1. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Tuesday, September 22, 2020, at 3:20 p.m. ET/12:20 p.m. PT.

    A live webcast of the presentation will be available online in the investor relations section of the company's website at https://ir.alpineimmunesciences.com/events. A replay of the presentation will be available on the company website for 90 days following the webcast.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Tuesday, September 22, 2020, at 3:20 p.m. ET/12:20 p.m. PT.

    A live webcast of the presentation will be available online in the investor relations section of the company's website at https://ir.alpineimmunesciences.com/events. A replay of the presentation will be available on the company website for 90 days following the webcast.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is creating multifunctional immunotherapies via unique protein engineering technologies to improve patients' lives. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on Twitter and LinkedIn.

    "Secreted Immunomodulatory Proteins," "SIP," "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

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  2. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020, at 10:30 a.m. ET/7:30 a.m. PT.

    A live webcast of the presentation will be available online in the investor relations section of the company's website at https://ir.alpineimmunesciences.com/events. A replay of the presentation will be available on the company website for 90 days following the webcast.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020, at 10:30 a.m. ET/7:30 a.m. PT.

    A live webcast of the presentation will be available online in the investor relations section of the company's website at https://ir.alpineimmunesciences.com/events. A replay of the presentation will be available on the company website for 90 days following the webcast.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is creating multifunctional immunotherapies via unique protein engineering technologies to improve patients' lives. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on Twitter and LinkedIn.

    "Secreted Immunomodulatory Proteins", "SIP", "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

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  3. - Signed option to license worldwide rights to ALPN-101 with AbbVie -

    - Received $60 million upfront cash payment from AbbVie; eligible to receive up to $805 million for exercise of the option and success-based development, regulatory and commercial milestones -

    - Dosed first patient in NEON-1 Phase 1 trial of ALPN-202 in patients with advanced malignancies -

    - Raised $60 million in July private placement led by Omega Funds -

    - Conference call and webcast today at 4:30 p.m. ET -

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today provided a corporate update and reported financial results for the…

    - Signed option to license worldwide rights to ALPN-101 with AbbVie -

    - Received $60 million upfront cash payment from AbbVie; eligible to receive up to $805 million for exercise of the option and success-based development, regulatory and commercial milestones -

    - Dosed first patient in NEON-1 Phase 1 trial of ALPN-202 in patients with advanced malignancies -

    - Raised $60 million in July private placement led by Omega Funds -

    - Conference call and webcast today at 4:30 p.m. ET -

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today provided a corporate update and reported financial results for the second quarter ended June 30, 2020.

    Key Second Quarter 2020 and Subsequent Highlights

    • Announced ALPN-101 Option and License Agreement with AbbVie for up to $865 million plus royalties on future sales. In June, Alpine and AbbVie announced an exclusive worldwide option and license agreement for ALPN-101, a first-in-class dual CD28/ICOS costimulation antagonist. Under the terms of the agreement, Alpine received an upfront payment of $60 million and is eligible to receive up to an aggregate of $805 million for exercise of the option and success-based development, regulatory, and commercial milestones. In addition, Alpine is eligible to receive tiered royalties on net sales of ALPN-101. In exchange, AbbVie received an exclusive option to an exclusive license for ALPN-101.
    • Initiated the first-in-human, Phase 1 Trial of ALPN-202. In June, Alpine announced the first patient had been successfully dosed in its NEON-1 Phase 1 study of ALPN-202, a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies.
    • Raised $60 Million in a Private Placement. In July, Alpine raised $60 million in gross proceeds through a private placement led by Omega Funds with participation from Avidity Partners, EcoR1 Capital, LLC, Invus Public Equities, L.P., and Samsara BioCapital, among others. Alpine intends to use the net proceeds to fund the development of its clinical and preclinical pipeline as well as for general corporate purposes.
    • Presented at Multiple Scientific Meetings. From April to June, Alpine made a number of presentations at important scientific conferences including:
      • ALPN-202 Study Design Presented at AACR I - "NEON-1: A first-in-human phase I open-label study of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies."
      • ALPN-202 Additional Preclinical Data at AACR II - "ALPN-202 combines checkpoint inhibition with conditional T cell costimulation to overcome T cell suppression by M2c macrophages and improve the durability of engineered T cell anti-tumor responses."
      • Novel Dual BAFF/APRIL Inhibitory Domains (ALPN-303) for B cell Mediated Autoimmune Diseases at EULAR 2020 - "B Cell Modulatory Variant TNF Receptor Domains (vTDs) Identified by Directed Evolution to Inhibit BAFF and APRIL, Alone or Combined with Variant Ig Domains (vIgD™) that Inhibit T Cell Costimulation, for the Treatment of Severe Autoimmune and/or Inflammatory Disease."
      • ALPN-101 Phase 1 Trial Data at EULAR 2020 - "A Double Blind, Placebo Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, in Healthy Volunteers (HV)."

    "The highlight of Alpine's second quarter was the signing of a transformative option and license agreement for ALPN-101 with AbbVie. This highly competitive deal provides validation of our scientific approach and our unique Directed Evolution platform," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "Importantly, the progression of ALPN-101 is now supported by our AbbVie partnership. Our platform has yielded multiple product candidates in addition to ALPN-101. First among these is ALPN-202, for which we dosed the first patient in our NEON-1 Phase 1 study during the quarter. In addition, we were able to further strengthen our balance sheet via a $60 million private financing, adding a number of high-quality institutions to our shareholder roster. I am very proud of all we have achieved of late and I look forward to further updating you on our progress."

    Financial Highlights

    • As of June 30, 2020, Alpine had cash, cash equivalents, restricted cash, and short-term investments totaling $90.5 million. This balance includes the $60 million upfront cash payment from AbbVie for the option to license ALPN-101, but does not include the $60 million of gross proceeds from our July private placement. Taking the recent private placement into account, we ended July 31, 2020 with $147.5 million in cash, cash equivalents, restricted cash, and short-term investments. This compares to $36.1 million as of March 31, 2020.
    • Net cash provided by operating activities for the six months ended June 30, 2020 was $44.8 million compared to $19.1 million in net cash used for the same period in 2019.
    • Alpine recorded a net loss of $9.9 million and $11.9 million for the second quarters ended June 30, 2020 and 2019, respectively, and $15.5 million and $24.2 million for the six months ended June 30, 2020 and 2019, respectively.
    • Research and development expenses for the second quarter ended June 30, 2020 were $7.1 million compared to $10.2 million for the second quarter ended June 30, 2019. For the first six months of 2020 they were $12.0 million compared to $20.5 million for the same period in 2019.
    • General and administrative expenses for the second quarter ended June 30, 2020 were $3.3 million compared to $2.6 million for the second quarter ended June 30, 2019, and $5.1 million and $4.9 million for the six months ended June 30, 2020 and 2019, respectively.

    Cash Guidance

    Taking the recent private placement into account, Alpine ended July 31, 2020 with $147.5 million in cash, cash equivalents, restricted cash, and short-term investments. Alpine expects that its current cash resources, combined with the potential $75 million in pre-option exercise milestones payable under its option and license agreement with AbbVie, for the development and commercialization of ALPN-101, are sufficient to fund Alpine's planned operations through 2024, including a planned Phase 2 study of ALPN-101 in systemic lupus erythematosus and the further development of ALPN-202 and ALPN-303.

    For additional information regarding Alpine's planned operations, please refer to "Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operation - Liquidity and Capital Resources" in Alpine's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, which Alpine anticipates filing with the Securities and Exchange Commission on or about August 11, 2020.

    Conference Call

    Individuals interested in listening to the conference call may do so by dialing (800) 816-3005 for domestic callers, or (857) 770-0069 for international callers, and using the conference ID: 1699961; or from the webcast link in the investor relations section of the company's website at: www.alpineimmunesciences.com. The recorded webcast will be available for replay for approximately 30 days following the call.

    About ALPN-101

    ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulatory ligand (ICOSL) variant immunoglobulin domain (vIgD™), a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In June 2020, Alpine and AbbVie signed an option and license agreement for the development and commercialization of ALPN-101. During the option period, Alpine will conduct a phase 2 study in systemic lupus erythematosus. Upon exercise of the option, AbbVie will conduct all future clinical development, manufacturing, and commercialization activities for ALPN-101.

    About ALPN-202

    ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. A phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) is currently enrolling.

    About ALPN-303

    ALPN-303 is a dual BAFF/APRIL B cell cytokine antagonist under development for the treatment of B cell-mediated inflammatory diseases. BAFF and APRIL are clinically validated targets, and in preclinical studies, ALPN-303 appears to have superior activity compared to other available inhibitors of these pathways, suggesting the potential to be best-in-class. Development activities to enable clinical trials have been initiated.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine is backed by world-class research and development capabilities, a highly productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on Twitter and LinkedIn.

    Forward-Looking Statements

    This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies; the timing of and results from clinical trials and pre-clinical development activities, including those related to our collaboration with AbbVie; clinical and regulatory objectives and the timing thereof; expectations regarding the sufficiency of cash combined with the potential $75 million in pre-option exercise milestones payable under our option and license agreement with AbbVie to fund operations through 2024; the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates, including those related to our collaboration with AbbVie; our ability to achieve milestones in our collaboration with AbbVie; the progress and potential of our other ongoing development programs; the efficacy of our clinical trial designs; expectations regarding our other ongoing collaborations; the expected use of proceeds from the July 2020 private placement; the timing of our public presentations and potential publication of future clinical data; and our ability to successfully develop and achieve milestones in our development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as "may," "will," "should," "would," "expect," "plan," "intend," and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of expanded product development and clinical activities on operating expenses; our assumptions regarding our planned expenditures and sufficiency of cash to fund operations may be incorrect; we may not achieve additional milestones pursuant to our collaborations; the impact of competition; adverse conditions in the general domestic and global economic markets, including as a result of the ongoing COVID-19 pandemic; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Secreted Immunomodulatory Proteins," "SIP," "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

     

    Alpine Immune Sciences, Inc.

     

     

     

     

    Selected Consolidated Balance Sheet Data

     

     

     

     

    (In thousands)

     

     

     

     

     

     

    June 30, 2020

     

    December 31, 2019

     

     

    (unaudited)

     

     

    Cash and cash equivalents

     

    $

    88,220

     

     

    $

    16,123

     

    Short-term investments

     

    1,998

     

     

    24,397

     

    Total current assets

     

    91,236

     

     

    42,302

     

    Total assets

     

    102,695

     

     

    54,093

     

    Total current liabilities

     

    28,179

     

     

    8,681

     

    Total stockholders' equity

     

    16,228

     

     

    29,474

     

    Total liabilities and stockholders' equity

     

    102,695

     

     

    54,093

     

     

    Consolidated Statement of Operations and

    Comprehensive Income (Loss) Data

     

     

     

     

     

     

     

    (In thousands, except share and per share amounts)

    Three Months Ended June 30,

     

    Six Months Ended June 30,

     

    2020

     

    2019

     

    2020

     

    2019

     

    (unaudited)

    Collaboration revenue

    $

    688

     

     

    $

    567

     

     

    $

    1,779

     

     

    $

    567

     

    Operating expenses:

     

     

     

     

     

     

     

    Research and development

    7,096

     

     

    10,166

     

     

    11,974

     

     

    20,516

     

    General and administrative

    3,344

     

     

    2,553

     

     

    5,122

     

     

    4,898

     

    Total operating expenses

    10,440

     

     

    12,719

     

     

    17,096

     

     

    25,414

     

    Loss from operations

    (9,752

    )

     

    (12,152

    )

     

    (15,317

    )

     

    (24,847

    )

    Other income (expense):

     

     

     

     

     

     

     

    Interest expense

    (226

    )

     

    (61

    )

     

    (346

    )

     

    (131

    )

    Interest income

    44

     

     

    357

     

     

    196

     

     

    741

     

    Loss before taxes

    (9,934

    )

     

    (11,856

    )

     

    (15,467

    )

     

    (24,237

    )

    Income tax benefit

    6

     

     

     

     

    6

     

     

     

    Net loss

    $

    (9,928

    )

     

    $

    (11,856

    )

     

    $

    (15,461

    )

     

    $

    (24,237

    )

    Comprehensive income (loss):

     

     

     

     

     

     

     

    Unrealized (loss) gain on investments

    (1

    )

     

    17

     

     

    (16

    )

     

    32

     

    Unrealized gain (loss) on foreign currency translation

    64

     

     

    4

     

     

    (49

    )

     

    (10

    )

    Comprehensive loss

    $

    (9,865

    )

     

    $

    (11,835

    )

     

    $

    (15,526

    )

     

    $

    (24,215

    )

    Weighted-average shares used to compute basic and diluted net loss per share

    18,588,993

     

     

    18,576,199

     

     

    18,588,442

     

     

    18,126,556

     

    Basic and diluted net loss per share

    $

    (0.53

    )

     

    $

    (0.64

    )

     

    $

    (0.83

    )

     

    $

    (1.34

    )

     

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  4. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12, 2020, at 1:45 p.m. ET/10:45 a.m. PT.

