SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 14, 2019
GENOCEA BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of
(Commission File Number)
Cambridge Discovery Park
100 Acorn Park Drive, 5th Floor
Cambridge, MA 02140
(Address of principal executive offices, including zip code)
(Registrant’s telephone number, including area code): (617) 876-8191
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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o 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
Name of each exchange on which registered
Common stock, $0.001 par value per share
NASDAQ Capital Market
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-2of the Securities Exchange Act of 1934 (§ 240 12b-2 of this chapter).
Emerging Growth Company x
If an emerging growth company, indicate by a 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. x
Item 1.01 Entry into a Material Definitive Agreement.
On November 14, 2019 (the "First Amendment Closing Date"), Genocea Biosciences, Inc. (the “Company”) entered into the first amendment (the “First Amendment”) to the Amended and Restated Loan and Security Agreement by and between Hercules Capital, Inc. (“Hercules”) and the Company, dated as of April 24, 2018.
As of the First Amendment Closing Date, the current outstanding principal balance of the Term Loan Advance is $12.9 million. The First Amendment increased the term loan interest rate to the greater of (a) the prime rate plus 3.00% or (b) 8.00%, and extended the interest-only period through January 1, 2021. The advance may be prepaid in whole or in part upon seven business days’ prior written notice to Hercules, subject to a prepayment charge of 2.0% if such advance is prepaid on or after the First Amendment Closing Date, but on or prior to November 24, 2020, and 1.0% if such advance is prepaid thereafter. The First Amendment also increased the end of term charge to $1,038,000.
The Loan Agreement contains customary covenants and representations, including a financial reporting covenant and limitations on dividends, indebtedness, collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, deposit accounts, and subsidiaries.
The foregoing description of the principal terms of the First Amendment is a general description only, does not purport to be complete, and is qualified in its entirety by reference to the terms of the First Amendment, which is attached as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 7.01 Regulation FD Disclosure.
On November 19, 2019, Genocea Biosciences, Inc. updated its corporate presentation. A copy of the presentation is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference. The presentation will also be available online at http://ir.genocea.com/events-and-presentations as of November 19, 2019, however the Company’s website and any information contained on the website are not incorporated herein.
The information contained in this Item 7.01 of this Current Report on Form 8-K, including the exhibits attached hereto, is being furnished and shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing.
Item 9.01 Financial Statements and Exhibits.
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 hereunto duly authorized.
GENOCEA BIOSCIENCES, INC.
/s/ DIANTHA DUVALL
Chief Financial Officer
(Principal Financial Officer)
Date: November 19, 2019
AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT
This FIRST AMENDMENT TO AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT (this “Amendment”) is dated as of November 14, 2019 and is entered into by and between (a) GENOCEA BIOSCIENCES, INC., a Delaware corporation (“Borrower”), (b) the several banks and other financial institutions or entities from time to time parties to the Loan Agreement (collectively, referred to as “Lender”) and (c) HERCULES CAPITAL, INC., a Maryland corporation, in its capacity as administrative agent and collateral agent for itself and the Lender (in such capacity, the “Agent”). Capitalized terms used herein without definition shall have the same meanings given them in the Loan Agreement (as defined below).
A.Borrower, Agent and Lender have entered into that certain Amended and Restated Loan and Security Agreement dated as of April 24, 2018, as amended by that certain Letter Agreement by and between Borrower, Agent and Lender dated as of July 26, 2019 (as may be further amended, restated, amended and restated, supplemented or otherwise modified from time to time, the “Loan Agreement”), pursuant to which Lender has agreed to extend and make available to Borrower certain advances of money.
B.The parties agree and acknowledge that, as of the First Amendment Closing Date (as defined herein), the current outstanding principal balance of the Term Loan Advance is Twelve Million Nine Hundred Twenty-Two Thousand Four Hundred Sixty-Eight and 87/100 Dollars ($12,922,468.87).
C.In accordance with Section 11.3 of the Loan Agreement, Borrower and Lender have agreed to amend the Loan Agreement upon the terms and conditions more fully set forth herein.
NOW, THEREFORE, in consideration of the foregoing Recitals and other good and valuable consideration, the receipt and adequacy of which is hereby acknowledged, and intending to be legally bound, the parties hereto agree as follows:
1.AMENDMENTS. Subject to the satisfaction of the conditions set forth in Section 4 of this Amendment, the Loan Agreement is hereby amended as follows:
1.1 The Loan Agreement shall be amended by deleting the following definitions appearing in Section 1.1 thereof (Definitions and Rules of Construction) and inserting in lieu thereof the following:
“ “Amortization Date” means January 1, 2021.”
