1. CAMBRIDGE, Mass., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan") today announced its participation in the following upcoming investor conferences:

    • Morgan Stanley 19th Annual Global Healthcare Conference taking place Thursday, September 9th through Wednesday, September 15th
      • Cullinan's CEO, Owen Hughes, will participate in a virtual fireside chat on Monday, September 13th, at 12:30pm ET, and will provide a corporate update at 4:15pm ET
    • H.C. Wainwright 23rd Annual Global Investment Conference on Monday, September 13th through Wednesday, September 15th
      • Cullinan's Chief Development Officer of Biologics, Jennifer Michaelson, will participate in a panel discussion titled "Engineered Cytokines: The Next Big Wave…

    CAMBRIDGE, Mass., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan") today announced its participation in the following upcoming investor conferences:

    • Morgan Stanley 19th Annual Global Healthcare Conference taking place Thursday, September 9th through Wednesday, September 15th
      • Cullinan's CEO, Owen Hughes, will participate in a virtual fireside chat on Monday, September 13th, at 12:30pm ET, and will provide a corporate update at 4:15pm ET
    • H.C. Wainwright 23rd Annual Global Investment Conference on Monday, September 13th through Wednesday, September 15th
      • Cullinan's Chief Development Officer of Biologics, Jennifer Michaelson, will participate in a panel discussion titled "Engineered Cytokines: The Next Big Wave in Immuno-oncology", which will be broadcast to conference participants on Tuesday, September 14th, from 1:30 – 3:00pm ET

    Members of Cullinan's management will be presenting virtually at each conference, as well as participating in one-on-one investor meetings. Please visit the investor section of Cullinan's website at www.investors.cullinanoncology.com for more information.

    About Cullinan Oncology

    Cullinan Oncology is a biopharmaceutical company that strives to deliver results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We seek to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes. Learn more about Cullinan at www.cullinanoncology.com.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeff Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com

     



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  2. Follow-up Cullinan Pearl data from Phase 1 portion of ongoing trial showed increased disease control rate (DCR) of 92% in the 100mg dose cohort

    IND clearance of two immuno-oncology pipeline programs, Cullinan MICA and Cullinan Florentine, with clinical trial starts for each program expected in 2H 2021

    Strong balance sheet with cash and investments of $456.3 million as of June 30, 2021

    CAMBRIDGE, Mass., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced its financial results for the second quarter ended June 30, 2021 and reported on recent business highlights.

    "Solid execution led to the advancement…

    Follow-up Cullinan Pearl data from Phase 1 portion of ongoing trial showed increased disease control rate (DCR) of 92% in the 100mg dose cohort

    IND clearance of two immuno-oncology pipeline programs, Cullinan MICA and Cullinan Florentine, with clinical trial starts for each program expected in 2H 2021

    Strong balance sheet with cash and investments of $456.3 million as of June 30, 2021

    CAMBRIDGE, Mass., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced its financial results for the second quarter ended June 30, 2021 and reported on recent business highlights.

    "Solid execution led to the advancement of our clinical pipeline this quarter," stated Owen Hughes, Chief Executive Officer of Cullinan Oncology. "We are pleased with the encouraging results of Cullinan Pearl (EGFR exon 20) showcased at ASCO as well as the recent IND clearance for the first two programs in our immuno-oncology pipeline, Cullinan MICA (MICA/B antibody) and Cullinan Florentine (FLT3 bispecific). With over $456 million of cash and investments on hand, we remain well capitalized to advance our broad pipeline through multiple clinical readouts. In the near term, we expect to provide updated preclinical data on Cullinan Amber at the Next-Gen Cytokine Therapeutics Summit in September as well as a Cullinan Pearl clinical and regulatory update in the fourth quarter."

    Q2 2021 Portfolio Highlights

    • Cullinan Pearl: Presented interim data at ASCO 2021 from ongoing Phase 1/2a trial evaluating CLN-081 in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 mutations (press release).
      • Safety: CLN-081 continues to demonstrate promising overall safety and tolerability, with an encouraging GI toxicity profile.
      • Efficacy: As of the ASCO data cutoff, there were 5 pending partial responses (PR), 4 of which subsequently confirmed. In addition, follow-up data from patients in the 100mg Phase 1 cohort showed the DCR, defined as best response of PR + stable disease ≥6 months, increased to 92% (12 / 13 patients).
      • Phase 1/2a trial status: Cullinan recently completed enrollment of the Phase 2a 100mg expansion cohort (total n=36) and initiated expansion at 150mg (from 7 patients treated to date to 13 total). Cullinan intends to provide a clinical and regulatory update in Q4 2021.
    • Cullinan MICA: Received U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug application (IND) for CLN-619, a novel MICA/B-targeted antibody for the treatment of solid tumors (press release). CLN-619 is a first-in-class monoclonal antibody designed to promote an antitumor response by engaging both natural killer (NK) and T cells through the MICA/B–NKG2D axis, with therapeutic potential for both solid and liquid tumor indications. Cullinan intends to initiate a first-in-human (FIH) trial of CLN-619 in 2H 2021, including a dose escalation cohort followed by dose expansion cohorts as a monotherapy and in combination with checkpoint inhibitor therapy.
    • Cullinan Florentine: Received FDA clearance of IND for CLN-049, a FLT3 x CD3 bispecific antibody for the treatment of relapsed/refractory acute myeloid leukemia (AML) (press release). CLN-049 is designed to simultaneously bind to FLT3 on target leukemic cells and to CD3 on T cells, triggering the T cells to kill the targeted cancer cells via their intrinsic cytolytic mechanisms. Studies have shown that FLT3 is expressed on AML blasts in over 75% of AML patients, regardless of FLT3 mutational status. Cullinan intends to initiate a FIH trial of CLN-049 in 2H 2021.
    • Cullinan Amber: Continued progress towards final candidate selection for CLN-617, a fusion protein combining two potent antitumor cytokines, IL-2 and IL-12, in a single molecule with a collagen-binding tumor retention domain for the treatment of solid tumors. IND-enabling studies are planned to commence in the 2H 2021.
    • Cullinan NexGem: Continued to progress CLN-978, an internally developed half-life extended T cell engager designed to simultaneously engage CD19 and CD3, through IND-enabling development.

    Q2 2021 Financial Results

    • Cash Position: Cash, cash equivalents and investments were $456.3 million as of June 30, 2021, compared to $473.0 million as of March 31, 2021. Net cash used in operating activities for the second quarter of 2021 was $16.4 million.
    • R&D Expenses: Research and development (R&D) expenses were $11.8 million for the second quarter of 2021, including $2.3 million of non-cash equity-based compensation expense, compared to $12.5 million for the second quarter of 2020. The decrease in R&D expenses is primarily related to a non-recurring non-cash charge related to the MICA acquisition in the second quarter of 2020, partially offset by increased expenses from headcount growth as well as expanded clinical and CMC activity from other portfolio programs.
    • G&A Expenses: General and administrative (G&A) expenses were $4.8 million for the second quarter of 2021, including $1.9 million of non-cash equity-based compensation expense, compared to $1.6 million for the second quarter of 2020. The increase in G&A expenses is primarily related to headcount growth as well as additional costs associated with operations as a public company.
    • Net loss: The Company's net loss (before items attributable to noncontrolling interest) was $16.4 million for the second quarter of 2021, compared to $13.9 million for the second quarter of 2020, driven predominantly by increases in costs associated with public company operations and non-cash equity-based compensation expenses.

    About Cullinan Oncology



    Cullinan Oncology is a biopharmaceutical company that strives to deliver results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We seek to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes. Learn more about Cullinan at www.cullinanoncology.com.

    Forward-Looking Statements



    This press release contains forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan's beliefs and expectations regarding our preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including but not limited to: the timing and success of our planned preclinical and clinical development of our programs, including for CLN-081, CLN-619, and CLN-049, and the timing and success of our planned regulatory submissions; our expectations and beliefs around the safety and activity of CLN-081 in our Phase 1/2a trial in patients with NSCLC harboring EGFRex20ins mutations that have had at least one prior treatment; our ability to evaluate strategic opportunities to accelerate development timelines; the presentation of additional data at upcoming scientific conferences in 2021; our ability to optimize the impact of our collaborations and license agreements with external parties; our ability to continue our growth; and our expectations regarding our use of capital.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our therapeutic candidates; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission (SEC), including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither Cullinan nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.



    Cullinan Oncology, Inc.