    A live webcast of the presentation will be available online in the investor relations section of the company's website at https://ir.alpineimmunesciences.com/events. A replay of the presentation will be available on the company website for 90 days following the webcast.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics. With…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12, 2020, at 1:45 p.m. ET/10:45 a.m. PT.

    A live webcast of the presentation will be available online in the investor relations section of the company's website at https://ir.alpineimmunesciences.com/events. A replay of the presentation will be available on the company website for 90 days following the webcast.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is creating multifunctional immunotherapies via unique protein engineering technologies to improve patients' lives. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on Twitter and LinkedIn.

    "Secreted Immunomodulatory Proteins," "SIP," "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

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  5. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will release second quarter 2020 financial results on Tuesday, August 11, 2020 after the close of market. Alpine will host a corresponding conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on the same day to discuss the results and provide a corporate update.

    Conference Call and Webcast Details

    To access the live call by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international). To access a live webcast of the call, please visit the Investor Relations section of the Alpine Immune Sciences website at www.alpineimmunesciences.com

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will release second quarter 2020 financial results on Tuesday, August 11, 2020 after the close of market. Alpine will host a corresponding conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on the same day to discuss the results and provide a corporate update.

    Conference Call and Webcast Details

    To access the live call by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international). To access a live webcast of the call, please visit the Investor Relations section of the Alpine Immune Sciences website at www.alpineimmunesciences.com. The recorded webcast will be available for replay for approximately 30 days following the call.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is creating multifunctional immunotherapies via unique protein engineering technologies to improve patients' lives. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on Twitter and LinkedIn.

    "Secreted Immunomodulatory Proteins", "SIP", "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

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  6. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced it has entered into a definitive securities purchase agreement for the sale of common units and prefunded warrant units, as described below, in a private placement with certain institutional and other accredited investors for gross proceeds to Alpine of approximately $60 million, before deducting placement agent commissions and other offering expenses. The private placement is being led by Omega Funds with participation from Avidity Partners, EcoR1 Capital, LLC, Invus Public Equities, L.P., and Samsara BioCapital, among others.

    "The team at Alpine…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced it has entered into a definitive securities purchase agreement for the sale of common units and prefunded warrant units, as described below, in a private placement with certain institutional and other accredited investors for gross proceeds to Alpine of approximately $60 million, before deducting placement agent commissions and other offering expenses. The private placement is being led by Omega Funds with participation from Avidity Partners, EcoR1 Capital, LLC, Invus Public Equities, L.P., and Samsara BioCapital, among others.

    "The team at Alpine is passionate about solving complex problems in immuno-oncology and autoimmune disease to create innovative and meaningful therapies for patients," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine Immune Sciences. "Following the announcement of our transformative collaboration with AbbVie, we are entering into a dynamic phase of growth, with two clinical-stage programs in ALPN-101 and ALPN-202, and a third program, ALPN-303, poised to enter the clinic next year. We believe this is just the beginning, and with the support of a distinguished syndicate of new investors, we expect our cash on hand, potential pre-option exercise milestones under our collaboration with AbbVie, and the cash from this private placement to fund our planned operations through 2024."

    "The whole Omega Funds' team is delighted to partner with Mitch and the Alpine team on this transaction," said Otello Stampacchia, Ph.D., Founder and Managing Director of Omega Funds. "The transformative potential of Alpine's innovative pipeline is impressive. Following the close of this financing, Alpine is well-positioned to advance the development of multiple therapies focused on dramatically improving the standard of care for those living with autoimmune disease and cancer."

    Pursuant to the terms of the securities purchase agreement, at the closing of the private placement, Alpine will issue common units representing an aggregate of approximately 5.1 million shares of common stock and warrants to purchase an aggregate of approximately 1.5 million shares of common stock and prefunded warrant units representing prefunded warrants to purchase an aggregate of approximately 0.8 million shares of common stock and warrants to purchase an aggregate of approximately 0.2 million shares of common stock. Each common unit consists of one share of common stock plus a warrant to purchase 0.3 shares of common stock, and each prefunded warrant unit consists of one prefunded warrant to purchase one share of common stock plus a warrant to purchase 0.3 shares of common stock. Both common units and prefunded warrant units will be sold at a price per unit of $10.1175. The warrants will have a per share exercise price of $12.74 and will be exercisable at any time on or after the closing date and will have a 3.5-year term. The prefunded warrants will have a per share exercise price of $0.001 and will be exercisable at any time on or after the closing date. The price of the common units and prefunded warrant units was based in part on the closing price of $10.08 per share of common stock on the Nasdaq Global Market on July 23, 2020.

    The private placement is expected to close on or about July 28, 2020, subject to the satisfaction of customary closing conditions. Additional details regarding the private placement will be included in a Form 8-K to be filed by Alpine with the Securities and Exchange Commission ("SEC").

    Alpine intends to use the net proceeds to fund the development of its preclinical and clinical pipeline, including ALPN‑101, in systemic lupus erythematosus, ALPN-202, in patients with advanced malignancies, ALPN-303 in B cell-mediated inflammatory diseases, and for general corporate purposes.

    Cowen and Company, LLC acted as lead placement agent and Oppenheimer & Co. Inc. acted as a placement agent in the transaction.

    The securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. Alpine has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable in connection with the private placement and upon exercise of the warrants.

    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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine is backed by world-class research and development capabilities, a highly productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on Twitter and LinkedIn.

    About Omega Funds

    Founded in 2004, Omega Funds is a leading international investment firm that creates and invests in life sciences companies that target our world's most urgent medical needs. Omega focuses on identifying and supporting companies through value inflection points across the full arc of innovation, from company formation through clinical milestones and commercial adoption. Omega Funds' portfolio companies have brought 37 products to market in multiple therapeutic areas, including oncology, rare diseases, precision medicine and others. Please visit www.omegafunds.com for additional information.

    Forward-Looking Statements

    This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact, and include statements regarding Alpine's platform technology, potential therapies, clinical development plans and the timing thereof, the receipt of potential milestones under Alpine's collaborations, the anticipated closing of the private placement and the timing thereof, the sufficiency of Alpine's cash on hand, potential pre-option exercise milestones under its collaboration with AbbVie and the cash to be received from the private placement to fund its planned operations through 2024, and the expected receipt and use of proceeds from the private placement. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "intend," and other similar expressions among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: Alpine's development programs may not advance into the clinic, succeed in the clinic or result in approved products on a timely or cost-effective basis or at all; Alpine's assumptions regarding its planned expenditures and sufficiency of its cash to fund operations may be incorrect; Alpine may not achieve additional milestone payments pursuant to its collaborations; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in Alpine's filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Alpine undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    The Alpine logo is a registered trademark or trademark of Alpine Immune Sciences, Inc. in various jurisdictions.

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  7. - ALPN-202 is a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor -

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced that the first patient has been successfully dosed in its NEON-1 Phase 1 study of ALPN‑202, a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, in patients with advanced malignancies.

    "This is a particularly exciting milestone," said Mitchell Gold, MD, Alpine's Chairman and CEO, "because ALPN-202 embodies the unique founding concepts of Alpine's vIgD platform, incorporating tri-functional agonism and antagonism in a single proprietary…

    - ALPN-202 is a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor -

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced that the first patient has been successfully dosed in its NEON-1 Phase 1 study of ALPN‑202, a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, in patients with advanced malignancies.

    "This is a particularly exciting milestone," said Mitchell Gold, MD, Alpine's Chairman and CEO, "because ALPN-202 embodies the unique founding concepts of Alpine's vIgD platform, incorporating tri-functional agonism and antagonism in a single proprietary functional domain. As we continue with the study, ALPN-202 will hopefully help establish the clinical relevance of localized CD28 costimulation to checkpoint inhibition in cancer."

    NEON-1 includes two parts: dose escalation and expansion cohort(s). It will enroll adults with advanced solid tumors or lymphoma refractory or resistant to standard therapy, including checkpoint inhibitors when indicated. Measurable disease is required for most participants, as are an ECOG status of 0 to 2 and adequate hematological, renal, and hepatic function. Dose escalation begins with single-participant cohorts to minimize the number of participants anticipated to receive subtherapeutic doses, followed by standard 3 + 3 cohorts where two dose regimens, weekly versus every three weeks, will be studied in parallel. Expansion cohorts will explore specific tumor types and/or biomarker-selected tumors, based upon the experience during dose escalation. Safety endpoints include dose-limiting toxicities, adverse events, and circulating cytokines. Objective responses will be assessed by RECIST v1.1 for solid tumors and Lugano criteria for lymphoma. Pharmacokinetics and pharmacodynamics will also be evaluated. More information is available at www.clinicaltrials.gov (NCT04186637).

    About ALPN-202

    ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor designed to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a Phase 1 study of ALPN-202 in patients with advanced malignancies, is currently enrolling.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine is backed by world-class research and development capabilities, a highly productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on Twitter and LinkedIn.

    Forward-Looking Statements

    This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the timing of and results from clinical trials and pre-clinical development activities, clinical and regulatory objectives and the timing thereof, the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates, the efficacy of our clinical trial designs, and our ability to successfully develop and achieve milestones in our development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as "may," "will," "should," "would," "expect," "plan," "intend," and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Secreted Immunomodulatory Proteins", "SIP", "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

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  8. - Alpine Immune Sciences grants AbbVie option to license worldwide rights to ALPN-101, a phase 2-ready, first-in-class dual CD28/ICOS costimulation antagonist, building on AbbVie's commitment to developing novel therapies in Immunology

    - Alpine Immune Sciences to receive $60 million in an upfront cash payment; eligible to receive up to $805 million for exercise of the option and success-based development, regulatory and commercial milestones

    - Alpine Immune Sciences to conduct a phase 2 study in systemic lupus erythematosus during the option period

    - Alpine will host a conference call today at 8:30 a.m. ET -

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments…

    - Alpine Immune Sciences grants AbbVie option to license worldwide rights to ALPN-101, a phase 2-ready, first-in-class dual CD28/ICOS costimulation antagonist, building on AbbVie's commitment to developing novel therapies in Immunology

    - Alpine Immune Sciences to receive $60 million in an upfront cash payment; eligible to receive up to $805 million for exercise of the option and success-based development, regulatory and commercial milestones

    - Alpine Immune Sciences to conduct a phase 2 study in systemic lupus erythematosus during the option period

    - Alpine will host a conference call today at 8:30 a.m. ET -

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, and AbbVie Inc. (NYSE:ABBV), a research-based global biopharmaceutical company, today announced an exclusive worldwide option and license agreement for ALPN-101, a first-in-class dual CD28/ICOS costimulation antagonist.

    CD28 and ICOS are key costimulatory molecules that likely play critical roles in multiple autoimmune and inflammatory diseases. ALPN-101 is a potent inhibitor of both CD28 and ICOS pathways with demonstrated efficacy in multiple preclinical disease models, superior to blockade of either pathway alone. Favorable safety and tolerability, pharmacokinetics and pharmacodynamics have been observed in a first-in-human study in adult healthy volunteers.

    "We are very pleased to partner ALPN-101 with AbbVie, a world leader in the development and commercialization of innovative immunology therapies," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine Immune Sciences. "AbbVie is an ideal partner for ALPN-101, with the therapeutic area expertise, R&D commitment, and global resources needed to maximize ALPN-101's potential for patients suffering from autoimmune diseases. Today's agreement validates our unique Directed Evolution platform that has yielded multiple product candidates, including ALPN-101. We look forward to working with our colleagues at AbbVie to potentially transform clinical outcomes in systemic lupus erythematosus, a disease with currently few appealing treatment options."

    "AbbVie's expertise in Immunology has led to remarkable breakthroughs in the treatment of autoimmune diseases," said Tom Hudson, M.D., Senior Vice President and Chief Scientific Officer, AbbVie. "ALPN-101's dual mechanism of action has compelling potential as a next-generation treatment in systemic lupus erythematosus and other autoimmune diseases. We are excited to partner with the team at Alpine on the development of this novel therapeutic."

