Geron (NASDAQ: GERN ) managed to get imetelstat (branded Rytelo) approved despite giving investors quite a scare after the FDA's negative comments before the advisory committee meeting. That was in March. The approval came in June - for "low- to intermediate-1 risk myelodysplastic syndromes (MDS) with About the TPT service Thanks for reading. At the Total Pharma Tracker, we offer the following :- Projected American Shared Revenue Backlog $250 $213 $200 ing Balance (million $150 $106 $104 $101 $100 $50 $0 12 ...

Geron (GERN) came out with a quarterly loss of $0.10 per share versus the Zacks Consensus Estimate of a loss of $0.11. This compares to loss of $0.09 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 9.09%. A quarter ago, it was expected that this drugmaker would post a loss of $0.10 per share when it actually produced a loss of $0.09, delivering a surprise of 10%. Over the last four quarters, the company has surpassed consensu ...

Geron Corporation (GERN) obtained FDA approval for pipeline candidate imetelstat for the treatment of adult patients with low to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks. Shares of the company rose 18% on Jun 7, on the news. The FDA approved imetelstat, a telomerase inhibitor, under the brand name Rytelo for the above-mentioned indication. Current treatment options for those failing ESA are limited to s ...

Core Viewpoint - Geron Corp's stock surged approximately 32% following the FDA approval of its first drug, Rytelo, for treating low- to intermediate-risk myelodysplastic syndromes (MDS) [1][3][9] Group 1: Product Approval and Market Potential - Rytelo is approved for patients with MDS, a condition affecting about 60,000 Americans, with around 16,000 new cases annually [3] - Analysts predict peak sales for Rytelo could exceed $1 billion due to its benefits in reducing blood transfusion dependence [4] - Rytelo is the first cancer therapy that inhibits telomerase activity, potentially allowing Geron to capture a significant market share [10] Group 2: Clinical Efficacy and Safety Concerns - In the pivotal IMerge trial, 28% of patients treated with Rytelo achieved transfusion independence for 24 weeks or longer, compared to only 3% in the placebo group [11] - However, 72% of patients experienced a significant loss of immune cells, necessitating intervention, which raises safety concerns [5] Group 3: Market Challenges and Sales Strategy - The complexity of Rytelo's indication may lead to challenges in securing insurance reimbursement, as it targets a niche patient population [6][14] - Finding physicians who treat MDS patients with anemia unresponsive to existing treatments will be a significant hurdle for Geron's sales team [15] - Despite the stock's recent rise, expectations for Rytelo's sales may not be fully reflected in Geron's market cap of approximately $2.8 billion [12]

Core Insights - The FDA approval of RYTELO™ (imetelstat) has significantly boosted Geron Corporation's stock price and investor interest, marking a pivotal moment for the company in the healthcare and biotech sectors [1][6][13] Geron's Scientific and Financial Foundations - Imetelstat is a telomerase inhibitor that targets cancer cells by halting the replenishment of telomeres, leading to selective apoptosis in malignant cells [2] - Geron's Q1 2024 earnings report indicated a net loss of $55.4 million, or $0.09 per share, but the company maintains a strong financial position with over $465 million in cash and marketable securities as of March 31, 2024 [5][11] Market Impact of FDA Approval - The approval of RYTELO™ was based on positive results from the IMerge Phase 3 clinical trial, which demonstrated significant transfusion independence rates and a median duration of over one year for patients achieving independence [4][16] - Geron's stock has reached a new 52-week high following the FDA approval, reflecting a positive market outlook and strong analyst support for the stock [6][19] Strategic Outlook and Growth Drivers - Geron is conducting a pivotal Phase 3 trial, IMpactMF, to explore imetelstat's efficacy in treating myelofibrosis, which could expand RYTELO™'s market potential [7] - The company is focused on building its commercial infrastructure to ensure the successful launch and adoption of RYTELO™, including developing a dedicated sales force and marketing strategy [20]

Core Viewpoint - Geron Corporation (NASDAQ: GERN) received FDA approval for its drug RYTELO, leading to a significant increase in its stock price [1][3]. Company Summary - RYTELO is designed for adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have transfusion-dependent anemia, a condition that often results in anemia, fatigue, and reduced survival [4]. - The clinical benefits of RYTELO include sustained and durable transfusion independence and increases in hemoglobin levels, all while maintaining a manageable safety profile [5]. Stock Performance - Following the FDA approval, GERN stock rose by 18.4% on Friday morning and has increased by 114.9% since the beginning of the year [3]. - Heavy trading activity was noted, with over 54 million shares traded, significantly surpassing the average daily trading volume of approximately 12.9 million shares [5].

