KDMN Kadmon Holdings Inc.

4.13
-0.04  -1%
Previous Close 4.17
Open 4.12
52 Week Low 2.04
52 Week High 5.5
Market Cap $706,796,087
Shares 171,137,067
Float 170,889,506
Enterprise Value $596,215,828
Volume 944,689
Av. Daily Volume 2,539,854
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Upcoming Catalysts

Drug Stage Catalyst Date
KD025 - ROCKstar (KD025-213)
Chronic graft-versus-host disease (cGVHD)
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
KD025
Systemic sclerosis (scleroderma)
Phase 2
Phase 2
Phase 2 trial enrolling.
KD045
Fibrosis (kidney/lung/liver)
Phase 1
Phase 1
Phase 1 trial planned.
KD033
Advanced Solid Tumors
Phase 1
Phase 1
Phase 1 dosing of first patient announced June 23, 2020.
KD025
Idiopathic pulmonary fibrosis (IPF)
Phase 2
Phase 2
Phase 2 data released February 12, 2018. Open label - noted data were "positive".

Latest News

  1. NEW YORK, NY / ACCESSWIRE / August 13, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced the appointment of Nancy Miller-Rich to its Board of Directors.

    "Nancy possesses an extensive, decades-long track record of business development and commercialization success in varying roles across globally focused healthcare organizations," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We expect Nancy's guidance will be instrumental as we prepare strategically for a number of key milestones, including our planned NDA submission of belumosudil for cGVHD. We are pleased to welcome Nancy to our Board and we look forward to leveraging her insights on our corporate strategy and global commercialization plans."

    Ms. Miller-Rich has 35 years…

    NEW YORK, NY / ACCESSWIRE / August 13, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced the appointment of Nancy Miller-Rich to its Board of Directors.

    "Nancy possesses an extensive, decades-long track record of business development and commercialization success in varying roles across globally focused healthcare organizations," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We expect Nancy's guidance will be instrumental as we prepare strategically for a number of key milestones, including our planned NDA submission of belumosudil for cGVHD. We are pleased to welcome Nancy to our Board and we look forward to leveraging her insights on our corporate strategy and global commercialization plans."

    Ms. Miller-Rich has 35 years of experience in the pharmaceutical industry. Since September 2017, Ms. Miller-Rich has served as a consultant to several biopharmaceutical companies and healthcare organizations. Previously, Ms. Miller-Rich served as Senior Vice President, Global Human Health Business Development & Licensing, Strategy and Commercial Support at Merck from 2013 to 2017. At Merck, Ms. Miller-Rich's responsibilities included direct global business development, alliance management, strategy and commercial assessment. Prior to this role, Ms. Miller-Rich was Group Vice President, Consumer Care Global New Ventures and Strategic Commercial Development at Schering-Plough from 2007 to 2013. Prior to joining Schering-Plough in 1990, Ms. Miller-Rich served in a variety of commercial and marketing roles at Sandoz (now Novartis) and at Sterling Drug. Ms. Miller-Rich currently serves as a member of the Board of Directors of Intercept Pharmaceuticals, Aldeyra Therapeutics and the TB Alliance as well as an advisor to 1063 Therapeutics and Aurora Bio. Ms. Miller-Rich received her B.S. in Business Administration and marketing from Ithaca College in Ithaca, New York.

    About Belumosudil (KD025)

    Belumosudil (KD025) is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response. The Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for belumosudil for the treatment of patients with chronic graft-versus-host disease (cGVHD) who have received at least two prior lines of systemic therapy. The FDA has also granted Orphan Drug Designation to belumosudil for the treatment of cGVHD. The FDA has accepted belumosudil for review under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. Belumosudil is also being studied in an ongoing Phase 2 clinical trial in adults with diffuse cutaneous systemic sclerosis (KD025-209).

    About Kadmon

    Kadmon is a clinical-stage biopharmaceutical company that discovers, develops and delivers transformative therapies for unmet medical needs. Our clinical pipeline includes treatments for immune and fibrotic diseases as well as immuno-oncology therapies.

