On May 14, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported financial results for the first quarter ended March 31, 2024, and provided a corporate update (Press release, Sellas Life Sciences, MAY 14, 2024, View Source [SID1234643219]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"SELLAS had a very productive and successful first quarter of 2024," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We reported strong preliminary data from the Phase 2a study of SLS009 in r/r AML showing high anti-leukemic activity in the selected optimal dose regimen of 30 mg BIW, including a 100% response rate in patients with ASXL1 mutation. Based on these results we are expanding the cohort to participants bearing the ASXL1 mutation. This mutation is prevalent in AML, as well as solid tumors including colon cancer, and is associated with poor prognosis. We strongly believe in SLS009’s potential and hope to deliver its promise to this heavily pretreated, underserved patient population. The data thus far are indeed extremely encouraging both in terms of safety and efficacy."

Dr. Stergiou continued: "We are also excited with the ongoing progress in the Phase 3 REGAL study of GPS. Based on its recent efficacy and safety assessment, the IDMC recommended the trial continue without modification. We look forward to the next IDMC meeting, scheduled for June, during which the Committee will review data from all enrolled 127 patients and the most recent information regarding the number of events required for triggering the interim analysis. Furthermore, with the recent financing, we were able to strengthen our balance sheet as we expect further significant catalysts throughout 2024."

Pipeline Highlights

Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic
Phase 3 REGAL study in AML: Reached planned enrollment of patients in the United States, Europe, and Asia, following the predetermined statistical analysis plan. The IDMC conducted a prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. The IDMC scheduled its next meeting in June 2024 to review the safety and efficacy data from all enrolled 127 patients.

SLS009: highly selective and specific CDK9 inhibitor

Announced Positive Phase 2 Data of SLS009 in r/r AML: The preliminary data showed 62% and 67% anti-leukemic activity at all dose levels and in the 30 mg BIW cohort, respectively, with a favorable safety profile. A 100% overall response rate (CR/CRi/MLFS) was achieved in patients with ASXL1 mutation in the 30 mg BIW cohort to date. Enrollment is ongoing at the 30 mg BIW cohort with ASXL1 mutation.
IP Protection: Based on the SLS009 efficacy data in r/r AML patients with ASXL1 mutation, SELLAS filed a provisional patent application. The ASLX1 mutations are associated with poor prognosis in all myeloid diseases, owing to the reduced response to the current treatment options.

Phase 1b/2 clinical trial in combination with BTK inhibitor, Brukinsa (zanubrutinib), in r/r DLBCL: GenFleet Therapeutics (Shanghai), Inc. entered into a clinical trial collaboration and supply agreement with BeiGene Switzerland GmbH and dosed the first patient in March 2024. The trial is an open-label single-arm multicenter Phase 1b/2 study to be conducted in two parts. In the Phase 1b portion, 6-18 patients will be enrolled and in the Phase 2 portion, approximately 45 patients will be enrolled. This study is being conducted in China and is funded by GenFleet which intends to focus on DLBCL as its lymphoma target with SLS009.

National Institute of Health PIVOT program in Pediatric Tumors: The program in multiple pediatric cancer indications continues in collaboration with the National Cancer Institute (NCI). Initial safety and efficacy data are expected to be reported throughout 2H 2024.
Financial Results for the First Quarter 2024:
R&D Expenses: Research and development expenses for the quarter ended March 31, 2024 were $5.1 million, compared to $7.2 million for the same period in 2023. The decrease was primarily due to the timing of a clinical drug supply purchase in the prior period and decreases in consultants, personnel related expenses due to changes in headcount, and licensing fees.
G&A Expenses: General and administrative expenses for the first quarter of 2024 were $4.5 million, as compared to $4.1 million for the same period in 2023. The slight increase was primarily attributed to the initial recognition of a one-time severance charge in the first quarter of 2024, partially offset by decreases in outside services and public company costs and other personnel related expenses.
Net Loss: The net loss was $9.6 million for the first quarter of 2024, or a basic and diluted loss per share of $0.21, as compared to a net loss of $11.1 million for the first quarter of 2023, or a basic and diluted loss per share of $0.47.
Cash Position: As of March 31, 2024, cash and cash equivalents totaled approximately $18.4 million.

