SELLAS Life Sciences Group, Inc. - Business Update and First Quarter 2022 Highlights Call

SELLAS Life Sciences Group, Inc. - Business Update and First Quarter 2022 Highlights Call, April 6, 2022

CORPORATE PARTICIPANTS

Angelos M. Stergiou, CEO

CONFERENCE CALL PARTICIPANTS

Allison Soss, KCSA Strategic Communications

Okay, let us begin with the forward looking statements: Good morning,

everyone, and welcome to SELLAS shareholder update call.

I am Allison Soss, Senior Vice President, KCSA Strategic

communications. Before we begin, I would like to remind you that SELLAS will be making statements on today's call related to future

expectations regarding the clinical development of its clinical candidates GPS and GFH009 the potential for GPS and GFH009 as drug

development candidates for various cancer indications alone and in combination with other therapeutic agents and the timing

regarding data analysis as well as the company's financials and its corporate strategy. These statements constitute forward looking

statements for the purpose of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and by their

nature involve estimates, projections, goals, forecasts, and assumptions, and are subject to risks and uncertainties which include,

without limitation risks and uncertainties associated with the COVID 19 pandemic and its impact on the Company's clinical plans

risks and uncertainties associated with immunotherapy product development and clinical success thereof, the uncertainty of

regulatory approval and other risk and uncertainties affecting SELLAS and its development programs that could cause actual results

or outcomes to differ materially from those expressed in the forward-looking statements. These forward-looking statements speak only

as of the date of this conference call, and should not be relied upon as predictions of future events. While SELLAS may elect to

update these forward-looking statements at some point in the future the company disclaims any obligation to do so, even if the

company's views change. Additional information about the material factors and assumptions forming the basis of the forward-looking

statements and risk factors can be found under the caption Risk Factors in SELLAS's Annual report on Form 10 K filed on March,

the 31st, 2022, and in other SEC filings. With that I would like to turn the call over to Angelos Stergiou, President and Chief

Executive Officer of SELLAS.

Thank you, Allison, and good morning, and thank you for taking

time out of your busy schedules to listen in to today's video conference. With the announcement last Thursday of both the

transformative in license of our CDK9 inhibitor and the financing, I would like to speak directly to our valued shareholders. While,

I would have liked to have had this call with you last Thursday after we announced a license agreement with GenFleet because of

legal and regulatory requirements around the financingwe were prohibited from issuing any announcements or holding a conference call

until the public offering officially closed, which happened yesterday. That said, it is my hope that at the conclusion of today's

discussion SELLAS investors walk away with a better understanding of, and are excited about, the direction we are taking the

business. I will also do my best to address many of the questions we have received over the past few days.

Let me also say that I wholeheartedly appreciate all of your

support, which I do not take for granted. As we have grown the organization over the last 4 years transforming a company that was

previously riddled with legal and financial challenges, which we inherited from our predecessor, to a company that has no debt and

no legal overhang with assets that include a pivotal phase 3 study in acute myeloid leukemia with GPS, well as in Phase 1 and 2

studies in combination with checkpoint blockade. We also have a license agreement for GPS in China, for which we achieved a

$1,000,000 milestone last week which brings the total we have received from that agreement to more than $10,000,000 of non-dilutive

capital over the past 16 months, and we expect additional milestone triggering events this calendar year. And now, as a result of

the recent addition of our highly selective CDK9 inhibitor, for which we have global rights outside of Greater China, and with the

proceeds from the $25,000,000 offering with SVP Leerink and Cantor, we believe that SELLAS is well positioned for future

You know, our core mission at SELLAS is to prolong patients'

lives and to develop and deliver innovative treatments for patients battling cancer. The late Ruth Bader Ginsburg once said, Fight for

the things that you care about, but do it in a way that will lead others to join you. I'm confident that we're doing just that. With GPS,

our lead program and our new CDK9 inhibitor program, we now have 2 solid clinical assets with multiple shots on goal to develop and potentially

commercialize cancer drugs that can make a difference in patients' lives and I'm very grateful for that.

Before I jump into the presentation, allow me to explain why we brought

in GFH009 and completed the concurrent financing. By taking these actions we are diversifying our clinical assets and strengthening our

balance sheet. While we remain confident in the potential success of GPS in the pivotal Regal trial, having all our eggs in one basket

is a reality that we have chosen not to maintain. Leveraging our vast clinical experience and scientific expertise in acute myeloid leukemia,

as well as other indications, the in licensing of GFH009 will allow us to further expand our clinical programs in AML as well as expand

our clinical footprint into additional tumor types.

