On August 8, 2022 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing cancer therapies for patients in need of new treatment options, reported financial results for the three and six months ended June 30, 2022, and provided a business update (Press release, Salarius Pharmaceuticals, AUG 8, 2022, View Source [SID1234618307]). Highlights of the quarter and recent weeks included:

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Financial Highlights

Cash and equivalents were $22.6 million as of June 30, 2022, compared with $29.2 million as of December 31, 2021
Tightly managed expenses while progressing toward multiple near-term milestones
Net loss of $4.7 million, or $0.09 per share, compared with net loss of $3.1 million, or $0.07 per share, for the second quarter of 2021
Seclidemstat (Targeted Protein Inhibitor) Highlights

Added the Seattle Cancer Care Alliance – which is comprised of the Fred Hutchinson Cancer Research Center, Seattle Children’s Hospital and University of Washington Medical Center – and Oregon Health & Sciences University as clinical trial sites, bringing the total number of sites supporting the Phase 1/2 sarcoma clinical trial to 15 with 23 locations across the U.S.
Entered into a development collaboration with Volition Rx to advance rapid epigenetic profiling using Volition’s Nu.Q technology to support further development of seclidemstat
Continued patient enrollment in both the Salarius-sponsored seclidemstat sarcoma clinical trial and the M.D. Anderson Cancer Center investigator-initiated hematologic clinical trial
SP-3164 (Targeted Protein Degrader) Highlights

Advanced plans for filing an Investigational New Drug (IND) application in 1H23 after completing the pre-Investigational New Drug meeting process with the U.S. Food and Drug Administration (FDA)
Introduced SP-3164 to potential strategic partners at BIO International Conference
"The second quarter and recent weeks were extremely productive for Salarius as we advanced both our programs toward multiple near-term milestones. Our Phase 1/2 study with seclidemstat in Ewing’s and other FET-rearranged sarcomas is progressing and the investigator-initiated clinical trial with seclidemstat in hematologic or blood cancers at M.D. Anderson Cancer Center is also progressing. We continue to expect clinical updates from both these programs in the second half of the year," stated David Arthur, CEO of Salarius Pharmaceuticals. "In addition, our development collaboration with Volition Rx should support further development of seclidemstat by studying potential biomarkers to allow for a noninvasive method of determining target engagement and assessing potential drug activity in patients."

Mr. Arthur continued, "And, we were thrilled to add SP-3164 – a type of targeted protein degrader called a molecular glue – to our development pipeline earlier this year. We completed the pre-IND meeting process with the FDA and are proceeding with plans to file an IND in the first half of 2023 and begin clinical studies shortly thereafter. Protein degraders have recently received enormous attention based on their exceptional promise to selectively eliminate cancer-promoting proteins and provide the ability to pursue historically undruggable cancer-promoting targets. We believe protein degradation is an exciting area, in part driven by the commercial success of the first-generation molecular glues, Revlimid and Pomalyst, which together generated more than $16 billion in 2021 global sales. We look forward to providing pre-clinical data updates later this year."

Second Quarter Financial Results

Net loss for the second quarter of 2022 was $4.7 million, or $0.09 per share, compared with a net loss of $3.1 million, or $0.07 per share, for the second quarter of 2021. The increase in net loss was due to higher operating expenses, including development spending on SP-3164, our targeted protein degradation technologies purchased in January 2022. There was no grant revenue in the current quarter.

Net cash used for operating activities during the second quarter of 2022 was $3.6 million, compared with $3.2 million during the same quarter last year.

Six Month Financial Results

Net loss for the first half of 2022 was $10.8 million, or $0.22 per share, compared with a net loss of $4.9 million, or $0.13 per share, for the first half of 2021. The increase in net loss was primarily due to higher research and development expense, primarily resulting from the $2.0 million acquisition and development costs for the SP-3164 technology, seclidemstat development costs, and higher general and administrative expenses, when compared to the prior year. Additionally, there was no grant revenue in the current year, compared with grant revenue of $1.8 million in the first half of 2021.

Net cash used in operating activities for the first half of 2022 was $7.1 million, an increase of $1.2 million from the prior-year period. The increase is primarily due to higher research and development expense.

As of June 30, 2022, Salarius had cash, cash equivalents and restricted cash of $22.6 million, compared with $29.2 million as of December 31, 2021. Current cash and cash equivalents are expected to fund the company’s planned operations into 2023.

Conference Call

Salarius will host a conference call and webcast today, beginning at 11:00 a.m. ET to discuss financial results for the second quarter of 2022 and provide a business update.

Participants are encouraged to pre-register for the conference call here to receive a dedicated dial-in number and personal PIN.

