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): August 9, 2016

         

GALENA BIOPHARMA, INC.(Exact name of registrant as specified in its charter)

         Delaware   001-33958   20-8099512

(State or other jurisdiction ofincorporation or organization)

 

(Commission File Number)

 

(I.R.S. Employer Identification No.)

         

   

2000 Crow Canyon Place, Suite 380,San Ramon, CA 94583

(855) 855-4253

   

   

(Address of Principal ExecutiveOffices) (Zip Code)

            

Registrant’s telephone number, including area code: (855) 855-4253

         

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 thefollowing provisions (see General Instruction A.2. below):

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))

Item 2.02 Results of Operations and Financial Condition.

On August 9, 2016 , Galena Biopharma, Inc. (“we,” “us,” “our” and the “company”) issued a press release announcing our financial results for the three and sixmonths ended June 30, 2016 and providing an update on recent business developments. A copy of the press release is attached to this Report as Exhibit 99.1 andis incorporated herein by reference. The slides from the presentation will be referenced below are incorporated by reference.

The information furnished under this Item 2.02, including the accompanying Exhibit 99.1, shall not be deemed to be “filed” for the purposes of Section 18 of theSecurities Exchange Act of 1934, as amended, (the “Exchange Act”), or otherwise subject to the liabilities of such section, nor shall such information be deemed tobe incorporated by reference in any filing by the company under the Securities Act of 1933, as amended, or the Exchange Act, regardless of the generalincorporation language of such filing, except as specifically stated in such filing.

Item 5.02 Departure of Directors or Certain Directors; Election of directors; Appointment of Certain Officers; Compensatory Arrangements ofCertain Officers.

(e) On August 8, 2016, we revised the compensation arrangement with our controller and principal accounting officer by promoting John T. Burns, CPA to VicePresident of Finance and Corporate Controller, with a salary of $215,000 per year effective Monday, August 8th, 2016.

Item 7.01 Regulation FD Disclosure.

On August 9, 2016 , the Company will host a conference call with investors to discuss the Company's financial and operating results for the three and six monthsended June 30, 2016. The discussion including slides will be made available to the public via conference call and webcast that will include slides. The slides fromthe presentation are being furnished as Exhibit 99.2 to this Current Report on Form 8-K. The information in this Item 7.01 and Exhibits 99.2 to this Form 8-K shallnot be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated byreference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

     

Exhibit No. Description   

99.1 Press Release of Galena Biopharma, Inc. dated August 9, 2016.99.2   The corporate update presentation slides dated August 9, 2016.

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 undersignedhereunto duly authorized.

                 

    GALENA BIOPHARMA, INC.

         

Date: August 9, 2016   By: /s/ Mark W. Schwartz

        Mark W. Schwartz Ph.D.President and Chief Executive Officer

Galena Biopharma Reports Second Quarter 2016 Financial Results and Provides a Corporate Update

• Advancing GALE-401 (Anagrelide CR) into a pivotal trial for the treatment of essential thrombocythemia• Closing NeuVax Phase 3 PRESENT trial• NeuVax combination trials with trastuzumab continue• Webcast and conference call scheduled for today at 2:00 p.m. P.T. / 5:00 p.m. E.T.

 San Ramon, California, August 9, 2016 - Galena Biopharma, Inc. (NASDAQ: GALE), a biopharmaceutical company committed to thedevelopment and commercialization of hematology and oncology therapeutics that address unmet medical needs, today reported its financialresults for the quarter ended June 30, 2016.

As announced on June 29, 2016, Galena discontinued its NeuVax™ (nelipepimut-S) Phase 3 PRESENT ( P revention of R ecurrence in E arly- Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 E xpression with NeuVax T reatment) clinical trial due to futility inaccordance with the recommendation from the Independent Data Monitoring Committee (IDMC). With support from outside experts, theCompany conducted a thorough investigation of the trial that confirmed the IDMC recommendation and found no evidence of a systemic reversalof the treatment arms, as suggested by the IDMC letter dated June 27, 2016. As a result, Galena is closing the PRESENT trial.