We've been looking for earlystage oncology clinical assets to broaden

our pipeline for quite some time. The criteria we established for acquiring a new asset was that it had to firstly, be complementary to

our GPS program. Second leverage our existing scientific and clinical expertise, especially with regard to hematological malignancies.

Third already be in the clinic in the U.S. with an open IND. Fourth be a small molecule with a highly selective on target profile. Fifth

address an exciting target with unique attributes versus competitors, and finally have economic terms that would allow it to be accessible

After diligently reviewed many assets, GFH009 out of GenFleet Therapeutics

stood out as having the potential to be first and best in class, a highly selective targeted CDK 9 Inhibitor. CDK9 activity has been shown

to negatively correlate with overall survival in a number of cancer types, including hematologic cancers, such as AML and lymphomas as

well as solid cancers. GenFleet, based in Shanghai, China, is a leading drug discovery and clinical stage biotechnology company, developing

cutting-edge therapeutics in oncology, and immunology, with industry- leading capabilities and expertise in developing novel drugs, both

small molecules and biologics. GenFleet designed its R&D platform on the basis of disease biology and translational medicine and researches

the latest biological mechanism of cancer pathways, tumor micro-environment and human immunoregulation.

We believe that there is a great interest in cancer transcription,

and that it represents a major relatively unexplored opportunity for cancer treatment. With recent advancements in the understanding of

biomarkers, there's a newly designated category of transcription addicted cancers. CDK9 is one of the better studied lynchpins of transcription.

In addition to AML lymphomas and soft tissue sarcomas, a significant percentage of almost all major cancer indications turn out to be

what we call transcription addicted, including breast cancer, osteosarcoma, endometrial cancer, lung cancer, prostate, cancer, melanoma,

and ovarian cancer. With established biomarkers, there's a huge potential for use across broad swaths of cancers with potentially hundreds

of thousands of patients.

We have in-licensed the worldwide rights outside of the greater China

territory to GFH009, which is already in a clinical trial in both the U.S. and China, under respective INDs and we are planning to complete

the U.S. trial by year end and start a phase 2 trial in combination with venetoclax and azacitidine by the end of the second quarter of

next year. This new drug candidate has the potential to allow us to expand further into the AML space beyond the maintenance phase, which

is the indication for the GPS REGAL study. In pre-clinical models GFH009 has shown a strong synergy with venetoclax, a proven treatment

of certain cancers, including AML. Furthermore, GFH009also provides us an opportunity to address additional indications and tumor types,

including a very important pediatric market of soft tissue sarcomas and positive results from this program could ultimately provide the

basis for a rare pediatric disease priority voucher. Additionally, by conducting various programs in China and sharing the related data,

GenFleet will effectively help SELLAS to analyze additional indications, in a cost and time effective manner, fast tracking the overall

process and giving SELLAS the opportunity to launch pivotal studies in our own territories. Parallel development in different indications

allows both companies to leverage a much broader body of safety and efficacy data, thus significantly accelerating clinical development,

and that's very exciting.

Turning to the financing, by strengthening our balance sheet we now

have a longer cash one way to advance our clinical programs in anticipation of achieving multiple milestones. As you know, biotech companies

are trading at historically low levels, and it's unclear how long the sector will be in a bear market. So we are pleased to be able to

consummate the public offering underwritten by 2 notable banks, which will provide us with additional runway to execute our development

programs. It should not be lost on investors the importance of working with standout life science focused investment banks such as SVP

Leerink and Cantor, who were able to raise capital and extraordinarily difficult market conditions and to bring institutional and fundamental

life science funds into the fold.

In addition to strengthening our clinical asset base and balance sheet,

we recently strengthened our management team, naming Robert Francomano, a highly seasoned, experienced Pharma executive as Chief Commercial

Officer. Strategic commercial intervention during clinical development is crucial to ensure that the pivotal data package resonates with

payers and ensures adequate access to patients across the global markets. Clinical development programs that more precisely articulate

patient reported outcomes, healthy economics, and other key measures to support the value proposition inherently yield upon appropriate

asset pricing and broad access for patients. Only 52% of companies that launched drugs for the first time in the U.S. between 2016 and

2018 were classified as overperforming or having met forecasted sales 2 years after launch. Conversely, those companies that started commercial

activities earlier achieved greater launch success. Thus, you can hopefully appreciate the importance of getting the commercial launch

right, and Robert is the keystone for this.

Turning to NPS, as you know, we've been focusing our