1. BOSTON, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Ikena Oncology, Inc. (NASDAQ:IKNA), a targeted oncology company focused on developing novel cancer therapies targeting key signaling pathways, today announced that management will participate in the virtual Morgan Stanley 19th Annual Global Healthcare Conference taking place on September 9-15, 2021, and the H.C. Wainwright 23rd Annual Global Investment Conference, taking place on September 13-15, 2021.

    Details are as follows:

    Conference: Morgan Stanley 19th Annual Global Healthcare Conference
    Fireside Chat: Friday, September 10, 2021, 10:15am EST; live and available for replay        
    Webcast Link

    Conference: H.C. Wainwright 23rd Annual Global Investment Conference
    Date: Monday, September 13, 2021…

    BOSTON, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Ikena Oncology, Inc. (NASDAQ:IKNA), a targeted oncology company focused on developing novel cancer therapies targeting key signaling pathways, today announced that management will participate in the virtual Morgan Stanley 19th Annual Global Healthcare Conference taking place on September 9-15, 2021, and the H.C. Wainwright 23rd Annual Global Investment Conference, taking place on September 13-15, 2021.

    Details are as follows:

    Conference: Morgan Stanley 19th Annual Global Healthcare Conference

    Fireside Chat: Friday, September 10, 2021, 10:15am EST; live and available for replay        

    Webcast Link

    Conference: H.C. Wainwright 23rd Annual Global Investment Conference

    Date: Monday, September 13, 2021; available for replay        

    Webcast Link

    The presentation webcasts can be accessed by visiting the Investors & Media section of the company's website at www.ikenaoncology.com. The webcast will be archived for a period of 90 days following the conclusion of the live event.

    About Ikena Oncology

    Ikena Oncology is focused on developing novel therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing multiple programs that target tumor markers as well as programs targeting the tumor microenvironment. The Company's lead program, IK-930, is a TEAD inhibitor targeting the Hippo signaling pathway, a pathway that can drive formation and increase survival of tumors and also drives development of resistance to multiple existing therapies. Additional programs include an ERK5 inhibitor program targeting the KRAS signaling pathway and several programs targeting the tumor microenvironment and immune signals, two of which are being developed in collaboration with Bristol Myers Squibb. Ikena's pipeline is built on targeting genetically defined or biomarker-driven cancers and developing therapies that can serve specific patient populations in need of new therapeutic options. To learn more, visit www.ikenaoncology.com or follow us on Twitter and LinkedIn.

    Media Contact:

    Gwen Schanker

    LifeSci Communications

    gschanker@lifescicomms.com



    Investor Contact:

    Rebecca Cohen

    Ikena Oncology

    rcohen@ikenaoncology.com

     



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  2. IK-930 IND on track for submission in 2021; multiple upcoming preclinical and translational conference presentations on TEAD inhibition by IK-930

    Progressing IK-175 clinical trial monotherapy expansion cohort in bladder cancer patients

    Continued progress across targeted oncology pipeline towards research and clinical milestones

    BOSTON, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Ikena Oncology, Inc. (NASDAQ:IKNA, "Ikena"))), a targeted oncology company focused on developing novel cancer therapies targeting key signaling pathways, today announced financial results for the quarter that ended June 30, 2021. The Company also shared updates on several pipeline programs targeting tumor signaling pathways, including Hippo, RAS, and the tumor…

    IK-930 IND on track for submission in 2021; multiple upcoming preclinical and translational conference presentations on TEAD inhibition by IK-930

    Progressing IK-175 clinical trial monotherapy expansion cohort in bladder cancer patients

    Continued progress across targeted oncology pipeline towards research and clinical milestones

    BOSTON, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Ikena Oncology, Inc. (NASDAQ:IKNA, "Ikena"))), a targeted oncology company focused on developing novel cancer therapies targeting key signaling pathways, today announced financial results for the quarter that ended June 30, 2021. The Company also shared updates on several pipeline programs targeting tumor signaling pathways, including Hippo, RAS, and the tumor microenvironment.

    "In recent months, the Ikena team has continued to generate data on the important targets we are exploring and our development candidates. This work has further elucidated the potential of TEAD inhibition as a monotherapy and in combination with other targeted therapies, and enables us to further refine the clinical development strategy for IK-930, our novel TEAD inhibitor," said Mark Manfredi, PhD, Chief Executive Officer of Ikena Oncology. "We look forward to sharing these and more updates as our data matures and we make strides towards our goal to transform the landscape of cancer treatment to a targeted, patient-focused treatment paradigm."

