On March 14, 2024 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported full year 2023 financial results and provides a review of 2023 accomplishments and anticipated upcoming developments (Press release, Intensity Therapeutics, MAR 14, 2024, View Source [SID1234641167]).

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2023 and Other Recent Highlights

•Study May Proceed letter received from the U.S. Food and Drug Administration ("FDA") for the Company’s Phase 3 protocol in soft tissue sarcoma using INT230-6 (the "INVINCIBLE-3" study)
•Completed IT-01 study, a 110-patient Phase 1/2 study using INT230-6 in refractory cancers
◦Dosing completed in over 20 different cancers, with favorable safety and strong signals of efficacy shown with immune activation
•Completed dosing, database lock and tables, listings and figures for a 91-patient Phase 2 study using INT230-6 in pre-adjuvant breast cancer (the "INVINCIBLE-2" study)
•Presented INVINCIBLE-2 data at the San Antonio Breast Cancer Symposium ("SABCS") in an oral podium spotlight discussion session
◦INT230-6 induced up to 95% necrosis in tumors following a single injection

◦Favorable safety profile observed
◦Increase in CD4 T-cells and NK cells observed within tumors
•Data presented at Connective Tissue Oncology Society ("CTOS") Annual Meeting showing INT230-6 extended survival in refractory soft tissue sarcoma subjects by 15 months compared to a synthetic control group with a 93% disease control rate when used as monotherapy
•Received Orphan Drug Designation for the three key ingredients in INT230-6 for the treatment of soft tissue sarcoma
•Presented two posters at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting reporting anti-cancer immune activation in both breast cancer and sarcoma, which are cancers that are considered to be non-immunogenic
•Closed an up-sized initial public offering on the Nasdaq exchange with a full exercise of the underwriters’ over-allotment option at the top of the range, raising over $22 million in gross proceeds
•Bolstered management team by adding Chief Financial Officer, Vice President of Clinical Operations, Vice President of Regulatory Affairs and manufacturing engineering staff
"We had a pivotal year in 2023 culminating with the receipt of an FDA ‘Study May Proceed’ letter to enter into Phase 3 clinical trials for our lead drug candidate, INT230-6 for metastatic soft tissue sarcoma," said Lewis H. Bender, Founder, President and Chief Executive Officer. "Our selection this year by the review committees at ASCO (Free ASCO Whitepaper), CTOS and SABCS, including oral podium presentations, validated our science and indicated interest by oncologists in our results. We are on track to initiate our Phase 3 sarcoma study in mid-2024. Following our IPO, our cash position remains strong, and we believe we have sufficient runway to meet near term milestones."
In the INVINCIBLE-3 study, the Company plans to enroll 333 patients with an endpoint of overall survival. "Current U.S. standard-of-care drugs used for sarcoma after progression of the first line therapies require extensive safety monitoring. The standard-of-care ("SOC") medicines cause severe toxicities and provide median overall survival of only between 12 to 15 months depending on the drug and sarcoma subtype," stated Mr. Bender. "Our data suggests the potential for a significant survival increase with fewer and less severe toxicities. Sarcoma patients are in need of new and meaningful ways to treat their disease. A successful outcome of our Phase 3 survival study could be critical in treatment of other fatty, dense tumor types such as breast and pancreatic cancers."
The Company also plans to initiate a Phase 2/3 program in presurgical breast cancer with the start of a Phase 2 randomized controlled trial testing two doses of INT230-6 prior to SOC compared to the SOC alone (the "INVINCIBLE-4" study). The endpoint for this portion of the study is the change in the pathological complete response rate for the combination, which is an accepted FDA endpoint for accelerated approval. The Company expects to initiate INVINCIBLE-4 in mid-2024, which will provide data to size the Phase 3 portion of the program. As Dr. Angel Arnout M.D., MSc., and the Principal Investigator from the INVINCIBLE-2 study stated in San Antonio, "the ability for INT230-6 to induce necrosis and noted immune effects prior to a patient’s surgery, while maintaining a favorable safety profile, would be a major move forward for the treatment paradigm of breast cancer and potentially many other cancers." The Company will provide further updates on the progress of this study in the coming months.

