UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): March 2, 2020
Cue Biopharma, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38327 | 47-3324577 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 21 Erie St., Cambridge, Massachusetts | 02139 | |
| (Address of principal executive offices) | (Zip Code) |
(Registrant’s telephone number, including area code): (617) 949-2680
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
| Common Stock, par value $0.001 per share | CUE | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
| Item 7.01 | Regulation FD Disclosure |
On March 2, 2020, Cue Biopharma Inc. presented at the Cowen & Co. 40th Annual Health Care Conference. The materials for this presentation are furnished as Exhibit 99 to this Current Report on Form 8-K.
The information contained in this Item 7.01 of this report is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in this Item 7.01 shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits |
| Exhibit |
Description | |
| 99 | Cue Biopharma Corporate Presentation, Cowen 40th Annual Health Care Conference, March 2, 2020, furnished herewith | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Cue Biopharma, Inc. | ||||||
| Date: March 2, 2020 | By: | /s/ Daniel R. Passeri | ||||
| Name: | Daniel R. Passeri | |||||
| Title: | Chief Executive Officer | |||||
Nasdaq: CUE | March 2020 Corporate Presentation Immune Responses, On Cue™ Cowen & Co. 40th Annual Healthcare Conference | March 2, 2020 EXHIBIT 99
Forward-Looking Statements This presentation has been prepared by Cue Biopharma, Inc. (“we,” “us,” “our,” “Cue” or the “Company”) and is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities, nor shall there be any sale of any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein are made as of the date of this presentation unless stated otherwise, and neither this presentation, nor any sale of securities, shall under any circumstances create an implication that the information contained herein is correct as of any time after such date or that information will be updated or revised to reflect information that subsequently becomes available or changes occurring after the date hereof. This presentation contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” or other comparable terms. All statements other than statements of historical facts included in this press release regarding our strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding anticipated results of our drug development efforts, including study results, our expectations regarding the timing of milestone events, regulatory developments and expected future operating results. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, our limited operating history, limited cash and a history of losses; our ability to achieve profitability; our ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for our product candidates and the breadth of any approved indication; negative or inconclusive results from our clinical studies or serious and unexpected drug-related side effects or other safety issues experienced by participants in our clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; our reliance on licensors, collaborations and strategic alliances; our ability to obtain adequate financing to fund our business operations in the future; and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by us in this presentation is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Corporate Highlights Distinct mechanism of action for selective modulation of disease-relevant T cells directly in a patient’s body Modular therapeutic frameworks targeting cancer and autoimmune disease Industry-standard manufacturing, without need for ex vivo manipulation LG Chem collaboration to expand IL-2 based CUE-100 series in immuno-oncology Merck collaboration to establish proof of mechanism for Immuno-STAT platform in autoimmune disease CUE-101 in Phase 1 for R/M HPV+ head and neck cancer with initial data in 1H 2020 Platform modularity demonstrated through CUE-102 for WT1-associated cancers Neo-STAT capability enhances R&D efficiency and offers potential for personalized immunotherapy Strong financial position supports key readouts from ongoing CUE-101 clinical study and further expansion of Immuno-STAT platform Disruptive Platform for T Cell Modulation In Vivo Strategic Partnerships to Accelerate Expansion Focused Execution Against Platform Validation
Emulating Nature’s Cues to Selectively Modulate T Cells FC Immuno-STAT Fc Signal 1 Signal 2 Co-Stimulatory/ Co-Regulatory Signal Major Histocompatibility Complex (MHC) T Cell Receptor (TCR) Co-Stimulatory/ Co-Regulatory Receptor Selectivity/ Specificity Induction/ Control T Cell Antigen-Presenting Cell Signal 1 Signal 2 Rationally engineered Immuno-STAT biologics selectively target and modulate the activity of disease-relevant T cells