    Consolidated Balance Sheets (Unaudited)

    (in thousands, except shares and per share amounts)

      December 31,

    2020
      June 30,

    2021
     
    Assets        
    Current assets:        
    Cash and cash equivalents $168,198  $123,670 
    Short-term investments  42,008   213,035 
    Prepaid expenses and other current assets  2,072   7,762 
    Total current assets  212,278   344,467 
    Property and equipment, net  130   102 
    Other assets  2,300   147 
    Long-term investments     119,637 
    Total assets $214,708  $464,353 
    Liabilities and Stockholders' Equity        
    Current liabilities:        
    Accounts payable $9,679  $1,510 
    Accrued expenses and other current liabilities  4,641   4,233 
    Total current liabilities  14,320   5,743 
    Long-term liabilities:        
    Deferred rent  74   70 
    Total liabilities  14,394   5,813 
    Commitments and contingencies (Note 11)        
    Stockholders' equity:        
    Common stock, $0.0001 par value, 34,900,878 and 150,000,000 shares authorized as of December 31, 2020 and June 30, 2021, respectively; 29,831,125 and 43,526,224 shares issued and outstanding as of December 31, 2020 and June 30, 2021, respectively.  3   4 
    Additional paid-in capital  292,348   564,705 
    Accumulated other comprehensive loss  (2)  (115)
    Accumulated deficit  (93,339)  (109,045)
    Total Cullinan stockholders' equity  199,010   455,549 
    Noncontrolling interests  1,304   2,991 
    Total stockholders' equity  200,314   458,540 
    Total liabilities and stockholders' equity $214,708  $464,353 



    Cullinan Oncology, Inc.

    Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

    (in thousands, except shares and per share amounts)

      Three Months Ended June 30,  Six Months Ended June 30, 
      2020  2021  2020  2021 
    License revenue $  $  $  $18,943 
    Operating expenses:                
    Research and development  12,496   11,778   16,669   24,193 
    General and administrative  1,626   4,826   2,994   9,982 
    Total operating expenses  14,122   16,604   19,663   34,175 
    Loss from operations  (14,122)  (16,604)  (19,663)  (15,232)
    Other income (expense):                
    Interest income 246  173  624  222 
    Other income (expense), net  1   (8)  1   (10)
    Net loss  (13,875)  (16,439)  (19,038)  (15,020)
    Net income/(loss) attributable to noncontrolling interest  (5,253)  (803)  (5,443)  686 
    Net loss attributable to common stockholders of Cullinan $(8,622) $(15,636) $(13,595) $(15,706)
    Net loss per share, basic and diluted $(0.44) $(0.36) $(0.71) $(0.37)
    Total weighted-average shares used in computing net loss per share, basic and diluted  19,619,748   43,295,372   19,115,380   42,713,059 
    Comprehensive loss:                
    Net loss $(13,875) $(16,439) $(19,038) $(15,020)
    Unrealized gain/(loss) on investments 177   (55) 207   (113)
    Comprehensive loss  (13,698)  (16,494)  (18,831)  (15,133)
    Comprehensive income/(loss) attributable to noncontrolling interest  (5,253)  (803)  (5,443)  686 
    Comprehensive loss attributable to Cullinan $(8,445) $(15,691) $(13,388) $(15,819)

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeffrey Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com

     



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  3. CAMBRIDGE, Mass., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan") announced today that it will be participating in the 41st Annual Canaccord Genuity Growth Conference from August 10th to August 12th, 2021.

    Jeff Trigilio, Cullinan's Chief Financial Officer, will be presenting on Thursday, August 12th at 4:00pm ET. The presentation will be accessible through the Canaccord conference portal.

    Event: Canaccord Genuity Growth Conference
    Date: Thursday, August 12th
    Time: 4:00pm ET
    Location: Virtual

    Management will also be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with Cullinan's management should contact their Canaccord representative…

    CAMBRIDGE, Mass., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan") announced today that it will be participating in the 41st Annual Canaccord Genuity Growth Conference from August 10th to August 12th, 2021.

    Jeff Trigilio, Cullinan's Chief Financial Officer, will be presenting on Thursday, August 12th at 4:00pm ET. The presentation will be accessible through the Canaccord conference portal.

    Event: Canaccord Genuity Growth Conference

    Date: Thursday, August 12th

    Time: 4:00pm ET

    Location: Virtual

    Management will also be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with Cullinan's management should contact their Canaccord representative.

    About Cullinan Oncology

    Cullinan Oncology is a biopharmaceutical company that strives to deliver results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We seek to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes. Learn more about Cullinan at www.cullinanoncology.com.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeff Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com



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    • CLN-619 will be the first MICA/B-targeted antibody to enter human clinical trials

    • Cullinan will initiate a FIH trial in 3Q21, including a dose escalation cohort followed by dose expansion cohorts as a monotherapy and in combination with checkpoint inhibitor therapy

    CAMBRIDGE, Mass., June 29, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced that the U.S. Food and Drug Administration (FDA) has cleared Cullinan MICA's IND application for CLN-619. CLN-619 is a first-in-class monoclonal antibody designed to promote an antitumor response by engaging both natural killer (NK) and T cells through the MICA/B–NKG2D axis, with…

    • CLN-619 will be the first MICA/B-targeted antibody to enter human clinical trials



    • Cullinan will initiate a FIH trial in 3Q21, including a dose escalation cohort followed by dose expansion cohorts as a monotherapy and in combination with checkpoint inhibitor therapy

    CAMBRIDGE, Mass., June 29, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced that the U.S. Food and Drug Administration (FDA) has cleared Cullinan MICA's IND application for CLN-619. CLN-619 is a first-in-class monoclonal antibody designed to promote an antitumor response by engaging both natural killer (NK) and T cells through the MICA/B–NKG2D axis, with therapeutic potential for both solid and liquid tumor indications.

    "The MICA/B-targeted antibody CLN-619 represents a novel approach to broadly engage both innate and adaptive immune cells to achieve tumor cell lysis through multiple mechanisms of action," stated Jennifer Michaelson, Cullinan's Chief Development Officer, Biologics. "Given that MICA/B ligands are expressed across a wide range of solid and liquid tumors and the strong biological rationale for combination with other therapies, successful clinical development of CLN-619 may demonstrate the potential to become a novel backbone agent for immuno-oncology therapy. We are excited to now focus our efforts on initiating a clinical trial evaluating the safety, tolerability and single-agent anti-tumor activity of CLN-619 in multiple solid tumor types. The trial design also includes a module to evaluate the safety, tolerability and anti-tumor activity of CLN-619 in combination with checkpoint inhibitor therapy."

    About CLN-619



    CLN-619 is a humanized IgG1 monoclonal antibody that binds to MICA and MICB expressed on a wide variety of cancer cells. MICA/B are stress-induced ligands that are recognized by both cytotoxic innate and adaptive immune cells via their NKG2D receptor. To evade lysis by these immune cells, tumor cells shed MICA/B from their cell surface. CLN-619 promotes an antitumor response through multiple mechanisms of action, including prevention of the proteolytic release of MICA/B from cancer cells, antibody-dependent cell-mediated cytotoxicity, or ADCC, enhancement of MICA/B binding to NKG2D, and reduction of the inhibitory effect of shed MICA/B.

    In preclinical studies, animals treated with CLN-619 as a monotherapy demonstrated significant inhibition of tumor growth and a dramatic reduction of serum levels of soluble MICA. Multiple studies evaluating serum samples from cancer patients have demonstrated that high serum levels of shed MICA correlate with a poor prognosis.

    About Cullinan Oncology



    Cullinan Oncology is a biopharmaceutical company that strives to deliver results for its various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We seek to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, unique modes of action, and are either first- or best-in-class. Learn more about Cullinan at www.cullinanoncology.com.

    About Cullinan MICA



    Cullinan MICA is a Cullinan Oncology company that acquired exclusive worldwide rights to CLN-619, which was discovered by PDI Therapeutics, a portfolio company of Avalon Ventures.

    Forward-Looking Statements



    This press release contains forward-looking statements of Cullinan Oncology, Inc. ("Cullinan," "we" or "our") within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan's beliefs and expectations regarding our preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including but not limited to our expectations and beliefs around the safety and efficacy of CLN-619. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our therapeutic candidates; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither Cullinan nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeffrey Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com

     



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  4. CAMBRIDGE, Mass., June 07, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced that the U.S. Food and Drug Administration (FDA) has cleared Cullinan Florentine's IND application for CLN-049, a FLT3 x CD3 bispecific antibody for the treatment of relapsed/refractory acute myeloid leukemia (AML).

    "IND clearance by the FDA paves the way to test a differentiated treatment approach by targeting extracellular FLT3, an oncogenic driver in AML," stated Patrick Baeuerle, Cullinan's Chief Scientific Officer, Biologics. "We are excited to initiate human dosing of CLN-049, a T cell-engaging, IgG-like antibody in patients with…

    CAMBRIDGE, Mass., June 07, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced that the U.S. Food and Drug Administration (FDA) has cleared Cullinan Florentine's IND application for CLN-049, a FLT3 x CD3 bispecific antibody for the treatment of relapsed/refractory acute myeloid leukemia (AML).

    "IND clearance by the FDA paves the way to test a differentiated treatment approach by targeting extracellular FLT3, an oncogenic driver in AML," stated Patrick Baeuerle, Cullinan's Chief Scientific Officer, Biologics. "We are excited to initiate human dosing of CLN-049, a T cell-engaging, IgG-like antibody in patients with relapsed/refractory AML."

