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– Reported encouraging updated knowledge in the current quarter from two clinical trials of galinpepimut-S (GPS) in combination with checkpoint inhibitors –
– Provides an update for the GFH009 program –
– Cash of $27. 0 million as of June 30, 2022 –
– To a virtual investor symposium on GPS on September 15, 2022 –
NEW YORK, Aug. 11, 2022 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), an advanced-stage clinical biopharmaceutical company focused on upcoming novel treatments for a wide variety of cancer indications, provided an update to its operations and announced its monetary effects for the quarter ended June 30, 2022.
“During the current quarter of 2022, SELLAS continued to advance our portfolio of remedies features to improve and make the lives of cancer patients greater, with our number one asset, GPS, achieving several vital milestones,” said Angelos Stergiou, M. D. , Sc. RE. h. c. , President and CEO of SELLAS. “We reported the clinical benefits observed in the initial knowledge of our Phase 1/2 clinical trial of GPS in combination with the keytrud checkpoint® inhibitor in patients with WT1 complex ovarian cancer, as well as encouraging up-to-date clinical knowledge from an investigator-sponsored Phase 1 clinical trial. GPS in combination with another checkpoint inhibitor, OPDIVO®, in patients with malignant pleural mesothelioma (MPM). In our Phase 3 REGAL study, he continued to enroll patients and activate more sites in the United States, Europe, and Asia.
“In addition, we are pleased to announce the encouraging initial effects of our GFH009 program, a new highly selective CDK9 inhibitor, potentially the first and most productive of its kind. United and China in refractory and relapsed complex lymphoma and acute myeloid leukemia (AML) do not show dose-limiting toxicity at all dose grades studied to date, while also demonstrating early indications of biological efficacy in dose-evaluable patients. effects and data from in vitro preclinical studies showing significant inhibition of mobile cancer expansion across four mobile lines announced this week, and we look to the future to proceed to examine GFH009 to further explore its anticancer effects,” concluded Dr. Stergiou.
Pipeline upgrades:
Galinpepimut-S (GPS): Wilms-1 tumor peptide immunotherapeutic (WT1)
Phase 1/2 in combination with KEYTRUDA (pembrolizumab): In May 2022, SELLAS announced key clinical insights showing the clinical advantages of its Phase 1/2 trial of GPS in combination with Merck’s anti-PD-1 therapy, KEYTRUDA, in patients diagnosed with relapsed or platinum-resistant WT1 complex metastatic ovarian cancer.
Phase 1 study in combination with OPDIVO (nivolumab): In June 2022, SELLAS announced the promotion of up-to-date clinical information from a phase 1 clinical trial sponsored by a GPS investigator in combination with the CHECKPOINT inhibitor OPDIVO in patients with MPM who were refractory or recurrent after at least one line of popular remedy.
REGAL Phase 3 Study: During the current quarter of 2022, SELLAS continued to enroll patients and find more sites in Poland, Greece, and Hungary for its actual global Phase 3 clinical trial in AML patients. Enrollment in the study is expected to end. in early 2023, and an interim study is expected by the end of the first half of 2023. This timeline builds on existing assumptions similar to COVID-19 and will affect clinical site operations as well as the duration of the pandemic. Because the interim investigation is event-driven, it may be conducted at a different time than currently planned. The company plans to open more sites in the United States and several countries in Europe and Asia by the end of 2022, adding Serbia, Spain, Italy, Poland, Turkey and Taiwan.
GFH009: small molecule, selective CDK9 INHIBITOR
In vitro preclinical studies in mobile lines against cancer and AML: In early August, the company announced the results of its in vitro preclinical studies in mobile lines against cancer and AML. in mobile lines with cancer inhibited mobile expansion of 90-100% in 3 of the 4 mobile lines and more than 50% in the 4th mobile line.
Clinical update on the phase 1 trial: Effective August 1, 2022, enrollment was completed at the first of all scheduled doses, administered twice weekly, in the AML organization (30 mg) and at the 22. 5 mg dose for lymphoma organization. Among the 30 patients evaluable for protection and efficacy, no dose-limiting toxicity was observed. Four patients with lymphoma (three with 4. 5 mg and one with nine mg) developed solid disease (SD). A patient with peripheral T-cell lymphoma treated at a dose of nine mg experienced a minimum of 62% in the sum of the perpendicular diameter product for multiple lesions (SPD) based on computed tomography (CT) scans. Two patients with AML, one treated with a dose of nine mg and the other treated at a dose of 15 mg, experienced a reduction in medullary blasts equivalent to or greater than 50%.