“While we are clearly disappointed in the outcome of the PRESENT trial, we are fortunate to have a diversified, robust pipeline which includesGALE-401 that we are advancing into late stage development,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “We planto meet with the FDA by the end of the year to discuss our Phase 2/3 clinical trial design for GALE-401. We expect to initiate a pivotal trial in thefirst half of 2017 addressing an unmet medical need in patients with essential thrombocythemia.”

Dr. Schwartz continued, “We remain committed to the prevention of recurrence in breast, ovarian, and endometrial cancers. We have shared thePRESENT information with our investigators for the NeuVax plus trastuzumab combination trials in breast cancer, and those trials are continuingas planned. The first data presentation of the interim safety analysis from the HER2 1+/2+ patients will be at the European Society for MedicalOncology Congress in October. Our GALE-301 and GALE-302 trials are also ongoing with multiple data presentations expected this year.”

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Galena will host a webcast and conference call today at 2:00 p.m. P.T./5:00 p.m. E.T. to discuss its financial and business results. The livewebcast will include slides that can be accessed on the Company's website under the Investors section/Events and Presentations:http://investors.galenabiopharma.com/events.cfm . The conference call can be accessed by dialing (844) 825-4413 toll-free in the U.S., or (973)638-3403 for participants outside the U.S. The Conference ID number is: 51743330. The archived webcast replay will be available on theCompany's website for one year.

FINANCIAL REVIEW

Operations

Operating loss from Galena’s development programs and general and administrative expenses, classified as continuing operations, during thethree months ended June 30, 2016 was $9.3 million, including $0.6 million in non-cash stock-based compensation, compared to an operating lossfrom continuing operations of $9.1 million, including $0.4 million in non-cash stock-based compensation for the same period in 2015. Operatingloss for the first half of 2016 was $18.3 million, including $1.3 million in non-cash stock-based compensation, compared to an operating loss fromcontinuing operations of $18.0 million, including $0.8 million in non-cash stock-based compensation for the same period in 2015.

Income from continuing operations for Q2 2016 was $8.3 million, or $0.05 per basic and diluted share, including $17.6 million in non-operatingincome. Loss from continuing operations for Q2 2015 was $13.5 million, or $0.08 per basic and diluted share, including a $4.3 million non-cashloss on the change in the warrant liability. Loss from continuing operations for the first half of 2016 was $4.8 million, or $0.03 per basic anddiluted share, including $13.4 million in non-operating income. Loss from continuing operations for the first half of 2015 was $21.8 million, or$0.15 per basic and diluted share, including a $3.1 million non-cash loss on the change in the warrant liability.

The increase in Galena's net non-operating income during the three and six months ended June 30, 2016 compared to the three and six monthsended June 30, 2015 was largely due to two factors: a significant decrease in the estimated fair value of warrants accounted for as liabilities drivenby the decline in Galena's common stock price; and, the significant decrease in the fair value of the contingent purchase price liability for NeuVaxgiven the decision to terminate the PRESENT study. This increase in net non-operating income is reflected as a non-cash gain in the consolidatedfinancial statements. Management believes the most relevant measure of our performance is operating loss and loss from discontinued operations.The non-cash gains in non-operating income were partially offset by $1.8 million in opt-out litigation settlements that were paid in July 2016, with$1.65 million paid in shares of common stock and $0.15 million paid in cash.

Loss from discontinued operations from Galena's former commercial business for Q2 2016 was $2.9 million, or $0.02 per basic and diluted share,compared to $2.2 million, or $0.02 per basic and diluted share, for the same period of 2015. Loss from discontinued operations for the first

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half of 2016 was $6.3 million, or $0.03 per basic and diluted share, compared to $4.4 million, or $0.03 per basic and diluted share, for the sameperiod of 2015.

Net income for Q2 2016 was $5.4 million, or $0.03 per basic and diluted share, compared to net loss of $15.7 million, or $0.10 per basic anddiluted share, for the same period of 2015. Net loss for the first half of 2016 was $11.1 million, or $0.06 per basic and diluted share, compared to$26.2 million, or $0.18 per basic and diluted share, for the same period of 2015.

