SLS - NASDAQ

Remy Bernarda – Senior Vice President, Investor Relations and Corporate Communications Mark Schwartz – President and Chief Executive Officer Bijan Nejadnik – Executive Vice President and Chief Medical Officer John Burns – Vice President, Finance and Corporate Controller

Jason McCarthy – Maxim Group

Good day, ladies and gentlemen and thank you for standing by. Welcome to Galena Biopharma’s Second Quarter 2016 Financial Update. At this time, all participants are in a listen-only mode to prevent background noise. [Operator Instructions] We will have a question-and-answer session later and the instructions will be given at that time. And as a reminder, this conference is being recorded. Now I would like to welcome and turn the call to Remy Bernarda, Senior Vice President, Investor Relations and Corporate Communications. You may begin.

Good afternoon, everyone and thank you for joining our call today. For those of you listening via telephone, I would encourage you to visit our website and log into our webcast presentation. For our quarterly call, we will be using slides to enhance our information flow. The slides can be accessed on our website in the Investors section under Events and Presentations. These slides are posted both as a PDF document and will also be available on the webcast. The slides are viewer-controlled, meaning that you, the viewer, will need to advance the slides. Our speakers will alert you to the slide they are addressing. As listed on Slide number 2 on our presentation, during today's discussion, we may make forward-looking statements about our future financial conditions and result of operations and potential for profitability, the sufficiency of our cash resources, our ability to obtain additional equity or debt financing, possible partnering or other strategic opportunities for the development of our products and our clinical programs. Such statements include, but are not limited to, the development progress of our clinical product candidates, including patient enrollment, interim analysis, trial initiations and collaborations. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under Risk Factors in our Annual Report on Form 10-K and quarterly reports on Form 10-Q and other documents filed with the SEC and available on our website. Actual results may differ materially from those contemplated by these forward-looking statements. Please now turn to Slide 3, as I would like to introduce the members of management presenting on today's call, Dr. Mark Schwartz, our President and CEO; Dr. Bijan Nejadnik, Executive Vice President and Chief Medical Officer; and Mr. John Burns, our Vice President, Finance and Corporate Controller, who will discuss our financials. Please turn to Slide number 4 and Dr. Schwartz will begin our discussion.

Thank you, Remy and welcome everyone to our 2016 second quarter corporate update call. I’d first like to discuss the results of our investigation from our NeuVax Phase 3 PRESENT trial. As a reminder, PRESENT stands for the Prevention of Recurrence in Early Stage node-positive breast cancer with low to intermediate HER-2 Expression with NeuVax Treatment. As we announced at the end of June, the trials Independent Data Monitoring Committee or IDMC recommended as a trial we stopped for futility. We immediately stopped the PRESENT trial and initiated an investigation into the causes of the recommendation. We have completed our investigation into procedural and operational elements of the trial an un-blinded and analyzed the top line data. Our investigation into the trial confirmed the recommendation from the IDMC. Our internal team will support from outside experts conducted a thorough investigation and there is nothing that resulted in the identification of a systemic reversal of the treatment arms, as suggested by the IDMC letter. Our analysis of the data shows that there was a separation have occurred albeit not statistically significant with the control arm performing better than expected and a NeuVax arm performing consistent with our protocol assumptions for the control group. Because the study is being futile, we are officially closing a PRESENT trial and we expect to present the data at a future medical conference. Please turn to Slide 5. We still have many promising opportunities in our pipeline, Bijan will elaborate on momentarily. As the field of cancer immunotherapy continues to evolve more and more positions and companies are expanding their treatment regimen to include combination therapy with their assets. We do have always believed that our peptide vaccines in combination with other agents may be a viable treatment paradigm. Indeed ASCO has recently held such approaches the immunotherapy with traditional cancer treatments. As such our combination trials remain ongoing with new vaccine trastuzumab. In addition, our ongoing trials are other cancer immunotherapy assets GALE-301 and GALE-302 continue to progress in their earlier stage programs. As you can see at the top of our pipeline we will now be looking to advance GALE-401, our controlled release version of anagrelide into late stage development targeting patients with essential thrombocythemia or ET. As we have mentioned on our past few calls with the completion of our Phase 2 proof-of-concept trial, we have increased our efforts around GALE-401 and we continue to progresses development into a pivotal trial. With the 505(b)(2) regulatory designation, we anticipate a streamlined development program and accelerated regulatory process. And we believe this is an exciting opportunity to address an unmet medical need in a chronic and growing patient population in patients with ET. Upon confirmation of our plans with the FDA later this year, we believe we could start a pivotal trial in the first half of 2017. I would now like to turn the call over to Dr. Bijan Nejadnik to discuss our clinical programs. Please turn to Slide 6.