Phase 1 Clinical Trial Protocol Change: The company announced in July that a momentary weekly dose cohort has been added to its ongoing Phase 1 clinical trial in the U. S. The U. S. and China will examine weekly monitoring from the 30 mg dose that will provide more information for the protection and efficacy profile of GFH009.
Company Updates:
Guaranteed Public Offering: On April 5, 2022, the Company closed a guaranteed public offering providing gross revenues of $25. 0 million, from discounts and subscription commissions and supply fees.
Pay-per-milestone: The company earned a $1. 0 million milestone payment in May 2022 for approval through the China National Medical Products Administration (NMPA) of an IND app to launch the first clinical trial in China for GPS.
Financial results for the second quarter of 2022:
License Revenue: There was no license revenue for the current quarter of 2022 and $1. 0 million for the first part of 2022, similar to the approval through China’s NMPA of an IND application through 3-d Medicines. This compares to $1. 9 million for the current quarter of 2021 and $7. 6 million for the first part of 2021.
R Expenses
Ongoing studies and acquired progression: There were no ongoing studies and progression acquired in the current quarter of 2022. Ongoing studies and acquired progression amounted to $10. 0 million for the first part of 2022, as a result of the acquisition of GFH009. studies and progression acquired the same periods in 2021.
General and administrative expenses: General and administrative expenses for the current quarter of 2022 were $3. 1 million, compared to $2. 8 million for the same period of 2021. The increase is basically due to the expenses of the body of workers due to the accumulation of personnel. General and administrative expenses amounted to $6. 1 million for the first part of 2022, compared to $6. 4 million for the same time in 2021. The reduction is basically due to a reduction in depreciation and amortization expense related to the purchase prices of capitalized contracts of the 3 -d Drug Licensing Agreement and a reduction in professional fees, partially offset through an accumulation of worker expenses due to the accumulation of personnel.
Net Loss: Net loss of $8. 4 million for the current quarter of 2022, representing a fundamental and diluted loss consistent with a consistent percentage of $0. 41, compared to a net loss of $4. 6 million for the same period consisting of 2021, representing a fundamental and diluted loss consistent with a consistent percentage of $0. 30. Net loss of $25. 2 million for the first part of 2022, representing a fundamental and diluted loss consistent with a consistent percentage of $1. 39, compared to a net loss of $7. 0 million for the same period consisting of 2021, representing a fundamental and diluted loss consistent with a consistent percentage of $0. 47.
Cash: As of June 30, 2022, money and money equivalents totaled approximately $27. 0 million.
Next Investor Symposium
The Company will host a virtual symposium for investors on Thursday, September 15, 2022, at 1:00 p. m. m. a. at 17:00 to 14:00 ET. La occasion will focus on the company’s main clinical asset, GPS, and add the potential business opportunity for GPS in patients with AML.
Event:
Called Galinpepimut-S
Date:
September 15, 2022
Time:
13:00. ET
Live call:
1-877-407-9716 (toll-free in the U. S. ) or 1-201-493-6779 (international)
Webcast:
https://viavid. webcasts. com/starthere. jsp?ei=1550371
For those interested who are unable to participate in the convention call, there will be a replay through September 29, 2022 at 1-844-512-2921 (toll-free in the U. S. )USA) or 1-412-317-6671 (international). Participants must use the following code to access the reproduction of the call: 13730135. An archived edition of the webcast will also be available on the SELLAS Investor Relations website: https://www. sellaslifesciences . com/investors/
About SELLAS Life Sciences Group, Inc. SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a late-stage clinical biopharmaceutical company whose goal is to develop novel treatments for a wide variety of cancer indications. SELLAS’ lead product candidate, galinpepimut-S (GPS), is licensed by Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is provided in a variety of tumor types. GPS has potential as monotherapy or in combination with other treatments to treat a wide variety of hematological malignancies and tumor indications. The company is also developing GFH009, a highly selective small-molecule CDK9 inhibitor, which is licensed through GenFleet Therapeutics (Shanghai), Inc. , for all international curative and diagnostic uses outside of Greater China.
For more information about SELLAS, visit www. sellaslifesciences. com.