“ “Term Loan Interest Rate” means for any day, a floating per annum rate equal to the greater of (a) the Prime Rate plus three percent (3.00%), or (b) eight percent (8.00%). The Term Loan Interest Rate will change from time to time on the day the Prime Rate changes.”
1.2 The Loan Agreement shall be amended by inserting the following new definition to appear in proper alphabetical order in Section 1.1 thereof (Definitions and Rules of Construction):
“ “First Amendment Closing Date” means November 14, 2019.”
1.3 The Loan Agreement shall be amended by deleting Section 2.4 thereof (Prepayment) in its entirety and inserting in lieu thereof the following:
“2.4 Prepayment. At its option upon at least seven (7) Business Days prior notice to the Agent, Borrower may at any time prepay all or any portion of the outstanding Advance by paying the entire principal balance (or any portion thereof) with respect to the principal balance being prepaid, all accrued and unpaid interest thereon, together with a prepayment charge equal to the following percentage of the Advance amount being prepaid: if the Advance is prepaid in any of the first twelve (12) months following the Closing Date, three percent (3.0%); on or after the First Amendment Closing Date, but on or prior to November 24, 2020, two percent (2.0%); and thereafter, one percent (1.0%) (each, a “Prepayment Charge”). Borrower agrees that the Prepayment Charge is a reasonable calculation of Lender’s lost profits in view of the difficulties and impracticality of determining actual damages resulting from an early repayment of the Advance. Borrower shall prepay the outstanding amount of all principal and accrued interest through the prepayment date and the Prepayment Charge upon the occurrence of a Change in Control. Notwithstanding the foregoing, Agent and Lender agree to waive the Prepayment Charge if Agent and Lender (in its sole and absolute discretion) agree in writing to refinance the Advance prior to the Term Loan Maturity Date. For the avoidance of doubt, Lender and Agent hereby agree that the Term Loan Advance hereunder does not constitute prepayment of the Original Term Loan Advances.”
1.4 The Loan Agreement shall be amended by deleting Section 2.5 thereof (End of Term Charge) in its entirety and inserting in lieu thereof the following:
“2.5 End of Term Charge. On the earliest to occur of (i) the Term Loan Maturity Date, (ii) the date that Borrower prepays the outstanding Secured Obligations, or (iii) the date that the Secured Obligations (other than any inchoate indemnity obligations) become due and payable, Borrower shall pay Lender a charge equal to One Million Thirty-Eight Thousand Dollars ($1,038,000) (the “End of Term Charge”). Notwithstanding the required payment date of such charge, Nine Hundred Thirty-Eight Thousand Dollars ($938,000) shall be deemed earned by Lender as of the Closing Date and One Hundred Thousand Dollars ($100,000) shall be deemed earned by Lender as of the First Amendment Closing Date.”
2. BORROWER’S REPRESENTATIONS AND WARRANTIES. Borrower represents and warrants that:
2.1 Immediately upon giving effect to this Amendment (i) the representations and warranties contained in the Loan Documents are true, accurate and complete except to the extent such representations and warranties relate to an earlier date, in which case they are true and correct as of such date, after giving effect in all cases to any standard(s) of materiality contained in the Loan Agreement as to such representations and warranties, (ii) no fact or condition exists that could (or could, with the passage of time, the giving of notice, or both) reasonably be expected to constitute an Event of Default and (iii) no event that has had or could reasonably be expected to have a Material Adverse Effect has occurred or is continuing.
2.2 Borrower has the corporate power and authority to execute and deliver this Amendment and to perform its obligations under the Loan Agreement, as amended by this Amendment.
2.3 The certificate of incorporation, bylaws and other organizational documents of Borrower delivered to Agent and/or Lender on the Closing Date remain true, accurate and complete and have not been amended, supplemented or restated and are and continue to be in full force and effect.
2.4 The execution and delivery by Borrower of this Amendment and the performance by Borrower of its obligations under the Loan Agreement, as amended by this Amendment, have been duly authorized by all necessary corporate action on the part of Borrower.
2.5 This Amendment has been duly executed and delivered by Borrower and is the binding obligation of Borrower, enforceable against it in accordance with its terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization, liquidation, moratorium or other similar laws of general application and equitable principles relating to or affecting creditors’ rights.