On May 14, 2024 FogPharma, a clinical-stage biopharmaceutical company dedicated to delivering a new class of therapies that go beyond the limits of currently available medicines using its Helicon peptide platform, and ARTBIO, Inc. ("ARTBIO"), a clinical-stage radiopharmaceutical company developing a new class of 212Pb alpha radioligand therapies (ARTs), reported a collaboration to co-develop Helicon-enabled ARTs (HEARTs) to transform outcomes for patients with multiple types of cancer (Press release, FogPharma, MAY 14, 2024, View Source [SID1234643218]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ARTBIO and FogPharma will co-develop novel HEARTs against multiple targets, leveraging FogPharma’s field-leading Helicon platform of tunable stabilized α-helical peptides and ARTBIO’s AlphaDirect platform for the development of ARTs using the best-in-class isotope, 212Pb. ARTs with 212Pb have the ideal clinical profile due to a short half-life that delivers maximal energy into tumors with high stability and the ability to image with SPECT/CT. The synergy of these two powerful platforms offers promising potential to create next-generation ARTs with properties ideal for precise delivery to tumors.

"Our AI-enabled Helicon platform provides an unprecedented level of chemical flexibility and diversity for modifying the crucial chemical and biological properties of peptides, a capability that we have leveraged to address previously undruggable protein:protein interactions inside the cell. We are thrilled to begin our collaboration with ARTBIO, wherein we extend the use of our Helicons to bind extracellular proteins and use our Helicons to finely tune distribution and elimination properties, paving the way for a new safe and effective category of targeted radioligand therapy," stated Mathai Mammen, M.D., Ph.D., CEO of FogPharma. "Our aim is to revolutionize outcomes for cancer patients in critical need."

"Alpha radioligand therapy, and 212Pb in particular, has shown tremendous promise as a new class of radiopharmaceuticals. This collaboration with FogPharma enables ARTBIO to advance next-generation therapeutics specifically designed to treat solid tumors," said Emanuele Ostuni, Ph.D., CEO of ARTBIO. "FogPharma has a shared vision of radically changing the current treatment paradigms for cancers, and together we will fuse science, technology, and collective passion to improve patient outcomes."

The partners will contribute equally to the collaboration across research, development and commercialization phases; additional financial terms are undisclosed.

On May 14, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported financial results and business highlights for the first quarter ended March 31, 2024 (Press release, Delcath Systems, MAY 14, 2024, View Source [SID1234643217]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Business Highlights
During and since the first quarter, Delcath:

Recognized over $2.0 million of revenue from sales of HEPZATO KIT (melphalan/Hepatic Delivery System) and $1.1 million in CHEMOSAT sales through March 31, 2024;

Updated U.S. center activation guidance from 15 active centers to a total of 20 active centers by the end of 2024;

Activated four treating centers during the first quarter with an additional two centers in April. A further five centers are accepting patient referrals in anticipation of activation;

Raised $7.0 million in a private placement transaction with certain accredited investors comprised of existing investors, Delcath senior executives, and members of its Board of Directors;

Appointed Martha S. Rook, Ph.D, an experienced industry leader with more than 25 years of academic and industry experience, as Chief Operating Officer;

Received a permanent, product-specific J-code (J9248) and transitional pass-through payment status for HEPZATO KIT from the Centers for Medicare & Medicaid Services (CMS) which became effective on April 1, 2024;

Executed an amendment with Synerx Pharma, LLC and Mylan Teoranta for Delcath’s supply of melphalan hydrochloride which extends the term of the original agreement to December 31, 2028; and

Announced the publication of results from the pivotal Phase 3 FOCUS study of HEPZATO KIT in patients with unresectable metastatic Uveal Melanoma on May 4, 2024, in the journal Annals of Surgical Oncology.
"We continue to make steady progress in the training and activation of new treatment centers which is a testament to both the emerging role of HEPZATO in the treatment of patients with metastatic uveal melanoma and the capability and dedication of our field force," said Gerard Michel, Delcath’s Chief Executive Officer. "We are committed to expanding the availability of HEPZATO to patients in need and I am confident that we will reach our goal of 20 treating centers by the end of 2024."