    About CLN-049



    CLN-049 is a humanized bispecific antibody being developed for relapsed/refractory AML. CLN-049 is designed to simultaneously bind to FLT3 on target leukemic cells and to CD3 on T cells, triggering the T cells to kill the targeted cancer cells via their intrinsic cytolytic mechanisms. Studies have shown that FLT3 is expressed by FACS staining on AML blasts in at least 75% of AML patients, regardless of an oncogenic driver mutation. The expression of FLT3 on the surface of leukemic blasts in most AML patients and its role as a known oncogenic driver make it an attractive therapeutic target for a T cell engager approach.

    In preclinical studies, CLN-049 led to potent FLT3-dependent killing of leukemic cells in vitro at a wide range of FLT3 expression levels on AML cells. Treatment with CLN-049, even at low doses, led to survival benefit in an AML xenograft model and complete elimination of leukemic blasts in various mouse models implanted with primary patient leukemic cells or AML cell lines. 

    About Cullinan Oncology



    Cullinan Oncology is a biopharmaceutical company that strives to deliver results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We seek to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes. Learn more about Cullinan at www.cullinanoncology.com.

    About Cullinan Florentine

    Cullinan Florentine is a partially owned subsidiary of Cullinan Oncology that has exclusive worldwide rights to CLN-049 pursuant to a License with the Deutsches Krebsforschungszentrum, or DKFZ, Eberhard Karls University of Tübingen, Faculty of Medicine, or University of Tübingen, and Universitätsmedizin Gesellschaft für Forschung und Entwicklung mbH, Tübingen, or UFE.

    Forward-Looking Statements



    This press release contains forward-looking statements of Cullinan Oncology, Inc. ("Cullinan," "we" or "our") within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan's beliefs and expectations regarding our preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including but not limited to our expectations and beliefs around the safety and efficacy of CLN-049. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our therapeutic candidates; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither Cullinan nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com 

    Jeffrey Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com



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    • CLN-081 Continues to Demonstrate Acceptable Overall Safety and Tolerability, With Encouraging GI Toxicity Profile

    • As of the Data Cutoff, No Grade 3 TRAE Diarrhea at Doses Below 150mg BID; No Grade 3 Rash TRAEs

    • Objective Responses Were Observed Across the Dose Range, with a Confirmed Objective Response Rate of 46% in Patients Treated at 100 mg BID

    • Phase 2a Expansion Initiated at 100 mg BID

    CAMBRIDGE, Mass., June 04, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced additional details pertaining to Cullinan Pearl's ongoing Phase 1/2a trial of CLN-081 in Non-Small Cell Lung Cancer (NSCLC) patients whose tumors harbor epidermal…

    • CLN-081 Continues to Demonstrate Acceptable Overall Safety and Tolerability, With Encouraging GI Toxicity Profile



    • As of the Data Cutoff, No Grade 3 TRAE Diarrhea at Doses Below 150mg BID; No Grade 3 Rash TRAEs



    • Objective Responses Were Observed Across the Dose Range, with a Confirmed Objective Response Rate of 46% in Patients Treated at 100 mg BID



    • Phase 2a Expansion Initiated at 100 mg BID

    CAMBRIDGE, Mass., June 04, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced additional details pertaining to Cullinan Pearl's ongoing Phase 1/2a trial of CLN-081 in Non-Small Cell Lung Cancer (NSCLC) patients whose tumors harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations. CLN-081 is an orally available, irreversible EGFR inhibitor, utilizing a unique pyrrolopyrimidine scaffold that was designed to selectively target cells expressing mutant EGFR variants, including exon 20, while sparing cells expressing wild type (WT) EGFR.

    These data will be featured in an on-demand poster presentation available this morning at 9:00 am EDT at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and during a company sponsored webinar at 10:30 am EDT today, which can be accessed here or in the ‘Events' section on Cullinan's investor website.

    "We remain encouraged with CLN-081's emerging profile," stated Owen Hughes, Cullinan's Chief Executive Officer. "In heavily pretreated patients, CLN-081 continues to show antitumor activity across the dose range, with a safety profile that appears to be differentiated, most specifically with respect to GI adverse events."

    The current analysis of the ongoing trial evaluated a total of 45 NSCLC patients with EGFR exon 20 insertion mutations who received at least one dose of CLN-081 as of the April 1, 2021, data cutoff, and were evaluable for safety. CLN-081 was dosed orally, at dose levels including 30, 45, 65, 100 and 150 mg twice daily (BID). As of the data cutoff, 42 of 45 patients were response evaluable across all dose cohorts tested.

    Overall Safety:

    Regarding treatment related adverse events (TRAEs) associated with WT EGFR inhibition:

    • Rash has been limited to Grade 1 and 2 events (76% of patients experienced an event across all doses as of the data cutoff); events were manageable with conventional supportive care; no patients have experienced Grade ≥3 TRAE rash.



    • Similarly, diarrhea has been mostly limited to Grade 1 and 2 events (22% across the dose range) as of the data cutoff, with a single Grade ≥3 TRAE at the highest dose tested to date, 150 mg BID, which resolved with supportive care. No prophylactic regimen has been required to ameliorate the incidence or severity of diarrhea to date.

    Overall Efficacy:

    Objective partial responses (PR) were observed in 21 of 42 (50%) response evaluable patients treated across all dose levels.

    • Of the 21 PRs as of the data cutoff, 13 were confirmed (31% confirmed objective response rate), 5 were pending confirmation (i.e., patient had not reached their second post-baseline disease assessment as of the data cutoff), and 3 will remain unconfirmed.



    • 41 of 42 (98%) response evaluable patients have achieved a best response of stable disease (SD) or PR, with 76% of all patients showing some degree of tumor regression at the initial scan post baseline (week 6).

    100 mg BID Expansion Cohort:

    In February 2021, Cullinan announced a Phase 2a expansion at the 100mg BID cohort, allowing enrollment of up to 36 patients.

    • Safety: Treatment-related rash has been limited to Grade 1 and 2 events (66%), manageable with conventional supportive care; no patients have experienced Grade ≥3 TRAE rash. In addition, the overall incidence of treatment-related diarrhea was 26%, with no Grade ≥3 events to date.



    • Efficacy: As of the data cutoff, objective responses were observed in 7 of 13 (54%) response evaluable patients; 6 of which were confirmed (46%) and 1 will remain unconfirmed.



    • Of the 13 response evaluable patients, 9 (69%) patients achieved disease control (PR of any duration or SD ≥ 6 months) as of the data cutoff; an additional 3 patients had stable disease and remained on treatment but had started therapy less than 6 months prior to data cutoff.

    "We are pleased with the CLN-081 safety and efficacy data to date in our Phase 1/2a trial. CLN-081 has demonstrated antitumor activity in patients post systemic chemotherapy, including among patients who were also treated previously with other EGFR inhibitors and/or cancer immunotherapy, across the range of CLN-081 doses tested to date, and across a spectrum of exon-20 mutational sub-types," said Jon Wigginton, M.D., Chairman of the Cullinan Oncology Scientific Advisory Board and Senior Advisor. "We are working diligently to evaluate CLN-081 in additional patients, and to set the stage for further clinical advancement of CLN-081 in this group of patients with significant unmet need."

    About CLN-081



    CLN-081 is an orally available, irreversible EGFR inhibitor that was designed to selectively target cells expressing mutant EGFR variants, including Ins20, while sparing cells expressing wild type EGFR. In preclinical studies, CLN-081 demonstrated inhibition against traditional sensitizing mutations (exon 19 deletions and L858R), Ins20 (the third most common EGFR mutation), and other less common mutations (G719X, L861Q, and S768I).

    Cullinan is evaluating various doses of CLN-081 in a Phase 1/2a trial in patients with NSCLC harboring Ins20 mutations that have progressed post chemotherapy. Based on pre-specified efficacy and safety criteria, Cullinan recently initiated Phase 2a dose expansion in the 100 mg BID dosing cohort, which will enable enrollment of up to 36 patients at this dose level, inclusive of 13 previously enrolled patients.

    About Cullinan Oncology



    Cullinan Oncology is a biopharmaceutical company that strives to deliver results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We seek to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes. Learn more about Cullinan at www.cullinanoncology.com.

    Forward-Looking Statements



    This press release contains forward-looking statements of Cullinan Oncology, Inc. ("Cullinan," "we" or "our") within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan's beliefs and expectations regarding our preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including but not limited to our expectations and beliefs around the safety and activity of CLN-081. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our therapeutic candidates; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither Cullinan nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeffrey Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com 



    Primary Logo

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  5. CAMBRIDGE, Mass., May 21, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced that Jon Wigginton, M.D. is stepping down from his day-to-day role as Chief Medical Officer, and will assume the role of Chairman of the company's Scientific Advisory Board (SAB) and Senior Advisor to the CEO.

    "I want to thank Jon for his many contributions to Cullinan, having helped the company transition to a public, clinical-stage biotech company, and establishing the clinical infrastructure necessary to run multiple global clinical trials," stated Owen Hughes, Cullinan's Chief Executive Officer. "More importantly, I'm delighted that we…

    CAMBRIDGE, Mass., May 21, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced that Jon Wigginton, M.D. is stepping down from his day-to-day role as Chief Medical Officer, and will assume the role of Chairman of the company's Scientific Advisory Board (SAB) and Senior Advisor to the CEO.