Thank you, Mark and good afternoon to everyone. I will discuss our immunotherapy programs shortly. But I’d like to start with the discussion on GALE-401. So please turn to Slide 7. As Mark mentioned GALE-401 is ready to enter late stage development targeting platelet lowering in patients with ET. And we are quite excited about advancing GALE-401 for a number of reasons. For background, the marketed immediate-release version of anagrelide causes adverse events leading to intolerance in approximately 20% to 25% of those patients. Importantly patients with ET who have failed hydroxyurea and anagrelide IR have not approved third-line treatment options. Because ET is a chronic disease treating patients with intolerance is a significant challenge. And it has the potential to compound over time. As we discussed last quarter, we have done a thorough review of the data from our trials as well as an in-depth analysis on the treatment landscape for myeloproliferative neoplasms or MPNs. As a result, as you can see on the Slide 8. We have both strong clinical and development rational through advance GALE-401 into late stage development. In our Phase 2 trial, GALE-401 demonstrated a potentially faster onset of action, consistent efficacy and a clear indication of improved tolerability compared to the immediate-release version of anagrelide. The combined safety data encompassing all six of our trials was presented in June at the European Hematology Association meeting. In addition in the Phase 2 trial, we had an improved administration profile of twice a day dosing. As compared to the IR version that is indicated for treatment up to four times a day. Further based on the PK or pharmacokinetic profile of anagrelide CR or 401, we plan to assess once-a-day dosing in our pivotal trial that could provide significant patient compliance and commercial benefit for the drug. The development profile of GALE-401 also provides a number of advantages as we look to advance this registration program towards market approval. Our controlled release version of anagrelide is a novel proprietary formulation of FDA approved product with a known mechanism of action. We believe this will allow us to utilize the 505(b)(2) regulatory pathway for approval, reducing our overall development process and regulatory requirements. Importantly, we also have patent protection for GALE-401, leading to market exclusivity through 2029. Moving now to Slide 9, we laid out the treatment landscape for ET patients. Currently there are two primary treatment options available hydroxyurea and immediate-release version of anagrelide. Unfortunately, both come with a safety profile that can lead to premature discontinuation of the drug in a significant number of patients. As you can see in the bottom right box on this slide, there are no approved therapies for these patients who have failed the current standard of care treatment, presenting a significant unmet medical need in third-line therapy. As seen on Slide 10. The prevalence of ET is in the U.S. between 135,000 and 175,000 with approximately 75% of diagnosed patients receiving treatment. Based on these numbers our calculations estimate that there are approximately 9,000 drug treatable patients in the third-line. Besides no approved drug in this space there is limited competition with very few agents in development. And if successful in third-line, we believe there are multiple life cycle management opportunities. And as mentioned, we plan to assess once-a-day dosing, that could provide significant patient compliance and commercial benefit for the drug. Our next steps for GALE-401 are to finalize the Phase 2/3 clinical trial design and to meet with the FDA in a Type B meeting before the end of the year. Our current estimate is that we would be able to initiate a pivotal trial in the first half of 2017. Switching to our cancer immunotherapy programs. Please turn to Slide 11. In clinical trials NeuVax has demonstrated a capability to generate tumor-specific CD8 T-cells and it remains our belief that this capability can be beneficial in treatment of cancer. Based on published data demonstrating synergistic mechanism of action they believe the trastuzumab may substantially sensitized breast cancer cells to vaccine-induced T-cell killing. As a result, we initiated two combination studies investigating NeuVax plus trastuzumab in HER2 1+/2+ and in HER2 3+ patients. As you can see on the Slide 12, we have listed our current trials with NeuVax led by our two Phase 2 combination studies with trastuzumab. We have shared the top line data from the PRESENT study with the lead investigators and collaborators for these studies and they are supportive of continuing this investigator sponsored trials as planned. For the 300-patient trial targeting HER2 1+/2+ patients, the principal investigator reported to us that the first pre-specified interim safety analysis was completed by the trials data safety monitoring board in the second quarter. And the DSMB recommended that the trial continue as planned. We look forward to the first data presentation of the interim safety analysis at the European Society for Medical Oncology Congress in October. And the first pre-specified efficacy analysis at the end of next year. With the present investigation completed. We’ll be working with our collaborators on our clinical trials in ductal carcinoma in situ and in gastric cancer. Turning now to Slide 13, we have the overview for our clinical development program for other immunotherapy assets GALE-301 or E-39 and attenuated version of the peptide GALE-302 or E-39 prime are derived from folate binding protein and are targeting the prevention of recurrence in ovarian and endometrial cancers. During the second quarter, the FDA granted two orphan-drug designations for these two cancer immunotherapy peptides for the treatment including prevention of recurrence of ovarian cancer. Both trials have shown promising results to-date and the results from the primary analysis from the GALE-301 Phase 1/2a were presented in June and are depicted in the Slide 14. All those small numbers in the trial we were able to see a statistically significant survival benefit with estimated two year disease free survival rate of 73.5% in the patients optimally treated with the vaccine versus 38.1% in the control group with the statistically significant P-value of 0.03. You will also have additional biomarker and dosing data presentation later this year. With that, I would like to hand the call over to John Burns to discuss our financials. Please turn to Slide 15.