2.6 As of the date hereof, it has no defenses against the obligations to pay any amounts under the Secured Obligations. Borrower acknowledges that each of Agent and Lender has acted in good faith and has conducted in a commercially reasonable manner its relationships with Borrower in connection with this Amendment and in connection with the Loan Documents.
Borrower understands and acknowledges that each of Agent and Lender is entering into this Amendment in reliance upon, and in partial consideration for, the above representations and warranties, and agrees that such reliance is reasonable and appropriate.
3. LIMITATION. The amendments set forth in this Amendment shall be limited precisely as written and shall not be deemed (a) to be a waiver or modification of any other term or condition of the Loan Agreement or of any other instrument or agreement referred to therein or to prejudice any right or remedy which Agent and/or Lender may now have or may have in the future under or in connection with the Loan Agreement (as amended hereby) or any instrument or agreement referred to therein; or (b) to be a consent to any future amendment or modification or waiver to any instrument or agreement the execution and delivery of which is consented to hereby, or to any waiver of any of the provisions thereof. Except as expressly amended hereby, the Loan Agreement shall continue in full force and effect.
4. EFFECTIVENESS. This Amendment shall become effective upon the satisfaction of all the following conditions precedent:
4.1 Amendment. Borrower, Agent and Lender shall have duly executed and delivered this Amendment to Lender and such other documents as Agent may reasonably request.
4.2 Secretary’s Certificate and Borrowing Resolutions. A secretary’s certificate, together with a certified copy of resolutions of certified copy of resolutions of the Board of Directors evidencing approval of this Amendment.
4.3 Certificates of Good Standing. A certificate of good standing for Borrower from its state of incorporation and similar certificates from all other jurisdictions in which Borrower does business and where the failure to be qualified would have a Material Adverse Effect.
4.4 Organizational Documents. Certified copies of the Certificate of Incorporation and the By-Laws, as amended, of Borrower.
4.5 Payment of Lender Expenses. Borrower shall have paid all Lender expenses (including all attorneys' fees and expenses) incurred through the date of this Amendment for the documentation and negotiation of this Amendment.
5. RELEASE. In consideration of the agreements of Agent and each Lender contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Borrower, on behalf of itself and its successors, assigns, and other legal representatives, hereby to the extent possible under applicable law fully, absolutely, unconditionally and irrevocably releases, remises and forever discharges Agent and each Lender, and its successors and assigns, and its present and former shareholders, affiliates, subsidiaries, divisions, predecessors, directors, officers, attorneys, employees, agents and other representatives (Agent, Lender and all such other persons being hereinafter referred to collectively as the “Releasees” and individually as a “Releasee”), of and from all demands, actions, causes of action, suits, covenants, contracts, controversies, agreements, promises, sums of money, accounts, bills, reckonings, damages and any and all other claims, counterclaims, defenses, rights of set-off, demands and liabilities whatsoever of every name and nature, known or unknown, suspected or unsuspected, both at law and in equity, which Borrower, or any of its successors, assigns, or other legal representatives may now or hereafter own, hold, have or claim to have against the Releasees or any of them for, upon, or by reason of any circumstance, action, cause or thing whatsoever which arises at any time on or prior to the day and date of this Amendment, for or on account of, or in relation to, or in any way in connection with the Loan Agreement, or any of the other Loan Documents or transactions thereunder or related thereto. Borrower understands, acknowledges and agrees that the release set forth above may be pleaded as a full and complete defense and may be used as a basis for an injunction against any action, suit or other proceeding which may be instituted, prosecuted or attempted in breach of the provisions of such release. Borrower agrees that no fact, event, circumstance, evidence or transaction which could now be asserted or which may hereafter be discovered shall affect in any manner the final, absolute and unconditional nature of the release set forth above. Borrower waives the provisions of California Civil Code section 1542, which states:
A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS THAT THE CREDITOR OR RELEASING PARTY DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE AND THAT IF KNOWN BY HIM OR HER, WOULD HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR OR RELEASED PARTY.
6. COUNTERPARTS. This Amendment may be signed in any number of counterparts, and by different parties hereto in separate counterparts, with the same effect as if the signatures to each such counterpart were upon a single instrument. All counterparts shall be deemed an original of this Amendment. This Amendment may be executed by facsimile, portable document format (.pdf) or similar technology signature, and such signature shall constitute an original for all purposes.