First Quarter 2024 Results
Cash, cash equivalents and investment totaled $27.2 million as of March 31, 2024, which includes a $7.0 million private placement financing which closed on March 19, 2024.

Total revenue for the quarter ended March 31, 2024 was $3.1 million compared to $0.6 million for the same period in the prior year from our sales of HEPZATO in the U.S. and CHEMOSAT in Europe.

Research and development expenses for the quarter ended March 31, 2024, were $3.7 million compared to $4.6 million for the same period in the prior year. The change in research and development expenses is primarily due to a decrease in clinical trial activities and expenses related to the FDA inspection offset by an increase in personnel related expenses.

Selling, general and administrative expenses for the quarter ended March 31, 2024, were $8.8 million compared to $4.2 million for the same period in the prior year. The increase primarily relates to commercial launch activities including marketing-related expenses and additional personnel in the commercial team.

Conference Call Information
To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date:

Tuesday, May 14, 2024

Time:

8:30 AM Eastern Time

Participant Numbers

Toll Free:

1-833-630-1960

International:

1-412-317-1841

Webcast:

View Source

Conference Replay

US Toll Free:

1-877-344-7529

International Toll:

1-412-317-0088

Replay Access Code:

9490444

End Date:

May 21, 2024

On May 14, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies, reported the issuance of several new patents, as well as new allowances of patent applications belonging to different Patent Families in Defence’s vast and diverse portfolio (Press release, Defence Therapeutics, MAY 14, 2024, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-strengthens-and-expands-global-patent-protection-on-key-technologies [SID1234643216]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Defence’s vaccine enhancer platform technology based on simple admixture of Accum and variants thereof with specific antigens, is further expanded by the recent allowance of Defence’s US application no. 18/169,440 by the USPTO. The newly allowed subject-matter, which includes valuable composition-of-matter claims directed to Accum or variants thereof as standalone agents for enhancing antigen presentation, or in admixture with of any vaccine antigen, elegantly compliments Defence’s previously granted US patent no. 11,612,651 covering methods of improving polypeptide antigen immunogenicity. Importantly, this Patent Family is the first family broadly covering Defence’s anticancer ARM vaccine platform. Recent pre-clinical studies using Defence’s ARM-002 vaccine suggest potent antitumor responses in in vivo melanoma, lymphoma, and pancreatic cancer models when combined with the anti-PD-1 immune-checkpoint inhibitor, paving the way for upcoming Phase I clinical trials.

Defence is also pleased to announce the securing of a new patent in Australia protecting its ADC platform technology based on the ability of the original Accum to form potent antibody-drug conjugates leading to targeted cellular accumulation of a payload. Granted on February 1, 2024, Australian patent no. 2017233725 broadly protects not only Defence’s original Accum but also important variants thereof, which further strengthens the company’s patent protection in this valuable and growing therapeutic space. This represents a significant milestone in the future development and commercialization of novel ADCs for treating and detecting many cancers, and adds to Defence’s previous granted patents in the United States (US 11,352,437), Japan (JP 7,126,956), and Israel (IL 261765).

In addition, Defence’s vaccine platform technology based on covalent conjugation of Accum and variants thereof to specific antigens, which already included US patent no. 11,291,717, now includes Canadian patent no. 3,201,103 granted on December 12, 2023, as well as Australian patent no. 2021402007 granted on March 14, 2024. Furthermore, counterpart Japanese application no. 2023-535891 was recently allowed by the Japanese Patent Office and the Japanese patent is expected to be granted imminently. These patents include claims broadly covering a method of improving polypeptide antigen immunogenicity by covalently conjugating any antigen to Accum or any variant thereof, and also include independent composition-of-matter claims covering potential vaccine compositions.

"We are thrilled to announce the issuance of these patents and allowances with broad claims covering our ADC and vaccine platforms, which underscore our relentless pursuit of innovation and our unwavering commitment to improving human health" says Mr. Plouffe, CEO and president of Defence.