Cash and Cash Equivalents

Galena had cash and cash equivalents of approximately $19.6 million as of June 30, 2016, compared with $29.7 million as of December 31, 2015.The decrease of approximately $10.1 million in cash and cash equivalents from December 31, 2015 to June 30, 2016 was attributable primarily to$24.7 million used in operating activities, $1.1 million in selling expenses related to the sale of the Company’s commercial products, and $4.8million in payments on long-term debt. The decrease was partially offset by $20.2 million in net proceeds from issuance of common stock andwarrants to purchase common stock in January 2016.

Subsequent to quarter end, on July 13, 2016, Galena closed the sale to certain institutional investors of common stock in a registered directoffering, and warrants to purchase common stock in a concurrent private placement. The net proceeds to Galena, after deducting placement agentfees and estimated offering expenses, were approximately $11.7 million.

Additionally, on May 10, 2016, Galena entered into a Securities Purchase Agreement with JGB Newton Ltd. to sell $25.5 million principalamount of Debentures. The Debentures include a 6.375% original issue discount, and, after broker and other expenses, net proceeds wereapproximately $23.4 million. The net proceeds are currently restricted cash, and Galena is in discussions with the holder of the Debentures tomodify the agreement.

SECOND QUARTER AND RECENT ACTIVITIES

Clinical Development

Discontinued NeuVax Phase 3, PRESENT Interim Analysis based on Independent Data Monitoring Committee RecommendationOn June 24, 2016, the IDMC met to conduct a pre-planned safety and futility analysis of the Phase 3 PRESENT ( P revention of R ecurrence in  Early- S tage, Node- Positive Breast Cancer with Low to Intermediate HER2  E xpression with  NeuVax T reatment) clinical trial. On June 29,2016, the Company announced the IDMC recommendation to stop the trial for futility. The Company immediately stopped the PRESENT trial,and initiated an investigation into the causes of the recommendation.

Presented GALE-401 Combined Safety Data at the European Hematology Association 21 st Congress. A total of six trials have been runwith GALE-401, five Phase 1 trials in healthy volunteers (N=98), and one Phase 2 single arm, open label pilot study in patients withmyeloproliferative neoplasms (MPNs) (N=18). The poster, entitled, “ Anagrelide Controlled

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Release (GALE-401) Safety Profile Consistently Well Tolerated in Myeloproliferative Neoplasms Patients and Healthy Volunteers ” was designedto characterize the safety profile of GALE-401 in all subjects treated to date. The results demonstrated that GALE-401 is well tolerated in MPNpatients as well as in healthy volunteers and predominantly mild to moderate toxicities were observed that did not reveal any unexpected adverseevents.

Received Two Orphan Drug Designations for GALE-301 and GALE-301/GALE-302The U.S. Food and Drug Administration granted two orphan-drug designations for Galena’s two cancer immunotherapy peptides derived fromFolate Binding Protein (FBP) for the treatment (including prevention of recurrence) of ovarian cancer: one for GALE-301 (E39), and one forGALE-301 (E39) and GALE-302 (E39’).

Presented GALE-301 Phase 1/2a Primary Analysis at the American Society of Clinical Oncology Annual Meeting 2016. The poster,entitled, “ The primary analysis of a phase I/IIa dose finding trial of a folate binding protein vaccine, E39 + GM-CSF in ovarian and endometrialcancer patients to prevent recurrence ,” demonstrated that the vaccine is well tolerated and immunogenic. In the optimal dose group, the resultsdemonstrate potential clinical benefit for GALE-301 to prevent recurrence in these patients, and that boosters may sustain this effect.

Received Fast Track Designation for NeuVaxOn June 1, 2016, Galena announced that the FDA has designated NeuVax™, combined with GM-CSF, as a Fast Track development program forthe treatment of patients with early stage, node positive breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or2+, following standard of care.