7. INCORPORATION BY REFERENCE. The provisions of Section 11 of the Loan Agreement shall be deemed incorporated herein by reference, mutatis mutandis.
[Signature Page Follows]
IN WITNESS WHEREOF, the parties have duly authorized and caused this Amendment to be executed as of the date first written above.
GENOCEA BIOSCIENCES, INC.
Signature: /s/ Diantha Duvall
Print Name: Diantha Duvall
Title: Chief Financial Officer
HERCULES CAPITAL, INC.
Signature: /s/ Jennifer Choe
Print Name: Jennifer Choe
Title: Assistant General Counsel
HERCULES CAPITAL FUNDING TRUST 2018-1
Signature: /s/ Jennifer Choe
Print Name: Jennifer Choe
Title: Assistant General Counsel
HERCULES CAPITAL FUNDING TRUST 2019-1
Signature: /s/ Jennifer Choe
Print Name: Jennifer Choe
Title: Assistant General Counsel
Next generation neoantigen immunotherapies | CONFIDENTIAL 1
This presentation contains “forward-looking” statements that are within the meaning of federal securities laws and are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies, clinical trials and pre-clinical studies, regulatory approval of our product candidates, liquidity position and capital needs, financing plans, industry environment, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “expects,” “could,” “seeks,” “estimates,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Forward-looking statements represent our management’s beliefs and assumptions only as of the date of this presentation. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or combination of which, could materially affect our results of operations and whether the forward-looking statements D i s c l a i m e r ultimately prove to be correct. Factors that may materially affect our results of operations include, among other things, our ability to progress product candidates in preclinical and clinical trials, the ability of ATLAS™ to identify promising oncology vaccine and immunotherapy product candidates, the scope, rate and progress of our preclinical and clinical trials and other research and development activities, anticipated timing of IND applications and new clinical trials, the amount of funds that we may require to conduct our clinical trials for our product candidates, the timing of, and ability to, obtain and maintain necessary regulatory approvals for our product candidates, and those listed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and other filings with the Securities and Exchange Commission (“SEC”). Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. You may get copies of our Annual Report on Form 10-K, Quarterly Report on Form 10-Q and our other SEC filings for free by visiting EDGAR on the SEC website at http://www.sec.gov. | CONFIDENTIAL 2
A b o u t Differentiated Immunotherapies Through Precision Antigen Selection GEN - 009 GEN-011 Neoantigen Personalized immune Neoantigen vaccine response profiling cell therapy | CONFIDENTIAL 3
Antigen Selection: The Critical Differentiator 1 st Generation Therapies • Prediction-based neoantigen vaccines • TIL therapy (non -specific) Unmet Needs • Relevant antigen identification • Inhibitory antigen exclusion N e x t W a v e Immunotherapies based on antigens customized both to tumor and immune system for more cancer -free patients | CONFIDENTIAL 4
A b o u t Personalized immune response profiling Identifies antigens of proven T cell responses Unique and relevant biological readout Optimal approach for identifying both anti-tumor and pro- tumor (inhibitory) responses TARGETS MATTER Comprehensive and flexible For any patient, any antigen type, any cancer, and both CD8 + and CD4 + T cells | CONFIDENTIAL 5
Profiles the T cell Immune Repertoire for Each Patient Inhibitory antigen: suppresses anti-tumor T cell response | CONFIDENTIAL 6
Profiling Both T cell and Tumor Critical to Antigen Selection ATLAS: Antigens eliciting anti-tumor T cell response T cell Identifies a nt i ge n s Surface peptides relevant to T cell receptor recognized by T cells Relevance t u m o r a n d Candidate antigen i m m u n e syste m – MHC molecule Peptides predicted to be b y d e s i g n surface expressed Tumor cell Personalized tumor mutations | CONFIDENTIAL 7