    Forward Looking Statements

    This press release contains forward-looking statements. Such statements may be preceded by the words "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "targets," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We believe that these factors include, but are not limited to, (i) the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; (ii) our ability to advance product candidates into, and successfully complete, clinical trials; (iii) the impact of the COVID-19 pandemic on our business, workforce, patients, collaborators and suppliers, including delays in anticipated timelines and milestones of our clinical trials and on various government agencies who we interact with and/or are governed by; (iv) our reliance on the success of our product candidates; (iv) the timing or likelihood of regulatory filings and approvals, especially in light of the COVID-19 pandemic; (v) our ability to expand our sales and marketing capabilities; (vi) our ability to expand our sales and marketing capabilities; (vii) the commercialization, pricing and reimbursement of our product candidates, if approved; (viii) the implementation of our business model, strategic plans for our business, product candidates and technology; (ix) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (x) our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; (xi) costs associated with defending intellectual property infringement, product liability and other claims; (xii) regulatory developments in the United States, Europe, and other jurisdictions; (xiii) estimates of our expenses, future revenues, capital requirements and our needs for additional financing; (xiv) the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; (xv) our ability to maintain and establish collaborations; (xvi) the rate and degree of market acceptance of our product candidates, if approved; (xvii) developments relating to our competitors and our industry, including competing therapies; (xviii) our ability to effectively manage our anticipated growth; (xix) our ability to attract and retain qualified employees and key personnel; (xx) our expected use of cash and cash equivalents and other sources of liquidity; (xxi) the potential benefits of any of our product candidates being granted orphan drug designation; (xxii) the future trading price of the shares of our common stock and impact of securities analysts' reports on these prices; (xxiii) our ability to apply unused federal and state net operating loss carryforwards against future taxable income and/or (xxiv) other risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the U.S. Securities and Exchange Commission (the "SEC"), including Kadmon's Annual Report on Form 10-K for the fiscal year ended December 31, 2019. Investors and security holders are urged to read these documents free of charge on the SEC's website at www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

    Contact Information

    Ellen Cavaleri, Investor Relations
    646.490.2989

    SOURCE: Kadmon Holdings, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/601650/Kadmon-Announces-Appointment-of-Nancy-Miller-Rich-to-Board-of-Directors

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  2. NEW YORK, NY / ACCESSWIRE / August 6, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today provided a business update and reported financial and operational results for the second quarter of 2020.

    "Following positive topline results from the primary analysis of the ROCKstar pivotal trial of belumosudil in cGVHD announced in May 2020, we have had an extremely busy and productive quarter. We are preparing our New Drug Application for belumosudil, which remains on track for submission in the fourth quarter of this year," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We believe the ROCKstar data continue to demonstrate the promise of belumosudil in cGVHD, and as such we are scaling up our launch preparation activities in anticipation of potential…

    NEW YORK, NY / ACCESSWIRE / August 6, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today provided a business update and reported financial and operational results for the second quarter of 2020.

    "Following positive topline results from the primary analysis of the ROCKstar pivotal trial of belumosudil in cGVHD announced in May 2020, we have had an extremely busy and productive quarter. We are preparing our New Drug Application for belumosudil, which remains on track for submission in the fourth quarter of this year," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We believe the ROCKstar data continue to demonstrate the promise of belumosudil in cGVHD, and as such we are scaling up our launch preparation activities in anticipation of potential approval. Following the raise of $50 million this quarter through our At-The-Market facility, we are well capitalized through the NDA filing, approval and launch of belumosudil."

    Dr. Waksal continued, "Furthermore, we were pleased to announce this quarter that the first patient was dosed in a Phase 1 clinical trial of KD033, our novel anti-PD-L1/IL-15 immuno-oncology fusion protein, in patients with metastatic or locally advanced solid tumors. This is an important milestone for our biologics platform and we look forward to sharing key updates as the trial advances."

    Upcoming Milestones:

    Belumosudil (KD025)

    • Submit New Drug Application (NDA) for belumosudil in chronic graft-versus-host disease (cGVHD) to the U.S. Food and Drug Administration (FDA) in Q4 2020; the FDA has accepted belumosudil for review under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible
    • Continue ongoing discussions with the European Medicines Agency (EMA) to determine a regulatory path forward for belumosudil in cGVHD; the Company plans to share 12-month data from the ROCKstar pivotal trial with the EMA, which will include key secondary endpoints such as Overall Survival and Failure-Free Survival; the Company expects to share an update on the path forward for belumosudil in Europe in 1H 2021
    • Continue enrollment in ongoing placebo-controlled Phase 2 clinical trial in diffuse cutaneous systemic sclerosis (KD025-209); enrollment is delayed due to the COVID-19 pandemic
    • Initiate small (12-15 patient), open-label Phase 2 clinical trial of belumosudil in patients with diffuse cutaneous systemic sclerosis in Q1 2021