Presented GALE-301 Phase 1/2a Clinical Booster Data at the American Association for Cancer Research (AACR) Annual Meeting. Theposter, entitled, “ Comparing an attenuated booster (E39’) vs. E39 booster to potentiate the clinical benefit of the folate binding protein (FBP)-derived vaccine (E39 + GM-CSF) in a phase I/IIa trial to prevent recurrence in endometrial (EC) and ovarian cancer (OC) patients,”randomized patients to two different boosters: the wildtype peptide (GALE-301/E39), versus the attenuated peptide (GALE-302/E39’). Bothpeptides demonstrated the same tolerable safety profile with only Grade 1 local reactions and minimal Grade 2 toxicities.  Importantly, thepercentage of patients who received two booster inoculations and remained disease free showed a statistically significantly improvement in thedrug treatment arm, versus the control arm, regardless of which booster was used.

Corporate

Closed an Underwritten Public Equity Offering. On July 13, 2016, Galena closed the previously announced underwritten public offering ofcommon stock and warrants. The net proceeds to the Company were approximately $11.7 million.

Derivative and Securities Class Action Lawsuits Granted Final Court Approval. On June 24, 2016, the U.S. District Court for the District ofOregon entered a final order and partial

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judgment in  In re Galena Biopharma, Inc. Securities Litigation , granting final approval of the settlement. On the same day, the Court also issuedan opinion and order awarding attorney’s fees of $4.5 million plus costs, which is paid out of the settlement funds. The settlement provides for apayment of $20 million to the class and the dismissal of all claims against the Company and current and former officers and directors inconnection with the consolidated federal securities class actions. Of the $20 million settlement payment to the class, $16.7 million was paid byGalena’s insurance carriers and $2.3 million in cash was paid by Galena on July 1, 2016, along with $1 million in shares of common stock(480,053 shares) issued on July 6, 2016.

Appointed Mary Ann Gray, Ph.D. to the Company’s Board of Directors. Effective April 25, 2016, the Board increased the number ofdirectors from eight to nine directors and appointed Mary Ann Gray, Ph.D. as a Class III director. Dr. Gray is President of Gray StrategicAdvisors, LLC, which provides strategic advice to both public and private biotechnology companies. Previously, she worked at the FederatedKaufmann Fund focusing on both public and private healthcare investments, and was also a sell-side biotechnology analyst for nine years. Earlierin her career, Dr. Gray held scientific positions at Schering Plough and NeoRx, managed pre-clinical toxicology studies for the National CancerInstitute through Battelle Memorial Institute, and worked in a hospital laboratory. Dr. Gray has a Ph.D. in Pharmacology from the University ofVermont where she focused on novel chemotherapeutic agents for the treatment of cancer, and she received her B.S. in biology from theUniversity of South Carolina. She completed her postdoctoral work at Northwestern University Medical School and Yale University School ofMedicine. 

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GALENA BIOPHARMA, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)(Amounts in thousands, except share and per share data)

 Three Months Ended

June 30,  Six Months Ended

June 30,

  2016   2015   2016   2015Operating expenses:              

Research and development $ 6,175   $ 7,197   $ 11,618   $ 13,022General and administrative 3,117   1,886   6,642   4,973

Total operating expenses 9,292   9,083   18,260   17,995Operating loss (9,292)   (9,083)   (18,260)   (17,995)Non-operating income (expense):              

Litigation settlements (1,800)   —   (1,800)   —Change in fair value of warrants potentially settleable in cash 14,392   (4,267)   10,520   (3,115)Interest expense, net (519)   (207)   (611)   (432)Change in fair value of the contingent purchase price liability 5,497   83   5,327   (238)

Total non-operating income (expense), net 17,570   (4,391)   13,436   (3,785)Income (loss) from continuing operations $ 8,278   $ (13,474)   $ (4,824)   $ (21,780)Discontinued operations              

Loss from discontinued operations(2,889)   (2,186)   (6,280)   (4,417)

Net income (loss) $ 5,389   $ (15,660)   $ (11,104)   $ (26,197)Net income (loss) per common share:              