Company Overview - Geron Corporation is a late-stage biopharmaceutical company focused on developing therapies for hematological diseases, particularly through its product Imetelstat, a telomerase inhibitor [5][9] - The company's research is based on Nobel Prize-winning discoveries related to telomeres and telomerase, which play a critical role in cell division and aging [5][6] - Imetelstat is the first telomerase inhibitor to advance in clinical development, with potential commercialization in the coming months [9] Product Development and Clinical Trials - Imetelstat has shown promising results in the IMerge Phase 3 clinical trial, demonstrating a 60% transfusion reduction rate and a 40% response rate compared to 15% for placebo [14][16] - The drug targets low-risk Myelodysplastic Syndrome (MDS) and has shown broad efficacy across various MDS subtypes [15][16] - Geron is also conducting a Phase 3 trial called IMpactMF for intermediate or high-risk Myelofibrosis (MF), with results expected in 2025 and 2026 [18] Regulatory and Market Potential - The FDA accepted Geron's New Drug Application (NDA) for Imetelstat in August 2023, with a Prescription Drug User Fee Act (PDUFA) date set for June 16, 2024 [10] - The European Medicines Agency (EMA) is expected to review the Marketing Authorization Application (MAA) in 2025, with a potential launch in the EU the same year [11] - The total addressable market (TAM) for Imetelstat is estimated at $7 billion by 2031, with Geron potentially capturing 20% of this market [3][21] Financial Projections - Geron's revenue is projected to grow from $175 million in 2025 to $1.4 billion in 2031, assuming a 20% market share [26] - The company is expected to achieve positive net profit starting in 2028, with an estimated EPS of $0.13, growing to $0.39 by 2031 [28][29] - The compound annual growth rate (CAGR) for EPS from 2028 to 2031 is projected at 32.5% [29] Competitive Landscape - Imetelstat's mechanism of action, which focuses on transfusion independence, differentiates it from current standard treatments like erythropoiesis-stimulating agents (ESAs) and blood transfusions [19][20] - There are currently no similar treatments on the market that offer transfusion independence, giving Imetelstat a unique competitive advantage [20] Hedge Fund and Insider Activity - Hedge fund interest in Geron has increased significantly, with 29 funds holding positions in Q1 2024, a 50% increase compared to the 2023 average [33][34] - The company has approximately $465 million in cash and marketable securities, which is expected to fund operations until Q1 2026 [35][36] Intellectual Property and Future Prospects - Geron holds patents for Imetelstat in the US and EU, providing protection until 2033 for MDS and MF treatments [30] - The company's future growth is contingent on the successful approval and commercialization of Imetelstat, with potential for significant returns if the product gains market traction [32][42]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File Number: 000-20859 GERON CORPORATION (Exact name of registrant as specified in its charter) DELAWARE 75-2287752 (State or other jurisdictio ...

Financial Data and Key Metrics Changes - As of March 31, 2024, the company had approximately $465 million in cash and marketable securities, including net proceeds of approximately $141 million from a public offering [5][80] - Total operating expenses for Q1 2024 were $56.4 million, compared to $40.1 million for the same period in 2023, reflecting increased investment in commercial activities [58] - General and administrative expenses for Q1 2024 were $27.1 million, up from $12.9 million in Q1 2023, primarily due to commercial preparatory activities [31] Business Line Data and Key Metrics Changes - The company is in the final stages of commercial readiness for Imetelstat, with a sales force being brought on in April 2024 [9][12] - The clinical trial for Imetelstat in lower-risk MDS is ongoing, with the Data Monitoring Committee recommending the trial continue based on unblinded data [10][50] Market Data and Key Metrics Changes - Market research indicates that Imetelstat is highly differentiated in the transfusion-dependent low-risk MDS market, with significant dissatisfaction among medical and payer stakeholders regarding current treatment options [13][20] - The company expects meaningful uptake of Imetelstat among ESA ineligible patients, particularly those who are RS negative [19][20] Company Strategy and Development Direction - The company is focused on executing a successful U.S. launch of Imetelstat upon potential FDA approval, with a PDUFA date set for June 16, 2024 [36][60] - The company plans to engage with NCCN to update treatment guidelines for Imetelstat following FDA approval [18][66] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's readiness for the U.S. launch of Imetelstat, highlighting the positive ODAC outcome and the need for new treatment options in the low-risk MDS space [5][60] - The company acknowledges the challenges in enrollment for the myelofibrosis trial, attributing it to factors such as competition from newly approved JAK inhibitors [69][70] Other Important Information - The company has established commercial supply arrangements and finalized its specialty distribution network in preparation for the launch [40] - The company anticipates that existing cash and projected revenues will support operations into the second quarter of 2026 [59] Q&A Session Summary Question: Can you comment on the myelofibrosis trial timeline? - Management noted that both enrollment and death rates are lower than anticipated, impacting timelines by approximately six months [62][63] Question: Have you initiated labeling discussions with the FDA for Imetelstat? - The company confirmed that it has received comments from the FDA on the draft label and is looking forward to continuing discussions as the PDUFA date approaches [65] Question: How quickly could NCCN guidelines be updated following approval? - The company expects to submit the necessary documentation to NCCN upon approval, with updates to guidelines typically occurring within two to three months [66] Question: What challenges are impacting enrollment in the myelofibrosis trial? - Management indicated that the approval of additional JAK inhibitors and resource issues at trial sites have contributed to slower enrollment rates [69][70] Question: What are the major steps remaining for launch preparation? - The company is focused on completing onboarding of the commercial team and ensuring full commercial supply and distribution networks are in place [72][88]

Geron (GERN) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.10. This compares to loss of $0.07 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 10%. A quarter ago, it was expected that this drugmaker would post a loss of $0.10 per share when it actually produced a loss of $0.09, delivering a surprise of 10%.Over the last four quarters, the company has surpassed consensus EP ...