Important Potential Implications of Inhibitory Responses Inclusion of Inhibitory Neoantigens Can Reverse Efficacy of a Protective Therapy Vaccine Typical s.c. endpoint >3000mm3 D0 D3 D10 D17 B16F10 s.c. 3000 Vehicle (PBS) 1,600 Adjuvant only 1,000 (S10 + M30 + Trp2) 2500 M30 + Trp2 + adjuvant 1,400 (M27 + M30 + Trp2) ) Adjuvant only M27 + M30 + Trp2 + adjuvant ) ) 3 (In01 + M30 + Trp2) + Adjuvant 3 S10 + M30 + Trp2 + adjuvant 3 m 800 Inhib PoolIn01-04 + Adjuvant m 1,200 m (M30 + Trp2) m ( 2000 m m ( ( Saline e e 1,000 e m 600 m m u l 1500 u u l o l 800 o v o v r v ** r o r 400 600 1000 o o m m u m u T * u 400 T 500 T 200 **** *** 200 0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 0 0 0 6 8 10 12 14 16 18 0 2 4 6 8 10 12 14 16 18 20 22 24 Day Day Immunization (D3, D10, D17) Day • Vaccine containing either the published (M27) or ATLAS -identified ( S10) neoantigen protects againt tumor growth • Vaccine containing the inhibitory neoantigens( In1-4) drives accelerated tumor growth • Inhibitory responses can abrogate protective responses | CONFIDENTIAL 8
Important Potential Implications of Inhibitory Responses Clinical Data Suggest ICI Failure May Be Influenced by Inhibitory Responses 70% 60% 50% Non-responder Responder 40% Circle size represents tumor mutational burden (TMB) 30% % Stimulatory % 20% 10% 0% 0% 5% 10% 15% 20% 25% % Inhibitory Pre-treatment ATLAS screening from cancer patients identified the proportion of stimulatory and inhibitory neoantigen -specific T cell responses. | CONFIDENTIAL 9
ATLAS Has a Compelling Suite of Novel Shared Antigens Shared neoantigens Novel TAAs Novel viral antigens • 10 shared neoantigens identified • CRC and NSCLC • EBV from 20 shared mutations (n = 63 • Several known TAAs shown to patients) have predominantly inhibitory • 7 have not been found to be responses immunogenic • Melanoma (dominant inhibitory • 3 have only generated inhibitory TAA) responses | CONFIDENTIAL 10
ATLAS Antigens Drive Next-Generation Immunotherapies Tailored to tumor and immune system • Expressed by tumor • Immunogenic Next Wave I/O D r i v e a n t i - tumor responses • Rule out inhibitory responses Genocea-owned • Include CD8 + and CD4 + Antigen selectivity & Excluding inhibitory for partnership Complement cornerstone t h e r a p i e s • Unleash pre-existing T cell responses | CONFIDENTIAL 11
Drives Emerging Immunotherapy Pipeline D i s c o v e r y P r e - IND P h a s e 1 / 2 a P i v o t a l Status & Anticipated Milestones GEN-009 - Neoantigen cancer vaccine • Pioneering immunogenicity: ASCO 2019 Top 10 study • Preliminary clinical results in mid-2020 GEN-011 - Neoantigen T cell therapy • IND in 1H 2020 • Preliminary clinical results in 1H 2021 GEN-010 - Follow-on neoantigen cancer vaccine • Proprietary vaccine modality Shared antigen cancer vaccines • Proprietary shared neoantigens in multiple tumor types • Novel TAAs in CRC and NSCLC Vaccines for cancers of viral origin • Novel antigens discovered for Epstein-Barr Virus | CONFIDENTIAL 12
GEN - 009 Generating unprecedented Neoantigen immune responses V a c c i n e | CONFIDENTIAL 13
GEN - 009 Optimized Neoantigen Vaccine Collect tumor ATLAS to select Synthesize vaccine Deliver GEN-009 to and blood neoantigens of pre- (synthetic long clinical site samples, existing CD4 + and peptides + Poly ICLC) sequence exome CD8 + T cell responses Excludes inhibitory neoantigens | CONFIDENTIAL 14
T r i a l GEN - 009 Phase 1/2a Trial Designed to Showcase Vaccine Benefits In ICI Patients P a r t A • Patient cohort: No evidence of disease • Multiple tumor types with ICI approval • Objectives: safety, immunogenicity • Enrollment complete 15 | CONFIDENTIAL 15
Enables Unparalleled Vaccine Immune Responses Frequency % neoantigens with immune responses 60% 99% Best Peer Results 1 GEN - 0092 Potential Patient Benefits Response breadth to prevent 1 Sahin, et al, Nature 2017 (N=8); Ott, et al, Nature 2017 (N=8) 2 N=8 tumor escape • Results shown represent highest neoantigen vaccine percentage responses in peer publications • No comparison or head-to-head studies were performed between GEN-009 and the other product candidates noted above. Clinical trial criteria, including, without limitation, number of patients, inclusion and exclusion criteria, and primary endpoints were not necessarily the same. | CONFIDENTIAL 16
Enables Unparalleled Vaccine Immune Responses E x V i v o Assay (effector function) IVS Assay (central memory) Best peer results 1 GEN - 0092 Best peer results 1 GEN - 0092 51% 87% 41% 57% 57% 23% 17% 0% Potential Patient Benefits Potential Patient Benefits Rapid tumor killing Durable efficacy 1 Sahin, et al, Nature 2017 (N=8); Ott, et al, Nature 2017 (N=8) 2 N=8 • Results shown represent highest neoantigen vaccine percentage responses in peer publications • No comparison or head-to-head studies were performed between GEN-009 and the other product candidates noted above. Clinical trial criteria, including, without limitation, number | CONFIDENTIAL 17 of patients, inclusion and exclusion criteria, and primary endpoints were not necessarily the same.
