On February 21, 2024 Bio-Path Holdings, Inc. (NASDAQ: BPTH) (the "Company"), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it intends to effect a reverse stock split of its outstanding common stock, par value $0.001 per share, at a ratio of 1-for-20 (Filing, 8-K, Bio-Path Holdings, FEB 23, 2024, View Source [SID1234640412]). The reverse stock split will be effective as of 5:30 p.m., Eastern Time on February 22, 2024, and the Company’s common stock will begin trading on a split-adjusted basis on the Nasdaq Capital Market at the commencement of trading on February 23, 2024 under the Company’s existing symbol "BPTH." The Company’s common stock has been assigned a new CUSIP number of 09057N409.

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Upon the effectiveness of the reverse stock split, every 20 shares of common stock issued and outstanding as of the effective date will be automatically combined into one share of common stock. No fractional shares of common stock will be issued in connection with the reverse stock split. If as a result of the reverse stock split, a stockholder of record would otherwise hold a fractional share, the stockholder will receive one whole share in lieu of the issuance of any such fractional share. The reverse stock split will not change the par value of the common stock or modify the rights or preferences of the common stock. The Company anticipates that the reverse stock split will reduce the number of shares of the Company’s common stock issued and outstanding from 12,352,664 shares to approximately 617,833 shares. All outstanding securities entitling their holders to purchase shares of common stock or acquire shares of common stock of the Company, including stock options and warrants, will be adjusted as a result of the reverse stock split, as required by the terms of those securities.

The Company’s transfer agent, Equiniti Trust Company, LLC will continue to maintain the book-entry records for the Company’s common stock. Registered stockholders holding pre-split shares of the Company’s common stock electronically in book-entry form are not required to take any action to receive post-split shares. Stockholders owning shares via a broker, bank, trust or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to such broker’s particular processes and procedures; if you hold your shares with such a broker, bank trust or other nominee and if you have questions in this regard, you are encouraged to contact your nominee.

On February 22, 2024 REGiMMUNE Limited, a clinical-stage biopharmaceutical company focused on creating innovative immunotherapies for immune disorders and cancer, reported the positive results of their phase 2b clinical trial for the prevention of acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic cell transplantation (alloHCT) at the 2024 Tandem Meeting of ASTCT and CIBMTR (Press release, REGimmune, FEB 22, 2024, View Source [SID1234642235]).

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aGVHD, primarily mediated by effector T-lymphocytes, is a major cause of morbidity and mortality after alloHCT. RG1-2001 contains the active moiety α-GalCer, which binds the CD1d receptor of antigen-presenting cells resulting in activation of iNK T cells, resulting in a cytokine-dependent Treg proliferation. This phase 2b trial is an open-label, multi-center, single-arm study. RGI-2001, added to standard immunosuppression, is being evaluated for the potential to reduce the incidence or severity of aGVHD in patients following alloHCT. The results are compared with a contemporaneous CIBMTR cohort (NCT04014790).

Through day 100, the incidence of grades II-IV aGVHD was 22.9% of subjects on RGI-2001 compared to 38.8% of those in the CIBMTR cohort. RGI-2001 also demonstrates higher rates of acute GVHD-free survival (72.9% in grade II-IV and 91.7% in grades III-IV compared with 50.7% and 77.3% in those on CIBMTR cohort, respectively) and overall survival (91.7% compared with 79.2% on CIBMTR cohort). Relapse rates between the 2 cohorts are similar, suggesting no compromise of the graft-versus-leukemia effect.

"We are thrilled to be selected for oral presentation at the Tandem Meeting. The results showed promising safety and efficacy outcomes using RGI-2001 in addition to the standard GVHD prevention medications, providing a strong foundation to advance our plans for phase 3 study." said Kenzo Kosuda, CEO of REGiMMUNE.

REGiMMUNE concludes that RGI-2001 added to standard-of-care shows positive results for acute GVHD prevention with survival benefit and no increase in relapse compared to CIBMTR control. Based on these results, a phase 3 randomized controlled study is being planned to confirm the efficacy and safety of RGI-2001 in alloHCT.