    Under the terms of the agreement, Alpine will receive an upfront payment of $60 million, and will also be eligible to receive up to an aggregate of $805 million for exercise of the option and success-based development, regulatory and commercial milestones. In addition, Alpine is eligible to receive tiered royalties on net sales of ALPN-101. In exchange, AbbVie will receive an option to an exclusive license for ALPN-101. During the option period, Alpine will conduct a phase 2 study in systemic lupus erythematosus. Upon exercise of the option, AbbVie will conduct all future clinical development, manufacturing and commercialization activities for ALPN-101.

    Alpine Immune Sciences will host a conference call today at 8:30 a.m. ET to discuss the option and license agreement and outline the company's strategic focus moving forward.

    Conference Call and Webcast Details

    Alpine Immune Sciences will host a conference call today at 8:30 a.m. ET to discuss today's announcement. To access the live call by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international) using participant passcode 3770288. To access a live webcast of the call, please visit the Investor Relations section of the Alpine Immune Sciences website at www.alpineimmunesciences.com. The recorded webcast will be available for replay for approximately 30 days following the call.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine is backed by world-class research and development capabilities, a highly productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on Twitter and LinkedIn.

    About AbbVie

    AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    Forward-Looking Statements

    Alpine Immune Sciences, Inc:

    This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies; the timing of and results from clinical trials and pre-clinical development activities, including those related to our collaboration with AbbVie; clinical and regulatory objectives and the timing thereof; the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates, including those related to our collaboration with AbbVie; our ability to achieve milestones in our collaboration with AbbVie; the progress and potential of our other ongoing development programs; the efficacy of our clinical trial designs; expectations regarding our other ongoing collaborations; and our ability to successfully develop and achieve milestones in our development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as "may," "will," "should," "would," "expect," "plan," "intend," and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of expanded product development and clinical activities on operating expenses; the impact of competition; adverse conditions in the general domestic and global economic markets, including as a result of the ongoing COVID-19 pandemic; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    AbbVie:

    Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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  9. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will present a poster at the AACR Virtual Annual Meeting II, taking place June 22-24, 2020.

    Details of the presentation are as follows:

    Presentation Title: ALPN-202 combines checkpoint inhibition with conditional T cell costimulation to overcome T cell suppression by M2c macrophages and improve the durability of engineered T cell anti-tumor responses
    Session Title: LBPO.IM01 - Late-Breaking Research: Immunology 1
    Date: June 22, 2020, 9:00 AM - 6:00 PM EDT
    Presentation Location: Virtual Meeting II: E-Posters
    Session Type: Virtual…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will present a poster at the AACR Virtual Annual Meeting II, taking place June 22-24, 2020.

    Details of the presentation are as follows:

    Presentation Title: ALPN-202 combines checkpoint inhibition with conditional T cell costimulation to overcome T cell suppression by M2c macrophages and improve the durability of engineered T cell anti-tumor responses

    Session Title: LBPO.IM01 - Late-Breaking Research: Immunology 1

    Date: June 22, 2020, 9:00 AM - 6:00 PM EDT

    Presentation Location: Virtual Meeting II: E-Posters

    Session Type: Virtual Poster Session

    Poster Number: LB-085 / 12

    A copy of the poster will also be made available in the "Scientific Publications" section of Alpine's website at www.alpineimmunesciences.com.

    About ALPN-202

    ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. A phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) is open for enrollment.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two programs in clinical development. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation antagonist engineered to reduce pathogenic T and B cell immune responses by inhibiting ICOS and CD28. ALPN-101 has recently completed a phase 1 healthy volunteer study, and BALANCE, a phase 1b/2 study in acute GVHD, has recently been initiated. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor, and enrollment is open in NEON-1, a phase 1 study in advanced malignancies. Alpine is backed by world-class research and development capabilities, a highly productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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  10. -- ALPN-101 was well tolerated and exhibited potent pharmacodynamic activity, enabling Phase 2 development --

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, presented updated results from its Phase 1 Healthy Volunteer Study of ALPN-101, the company's first-in-class dual CD28/ICOS costimulation antagonist for the treatment of autoimmune and inflammatory diseases.

    The poster, entitled "A Double Blind, Placebo Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, in Healthy Volunteers (HV)", was presented during the SLE, Sjögren's…

    -- ALPN-101 was well tolerated and exhibited potent pharmacodynamic activity, enabling Phase 2 development --

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, presented updated results from its Phase 1 Healthy Volunteer Study of ALPN-101, the company's first-in-class dual CD28/ICOS costimulation antagonist for the treatment of autoimmune and inflammatory diseases.

    The poster, entitled "A Double Blind, Placebo Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, in Healthy Volunteers (HV)", was presented during the SLE, Sjögren's, and APS – Treatment poster session of the European League Against Rheumatism (EULAR) E-Congress on Saturday, June 6, 2020.

    This first-in-human study (NCT03748836) randomized 96 healthy adults to receive single or multiple, intravenous or subcutaneous, placebo or ALPN-101 at doses ranging from 1 μg/kg to 10 mg/kg. At all dose levels, ALPN-101 was well tolerated with no severe adverse events, clinically-significant immunogenicity events, or evidence of cytokine release. Pharmacokinetics and pharmacodynamics exhibited desirable dose dependence, with increasing doses corresponding to increasing duration of complete or near-complete target saturation, as well as inhibition of antibody responses to keyhole limpet hemocyanin (KLH) immunization.

    "These findings extend upon the previously disclosed single ascending dose data and continue to encourage us regarding ALPN-101's future potential," said Stanford Peng, MD PhD, Alpine's President and Head of Research and Development. "They demonstrate the safety, tolerability, and pharmacological activity of multi-dose regimens, enabling the design of Phase 2 studies. We look forward to the opportunity to explore ALPN-101 in multiple inflammatory diseases in the future."

    A copy of the poster is available in the "Scientific Publications" section of Alpine's website at www.alpineimmunesciences.com.

    About ALPN-101

    ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™), a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 - CD80/86 and/or ICOS - ICOSL pathways alone. A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) has been initiated.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two programs in clinical development. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation antagonist engineered to reduce pathogenic T and B cell immune responses by inhibiting ICOS and CD28. ALPN-101 has recently completed enrollment of a phase 1 healthy volunteer study, and BALANCE, a phase 1b/2 study in acute GVHD, has recently been initiated. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor, and enrollment is open in NEON-1, a phase 1 study in advanced malignancies. Alpine is backed by world-class research and development capabilities, a highly productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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  11. First presentation of Alpine's Variant Tumor Necrosis Factor (TNF) Receptor Domain (vTD) Program demonstrating expanded applicability of its directed evolution platform

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today presented a new preclinical program targeting B cell diseases in a poster session at the European Congress of Rheumatology (EULAR) E-Congress 2020.

    The poster, entitled "B Cell Modulatory Variant TNF Receptor Domains (vTDs) Identified by Directed Evolution to Inhibit BAFF and APRIL, Alone or Combined with Variant Ig Domains (vIgD™) that Inhibit T Cell Costimulation, for the Treatment…

    First presentation of Alpine's Variant Tumor Necrosis Factor (TNF) Receptor Domain (vTD) Program demonstrating expanded applicability of its directed evolution platform

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today presented a new preclinical program targeting B cell diseases in a poster session at the European Congress of Rheumatology (EULAR) E-Congress 2020.

    The poster, entitled "B Cell Modulatory Variant TNF Receptor Domains (vTDs) Identified by Directed Evolution to Inhibit BAFF and APRIL, Alone or Combined with Variant Ig Domains (vIgD™) that Inhibit T Cell Costimulation, for the Treatment of Systemic Lupus Erythematosus and Other Severe Autoimmune Diseases", was presented during the EULAR virtual meeting during the poster session titled "New perspectives: Mechanisms driving SLE, Sjögren's and APS".

    BAFF and APRIL are tumor necrosis factor (TNF) superfamily cytokines which play key roles in B cell development, differentiation, and survival, contributing to the pathogenesis of B cell-related autoimmune diseases like systemic lupus erythematosus (SLE). Alpine's proprietary directed evolution platform was used to identify vTDs, derived from the TNF superfamily receptors TACI or BCMA, exhibiting enhanced affinity for BAFF and APRIL. When developed as Fc fusion proteins, such vTDs dramatically reduced B cell function, including antibody production, sometimes more effectively if the vTDs were also fused with CTLA-4 variant immunoglobulin domains (vIgDs) inhibiting the CD80/CD86 T cell costimulatory molecules. Both the vTD-Fc and vIgD-vTD-Fc fusion variants effectively inhibited T-dependent antibody production in keyhole limpet hemocyanin (KLH)-immunized mice and significantly reduced both anti-DNA antibodies and renal disease (nephritis) in a NZB/WF1 mouse lupus model.

    "This work is particularly important to us since it demonstrates the expanded applicability of our directed evolution platform to protein families beyond the immunoglobulin superfamily, the protein family Alpine initially focused upon when founded," remarked Mitchell Gold, MD, Alpine's Executive Chairman and Chief Executive Officer. "Furthermore, this preclinical work suggests these domains may be superior to approved and/or clinical-stage therapeutics like belimumab, abatacept or telitacicept – suggesting they have the potential to be best-in-class clinical candidates for a number of B cell autoimmune diseases like lupus or other connective tissue diseases. We look forward to advancing one or more of these product candidates towards the clinic in the near future."

    A copy of this poster is available in the "Scientific Publications" section of Alpine's website at alpineimmunesciences.com.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two programs in clinical development. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation antagonist engineered to reduce pathogenic T and B cell immune responses by inhibiting ICOS and CD28. ALPN-101 has recently completed enrollment of a phase 1 healthy volunteer study, and BALANCE, a phase 1b/2 study in acute GVHD, has recently been initiated. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor, and enrollment is open in NEON-1, a phase 1 study in advanced malignancies. Alpine is backed by world-class research and development capabilities, a highly productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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  12. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced that the company will present two posters at the EULAR 2020 E-Congress, taking place virtually June 3-6, 2020.

    Details of the presentations are as follows:

    • Presentation Title: B Cell Modulatory Variant TNF Receptor Domains (vTDs) Identified by Directed Evolution to Inhibit BAFF and APRIL, Alone or Combined with Variant Ig Domains (vIgD™) that Inhibit T Cell Costimulation, for the Treatment of Severe Autoimmune and/or Inflammatory Disease
    • Session Title: New perspectives: Mechanisms driving SLE, Sjögren's and APS
    • Dates and Times: Thursday…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced that the company will present two posters at the EULAR 2020 E-Congress, taking place virtually June 3-6, 2020.

    Details of the presentations are as follows:

    • Presentation Title: B Cell Modulatory Variant TNF Receptor Domains (vTDs) Identified by Directed Evolution to Inhibit BAFF and APRIL, Alone or Combined with Variant Ig Domains (vIgD™) that Inhibit T Cell Costimulation, for the Treatment of Severe Autoimmune and/or Inflammatory Disease
    • Session Title: New perspectives: Mechanisms driving SLE, Sjögren's and APS
    • Dates and Times: Thursday, June 4, 2020, 11:50 - 13:30
    • Presentation Location: Virtual Meeting
    • Session Type: Poster Tour
    • Poster Number: THU0222
    • Presentation Title: A Double Blind, Placebo Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, in Healthy Volunteers (HV)
    • Session Title: SLE, Sjögren's and APS - Treatment
    • Dates and Times: Saturday, June 6, 2020, 10:30 - 12:00
    • Presentation Location: Virtual Meeting
    • Session Type: Poster View
    • Poster Number: SAT0196

    An abstract of the presentation will be available on the EULAR E-Congress 2020.

    About ALPN-101

    ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™), a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 - CD80/86 and/or ICOS - ICOSL pathways alone. A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) has been initiated.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two programs in clinical development. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation antagonist engineered to reduce pathogenic T and B cell immune responses by inhibiting ICOS and CD28. ALPN-101 has recently completed enrollment of a phase 1 healthy volunteer study, and BALANCE, a phase 1b/2 study in acute GVHD, has recently been initiated. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor, and enrollment is open in NEON-1, a phase 1 study in advanced malignancies. Alpine is backed by world-class research and development capabilities, a highly productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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  13. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced its participation in an analyst-led fireside chat at the Jefferies Virtual Global Healthcare Conference on Tuesday, June 2, at 10:00 a.m. ET.

    A live webcast of the presentation will be available online in the investor relations section of the company's website at https://ir.alpineimmunesciences.com/events. A replay of the presentation will be available on the company website for 90 days following the webcast.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced its participation in an analyst-led fireside chat at the Jefferies Virtual Global Healthcare Conference on Tuesday, June 2, at 10:00 a.m. ET.