    Ikena is also evaluating our novel AHR antagonist, IK-175, in a Phase I clinical trial as a monotherapy and in combination with nivolumab for the treatment of advanced or metastatic solid tumors, including in urothelial carcinoma, a type of bladder cancer where there is a significant unmet need. After completing the monotherapy dose escalation we are progressing the expansion cohort and enrolling additional urothelial carcinoma patients to continue evaluating IK-175 as a monotherapy and the path towards proof-of-concept in this patient population.

    "The emerging clinical data observed for IK-175 monotherapy in urothelial carcinoma and the expansion of the cohort are great steps toward establishing proof of concept. These patients have very limited options for treatment, and we are hopeful that IK-175 could have significant impact in this setting," said Sergio Santillana, MD, Chief Medical Officer at Ikena. "The monotherapy cohort expansion is an encouraging development for the Ikena team and ultimately for the patients whose cancer could be treated with this novel therapy. We look forward to generating additional data and providing an update on safety and preliminary anti-tumor activity of IK-175 at a medical conference in 2022."  

    Recent Pipeline Progress and Corporate Update

    • IK-930: TEAD Inhibitor in the Hippo Signaling Pathway in IND-enabling Studies
      • IND-enabling studies continued to progress and the IND submission is on track for the end of 2021.
      • Translational and preclinical data will be shared at the EORTC-NCI-AACR 2021 Virtual International Conference on Molecular Targets and Cancer Therapeutics taking place October 7-10, 2021.

        • Virtual Poster Presentation of IK-930 indication selection methodology and data, highlighting a novel method to assess activation across the Hippo pathway and the rationale behind mesothelioma as a cancer type that could benefit from TEAD inhibition as a monotherapy
        • Virtual Poster Presentation of the tumor growth inhibition observed in in vivo preclinical models of lung and colon cancer with IK-930 combined with inhibition of MEK and EGFR, separately and in triplet
    • IK-175:  Clinical Stage AHR Antagonist Partnered with Bristol Myers Squibb (BMS)
      • Ikena is expanding the monotherapy bladder cancer cohort to treat additional patients in the current dose expansion cohort per protocol of the ongoing Phase 1 clinical trial.
      • Translational and preclinical data will be shared at scientific conferences in the second half of 2021.
      • Clinical data presentation planned for a major medical conference in 2022.
    • IK-412: Novel Enzymatic Therapeutic Degrading Kynurenine Partnered with BMS
      • Ikena was notified in the second quarter that a key component required in the manufacturing of IK-412 is also required for the manufacturing of COVID-19 vaccines and therapies. As a result, the availability of the component for purposes other than vaccine production is extremely limited in the near-term.
        • This situation impacted our manufacturing lead times, delaying the planned IND submission for IK-412.
        • Updated guidance on IND submission timing will be provided when material supply of this key component can be reliably projected.
        • We continue to work closely with our supplier and contract manufacturing organization, as well as our partner BMS, to advance the program toward IND submission.
      • IND-enabling studies of IK-412 continue to progress as planned.
    • Additional Pipeline Programs Continue to Progress

    Financial Results for the Quarter Ended June 30, 2021

    As of June 30, 2021, the Company had cash and cash equivalents totaling $264.0 million, which will fund operations through 2023. Net cash used in operations was $15.7 million for the second quarter of 2021 as compared to $7.7 million for the second quarter of 2020.

    Research and development expenses for the second quarter 2021 were $11.4 million, compared to $6.3 million for the second quarter 2020. The increase in R&D expense was primarily related to on-going IND-enabling studies and manufacturing development costs for IK-930, ongoing IND-enabling studies for IK-412, increased research activities of other discovery stage programs and increased personnel expenses due to increase in headcount. The increase in research and development expenses was offset by a decrease in expense attributable to drug manufacturing of IK-175 and a decrease in clinical activities for IK-007.

    General and administrative expenses for the second quarter were $4.9 million, compared to $1.8 million for the second quarter 2020. The increase in G&A expense was primarily related to compensation expense due to an increase in headcount, as well as general increases in audit, legal and consulting expenses to support our operations as a public company.

    Net loss for the second quarter 2021 was $12.7 million, compared to $5.0 million for the second quarter 2020, driven by increases in research and development and general and administrative expenses.