Basic and diluted net income (loss) per share, continuingoperations $ 0.05   $ (0.08)   $ (0.03)   $ (0.15)Basic and diluted net income (loss) per share, discontinuedoperations $ (0.02)   $ (0.02)   $ (0.03)   $ (0.03)

Basic net income (loss) per share $ 0.03   $ (0.10)   $ (0.06)   $ (0.18)Weighted-average common shares outstanding: basic 182,034,593   161,383,398   180,703,456   148,647,581Weighted-average common shares outstanding: diluted 185,477,330   161,383,398   180,703,456   148,647,581

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GALENA BIOPHARMA, INC.CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)(Amounts in thousands)

  June 30, 2016   December 31, 2015ASSETS      

Current assets:      Cash and cash equivalents $ 19,590   $ 29,730Restricted cash 24,401   401Litigation settlement insurance recovery —   21,700Prepaid expenses and other current assets 1,210   1,398Current assets of discontinued operations 83   392

Total current assets 45,284   53,621Equipment and furnishings, net 259   335In-process research and development 12,864   12,864GALE-401 rights 9,255   9,255Goodwill 5,898   5,898Deposits 218   171

Total assets $ 73,778   $ 82,144LIABILITIES AND STOCKHOLDERS’ EQUITY      

Current liabilities:      Accounts payable $ 1,273   $ 1,597Accrued expense and other current liabilities 4,703   5,292Litigation settlement payable 5,100   25,000Fair value of warrants potentially settleable in cash 9,264   14,518Current portion of long-term debt 23,157   4,739Current liabilities of discontinued operations 3,727   5,925

Total current liabilities 47,224   57,071Deferred tax liability, non-current 5,418   5,418Contingent purchase price consideration, net of current portion 815   6,142

Total liabilities 53,457   68,631Stockholders’ equity 20,321   13,513

Total liabilities and stockholders’ equity $ 73,778   $ 82,144

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About Galena Biopharma

Galena Biopharma, Inc. is a biopharmaceutical company committed to the development and commercialization of hematology and oncologytherapeutics that address unmet medical needs. Galena’s pipeline consists of multiple mid-to-late-stage clinical assets led by our hematology asset,GALE-401, and our novel cancer immunotherapy programs including NeuVax™ (nelipepimut-S) and GALE-301/GALE-302. For moreinformation, visit www.galenabiopharma.com .

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Suchstatements include, but are not limited to, statements about development of our products, our future financial condition and results of operationsand potential for profitability, the sufficiency of our cash resources, our ability to obtain additional equity or debt financing, possible partneringor other strategic opportunities for the development of our products, as well as other statements related to the progress and timing of our productcommercialization and development activities, present or future licensing, collaborative or financing arrangements or that otherwise relate tofuture periods. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under“Risk Factors” in Galena’s Annual Report on Form 10-K for the year ended December 31, 2015 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does notundertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date ofthis press release.

NeuVax is a trademark of Galena Biopharma, Inc.

Contact:

Remy BernardaSVP, Investor Relations & Corporate Communications(925) 498-7709ir@galenabiopharma.com

Source: Galena Biopharma, Inc.

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Q2, 2016   Financial Results &   Corporate Update   

 

FORWARD LOOKING STATEMENT   This presentation contains forward-looking statements within the meaning of the   Private Securities Litigation Reform Act of 1995. Such statements include, but   are not limited to, statements about the divestiture of the commercial operations   including the two commercial products, the issuance and exclusivity of patents,   and the progress of development of Galena’s product candidates, including   patient enrollment in our clinical trials, interim analysis, time to complete the trials,   and expected time periods for results. These forward-looking statements are   subject to a number of risks, uncertainties and assumptions, including those   identified under “Risk Factors” in Galena’s Annual Report on Form 10-K for the   year ended December 31, 2015 and most recent Quarterly Reports on Form 10-Q   filed with the SEC. Actual results may differ materially from those contemplated   by these forward-looking statements. Galena does not undertake to update any of   these forward-looking statements to reflect a change in its views or events or   circumstances that occur after the date of this press release.   2   