    KD033

    • Continue enrollment in ongoing dose-escalation Phase 1 clinical trial of KD033, Kadmon's anti-PD-L1/IL-15 fusion protein, in patients with metastatic or locally advanced solid tumors

    KD045

    • Continue ongoing Investigational New Drug Application (IND)-enabling activities of KD045, Kadmon's next-generation ROCK inhibitor for the treatment of fibrotic diseases

    Financial Results

    Second Quarter 2020 Results

    Loss from operations for the three and six months ended June 30, 2020 was $26.9 million and $43.0 million, respectively, compared to $24.8 million and $47.6 million for the same periods in 2019.

    The decrease in loss from operations for the six months ended June 30, 2020 as compared to 2019 was primarily due to $6.0 million of license revenue recognized by the Company during the six months ended June 30, 2020 related to the strategic partnership with Meiji Seika Pharma Co., Ltd.

    The increase in loss from operations for the three months ended June 30, 2020 as compared to 2019 was primarily attributable to increased expenses related to preparation for the potential launch of belumosudil.

    Liquidity and Capital Resources

    At June 30, 2020, the Company's cash and cash equivalents totaled $169.8 million, compared to $139.6 million at December 31, 2019. The increase reflects $50.0 million in gross proceeds the Company accessed through its At-The-Market (ATM) facility along with $15.5 million in non-dilutive financing the Company accessed through the divestiture of 1.1 million ordinary shares of MeiraGTx Holdings plc; both transactions took place in May 2020. As of June 30, 2020, the Company held approximately 1.0 million ordinary shares of MeiraGTx Holdings plc, a clinical-stage gene therapy company. The increase in cash and cash equivalents related to these transactions was partially offset by cash used in operating activities of $37.5 million during the six months ended June 30, 2020.

    About ROCKstar

    ROCKstar (KD025-213) is an ongoing open-label trial of belumosudil (KD025) in adults and adolescents with cGVHD who have received at least two prior lines of systemic therapy. Patients were randomized to receive belumosudil (KD025) at 200 mg QD or 200 mg BID, enrolling 66 patients per arm. The primary endpoint of the study is Overall Response Rate (ORR). Statistical significance is achieved if the lower bound of the 95% CI of ORR exceeds 30%. The ORR endpoint was met at the interim analysis, conducted two months after completion of enrollment. At the study's primary analysis, conducted six months after completion of enrollment, belumosudil achieved ORRs of 73% and 74% in the respective arms. Kadmon plans to submit results from the ROCKstar primary analysis for presentation at an upcoming scientific meeting.

    About Belumosudil (KD025)

    Belumosudil (KD025) is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response. The FDA has granted Breakthrough Therapy Designation for belumosudil for the treatment of patients with cGVHD who have received at least two prior lines of systemic therapy. The FDA has also granted Orphan Drug Designation to belumosudil for the treatment of cGVHD. The FDA has accepted belumosudil for review under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. Belumosudil is also being studied in an ongoing Phase 2 clinical trial in adults with diffuse cutaneous systemic sclerosis (KD025-209).

    About Kadmon

    Kadmon is a clinical-stage biopharmaceutical company that discovers, develops and delivers transformative therapies for unmet medical needs. Our clinical pipeline includes treatments for immune and fibrotic diseases as well as immuno-oncology therapies.