    "I want to thank Jon for his many contributions to Cullinan, having helped the company transition to a public, clinical-stage biotech company, and establishing the clinical infrastructure necessary to run multiple global clinical trials," stated Owen Hughes, Cullinan's Chief Executive Officer. "More importantly, I'm delighted that we will continue to benefit from Jon's experience and clinical development expertise as we progress a diversified pipeline of novel targeted and immuno-oncology agents into the clinic."

    "I am pleased to continue to work with Owen and my valued colleagues at Cullinan in our quest to help those living with cancer," stated Dr. Wigginton. "I am looking forward to further assisting the outstanding team at Cullinan, and to providing strategic oversight of the depth and breadth of Cullinan's innovative development programs."

    About Cullinan Oncology



    Cullinan Oncology is a biopharmaceutical company that strives to deliver results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We seek to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes. Learn more about Cullinan at www.cullinanoncology.com.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeffrey Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com



    Primary Logo

    View Full Article Hide Full Article
  6. CAMBRIDGE, Mass., May 19, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced that it will provide a clinical update on CLN-081 during a webinar on Friday, June 4th, 2021 at 10:30 am ET ("Pearl Clinical Update Webinar").

    During the webinar, members of Cullinan's management team will review updated safety and efficacy data from an ongoing Phase 1/2a trial evaluating CLN-081 in Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) Exon 20 insertion mutations (Ins20).

    As previously announced, data from this trial was selected for a poster presentation at the 2021 American Society…

    CAMBRIDGE, Mass., May 19, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced that it will provide a clinical update on CLN-081 during a webinar on Friday, June 4th, 2021 at 10:30 am ET ("Pearl Clinical Update Webinar").

    During the webinar, members of Cullinan's management team will review updated safety and efficacy data from an ongoing Phase 1/2a trial evaluating CLN-081 in Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) Exon 20 insertion mutations (Ins20).

    As previously announced, data from this trial was selected for a poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. The poster will include information using an April 1st, 2021 data cutoff and it will be available for on-demand viewing starting on Friday, June 4th at 9:00 am ET. Cullinan is hosting the Pearl Clinical Update Webinar at 10:30 am ET, after the poster release, in order to align with ASCO's embargo policies.

    Pearl Clinical Update Webinar Information

    Please register for the webinar directly here, or through the ‘Events' section on Cullinan's investor website here (https://investors.cullinanoncology.com/news-events/events). All materials presented will be accessible on the Cullinan website, and an archived recording of the live audio webcast will be available on Cullinan's website for approximately 30 days.

    ASCO Poster Presentation Information

    Abstract Title: Safety and activity of CLN-081 (TAS6417) in NSCLC with EGFR Exon 20 insertion mutations (Ins20)

    Abstract Number: 9077

    Date and Time: June 4th, 2021, 9:00 am ET (On-Demand)

    About CLN-081



    CLN-081 is an orally available, irreversible EGFR inhibitor that was designed to selectively target cells expressing mutant EGFR variants, including Ins20, while sparing cells expressing wild type EGFR. In preclinical studies, CLN-081 demonstrated inhibition against traditional sensitizing mutations (exon 19 deletions and L858R), Ins20 (the third most common EGFR mutation), and other less common mutations (G719X, L861Q, and S768I).

    Cullinan is evaluating various doses of CLN-081 in a Phase 1/2a trial in patients with NSCLC harboring Ins20 mutations that have progressed post chemotherapy. Based on pre-specified efficacy and safety criteria, Cullinan recently initiated Phase 2a dose expansion in the 100 mg BID dosing cohort, which will enable enrollment of up to 36 patients at this dose level, inclusive of 13 previously enrolled patients.

    About Cullinan Oncology



    Cullinan Oncology is a biopharmaceutical company that strives to deliver results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We seek to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes. Learn more about Cullinan at www.cullinanoncology.com.

    Forward-Looking Statements



    This press release contains forward-looking statements of Cullinan Oncology, Inc. ("Cullinan," "we" or "our") within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan's beliefs and expectations regarding our preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including but not limited to our expectations and beliefs around the safety and activity of CLN-081. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our therapeutic candidates; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither Cullinan nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeffrey Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com



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  7. Continued advancement of broad portfolio, highlighted by initiation of Phase 2a dose expansion of Cullinan Pearl in NSCLC patients with EGFRex20ins mutations

    Cash, cash equivalents and investments of $473.0 million as of March 31, 2021 post completion of Initial Public Offering in early January 2021

    Updated Cullinan Pearl data to be presented during a poster session at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

    CAMBRIDGE, Mass., May 14, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced its financial results for the first quarter ended March 31, 2021 and reported on recent business highlights…

    Continued advancement of broad portfolio, highlighted by initiation of Phase 2a dose expansion of Cullinan Pearl in NSCLC patients with EGFRex20ins mutations

    Cash, cash equivalents and investments of $473.0 million as of March 31, 2021 post completion of Initial Public Offering in early January 2021

    Updated Cullinan Pearl data to be presented during a poster session at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

    CAMBRIDGE, Mass., May 14, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced its financial results for the first quarter ended March 31, 2021 and reported on recent business highlights.

    "I am pleased with the progress we have made across our portfolio and our organization thus far in 2021," stated Owen Hughes, Chief Executive Officer of Cullinan. "Our recently completed Series C financing and Initial Public Offering will support continued development and expansion of our diverse pipeline. In addition, we look forward to sharing both clinical and preclinical updates throughout the year, including a poster presentation with updated clinical data for Cullinan Pearl at ASCO in June and updated preclinical data on Cullinan Amber at the Next-Gen Cytokine Therapeutics Summit in the third quarter."  

    Q1 2021 Portfolio Highlights

    • Cullinan Pearl: Based on pre-specified efficacy and safety criteria, we initiated Phase 2a dose expansion in the 100 mg BID cohort of our ongoing Phase 1/2a trial evaluating CLN-081 in NSCLC patients with EGFR ex20ins mutations. An abstract containing data from this trial as of November 2020 was selected for a poster presentation at ASCO. The poster presentation will contain updated safety and efficacy data subsequent to the November 2020 cutoff and will be available during the conference, which takes place from June 4 – 8, 2021.
    • Cullinan MICA: Continued to advance CLN-619, a novel MICA/B-targeted antibody designed to engage innate and adaptive immune cell responses, through IND-enabling activities, including drug product manufacturing, to support an IND submission in the second quarter of 2021.
    • Cullinan Florentine: Based on FDA feedback, amended the proposed clinical trial protocol for CLN-049, a bispecific FLT3 x CD3 antibody, to support an IND resubmission in mid-2021.
    • Cullinan Amber:   Expanded the preclinical data package for Cullinan Amber's lead program, CLN-617, a fusion protein uniquely combining two potent antitumor cytokines, IL-2 and IL-12, in a single molecule with a collagen-binding domain for the treatment of solid tumors.
    • Cullinan NexGem: Continued to progress CLN-978, an internally developed half-life extended T cell engager designed to simultaneously engage CD19 and CD3, through IND-enabling development.

    Q1 2021 Financial Results

    • Cash Position: Cash, cash equivalents and investments were $473.0 million as of March 31, 2021, compared to $210.2 million as of December 31, 2020. Net cash used in operating activities was $1.5 million. Net cash provided from financing activities was $264.6 million, which included net proceeds from the company's IPO completed in January 2021.
    • R&D Expenses: Research and development expenses were $12.4 million for the quarter ended March 31, 2021, including $3.0 million of sub-licensing expense and $1.6 million of non-cash equity-based compensation expense.
    • G&A Expenses: General and administrative expenses were $5.2 million for the quarter ended March 31, 2021, including $1.9 million of non-cash equity-based compensation expense.
    • Net Income: The Company's net income was $1.4 million for the quarter ended March 31, 2021, which included $18.9 million of revenue from the license agreement with Zai Lab (Shanghai) Co., Ltd.

    About Cullinan Oncology

    Cullinan Oncology is a biopharmaceutical company that strives to deliver results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We seek to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes. Learn more about Cullinan at www.cullinanoncology.com.

    Forward-Looking Statements

    This press release contains forward-looking statements of Cullinan Oncology, Inc. ("Cullinan," "we" or "our") within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan's beliefs and expectations regarding our preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including but not limited to: the timing and success of our planned preclinical and clinical development of our programs, and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, including for CLN-081, CLN-619, CLN-049, CLN-617, and CLN-978; our intention to submit INDs for CLN-619 in the second quarter of 2021 and for CLN-617 and CLN-978 in 2022; our CLN-049 IND resubmission in mid-2021; our expectations and beliefs around the safety and activity of CLN-081 in our Phase 1/2a trial in patients with NSCLC harboring EGFRex20ins mutations that have had at least one prior treatment; our ability to evaluate strategic opportunities to accelerate development timelines; our plans to advance and complete preclinical studies for our programs; the presentation of additional data at upcoming scientific conferences in 2021; our ability to optimize the impact of our collaborations and license agreements with external parties, including but not limited to Zai Lab; our ability to continue our growth and realize the anticipated contribution of the members of our board of directors and executives to our operations and programs; and our expectations regarding our use of capital and other financial results during the remainder of 2021.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our therapeutic candidates; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither Cullinan nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

    Cullinan Oncology, Inc.

