SELLAS Life Sciences Reports Third Quarter 2021 Financial Results and Provides Business Update


NEW YORK, Nov. 12, 2021 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Firm”), a late-stage medical biopharmaceutical firm centered on creating novel most cancers immunotherapies for a broad vary of indications, right this moment reported its monetary outcomes for the quarter ended September 30, 2021 and offered a enterprise replace.

“In the course of the third quarter of 2021, along with persevering with to enroll sufferers in the US and Europe for our Part 3 REGAL research of galinpepimut-S (GPS) in acute myeloid leukemia (AML) sufferers, we additionally commenced medical and regulatory preparations for a possible new Part 2/3 research of GPS in AML sufferers following a bone marrow transplant (BMT) who harbor minimal residual illness (MRD),” mentioned Angelos M. Stergiou, MD, ScD. h.c., President and Chief Govt Officer of SELLAS. “We’re excited to start exploring GPS as a remedy choice for this post-BMT inhabitants which, based mostly on the retrospective outcomes information revealed earlier in the summertime, stays an space of unmet want. We imagine there may be vital alternative for GPS to turn into the important thing antileukemic vaccine immunotherapy in numerous AML settings, with the potential to deal with sufferers who’ve undergone a BMT in addition to sufferers who’ve achieved second remission in AML (CR2), the indication of our REGAL research.”

Dr. Yair Levy, Director of Hematologic Malignancies on the Baylor College Medical Heart, said “I stay up for a medical trial in transplanted sufferers that might tackle the excessive relapse charge amongst MRD constructive (MRD+) AML sufferers. Though BMT stays the one really healing remedy for AML sufferers with any vital illness danger, its profit is proscribed by relapses in about 50% of sufferers who enter transplant with MRD. The trial being deliberate by SELLAS would discover whether or not GPS might be a remedy choice for a a lot bigger inhabitants of AML sufferers – i.e., these sufferers who’ve undergone BMT whose possibilities of remaining in remission may considerably enhance in addition to the massive variety of MRD+ sufferers who’ve been proven to have a excessive relapse charge after BMT or who don’t endure a BMT as a result of they’re thought of unlikely to learn from it.”

Pipeline Replace and Company Highlights:

  • Part 3 REGAL Examine:

    • Extra websites in the US and European Union have been activated throughout the third quarter with enrollment persevering with. As well as, regulatory approval to begin the REGAL research was acquired in each Hungary and Taiwan throughout the quarter.

    • The ultimate statistical evaluation plan (SAP) for the REGAL research gives for a deliberate interim security and futility evaluation after 80 occasions (deaths) which the Firm had anticipated would happen within the first half of 2022, offered that the continuing COVID-19 pandemic didn’t considerably adversely influence our projected timeline for enrollment. During the last 12 to 18 months, the Firm has monitored the influence of the COVID-19 pandemic on the projected timeline for the REGAL research. Throughout this era, the Firm took a number of steps to mitigate attainable and precise delays as a result of COVID-19 pandemic, together with rising the variety of medical websites and the variety of international locations during which websites are situated with the intention to preserve the unique timeline. Regardless of these mitigation steps, the Firm now anticipates that the interim evaluation will happen within the second half of 2022, offered that the continuing COVID-19 pandemic doesn’t proceed to adversely influence the projected timeline for enrollment. Along with the deliberate interim evaluation below the SAP, the ultimate constitution for the Unbiased Knowledge Monitoring Committee for the REGAL research gives for enrollment-based security, futility, and efficacy analyses previous to the deliberate interim evaluation.

  • Planning for Potential Part 2/3 GPS Examine in AML Put up-Transplant Sufferers: In August 2021, SELLAS hosted a Digital Investor Symposium which centered on the potential for GPS in AML sufferers following a BMT. SELLAS administration, Dr. Stergiou and Dr. Dragan Cicic, SVP, Medical Growth, have been joined by main most cancers researcher Dr. Yair Levy, Director of Hematologic Malignancies on the Baylor College Medical Heart. To entry the occasion replay, click on here. The Firm is presently within the regulatory and medical planning phases for a possible Part 2/3 medical trial of GPS on this affected person inhabitants.

