On March 5, 2024 Nuvectis Pharma, Inc (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported its financial results for the fiscal year 2023 and provided an update on recent business progress (Press release, Nuvectis Pharma, MAR 5, 2024, View Source [SID1234640788]).

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "2023 was an eventful year for Nuvectis as we continued to make important strides with our two clinical-stage drug candidates, NXP800 and NXP900. For NXP800, we initiated the Phase 1b in platinum resistant ARID1a-mutated ovarian carcinoma and an investigator-sponsored clinical trial in cholangiocarcinoma in collaboration with the Mayo Clinic. Additional preclinical data presented during the year demonstrated the potency of NXP800 in ARID1A-mutated endometrial carcinoma, providing another potential development path for NXP800 within the gynecology-oncology space." Mr. Bentsur continued, "For NXP900, we initiated the Phase 1a dose escalation clinical trial and presented additional preclinical data that demonstrated the potential of NXP900 as a single agent and in combination with certain market-leading therapies."

Mr. Bentsur added, "We expect several catalysts in 2024 for NXP800 and NXP900, starting with the preliminary clinical data update later this month from the NXP800 Phase 1b study in platinum resistant ARID1a-mutated ovarian cancer. We also expect to provide updates from all our clinical trials throughout the year."

Mr. Bentsur concluded, "We remain cash efficient and highly focused on our mission of developing important precision medicines for the treatment of serious conditions of unmet medical need in oncology."

Full Year 2023 Financial Results

Cash, and cash equivalents were $19.1 million as of December 31, 2023, compared to $20.0 million as of December 31, 2022. The decrease of $0.9 million was a result of the Company’s continued operations, offset primarily by the exercise of warrants issued in our 2022 PIPE transaction.

The Company’s net loss was $22.3 million for the year ended December 31, 2023, compared to $19.1 million for the year ended December 31, 2022, an increase in net loss of $2.2 million. Net loss for the 2023 fiscal year included $4.7 million in non-cash stock-based compensation and $2.3 million in one-time non-recurring expenses.

Research and development expenses, including non-cash stock-based compensation and one-time non-recurring expenses, were $15.4 million for the year ended December 31, 2023, compared to $13.2 million for the year ended December 31, 2022, an increase of $2.2 million.

General and administrative expenses, including non-cash stock-based compensation and one-time non-recurring expenses, were $7.5 million for the year ended December 31, 2023, compared to $6.0 million for the year ended December 31, 2022, an increase of $1.5 million.

Interest income was $0.6 million for the year ended December 31, 2023, compared to $0.1 million for the year ended December 31, 2022, an increase of $0.5 million.

On March 5, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, reported positive preclinical imaging data of a therapeutic radioisotope bound to its proprietary uPAR (urokinase plasminogen activator receptor) targeting agent MNPR-101 (Press release, Monopar Therapeutics, MAR 5, 2024, View Source [SID1234640787]). The data clearly demonstrate highly preferential uptake in the tumor. This is an extension of the tumor imaging and efficacy data Monopar released on February 22 (link), where Monopar disclosed biodistribution data with a diagnostic imaging radioisotope (Zirconium-89) as well as efficacy data with therapeutic radioisotopes (e.g., Actinium-225) bound to MNPR-101 in human tumor xenograft models. The new imaging data released today provide additional support for the tumor-targeting ability of MNPR-101 and help explain the near complete elimination of tumors (link) observed after a single injection of therapeutic radioisotopes bound to MNPR-101.

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Biodistribution of a Therapeutic Radioisotope Conjugated to MNPR-101

Two of the most commercially successful radiopharmaceuticals, Pluvicto and Lutathera, use the therapeutic radioisotope Lutetium-177 (Lu-177). Beyond killing cancer cells, this radioisotope has the added advantage that its biodistribution can be visualized via SPECT (single-photon emission computed tomography) imaging. Monopar collected a sequential SPECT imaging time-series utilizing MNPR-101 conjugated to Lu-177 (MNPR-101-Lu) in a uPAR-expressing human pancreatic cancer xenograft model. The results can be seen in Figure 1. High specificity and durable uptake of MNPR-101-Lu in the tumor relative to normal tissue is readily apparent, and these results are consistent with the previously released data for Monopar’s diagnostic imaging radiopharmaceutical MNPR-101-Zr.

"Delivering a high dose to the tumor relative to normal tissue is of central importance in radiopharmaceutical therapy," said Andrew Cittadine, Monopar’s Chief Operating Officer. "These data help explain the compelling and durable anti-tumor benefits observed to-date in preclinical studies using MNPR-101 conjugated to therapeutic radioisotopes."

Monopar recently announced it received Human Research Ethics Committee (HREC) clearance in Australia to commence a Phase 1 dosimetry clinical trial for MNPR-101-Zr in advanced cancer patients (link). The data disclosed today further support Monopar’s efforts to create a radiodiagnostic and radiotherapeutic pairing to image and treat uPAR-positive cancers.