Anticipated Near-Term Milestones
•Initiate INVINCIBLE-3 Study in certain metastatic soft tissue sarcoma subtypes. The Company plans to enroll 333 patients with an endpoint of overall survival. The study will compare INT230-6 as a monotherapy treatment to the three current SOC drugs in 2nd and 3rd line soft tissue sarcoma subtypes.
•Initiate the Phase 2/3 program in presurgical breast cancer with the start of INVINCIBLE-4, a Phase 2 randomized controlled trial testing two doses of INT230-6 prior to SOC (immune-chemotherapy) compared to the SOC alone. The endpoint for this portion of the study is the change in the pathological complete response rate for the combination. The Company expects to initiate INVINCIBLE-4 in mid-2024, which will provide data to size the Phase 3 portion of the program.

Year-End 2023 Financial Results
Research and development expenses were $4.8 million for the year ended December 31, 2023, compared to $5.1 million for the same period in 2022. The decrease was primarily due to the completion of enrollment in the IT-01 study in mid-2022. This decrease was partially offset by higher 2023 expenses for start-up work on the INVINCIBLE-3 study and a new manufacturing batch of INT230-6.
General and administrative expenses were $3.5 million for the year ended December 31, 2023, compared to $2.4 million for the same period in 2022. The increase was primarily due to salary and bonus increases, including the hiring of a new chief financial officer in the fourth quarter of 2023, higher stock-based compensation expense, and overall higher accounting fees, consulting, directors and officers insurance and other expenses as we transitioned into a publicly traded company.
In 2023, the Company also recognized a non-cash $2.3 million loss on debt conversion at the time of the initial public offering, along with a non-cash preferred stock deemed dividend of $1.3 million, representing the value that was transferred to the Series B and C preferred stockholders upon triggering of anti-dilution provisions.
Overall, net loss was $10.5 million for the year ended December 31, 2023, compared to $7.6 million for the year ended December 31, 2022.
As of December 31, 2023, cash, cash equivalents and marketable debt securities totaled $14.8 million, which the Company expects will be sufficient to fund operations through the end of the first quarter in 2025.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient’s malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression that so often occurs with systemic chemotherapy.

On March 14, 2024 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported financial results and business highlights for the fourth quarter and full-year ended December 31, 2023 (Press release, In8bio, MAR 14, 2024, View Source [SID1234641166]).

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"IN8bio entered 2024 with significant momentum behind the company," said William Ho, CEO and co-founder of IN8bio. "Despite the difficult environment in 2023, the IN8bio team executed operationally and successfully advanced our programs. We presented positive data across our major clinical programs in leukemia and GBM, broadened our clinical portfolio, and strengthened our financial position by securing funding into 1Q 2025. We presented updated data from our INB-100 study at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which was the first time any allogeneic cellular therapy has reported sustained efficacy and long-term cell persistence through 365 days. This showcases the potential of gamma-delta T cells to provide long-term durable remissions for patients with leukemia. We believe that IN8bio is well-positioned for significant near- and long-term catalysts as we advance our pipeline of gamma-delta T cell therapies to potentially extend survival in some of the most aggressive forms of cancer."