    A live webcast of the presentation will be available online in the investor relations section of the company's website at https://ir.alpineimmunesciences.com/events. A replay of the presentation will be available on the company website for 90 days following the webcast.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two programs in clinical development. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation antagonist engineered to reduce pathogenic T and B cell immune responses by inhibiting ICOS and CD28. ALPN-101 has recently completed enrollment of a phase 1 healthy volunteer study, and BALANCE, a phase 1b/2 study in acute GVHD, has recently been initiated. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor, and enrollment is open in NEON-1, a phase 1 study in advanced malignancies. Alpine is backed by world-class research and development capabilities, a highly productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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  14. - Granted FDA Orphan Drug Designations for ALPN-101 in Acute GVHD -

    - BALANCE and NEON-1 Trials Open for Enrollment -

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today provided a corporate update and reported financial results for the first quarter ended March 31, 2020.

    First Quarter 2020 Highlights and Subsequent Updates:

    • The U.S. FDA Granted Orphan Drug Designations for ALPN-101 in the Prevention and Treatment of Acute Graft Versus Host Disease. In March, the United States Food and Drug Administration (FDA) granted two orphan drug designations for ALPN-101, our first-in-class inhibitor of the…

    - Granted FDA Orphan Drug Designations for ALPN-101 in Acute GVHD -

    - BALANCE and NEON-1 Trials Open for Enrollment -

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today provided a corporate update and reported financial results for the first quarter ended March 31, 2020.

    First Quarter 2020 Highlights and Subsequent Updates:

    • The U.S. FDA Granted Orphan Drug Designations for ALPN-101 in the Prevention and Treatment of Acute Graft Versus Host Disease. In March, the United States Food and Drug Administration (FDA) granted two orphan drug designations for ALPN-101, our first-in-class inhibitor of the CD28 and ICOS inflammation pathways, for the prevention of, and for the treatment of, acute GVHD.
    • ALPN-202 Study Design Presented at AACR. In April, Alpine presented the design of NEON-1, the first-in-human study of ALPN-202, our first-in-class clinical stage conditional CD28 costimulator and dual checkpoint inhibitor, at the American Association of Cancer Research (AACR) Virtual Annual Meeting I, in the Phase I Trials in Progress Virtual Poster Session.
    • ALPN-101 Preclinical Data in Inflammatory Bowel Disease (IBD) Presented at 2020 Crohn's & Colitis Congress and Digestive Disease Week 2020. ALPN-101 modulated inflammatory cytokines in vitro from human IBD peripheral blood mononuclear cells (PBMC) more potently than CD28 or ICOS single-pathway inhibitors and significantly reduced disease activity in vivo in the CD4+CD45RBhi T cell transfer mouse colitis model.
    • ALPN-101 and ALPN-202 Clinical Trials Ongoing. A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) has been initiated. The NEON-1 trial of ALPN-202 (NCT04186637) is open for enrollment.

    "The first quarter was a highly productive one, with now two open clinical studies for both our lead product candidates," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "We were gratified to receive orphan drug designations for ALPN-101 in acute GVHD, where current standard therapies remain inadequate to prevent or control the disease. We also reiterate our excitement over ALPN-202, which is now poised clinically to address a potential key mechanism accounting for checkpoint inhibitor resistance."

    First Quarter 2020 Financial Results

    • As of March 31, 2020, Alpine had cash, cash equivalents, restricted cash, and short-term investments totaling $36.1 million. Net cash used in operating activities for the first quarter ended March 31, 2020 was $9.7 million compared to $11.2 million for the first quarter ended March 31, 2019. Alpine recorded a net loss of $5.5 million and $12.4 million for the first quarters ended March 31, 2020 and 2019, respectively.
    • Research and development expenses for the first quarter ended March 31, 2020 were $4.9 million compared to $10.4 million for the first quarter ended March 31, 2019.
    • General and administrative expenses for the first quarter ended March 31, 2020 were $1.8 million compared to $2.3 million for the first quarter ended March 31, 2019.

    Cash Guidance

    Alpine expects to have sufficient cash to fund its planned operations for at least the next 12 months, including the clinical advancement of Alpine's lead autoimmune/inflammatory program, ALPN-101, and its lead oncology program, ALPN-202.

    For additional information regarding Alpine's planned operations, please refer to "Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operation - Liquidity and Capital Resources" in Alpine's Quarterly Report on Form 10-Q for the three months ended March 31, 2020, which Alpine anticipates filing with the Securities and Exchange Commission on or about May 14, 2020.

    About ALPN-101

    ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™), a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 - CD80/86 and/or ICOS - ICOSL pathways alone. A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) has been initiated.

    About ALPN-202

    ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. A phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) is open for enrollment.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two programs in clinical development. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation antagonist engineered to reduce pathogenic T and B cell immune responses by inhibiting ICOS and CD28. ALPN-101 has recently completed enrollment of a phase 1 healthy volunteer study, and BALANCE, a phase 1b/2 study in acute GVHD, has recently been initiated. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor, and enrollment is open in NEON-1, a phase 1 study in advanced malignancies. Alpine is backed by world-class research and development capabilities, a highly productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

    Forward-Looking Statements

    This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the timing of and results from clinical trials and pre-clinical development activities, clinical and regulatory objectives and the timing thereof, expectations regarding the sufficiency of cash to fund operations, the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates, the timing of our public presentations and potential publication of future clinical data, the efficacy of our clinical trial designs, expectations regarding our ongoing collaborations, and our ability to successfully develop and achieve milestones in our development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as "may," "will," "should," "would," "expect," "plan," "intend," and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Secreted Immunomodulatory Proteins", "SIP", "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

    Alpine Immune Sciences, Inc.

     

     

     

     

    Selected Consolidated Balance Sheet Data

     

     

     

     

    (In thousands)

     

     

     

     

     

     

    March 31, 2020

     

    December 31, 2019

     

     

    (unaudited)

     

     

    Cash and cash equivalents

     

    $

    24,446

     

     

    $

    16,123

     

    Short-term investments

     

    11,237

     

     

    24,397

     

    Total current assets

     

    38,088

     

     

    42,302

     

    Total assets

     

    49,849

     

     

    54,093

     

    Total current liabilities

     

    5,105

     

     

    8,681

     

    Total stockholders' equity

     

    24,859

     

     

    29,474

     

    Total liabilities and stockholders' equity

     

    49,849

     

     

    54,093

     

    Consolidated Statement of Operations and

    Comprehensive Income (Loss) Data

     

     

     

     

    (In thousands, except share and per share amounts)

     

    Three Months Ended March 31,

     

     

    2020

     

    2019

     

     

    (unaudited)

    Collaboration revenue

     

    $

    1,091

     

     

    $

     

    Operating expenses:

     

     

     

     

    Research and development

     

    4,878

     

     

    10,350

     

    General and administrative

     

    1,778

     

     

    2,345

     

    Total operating expenses

     

    6,656

     

     

    12,695

     

    Loss from operations

     

    (5,565

    )

     

    (12,695

    )

    Other income (expense):

     

     

     

     

    Interest expense

     

    (120

    )

     

    (70

    )

    Interest income

     

    152

     

     

    384

     

    Net loss

     

    $

    (5,533

    )

     

    $

    (12,381

    )

    Comprehensive income (loss):

     

     

     

     

    Unrealized (loss) gain on investments

     

    (15

    )

     

    15

     

    Unrealized loss on foreign currency translation

     

    (113

    )

     

    (14

    )

    Comprehensive loss

     

    $

    (5,661

    )

     

    $

    (12,380

    )

    Weighted-average shares used to compute basic and diluted net loss per share

     

    18,587,892

     

     

    17,671,918

     

    Basic and diluted net loss per share

     

    $

    (0.30

    )

     

    $

    (0.70

    )

     

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  15. - NEON-1 is now open for enrollment for patients with advanced malignancies -

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today presented the design of NEON-1, the first-in-human study of ALPN-202, a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor, at the American Association of Cancer Research (AACR) Virtual Annual Meeting I, in the Phase I Trials in Progress Virtual Poster Session.

    Many patients treated with checkpoint inhibitors fail to achieve an objective or complete anti-tumor response. This could be due to a lack of sufficient T cell costimluation in the tumor microenvironment…

    - NEON-1 is now open for enrollment for patients with advanced malignancies -

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today presented the design of NEON-1, the first-in-human study of ALPN-202, a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor, at the American Association of Cancer Research (AACR) Virtual Annual Meeting I, in the Phase I Trials in Progress Virtual Poster Session.

    Many patients treated with checkpoint inhibitors fail to achieve an objective or complete anti-tumor response. This could be due to a lack of sufficient T cell costimluation in the tumor microenvironment, such as inadequate CD28 ligands. To address this, ALPN-202 was designed to inhibit both the PD-L1 and CTLA-4 checkpoints, while also providing a CD28 costimulatory signal. Importantly, ALPN-202's costimulatory function is designed to depend upon PD-L1, to help ensure clinical safety and tolerability.

    NEON-1 includes two parts: dose escalation and expansion cohort(s). It will enroll adults with advanced solid tumors or lymphoma refractory or resistant to standard therapy, including checkpoint inhibitors when indicated. Measurable disease is required for most participants, as are an ECOG status of 0 to 2 and adequate hematological, renal, and hepatic function. Dose escalation begins with single-participant cohorts to minimize the number of participants anticipated to receive subtherapeutic doses, followed by standard 3 + 3 cohorts where two dose regimens, weekly versus every three weeks, will be studied in parallel. Expansion cohorts will explore specific tumor types and/or biomarker-selected tumors, based upon the experience during dose escalation. Safety endpoints include dose-limiting toxicities, adverse events, and circulating cytokines. Objective responses will be assessed by RECIST v1.1 for solid tumors and Lugano criteria for lymphoma. Pharmacokinetics and pharmacodynamics will also be evaluated.

    "We are particularly pleased to see ALPN-202 enter the clinic," said Mitchell Gold, MD, Alpine's Chairman and CEO. "ALPN-202 embodies the unique founding concepts of Alpine's vIgD platform, incorporating tri-functional agonism and antagonism in a single proprietary functional domain. It is now positioned to determine the clinical relevance of localized CD28 costimulation to the immunotherapy of cancer. We look forward to opportunities to report upon its progress in appropriate future settings."

    AACR has made the 2020 virtual Annual Meeting presentations freely available. Alpine's recorded oral presentation of the NEON-1 trial design can be accessed here.

    About ALPN-202

    ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. A phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) is open for enrollment.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two programs in clinical development. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation antagonist engineered to reduce pathogenic T and B cell immune responses by inhibiting ICOS and CD28. ALPN-101 has recently completed a phase 1 healthy volunteer study, and enrollment is currently open in BALANCE, a phase 1b/2 study in acute GVHD. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor, and enrollment is open in NEON-1, a phase 1 study in advanced malignancies. Alpine is backed by world-class research and development capabilities, a highly productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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  16. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will present a poster at the AACR Virtual Annual Meeting I, taking place April 27-28, 2020.

    Details of the presentation are as follows:

    • Presentation Title: NEON-1: A first-in-human phase I open-label study of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies
    • Session Title: VPO.CT07.01 - Phase I Trials in Progress
    • Date: Monday, April 27, 2020
    • Presentation Location: Virtual Meeting
    • Session Type: Virtual Poster Session
    • Poster Number: CT245

    An abstract of the presentation will…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will present a poster at the AACR Virtual Annual Meeting I, taking place April 27-28, 2020.

    Details of the presentation are as follows:

    • Presentation Title: NEON-1: A first-in-human phase I open-label study of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies
    • Session Title: VPO.CT07.01 - Phase I Trials in Progress
    • Date: Monday, April 27, 2020
    • Presentation Location: Virtual Meeting
    • Session Type: Virtual Poster Session
    • Poster Number: CT245

    An abstract of the presentation will be available on the AACR Virtual Annual Meeting I website.

    About ALPN-202

    ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. A phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) is open for enrollment.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two programs in clinical development. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation antagonist engineered to reduce pathogenic T and B cell immune responses by inhibiting ICOS and CD28. ALPN-101 has recently completed a phase 1 healthy volunteer study, and enrollment is currently open in BALANCE, a phase 1b/2 study in acute GVHD. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor, and enrollment is open in NEON-1, a phase 1 study in advanced malignancies. Alpine is backed by world-class research and development capabilities, a highly productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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    • Completion of Phase 1 Study for Lead Autoimmune/Inflammatory Disease Program, ALPN-101
    • BALANCE Trial of ALPN-101 in Acute GVHD Open for Enrollment
    • NEON-1 Trial of ALPN-202 in Advanced Malignancies Open for Enrollment
    • Orphan Drug Designations by the U.S. FDA for ALPN-101 for the Treatment and Prevention of Acute GVHD
    • Conference Call Scheduled for 4:30 p.m. ET Today

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today provided a corporate update and reported financial results for the fourth quarter and year ended December 31, 2019.