Acceleration of examination of the remaining applications in both of Defence’s vaccine platform Patent Families via the Patent Prosecution Highway (PPH) program is currently being pursued based on these broad issued and allowed claims. The issuance of new patents in these families is therefore expected shortly.

On May 14, 2024 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported first quarter financial results and provided a business update (Press release, Cyclacel, MAY 14, 2024, View Source [SID1234643215]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to report that we have begun enrolling patients in the Phase 2, proof of concept (PoC) stage of our 065-101 study of fadraciclib, our oral CDK2/9 inhibitor, and are on track to deliver key readouts this year," said Spiro Rombotis, President and Chief Executive Officer. "Receipt of $8.0 million gross proceeds in a private placement together with existing resources support our ongoing clinical program. Pharmacokinetic, pharmacodynamic, safety and anticancer activity data from the Phase 1, dose escalation stage of 065-101 in patients with advanced solid tumors and lymphoma will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Data to date suggest that fadraciclib is differentiated from other next generation CDK inhibitors."

"Having determined the recommended Phase 2 dose for fadraciclib we are now enrolling patients in the Phase 2 PoC stage of 065-101" said Brian Schwartz, M.D., interim Chief Medical Officer. "We are initially concentrating on the biomarker cohort which is enrolling patients prospectively selected for CDKN2A/CDKN2B alterations to be followed by patients with T-cell lymphoma. There are no approved medicines for patients with CDKN2A/CDKN2B alterations. Including currently opened trial sites, we expect a total of up to seven sites will participate with the majority in the United States. We are encouraged about fadra’s prospects and look forward to presenting emerging data from the 065-101 study later in the year."

Key Upcoming Milestones for 2024

· Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma at the ASCO (Free ASCO Whitepaper) 2024 Annual Meeting
· Report interim data from initial cohorts in Phase 2 proof-of-concept stage of 065-101 study with oral fadraciclib in patients with advanced solid tumors and lymphoma

Financial Highlights

As of March 31, 2024, pro forma cash and cash equivalents totalled $9.9 million, including proceeds from this month’s private placement and $0.8 million received for the United Kingdom research & development tax credit. Cash and cash equivalents as of March 31, 2024, totalled $2.8 million, compared to $3.4 million as of December 31, 2023.

Net cash used in operating activities was $0.5 million for the three months ended March 31, 2024, which includes $2.9 million received in March in respect of the United Kingdom research & development tax credit, compared to $6.9 million for the same period of 2023. The Company estimates that its current cash resources will fund planned programs into the fourth quarter of 2024.

Research and development (R&D) expenses were $2.8 million for the three months ended March 31, 2024, as compared to $5.7 million for the same period in 2023. R&D expenses relating to fadraciclib were $1.8 million for the three months ended March 31, 2024, as compared to $4.1 million for the same period in 2023 due to a decrease in clinical trial and other non-clinical expenditures. R&D expenses related to plogosertib were $1.0 million for the three months ended March 31, 2024, as compared to $1.4 million for the same period in 2023 due to a decrease in manufacturing and other non-clinical expenditures.

General and administrative expenses remained relatively flat at approximately $1.6 million for each of the three months ended March 31, 2024 and 2023.

Total other expenses, net, for the three months and year ended March 31, 2024, were $0.1 million, compared to $0.2 million for the same period of the previous year.

United Kingdom research & development tax credits for the three months March 31, 2024, were $1.4 million, which includes $0.8 million related to the 2023 claim which was received in May 2024, compared to $1.3 million for the same period of the previous year and are directly correlated to qualifying research and development expenditure.

Net loss for the three months March 31, 2024, was $2.9 million (including stock-based compensation expense of $0.2 million), compared to $5.8 million (including stock-based compensation expense of $0.4 million) for the same period in 2023.

Conference call information:

Call: (888) 632-3384 / international call: (785) 424-1794

Archive: (800) 938-1584 / international archive: (402) 220-1542

Code for live and archived conference call is CYCCQ124. Webcast link

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.