KEYTRUDA® is a registered trademark of Merck Sharp
Forward-Looking Statements This press release includes forward-looking statements. All statements other than statements of past fact are “forward-looking statements”, including those relating to long-term events. In some cases, forward-looking statements may be known by terms such as “plan”, “expect”, “anticipate”, “possibly”, “may also just”, “will”, “should”, “project”. , “believe”, “estimate”, “predict”, “prospective”, “intend” or “continue”, and other words or terms of similar meaning. Such statements include, but are not limited to, statements relating to the clinical progression of GPS and GFH009 for various cancer indications, including timing of initiation and completion of clinical trials and knowledge of such clinical trials, perspective of GPS and GFH009 as drug progression applicants for various cancer indications, alone or in combination with other curative agents and the timing of the final touch of enrollment for the GPS REGAL Phase 3 clinical trial. These forward-looking statements are based on plans, objectives, estimates, expectations and intentions exist, and inherently involve significant dangers and uncertainties. The actual effects and timing of events may also differ materially from those expected in those forward-looking statements due to such risks and uncertainties, including, without limitation, risks and uncertainties related to the COVID-19 pandemic and have an effect on the society. clinical plans, dangers and uncertainties related to the progression of oncology products and their clinical success, the uncertainty of regulatory approval and other dangers and uncertainties of SELLAS and its progression programs, as set forth under the heading “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 31, 2022 and in its other filings with the SEC. Other dangers and uncertainties not currently known to SELLAS could also make SELLAS forward-looking statements and possibly cause actual effects and the timing of events differed materially from those expected. The forward-looking statements contained in this document speak only as of the date hereof. SELLAS assumes no legal responsibility to update or supplement any forward-looking statements to reflect actual effects, new information, long-term events, adjustments in its expectations, or other occurrences that exist after the date on which the forward-looking statements have been made.
Investor ContactAllison SossKCSAEmail Strategic Communications: SELLAS@kcsa. com Phone: 212. 896. 1267
Media ContactDraw Cona / Michaela FawcettKCSAEmail Strategic Communications: SELLAS@kcsa. com Phone: 212. 896. 1276
SELLAS LIFE SCIENCES GROUP, INC. CONSOLIDATED INCOME STATEMENTS (Figures in thousands, consistent with consistent percentage and consistent with consistent percentage) (Not audited)
Quarter ended June 30
Semester ended June 30
2022
2021
2022
2021
License Revenue
Ps
—
Ps
Nineteen
Ps
1 000
Ps
7 600
Operating costs:
Cost of license revenue
—
100
100
200
Research and development
5 529
3 456
10 140
7 740
Ongoing and acquired progression
—
—
10 000
—
General and administrative
3 094
2 797
6 118
6 358
Total expenses
8 623
6 353
26 358
14 298
Business interruption
(8 623
)
(4 453
)
(25 358
)
(6 698
)
Source of non-operating income (expense), net:
Change in the fair of the liabilities by guarantee
48
(28
)
37
(59
)
Change in the fair of contingent consideration
115
(134
)
115
(263
)
Interest income
46
2
48
4
Total source of non-operating income (expense), net
209
(160
)
200
(318
)
Net loss
Ps
(8 414
)
Ps
(4 613
)
Ps
(25 158
)
Ps
(7 016
)
Information through the exchange:
Net loss consistent with non-unusual, fundamental and diluted holding
Ps
(0,41
)
Ps
(0,30
)
Ps
(1. 39
)
Ps
(0,47
)
Weighted average of outstanding, fundamental, and diluted non-unusual stocks
20 286 624
15 270 288
18 104 176
15 074 887
SELLAS LIFE SCIENCES GROUP, INC. CONSOLIDATED BALANCE SHEET (Amounts in thousands, consistent with percentage and knowledge consistent with consistent with percentage)(Not audited)
June 30, 2022
December 31, 2021
ASSETS
Current assets:
Cash and money equivalents
Ps
26 987
$
21 355
Allocated money and money equivalents
100
100
Expenses paid in advance and existing assets
1 650
1 589
Total assets
28 737
23 044
Assets under operating lease
1 045
723
Willingness
1 914
1 914
Deposits and assets
514
594
Total assets
Ps
32 210
Ps
26 275
COMMITMENTS AND EQUITY
Current liabilities:
Accounts payable
Ps
3 339
Ps
2 144
Accrued liabilities and existing liabilities
3 006
2 640
Operating debts
341
198
Ongoing and progression acquired to pay
5 500
—
Total liability
12 186
4 982
Operating debts, not current
783
610
Mandate responsibility
3
40
Conditional consideration
181
296
Total responsibilities
13 153
5 928
Commitments and Contingencies (Note 7)
Equity:
Preferred Shares, at par with $0. 0001; 5,000,000 authorized shares; Series A Convertible Preferred Shares, 17,500 designated shares; no issued and notable shares as of June 30, 2022 and December 31, 2021
—
—
Common shares, at par with $0. 0001; 350,000,000 legal actions, 20,551,918 and 15,895,637 shares issued and notable as of June 30, 2022 and December 31, 2021, respectively,
2
2
issue premium
182 816
158 948
Accumulated deficit
(163 761
)
(138 603
)
Total equity for shareholders
19 057
20 347
Total liabilities and equity
Ps
32 210
Ps
26 275