Attached files
| file | filename |
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| EX-99.1 - EXHIBIT 99.1 - SELLAS Life Sciences Group, Inc. | gale-20160809ex991.htm |
| 8-K - 8-K - SELLAS Life Sciences Group, Inc. | gale-201608098xk.htm |
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