  • Crimson Door Neighborhood Award: On November 11, 2021, Angelos M. Stergiou, MD, ScD. h.c., President and Chief Govt Officer of SELLAS, was honored on behalf of SELLAS by the Crimson Door Neighborhood (previously Gilda’s Membership) with the Crimson Door Award for Advances in Analysis.

Monetary Outcomes for the Third Quarter 2021:

Licensing income: There was no licensing income for the third quarter of 2021 and $7.6 million for the 9 months ended September 30, 2021, which consists of the popularity of income from the Firm’s license settlement with 3D Medicines. The Firm didn’t report any licensing income for the primary 9 months of 2020.

R&D Bills: Analysis and improvement bills for the third quarter of 2021 have been $4.5 million, as in comparison with $2.4 million for a similar interval in 2020. Analysis and improvement bills for the 9 months ended September 30, 2021 have been $12.3 million as in comparison with $6.5 million for a similar interval in 2020. The rise was primarily because of a rise in medical trial bills associated to the Firm’s Part 3 REGAL medical trial of GPS in AML sufferers and a ramp up of the manufacture of medical trial supplies and registration batches of GPS, a know-how switch to a brand new contract producer, medical drug provide buy prices within the European Union in preparation for opening websites and enrolling sufferers in EU international locations, and personnel associated bills because of elevated headcount.

G&A Bills: Common and administrative bills for the third quarter of 2021 have been $2.4 million, as in comparison with $2.1 million for a similar interval in 2020. Common and administrative bills for the 9 months ended September 30, 2021 have been $8.8 million, as in comparison with $6.3 million for a similar interval in 2020. The rise was primarily because of amortization expense related to the capitalized contract acquisition prices of the 3D Medicines license settlement, a rise in authorized charges as in comparison with the identical interval in 2020 throughout which nearly all of authorized bills have been offset by a reimbursement credit score, and personnel associated bills because of elevated headcount.

Web Loss: Web loss attributable to frequent stockholders was $7.1 million for the third quarter of 2021, or a primary and diluted loss per share attributable to frequent stockholders of $0.45, as in comparison with a internet loss attributable to frequent stockholders of $4.5 million for a similar interval in 2020, or a primary and diluted loss per share attributable to frequent stockholders of $0.53. Web loss attributable to frequent stockholders was $14.1 million for the 9 months ended September 30, 2021, or a primary and diluted loss per share attributable to frequent stockholders of $0.92, as in comparison with a internet loss attributable to frequent stockholders of $13.1 million for a similar interval in 2020, or a primary and diluted loss per share attributable to frequent stockholders of $1.83.

Money Place: As of September 30, 2021, money and money equivalents totaled roughly $26.3 million.

About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage medical biopharmaceutical firm centered on creating novel most cancers immunotherapeutics for a broad vary of indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Most cancers Heart and targets the WT1 protein, which is current in an array of tumor varieties. GPS has potential each as a monotherapy and together to deal with a broad spectrum of hematologic malignancies and stable tumor indications. SELLAS’ second product candidate, nelipepimut-S (NPS), is a HER2-directed most cancers immunotherapy with potential to deal with sufferers with early-stage breast most cancers with low to intermediate HER2 expression, in any other case often known as HER2 1+ or 2+, which incorporates TNBC sufferers, following the usual of care.

For extra info on SELLAS, please go to www.sellaslifesciences.com.

Ahead-Trying Statements
This press launch accommodates forward-looking statements. All statements apart from statements of historic info are “forward-looking statements,” together with these regarding future occasions. In some circumstances, forward-looking statements might be recognized by terminology resembling “plan,” “anticipate,” “anticipate,” “could,” “would possibly,” “will,” “ought to,” “challenge,” “imagine,” “estimate,” “predict,” “potential,” “intend,” or “proceed” and different phrases or phrases of comparable which means. These statements embody, with out limitation, statements associated to the medical improvement of GPS for AML, and the potential for GPS as a drug improvement candidate. These forward-looking statements are based mostly on present plans, goals, estimates, expectations, and intentions, and inherently contain vital dangers and uncertainties. Precise outcomes and the timing of occasions may differ materially from these anticipated in such forward-looking statements because of these dangers and uncertainties, which embody, with out limitation, dangers and uncertainties related to the COVID-19 pandemic and its influence on the Firm’s medical plans, dangers and uncertainties related to immune-oncology product improvement and medical success thereof, the uncertainty of regulatory approval, and different dangers and uncertainties affecting SELLAS and its improvement applications as set forth below the caption “Danger Elements” in SELLAS’ Annual Report on Type 10-Ok filed on March 23, 2021 and in its different SEC filings. Different dangers and uncertainties of which SELLAS just isn’t presently conscious might also have an effect on SELLAS’ forward-looking statements and should trigger precise outcomes and the timing of occasions to vary materially from these anticipated. The forward-looking statements herein are made solely as of the date hereof. SELLAS undertakes no obligation to replace or complement any forward-looking statements to replicate precise outcomes, new info, future occasions, adjustments in its expectations or different circumstances that exist after the date as of which the forward-looking statements have been made.