    Consolidated Balance Sheets (Unaudited)

    (in thousands, except shares and per share amounts)

      December 31,

    2020
      March 31,

    2021
     
    Assets        
    Current assets:        
    Cash and cash equivalents $168,198  $293,537 
    Prepaid expenses and other current assets  2,072   6,419 
    Short term investments  42,008   147,337 
    Total current assets  212,278   447,293 
    Property and equipment, net  130  115 
    Other assets  2,300  147 
    Long term investments     32,111 
    Total assets $214,708  $479,666 
    Liabilities and Stockholders' Equity        
    Current liabilities:        
    Accounts payable $9,679  $3,879 
    Accrued expenses and other current liabilities  4,641   6,015 
    Total current liabilities  14,320   9,894 
    Long-term liabilities:        
    Deferred rent  74  73 
    Total liabilities  14,394   9,967 
    Commitments and contingencies        
    Stockholders' equity:        
    Common stock, $0.0001 par value, 34,900,878 and 150,000,000 shares authorized as of December 31, 2020 and March 31, 2021, respectively; 29,381,125 and 43,516,125 shares issued and outstanding as of December 31, 2020 and March 31, 2021, respectively  3  4 
    Additional paid-in capital  292,348   560,366 
    Accumulated other comprehensive loss  (2)  (60)
    Accumulated deficit  (93,339)  (93,409)
    Total Cullinan stockholders' equity  199,010   466,901 
    Noncontrolling interests  1,304   2,798 
    Total stockholders' equity  200,314   469,699 
    Total liabilities and stockholders' equity $214,708  $479,666 
             

    Cullinan Oncology, Inc.

    Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

    (in thousands, except shares and per share amounts)

      Three Months Ended

    March 31,
     
      2020  2021 
    License revenue $  $18,943 
    Operating expenses:        
    Research and development  4,173   12,415 
    General and administrative  1,368   5,156 
    Total operating expenses  5,541   17,571 
    Income/(loss) from operations  (5,541)  1,372 
    Other income (expense):        
    Interest income 378  49 
    Other income (expense), net     (2)
    Net Income/(loss)  (5,163)  1,419 
    Net income/(loss) attributable to noncontrolling interest  (190)  1,489 
    Net loss attributable to common stockholders of Cullinan $(4,973) $(70)
    Net loss per share, basic and diluted $(0.27) $(0.00)
    Total weighted-average shares used in computing net loss per share, basic and diluted  18,747,004   41,977,336 
    Comprehensive income/(loss):        
    Net income/(loss) $(5,163) $1,419 
    Unrealized gain/(loss) on investments 30   (58)
    Comprehensive income/(loss)  (5,133)  1,361 
    Comprehensive income/(loss) attributable to noncontrolling interest  (190)  1,489 
    Comprehensive income/(loss) attributable to Cullinan $(4,943) $(128)
             

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeffrey Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com



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  8. CAMBRIDGE, Mass., April 07, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan") announced today that the company's Chief Financial Officer, Jeff Trigilio, will present at the upcoming 20th Annual Needham Virtual Healthcare Conference.

    Event: Needham Virtual Healthcare Conference
    Date: Tuesday, April 13th
    Time: 11:45am EDT
    Location: Virtual

    The presentation will be accessible through the Needham conference portal for registered attendees only. Investors interested in scheduling a meeting with Mr. Trigilio should contact their Needham & Company representative.

    About Cullinan Oncology

    Cullinan Oncology is a biopharmaceutical company that seeks to drive shareholder returns by focusing on the patient. The Company's strategy…

    CAMBRIDGE, Mass., April 07, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan") announced today that the company's Chief Financial Officer, Jeff Trigilio, will present at the upcoming 20th Annual Needham Virtual Healthcare Conference.

    Event: Needham Virtual Healthcare Conference

    Date: Tuesday, April 13th

    Time: 11:45am EDT

    Location: Virtual

    The presentation will be accessible through the Needham conference portal for registered attendees only. Investors interested in scheduling a meeting with Mr. Trigilio should contact their Needham & Company representative.

    About Cullinan Oncology

    Cullinan Oncology is a biopharmaceutical company that seeks to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes. Learn more about Cullinan at www.cullinanoncology.com.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeff Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com



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  9. Pipeline Progress: Clinical and preclinical programs continue to advance, with encouraging initial Cullinan Pearl data and additional INDs to be filed in 2021 for immuno-oncology assets Cullinan Florentine and Cullinan MICA

    Balance Sheet: Completion of Series C financing ($131.2M) in December 2020 and IPO ($287.4M) in January 2021 enhances cash position, enabling pipeline progression / expansion

    Team: Key hires augment immuno-oncology acumen (CMO Jon Wigginton) and enhance business development capabilities (CFO Jeff Trigilio and CLO Ray Keane)

    CAMBRIDGE, Mass., March 30, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today…

    Pipeline Progress: Clinical and preclinical programs continue to advance, with encouraging initial Cullinan Pearl data and additional INDs to be filed in 2021 for immuno-oncology assets Cullinan Florentine and Cullinan MICA

    Balance Sheet: Completion of Series C financing ($131.2M) in December 2020 and IPO ($287.4M) in January 2021 enhances cash position, enabling pipeline progression / expansion

    Team: Key hires augment immuno-oncology acumen (CMO Jon Wigginton) and enhance business development capabilities (CFO Jeff Trigilio and CLO Ray Keane)

    CAMBRIDGE, Mass., March 30, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced its financial results for the full year ended December 31, 2020 and reported on recent business highlights.

    "We are proud of the significant progress across many facets of our business in 2020 and intend to maintain that momentum in 2021," stated Owen Hughes, Chief Executive Officer of Cullinan. "We remain laser focused on delivering results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We look forward to sharing additional clinical and pre-clinical updates as the year unfolds."

    2020 and Recent Portfolio Highlights:

    • Cullinan Pearl: Demonstrated encouraging clinical proof of concept for CLN-081 in NSCLC patients with EGFRex20ins mutations and initiated Phase 2a dose expansion in the 100 mg BID cohort.



      CLN-081 is an orally available, irreversible EGFR inhibitor that is designed to selectively target cells expressing mutant EGFR variants while sparing cells expressing wild type EGFR. Cullinan is evaluating various doses of CLN-081 in a Phase 1/2a trial in patients with NSCLC harboring EGFRex20ins mutations that have progressed post chemotherapy. As of the November 10, 2020 data cut-off, among 25 evaluable patients across all dose cohorts, we observed a best overall response of partial response in 10 patients (confirmed and unconfirmed), stable disease in 14 patients and disease progression in one patient. Cullinan recently initiated Phase 2a dose expansion at the 100 mg BID dosing level, which will enable enrollment of up to 36 patients at this dose level, inclusive of 13 previously enrolled patients. Cullinan is contemplating additional expansion cohorts and intends to provide updated safety and efficacy data in mid-2021.
    • Cullinan MICA: Advanced CLN-619 through IND-enabling activities, including drug product manufacturing, to support an IND submission planned for the second quarter of 2021.



      CLN-619 is a MICA/B-targeted, humanized IgG1 monoclonal antibody that Cullinan intends to develop in patients with advanced solid tumors. MICA/B are stress-induced ligands expressed on tumor cells and recognized by the activating NKG2D receptor present on innate and adaptive immune cells. To evade potential cytotoxic destruction by NK cells and T cells, tumors shed MICA/B from the cell surface. CLN-619 is designed to promote an antitumor response through multiple mechanisms of action, including preventing the proteolytic cleavage of MICA/B from cancer cells.
    • Cullinan Florentine: Acquired an exclusive license from the German Cancer Research Center (DKFZ) and the University of Tübingen to develop CLN-049, a novel FLT3 x CD3 bispecific antibody for the treatment of patients with acute myeloid leukemia (AML).



      CLN-049 is a humanized bispecific antibody targeting FLT3 on target leukemic cells and CD3 on T cells, triggering cancer cell lysis via T cell cytolytic mechanisms. FLT3 is expressed frequently on AML cells and leukemic blasts but minimally on healthy blood cells, unlike other tumor surface antigens such as CD33 and CD123. Cullinan submitted an IND to the U.S. Food and Drug Administration ("FDA") for its first-in-human clinical trial evaluating CLN-049 in relapsed or refractory AML patients in January 2021. After receiving FDA feedback, Cullinan is updating the clinical protocol and intends to resubmit its IND in mid-2021.
    • Cullinan Amber: Launched Cullinan Amber, a company focused on developing a next generation immuno-oncology platform to deliver immune-stimulatory cytokine combinations with an enhanced therapeutic window for the treatment of cancer.