    About Ikena Oncology

    Ikena Oncology is focused on developing novel therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing multiple programs that target tumor markers as well as programs targeting the tumor microenvironment. The Company's lead program, IK-930, is a TEAD inhibitor targeting the Hippo signaling pathway, a pathway that can drive formation and increase survival of tumors and also drives development of resistance to multiple existing therapies. Additional programs include an ERK5 inhibitor program targeting the KRAS signaling pathway and several programs targeting the tumor microenvironment and immune signals, two of which are being developed in collaboration with Bristol Myers Squibb. Ikena's pipeline is built on targeting genetically defined or biomarker-driven cancers and developing therapies that can serve specific patient populations in need of new therapeutic options. To learn more, visit www.ikenaoncology.com or follow us on Twitter and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding: the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; expectations regarding the timing of the expansion of the monotherapy cohort for IK-175; the future availability of key components in the manufacture of IK-412; our expectations regarding delays in our clinical trials, including for IK-412; our expectations regarding the progression of our preclinical studies, including IND-enabling studies for IK-412; our expectations regarding the timing of presentation of preclinical and clinical data; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the implementation of our business model, and strategic plans for our business and product candidates. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to: the timing and advancement of our targeted oncology programs; our ability to demonstrate the therapeutic benefit of our targeted oncology programs; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the implementation of our business model, and strategic plans for our business and product candidates: and other risks identified in our SEC filings, including our Registration Statement on Form S-1, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made and should not be relied on as representing our views as of any subsequent date. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

     
    Condensed Consolidated Balance Sheet Data

    (Unaudited)

    (in thousands)

             
      June 30,

    2021
      December 31,

    2020
     
    Cash and cash equivalents $264,004  $162,491 
    Total assets  278,827   168,404 
    Total liabilities  62,567   63,473 
    Redeemable convertible preferred stock  -   205,979 
    Additional paid-in-capital  349,960   10,288 
    Accumulated deficit  (133,736)  (111,339)
    Total stockholders' equity (deficit)  216,260   (101,048)
             



     
    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)

    (in thousands)

                     
      Three Months Ended June 30,  Six Months Ended June 30, 
      2021  2020  2021  2020 
    Research and development revenue under collaboration agreement $3,549  $3,073  $7,023  $6,300 
    Operating expenses:                
    Research and development  11,374   6,334   21,396   14,226 
    General and administrative  4,862   1,798   8,035   4,308 
    Total operating expenses  16,236   8,132   29,431   18,534 
    Loss from operations  (12,687)  (5,059)  (22,408)  (12,234)
    Other income (expense), net  6   21   11   251 
    Net loss and comprehensive loss $(12,681) $(5,038) $(22,397) $(11,983)
    Net loss per share attributable to common stockholders basic and diluted $(0.35) $(1.89) $(1.12) $(4.51)
    Weighted-average common stocks outstanding, basic and diluted  35,853,341   2,658,800   19,940,204   2,657,283 
                     

    Media Contact:

    Gwen Schanker

    LifeSci Communications

    gschanker@lifescicomms.com

    Investor Contact:

    Rebecca Cohen

    Ikena Oncology

    rcohen@ikenaoncology.com



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  3. BOSTON, July 08, 2021 (GLOBE NEWSWIRE) -- Ikena Oncology, Inc. (NASDAQ:IKNA), a targeted oncology company focused on developing therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced that Dr. Mark Manfredi, CEO of Ikena Oncology, will participate in a panel discussing next-generation approaches to targeted oncology at the upcoming virtual William Blair Biotech Focus Conference.

    Details on the panel webcast can be found below.

            Date: Thursday, July 15, 2021
            Time: 9:00 – 9:45 a.m. ET
            Webcast Link: Register

    The panel will be webcast live and can be accessed by visiting the Investors & Media section of the company's website at www.ikenaoncology.com. The webcast will be…

    BOSTON, July 08, 2021 (GLOBE NEWSWIRE) -- Ikena Oncology, Inc. (NASDAQ:IKNA), a targeted oncology company focused on developing therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced that Dr. Mark Manfredi, CEO of Ikena Oncology, will participate in a panel discussing next-generation approaches to targeted oncology at the upcoming virtual William Blair Biotech Focus Conference.

    Details on the panel webcast can be found below.

            Date: Thursday, July 15, 2021

            Time: 9:00 – 9:45 a.m. ET

            Webcast Link: Register

    The panel will be webcast live and can be accessed by visiting the Investors & Media section of the company's website at www.ikenaoncology.com. The webcast will be archived for a period of 30 days following the conclusion of the live event.

    About Ikena Oncology

    Ikena Oncology is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies: IK-930, a TEAD inhibitor targeting the Hippo signaling pathway; an ERK5 inhibitor program targeting the KRAS signaling pathway; IK-175, an AHR antagonist; IK-412, a kynurenine-degrading enzyme; and IK-007, an EP4 receptor antagonist. Ikena has entered into a global strategic collaboration with Bristol-Myers Squibb Company for its IK-175 and IK-412 programs. To learn more visit www.ikenaoncology.com or follow us on Twitter and LinkedIn.