Investor Contact
Allison Soss
KCSA Strategic Communications
Electronic mail: SELLAS@kcsa.com
Telephone: 212.896.1267

Media Contact
Raquel Cona
KCSA Strategic Communications
Electronic mail: SELLAS@kcsa.com
Telephone: 212.896.1276

SELLAS LIFE SCIENCES GROUP, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Quantities in hundreds, besides share and per share information)
(Unaudited)

Three Months Ended September 30,

9 Months Ended September 30,

2021

2020

2021

2020

Licensing income

$

$

$

7,600

$

Working bills:

Value of licensing income

200

Analysis and improvement

4,541

2,367

12,281

6,511

Common and administrative

2,436

2,125

8,794

6,312

Whole working bills

6,977

4,492

21,275

12,823

Working loss

(6,977

)

(4,492

)

(13,675

)

(12,823

)

Non-operating revenue (expense), internet:

Change in truthful worth of warrant legal responsibility

30

6

(29

)

25

Change in truthful worth of contingent consideration

(140

)

13

(403

)

(268

)

Curiosity revenue

2

6

25

Whole non-operating revenue (expense), internet

(108

)

19

(426

)

(218

)

Web loss

(7,085

)

(4,473

)

(14,101

)

(13,041

)

Deemed dividend arising from warrant modifications

(78

)

Web loss attributable to frequent stockholders

$

(7,085

)

$

(4,473

)

$

(14,101

)

$

(13,119

)

Per share info:

Web loss per frequent share attributable to frequent stockholders, primary and diluted

$

(0.45

)

$

(0.53

)

$

(0.92

)

$

(1.83

)

Weighted common frequent shares excellent, primary and diluted

15,874,076

8,418,038

15,344,210

7,174,859

SELLAS LIFE SCIENCES GROUP, INC.
CONSOLIDATED BALANCE SHEETS
(Quantities in hundreds, besides share and per share information)
(Unaudited)

September 30,

December 31,

2021

2020

ASSETS

Present property:

Money and money equivalents

$

26,281

$

35,302

Restricted money and money equivalents

100

100

Contract asset

1,128

Pay as you go bills and different present property

2,593

395

Whole present property

28,974

36,925

Working lease right-of-use asset

767

896

In-process analysis and improvement

5,700

5,700

Goodwill

1,914

1,914

Deposits and different property

597

614

Whole property

$

37,952

$

46,049

LIABILITIES AND STOCKHOLDERS’ EQUITY

Present liabilities:

Accounts payable

$

2,545

$

4,657

Accrued expense and different present liabilities

2,584

1,913

Working lease legal responsibility

190

166

Deferred income

5,600

Whole present liabilities

5,319

12,336

Working lease legal responsibility, non-current

667

825

Deferred tax legal responsibility

239

239

Warrant legal responsibility

84

55

Contingent consideration

5,036

4,633

Whole liabilities

11,345

18,088

Commitments and contingencies

Stockholders’ fairness:

Most well-liked inventory, $0.0001 par worth; 5,000,000 shares approved; Collection A convertible most well-liked inventory, 17,500 shares designated; no shares issued and excellent at September 30, 2021 and December 31, 2020

Widespread inventory, $0.0001 par worth; 350,000,000 shares approved, 15,874,131 and 14,254,554 shares issued and excellent at September 30, 2021 and December 31, 2020, respectively

2

1

Extra paid-in capital

158,610

145,864

Amassed deficit

(132,005

)

(117,904

)

Whole stockholders’ fairness

26,607

27,961

Whole liabilities and stockholders’ fairness

$

37,952

$

46,049



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