    "This past year has been a very productive year for the company…

    • Completion of Phase 1 Study for Lead Autoimmune/Inflammatory Disease Program, ALPN-101
    • BALANCE Trial of ALPN-101 in Acute GVHD Open for Enrollment
    • NEON-1 Trial of ALPN-202 in Advanced Malignancies Open for Enrollment
    • Orphan Drug Designations by the U.S. FDA for ALPN-101 for the Treatment and Prevention of Acute GVHD
    • Conference Call Scheduled for 4:30 p.m. ET Today

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today provided a corporate update and reported financial results for the fourth quarter and year ended December 31, 2019.

    "This past year has been a very productive year for the company. We received orphan drug designations from the FDA, presented updated data at multiple conferences including ASH, ACR, SITC, and the Crohn's & Colitis Congress, and completed enrollment in our Phase 1 study of ALPN-101, our lead therapeutic for the potential treatment of autoimmune and inflammatory diseases," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "We have opened enrollment in BALANCE, a trial for ALPN-101 in acute GVHD, and NEON-1, a trial for ALPN-202 in advanced malignancies, beginning the next phase of evolution for the company as we test these novel molecules in patients in need of better therapeutic options."

    Recent Corporate and Clinical Highlights

    Key Clinical and Preclinical Data Presentations at Biomedical Meetings: We showcased clinical and/or preclinical data for our lead programs, ALPN-101 and ALPN-202, at the following recent medical meetings:

    • Initial ALPN-101 phase 1 healthy volunteer study data presented at the American Society of Hematology meeting in December: In adult healthy volunteers, ALPN-101 was well tolerated as single intravenous or subcutaneous doses, without cytokine release, infusion-related reactions, hypersensitivity, or other signs of agonist activity. Dose-dependent pharmacodynamic activity was observed, including inhibition of T cell activation, assessed ex vivo based on inhibition of staphylococcal enterotoxin B (SEB)-induced cytokine production, and inhibition of antibody responses, assessed following immunization with keyhole limpet hemocyanin (KLH). Based on activity in models, together with favorable tolerability and pharmacodynamics in healthy volunteers, ALPN-101 has the potential to be a clinically meaningful immunomodulator for the treatment of inflammatory diseases such as GVHD.
    • ALPN-101 preclinical data presented at ACR: The two posters presented a unique potency of ALPN-101, often superior even to combinations of biologics individually targeting the CD28 and ICOS pathways, as measured by in vitro assays involving patient-derived immune cells and in vivo mouse models of inflammatory arthritis, lupus, and Sjögren's Syndrome.
    • ALPN-202 preclinical data presented in posters at SITC: One poster presented mechanistic data supporting ALPN-202 inhibits both the PD-L1 and CTLA-4 checkpoint pathways while also providing PD-L1-dependent CD28 costimulation, as intentionally designed. A second poster demonstrated the ability of ALPN-202 to improve significantly upon the activity of existing cancer therapeutics when given alone and/or in combination in preclinical models. In addition, crystallographic study suggested ALPN-202 binds PD-L1 and CD28 at distinct, non-overlapping epitopes enabling its potentially unique functionality.
    • ALPN-101 preclinical data in IBD presented at 2020 Crohn's & Colitis Congress: These new data showed ALPN-101 modulated inflammatory cytokines in vitro from human IBD peripheral blood mononuclear cells (PBMC) more potently than CD28 or ICOS single-pathway inhibitors, and significantly reduced disease activity in the CD4+CD45RBhi T cell transfer mouse colitis model.

    ALPN-101 Received FDA Orphan Drug Designations for the Prevention and Treatment of Acute Graft Versus Host Disease: Earlier this month, the United States Food and Drug Administration (FDA) granted two orphan drug designations for ALPN-101, one for the prevention of and one for the treatment of acute GVHD.

    Clinical Trials in Patients Now Open for Both Development Programs: A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) and a phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) are now both open for enrollment.

    Full Year 2019 Financial Results

    As of December 31, 2019, we had cash, cash equivalents, restricted cash, and short-term investments totaling $40.9 million. Net cash used in operating activities for the year ended December 31, 2019 was $35.3 million compared to $28.4 million for the year ended December 31, 2018. We recorded a net loss of $41.9 million and $36.5 million for the years ended December 31, 2019 and 2018, respectively.

    Collaboration revenue for the year ended December 31, 2019 was $1.7 million compared to $0.7 million for the year ended December 31, 2018. The increase was primarily attributable to $1.3 million in revenue recognized from the Adaptimmune Collaboration Agreement and a $0.4 million milestone payment from Laurel from the sale of our GSNOR assets.

    Research and development expenses for the year ended December 31, 2019 were $35.8 million compared to $29.0 million for the year ended December 31, 2018. The increase was primarily attributable to an increase in clinical trial activity, direct research activities, personnel-related expenses as a result of growth in headcount to support ongoing discovery and development programs, related overhead and facility costs for these programs, and an increase in stock-based compensation.

    General and administrative expenses for the year ended December 31, 2019 were $9.5 million compared to $8.4 million for the year ended December 31, 2018. The increase was primarily attributable to personnel-related expenses related to an increase in administrative headcount, increases in professional and legal services, and an increase in facility costs to support the growth of our business.

    Fourth Quarter and Full Year 2019 Conference Call and Webcast Details

    Alpine will hold a conference call and webcast to discuss results from the fourth quarter and full year 2019 on March 30, 2020 at 4:30 pm EDT. To access the live call by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international) using participant passcode 6877935. To access a live webcast of the call, please visit the Investor Relations section of the Alpine Immune Sciences website at ir.alpineimmunesciences.com. The recorded webcast will be available for replay for approximately 30 days following the call.

    About ALPN-101

    ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™), a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 - CD80/86 and/or ICOS - ICOSL pathways alone. A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) is open for enrollment.

    About ALPN-202

    ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. A phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) is open for enrollment.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two programs in clinical development. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation antagonist engineered to reduce pathogenic T and B cell immune responses by inhibiting ICOS and CD28. ALPN-101 has recently completed a phase 1 healthy volunteer study, and enrollment is currently open in BALANCE, a phase 1b/2 study in acute GVHD. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor, and enrollment is open in NEON-1, a phase 1 study in advanced malignancies. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

    Forward-Looking Statements

    This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the timing of and results from clinical trials and pre-clinical development activities, clinical and regulatory objectives and the timing thereof, expectations regarding the sufficiency of cash to fund operations, the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates, the timing of our public presentations and potential publication of future clinical data, the efficacy of our clinical trial designs, expectations regarding our ongoing collaborations, and our ability to successfully develop and achieve milestones in our development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as "may," "will," "should," "would," "expect," "plan," "intend," and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Secreted Immunomodulatory Proteins", "SIP", "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

    Alpine Immune Sciences, Inc.

     

     

     

     

    Selected Consolidated Balance Sheet Data

     

     

     

     

    (In thousands)

     

     

     

     

     

     

    December 31, 2019

     

    December 31, 2018

    Cash and cash equivalents

     

    $

    16,123

     

     

    $

    10,711

     

    Short-term investments

     

    24,397

     

     

    41,592

     

    Total current assets

     

    42,302

     

     

    53,545

     

    Total assets

     

    54,093

     

     

    54,873

     

    Total current liabilities

     

    8,681

     

     

    8,127

     

    Total stockholders' equity

     

    29,474

     

     

    44,591

     

    Total liabilities and stockholders' equity

     

    54,093

     

     

    54,873

     

    Consolidated Statement of Operations and

    Comprehensive Income (Loss) Data

     

     

     

     

     

     

     

    (In thousands, except share and per share amounts)

    Three Months Ended December 31,

     

    Twelve Months Ended December 31,

     

    2019

     

    2018

     

    2019

     

    2018

     

    (unaudited)

     

     

     

     

    Collaboration revenue

    $

    884

     

     

    $

     

     

    $

    1,740

     

     

    $

    705

     

    Operating expenses:

     

     

     

     

     

     

     

    Research and development

    5,799

     

     

    8,931

     

     

    35,847

     

     

    28,970

     

    General and administrative

    2,102

     

     

    2,514

     

     

    9,467

     

     

    8,362

     

    Loss on sale of intangible asset

     

     

     

     

     

     

    1,203

     

    Total operating expenses

    7,901

     

     

    11,445

     

     

    45,314

     

     

    38,535

     

    Loss from operations

    (7,017

    )

     

    (11,445

    )

     

    (43,574

    )

     

    (37,830

    )

    Other income (expense):

     

     

     

     

     

     

     

    Bargain purchase gain

     

     

     

     

     

     

     

    Interest and other expense

    (141

    )

     

    (76

    )

     

    (338

    )

     

    (319

    )

    Interest income

    206

     

     

    325

     

     

    1,248

     

     

    1,296

     

    Other income

    812

     

     

     

     

    812

     

     

     

    Loss before taxes

    (6,140

    )

     

    (11,196

    )

     

    (41,852

    )

     

    (36,853

    )

    Income tax benefit

     

     

    61

     

     

     

     

    366

     

    Net loss

    $

    (6,140

    )

     

    $

    (11,135

    )

     

    $

    (41,852

    )

     

    $

    (36,487

    )

    Comprehensive income (loss):

     

     

     

     

     

     

     

    Unrealized gain (loss) on investments

    (8

    )

     

    12

     

     

    29

     

     

    46

     

    Unrealized loss on foreign currency translation

    11

     

     

     

     

    (6

    )

     

     

    Comprehensive loss

    $

    (6,137

    )

     

    $

    (11,123

    )

     

    $

    (41,829

    )

     

    $

    (36,441

    )

    Weighted-average shares used to compute basic and diluted net loss per share

    18,587,817

     

     

    13,852,729

     

     

    18,358,864

     

     

    13,849,470

     

    Basic and diluted net loss per share

    $

    (0.33

    )

     

    $

    (0.80

    )

     

    $

    (2.28

    )

     

    $

    (2.63

    )

     

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  17. Company to Hold Conference Call to Discuss Fourth Quarter and Full Year 2019 Results on March 30, 2020

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN) , a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the United States Food and Drug Administration (FDA) has made two orphan drug designations for ALPN-101, Alpine's first-in-class selective dual T cell costimulation inhibitor, for the prevention and for the treatment of acute GVHD.

    "We are pleased to receive these important designations from the FDA in acute GVHD, where current standard therapies remain inadequate to prevent or control the disease," said Mitchell H. Gold, MD, Executive Chairman…

    Company to Hold Conference Call to Discuss Fourth Quarter and Full Year 2019 Results on March 30, 2020

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN) , a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the United States Food and Drug Administration (FDA) has made two orphan drug designations for ALPN-101, Alpine's first-in-class selective dual T cell costimulation inhibitor, for the prevention and for the treatment of acute GVHD.

    "We are pleased to receive these important designations from the FDA in acute GVHD, where current standard therapies remain inadequate to prevent or control the disease," said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. "ALPN-101's unique mechanism has the potential to serve as a groundbreaking medicine for patients suffering from a range of progressive and devastating autoimmune/inflammatory indications with little or no treatment options available to them today."

    Orphan designation is granted by the FDA Office of Orphan Products Development to advance the evaluation and development of safe and effective therapies for the treatment or prevention of rare diseases or conditions affecting fewer than 200,000 people in the U.S. Under the Orphan Drug Act, the FDA may provide grant funding toward clinical trial costs, tax advantages, FDA user-fee benefits, and seven years of market exclusivity in the U.S. following marketing approval by the FDA. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. For more information about orphan designation, please visit the FDA website at www.fda.gov.

    Fourth Quarter and Full Year 2019 Conference Call and Webcast Details

    Alpine will hold a conference call and webcast to discuss results from the fourth quarter and full year 2019 on March 30, 2020 at 4:30 p.m. ET. To access the live call by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international) using participant passcode 6877935. To access a live webcast of the call, please visit the Investor Relations section of the Alpine Immune Sciences website at ir.alpineimmunesciences.com. The recorded webcast will be available for replay for approximately 30 days following the call.

    About Graft Versus Host Disease (GVHD)

    Graft versus host disease (GVHD) is the most common life-threatening complication of a hematopoietic cell transplant. It occurs when donor cells see recipient cells as foreign and attack them. Acute GVHD typically occurs within the early weeks and months after transplant, usually involving the skin, liver, and gastrointestinal tract. GVHD patients remain at risk of organ system damage and increased mortality due to the disease and to high dose glucocorticoids.