Thank you, Bijan and good afternoon everyone. Today's press release and slides, our financials are presented in a manner such that you can distinguish between our continuing and discontinued operations and all of our figures are in U.S. dollars. Our Statement of Operations can be seen on Slide 16, as filed in our press release. First, I would like to focus on our operating loss which includes our general administrative and clinical development expenses. As reported, our operating loss was $9.3 million in the second quarter of 2016 which is consistent with the loss of $9.1 million in the second quarter of 2015. Research and development expense decreased slightly quarter-over-quarter primarily due to the decrease in enrollment efforts surrounding our Phase 3 PRESENT clinical trial. The decrease in expenses related to PRESENT, were partially offset by additional outside services, to prepare for the PRESENT interim analysis as well as recruitment, enrollment and monitoring expenses in our other clinical trials. The increase in our G&A expense was driven by an increase in legal expenses related to the final approval of our derivative and class action litigation settlement on June 24 and an increase in non cash stock-based compensation and personnel-related expenses. Based on the settlement agreement the payout of our derivative and class action settlement of $2.3 million in cash and $1 million in shares of our common stock was made in early July of this year. Income from continuing operations includes operating losses just described as well as non-operating income and expense. Non-operating income during Q2 2016 was primarily due to $14.4 million decreased in the fair value of warrants accounted for as liabilities resulting from the decline in our common stock price and our continued purchase price consideration liability related to the approval of NeuVax. Change in the fair value of the contingent purchase price liability was a $5.5 million non-cash gain in the second quarter 2016 compared to $0.1 million non-cash gain in the same quarter of 2015. These non-cash gains were partially offset by $1.8 million in additional opt-out litigation settlements. Based on the operating loss and the non-operating income and expense I just described. Income from continuing operations was $8.3 million in Q2 2016, compared to a loss from continuing operations of $13.5 million in Q2 2015. Loss from discontinued operations from our former commercial business for Q2 2016 was $2.9 million, as compared to $2.2 million for Q2 2015. This loss includes legal expenses conjunction with the cooperation for the subpoenas related to ABSTRAL and additional channel obligations related to Medicaid. Separately, as noted on the slide, I’ve highlighted the quarterly breakdowns of our earnings per share calculations. As previously noted our Q2 2016 earnings was significantly impacted by the non-cash gains from the decreases in our warrant liability and contingent purchase price liability. While this created net income of $5.4 million. Management believes most relevant measure of our performance to $9.3 million operating loss and a $2.9 million loss from discontinued operations. Now turn to Slide 17, for a current financial overview. As of June 30, 2016 our cash balance is $19.6 million. Subsequent to quarter-end, on July 13, 2016, we closed on a registered direct public offering for net proceeds of $11.7 million. We also have $24 million in net proceeds that are currently restricted cash and we have discussions with the holder of the debentures to modify the agreement. Of note on our financial payment fee debentures, net of unamortized discounts represent this current liabilities in the condensed consolidated balance sheet. In the second quarter, our cash payment related to operating expenses was $11.5 million, which was within our guidance of $13 million to $15 million, as we made a $2.3 million cash payment related to the derivative and class action settlements on July 1, 2016 in accordance with the final court approval. Going forward, we anticipate costs associated with closing the PRESENT trial will run through the end of the year, with the majority of the expenses being occurred in the third quarter. As a result, we maintain our previous third quarter guidance of between $12 million to $13 million adjusting for the timing of the settlement payment. With a reduced headcount and lower development expenses we expect fourth quarter and future burn rates to be between $8 million to $10 million. Moving to Slide 18, I will now turn the call back over to Mark.