Details of presentation, please see RGI-2001 Tandem 2024 Oral Presentation

On February 22, 2024 Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options, reported that its Board of Directors is implementing a series of additional cost-savings measures designed to extend Salarius’ expected cash runway into the first half of 2025 (Press release, Salarius Pharmaceuticals, FEB 22, 2024, View Source [SID1234640420]). These measures will allow Salarius to support the generation of additional clinical data for seclidemstat in the ongoing MD Anderson Cancer Center (MDACC) investigator-initiated Phase 1/2 clinical trial in hematologic cancers and Salarius’ Phase 1/2 trial in Ewing sarcoma.

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Earlier this year Salarius announced that MDACC had resumed enrollment in the hematologic cancer trial, and based on the available data Salarius is encouraged by the 50% objective response rate (ORR) previously reported by MDACC researchers. Salarius also reported earlier this year that an additional Ewing sarcoma patient treated with a combination of seclidemstat, topotecan and cyclophosphamide (TC) achieved a partial response, increasing the ORR among first-relapse Ewing sarcoma patients to 60%.

In connection with the cost-savings measures, David Arthur, the Company’s President and Chief Executive Officer, has ended his full-time employment and transitioned to a part-time consultant role, effective February 20, 2024. He will continue to serve as Chief Executive Officer and support Salarius’ ongoing activities. The cost-savings measures also include reducing operating expenses and reducing the cash compensation payable to the Company’s non-employee directors beginning in the second quarter of 2024.

In August 2023 Salarius announced that it had retained Canaccord Genuity, LLC to lead a comprehensive review of strategic alternatives focusing on maximizing shareholder value. While these efforts are ongoing, the Company continues to support its clinical programs, as appropriate, and the cost-savings measures approved by the Board of Directors are designed to enable the Company to continue supporting such activities.

"With these additional expense reductions, we are able to extend our cash runway to allow for the generation of additional clinical data in both seclidemstat clinical trials. The Board of Directors believes this decision is in the best interest of shareholders, and the additional data may enhance our opportunities to maximize shareholder value," said Dr. William McVicar, Chair of the Board. "By further reducing expenses, we are able to support the ongoing clinical development of seclidemstat into the first half of 2025. We look forward to reviewing the updated clinical data from both trials later this year and to sharing those data with prospective strategic partners and other interested parties."

About Seclidemstat
Seclidemstat is a novel oral reversible inhibitor of the LSD1 enzyme and has received fast track, orphan drug and rare pediatric disease designations for Ewing sarcoma from the FDA. In addition to the MDACC investigator-initiated trial, seclidemstat has been studied in a company-sponsored Phase 1/2 trial evaluating its use in combination with TC for the treatment of relapsed/refractory Ewing sarcoma.

Researchers at MDACC previously reported interim clinical trial results evaluating seclidemstat in combination with azacitidine for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) patients who relapsed or progressed after hypomethylating agent therapy. Of eight evaluable patients, four (50%) had an objective response. These researchers reported a 90% probability of survival for 11 months in patients receiving seclidemstat plus azacitidine. Typically,

overall survival is four to six months after failing therapy with hypomethylating agents. The hematologic cancer Phase 1/2 clinical trial being conducted at the University of Texas MD Anderson Cancer Center is now listed as active and recruiting on clinical trials.gov – trial NCT04734990.
The Company-sponsored Ewing sarcoma clinical trial focuses on seclidemstat in combination with topotecan and cyclophosphamide as a treatment for relapsed and refractory Ewing sarcoma. To date, a total of 13 relapsed Ewing sarcoma patients, including five patients with first relapse and eight patients with second relapse, have been enrolled at seclidemstat doses of 600 mg or 900 mg twice daily in combination with TC.
•The five first-relapse patients demonstrated a 60% ORR and a 60% disease control rate (DCR) including one complete response and two partial responses. Among the three patients achieving OR, the median progression-free survival (mPFS) has not been reached with these patients still alive and have disease control and objectives responses at 17.4, 25.7 and 27.2 months, and increasing, after starting seclidemstat + TC combination treatment.
•The eight second-relapse patients demonstrated a 13% ORR, a 25% DCR and a mPFS of 1.6 months (range: 0.0 months to 10.7 months).
•Together the 13 first- and second-relapse patients demonstrated a mPFS of 8.1 months (range: 2.0 months to 27.2 months). Five patients, or 38%, achieved confirmed disease control and progression has not been observed in any of these patients while on study.