      Cullinan Amber's lead program, CLN-617, is a fusion protein uniquely combining in a single agent two potent antitumor cytokines, IL-2 and IL-12, with a collagen-binding domain for the treatment of solid tumors. The collagen-binding domain engineered into CLN-617 is designed to retain cytokines in the tumor microenvironment following intratumoral administration, thereby minimizing systemic dissemination and associated toxicities while prolonging immunostimulatory antitumor activity. In preclinical studies, murine surrogates of CLN-617 demonstrated robust single agent antitumor activity in both injected and non-injected contralateral tumors without inducing systemic toxicity. Cullinan expects to submit an IND for CLN-617 in 2022.
    • Cullinan NexGem: Initiated IND-enabling studies for CLN-978, an internally derived asset that seeks to address the limitations of existing CD19 bispecific antibodies.



      CLN-978 is a half-life extended, humanized, single-chain T cell engager designed to simultaneously engage CD19 on target cancer cells and CD3 on T cells, triggering redirected T cells to lyse the target cancer cells. In addition to CD19 and CD3 binding domains, CLN-978 has a human serum albumin binding domain, which is designed to prolong half-life. Several design components of CLN-978, including its high affinity binder to CD19, its serum half-life extension component and its overall stability, are intended to address limitations related to blinatumomab, the only CD19-targeting bispecific T cell engager approved for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia, or ALL. Cullinan expects to submit an IND for CLN-978 in 2022.

    2020 and Recent Corporate Highlights:

    • Executed a strategic collaboration and licensing agreement in December 2020 with Zai Lab (Shanghai) Co., Ltd. ("Zai Lab") to develop and commercialize CLN-081 in Greater China.
    • Raised $131.2 million in gross proceeds from an oversubscribed Series C financing in December 2020, which broadened Cullinan's shareholder base to include additional leading life sciences focused institutions.
    • Completed an oversubscribed initial public offering (IPO). In January 2021, Cullinan announced the closing of its IPO of 13,685,000 shares of common stock, including the exercise in full by the underwriters of their over-allotment option, at a public offering price of $21.00 per share for gross proceeds of $287.4 million before deducting underwriting discounts and commissions and other offering expenses.
    • Strengthened and expanded Cullinan's management team and Board of Directors in 2020 by promoting Jennifer Michaelson, PhD, to Chief Development Officer, Biologics, and by adding Jon Wigginton, M.D. as Chief Medical Officer, Jeff Trigilio as Chief Financial Officer, and Raymond T. Keane, Esq. as Chief Legal Officer, along with Stephen Webster to its Board of Directors.

    Financial Results for Full Year 2020

    • Cash Position: Cash, cash equivalents and short-term investments were $210.2 million as of December 31, 2020, compared to $98.6 million as of December 31, 2019. This does not include $264.7 million in net proceeds from the company's IPO completed in January 2021 nor does it include upfront proceeds from the Zai Lab transaction, which were received in Q1 2021. Net cash used in operating activities was $29.8 million while net cash provided from financing activities was $140.1 million for the year ended December 31, 2020.
    • R&D Expenses: Research and development expenses were $43.2 million for the year ended December 31, 2020, including $5.9 million of non-cash equity-based compensation expense and $6.4 million of non-cash IPR&D expense related to the Cullinan MICA transaction, which was treated as an asset acquisition.
    • G&A Expenses: General and administrative expenses were $17.1 million, including $9.0 million of non-cash equity-based compensation expense.
    • Net loss: The Company's net loss was $59.5 million for the year ended December 31, 2020, which included $22.8 million of non-cash charges.

    About Cullinan Oncology



    Cullinan Oncology is a biopharmaceutical company that seeks to drive shareholder returns by focusing on the patient. The Company's strategy is to build a diversified pipeline of targeted and immuno-oncology therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes. Learn more about Cullinan at www.cullinanoncology.com.

    Forward-Looking Statements



    This press release contains forward-looking statements of Cullinan Oncology, Inc. ("Cullinan," "we" or "our") within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan's beliefs and expectations regarding our preclinical and clinical development plans, clinical trial designs, clinical and therapeutic potential, and strategy of our product candidates, including but not limited to: the timing and success of our planned preclinical and clinical development of our programs, and the timing and success of any such continued preclinical and clinical development and planned regulatory submissions, including for CLN-081, CLN-619, CLN-049 and CLN-617; our plans to submit INDs for CLN-619 and CLN-617 in the second quarter of 2021 and in 2022, respectively; our plans to update our clinical protocol and planned resubmission of the IND for CLN-049 in mid-2021; our expectations and beliefs around the safety and activity of CLN-081 in our Phase 1/2a trial in patients with NSCLC harboring EGFRex20ins mutations that have had at least one prior treatment; our ability to evaluate strategic opportunities to accelerate development timelines; our plans to advance and complete preclinical studies for our programs; the presentation of additional data at upcoming scientific conferences in 2021; our ability to optimize the impact of our collaborations and license agreements with external parties, including but not limited to Zai Lab, the German Cancer Research Center and the University of Tübingen; ability to continue its growth and realize the anticipated contribution of the members of its board of directors and executives to its operations and programs; and our expectations regarding our use of capital and other financial results during 2021.

    Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events, and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our therapeutic candidates; risks related to the impact of COVID-19 affecting countries or regions in which we have operations or do business, including potential negative impacts on our employees, customers, supply chain and production as well as global economies and financial markets; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither Cullinan nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.



    Cullinan Oncology, LLC

    Consolidated Balance Sheets (Unaudited)

    (in thousands, except units and per unit amounts)


     
      December 31,

    2019
      December 31,

    2020
     
    Assets        
    Current assets:        
      Cash and cash equivalents $63,250  $168,198 
      Prepaid expenses and other current assets  1,461   2,072 
      Short term investments  35,380   42,008 
       Total current assets  100,091   212,278 
    Property and equipment, net  182   130 
    Other assets  188   2,300 
       Total assets $100,461  $214,708 
    Liabilities, Redeemable Preferred Units and Members' Deficit        
    Current liabilities:        
      Accounts payable $934  $9,679 
      Accrued expenses and other current liabilities  1,589   4,641 
       Total current liabilities  2,523   14,320 
    Long-term liabilities:        
      Deferred rent  73   74 
       Total liabilities  2,596   14,394 
    Commitments and contingencies        
    Redeemable Preferred Units:        
      Series Seed Redeemable Preferred Units, $0.0001 par value:        
      16,000,000 units authorized, issued and outstanding (liquidation        
      value: $5,010) at December 31, 2019 and 2020.  3,956   3,956 
      Series A1 Redeemable Preferred Units, $0.0001 par value:         
      50,000,000 units authorized, issued and outstanding (liquidation        
      value: $61,038) at December 31, 2019 and 2020.  49,946   49,946 
      Series B Redeemable Preferred Units, $0.0001 par value:        
      64,200,000 authorized and 54,006,407 and 63,141,016 units        
      issued and outstanding (liquidation value: $105,645) at        
      December 31, 2019 and 2020, respectively.  83,872   97,909 
      Series C Redeemable Preferred Units, $0.0001 par value:        
      66,599,045 units authorized, issued and outstanding (liquidation        
      value: $131,524) at December 31, 2020.     124,841 
        Total Redeemable Preferred Units  137,774   276,652 
    Members' deficit:        
      Non-Voting Incentive Units, $0.0001 par value: 11,896,500 units        
      authorized, 11,896,500 units issued and outstanding at        
      December 31, 2019 and 2020.  1   1 
      Common units, $0.0001 par value: 36,972,854 units authorized, 0        
      and 2,346,094 units issued and outstanding at December 31,        
      2019 and 2020, respectively.      
      Noncontrolling interest in subsidiaries  864   1,304 
      Additional paid-in capital  770   15,698 
      Accumulated other comprehensive loss  (4)  (2)
      Accumulated deficit  (41,540)  (93,339)
        Total members' deficit  (39,909)  (76,338)
        Total liabilities, redeemable preferred units and members' deficit $100,461  $214,708 



    Cullinan Oncology, LLC

    Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

    (in thousands, except units and per unit amounts)
     
      Year Ended December 31, 
      2019  2020 
    Operating expenses:        
      Research and development $16,788  $43,211 
      General and administrative  5,482   17,124 
        Total operating expenses  22,270   60,335 
        Loss from operations  (22,270)  (60,335)
    Other income (expense):        
      Interest income  620   888 
      Other income (expense), net  (4)  (11)
    Net loss  (21,654)  (59,458)
      Net loss attributable to noncontrolling interest  (997)  (7,659)
    Net loss attributable to Cullinan $(20,657) $(51,799)
    Net loss per unit attributable to Common and Non-Voting Incentive        
     Unitholders, basic and diluted $(3.23) $(5.48)
    Total weighted-average Common and Non-Voting Incentive Units        
     used in computing net loss per unit, basic and diluted  6,397,443   9,447,147 
    Comprehensive loss:        
      Net loss $(21,654) $(59,458)
      Unrealized gain/(loss) on investments  (4)  2 
    Comprehensive loss $(21,658) $(59,456)
      Comprehensive loss attributable to noncontrolling interest  (997)  (7,659)
    Comprehensive loss attributable to Cullinan $(20,661) $(51,797)



    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeff Trigilio

    +1 617.410.4650

    jtrigilio@cullinanoncology.com



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  10. CAMBRIDGE, Mass., March 02, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies, today announced that the company's Chief Executive Officer, Owen Hughes, will present at the upcoming H.C. Wainwright Global Life Sciences Conference.