Thank you, John. If you turn to Slide 19, represents the second half milestones that we look forward to accomplishing over the remainder of the year. While we are clearly disappointed in the outcome of the PRESENT trial, we are fortunate to have a diversified, robust pipeline which we are levering across numerous programs including GALE-401 based on our clinical evidence and our identification of an unmet medical need. We believe GALE-401 is strongly positioned for clinical and commercial success. And we are excited to initiate a pivotal trial for the asset next year. We look forward to the ongoing progress in combination trials in a presentation of safety data in our HER2 1+/2+ patient population as well data presentations for GALE-301 later this year. As we proceed through the second half of this year, we are actively pushing our programs forward and we remain committed to corporate development opportunities that can increase shareholder value and help patients living with diseases in areas of unmet medical need. We will now open the call for questions.

Thank you. [Operator Instructions] And our first question is from the line of Jason McCarthy with Maxim Group. Go ahead.

Hi, Mark. Thanks for taking the question. Couple of questions first, what is the size and scope you’re thinking about for a trial in thrombocythemia. For GALE-401, if it’s a Phase 2/3 or is it going to be Phase 3, can you kind of walk us through what you’re thinking in terms of how many patients and if you start the trial in early first half of 2017. How long would it take to we start to see some data from that study?

Hi, thanks Jason, appreciate you dialing in. Let me take a first whack at that and Bijan can jump in here and fill in some details. Since our goal is to develop this under a 505(b)(2), it is not have to be the size and scope of our NME type of trial. And our current thinking right now is, I think as Bijan mentioned on the call here. That we have completed twice a day dosing we’re looking at once-a-day dosing. So right now we’re preparing a small essentially run in our Phase 2 portion comparing twice a day to once-a-day dosing. And that optimal dose, we’d expect to carry forward in a trial that’s somewhere in the low 100-patient range, 100 to 120 or so somewhere in that range. And since its third-line, we really under 505(b)(2) at this point we really have to show non-inferiority to the best available therapies versus having to go head to head against another drug. So I think on a relative scale that’s a fairly cost effective and accelerated timeline versus a new product, a new compound, a new molecule on NME. And at this point, we’re looking at roughly around 2 years, but that’s still under development and we’ll have a more explicit details around a protocol here as the year goes on.

Okay, great. And if I can go back to NeuVax so just a second I know the two investigator sponsored studies in combination with Herceptin are going to continue. So they must have seen data from PRESENT that that they did like or didn’t meet the expectations of the trial protocol. Can you walk us through, what the potential synergies are with Herceptin because you did mention that treatment with Herceptin might make a breast cancer cells more vulnerable to a vaccine like NeuVax.