Salarius has completed FDA Type B End of Phase 2 (EOP2) meeting process for the Seclidemstat Ewing sarcoma development program and has amended the current clinical trial protocol to reflect guidance agreed to with FDA. There is currently one patient enrolled in the Ewing sarcoma clinical trial, who recently achieved a partial response defined by a 30% or greater reduction in their target lesions, and this patient is continuing treatment with seclidemstat plus TC therapy. The Ewing sarcoma trial is currently active but is not currently enrolling additional patients.

On February 22, 2024 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancers, reported that members of the management will host a corporate update call on March 28, 2024, at 2:00 p.m., EST, to dive into the recent corporate updates and exciting positive results produced from a compassionate use study leveraging Propanc’s proenzyme therapy (Press release, Propanc, FEB 22, 2024, View Source [SID1234640409]).

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The compassionate use study results highlight clinical effects studied in 46 patients with advanced metastatic cancers of different origin (prostate, breast, ovarian, pancreatic, colorectal, stomach, non-small cell lung, bowel, and melanoma) after treatment with a rectal formulation of pancreatic proenzymes. Nineteen of 46 patients (41.3%) with advanced malignant diseases, most of them suffering from metastases, had a survival time significantly longer than the expected life span (mean survival of 9.0 months vs life expectancy of 5.6 months), with no severe or serious adverse events related to administration.

Participants Include:

Dr. Julian Kenyon, MD, MB, ChB, Chief Scientific Officer & Cofounder
Professor Klaus Kutz M.D., Acting Chief Medical Officer
Dr. Ralf Brandt PhD, Scientific Advisory Board Member & Coinventor
Mr. James Nathanielsz BAS, MEI, Chief Executive Officer, Executive Chairman & Chief Financial Officer
To Register:

LinkedIn Registration Here
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About PRP:

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include pancreatic, ovarian, kidney, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers. Orphan Drug Designation status of PRP has been granted from the US Food and Drug Administration (FDA) for treatment of pancreatic cancer.

To view the Company’s "Mechanism of Action" video on the Company’s lead asset, PRP, please click on the following link: View Source

On February 22, 2024 Novocure (NASDAQ: NVCR) reported financial results for the quarter and full year ended December 31, 2023 (Press release, NovoCure, FEB 22, 2024, View Source [SID1234640408]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

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"In 2023, we reached many milestones in our commercial, clinical and product development programs," said Asaf Danziger, Novocure’s Chief Executive Officer. "Our launch in France is off to a strong start and globally we finished the year with 9% year-over-year growth in active patients.

"Our LUNAR phase 3 clinical trial in non-small cell lung cancer met its primary endpoint and we submitted marketing applications to the regulatory bodies in our key markets," continued Mr. Danziger. "We also completed enrollment of three additional phase 3 trials – METIS, PANOVA-3, and most recently, TRIDENT. Finally, we successfully introduced our next generation arrays in several European markets and we have filed for regulatory approval to launch in the U.S. I am incredibly proud of our colleagues’ achievements in 2023 and look forward to an exciting 2024."

"2024 will be a pivotal year for Novocure," said William Doyle, Novocure’s Executive Chairman. "We are laser-focused on achieving three core objectives – growing our GBM business, launching TTFields therapy in non-small cell lung cancer, and delivering the promise of our clinical trial and product development pipelines. Achieving our goals should position Novocure for sustained success for years to come."