    Media Contact:

    Gwen Schanker

    LifeSci Communications

    gschanker@lifescicomms.com



    Investor Contact:

    Rebecca Cohen

    Ikena Oncology

    rcohen@ikenaoncology.com



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  4. Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today announced the formation of its Scientific Advisory Board, with the appointment of five leading scientists in the fields of immunology, oncology and protein therapeutics. The initial members of Asher Bio's Scientific Advisory Board are:

    George Georgiou, Ph.D., Professor and member of the faculties of Chemical Engineering, Molecular Biosciences, Biomedical Engineering as well as the Department of Oncology, Dell Medical School, University of Texas at Austin.

    Miriam Merad, M.D., Ph.D., Director of the Precision Immunology Institute at Mount Sinai School of Medicine and Director of the Mount Sinai…

    Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today announced the formation of its Scientific Advisory Board, with the appointment of five leading scientists in the fields of immunology, oncology and protein therapeutics. The initial members of Asher Bio's Scientific Advisory Board are:

    George Georgiou, Ph.D., Professor and member of the faculties of Chemical Engineering, Molecular Biosciences, Biomedical Engineering as well as the Department of Oncology, Dell Medical School, University of Texas at Austin.

    Miriam Merad, M.D., Ph.D., Director of the Precision Immunology Institute at Mount Sinai School of Medicine and Director of the Mount Sinai Human Immune Monitoring Center.

    Robert D. Schreiber, Ph.D., Bursky Distinguished Professor and Interim Head, Immunobiology Division, Department of Pathology and Immunology at Washington University School of Medicine; Director, Bursky Center for Human Immunology and Immunotherapy Programs

    Ton Schumacher, Ph.D., Principal Investigator at The Netherlands Cancer Institute and Oncode Institute and Professor of Immunotechnology at Leiden University.

    Mario Sznol, M.D., Professor of Internal Medicine, Leader of the Melanoma-Renal Cancer Disease-Associated Translational Research Team, and Co-Leader of the Cancer Immunology Program at the Yale Cancer Center.

    "We are excited to welcome these highly accomplished scientists to our Scientific Advisory Board," said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. "Their experience and expertise will complement that of our management team and scientific founders. We look forward to working together to advance our lead program, AB248, into oncology indications and to apply our cis-targeting platform to additional immunomodulators and immune cell types to improve therapeutic outcomes."

    "Asher's approach to targeting the most important immune cells in a wide range of range of diseases holds enormous therapeutic promise," said Dr. Schumacher, who will serve as chair of the SAB. "As a co-founder of Asher and member of the SAB, I see the potential of this entirely new biotherapeutic class we are creating and look forward to the benefit it can bring to patients."

    George Georgiou, Ph.D.

    Dr. Georgiou is the Dula D. Cockrell Centennial Chair Professor at University of Texas at Austin where he serves on the faculties of Chemical Engineering, Molecular Biosciences, Biomedical Engineering and in the Department of Oncology at the Dell Medical School. His research is focused on the discovery/preclinical development of protein therapeutics, the molecular level understanding of the serological antibody repertoire in human health and disease, and engineering second generation therapeutic antibodies. Dr. Georgiou founded GGMJD in 1999 (acquired by Maxygen in 2000), Aeglea Biotherapeutics in 2013 (NASDAQ:AGLE) and Kyn Therapeutics Inc. in 2016 ((renamed Ikena Oncology, NASDAQ:IKNA). He served as Director of Aeglea Biotherapeutics and Ikena Oncology. He is co-inventor on the foundational patents for one approved and four clinical-stage protein therapeutics.

    Miriam Merad, M.D., Ph.D.

    Dr. Merad is the Director of the Precision Immunology Institute at Mount Sinai School of Medicine in New York and founded the Human Immune Monitoring Center at Mount Sinai, one of the world's most sophisticated research centers, which uses cutting-edge single-cell technology to understand the contribution of immune cells to major human diseases or treatment responses. Dr. Merad is a leader in the fields of dendritic cell and macrophage biology. She identified the tissue resident macrophage lineage and established the contribution of this macrophage lineage to cancer progression and inflammatory diseases. Dr. Merad is also known for her work on dendritic cells, a group of cells that control adaptive immunity. She identified a new subset of dendritic cells, which is now considered a key target of antiviral and antitumor immunity.

    Robert Schreiber, Ph.D.