    Forward Looking Statements

    This press release contains forward-looking statements. Such statements may be preceded by the words "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "targets," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We believe that these factors include, but are not limited to, (i) the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; (ii) our ability to advance product candidates into, and successfully complete, clinical trials; (iii) the impact of the COVID-19 pandemic on our business, workforce, patients, collaborators and suppliers, including delays in anticipated timelines and milestones of our clinical trials and on various government agencies who we interact with and/or are governed by; (iv) our reliance on the success of our product candidates; (iv) the timing or likelihood of regulatory filings and approvals, especially in light of the COVID-19 pandemic; (v) our ability to expand our sales and marketing capabilities; (vi) our ability to expand our sales and marketing capabilities; (vii) the commercialization, pricing and reimbursement of our product candidates, if approved; (viii) the implementation of our business model, strategic plans for our business, product candidates and technology; (ix) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (x) our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; (xi) costs associated with defending intellectual property infringement, product liability and other claims; (xii) regulatory developments in the United States, Europe, and other jurisdictions; (xiii) estimates of our expenses, future revenues, capital requirements and our needs for additional financing; (xiv) the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; (xv) our ability to maintain and establish collaborations; (xvi) the rate and degree of market acceptance of our product candidates, if approved; (xvii) developments relating to our competitors and our industry, including competing therapies; (xviii) our ability to effectively manage our anticipated growth; (xix) our ability to attract and retain qualified employees and key personnel; (xx) our expected use of cash and cash equivalents and other sources of liquidity; (xxi) the potential benefits of any of our product candidates being granted orphan drug designation; (xxii) the future trading price of the shares of our common stock and impact of securities analysts' reports on these prices; (xxiii) the future trading price of our holdings of shares of MeiraGTx and our potential inability to sell those securities; (xxiv) our ability to apply unused federal and state net operating loss carryforwards against future taxable income and/or (xxv) other risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the U.S. Securities and Exchange Commission (the "SEC"), including Kadmon's Annual Report on Form 10-K for the fiscal year ended December 31, 2019. Investors and security holders are urged to read these documents free of charge on the SEC's website at www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

    Kadmon Holdings, Inc.
    Consolidated Statements of Operations - Unaudited
    (in thousands, except share and per share data)

    Three Months Ended Six Months Ended
    June 30, June 30,
    2020 2019 2020 2019
    Revenues
    Net sales
    $299 $47 $888 $114
    Other revenue
    149 179 6,295 353
    Total revenue
    448 226 7,183 467
    Cost of sales
    162 45 490 76
    Write-down of inventory
    622 932 906 932
    Gross profit
    (336) (751) 5,787 (541)
    Operating expenses:
    Research and development
    16,516 15,108 29,390 30,099
    Selling, general and administrative
    10,068 8,981 19,434 16,927
    Total operating expenses
    26,584 24,089 48,824 47,026
    Loss from operations
    (26,920) (24,840) (43,037) (47,567)
    Total other (expense) income
    (232) 34,000 (13,412) 60,319
    Income tax expense
    - - - -
    Net (loss) income
    $(27,152) $9,160 $(56,449) $12,752
    Deemed dividend on convertible preferred stock
    518 508 1,035 1,023
    Net (loss) income attributable to common stockholders
    $(27,670) $8,652 $(57,484) $11,729
    Basic net (loss) income per share of common stock
    $(0.17) $0.07 $(0.36) $0.09
    Diluted net (loss) income per share of common stock
    $(0.17) $0.07 $(0.36) $0.09
    Weighted average basic shares of common stock outstanding
    162,416,059 129,080,221 161,101,923 127,713,099
    Weighted average diluted shares of common stock outstanding
    162,416,059 129,090,983 161,101,923 127,750,765

    Kadmon Holdings, Inc.
    Condensed Consolidated Balance Sheets - Unaudited
    (in thousands)

    June 30, December 31,
    2020 2019
    Cash and cash equivalents
    $169,803 $139,597
    Other current assets
    3,151 3,010
    Investment, equity securities
    12,492 41,997
    Right of use lease asset
    17,902 19,651
    Other noncurrent assets
    9,896 10,543
    Total assets
    $213,244 $214,798
    Current liabilities
    30,138 28,742
    Lease liability - noncurrent
    17,689 19,759
    Other long term liabilities
    2,160 562
    Total liabilities
    49,987 49,063
    Total stockholders' equity
    163,257 165,735
    Total liabilities and stockholders' equity
    $213,244 $214,798

    Contact Information

    Ellen Cavaleri, Investor Relations
    646.490.2989

    SOURCE: Kadmon Holdings, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/600625/Kadmon-Provides-Business-Update-and-Reports-Second-Quarter-2020-Financial-Results

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  3. NEW YORK, NY / ACCESSWIRE / June 23, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced that the first patient has been dosed in a Phase 1 clinical trial evaluating KD033, an anti-PD-L1/IL-15 fusion protein, in patients with metastatic or locally advanced solid tumors. KD033 is a novel immunotherapy designed to stimulate innate and adaptive immune responses directed to the tumor microenvironment.