Financial updates for the full year and fourth quarter ended December 31, 2023:

Total net revenues for the year were $509.3 million, a decrease of 5% year-over-year. This decrease resulted primarily from $48 million in reduced collections from denied or appealed claims in the U.S., which were largely exhausted in 2022. We expect future net revenue to more closely reflect core drivers of net revenue: number of active patients on therapy, duration of therapy, and net realized price per month.
Total net revenues for the quarter were $133.8 million, an increase of 4% year-over-year.
The United States, Germany and Japan contributed $91.3 million, $14.7 million and $7.6 million in quarterly net revenues, respectively, with our other active markets contributing $15.9 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.4 million.
Gross margin for the quarter was 76%. Gross margin was impacted by increased investments in patient support capacity and the rollout of our next generation arrays. In time, we expect these impacts to be offset by increased active patient counts as well as improved efficiencies and scale within our supply chain as we optimize manufacturing for our new arrays.
Research, development and clinical studies expenses for the quarter were $54.3 million, a decrease of 1% from the same period in 2022. Clinical trial expenses can fluctuate quarter-to-quarter dependent upon the number of clinical trials actively underway, amount of clinical research organization services delivered and clinical materials procured.
Sales and marketing expenses for the quarter were $59.2 million, an increase of 19% from the same period in 2022. This primarily reflects increased costs associated with geographic expansion and pre-launch activities intended to increase awareness of TTFields therapy in anticipation of our launch in non-small cell lung cancer (NSCLC).
General and administrative expenses for the quarter were $39.4 million, an increase of 4% from the same period in 2022.
Net loss for the quarter was $47.1 million with loss per share of $0.45.
Adjusted EBITDA* for the quarter was $(31.6) million.
Cash, cash equivalents and short-term investments were $910.6 million as of December 31, 2023.
Operational updates for the fourth quarter ended December 31, 2023:

1,564 prescriptions were received in the quarter, an increase of 14% year-over-year. Prescriptions from the United States, Germany and Japan contributed 960, 217 and 105 prescriptions, respectively, with the remaining 282 prescriptions received in our other active markets.
As of December 31, 2023, there were 3,755 active patients on therapy, an increase of 9% year-over-year. Active patients from the United States, Germany and Japan contributed 2,162, 525 and 375 active patients, respectively, with the remaining 693 active patients contributed by our other active markets.
Quarterly updates and achievements:

In December, Novocure submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) seeking approval for the use of TTFields therapy together with standard therapies for the treatment of NSCLC, following progression on or after platinum-based therapy. In January, the FDA accepted the application for filing and it is now under substantive review as of December 15, 2023. Novocure also has active regulatory submissions under review in the European Union and Japan.
In December 2023, Novocure submitted a PMA supplement to the FDA for Optune Gio next generation arrays for newly diagnosed glioblastoma.
In January, Novocure completed enrollment in the phase 3 TRIDENT clinical trial evaluating the efficacy of initiating Optune Gio use concurrent with radiation therapy and temozolomide for the treatment of adult patients with newly diagnosed GBM. Patients will be followed for a minimum of 24 months with data anticipated in 2026.
In January, Novocure announced the appointment of Dr. Nicolas Leupin to the role of Chief Medical Officer. Dr. Leupin joins Novocure with an established track record of leadership and innovation in the biopharmaceutical sector, built upon extensive experience as a practicing medical oncologist and educator.
Anticipated clinical milestones:

Top-line data from the phase 3 METIS clinical trial in brain metastases (late Q1 2024)
Top-line data from the phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer (Q4 2024)
Data from the phase 3 TRIDENT clinical trial in newly diagnosed glioblastoma (2026)
Conference call details
Novocure will host a conference call and webcast to discuss fourth quarter and full year 2023 financial results at 8:00 a.m. EST today, Thursday, February 22, 2024. To access the conference call by phone, use the following conference call registration link, and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast and earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.