    Dr. Schreiber is the Bursky Distinguished Professor and Interim Head, Immunobiology Division, Department of Pathology and Immunology at Washington University School of Medicine in St. Louis. He is also Director of the Bursky Center for Human Immunology and Immunotherapy Programs, Co-Leader of the Tumor Immunology Program at the Siteman Comprehensive Cancer Center at Washington University, an Extramural Member Researcher of the Parker Institute for Cancer Immunotherapy, an Associate Director of the Scientific Advisory Council of the Cancer Research Institute, and a member of the Board of Scientific Advisors to the National Cancer Institute. Dr. Schreiber has made significant contributions to the understanding of the role of the immune system in controlling and shaping cancer. His work has focused on elucidating the biochemistry and molecular cell biology of cytokines and defining the role they play in promoting immune responses to cancer.

    Ton Schumacher, Ph.D.

    Dr. Schumacher is Principal Investigator at The Netherlands Cancer Institute and Oncode Institute and is Professor of Immunotechnology at Leiden University. In his academic role, he has made seminal contributions to the understanding of how T cells recognize human cancer and the central role of cancer neoantigens in cancer immunotherapies. Dr. Schumacher has been the founder of several biotech companies, including T Cell Factory (acquired by Kite Pharma), Neon Therapeutics (acquired by BioNTech), Neogene Therapeutics, and is a Venture Partner at Third Rock Ventures.

    Mario Sznol, M.D.

    Dr. Sznol is Professor of Internal Medicine, Leader of the Melanoma-Renal Cancer Disease-Associated Translational Research Team, and Co-Leader of the Cancer Immunology Program at the Yale Cancer Center. He spent twelve years in the Biologics Evaluation Section (BES), Investigational Drug Branch (IDB), Cancer Therapy Evaluation Program of the National Cancer Institute, and was Head of the BES from 1994-1999. From 1999-2004, he served as Vice President of Clinical Development and Executive Officer of Vion Pharmaceuticals and joined the faculty at Yale in 2004. Dr. Sznol is a past President of the Society for Immunotherapy of Cancer (SITC).

    About Asher Bio

    Asher Bio is a biotechnology company developing precisely targeted immunotherapies for cancer and other diseases. Our cis-targeting platform aims to enable selective activation of specific immune cell types, addressing the inherent limitations of otherwise pleiotropic immunotherapies that act on multiple cell types. Our approach has the potential to precisely direct different immune mediators against a range of target immune cell-types and create best-in-class immunotherapies in cancer, autoimmune and infectious diseases. Asher Bio is backed by Third Rock Ventures and is located in South San Francisco. For more information, please visit www.asherbio.com and follow us on Twitter @AsherBio and on LinkedIn.

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  5. Ikena Oncology, Inc. (NASDAQ:IKNA), a targeted oncology company focused on developing therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced that management will participate in a fireside chat at the 2021 Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 2:00 p.m. ET.

    The fireside chat will be webcast live and can be accessed by visiting the Investors & Media section of the company's website at www.ikenaoncology.com. The webcast will be archived for a period of 30 days following the conclusion of the live event.

    About Ikena Oncology

    Ikena Oncology is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation…

    Ikena Oncology, Inc. (NASDAQ:IKNA), a targeted oncology company focused on developing therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced that management will participate in a fireside chat at the 2021 Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 2:00 p.m. ET.

    The fireside chat will be webcast live and can be accessed by visiting the Investors & Media section of the company's website at www.ikenaoncology.com. The webcast will be archived for a period of 30 days following the conclusion of the live event.

    About Ikena Oncology

    Ikena Oncology is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies: IK-930, a TEAD inhibitor targeting the Hippo signaling pathway; an ERK5 inhibitor program targeting the KRAS signaling pathway; IK-175, an AHR antagonist; IK-412, a kynurenine-degrading enzyme; and IK-007, an EP4 receptor antagonist. Ikena has entered into a global strategic collaboration with Bristol-Myers Squibb Company for its IK-175 and IK-412 programs. To learn more visit www.ikenaoncology.com or follow us on Twitter and LinkedIn.

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  6. Closed IPO and Raised $144 Million in Gross Proceeds to Fund Targeted Oncology Therapies

    IND Submissions for Lead Targeted Oncology Program, IK-930, and BMS-partnered program, IK-412, Remain on Track for Second Half of 2021

    Ikena Oncology, Inc. (NASDAQ:IKNA), a targeted oncology company focused on developing therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced financial results for the quarter ended March 31, 2021.

    "This first quarter marked important milestones for Ikena, both with our entrance into the public markets and the advances we have made across our pipeline. We continued to progress our clinical development programs and our lead targeted oncology program is on track for an IND…

    Closed IPO and Raised $144 Million in Gross Proceeds to Fund Targeted Oncology Therapies

    IND Submissions for Lead Targeted Oncology Program, IK-930, and BMS-partnered program, IK-412, Remain on Track for Second Half of 2021

    Ikena Oncology, Inc. (NASDAQ:IKNA), a targeted oncology company focused on developing therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced financial results for the quarter ended March 31, 2021.