    About ALPN-101

    ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™), a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 – CD80/86 and/or ICOS - ICOSL pathways alone.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. ALPN-101 has recently completed enrollment in a Phase 1 healthy volunteer trial. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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  18. Alpine Immune Sciences, Inc. (NASDAQ:ALPN) announced today the cancellation of the Company's presentation and webcast at the Cowen 40th Annual Healthcare Conference scheduled for Tuesday, March 3, 2020 at 11:20 am. Eastern Time. The Company is taking precautionary measures in response to the evolving coronavirus (COVID-19) situation in the Seattle area.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation blocker…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN) announced today the cancellation of the Company's presentation and webcast at the Cowen 40th Annual Healthcare Conference scheduled for Tuesday, March 3, 2020 at 11:20 am. Eastern Time. The Company is taking precautionary measures in response to the evolving coronavirus (COVID-19) situation in the Seattle area.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. ALPN-101 has recently completed enrollment in a Phase 1 healthy volunteer trial. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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  19. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company focused on developing treatments for autoimmune/inflammatory diseases and cancer, today announced the company will present at two upcoming investor healthcare conferences in March.

    Cowen 40th Annual Healthcare Conference

    Tuesday, March 3, 2020 at 11:20 a.m. Eastern Time in Boston, MA

    Oppenheimer & Co. 30th Annual Healthcare Conference

    Tuesday, March 17, 2020, at 4:30 p.m. Eastern Time in New York, NY

    A live webcast of each presentation will be available online by visiting the investor relations page of the Company's website, at https://ir.alpineimmunesciences.com/events. An archive of each webcast will be available on the Company's website for 30 days.

    About Alpine

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company focused on developing treatments for autoimmune/inflammatory diseases and cancer, today announced the company will present at two upcoming investor healthcare conferences in March.

    Cowen 40th Annual Healthcare Conference

    Tuesday, March 3, 2020 at 11:20 a.m. Eastern Time in Boston, MA

    Oppenheimer & Co. 30th Annual Healthcare Conference

    Tuesday, March 17, 2020, at 4:30 p.m. Eastern Time in New York, NY

    A live webcast of each presentation will be available online by visiting the investor relations page of the Company's website, at https://ir.alpineimmunesciences.com/events. An archive of each webcast will be available on the Company's website for 30 days.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. ALPN-101 has recently completed enrollment in a Phase 1 healthy volunteer trial. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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  20. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, presented new preclinical data on its lead autoimmune/inflammatory clinical program, ALPN-101, at the 2020 Crohn's & Colitis Congress in Austin, Texas.

    ALPN-101 is a novel inhibitor of both the CD28 and ICOS T cell co-stimulatory pathways on both naïve and activated pathogenic T cells to provide superior efficacy to therapeutics which only interfere with a single pathway. The new data demonstrate the unique potency of ALPN-101 as measured by in vitro assays involving PBMC's (Peripheral Blood Mononuclear Cells) from patients with Crohn's Disease (CD) or Ulcerative…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, presented new preclinical data on its lead autoimmune/inflammatory clinical program, ALPN-101, at the 2020 Crohn's & Colitis Congress in Austin, Texas.

    ALPN-101 is a novel inhibitor of both the CD28 and ICOS T cell co-stimulatory pathways on both naïve and activated pathogenic T cells to provide superior efficacy to therapeutics which only interfere with a single pathway. The new data demonstrate the unique potency of ALPN-101 as measured by in vitro assays involving PBMC's (Peripheral Blood Mononuclear Cells) from patients with Crohn's Disease (CD) or Ulcerative colitis (UC) and in vivo mouse models of colitis.

    In the poster titled, "ALPN-101, A First-In-Class Dual ICOS/CD28 Antagonist, Demonstrates Efficacy in Patient-Derived PBMC In Vitro and in an In Vivo T Cell Transfer Model of Chronic Inflammatory Bowel Disease (IBD)," ALPN-101 demonstrates superior suppression of proinflammatory cytokines in vitro from human colitis patient's PBMC's more potently than single CD28 or ICOS pathway inhibitors and effector memory T cell and cytokine suppression in mouse in vivo translational models of IBD.

    "The new data demonstrates the remarkable ability of ALPN-101 to suppress the progression of and completely prevent the development of colitis in preclinical models," commented Stanford Peng, M.D., Ph.D., President and Head of Research and Development at Alpine. "A single dose of ALPN-101 at either day 0 or day 14 resulted in milder colitis compared to study control. We are encouraged by these results and believe this data will further support the clinical advancement of ALPN-101 in the treatment of Crohn's disease and colitis."

    ALPN-101 has previously been shown to have potent immunosuppressive activity in various in vitro and in vivo models of disease, including acute graft versus host disease, inflammatory arthritis, and multiple sclerosis, Sjögren's Syndrome and Systemic Lupus Erythematosus.

    The full poster presentation can be found on Alpine's website, here.

    About ALPN-101

    ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™), and a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely-related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, Crohn's disease, colitis, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 – CD80/86 or ICOS - ICOSL pathways alone.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. ALPN-101 has recently completed enrollment in a Phase 1 healthy volunteer trial. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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  21. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will present a poster at the 2020 Crohn's & Colitis Congress taking place January 23-25, 2020, in Austin, Texas.

    Details of the presentation are as follows:

    • Presentation Title: ALPN-101, A First-In-Class Dual ICOS/CD28 Antagonist, Demonstrates Efficacy in Patient-Derived PBMC In Vitro and in an In Vivo T Cell Transfer Model of Chronic Inflammatory Bowel Disease (IBD)
    • Session Title: Animal Models: Pre-Clinical Treatment of Intestinal Inflammation
    • Dates and Times: Thursday, January 23, 2020, 7:00 – 9:00 p.m. and Friday, January…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today announced the company will present a poster at the 2020 Crohn's & Colitis Congress taking place January 23-25, 2020, in Austin, Texas.

    Details of the presentation are as follows:

    • Presentation Title: ALPN-101, A First-In-Class Dual ICOS/CD28 Antagonist, Demonstrates Efficacy in Patient-Derived PBMC In Vitro and in an In Vivo T Cell Transfer Model of Chronic Inflammatory Bowel Disease (IBD)
    • Session Title: Animal Models: Pre-Clinical Treatment of Intestinal Inflammation
    • Dates and Times: Thursday, January 23, 2020, 7:00 – 9:00 p.m. and Friday, January 24, 2020, 3:50 – 4:20 p.m.
    • Presentation Location: Exhibit Hall 1, Austin Convention Center
    • Session Type: Poster Session
    • Poster Number: P156

    An abstract of the presentation is available in the online planner section of the Crohn's & Colitis Congress website and in the Congress Mobile App.

    About ALPN-101

    ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™), and a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely-related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 – CD80/86 or ICOS - ICOSL pathways alone.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. ALPN-101 has recently completed enrollment in a Phase 1 healthy volunteer trial. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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  22. ALPN-101 demonstrates ability to potently inhibit both T and B cell responses in first-in-human study

    Human experience supports both IV and SQ dosing regimens

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, presented Phase 1 data yesterday from the healthy volunteer study of ALPN-101, a first-in-class dual CD28/ICOS antagonist, and details on its upcoming Phase 1/2 BALANCE study of ALPN-101 in steroid-resistant or steroid-refractory acute graft-versus-host disease (GVHD) at the 61st American Society of Hematology Annual Meeting (ASH) in Orlando, FL.

    Jan Hillson, MD, Senior Vice President of Clinical Development…

    ALPN-101 demonstrates ability to potently inhibit both T and B cell responses in first-in-human study

    Human experience supports both IV and SQ dosing regimens

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, presented Phase 1 data yesterday from the healthy volunteer study of ALPN-101, a first-in-class dual CD28/ICOS antagonist, and details on its upcoming Phase 1/2 BALANCE study of ALPN-101 in steroid-resistant or steroid-refractory acute graft-versus-host disease (GVHD) at the 61st American Society of Hematology Annual Meeting (ASH) in Orlando, FL.

    Jan Hillson, MD, Senior Vice President of Clinical Development at Alpine, presented "An Open Label Study of ALPN-101, a First-in-Class Dual CD28/ICOS Antagonist, in Subjects with Steroid-Resistant or Steroid-Refractory Acute Graft Versus Host Disease (BALANCE)" as part of the oral session, "Chemical Biology and Experimental Therapeutics: Novel Compounds and Mechanisms of Action."

    Highlights included:

    • T cell costimulation via the CD28 and ICOS pathways is critical to the pathogenesis of GVHD. Available therapies blocking the CD28 – CD80/86 pathway, such as abatacept and belatacept (CTLA4-Ig), may be at least partially beneficial in acute GVHD, but based on models they appear also to permit escape of ICOS+ T cells, which correlate with disease activity.
    • ALPN-101 is a dual inhibitor of CD28 and ICOS and demonstrates potent efficacy in preclinical models. It exhibits a potent, unique activity superior to combinations of biologics individually antagonizing the CD28 – CD80/86 and ICOS – ICOSL pathways.
    • In adult healthy volunteers, ALPN-101 has been well tolerated as single intravenous or subcutaneous doses, without cytokine release, infusion-related reactions, hypersensitivity, or other signs of agonist activity.
    • Dose-dependent pharmacodynamic activity was observed, including inhibition of T cell activation, assessed ex vivo based on inhibition of staphylocococcal entereotoxin B (SEB)-induced cytokine production, and inhibition of antibody responses, assessed following immunization with keyhole limpet hemocyanin (KLH).
    • Based on activity in models, together with favorable tolerability and pharmacodynamics in healthy volunteers, ALPN-101 has the potential to be a clinically meaningful immunomodulator for the treatment of inflammatory diseases such as GVHD.
    • BALANCE is a Phase 1/2, first-in-disease dose escalation and expansion study of ALPN-101 in patients with active, steroid-refractory or steroid-resistant acute GVHD. It will explore the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ALPN-101.

    "Despite decades of intense research, GVHD remains a major cause of morbidity and mortality after hematopoietic stem cell transplantation," commented Sophie Paczesny, MD, PhD, Professor of Immunology and Pediatrics at Indiana University School of Medicine and lead of the Biomarkers Stem Cell Transplantation Program and one of Alpine's research collaborators. "Current therapies are associated with significant toxicities or are simply insufficient to control the disease. CD28 and ICOS appear to be key pathways in the pathogenesis of GVHD, and the presented data with ALPN-101 appear uniquely strong. I look forward to the BALANCE study, which may demonstrate the therapeutic potential of ALPN-101."

    About Graft Versus Host Disease (GVHD)

    Graft versus host disease (GVHD) is the most common life-threatening complication of a hematopoietic cell transplant. It occurs when donor cells see recipient cells as foreign and attack them. Acute GVHD typically occurs within the early weeks and months after transplant, usually involving the skin, liver, and gastrointestinal tract. GVHD patients remain at risk of organ system damage and increased mortality due to the disease and to high dose glucocorticoids.

    About ALPN-101

    ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™), and a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely-related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 – CD80/86 or ICOS - ICOSL pathways alone.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. ALPN-101 has recently completed enrollment in a Phase 1 healthy volunteer trial. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

    Forward-Looking Statements

    This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the timing of and results from clinical trials and pre-clinical development activities, clinical and regulatory objectives and the timing thereof, expectations regarding the sufficiency of cash to fund operations, the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates, the timing of our public presentations and potential publication of future clinical data, the efficacy of our clinical trial designs, expectations regarding our ongoing collaborations, and our ability to successfully develop and achieve milestones in our development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as "may," "will," "should," "would," "expect," "plan," "intend," and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Secreted Immunomodulatory Proteins", "SIP", "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

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  23. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today announced participation in an analyst-led fireside chat at the 31st Annual Piper Jaffray Healthcare Conference on Tuesday, December 3, 2019 at 3:00 p.m. Eastern Time in New York, NY.

    A live webcast of the fireside chat will be available online in the investor relations section of the company's website at https://ir.alpineimmunesciences.com/events. A replay of the presentation will be available on the company website for 90 days following the webcast.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today announced participation in an analyst-led fireside chat at the 31st Annual Piper Jaffray Healthcare Conference on Tuesday, December 3, 2019 at 3:00 p.m. Eastern Time in New York, NY.

    A live webcast of the fireside chat will be available online in the investor relations section of the company's website at https://ir.alpineimmunesciences.com/events. A replay of the presentation will be available on the company website for 90 days following the webcast.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T-cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. ALPN-101 has recently completed enrollment in a phase 1 healthy volunteer trial. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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  24. Company Advancing ALPN-101 into a Phase 1/2 Acute Graft versus Host Disease Study (BALANCE)

    Phase 1 Study (NEON-1) of Lead Oncology Program ALPN-202 Planned to Commence in Q1 2020

    Conference Call Scheduled for 4:30 p.m. ET Today

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today reported a corporate update and financial results for the third quarter ended September 30, 2019.