T r i a l GEN - 009 Phase 1/2a Trial Designed to Showcase Vaccine Benefits in ICI Pat i e nt s P a r t B • Combination of GEN-009 and standard-of-care PD-1 based regimen intended in cohorts of patients with advanced disease • Vaccination after response to PD -1 regimen determined • Objectives: Safety, immunogenicity, efficacy (initial efficacy: 3 months post vaccination) • Tumor types: Melanoma, NSCLC, SCCHN, Urothelial, RCC 18 | CONFIDENTIAL 18
GEN - 011 Potential first-in-class solid Neoantigen tumor T cell therapy T cell Therapy | CONFIDENTIAL 19
TIL Therapy Has Changed the Narrative For Neoantigen - s p e c i f i c T cell Therapy to Treat Solid Tumors Tumor infiltrating lymphocyte (TIL) therapy has delivered durable efficacy in hard -to- treat solid tumor patients • 44% ORR in late-stage cervical cancer patients • Similar benefits in heavily pretreated metastatic melanoma patients • These data have enabled an accelerated path to approval • Single arm pivotal studies planned | CONFIDENTIAL 20
Lessons Learned From TIL Therapy M u l t i p l e C D 4 + a n d C D 8 + T c e l l s neoantigen targets CD4 + T cells support activity • Attacks tumor heterogeneity, and persistence of CD8 + T limits tumor escape CD4+ CD8+ cells and can directly kill • Intracellular as well as tumor cells extracellular targets Patient safety Diversity of TCRs • Autologous, non -engineered T Multiple “shots on goal” for cell safety every neoantigen • Avoid toxicity observed with CAR-T and TCR -T approaches | CONFIDENTIAL 21
Still Significant Opportunities to Enhance T cell Therapy for Solid Tumors Approaches to Address Increase target breadth & specificity TILs only target a limited proportion of neoantigens Neoantigen selection via Avoid deleterious T cell responses Inhibitory, pro -tumor responses to neoantigens should be avoided in a therapeutic context Improve T cell activity & proliferative potential TILs typically exhausted and expansion protocols exacerbate condition Use peripheral blood lymphocytes (PBLs) Broaden addressable tumor types TILs must be sterilely extracted from resectable ‘hot’ tumors | CONFIDENTIAL 22
GEN - 011 ATLAS-Enabled T cell Therapy for Solid Tumors Autologous T cell therapy Advancing rapidly to the clinic T cells expanded from peripheral blood : Proof of concept for key IND - e n a b l i n g activities has been achieved: • Both CD4 + and CD8 + T cells with validated antigen • CMC activities underway enabling 1H 2020 responses IND target • Multiple specificities for broader coverage, • Desired cell phenotypes reduced potential for metastatic escape • Neoantigen-specific cell killing in vitro • HLA agnostic • Initial clinical readout anticipated for 1H • Ability to address a range of tumor types 2021 in checkpoint-resistant patients | CONFIDENTIAL 23
Driving the Next-Generation of Immunotherapies U n i q u e Differentiated Next-generation Antigen validation Clinical responses: Neoantigen cell therapy platform, ATLAS, enables Phase 1/2a GEN-009 product candidate GEN- personalized immune (neoantigen vaccine) 011, with IND filing 1H response profiling immunogenicity enables 2020 and preliminary mid-2020 preliminary clinical results in 1H 2021 clinical results | CONFIDENTIAL 24
NASDAQ: GNCA 100 Acorn Park Drive Cambridge, MA 02140 USA +1 617.876.8191 | CONFIDENTIAL www.genocea.com25