Yes, Jason. This is Bijan here, thank you for the question. So the question we’ve got in a synergetic effect with Herceptin, what do we think that could offer value to the patients. Absolutely I mean there are some preclinical data clearly showing that. For example the cells have been sensitized to Herceptin they have a much more cytotoxicity in the statistically significant then the cells who have not been, when they are exposed to the cytotoxic T-cells from NeuVax. Additionally there have been some clinical trials that showed that in the patients who have been exposed to a combination, they did better although that the numbers were small, there were 30 and about 40 patients in each group and there was a subgroup analysis of another study. However the data were pretty compelling. Also there are some reasons to believe that with Herceptin as a mechanism of action they would be more exposure of the E-75 over the sales and it sees. And therefore there would be reasons to believe in those situations, that there would be more of an activity of cytotoxic T-cells. So these are all gone to mechanism of action to other preclinical, and some clinical activities are pointed toward that. And that’s why the study just started the way that is started. And the investigators seem to believe that that would be beneficial to the patients at the end of the day.

Great.

And Jason, let me just add that. As we had indicated, we shared the top line data with the collaborators. So they can certainly review the data and make the decision that they feel is appropriate for the trial. As well though, those trials are single blinded, so the patient and the treating physician are blinded as to the treatment, but the PI and the sponsors are un-blinded to the data. And so the trial sponsors have the ability to get a reasonably deep dive into the data to make decisions on continuing the trial.

Right. Okay, great. And just one question for John. Can you with the PRESENT study now terminated and you’re evaluating the data still. Can you kind of walk us through what you think the cash burn will be over the next – for the rest of this year and into 2017?

Yes, Jason. So on Slide 17, if you sort out a little bit, in Q3 we expect $12 million to $13 million, so within there we included the $2.3 million settlement which was slide from Q2 to Q3 based on the final court approval. So within there we are – and in Q4 we’re typically around $8 million to $10 million. Within there we expected $2.5 million to $3.5 million for closing down the PRESENT trial, just doing we are about closer in getting – make sure the data I mean useful as possible for our team here. So we do see our cash burn sliding down and into next year.

Okay, great. Thanks.

And we also expect the legal expenses we’ll always had to continue to slide down as well.

As we settle some of these opted-outs in the derivatives and class action suits.

I see. Okay. Thank you for taking the questions guys.

Thank you.

And our next question is from the line of Ren Benjamin with Raymond James. Please go ahead.

Hello, this is David on for Ren. Thanks for taking the question. Just to start off, I think you may have touched on this a little bit, but precisely what kind of data from the combination studies with NeuVax would get you guys excited? What would you be looking forward to feel confident, developing the asset into advanced clinical trials? And potentially would you be willing to wait for a partner to move the program forward?

So I think at this point I’ve seen an impact on recurrence rates. DFS would certainly get us very excited. I think we would get a lot of people excited in this patient population. Although this is a trial in the 1+/2+ case of NeuVax plus Herceptin the same marketplace is exist as existed for the present trial. There is no directed therapy or HER2 directed these women in there. They do tend to recur in the 20% to 25% range over three years. And when they do have a recurrence, it’s most often fatal. So it’s still an unmet medical need, it’s still a significant opportunity in the marketplace. And I think if we could – if we saw an impact, a clinically important impact on recurrence rate, I think we would take a very significant look at developing it.

Great.

As to how it might be developed in the future, I'll leave that to be addressed when we get there, because obviously it will be a little ways down the road, and there will be many, many changes in the company, in the markets, in the world at large, and I think that to be addressed at that point in time.

Got it. And then maybe if I can squeeze in one more.

Sure.

Sort of given some of the cash constraints and prioritization of anagrelide, what might the development timelines for GALE-301 and GALE-302 look like? And what would the next steps be for those programs?

So the next steps for those programs the final data is coming off, so we still have some additional data analysis to do. And they've done an analysis some development path forward analysis to do. And I think, David, your comments are well taken. I think part of our mission here is to find a way to move those forward without impacting our other development programs that are further along. And frankly, a bit higher priority given there, they are more advanced data. And so I think that will be determined as we progress go through getting anagrelide into trial start. The combination trials moving forward and we'll have to see how our financial situation develops to figure out the best option to move those forward.

Great. Thank you.

And this concludes our Q&A…

I'm sorry.

Go ahead.

So I'd like to thank everybody for their time this afternoon. Have a great summer. And I look forward to talking to you next quarter.