    "The third quarter of 2019 included several significant milestones for Alpine, highlighted by completion of enrollment in our Phase 1 study in healthy volunteers for our lead program, ALPN-101," said Mitchell H. Gold…

    Company Advancing ALPN-101 into a Phase 1/2 Acute Graft versus Host Disease Study (BALANCE)

    Phase 1 Study (NEON-1) of Lead Oncology Program ALPN-202 Planned to Commence in Q1 2020

    Conference Call Scheduled for 4:30 p.m. ET Today

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today reported a corporate update and financial results for the third quarter ended September 30, 2019.

    "The third quarter of 2019 included several significant milestones for Alpine, highlighted by completion of enrollment in our Phase 1 study in healthy volunteers for our lead program, ALPN-101," said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. "We believe ALPN-101 has the potential to deliver significantly differentiated efficacy outcomes across a range of inflammatory and autoimmune diseases. We look forward to highlighting our upcoming Phase 1/2 BALANCE study of ALPN-101 during an oral presentation at the ASH annual meeting next month."

    "In addition, we are actively preparing for the initiation of the Phase 1 NEON-1 study of our lead immuno-oncology program, ALPN-202," Dr. Gold said. "At Alpine, we share a deep commitment and drive to deliver the next generation of immunotherapies to patients suffering from debilitating and deadly diseases and I am proud of the work our entire team has done in the transformation of Alpine to an established, clinical-stage company."

    Recent Pipeline and Company Highlights

    ALPN-101 Clinical Advancement

    • Completed enrollment of Phase 1 Study of ALPN-101: On October 30, 2019, Alpine announced completion of enrollment of its Phase 1 study of ALPN-101, a first-in-class dual ICOS/CD28 antagonist. Results from this trial will help inform further development of ALPN-101 in serious autoimmune and inflammatory diseases.
      • Overall, ALPN-101 was generally well-tolerated, without evidence of cytokine storm, cytokine release, or clinical immunogenicity while being dosed as single or multiple doses, intravenously or subcutaneously.
      • Preliminary analyses indicate well-behaved pharmacokinetics and pharmacodynamics, including on-target inhibition of immune functionality, such as antibody responses to keyhole limpet hemocyanin (KLH) and ex vivo staphylococcal enterotoxin B (SEB)-induced cytokine responses.
      • These initial findings will be included as part of an oral presentation at ASH next month, and further details after completion of final analyses are expected to be reported in presentations in the first half of 2020.
    • New ALPN-101 Data Presented at American College of Rheumatology (ACR) Annual Meeting: Earlier this week, Alpine presented new preclinical data on ALPN-101 in two posters during sessions at ACR. The new data highlighted ALPN-101's novel dual mechanism of action which modulates unique inflammatory pathways, distinct from the other biologic therapies singly targeting the ICOS or CD28 pathways, and results in potent efficacy in multiple disease models. The full posters from ACR can be viewed here.
    • Upcoming Oral Presentation at American Society of Hematology (ASH) Annual Meeting: Alpine will present on its upcoming Phase 1/2 BALANCE study of ALPN-101 in steroid-resistant or steroid-refractory acute Graft-versus-Host Disease (GvHD). Dr. Jan Hillson, Senior Vice President, Clinical Development for Alpine, will present on December 8, 2019 at 11:00 a.m. ET. The full abstract can be viewed here.

    ALPN-202 Preparing for Phase I Study

    • New ALPN-202 Data Presented at Society for Immunotherapy of Cancer (SITC) Annual Meeting: On November 8, 2018, Alpine presented two posters with new preclinical data on its lead oncology program ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor. The new preclinical data further highlight ALPN-202's novel mechanism of action and its superior anti-tumor activity, as well as its potential to be uniquely effective as a monotherapy and in combination with immune checkpoint inhibitors or chemotherapy. The full posters from SITC can be viewed here.
    • Data presented at SITC supports the advancement of ALPN-202 towards its first Phase 1 clinical trial, which Alpine expects to initiate, upon authorization, in the first quarter of 2020.

    Financial Results for Third Quarter and Nine Months Ended September 30, 2019

    Alpine recorded a net loss of $11.5 million and $12.1 million for the third quarters ended September 30, 2019 and 2018, respectively, and $35.7 million and $25.4 million for the nine months ended September 30, 2019 and 2018, respectively.

    Research and development expenses for the third quarter ended September 30, 2019 were $9.5 million compared to $10.5 million for the third quarter ended September 30, 2018. For the nine months ended September 30, 2019 and 2018, research and development expenses were $30.0 million and $20.0 million, respectively. The company expects a continued increase to research and development activities to support the clinical advancement of its ALPN-101 and ALPN-202 programs.

    General and administrative expenses for the third quarter ended September 30, 2019 were $2.5 million compared to $1.9 million for the third quarter ended September 30, 2018. For the nine months ended September 30, 2019 and 2018, general and administration expenses were $7.4 million and $5.8 million, respectively. The increase was primarily attributable to professional and legal services and an increase in facility costs to support the growth and expansion of our business.

    Cash Position

    As of September 30, 2019, Alpine had cash, cash equivalents, restricted cash, and short-term investments totaling $47.0 million. For the nine months ended September 30, 2019, net cash used in operating activities was $29.7 million compared to $19.0 million for the nine months ended September 30, 2018.

    Management will provide updates to cash guidance on the conference call scheduled to discuss third quarter 2019 financial results.

    Conference Call and Webcast Details

    Alpine will host a conference call to discuss key data, clinical highlights and provide an update on third quarter 2019 results on Wednesday, November 13, 2019 at 4:30 p.m. ET. To access the live call by phone, dial (877) 407-0789 (domestic) or (201) 689-8562 (international). To access a live webcast of the call, please visit the Investor Relations section of the Alpine Immune Sciences website at www.alpineimmunesciences.com. The recorded webcast will be available for replay for approximately 30 days following the call.

    About ALPN-101

    ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™), and a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely connected to multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease and multiple sclerosis, ALPN-101 demonstrates efficacy superior to blockade of the CD28 or ICOS pathways alone.

    About ALPN-202

    ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor, which has the potential to improve upon the efficacy of combined checkpoint inhibition without significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. We anticipate initiation, upon authorization, of the first-in-human clinical study of ALPN-202 to begin in the first quarter of 2020.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T-cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. ALPN-101 has recently completed enrollment in a phase 1 healthy volunteer trial. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

    Forward-Looking Statements

    This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the timing of and results from clinical trials and pre-clinical development activities, clinical and regulatory objectives and the timing thereof, expectations regarding the sufficiency of cash to fund operations, the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates, the timing of our public presentations and potential publication of future clinical data, the efficacy of our clinical trial designs, expectations regarding our ongoing collaborations, and our ability to successfully develop and achieve milestones in our development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as "may," "will," "should," "would," "expect," "plan," "intend," and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Secreted Immunomodulatory Proteins", "SIP", "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

     

    Alpine Immune Sciences, Inc.

     

     

     

     

    Selected Condensed Consolidated Balance Sheet Data

     

     

     

     

    (In thousands)

     

     

     

     

     

     

    September 30,

    2019

     

    December 31,

    2018

     

     

    (unaudited)

     

     

    Cash and cash equivalents

     

    $

    17,395

     

    $

    10,711

    Short-term investments

     

    29,193

     

    41,592

    Total current assets

     

    52,454

     

    53,545

    Total assets

     

    64,739

     

    54,873

    Total current liabilities

     

    13,672

     

    8,127

    Total stockholders' equity

     

    34,831

     

    44,591

    Total liabilities and stockholders' equity

     

    64,739

     

    54,873

     
     

    Condensed Consolidated Statement of Operations and Comprehensive Income (Loss) Data

    (In thousands, except share and per share amounts)

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

    2019

     

    2018

     

    2019

     

    2018

     

    (unaudited)

    Collaboration revenue

    $

    289

     

     

    $

     

     

    $

    856

     

     

    $

    705

     

    Operating expenses:

     

     

     

     

     

     

     

    Research and development

    9,532

     

     

    10,529

     

     

    30,048

     

     

    20,039

     

    General and administrative

    2,467

     

     

    1,857

     

     

    7,365

     

     

    5,848

     

    Loss on sale of intangible asset

     

     

     

     

     

     

    1,203

     

    Total operating expenses

    11,999

     

     

    12,386

     

     

    37,413

     

     

    27,090

     

    Loss from operations

    (11,710

    )

     

    (12,386

    )

     

    (36,557

    )

     

    (26,385

    )

    Other income (expense):

     

     

     

     

     

     

     

    Interest expense

    (66

    )

     

    (82

    )

     

    (197

    )

     

    (243

    )

    Interest and other income

    301

     

     

    329

     

     

    1,042

     

     

    971

     

    Loss before taxes

    (11,475

    )

     

    (12,139

    )

     

    (35,712

    )

     

    (25,657

    )

    Income tax benefit

     

     

     

     

     

     

    305

     

    Net loss

    $

    (11,475

    )

     

    $

    (12,139

    )

     

    $

    (35,712

    )

     

    $

    (25,352

    )

    Comprehensive income (loss):

     

     

     

     

     

     

     

    Unrealized gain on investments

    5

     

     

    30

     

     

    37

     

     

    34

     

    Unrealized loss on foreign currency translation

    (7

    )

     

     

     

    (17

    )

     

     

    Comprehensive loss

    $

    (11,477

    )

     

    $

    (12,109

    )

     

    $

    (35,692

    )

     

    $

    (25,318

    )

    Weighted-average shares used to compute basic and diluted net loss per share

     

    18,586,950

     

     

     

    13,851,336

     

     

     

    18,281,707

     

     

     

    13,848,371

     

    Basic and diluted net loss per share

    $

    (0.62

    )

     

    $

    (0.88

    )

     

    $ (1.95

    )

     

    $

    (1.83

    )

     

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  25. ALPN-101 is distinct from the other biologic therapies and superior to combination biological blockade

    Preclinical activity suggests unique effectiveness across a range of rheumatic and other inflammatory diseases

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, presented new preclinical data on ALPN-101, a first-in-class dual CD28/ICOS antagonist for the treatment of autoimmune/inflammatory diseases, at the 2019 American College of Rheumatology Annual Meeting (ACR) in Atlanta, GA.

    ALPN-101 is designed to inhibit two key costimulatory pathways that regulate disease-relevant, pathogenic T and B…

    ALPN-101 is distinct from the other biologic therapies and superior to combination biological blockade

    Preclinical activity suggests unique effectiveness across a range of rheumatic and other inflammatory diseases

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, presented new preclinical data on ALPN-101, a first-in-class dual CD28/ICOS antagonist for the treatment of autoimmune/inflammatory diseases, at the 2019 American College of Rheumatology Annual Meeting (ACR) in Atlanta, GA.

    ALPN-101 is designed to inhibit two key costimulatory pathways that regulate disease-relevant, pathogenic T and B lymphocytes. The new data demonstrate a unique potency of ALPN-101, often superior even to combinations of biologics individually targeting the CD28 and ICOS pathways, as measured by in vitro assays involving patient-derived immune cells and in vivo mouse models of inflammatory arthritis, lupus, and Sjögren's Syndrome.

    The data were presented in two posters:

    1531. ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, Suppresses Key Effector Mechanisms Underlying Rheumatoid and Psoriatic Arthritis

    2416: ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, Suppresses Key Effector Mechanisms Associated with Sjögren's Syndrome and Systemic Lupus Erythematosus

    "Particularly intriguing are the unique inflammatory pathways that appear to be affected by ALPN-101, distinct from the other biologic therapies studied, as well as its potent efficacy in the animal models," commented Stanford Peng, M.D., Ph.D., President and Head of Research and Development at Alpine. "Such observations are especially timely as we are presently completing our Phase I study and are considering a number of different Phase II options. With these new data, future development options expand to include Sjögren's Syndrome and Systemic Lupus Erythematosus."

    Both full poster presentations can be found in the autoimmune/inflammation pipeline section of the alpineimmunesciences.com website.

    About ALPN-101

    ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™), and a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely connected to multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease and multiple sclerosis, ALPN-101 demonstrates efficacy superior to blockade of the CD28 or ICOS pathways alone.