    "We are pleased to initiate clinical development of KD033, which has demonstrated encouraging efficacy and durability in a variety of tumor types in preclinical models," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "By directing the anti-tumor activity of IL-15 to the tumor microenvironment, KD033 has the potential to stimulate patients…

    NEW YORK, NY / ACCESSWIRE / June 23, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced that the first patient has been dosed in a Phase 1 clinical trial evaluating KD033, an anti-PD-L1/IL-15 fusion protein, in patients with metastatic or locally advanced solid tumors. KD033 is a novel immunotherapy designed to stimulate innate and adaptive immune responses directed to the tumor microenvironment.

    "We are pleased to initiate clinical development of KD033, which has demonstrated encouraging efficacy and durability in a variety of tumor types in preclinical models," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "By directing the anti-tumor activity of IL-15 to the tumor microenvironment, KD033 has the potential to stimulate patients' immune responses to fight cancer while avoiding systemic toxicities. This study initiation represents an important milestone for Kadmon and our platform of IL-15-containing fusion proteins. We look forward to providing further updates on this trial as they become available."

    Recombinant IL-15 (rIL-15) is an immunostimulatory cytokine that has demonstrated clinical activity in the treatment of several cancers. rIL-15 expands key tumor-fighting cell types, including natural killer (NK), natural killer T (NKT) cells and memory T cells, without expanding immunosuppressive Treg cells, allowing for robust and durable anti-tumor responses. Clinical use of rIL-15 has been limited by its short half-life and narrow therapeutic window. To address these challenges, Kadmon has developed KD033, which is designed to direct IL-15 activity to the tumor microenvironment of PD-L1-expressing tumors and to achieve a greater therapeutic window. KD033 is designed to promote long-lasting efficacy while reducing systemic exposure of IL-15 to potentially increase safety and tolerability.

    In preclinical studies, a single dose of KD033 demonstrated robust in vivo pharmacological activity and inhibited tumor growth across multiple syngeneic mouse models. KD033 also induced T-cell memory, resulting in mice that remained tumor-free following several tumor re-challenges. KD033 demonstrated significant tumor inhibition in animal models that are resistant to approved immunotherapies such as PD-L1, PD-1 or CTLA-4 antibodies.

    About the KD033-101 Clinical Trial

    KD033-101 is a Phase 1, open-label, dose-escalation and dose-expansion study investigating the safety and efficacy of KD033 in patients with metastatic or locally advanced solid tumors. The dose-escalation phase of the study will evaluate the pharmacokinetics and pharmacodynamics and identify the maximum tolerated dose (MTD) of KD033. The dose-expansion phase of the study will enroll approximately 15 patients who have progressed or are refractory to programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor therapy to assess safety, efficacy and determine the recommended Phase 2 dose (RP2D) of KD033.

    About KD033

    KD033 is a novel immunotherapy developed in-house and is fully owned by Kadmon. KD033 combines an anti-PD-L1 antibody with IL-15, a cytokine that expands key tumor-fighting cell types, including natural killer (NK), natural killer T (NKT) and memory T cells, to potentially induce durable responses and inhibit tumor growth. The anti-PD-L1 antibody directs IL-15 activity to the tumor microenvironment, limiting systemic exposure of IL-15 to potentially increase safety and tolerability. KD033 was well tolerated in GLP toxicology studies at clinically relevant doses. KD033 process development and manufacturing was completed through a successful collaboration with Wuxi Biologics and exhibited desired manufacturability and stability criteria.

    KD033 is the most advanced candidate from Kadmon's IL-15 fusion protein platform. The Company is developing a portfolio of therapies combining IL-15 with select antibodies for the treatment of cancer.

    About Kadmon

    Kadmon is a biopharmaceutical company developing innovative products for significant unmet medical needs. Our product pipeline is focused on inflammatory and fibrotic diseases as well as immuno-oncology.