"Some of the most aggressive, deadly cancers express uPAR, such as triple negative breast cancer and pancreatic cancer," said Chandler Robinson, MD, Monopar’s Chief Executive Officer. "These data further support the potential of a MNPR-101 based radiopharmaceutical to provide a very meaningful clinical benefit to patients with uPAR-positive tumors."

On March 5, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Jannie Oosthuizen, president, Human Health U.S., is scheduled to participate in a fireside chat at the Barclays 26th Annual Global Healthcare Conference on Tuesday, March 12, 2024, at 3:05 p.m. EDT (Press release, Merck & Co, MAR 5, 2024, View Source [SID1234640786]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

On March 5, 2024 MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics and innovative bioprocessing applications, reported revenue guidance for the full year of 2024 and reaffirmed 2023 preliminary results previously announced in January (Press release, MaxCyte, MAR 5, 2024, View Source [SID1234640785]).

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2023 Preliminary Results

Total revenue for the fiscal year of 2023 is expected to be between $41.1 million and $41.3 million, compared to $44.3 million for fiscal year 2022.

● Core revenue is expected to be between $29.6 million and $29.8 million, compared to $39.6 million for fiscal year 2022.
● SPL Program-related revenue is expected to be approximately $11.4 million, compared to $4.6 million for fiscal year 2022.

Total cash, cash equivalents, and investments as of December 31, 2023 is expected to be approximately $210 million.

2024 Guidance

Management is providing initial 2024 revenue guidance for core business revenue and SPL program-related revenue:

● Core revenue is expected to be flat to 5% growth compared to 2023.
● SPL Program-related revenue is expected to be approximately $3 million for the year.

Our outlook does not include SPL Program-related revenue from the sale of Vertex/CRISPR’s CASGEVY.

Management expects to end 2024 with $175 million in total cash, cash equivalents and investments.

"We are looking forward to continuing to execute across our business and provide best in class support to our customers in 2024 and the years to come. This year, MaxCyte has already signed three SPLs in which our cell and gene therapy clients will use our Flow Electroporation technology and ExPERT platform to further their pre-clinical and clinical programs," said Maher Masoud, President and Chief Executive Officer at MaxCyte. "As we continue to expand our SPL portfolio this year, we remain confident in our ability to support our current and prospective clients as new waves of next-generation cell therapies come to market."

Cowen Healthcare Conference

MaxCyte will be presenting at the 44th Annual Cowen Conference at 9:10 a.m. Eastern Time on Tuesday, March 5, 2024. A live and archived webcast of the Cowen presentation will be available on the "Event" section of the MaxCyte investor relations website at View Source

Fourth Quarter Earnings Conference Call Details

MaxCyte plans to release final financial results for the fourth quarter and full year 2023 after the U.S. market close on Tuesday, March 12, 2024. Company management will host a conference call to discuss financial results that day at 4:30 p.m. Eastern Time on Tuesday, March 12, 2024.

Investors interested in listening to the conference call are required to register online. It is recommended to register at least a day in advance. A live and archived webcast of the event will be available on the "Events" section of the MaxCyte website at View Source

On March 5, 2024 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported the completion of patient recruitment for the Phase 2a clinical trial[1] sponsored by AP-HP[2] and in collaboration with INRAE and Institut Gustave Roussy, evaluating MaaT013, the Company’s lead product candidate, in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy) and nivolumab (Opdivo) (Press release, MaaT Pharma, MAR 5, 2024, View Source [SID1234640784]).

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A total of 70 patients have been enrolled in 5 different centers in France in the randomized controlled Phase 2a PICASSO trial, which started in April 2022. The Company provided MaaT013 drug candidate and placebo and will contribute to the microbiome profiling of patients using its proprietary gutPrint research engine. The unblinding will be done at Week 27 (W27) to assess the primary endpoint which is safety. In parallel, the first efficacy data will be made available, assessed by the best overall response rate, rated by immunological Response Evaluation Criteria in Solid Tumors (iRECIST; 19).

Having reached this key recruitment milestone, the first publication will be submitted at the end of 2024 or in the first quarter of 2025.

The PICASSO trial is funded by the Directorate of Health Care Supply (DGOS: Direction Générale de l’Offre de Soins) and operated by the French National Cancer Institute (INCa: Institut National du Cancer) as part of a call for projects (project PHRC-K19-183).

[1] NCT04988841: Prospective randomIzed clinical trial assessing the tolerance and clinical benefit of feCAl tranSplantation in patientS with melanOma treated with CTLA-4 and PD-1 inhibitors.

[2] AP-HP: Assistance Publique – Hôpitaux de Paris

About MaaT013

MaaT013 is a full-ecosystem, off-the-shelf, standardized, pooled-donor, enema Microbiome Ecosystem TherapyTM for acute, hospital use. It is characterized by a consistently high diversity and richness of microbial species and the presence of ButycoreTM (group of bacterial species known to produce anti-inflammatory metabolites). MaaT013 aims to restore the symbiotic relationship between the patient’s functional gut microbiome and their immune system to correct the responsiveness and tolerance of immune functions and thus reduce steroid-resistant, gastrointestinal (GI)-predominant aGvHD. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).