 View source version on Contacts Investors: Andy MeyerJanux Therapeuticsameyer@ (202) 215-2579 Media: Jessica Yingling, Dog Communications (858) 344-8091 Sign in to access your portfolio