    Forward-Looking Statements

    This press release contains forward-looking statements. Such statements may be preceded by the words "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "targets," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We believe that these factors include, but are not limited to, (i) the impact of COVID-19 on our ability to conduct our business or our clinical trials, (ii) the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; (iii) our ability to advance product candidates into, and successfully complete, clinical trials; (iv) our reliance on the success of our product candidates; (v) the timing or likelihood of regulatory filings and approvals, including an NDA regarding belumosudil (KD025); (vi) our ability to expand our sales and marketing capabilities; (vii) the commercialization of our product candidates, if approved; (viii) the pricing and reimbursement of our product candidates, if approved; (ix) the implementation of our business model, strategic plans for our business, product candidates and technology; (x) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (xi) our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; (xii) costs associated with defending intellectual property infringement, product liability and other claims; (xiii) regulatory developments in the United States, Europe, China, Japan and other jurisdictions; (xiv) estimates of our expenses, future revenues, capital requirements and our needs for additional financing; (xv) the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; (xvi) our ability to maintain and establish collaborations or obtain additional grant funding; (xvii) the rate and degree of market acceptance of our product candidates; (xviii) developments relating to our competitors and our industry, including competing therapies; (xix) our ability to effectively manage our anticipated growth; (xx) our ability to attract and retain qualified employees and key personnel; (xxi) the use of proceeds from our recent public offerings; (xxii) the potential benefits of any of our product candidates being granted orphan drug designation; (xxiii) the future trading price of the shares of our common stock and impact of securities analysts' reports on these prices; and/or (xxiii) other risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the U.S. Securities and Exchange Commission (the "SEC"), including Kadmon's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and subsequent Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's website at www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

    Contact Information

    Ellen Cavaleri
    Investor Relations
    646.490.2989

    SOURCE: Kadmon Holdings, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/594820/Kadmon-Doses-First-Patient-in-Phase-1-Clinical-Trial-of-KD033-an-Anti-PD-L1IL-15-Fusion-Protein-in-Adults-with-Metastatic-or-Locally-Advanced-Solid-Tumors

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  4. NEW YORK, NY / ACCESSWIRE / June 11, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced that Harlan W. Waksal, M.D., President and Chief Executive Officer, will present at the Raymond James 2020 Virtual Human Health Innovation Conference on Thursday, June 18, 2020 at 1:00 p.m. ET.

    A live audio webcast of the presentation may be accessed on the Investors section of the Kadmon website at www.kadmon.com. A replay of the webcast will be available for 90 days.

    About Kadmon

    Kadmon is a biopharmaceutical company developing innovative products for significant unmet medical needs. Our product pipeline is focused on inflammatory and fibrotic diseases as well as immuno-oncology.

    Forward-Looking Statements

    This press release contains forward-looking statements.

    NEW YORK, NY / ACCESSWIRE / June 11, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced that Harlan W. Waksal, M.D., President and Chief Executive Officer, will present at the Raymond James 2020 Virtual Human Health Innovation Conference on Thursday, June 18, 2020 at 1:00 p.m. ET.

    A live audio webcast of the presentation may be accessed on the Investors section of the Kadmon website at www.kadmon.com. A replay of the webcast will be available for 90 days.

    About Kadmon

    Kadmon is a biopharmaceutical company developing innovative products for significant unmet medical needs. Our product pipeline is focused on inflammatory and fibrotic diseases as well as immuno-oncology.

    Forward-Looking Statements

    This press release contains forward-looking statements. Such statements may be preceded by the words "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "targets," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We believe that these factors include, but are not limited to, (i) the impact of COVID-19 on our ability to conduct our business or our clinical trials, (ii) the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; (iii) our ability to advance product candidates into, and successfully complete, clinical trials; (iv) our reliance on the success of our product candidates; (v) the timing or likelihood of regulatory filings and approvals, including an NDA regarding belumosudil (KD025); (vi) our ability to expand our sales and marketing capabilities; (vii) the commercialization of our product candidates, if approved; (viii) the pricing and reimbursement of our product candidates, if approved; (ix) the implementation of our business model, strategic plans for our business, product candidates and technology; (x) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (xi) our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; (xii) costs associated with defending intellectual property infringement, product liability and other claims; (xiii) regulatory developments in the United States, Europe, China, Japan and other jurisdictions; (xiv) estimates of our expenses, future revenues, capital requirements and our needs for additional financing; (xv) the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; (xvi) our ability to maintain and establish collaborations or obtain additional grant funding; (xvii) the rate and degree of market acceptance of our product candidates; (xviii) developments relating to our competitors and our industry, including competing therapies; (xix) our ability to effectively manage our anticipated growth; (xx) our ability to attract and retain qualified employees and key personnel; (xxi) the use of proceeds from our recent public offerings; (xxii) the potential benefits of any of our product candidates being granted orphan drug designation; (xxiii) the future trading price of the shares of our common stock and impact of securities analysts' reports on these prices; and/or (xxiii) other risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the U.S. Securities and Exchange Commission (the "SEC"), including Kadmon's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and subsequent Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's website at www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

    Contact Information

    Ellen Cavaleri
    Investor Relations
    646.490.2989

    SOURCE: Kadmon Holdings, Inc.