Alternatively, participants may access the conference call by dialing:

Following the conclusion of the conference call, a replay will be available until August 15, 2022, and can be accessed by dialing 877-344-7529 (U.S. toll-free), 855-669-9658 (Canada toll-free) or 412-317-0088 (International) with replay access code 2762786. An archive of the webcast will remain available for a period of time.

Verastem has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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MacroGenics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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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

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On August 8, 2022 The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) will host the ESMO (Free ESMO Whitepaper) congress 2022 September 9-13, 2022 (Press release, LamKap Bio Group, AUG 8, 2022, View Source [SID1234618009]). LamKap Bio alpha reported to present for the first time preclinical data on the development of NILK-2301 (CEAxCD3) and NILK-3301 (CEAxCD28) bispecific antibodies for immunotherapy of patients with carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5 aka CEA) expressing solid tumors.

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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

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"Novel CEAxCD3 (NILK-2301) and CEAxCD28 (NILK-3301) κλ bispecific antibodies for next generation immunotherapy of CEA-expressing cancer" will be presented on site in Hall 4 (poster area) on September 12 (presentation no. 752P).

A pdf file will be made available for download after presentation at the meeting.

On August 8, 2022 (GLOBE NEWSWIRE) — Merus N.V. (Nasdaq: MRUS) ("Merus", the "Company," "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported financial results for the second quarter that ended June 30, 2022 and provided a business update (Press release, Merus, AUG 8, 2022, View Source [SID1234617953]).

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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

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"At the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting, we provided an update on our lead bispecific antibody, Zeno, which demonstrated strong efficacy across multiple tumor types, clinically meaningful duration of response and a very well tolerated safety profile. We continue to believe Zeno has the potential to be both first in class and best in class for patients with NRG1 fusion cancer," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "Additionally, we continue to make progress with our pipeline and look forward to providing an update on MCLA-129 in the second half of 2022, and Peto in the first half of 2023."

Clinical Programs

Zenocutuzumab (Zeno or MCLA-128: HER3 x HER2 Biclonics): NRG1+ cancer and other solid tumors

We shared updated interim clinical data on our Zeno program (eNRGy trial and Early Access Program) in patients with NRG1 fusion (NRG1+) cancer at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting. Highlights from the presentation included:

As of the April 12, 2022 data cutoff date, 110 patients with NRG1+ cancer were treated with Zeno, efficacy was assessed in 79 patients with measurable disease having the opportunity for 6 months or more follow-up and who met the criteria for the primary analysis population
Overall Response Rate (ORR) per RECIST criteria as assessed by investigator was 34% (27/79) (95% Cl; 24%-46%) across multiple tumor types
Pancreatic ductal adenocarcinoma ORR 42% (8/19) (95% CI: 20-67%)
Non-small cell lung cancer (NSCLC) ORR 35% (16/46) (95% CI: 21-50%)
Tumor shrinkage was observed in 70% of patients (55/79)
Median time to response was 1.8 months, and median duration of exposure was 6.3 months
Median duration of response was 9.1 months, and 20/83 patients were continuing treatment as of the data cutoff date
Zeno has demonstrated a consistent and well tolerated safety profile, with few grade 3 or 4 treatment-related adverse events
As announced in 2021, based on feedback received from the U.S. Food and Drug Administration (FDA), Merus believes that the eNRGy trial design and planned enrollment has the potential to support a Biologics License Application submission for Zeno for a tumor agnostic indication for the treatment of patients with NRG1+ cancer. To date, we have enrolled a cohort of patients that we believe may constitute a registrational data set, and continue to enroll patients to gather further safety and efficacy data on Zeno in NRG1+ cancer. We believe Zeno has the potential to be first and best in class and a new standard of care for patients with NRG1+ cancer.

We believe the favorable safety profile of Zeno may also allow for future, potential benefit in combination with other cancer therapies. Accordingly, we are initiating a clinical trial evaluating Zeno in combination with afatinib for NRG1+ NSCLC. In addition, beyond NRG1+ cancer, we are initiating a clinical trial evaluating Zeno as a treatment for castration resistant prostate cancer, and are actively exploring ways in which targeting both HER2 and HER3 with Zeno has potential for the treatment of other cancers.

Details of the eNRGy trial can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com, or by calling 1-833-NRG-1234.

Petosemtamab (Peto or MCLA-158: Lgr5 x EGFR Biclonics): Solid Tumors
Dose expansion continues in the phase 1 trial: clinical update planned for 1H2023

Peto is currently enrolling patients with advanced solid tumors in the expansion phase of a phase 1 open-label, multicenter study.

We plan to provide a clinical update for Peto at a medical conference in the first half of 2023. The planned presentation will provide the opportunity to present a robust update across the program, including approximately 40 patients with head and neck squamous cell carcinoma with meaningful clinical follow up, and an update on the gastro-esophageal cohort, to inform clinical development strategy and planned regulatory interactions.