    "This first quarter marked important milestones for Ikena, both with our entrance into the public markets and the advances we have made across our pipeline. We continued to progress our clinical development programs and our lead targeted oncology program is on track for an IND submission in the second half of the year," said Mark Manfredi, PhD, President & Chief Executive Officer of Ikena. "We are thrilled that through our IPO, we brought in new long-term partners and deepened our relationships with our current investors. The funding, along with a dedicated and passionate team, are propelling us towards our mission of bringing novel targeted cancer therapies to patients."

    Recent Business Highlights and Corporate Update

    Financial and Corporate

    • In March 2021, Ikena completed a successful initial public offering (IPO), raising $143.8 million in aggregate gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, and listed on The Nasdaq Global Market. The IPO followed the closing of a Series B crossover financing of $120 million in gross proceeds in December 2020.
    • In April 2021, Maria Koehler, MD, PhD, current Chief Medical Officer of Repare Therapeutics, Inc. (NASDAQ:RPTX), was appointed to the Ikena Board of Directors. Dr. Koehler is a board-certified hematologist and oncologist with more than 20 years of pharmaceutical and biotech oncology experience in clinical development, including senior roles at Pfizer where she contributed to the strategic direction of the oncology portfolio.

    Development Pipeline

    • IK-930: IND-enabling studies are ongoing for Ikena's lead targeted oncology program, IK-930, a potent, selective and well tolerated oral small molecule TEAD inhibitor in the Hippo signaling pathway. In preclinical studies, IK-930 demonstrated anti-tumor activity in Hippo pathway-driven cancer models and synergy with EGFR inhibition and MEK inhibition.
    • ERK5 Inhibitor: Lead optimization is ongoing for Ikena's ERK5 inhibitor program which is being developed for the treatment of KRAS mutant tumors. Ikena's ERK5 tool molecule inhibitor has shown single agent and synergistic anti-tumor activity with MEK inhibition in preclinical models of KRAS mutant pancreatic cancer and lung adenocarcinoma.
    • IK-175: The ongoing Phase 1b clinical trial with IK-175, Ikena's AHR antagonist, continues to enroll patients in the monotherapy dose expansion arm. In addition, the first patient was recently dosed in the dose escalation combination arm which consists of IK-175 with nivolumab in patients with bladder cancer, including patients with AHR-activated tumors.
    • IK-412: IND-enabling studies are currently ongoing for IK-412, a novel enzymatic therapeutic designed to lower levels of kynurenine, an immunosuppressive metabolite in the tumor microenvironment. IK-412 has demonstrated profound and durable kynurenine depletion in preclinical models.
    • IK-007: The ongoing Phase 1b clinical trial continues to enroll patients with advanced or progressive microsatellite stable colorectal cancer (MSS-CRC) with IK-007 in combination with pembrolizumab. The clinical trial is enriching for patients that have high urinary prostaglandin E metabolite (PGEM) biomarker.

    Milestones and Key Priorities for 2021

    • Complete IND-enabling studies for TEAD inhibitor, IK-930, and submit IND application to FDA during the second half of 2021.
    • Nominate ERK5 inhibitor development candidate and initiate IND-enabling studies in the second half of 2021.
    • Complete IND-enabling studies for kynurenine degrading enzyme, IK-412, and submit IND to FDA during the second half of 2021.
    • Complete enrollment into the Phase 1b study of EP4 antagonist IK-007 in combination with pembrolizumab in patients with advanced or progressive MSS-CRC.

    First Quarter 2021 Financial Results

    As of March 31, 2021, the Company had cash and cash equivalents totaling $281.0 million, which will fund operations through 2023. Net cash used in operations was $13.2 million for the first quarter of 2021 compared to $9.9 million for the first quarter of 2020.

    Research and development expenses for the first quarter 2021 were $10.0 million, compared to $7.9 million for the first quarter 2020. The increase in R&D expense was primarily related to on-going IND-enabling studies and manufacturing development costs for IK-930, on-going IND-enabling studies and manufacturing development costs for IK-142, increased research activities of other discovery stage programs and increased personnel expenses due to increase in headcount.

    General and administrative expenses for the first quarter were $3.2 million, compared to $2.5 million for the first quarter 2020. The increase in G&A expense were primarily related to compensation expense due to an increase in headcount, as well as general increases in audit, legal and consulting expenses to support our transition to becoming a public company.

    Net loss for the first quarter 2021 was $9.7 million, compared to $6.9 million for the first quarter 2020, driven predominantly by increase in research and development expenses.