 

EARNINGS CALL PARTICIPANTS   Presenters   Mark W. Schwartz, Ph.D.   President & Chief Executive   Officer    Bijan Nejadnik, M.D.   Executive Vice President,   Chief Medical Officer   John T. Burns, CPA   Vice President, Finance and   Corporate Controller       Other Participants    Remy Bernarda, IRC   SVP, Investor Relations &   Corporate Communications    Tom Knapp, Esq   Interim General Counsel     3   

 

OPENING   REMARKS   Mark W. Schwartz, Ph.D.   President and   Chief Executive Officer   4   

 

DEVELOPMENT PIPELINE   Product Therapeutic Area Phase 1 Phase 2 Phase 3 BLA / NDA   Hematology   GALE-401 (Anagrelide CR) Essential Thrombocythemia   Immunotherapy: Breast Cancer   NeuVax™ + Herceptin®   Node-positive or node negative/triple   negative HER2 IHC 1+/2+   NeuVax™ + Herceptin®   High risk, node-positive or negative,   HER2 IHC 3+   NeuVax™ Ductal Carcinoma in Situ (DCIS)   Immunotherapy: Gastric Cancer   NeuVax™ Gastric, HER2 IHC 1+/2+/3+   Immunotherapy: Gynecological Cancer   GALE-301 Ovarian & Endometrial   GALE-301 + GALE-302 Ovarian & Breast   *NeuVax is an investigational product. Efficacy has not been established. Herceptin is a registered trademark of Genentech.   Ongoing Planned   VADIS   5   2b   

 

CLINICAL   DEVELOPMENT   Bijan Nejadnik, M.D.   Executive Vice President,   Chief Medical Officer   6   

 

GALE-401   7   Anagrelide Controlled   Release (CR)   

 

GALE-401 Development Summary    Potential Clinical Benefits from Phase 2 trial   • Potentially faster onset of action   • Consistent efficacy   • Indication of improved tolerability vs anagrelide IR   • Twice a day dosing with a PK profile supportive of once-a-day dosing      Strong Development Rational   • Novel proprietary formulation of FDA approved product with known mechanism of   action   • 505(b)(2) regulatory pathway sufficient for approval (to be confirmed with the FDA)   • Intellectual property allowing market exclusivity through 2029   8   

 

ESSENTIAL THROMBOCYTHEMIA (ET):   CURRENT U.S. STANDARD OF CARE   9       • Generally first line therapy for ET   • Cytotoxic Myelosuppressive drug (reduces   other blood cells as well)   • Increased risk of developing acute leukemia   after long term; avoided in younger patients   • About 25% of patients are   intolerant/refractory       • Off-label third line use   • Non cytotoxic drug   • Not used in most patients because requires   injection and has flu like symptoms   • Used mostly in pregnant women           • Generally second line therapy for ET   • Non cytotoxic drug   • Decreases platelets formation   • Not associated with increased risk of   leukemia   • Side effects: palpitations, headaches   • About one-third are intolerant to Anagrelide           • Hydroxyurea and Anagrelide   Treatment Failure           Sources: Leukemia and Lymphoma Society: Essential Thrombocythemia Facts Cervantes, F. Hematology 2011; 215-221   1st Line: Hydroxyurea   2nd Line: Anagrelide IR   Interferon alpha   3rd Line: Unmet Need   

 

GALE-401 ET Development Opportunity    Significant unmet medical need   • No alternatives after Anagrelide IR and Hydroxyurea    Diagnosed patient population for ET   • US Prevalence: 135,000 - 175,000    ~75% of diagnosed patients receive treatment    ~9,000 third line patients    Limited competition with very few agents in development    Multiple life cycle management opportunities    Next steps   • Finalize the Phase 2/3 clinical trial design   • Type B meeting with the FDA   • Initiate pivotal trial in 1H, 2017   10   Sources: Harrison et al N Engl J Med 2005;353:33-45; Mehta et al, (2014) Epidemiology of myeloproliferative   neoplasms in the United States, Leukemia & Lymphoma, 55:3, 595-600, DOI: 10.3109/10428194.2013.813500   