    About Alpine Immune Sciences

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T-cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

    Forward Looking Statements

    This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the timing of and results from clinical trials and pre-clinical development activities, clinical and regulatory objectives and the timing thereof, and the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as "may," "will," "should," "would," "expect," "plan," "intend," and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Secreted Immunomodulatory Proteins", "SIP", "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

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  26.  Preclinical data support unique mechanism of action of ALPN-202 as a first in class conditional CD28 Agonist

    ALPN-202 able to increase CD8+ T-cells in tumors

    ALPN-202 has potent monotherapy activity and significantly improves upon the activity of multiple anticancer therapies in preclinical models

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today presented new preclinical data on ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor for the treatment of advanced malignancies, at The Society for Immunotherapy of Cancer's (SITC) 34th Annual Meeting. ALPN-202 is Alpine's lead…

     Preclinical data support unique mechanism of action of ALPN-202 as a first in class conditional CD28 Agonist

    ALPN-202 able to increase CD8+ T-cells in tumors

    ALPN-202 has potent monotherapy activity and significantly improves upon the activity of multiple anticancer therapies in preclinical models

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today presented new preclinical data on ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor for the treatment of advanced malignancies, at The Society for Immunotherapy of Cancer's (SITC) 34th Annual Meeting. ALPN-202 is Alpine's lead oncology program and remains on track to initiate a first-in-human clinical trial by the first quarter of 2020.

    ALPN-202 is designed to improve upon the safety and efficacy of existing combination checkpoint and/or costimulation therapeutic strategies. One poster presents mechanistic data supporting that ALPN-202 inhibits both the PD-L1 and CTLA-4 checkpoint pathways while also providing PD-L1-dependent CD28 costimulation, as intentionally designed. A second poster demonstrates the ability of ALPN-202 to improve significantly upon the activity of existing cancer therapeutics when given alone and/or in combination in preclinical models. In addition, crystallographic study suggests that ALPN-202 binds PD-L1 and CD28 at distinct, non-overlapping epitopes enabling its potentially unique functionality:

    P793. ALPN-202, a Conditional CD28 Costimulator and Dual Checkpoint Inhibitor, Utilizes Multiple Mechanisms to Elicit Potent Anti-Tumor Immunity Superior to Checkpoint Blockade

    P467. ALPN-202, a Conditional CD28 Costimulator and Dual Checkpoint Inhibitor, Enhances the Activity of Multiple Standard of Care Modalities

    Immune checkpoint inhibitors targeting the PD-1/PD-L1 and/or CTLA-4 pathways have demonstrated clinical activity in multiple cancers, but many patients still experience inadequate anti-tumor responses and/or relapse, which may be in part due to insufficient anti-tumor T cell activation and/or exhaustion. At the same time, combinations of checkpoint inhibitors and/or costimulatory agents can result in excessive immune-related toxicities. "ALPN-202 is engineered to address both of these issues by promoting T cell activity, but primarily only in a tumor-specific fashion, to produce specific, durable anti-tumor immune responses," said Stanford Peng, MD PhD, Alpine's President and Head of Research and Development. "These data continue to encourage us regarding the potential for ALPN-202 as a new, first-in-class cancer immunotherapy. We continue to look forward to initiating our first clinical trial of ALPN-202."

    The full poster presentations can be found at: https://www.alpineimmunesciences.com/alpn-202_sitc-2019_moa/ and https://www.alpineimmunesciences.com/alpn-202_sitc-2019_soc_combo/.

    About ALPN-202

    ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor, which has the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. We anticipate initiation of the first-in-human clinical study of ALPN-202 to begin by the first quarter of 2020.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T-cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

    Forward-Looking Statements

    This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the timing of and results from clinical trials and pre-clinical development activities, clinical and regulatory objectives and the timing thereof, and the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as "may," "will," "should," "would," "expect," "plan," "intend," and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Secreted Immunomodulatory Proteins", "SIP", "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

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  27. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today announced an abstract has been accepted for an oral presentation highlighting the company's lead autoimmune/inflammatory program ALPN-101 at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition to be held December 7-10, 2019 in Orlando, FL.

    The Company will present on its upcoming Phase 1/2 BALANCE study of ALPN-101 in steroid-resistant or steroid-refractory acute Graft-versus-Host Disease (GvHD). ALPN-101 is a first-in-class, dual inhibitor of the CD28 and ICOS costimulatory pathways with strong preclinical and translational…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today announced an abstract has been accepted for an oral presentation highlighting the company's lead autoimmune/inflammatory program ALPN-101 at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition to be held December 7-10, 2019 in Orlando, FL.

    The Company will present on its upcoming Phase 1/2 BALANCE study of ALPN-101 in steroid-resistant or steroid-refractory acute Graft-versus-Host Disease (GvHD). ALPN-101 is a first-in-class, dual inhibitor of the CD28 and ICOS costimulatory pathways with strong preclinical and translational rationale in GvHD.

    Last year, preclinical data on ALPN-101 was included in an oral presentation at the 60th ASH Annual Meeting, highlighting the novel role ICOS ligand (ICOS-L) plays in acute GvHD and extending what is currently understood about the CD28/B7 protein family in disease pathogenesis. Since then, Alpine has been conducting a first-in-human, randomized, placebo-controlled single- and multiple-ascending dose Phase I study in adult healthy volunteers. "This year's presentation will discuss the translational and therapeutic potential of ALPN-101 based on our learnings to date," indicated Stanford Peng, M.D. Ph.D., President and Head of Research and Development at Alpine.

    61st ASH Annual Meeting Oral Presentation

    • Title: An Open Label Study of ALPN-101, a First-in-Class Dual CD28/ICOS Antagonist, in Subjects with Steroid-Resistant or Steroid-Refractory Acute Graft Versus Host Disease (aGvHD)
    • Presenter: Dr. Jan Hillson, Senior Vice President, Clinical Development, Alpine
    • Session Name: 802. Chemical Biology and Experimental Therapeutics: Novel Compounds and Mechanisms of Action (9:30 – 11:15 AM ET)
    • Oral Presentation Date and Time: Sunday, December 8, 2019: 11:00 AM ET
    • Location: OCCC, W414AB

    About Graft Versus Host Disease (GvHD)

    Graft versus host disease (GvHD) is the most common life-threatening complication of a hematopoietic cell transplant. It occurs when donor cells see recipient cells as different and attack them. Acute GvHD typically occurs within the early weeks and months after transplant, usually involving the skin, liver and gastrointestinal tract. Despite extensive studies of many different therapies in GvHD, corticosteroids remain its primary treatment.

    About ALPN-101

    ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™), and a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely connected to multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease and multiple sclerosis, ALPN-101 demonstrates efficacy superior to blockade of the CD28 and/or ICOS pathways alone.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T-cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

    Forward-Looking Statements

    This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the timing of and results from clinical trials and pre-clinical development activities, clinical and regulatory objectives and the timing thereof, and the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as "may," "will," "should," "would," "expect," "plan," "intend," and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Secreted Immunomodulatory Proteins", "SIP", "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

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  28. Company to Discuss Topline Results and Provide Company Update on Third Quarter 2019 Conference Call and Webcast Scheduled for November 13, 2019 at 4:30 p.m. ET

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today announced that it has completed enrollment in all planned cohorts of the Phase I study of its lead program, ALPN-101, a first-in-class dual ICOS/CD28 antagonist. Alpine will discuss the preliminary findings during its third quarter 2019 company update conference call and webcast scheduled for November 13, 2019 at 4:30 p.m. ET.

    The randomized, placebo-controlled, blinded study was designed to evaluate…

    Company to Discuss Topline Results and Provide Company Update on Third Quarter 2019 Conference Call and Webcast Scheduled for November 13, 2019 at 4:30 p.m. ET

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today announced that it has completed enrollment in all planned cohorts of the Phase I study of its lead program, ALPN-101, a first-in-class dual ICOS/CD28 antagonist. Alpine will discuss the preliminary findings during its third quarter 2019 company update conference call and webcast scheduled for November 13, 2019 at 4:30 p.m. ET.

    The randomized, placebo-controlled, blinded study was designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of ALPN-101 in adult healthy volunteers. The results from this trial will help inform further development of ALPN-101 in serious autoimmune and inflammatory diseases.

    The company will hold a conference call on November 13, 2019 to discuss third quarter results, recent development progress, and upcoming clinical development plans for both ALPN-101 and ALPN-202, Alpine's lead oncology program. The company will also review new ALPN-101 data presented at the American College of Rheumatology annual meeting and ALPN-202 data presented at the Society for the Immunotherapy of Cancer annual meeting.

    Conference Call and Webcast Details

    To access the live call by phone, dial (877) 407-0789 (domestic) or (201) 689-8562 (international). To access a live webcast of the call, please visit the Investor Relations section of the Alpine Immune Sciences website at www.alpineimmunesciences.com. The recorded webcast will be available for replay for approximately 30 days following the call.

    About ALPN-101

    ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD™), and a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely connected to multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease and multiple sclerosis, ALPN-101 demonstrates efficacy superior to blockade of the CD28 or ICOS pathways alone.

    About ALPN-202

    ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor, which has the potential to improve upon the efficacy of combined checkpoint inhibition without significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. We anticipate initiation of the first-in-human clinical study of ALPN-202 to begin by the first quarter of 2020.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T-cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

    Forward-Looking Statements

    This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the timing of and results from clinical trials and pre-clinical development activities, clinical and regulatory objectives and the timing thereof, and the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as "may," "will," "should," "would," "expect," "plan," "intend," and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "Secreted Immunomodulatory Proteins", "SIP", "Transmembrane Immunomodulatory Protein," "TIP," "Variant Ig Domain," "vIgD" and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

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  29. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today announced planned poster presentations at upcoming scientific meetings highlighting new preclinical data on the Company's lead programs: ALPN-101, a first-in-class dual CD28/ICOS inhibitor for the treatment of autoimmune diseases, and ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor for the treatment of cancers.

    2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting – National Harbor, MD

    Abstract Title: ALPN-202, a Conditional CD28 Costimulator and Dual Checkpoint Inhibitor, Utilizes Multiple Mechanisms to Elicit…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today announced planned poster presentations at upcoming scientific meetings highlighting new preclinical data on the Company's lead programs: ALPN-101, a first-in-class dual CD28/ICOS inhibitor for the treatment of autoimmune diseases, and ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor for the treatment of cancers.

    2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting – National Harbor, MD

    Abstract Title: ALPN-202, a Conditional CD28 Costimulator and Dual Checkpoint Inhibitor, Utilizes Multiple Mechanisms to Elicit Potent Anti-Tumor Immunity Superior to Checkpoint Blockade Alone

    Poster #: P793

    Date: Friday, November 8, 2019

    Time: 7:00 a.m. – 8:00 p.m. ET

    Abstract Title: ALPN-202, a Conditional CD28 Costimulator and Dual Checkpoint Inhibitor, Enhances the Activity of Multiple Standard of Care Modalities

    Poster #: P467

    Date: Friday, November 8, 2019

    Time: 7:00 a.m. – 8:00 p.m. ET

    American College of Rheumatology 2019 ACR/ARHP Annual Meeting – Atlanta, GA

    Abstract Title: ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, Suppresses Key Effector Mechanisms Underlying Rheumatoid and Psoriatic Arthritis

    Session Title: Spondyloarthritis Including PsA–Clinical Poster II: Treatment of Axial Spondyloarthritis and Psoriatic Arthritis

    Date: Monday, November 11, 2019

    Time: 9:00 a.m. – 11:00 a.m. ET

    Abstract Title: ALPN-101, a First-in-Class Dual ICOS/CD28 Antagonist, Suppresses Key Effector Mechanisms Associated with Sjögren's Syndrome

    Session Title: Sjögrenʼs Syndrome–Basic & Clinical Science Poster I

    Date: Tuesday, November 12, 2019

    Time: 9:00 a.m. – 11:00 a.m. ET

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T-cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28.. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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  30. Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today announced the company will present at the 2019 Ladenburg Thalmann Healthcare Conference on Tuesday, September 24, 2019 at 3:00 p.m. Eastern Time in New York, NY.

    A live webcast of the presentation will be available online in the investor relations section of the company's website at https://ir.alpineimmunesciences.com/events. A replay of the presentation will be available on the company website for 90 days following the webcast.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics…

    Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today announced the company will present at the 2019 Ladenburg Thalmann Healthcare Conference on Tuesday, September 24, 2019 at 3:00 p.m. Eastern Time in New York, NY.

    A live webcast of the presentation will be available online in the investor relations section of the company's website at https://ir.alpineimmunesciences.com/events. A replay of the presentation will be available on the company website for 90 days following the webcast.

    About Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T-cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. ALPN-101 is currently enrolling a phase I healthy volunteer trial. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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