Co-stim/Co-reg Distinct biological signals, including cytokines; cell-surface receptors; and/or other targeting modalities (e.g., scFv, etc.) MHC Different HLA alleles to address global patient populations Peptide Peptide epitopes to target different diseases Immuno-STAT Modularity Fc Backbone Fc engineering to dial in or out biological and effector functions Combinatorial diversity presents potential to generate therapeutic molecules for a broad set of diseases and patient populations
Pipeline Asia Rights to Three Oncology Targets LATE CLINICAL Collaboration for Autoimmune Disease PARTNER TARGET SELECTION PRE-CLINICAL PHASE 1 CUE-101 (HPV E7 / A02) CUE-102 (WT1 / A02) CUE-102 (WT1 / A24) CUE-103 (Undisclosed) CUE-201 (Undisclosed) CUE-301 (Proins / DR4) CUE-200 CD80 & 4-1BBL CUE-300 PD-L1 & Undisclosed CUE-100 IL-2 CUE-302 (Undisclosed)
CUE-100 Series: Exploiting IL-2 via Rational Protein Design CUE-100 Series Side View Top View Attenuated IL-2 Immune Signaling Components Peptide Loaded HLA Optimized for desired biological activity through two single amino acid changes Abrogates binding to IL-2R alpha Reduces binding affinity to IL-2R beta Maintains IL-2 ability to stimulate antigen-specific CD8+ T cells while reducing Treg expansion Stabilized peptide HLA complex to present disease-relevant epitope to T cell receptor Framework allows for incorporation of an array of HLA Class I alleles (i.e., A02, A11, A24) Provides “Signal 1” to the targeted antigen-specific CD8+ T cells, thereby enhancing the activity of the attenuated IL-2 Therapeutic framework is not dependent on barriers of antigen processing & presentation, and is designed to avoid systemic immune activation
CUE-100 Series: Mechanistic Differentiation Over Emerging “Not Alpha” IL-2 Landscape IL-2R⍺ IL-2Rβ IL-2Rγ Treg ⍺βγ βγ Anti-tumor Teff βγ Treg ⍺βγ βγ Anti-tumor Teff βγ Treg ⍺βγ βγ Anti-tumor Teff βγ Expansion of Tregs Expansion of non-tumor Teffs Expansion of tumor-specific T cells, if pre-existing Reduced expansion of Tregs Expansion of non-tumor Teffs Expansion of tumor-specific T cells, if pre-existing Reduced expansion of Tregs Reduced expansion of non-tumor Teffs Expansion of pre-existing tumor-specific T cells and priming of naïve T cells Wild Type IL-2 (e.g., Proleukin) CUE-100 IL-2 Series (e.g., CUE-101) “Not Alpha” IL-2 (e.g., THOR-707) Non-tumor Teff Non-tumor Teff Non-tumor Teff > = = = = << CUE-100 series is designed for selective induction and expansion of tumor-specific CD8+s without reliance on a pre-existing repertoire
CUE-101: Lead Clinical Candidate for HPV-Driven Malignancies CUE-101 Immuno-STAT Design Signal 1: HLA-A*02:01 + HPV-16 E711-20 peptide Signal 2: IL-2 variant Clinical Rationale CUE-101 is designed to selectively prime and expand HPV-specific T cells in vivo HPV is recognized as a growing driver of head and neck cancer and is now responsible for over 70% of oropharyngeal cancers in the US and EU Despite treatment with current standards of care, more than 50% of patients with advanced disease will experience recurrence with significant quality of life impacts The CUE-101 clinical development strategy builds upon robust translational preclinical data and patient stratification Fc
CUE-101: Directing IL-2 to the “Right” T Cells Selective Binding Intact & Selective Effector Function Immuno-STAT (nM) HPV-specific CD8+ T cells Immuno-STAT (nM) CMV-specific CD8+ T cells CUE-101 specifically targets and activates HPV-E7 T cells
CUE-101: In Vitro Expansion of HPV E7-Specific T Cells E711-20-Specific CD8+ T Cells Vehicle-Treated CUE-101-Treated CUE-101 selectively expands HPV-E7 T cells with minimal effects on regulatory T cells
CUE-101: Mitigating the Risk Associated with Systemic WT IL-2 Activation PBMC from healthy human donors were stimulated for 18 hours with increasing amounts of CUE-101 or recombinant human IL-2 Cytokine production was assessed in culture supernatant by MSD
Note: Publications and posters are available on the Investor Relations section of the Cue Biopharma website CUE-101: Foundational Data Published in CCR In Vitro Selective binding to HPV-specific CD8+ T cells Dose-dependent induction of effector function Expansion of HPV E7 T cells from human PBMCs Mitigation of risk associated with systemic IL-2 activation Animal Model Selective expansion of HPV E7 CD8+ T cells in the tumor and in the periphery Inhibition of tumor growth and survival in TC-1 syngeneic model, both as a monotherapy and in combination with anti-PD-1 Generation of immunologic memory against TC-1 tumor cells (i.e., re-challenge study)
CUE-101: Ongoing First-In-Human Study Design (CUE-101 Q3W) Part A: Dose Escalation (3+3) Part A: Safety Expansion (Up to 9 Patients) Part B: Dose Expansion (10-20 Pts at RP2D) Eligibility Part A & B: HPV+ H&N Cancer, R/M 2L+ Objectives Primary: Safety and Tolerability Secondary: PK/PD, Anti-Tumor Activity Biomarkers (Pre/Post CUE-101 Dose) HPV E7-specific CD8+ T cell counts HPV E7-specific CD8+ T cell functionality Immunophenotyping, cytokine release, and TCR sequencing Part A: Monotherapy Dose Escalation Part B: Monotherapy RP2D Expansion RP2D:BED/MTD Cohort 1 Cohort 2 Cohort 3 Cohort N Late Line Accelerated Monotherapy Approval Opportunity in H&N