MCLA-145 (CD137 x PD-L1 Biclonics): Solid Tumors
Phase 1 trial continues

MCLA-145 is currently enrolling a global, phase 1, open-label, single-agent clinical trial evaluating MCLA-145 in patients with solid tumors. The trial consists of a dose escalation phase, followed by a planned dose expansion phase. Merus is also planning to evaluate the combination of MCLA-145 with a PD-1 blocking antibody.

MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors
Phase 1 trial continues: clinical update planned for 2H2022

MCLA-129 is currently enrolling patients in a phase 1/2, open-label clinical trial consisting of dose escalation followed by dose expansion. MCLA-129 is subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to exclusively develop MCLA-129 in China, while Merus retains global rights outside of China. A clinical update is planned for the second half of 2022.

In July, Merus entered into a clinical supply agreement with AstraZeneca for Tagrisso (osimertinib), a third-generation EGFR-TKI, for a planned investigation of the combination of Tagrisso and MCLA-129 in patients with NSCLC in the dose expansion phase of the trial. Under the terms of the non-exclusive agreement, AstraZeneca will supply Tagrisso for use by Merus in the combination study.

Corporate Activities

Incyte
In the second quarter of 2022, Merus achieved a milestone payment for a pre-clinical candidate nomination of a novel bispecific antibody (target pair program) under the global collaboration and license agreement ("Agreement") with Incyte Corporation. This marks the third program to reach candidate nomination under the Agreement. Candidate nomination triggers a program advancing to the next phase of development for IND-enabling studies by Incyte. Incyte also recently announced its plan to initiate a clinical program later this year with INCA32459, a novel LAG3xPD-1 bispecific antibody developed under the collaboration agreement with Merus, that achieved candidate nomination in 2021.

Merus receives reimbursement for research activities related to the collaboration and is eligible to receive potential development, regulatory and commercial milestones and sales royalties for any products, if approved.

Cash Runway, Merus expects to be funded beyond 2024

As of June 30, 2022, Merus had $396.8 million cash and cash equivalents sufficient to fund company operations beyond 2024.

Second Quarter 2022 Financial Results

We ended the second quarter with cash, cash equivalents and marketable securities of $396.8 million compared to $430.7 million at December 31, 2021.

Collaboration revenue for the three months ended June 30, 2022 increased by $0.3 million as compared to the three months ended June 30, 2021, primarily as a result of an earned milestone in 2022 partially offset by decrease in amortization of upfront payment. The change in exchange rates did not significantly impact collaboration revenue.

Research and development expense for the three months ended June 30, 2022 increased by $6.5 million as compared to the three months ended June 30, 2021, primarily as a result of a personnel related expenses including stock-based compensation of $2.9 million due to an increase in employee headcount and an increase in external clinical services and drug manufacturing costs, including costs to fulfill our obligations under our collaboration agreements, related to our programs of $1.4 million.

General and administrative expense for the three months ended June 30, 2022 increased by $2.1 million as compared to the three months ended June 30, 2021, primarily as a result of an increase in stock-based compensation expense of $1.1 million, consulting costs of $0.7 million and personnel related expenses of $0.5 million due to an increase in employee headcount.

Collaboration revenue for the six months ended June 30, 2022 increased by $3.6 million as compared to the six months ended June 30, 2021, primarily as a result of an increase from Lilly upfront payment amortization and reimbursement revenues of $4.2 million partially offset by a decrease of Incyte revenue recognized of $0.2 million and a decrease in other upfront payment amortization and reimbursement revenues of $0.4 million. The Incyte decrease is primarily driven by a decrease in cost reimbursements of $0.9 million and amortization of upfront payments of $0.3 million, offset by the achievement and recognition of a $1.0 million development milestone in June 2022. The change in exchange rates did not significantly impact collaboration revenue.

Research and development expense for the six months ended June 30, 2022 increased by $12.7 million as compared to the six months ended June 30, 2021, primarily as a result of an increase in external clinical services and drug manufacturing costs, including costs to fulfill our obligations under our collaboration agreements, related to our programs of $5.2 million and an increase personnel related expenses including stock-based compensation of $5.0 million due to an increase in employee headcount.

General and administrative expense for the six months ended June 30, 2022 increased by $4.5 million as compared to the six months ended June 30, 2021, primarily as a result of an increase in stock-based compensation expense of $2.2 million, personnel related expenses of $1.1 million due to an increase in employee headcount, and finance and human resources costs of $0.9 million.

Other income (loss), net consists of interest earned and fees paid on our cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange (losses) gains on our foreign denominated cash, cash equivalents and marketable securities. Other gains or losses relate to the issuance and settlement of financial instruments.