Business Highlights and Recent Developments

Announced positive INB-100 data at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition demonstrating that 100% of evaluable leukemia patients (n=10) treated remained alive, progression-free, and in durable complete remission (CR) as of November 3, 2023. The data showed long-term in-vivo expansion and persistence of allogeneic gamma-delta T cells 365 days following a single administration of INB-100. The study demonstrated the first-ever durable persistence of an allogeneic cellular therapy.
Reported positive data on INB-200 at the 28th SNO Annual Meeting. All patients who completed mandated doses surpassed a median PFS of seven months, exceeded the standard-of-care median PFS of four to seven months, with one patient in Cohort 2 remaining alive and progression free past 28.5 months as of October 20, 2023. In addition, most patients exceeded the expected PFS based on their age and methylguanine-DNA methyltransferase (MGMT) status of their tumors.
Announced a private placement totaling up to $46.9 million in potential gross proceeds. The initial closing of $14.4 million is expected to support operational execution and extended the Company’s cash runway into 1Q 2025 with the potential for up to $32.5 million in additional capital at increasing valuations, subject to certain conditions.
Initiated enrollment for the Phase 2 study of INB-400 in newly diagnosed GBM.
Announced publication in Frontiers in Immunology on IN8bio’s DeltEx Drug Resistant Immunotherapy (DRI) as a rational therapeutic approach to newly diagnosed glioblastoma titled, "Adoptive Cell Therapy for High Grade Gliomas using Simultaneous Temozolomide and Intracranial MGMT-Modified γδ T cells Following Standard Post-Resection Chemotherapy and Radiotherapy: Current Strategy and Future Directions."
Appointed Dr. Corinne Epperly, M.D., M.P.H., an internationally recognized immuno-oncology and cell therapy executive with 20 years of experience, to the Board of Directors.
Upcoming Anticipated Pipeline Milestones and Events

INB-100: Enroll an additional 10 patients in an expansion cohort at the recommended Phase 2 dose (RP2D) and report Phase 1 long-term follow-up results at multiple medical meetings throughout 2024; potentially submit investigational new drug (IND) application for Phase 3 randomized control trial in 2024.
INB-200: Report Phase 1 long-term follow up results at multiple medical meetings in 2024.
INB-300: Present additional preclinical data demonstrating proof-of-concept for the nsCAR platform targeting CD33 and CD123 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2024.
INB-400: Dose first patient and treat up to 15 patients at multiple sites across the United States in the Phase 2 trial in newly diagnosed GBM; potentially submit IND for Phase 1b allogeneic gamma-delta T cell study in relapsed GBM in 2024.
Fourth Quarter and Full Year 2023 Financial Highlights

Research and Development (R&D) expenses: R&D expenses were $4.5 million for the three months ended December 31, 2023, compared to $4.0 million for the comparable prior year period. R&D expenses were $16.8 million for the year ended December 31, 2023, compared to $14.1 million in the prior year. The increase in R&D expenses was primarily due to increased personnel-related costs, including salaries, benefits, and non-cash stock-based compensation due to increased headcount, as well as increased third-party clinical trial-related activities for the INB-100 and INB-200 programs. The increase was partially offset by a reduction in contract research organization expenses for INB-400 related to the IND filing in the prior year.
General and administrative (G&A) expenses: G&A expenses were $3.1 million for the three months ended December 31, 2023, compared to $3.9 million for the comparable prior year period. G&A expenses were $13.5 million for the year ended December 31, 2023, compared to $14.5 million in the prior year. The decrease in G&A expenses was primarily due to cost savings related to D&O insurance premiums and reductions in professional services.
Net loss: The company reported a net loss of $7.6 million, or $0.22 per basic and diluted common share, for the three months ended December 31, 2023, compared to a net loss of $7.8 million, or $0.32 per basic and diluted common share, for the comparable prior year period. For the year ended December 31, 2023, net loss was $30.0 million, or $1.00 per basic and diluted common share, compared to a net loss of $28.5 million, or $1.36 per basic and diluted common share, for the prior year.
Cash position: As of December 31, 2023, the Company had cash of $21.3 million, compared to $18.2 million as of December 31, 2022.

On March 14, 2024 ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, reported that Tim McCarthy, CEO and Dr Tim Franklin, COO, will be attending BIO-Europe Spring (Press release, ImmuPharma, MAR 14, 2024, View Source [SID1234641165]). The event will be held between 18-20 March 2024, in Barcelona.

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BIO-Europe Spring is the premier springtime partnering event, designed to provide biotechnology companies with the opportunity to present to and connect with investors together with the global biopharma community.

On March 14, 2024 IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the "Company" or "IPA") (NASDAQ: IPA), an artificial intelligence-driven biotherapeutic research and technology company, reported financial results for its third quarter of the 2024 fiscal year ("FY24"), which ended January 31, 2024 (Press release, ImmunoPrecise Antibodies, MAR 14, 2024, View Source [SID1234641164]).