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  5. NEW YORK, NY / ACCESSWIRE / June 5, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced that it has raised gross proceeds of $50.0 million through its At-The-Market (ATM) facility, including participation based on interest received from existing shareholders and new healthcare specialist institutional investors. The Company sold approximately 11.1 million shares at then-prevailing market prices. With the closing of this transaction, the Company is capitalized through the anticipated filing, approval and launch of belumosudil in chronic graft-versus-host disease (cGVHD).

    The proceeds from the offering will be used to advance belumosudil toward a New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA), which is anticipated…

    NEW YORK, NY / ACCESSWIRE / June 5, 2020 / Kadmon Holdings, Inc. (NYSE:KDMN) today announced that it has raised gross proceeds of $50.0 million through its At-The-Market (ATM) facility, including participation based on interest received from existing shareholders and new healthcare specialist institutional investors. The Company sold approximately 11.1 million shares at then-prevailing market prices. With the closing of this transaction, the Company is capitalized through the anticipated filing, approval and launch of belumosudil in chronic graft-versus-host disease (cGVHD).

    The proceeds from the offering will be used to advance belumosudil toward a New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA), which is anticipated in the fourth quarter of 2020, and support related pre-commercialization activities and provide additional working capital for general corporate purposes.

    The shares of common stock were sold pursuant to an effective shelf registration statement on Form S-3 that the Company had previously filed with the Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 Belumosudil (KD025)

    Belumosudil (KD025) is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response. In November 2019, the Company announced that the primary endpoint was met in a pivotal trial of belumosudil in patients with cGVHD who have received at least two prior lines of systemic therapy (ROCKstar trial). Kadmon is submitting its NDA for belumosudil under the FDA's Real-Time Oncology Review (RTOR) pilot program. Belumosudil has been granted Breakthrough Therapy Designation by the FDA for the treatment of patients with cGVHD who have received at least two prior lines of systemic therapy. The FDA has also granted Orphan Drug Designation to belumosudil for the treatment of cGVHD.In addition to cGVHD, belumosudil is being studied in an ongoing Phase 2 clinical trial in adults with diffuse cutaneous systemic sclerosis (KD025-209).

    About Kadmon

    Kadmon is a biopharmaceutical company developing innovative products for significant unmet medical needs. Our product pipeline is focused on inflammatory and fibrotic diseases as well as immuno-oncology.

    Forward Looking Statements

    This press release contains forward-looking statements. Such statements may be preceded by the words "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "targets," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We believe that these factors include, but are not limited to, (i) the impact of COVID-19 on our ability to conduct our business or our clinical trials, (ii) the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; (iii) our ability to advance product candidates into, and successfully complete, clinical trials; (iv) our reliance on the success of our product candidates; (v) the timing or likelihood of regulatory filings and approvals, including an NDA regarding belumosudil (KD025); (vi) our ability to expand our sales and marketing capabilities; (vii) the commercialization of our product candidates, if approved; (viii) the pricing and reimbursement of our product candidates, if approved; (ix) the implementation of our business model, strategic plans for our business, product candidates and technology; (x) the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; (xi) our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; (xii) costs associated with defending intellectual property infringement, product liability and other claims; (xiii) regulatory developments in the United States, Europe, China, Japan and other jurisdictions; (xiv) estimates of our expenses, future revenues, capital requirements and our needs for additional financing; (xv) the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; (xvi) our ability to maintain and establish collaborations or obtain additional grant funding; (xvii) the rate and degree of market acceptance of our product candidates; (xviii) developments relating to our competitors and our industry, including competing therapies; (xix) our ability to effectively manage our anticipated growth; (xx) our ability to attract and retain qualified employees and key personnel; (xxi) the use of proceeds from our recent public offerings; (xxii) the potential benefits of any of our product candidates being granted orphan drug designation; (xxiii) the future trading price of the shares of our common stock and impact of securities analysts' reports on these prices; and/or (xxiii) other risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the U.S. Securities and Exchange Commission (the "SEC"), including Kadmon's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and subsequent Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's website at www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

    Contact Information

    Ellen Cavaleri, Investor Relations
    646.490.2989

    SOURCE: Kadmon Holdings, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/592873/Kadmon-Raises-50-Million-in-Gross-Proceeds-Through-Its-at-the-Market-Facility

    View Full Article Hide Full Article
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