    About Ikena Oncology

    Ikena Oncology is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies: IK-930, a TEAD inhibitor targeting the Hippo signaling pathway; an ERK5 inhibitor program targeting the KRAS signaling pathway; IK-175, an AHR antagonist; IK-412, a kynurenine-degrading enzyme; and IK-007, an EP4 receptor antagonist. Ikena has entered into a global strategic collaboration with Bristol-Myers Squibb Company for its IK-175 and IK-412 programs. To learn more visit www.ikenaoncology.com or follow us on Twitter and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; expectations regarding our new director; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the implementation of our business model, and strategic plans for our business and product candidates. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; expectations regarding our new director; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the implementation of our business model, and strategic plans for our business and product candidates, and other risks identified in our SEC filings, including our Registration Statement on Form S-1, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

    Condensed Consolidated Balance Sheet Data

    (Unaudited)

    (in thousands)

     

    March 31,

    2021

    December 31,

    2020

    Cash and cash equivalents

    $

    281,010

    $

    162,491

    Total assets

     

    293,662

     

    168,404

    Total liabilities

     

    66,018

     

    63,473

    Redeemable convertible preferred stock

     

    -

     

    205,979

    Additional paid-in-capital

     

    348,663

     

    10,288

    Accumulated deficit

     

    (121,055)

     

    (111,339)

    Total stockholders' equity (deficit)

     

    227,644

     

    (101,048)

    Condensed Consolidated Balance Sheets

    (Unaudited)

    (in thousands)

     

    Three Months Ended March 31,

    2021

    2020

    Research and development revenue under collaboration agreement

    $

    3,474

    $

    3,227

    Operating expenses:

    Research and development

     

    10,021

     

    7,893

    General and administrative

     

    3,173

     

    2,510

    Total operating expenses

     

    13,194

     

    10,403

    Loss from operations

     

    (9,720)

     

    (7,176)

    Other income

     

    4

     

    231

    Net loss and comprehensive loss

    $

    (9,716)

    $

    (6,945)

    Net loss per share attributable to common stockholders basic and diluted

    $

    (2.52)

    $

    (2.62)

    Weighted-average common stocks outstanding, basic and diluted

     

    3,850,264

     

    2,655,767

     

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  7. Ikena Oncology, Inc. (NASDAQ:IKNA) ("Ikena"), a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced the appointment of Maria Koehler, M.D., Ph.D. to its Board of Directors. Dr. Koehler is a board-certified hematologist and oncologist with more than 20 years of pharmaceutical and biotech oncology experience in clinical development, including senior roles at Pfizer where she led the development of Ibrance® (palbociclib) and contributed to the strategic direction of the oncology portfolio.

    "We are extremely pleased to welcome Maria to our Board of Directors at this important next stage of Ikena's evolution," said Mark Manfredi, President…

    Ikena Oncology, Inc. (NASDAQ:IKNA) ("Ikena"), a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced the appointment of Maria Koehler, M.D., Ph.D. to its Board of Directors. Dr. Koehler is a board-certified hematologist and oncologist with more than 20 years of pharmaceutical and biotech oncology experience in clinical development, including senior roles at Pfizer where she led the development of Ibrance® (palbociclib) and contributed to the strategic direction of the oncology portfolio.

    "We are extremely pleased to welcome Maria to our Board of Directors at this important next stage of Ikena's evolution," said Mark Manfredi, President & Chief Executive Officer of Ikena. "Maria is a highly accomplished biopharmaceutical veteran. During her distinguished career, she has led the development of numerous oncology drugs from early- to late-stage clinical investigation, through to commercialization. Her leadership and strategic expertise will be invaluable as we advance IK-930, our lead targeted oncology candidate, into clinical development, followed thereafter by our other pipeline programs targeting cancers with high unmet need."

    "It is a privilege to join Ikena's Board of Directors during such an exciting period of growth following the Company's recent IPO, and as Ikena advances IK-930 towards clinical development during the second half of 2021," said Dr. Koehler. "I look forward to working alongside Ikena's current Board members and executive management to advance Ikena's innovative drug candidates through clinical development and toward commercialization where they can truly benefit patients."

    Dr. Koehler brings deep experience in both early drug development and bringing new drugs to global markets, having developed strategies for product candidates at all stages of development. Dr. Koehler currently serves as the Chief Medical Officer at Repare Therapeutics (NASDAQ:RPTX), where she leads clinical strategy and oversees all operations. Dr. Koehler joined Repare from Bicycle Therapeutics (NASDAQ:BCYC) where she was Chief Medical Officer. Prior to Bicycle, she was Vice President of Strategy, Innovation and Collaborations for the Oncology Business Unit at Pfizer. Prior to Pfizer, she served in leadership roles at GlaxoSmithKline and at AstraZeneca. She is board certified in hematology and oncology. She began her career as a practicing physician and served as the clinical director of Bone Marrow Transplantation at University Hospital in Pittsburgh as well as the director of the Bone Marrow Transplant Program and associate professor at St. Christopher's Hospital in Philadelphia. Dr. Koehler received her M.D. and Ph.D. from the Silesian Medical School in Poland and has co-authored over 150 publications, book chapters, and patents.