 

IMMUNOTHERAPY   PROGRAMS   11   NeuVax™ (nelipepimut-S)   GALE-301/GALE-302   

 

NEUVAX: CURRENT CLINICAL TRIALS   Phase Treatment   HER2   Status   Indication Trial Status   Protocol   Defined   # of Patients   Collaborations   2b   Combination   with   trastuzumab   1+, 2+   BREAST   Node Positive or High   Risk Node Negative   HLA A2+, A3+,   A24+, A26+   Enrolling   U.S. only   33 centers   300   2   Combination   with   trastuzumab   3+ high   risk   BREAST   Node Positive   HLA A2+, A3+   Enrolling   U.S. only   28 centers   100   2   Single agent   VADIS Study   1+,   2+,3+   BREAST   Ductal Carcinoma in   Situ (DCIS)   HLA A2+   Suspended   U.S. only   4 centers   48   2 Single agent   1+,   2+,3+   GASTRIC   HLA A2+, A3+   Planned   India Only   50   12   

 

GALE-301 & GALE-302:   CURRENT CLINICAL DEVELOPMENT   13   Phase Treatment Cancer Type   Target   Indication   Current   Status   # of Enrolled   Patients   1/2a GALE-301   Ovarian,   Endometrial   HLA A2+   Ovarian Enrolled 51   1b   GALE-301 &   GALE-302   Ovarian, Breast   HLA A2+   Ovarian /   Breast   Enrolled 39   

 

GALE-301: OPTIMAL DOSE GROUP SHOWS   PRELIMINARY EFFICACY   0.0%  5.0%  10.0%  15.0%  20.0%  25.0%  30.0%  Vaccine Control  % of  Subj  e  ct  s    Recurrence   24.0% 13.3%   Source: Peoples, et. al, Poster Presentation, American Society of Clinical Oncology 2016 14   Phase 1/2a trial ongoing    Phase 1: Determined optimal dose and   demonstrated safety and potent immune   response    Phase 2a Preliminary data:   • At 16 months median follow-up:    Overall recurrence rate was 44.8% in   the VG versus 54.5% in the CG   (p=0.58),    Recurrence rate of 23.5% in patients   who received booster inoculations.   • Two year DFS estimate in 1000 mcg dose   group is 73.5% vaccine vs. 38.1% control   (p=.03)   • GALE-301 plus GM-CSF is well tolerated   and elicits a strong in vivo immune   response with primarily Grade 1 and   Grade 2 toxicities   Estimated 24 months Disease Free Survival by   Dosing Cohort   

 

FINANCE   John Burns   Vice President, Finance and   Corporate Controller   15   

 

STATEMENTS OF OPERATIONS   16   

 

FINANCIAL OVERVIEW   Cash Position (as of June 30, 2016) $19.6 million   Financing (July 13, 2016) + $11.7 million   Debt Financing (May 10, 2016) + $24 million (restricted cash)   Projected Quarterly Burn   Q3, 2016 $12 - $13 million   Q4, 2016 $8 - $10 million   Shares Outstanding (as of July 31, 2016) 214 million   Market Cap (as of August 8, 2016) ~$100 million   17   

 

MILESTONES &   CLOSING   REMARKS   Mark W. Schwartz, Ph.D.   President and   Chief Executive Officer     18   

 

2H, 2016 MILESTONES   19   PROGRAM MILESTONE   PROJECTED   DATE   GALE-401   (anagrelide CR)   Present combined safety data ✓   Confirmation of 505(b)2 pathway 2H   Submit final Phase 2 report Q4   NeuVax™   (nelipepimut-S)   Fast Track Designation ✓   Initiate DCIS trial Q2   Combo H&N 1+/2+ Interim safety data Q4   GALE-301   GALE-302   Present 301/302 booster data ✓   Present GALE-301 Phase 2a primary analysis ✓   Orphan Drug Designation ✓   Present GALE-301 Biomarker & Dosing Data Q4