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"ImmunoPrecise Antibodies proudly reports a fourth consecutive quarter of record revenue, demonstrating our capability to fulfill the rising needs of both new and existing clients through our comprehensive antibody discovery and development services. These services are designed to effectively reduce the risk, cost, and time associated with advancing safe and effective therapies to clinical trials. Key contributors to this revenue growth include our B Cell Select platforms and the enhanced capacity of our manufacturing facility, with additional support from our VHH antibody discovery technologies," stated Dr. Jennifer Bath, CEO of IPA.

She added "Up to this point in the fiscal year 2024, our cash burn has markedly reduced. At the end of the third quarter of fiscal year 2023, it stood at $19.4 million. Now, for the same period in fiscal year 2024, it’s down to $3.1 million. This figure does not include the funds received from our equity offering in December 2023. This reduction in cash burn is a result of both our increased revenue and strategic cost management efforts, even as we continue to invest in AI technologies to better serve our clients.

BioStrand, one of our subsidiaries, has started generating revenue from projects powered by its LENSai technology, and is making progress towards the further development and launch of its LENSai portal and SaaS platforms. Meanwhile, Talem Therapeutics is focused on leveraging its strategic partnerships to drive revenue through out-licensing opportunities, which also enhances contract research revenue and is creating new opportunities for BioStrand.

Overall, our strategy’s successful implementation has led to consistent revenue growth, lower operational costs, and strategic progress. This underscores our commitment to operational excellence and dedication to client support."

Business Highlights and Corporate Update

The strategy of IPA to provide a comprehensive range of services for antibody discovery and development is consistently yielding tangible outcomes. In the recent quarter, the Company recorded record revenues of $6.2 million and $18.1 million for the three- and nine-months ending January 31, 2024, respectively. These figures mark increases of 20.3% and 20.0% compared to the $5.2 million and $15.0 million revenues during the same periods in fiscal 2023. This is the third consecutive quarter in which we have experienced a year-over-year increase in revenue of approximately $1 million. Specifically, year-to-date IPA Canada’s laboratory revenue rose by 27%, while our Utrecht, Netherlands manufacturing facility experienced 32% growth in revenue, reinforcing our expansion strategy to meet customer needs.

BioStrand is generating fee-for-service revenue through its LENSai platform and is progressing in the development of commercial products to meet the needs of IPA’s client base of over 600 companies. During FY24 Q3, BioStrand introduced a new in silico service called epitope binning, which can be accessed by existing clients, as well as for standalone programs. This advancement is a significant step towards the upcoming rollout of the LENSai portal to all IPA clients, followed by the public launch of BioStrand’s comprehensive SaaS platform.

The Company’s decrease in R&D spending reflects the previous investments to develop the internal therapeutic Talem assets, which are now in the next phase of revenue generation, and now primarily represent BioStrand R&D. Efforts are underway to pursue out-licensing opportunities for those internally developed Talem assets. Simultaneously, the Company’s marketing partnerships are enhancing revenue in contract research and creating new opportunities in BioStrand.

The Company recently entered into a Sales Agreement for an "at the market" offering program with Clear Street, as sales agent, for the Company to offer and sell from time-to-time common shares.

Third Quarter FY24 Financial Results

Revenue: Total revenue was $6.2 million, compared to revenue of $5.2 million in fiscal year 2023 ("FY23") Q2. Project revenue generated $5.8 million, including $0.2 million of work completed by BioStrand, and compared to $4.8 million in FY23 Q3. Product sales and cryostorage revenue were $0.4 million, compared to $0.4 million in FY23 Q3.
Research & Development (R&D) Expenses: R&D expenses were $1 million, compared to $1.6 million in FY23 Q3, with the decrease reflecting reduced expenditures related to the build of the Company’s internal therapeutic Talem assets.
Sales & Marketing (S&M) Expenses: S&M expenses were $0.6 million, compared to $0.8 million in FY23 Q3.
General & Administrative (G&A) Expenses: G&A expenses were $4.2 million, compared to $4.1 million in FY23 Q3.
Net Loss: Net loss of $2.9 million, or $(0.11) per share on a basic and diluted basis, compared to a net loss of $4.7 million or $(0.19) on a basic and diluted basis in FY23 Q3.
Liquidity: Unrestricted cash totaled $6.2 million as of January 31, 2024, compared to $6 million as of October 31, 2023.
*Expressed in Canadian dollars, unless otherwise indicated.