    Event: H.C. Wainwright Global Life Sciences Conference
    Date: Tuesday, March 9th
    Time: 7:00am EST
    Location: Virtual

    The presentation will be available on-demand through the H.C. Wainwright conference portal, starting at 7am EST on Tuesday, March 9th, 2021, for registered attendees only.

    About Cullinan Oncology

    Cullinan Oncology is a biopharmaceutical company focused…

    CAMBRIDGE, Mass., March 02, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) ("Cullinan"), a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies, today announced that the company's Chief Executive Officer, Owen Hughes, will present at the upcoming H.C. Wainwright Global Life Sciences Conference.

    Event: H.C. Wainwright Global Life Sciences Conference

    Date: Tuesday, March 9th

    Time: 7:00am EST

    Location: Virtual

    The presentation will be available on-demand through the H.C. Wainwright conference portal, starting at 7am EST on Tuesday, March 9th, 2021, for registered attendees only.

    About Cullinan Oncology

    Cullinan Oncology is a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies. The Company's strategy is to build a pipeline of therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeff Trigilio

    +1 716.725.5019

    jtrigilio@cullinanoncology.com



    Primary Logo

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  11. February 22, 2021

    • Enrollment expansion in CLN-081 NSCLC EGFRex20ins Phase 1/2a trial
    • Cullinan withdraws IND application for CLN-049 in Relapsed/Refractory AML
    • CLN-619 IND submission planned for the second quarter of 2021
    • Cullinan to present at SVB Leerink Conference February 26, 2021

    CAMBRIDGE, Mass., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Cullinan Management, Inc. (NASDAQ:CGEM) ("Cullinan"), a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies, today announces the following business updates:

    Portfolio Overview and Updates:

    • Cullinan Pearl
      Based on pre-specified efficacy criteria, Cullinan recently initiated Phase 2a Dose Expansion at the 100 mg BID dosing level in the ongoing…

    February 22, 2021

    • Enrollment expansion in CLN-081 NSCLC EGFRex20ins Phase 1/2a trial
    • Cullinan withdraws IND application for CLN-049 in Relapsed/Refractory AML
    • CLN-619 IND submission planned for the second quarter of 2021
    • Cullinan to present at SVB Leerink Conference February 26, 2021

    CAMBRIDGE, Mass., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Cullinan Management, Inc. (NASDAQ:CGEM) ("Cullinan"), a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies, today announces the following business updates:

    Portfolio Overview and Updates:

    • Cullinan Pearl

      Based on pre-specified efficacy criteria, Cullinan recently initiated Phase 2a Dose Expansion at the 100 mg BID dosing level in the ongoing Phase 1/2a study evaluating CLN-081 in adult NSCLC patients with EGFRex20ins mutations. This expansion will enable enrollment of up to 36 patients, inclusive of 13 previously enrolled patients, at this dosing level. Cullinan is contemplating additional expansion cohorts and intends to provide updated safety and efficacy data in mid-2021.

    • Cullinan Florentine

      In January 2021, Cullinan submitted an IND to the U.S. Food and Drug Administration (FDA) for a Phase 1/2a clinical trial evaluating CLN-049, a bispecific antibody targeting FLT3 and CD3, in relapsed or refractory AML patients. The FDA subsequently provided feedback, including a request to consider alternative trial designs that would enable the collection of exploratory pharmacokinetic and pharmacodynamic data before dose escalation. Based on this information, Cullinan elected to withdraw the IND to determine the most efficient path forward.

    • Cullinan MICA

      Cullinan is completing the production of GMP drug product to support an IND submission and subsequent clinical trial for its investigational product CLN-619, a monoclonal antibody designed to stimulate natural killer (NK) and T cell responses by engaging a unique target, MICA/B. Consistent with prior guidance, Cullinan intends to submit an IND in the second quarter of 2021.

    SVB Leerink Global Healthcare Conference Event Details:

    Chief Executive Officer, Owen Hughes, will provide a company overview and update at the 10th Annual SVB Leerink Global Healthcare Conference.

    • Event: 10th Annual SVB Leerink Global Healthcare Conference
    • Location: Virtual
    • Date: Friday, February 26, 2021
    • Time: 4:20 PM ET/1:20PM PT

    Members of the Cullinan management team will also host investor meetings during the SVB Leerink Global Healthcare Conference.

    A webcast of the SVB Leerink presentation will be available in the Investors section of the Cullinan website at https://www.cullinanoncology.com/.

    About CLN-081

    CLN-081 is an orally available, irreversible EGFR inhibitor that is designed to selectively target cells expressing mutant EGFR variants, including EGFR exon 20 insertion mutations, with relative sparing of cells expressing wild type EGFR. CLN-081 is currently in a Phase 1/2a dose escalation and expansion trial evaluating oral, twice-daily administration of various doses in patients with NSCLC harboring EGFRex20ins mutations who have had at least one prior treatment with platinum-based chemotherapy or another approved standard therapy. CLN-081 is being developed in Cullinan Pearl, a Cullinan subsidiary.

    About CLN-049

    CLN-049 is a humanized bispecific antibody targeting FLT3 on target leukemic cells and CD3 on T cells, triggering cancer cell lysis via T cell cytolytic mechanisms. FLT3 is expressed frequently on AML cells and leukemic blasts but minimally on healthy blood cells, unlike other tumor surface antigens such as CD33 and CD123. CLN-049 is being developed in Cullinan Florentine, a Cullinan subsidiary.

    About CLN-619

    CLN-619 is MICA/B-targeted, humanized IgG1 monoclonal antibody that Cullinan intends to develop in patients with advanced solid tumors. MICA/B are stress-induced ligands that innate and adaptive immune cell populations recognize via the NKG2D receptor. To evade potential cytotoxic destruction by NK cells and T cells, tumors shed MICA/B from the cell surface. CLN-619 is designed to promote an antitumor response through multiple mechanisms of action, including shielding the proteolytic cleavage sites of MICA/B on cancer cells. CLN-619 is being developed in Cullinan MICA, a Cullinan subsidiary.

    About Cullinan Management

    Cullinan Management is a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies. The Company's strategy is to build a pipeline of therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact, including those related to our development plans for our therapeutic candidates, including the timing thereof, should be considered forward-looking statements. These forward-looking statements are based on management's current expectations. These statements involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the results of regulatory submissions, including our ability to agree with the FDA on an acceptable trial design for CLN-049; success of our clinical trials and preclinical studies; risks related to manufacturing, supply and distribution of our therapeutic candidates; and success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption "Risk Factors" in our Prospectus dated January 7, 2021 filed with the SEC on January 11, 2021 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com 

    Jeff Trigilio

    +1 716.725.5019

    jtrigilio@cullinanoncology.com 



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    • Participation from both existing and new investors
    • Total capital raised for company to date: c. £33 million (c. $45 million)
    • Capital utilised to accelerate lead programs: amyloid-β and α-synuclein
    • Company to nominate lead clinical amyloid-β candidate in Q1, 2021
    • α-synuclein being advanced in collaboration with Eisai Co., Ltd
    • Dr. Andrew C. von Eschenbach and Mr. Owen Hughes appointed to Board
    • Talent added at senior management level
    • Company to progress additional high-value targets: IAPP, tau & TDP-43
    • Initiated application of the kinetics platform to Oncology

    Wren Therapeutics Ltd., ("Wren"), a biopharmaceutical company pioneering a unique network kinetics approach to drug discovery for protein misfolding diseases, today announced…

    • Participation from both existing and new investors
    • Total capital raised for company to date: c. £33 million (c. $45 million)
    • Capital utilised to accelerate lead programs: amyloid-β and α-synuclein
    • Company to nominate lead clinical amyloid-β candidate in Q1, 2021
    • α-synuclein being advanced in collaboration with Eisai Co., Ltd
    • Dr. Andrew C. von Eschenbach and Mr. Owen Hughes appointed to Board
    • Talent added at senior management level
    • Company to progress additional high-value targets: IAPP, tau & TDP-43
    • Initiated application of the kinetics platform to Oncology

    Wren Therapeutics Ltd., ("Wren"), a biopharmaceutical company pioneering a unique network kinetics approach to drug discovery for protein misfolding diseases, today announced the closing of a £12.4 million (c. $17.0 million) financing.

    This financing brings the total capital raised to date to approximately £33 million (c. $45 million). The financing was led by existing shareholder The Baupost Group, with participation from existing investors including LifeForce Capital and new investors including Schooner Capital and Industry Ventures.

    Dr. Samuel Cohen, Chief Executive Officer of Wren, commented: "This support from both our existing as well as our new shareholders will accelerate the advancement of our two lead small molecule programs towards the clinic for the potential treatment of Alzheimer's disease and various synucleinopathies including Parkinson's disease."