CUE-101: Phase I Clinical Development Network Emory Winship Cancer Institute: Nabil Saba Karmanos Cancer Institute: Elizabeth Heath and Ammar Sukari MD Anderson Cancer Center: Bonnie Glisson MGH/Harvard and Dana Farber Cancer Institute: Sara Pai and Lori Wirth Moffitt Cancer Center: Christine Chung Stanford Cancer Center: A. Dimitrios Colevas University of Arizona Center: Julie Bauman University of Michigan Rogel Cancer Center: Frank Worden University of Washington Fred Hutch Cancer Center: Cristina Rodriguez Vanderbilt-Ingram Cancer Center: Jill Gilbert and Mike Gibson Washington University Siteman Cancer Center: Doug Adkins Yale Cancer Center: Barbara Burtness Cue has engaged a network of nationally recognized clinical investigators and 12 Phase I sites are now open
CUE-101: Clinical Development Plan 2019 2020 2021 Q1 Safety and Immunologic Effect Parts A & B H&N R/M 2L+ CUE-101 Monotherapy TBD Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 H&N R/M 1L CUE-101 + anti-PD-1 Combotherapy H&N Neoadjuvant Other HPV-Driven Cancers
Building Blocks of IO Growth Strategy Address broader set of tumors (i.e., WT1, KRAS) Address global patient populations (i.e., A11, A24) Address high need R/M H&N cancer patient population Provide safety and proof of platform in a clinical setting Proof of Platform Antigen & HLA Expansion Scalability Increase R&D efficiency via chemical attachment of antigens to HLA Enables targeting of multiple tumor antigens, including post-translationally modified peptides and neo-antigens CUE-100 Framework CUE-101 CUE-102 & Beyond Neo- STATTM
CUE-100 Series Extensibility: CUE-102 and KRAS Allele Expansion CUE-101 CUE-102 KRAS A02 A24 A11 HPV WT1 WT1 KRAS G12V Clinical Preclinical Target Selection KRAS G12V
Neo-STAT: Next-gen Evolution of the Immuno-STAT Framework CUE-100 Neo-STAT Top View Therapeutic scaffold receptive for chemical conjugation of peptides, that potentially: Increases R&D efficiency and reduces cost of the generation of clinical grade material on the CUE-100 framework Enables targeting of multiple tumor antigens including post-translationally modified peptides and neo-antigens for personalized therapy Therapeutic scaffold manufactured in bulk
Neo-STAT Driven T cell Expansion is Comparable to the Immuno-STAT Format CMV Responsive Donors MART-1 Responsive Donors CMV CUE-100 Series Immuno-STAT CMV Neo-STAT MART-1 Neo-STAT MART-1 CUE-100 Series Immuno-STAT MART-1 Neo-STAT CMV Neo-STAT
Restoring Immune Balance Outside of immuno-oncology, Cue has partnered with Merck to establish Immuno-STAT applications in autoimmune diseases Balance Cancer & Infection Autoimmune Disease Requires inhibition of pathogenic effector T cells and/or selective activation of Tregs Suppression Over Stimulation Requires expansion of tumor-specific effector T cells or reversal of exhausted T cells
Immuno-STAT Dampens Autoreactive CD4+ T cells Class II DRB1*04 Proinsulin76-90 Fc (Effector-less) PD-L1 Suppression of pathogenic antigen-specific CD4 T cell expansion D0 PBMC + pathogenic peptide D10 Tetramer readout Cognate (Proins) PD-L1 Immuno-STAT Non-cognate (GAD65) PD-L1 Immuno-STAT Expansion of pathogenic antigen-specific CD4 T cells Pathogenic T cell (orange) Proins76-90, K88S/DR4-PDL1 Immuno-STAT selectively inhibits antigen-specific CD4+ T Cell expansion from PBMCs of T1D donors No Peptide Patho. Peptide Patho. Peptide + Proins Immuno-STAT Patho. Peptide + GA65 Immuno-STAT
Early Intervention with Immuno-STAT Selectively Reduces Proinsulin Responsive CD4+ T Cells in Transgenic Mice Treatment with Immuno-STAT starting on Day 1 post immunization selectively suppresses expansion of PI-reactive cells without inhibiting expansion of HA-reactive cells Note: HA307-319 is a well-characterized viral antigen used as an experimental control
Corporate Highlights Distinct mechanism of action for selective modulation of disease-relevant T cells directly in a patient’s body Modular therapeutic frameworks targeting cancer and autoimmune disease Industry-standard manufacturing, without need for ex vivo manipulation LG Chem collaboration to expand IL-2 based CUE-100 series in immuno-oncology Merck collaboration to establish proof of mechanism for Immuno-STAT platform in autoimmune disease CUE-101 in Phase 1 for R/M HPV+ head and neck cancer with initial data in 1H 2020 Platform modularity demonstrated through CUE-102 for WT1-associated cancers Neo-STAT capability enhances R&D efficiency and offers potential for personalized immunotherapy Strong financial position supports key readouts from ongoing CUE-101 clinical study and further expansion of Immuno-STAT platform Disruptive Platform for T Cell Modulation In Vivo Strategic Partnerships to Accelerate Expansion Focused Execution Against Platform Validation