Conference Call and Webcast Details

The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Thursday, March 14, 2024, at 10:30AM ET.

The conference call will be webcast live and available for replay via a link provided in the Events section of the Company’s IR pages at View Source

On March 14, 2024 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, reported that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent (TD) anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs) (Press release, Geron, MAR 14, 2024, View Source [SID1234641163]).

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"We are pleased with the Committee’s decision to recognize the positive clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS. There are few treatment options and significant unmet medical need remains for these patients, particularly among those with difficult-to-treat subtypes of this blood cancer," said Faye Feller, M.D., Geron’s Executive Vice President, Chief Medical Officer. "We believe that imetelstat has the potential to be an important new medicine for patients and look forward to continuing our collaboration with the FDA as they complete their review of our New Drug Application."

The ODAC reviewed the results from the IMerge Phase 3 clinical trial. The primary endpoint of red blood cell transfusion independence (RBC-TI) for at least eight consecutive weeks was significantly higher with imetelstat vs. placebo (p<0.001), with median RBC-TI duration approaching one year for imetelstat ≥8-week RBC-TI responders. In addition, 28% of imetelstat-treated patients compared to 3% on placebo obtained a statistically significant improvement in the key secondary endpoint of at least 24-week RBC-TI. For those patients achieving ≥24-week RBC-TI, the median duration was 80 weeks. Clinically meaningful RBC-TI was achieved across key MDS subgroups irrespective of ring sideroblast (RS) status, baseline transfusion burden and International Prognostic Scoring (IPSS) risk category. Additionally, a sustained increase in mean hemoglobin levels in imetelstat-treated patients was observed over time compared to placebo patients. Consistent with prior imetelstat clinical experience, the most common Grade 3-4 adverse events were thrombocytopenia (62%) and neutropenia (68%) that were generally manageable and of short duration.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2024 for Geron’s New Drug Application (NDA) for imetelstat for the treatment of TD anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes, who have failed to respond, or have lost response to, or are ineligible for ESAs. The ODAC provides the FDA with independent opinions and recommendations from outside medical experts, patients and caregivers, though the recommendations are not binding. Geron plans to commercially launch imetelstat in the U.S. upon potential FDA approval.

About IMerge Phase 3

The Phase 3 portion of the IMerge Phase 2/3 trial is a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat in patients with IPSS Low or Intermediate-1 risk (lower-risk) transfusion-dependent MDS who were relapsed after, refractory to, or ineligible for, erythropoiesis stimulating agent (ESA) treatment, had not received prior treatment with either a hypomethylating agent or lenalidomide and were non-del(5q). To be eligible for IMerge Phase 3, patients were required to be transfusion-dependent, defined as requiring at least four units of packed red blood cells (RBCs), over an eight-week period during the 16 weeks prior to entry into the trial. The primary efficacy endpoint of IMerge Phase 3 is the rate of red blood cell transfusion independence (RBC-TI) lasting at least eight weeks, defined as the proportion of patients without any RBC transfusion for at least eight consecutive weeks since entry to the trial (8-week RBC-TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week RBC-TI), the duration of RBC-TI and the rate of hematologic improvement erythroid (HI-E), which is defined under 2006 IWG criteria as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden. A total of 178 patients were enrolled in IMerge Phase 3 across North America, Europe, the Middle East and Asia.

About Imetelstat

Imetelstat is a novel, first-in-class investigational telomerase inhibitor exclusively owned by Geron and being developed by Geron in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies, resulting in malignant cell apoptosis. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion-dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to Janus kinase (JAK) inhibitor treatment. Imetelstat is currently not approved by any regulatory authority.