    Dr. Cohen added: "The new capital, alongside our recently announced collaboration with Eisai, is a further endorsement of our unique chemical kinetics platform that has been industrialised by the Wren team over the previous four years, building on more than a decade of prior academic research. Our mission is to radically advance drug discovery for a wide range of protein misfolding diseases by creating molecules that will offer transformative therapeutic options for millions of patients globally suffering from these increasingly common medical disorders."

    Progress in advancing the platform

    Selected highlights include:

    • Advanced lead small molecule programs targeting amyloid-beta and alpha-synuclein, with first clinical candidate for amyloid-β in Q1 2021
    • Announced research collaboration with Eisai Co., Ltd for α-synuclein
    • Expanded the pipeline to three additional targets: IAPP for diabetes; tau for Alzheimer's disease and other tauopathies; and TDP-43 for motor neurone disease
    • Publication in Nature Structural & Molecular Biology, co-authored by Wren's scientific founders and senior Biogen scientists, demonstrating the predictive capability of Wren's chemical kinetics in assessing clinical-stage molecules for Alzheimer's disease
    • Added new disease area of Oncology with discovery work underway

    Board of Directors Expanded and Senior Management Strengthened

    Wren has expanded its Board of directors and strengthened its leadership team.

    Board appointments include Dr. Andrew C. von Eschenbach and Mr. Owen Hughes. Dr. von Eschenbach is the former Commissioner of the US Food and Drug Administration ("FDA"), and currently serves as president of Samaritan Health Initiatives Inc., and is a senior fellow at the Milken Institute and the Bipartisan Policy Center. Dr. von Eschenbach serves on the Board of Bausch Health (NYSE:BHC, TSX:BHC), Celularity Inc., and Radius Health (NASDAQ:RDUS).

    Mr. Owen Hughes is Chief Executive Officer of Cullinan Management, Inc. (NASDAQ:CGEM) and serves as an advisor to MPM Capital. The biographies for both directors are listed below. These board appointments complement the existing Board.

    In addition, the company has also significantly expanded its scientific and business operations team including the appointment of Dr. Alleyn Plowright to the position of Head of Translational Science and Pre-Clinical Development. Prior to this, Alleyn held the positions of Head, Integrated Drug Discovery with Sanofi (Germany) and Senior Principal Scientist at AstraZeneca.

    About New Board Directors

    Andrew C. von Eschenbach, M.D., currently serves as president of Samaritan Health Initiatives Inc. and as a senior fellow at the Milken Institute and the Bipartisan Policy Center.

    Dr. von Eschenbach was appointed Acting Commissioner of the U.S. FDA in 2005, was later confirmed by the Senate as Commissioner in 2006 and held this role until 2009. Prior to that, he served as director of the National Cancer Institute at the National Institutes of Health from 2002 to 2006. Dr. von Eschenbach also previously served as a physician, surgeon, oncologist and executive at the University of Texas MD Anderson Cancer Center from 1976 until 2002, and since 2009, he has continued to serve as an adjunct professor. Dr. von Eschenbach is an internationally renowned cancer specialist and the author of more than 300 scientific articles on cancer and medical topics.

    Dr. von Eschenbach earned a B.S. from St. Joseph's University and a M.D. from Georgetown University. Dr. von Eschenbach is a director of Bausch Health (NYSE:BHC, TSX:BHC), Celularity Inc., and Radius Health (NASDAQ:RDUS) and is a member of the Board of the Reagan Udall Foundation of the US FDA .

    Owen Hughes is the Chief Executive Officer of Cullinan Management, Inc. (NASDAQ:CGEM).

    Prior to joining Cullinan Oncology, Owen served as the Chief Business Officer and Head of Corporate Development at Intarcia Therapeutics. Previously, Owen served as a Director of Brookside Capital, under the Bain Capital umbrella, managing public and private healthcare investments. Prior to his tenure at Brookside, he was Senior Portfolio Manager at Pyramis Global Advisors, a Fidelity Investments Company. Owen has more than 18 years of Wall Street experience, on both the buy and sell sides. Owen received his B.A. from Dartmouth College.

    Owen currently serves as an advisor to MPM Capital, Chairman of the Board of Directors at Radius Health (NASDAQ:RDUS) and a member of the board of Translate Bio (NASDAQ:TBIO).

    About Wren Therapeutics Ltd.

    Wren is a spin-off company from the University of Cambridge (UK) and Lund University (Sweden), focused on drug discovery and development for protein misfolding diseases. Wren is advancing an entirely novel approach to address this class of diseases, based on more than a decade of research from its scientific founders focused on the chemical kinetics of the protein misfolding process. Wren's predictive, quantitative platform is built on concepts from the physical sciences and is a fundamental shift from the descriptive, qualitative methods of traditional biology, which have failed to successfully address these complex systems. Wren is using its unique approach to develop a broad pipeline of therapeutics for protein misfolding diseases.

    For more information on Wren, please visit: www.wrentherapeutics.com

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  12. CAMBRIDGE, Mass., Jan. 12, 2021 (GLOBE NEWSWIRE) -- Cullinan Management, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies with transformative potential for cancer patients, today announced the closing of its initial public offering of 13,685,000 shares of its common stock, including 1,785,000 shares sold pursuant to the full exercise of the underwriters' option to purchase additional shares, at a price to the public of $21.00 per share. The gross proceeds of the offering were $287.4 million, before deducting underwriting discounts and commissions and other offering expenses. The shares began trading on the Nasdaq Global Select Market on January 8…

    CAMBRIDGE, Mass., Jan. 12, 2021 (GLOBE NEWSWIRE) -- Cullinan Management, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies with transformative potential for cancer patients, today announced the closing of its initial public offering of 13,685,000 shares of its common stock, including 1,785,000 shares sold pursuant to the full exercise of the underwriters' option to purchase additional shares, at a price to the public of $21.00 per share. The gross proceeds of the offering were $287.4 million, before deducting underwriting discounts and commissions and other offering expenses. The shares began trading on the Nasdaq Global Select Market on January 8, 2021 under the symbol "CGEM." All shares in the offering were offered by Cullinan Management.

    Morgan Stanley & Co. LLC, SVB Leerink LLC, and Evercore Group LLC acted as joint book-running managers for the offering. H.C. Wainwright & Co., LLC acted as lead manager for the offering.

    Registration statements relating to these securities have been filed and were declared effective by the Securities and Exchange Commission on January 7, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at syndicate@svbleerink.com; and Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at (888) 474 0200, or by email at ecm.prospectus@evercore.com.

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

    About Cullinan Management

    Cullinan Management is a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies with transformative potential for cancer patients. The Company's strategy is to build a pipeline of therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes.

    Contacts:

    Investor Relations

    investors@cullinanoncology.com

    Jeff Trigilio

    +1 716.725.5019

    jtrigilio@cullinanoncology.com



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  13. CAMBRIDGE, Mass., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Cullinan Management, Inc., a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies with transformative potential for cancer patients, announced today the pricing of its upsized initial public offering of 11,900,000 shares of common stock at a price to the public of $21.00 per share. All shares are being offered by Cullinan Management. The gross proceeds to Cullinan Management from the offering, before deducting underwriting discounts, commissions and other offering expenses, are expected to be approximately $249.9 million. In addition, the underwriters have a 30-day option to purchase up to an additional 1,785,000 shares…

    CAMBRIDGE, Mass., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Cullinan Management, Inc., a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies with transformative potential for cancer patients, announced today the pricing of its upsized initial public offering of 11,900,000 shares of common stock at a price to the public of $21.00 per share. All shares are being offered by Cullinan Management. The gross proceeds to Cullinan Management from the offering, before deducting underwriting discounts, commissions and other offering expenses, are expected to be approximately $249.9 million. In addition, the underwriters have a 30-day option to purchase up to an additional 1,785,000 shares of common stock at the initial public offering price less underwriting discounts and commissions. The shares are expected to begin trading on The Nasdaq Global Select Market under the ticker symbol "CGEM" on January 8, 2021. The offering is expected to close on January 12, 2021, subject to the satisfaction of customary closing conditions.

    Morgan Stanley & Co. LLC, SVB Leerink LLC, and Evercore Group LLC are acting as joint book-running managers for the offering. H.C. Wainwright & Co., LLC is acting as lead manager for the offering.

    A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on January 7, 2021. The offering is being made only by means of a written prospectus. Copies of the final prospectus relating to the initial public offering can be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at syndicate@svbleerink.com; and Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at (888) 474 0200, or by email at ecm.prospectus@evercore.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 Cullinan Management



    Cullinan Management is a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies with transformative potential for cancer patients. The Company's strategy is to build a pipeline of therapeutic candidates that are uncorrelated across multiple dimensions, with a focus on assets that it believes have novel technology, employ differentiated mechanisms, are in a more advanced stage of development than competing candidates, or have a combination of these attributes.

    Contacts:



    Investor Relations

    investors@cullinanoncology.com

    Jeff Trigilio

    +1 716.725.5019

    jtrigilio@cullinanoncology.com



    Primary Logo

    View Full Article Hide Full Article