    About Ikena Oncology

    Ikena Oncology is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies: IK-930, a TEAD inhibitor targeting the Hippo signaling pathway; an ERK5 inhibitor program targeting the KRAS signaling pathway; IK-175, an AHR antagonist; IK-412, a kynurenine-degrading enzyme; and IK-007, an EP4 receptor antagonist. Ikena has entered into a global strategic collaboration with Bristol-Myers Squibb Company for its IK-175 and IK-412 programs. To learn more visit www.ikenaoncology.com or follow us on Twitter and LinkedIn.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; expectations regarding our new director; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the implementation of our business model, and strategic plans for our business and product candidates. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; expectations regarding our new director; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the implementation of our business model, and strategic plans for our business and product candidates, and other risks identified in our SEC filings, including our Registration Statement on Form S-1, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

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  8. Ikena Oncology, Inc. (NASDAQ:IKNA) ("Ikena"), a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced the closing of its initial public offering of 8,984,375 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,171,875 additional shares of common stock, at a public offering price of $16.00 per share. The aggregate gross proceeds to Ikena from the offering were approximately $143.8 million, before deducting underwriting discounts and commissions and other offering expenses.

    Jefferies, Cowen, Credit Suisse and William Blair acted as joint book-running managers for the offering.

    The…

    Ikena Oncology, Inc. (NASDAQ:IKNA) ("Ikena"), a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced the closing of its initial public offering of 8,984,375 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,171,875 additional shares of common stock, at a public offering price of $16.00 per share. The aggregate gross proceeds to Ikena from the offering were approximately $143.8 million, before deducting underwriting discounts and commissions and other offering expenses.

    Jefferies, Cowen, Credit Suisse and William Blair acted as joint book-running managers for the offering.

    The registration statement relating to these securities has been filed with the Securities and Exchange Commission ("SEC") and became effective on March 25, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@Jefferies.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at usa.prospectus@credit-suisse.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at prospectus@williamblair.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Ikena Oncology

    Ikena Oncology is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies: IK-930, a TEAD inhibitor targeting the Hippo signaling pathway; an ERK5 inhibitor program targeting the KRAS signaling pathway; IK-175, an AHR antagonist; IK-412, a kynurenine-degrading enzyme; and IK-007, an EP4 receptor antagonist. Ikena has entered into a global strategic collaboration with Bristol-Myers Squibb Company for its IK-175 and IK-412 programs.

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  9. Ikena Oncology, Inc. ("Ikena"), a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced the pricing of its initial public offering of 7,812,500 shares of common stock at a public offering price of $16.00 per share. The shares are expected to begin trading on the Nasdaq Global Market on March 26, 2021 under the ticker symbol "IKNA." The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Ikena, are expected to be $125.0 million. The offering is expected to close on March 30, 2021, subject to the satisfaction of customary closing conditions. In addition, Ikena has…

    Ikena Oncology, Inc. ("Ikena"), a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced the pricing of its initial public offering of 7,812,500 shares of common stock at a public offering price of $16.00 per share. The shares are expected to begin trading on the Nasdaq Global Market on March 26, 2021 under the ticker symbol "IKNA." The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Ikena, are expected to be $125.0 million. The offering is expected to close on March 30, 2021, subject to the satisfaction of customary closing conditions. In addition, Ikena has granted the underwriters a 30-day option to purchase up to an additional 1,171,875 shares of common stock at the initial public offering price.

    Jefferies, Cowen, Credit Suisse and William Blair are acting as joint book-running managers for the offering.

    The registration statement relating to these securities became effective on March 25, 2021. The offering will be made only by means of a prospectus, copies of which may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@Jefferies.com; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at usa.prospectus@credit-suisse.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at prospectus@williamblair.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Ikena Oncology

    Ikena Oncology is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies: IK-930, a TEAD inhibitor targeting the Hippo signaling pathway; an ERK5 inhibitor program targeting the KRAS signaling pathway; IK-175, an AHR antagonist; IK-412, a kynurenine-degrading enzyme; and IK-007, an EP4 receptor antagonist. Ikena has entered into a global strategic collaboration with Bristol-Myers Squibb Company for its IK-175 and IK-412 programs.

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