Geron Corporation (NASDAQ: GERN ) has been marketing Rytelo (imetelstat) for lower-risk myelodysplastic syndromes (LR-MDS) for a few quarters now, following US marketing approval in mid-2024. I rated GERN a hold in April 2024 as approval was somewhatScientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but don't constitute investment advice.Analyst’s ...

Core Insights - The article discusses the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2]. Group 1 - The service offers a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and live chat features for investors [2]. - A promotional offer is available for new subscribers, including a two-week free trial and a discounted annual subscription price of $399, which represents a 33.50% discount compared to the monthly rate [1]. - The author emphasizes that the analysis provided is independent and not influenced by any business relationships with the companies mentioned [3].

Core Viewpoint - Geron Corporation experienced a transformational year in 2024 with the FDA approval and commercial launch of Rytelo (imetelstat) for treating low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia, leading to a significant increase in its stock price [1][3]. Company Performance - Geron's shares increased by 61.1% over the past year, contrasting with a 15.6% decline in the industry [1]. - Rytelo generated sales of $28.2 million in its first full quarter post-launch, surpassing company expectations due to high unmet needs in lower-risk MDS [3]. - Loss estimates for Geron improved from 26 cents per share to 25 cents for 2024, and from 10 cents to 6 cents for 2025 over the past 60 days [8]. Regulatory Developments - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended Rytelo's approval in the EU, with a decision from the European Commission expected in the first half of 2025 [4]. Research and Development - Geron is conducting a phase III IMpactMF study for Rytelo in patients with relapsed/refractory myelofibrosis (MF), with early findings from the IMproveMF study indicating potential tolerability of imetelstat and ruxolitinib as a combination therapy for MF [5]. Financial Position - Geron secured $375 million in funding through synthetic royalty and debt financing, enhancing its cash position to support the commercial launch of Rytelo in the U.S. and potential EU launch, as well as ongoing studies in MF [6].

Performance and Growth - Geron (NASDAQ: GERN) has significantly outperformed expectations in the first full quarter of launch, with substantial investor interest driving financial inflows [1] - The company's performance metrics show remarkable growth percentages, including 1212%, 1200%, and 1000%, indicating a strong upward trajectory [2][4] Investor Tools and Resources - The Total Pharma Tracker service provides a comprehensive set of tools for DIY investors, including a software feature that allows users to enter any ticker and access extensive curated research material [2][3] - In-house experts offer hands-on support by utilizing these tools to identify the best investible stocks, complete with buy/sell strategies and alerts [3] Historical Performance - Historical data from 2017 to 2023 shows a cumulative performance with notable fluctuations, including a -6% in 2018 and a -19% in 2022, but overall positive growth trends [2][4]

Financial Performance - Total revenues for the nine months ended September 30, 2024, were $29,457,000, compared to $214,000 for the same period in 2023, representing a significant increase[6] - Product revenue for the nine months ended September 30, 2024, was $28,989,000, with royalties contributing $468,000[6] - The net loss for the nine months ended September 30, 2024, was $149,220,000, compared to a net loss of $132,154,000 for the same period in 2023[6] - Basic and diluted net loss per share for the nine months ended September 30, 2024, was $(0.23), consistent with the same period in 2023[6] - Comprehensive loss for the nine months ended September 30, 2024, was $148,387,000, compared to $132,885,000 for the same period in 2023, indicating an increase in losses[8] Assets and Liabilities - Total current assets increased to $398,057,000 as of September 30, 2024, up from $341,348,000 at the end of 2023, reflecting a growth of approximately 16.6%[4] - Total current liabilities rose to $137,933,000 as of September 30, 2024, compared to $108,070,000 at the end of 2023, indicating an increase of about 27.6%[4] - Cash and cash equivalents decreased to $60,344,000 as of September 30, 2024, from $70,023,000 at the end of 2023, a decline of approximately 9.5%[4] - The total stockholders' equity increased to $292,284,000 as of September 30, 2024, up from $247,949,000 at the end of 2023, representing a growth of about 17.8%[4] Expenses - Research and development expenses for the nine months ended September 30, 2024, totaled $80,305,000, down from $92,135,000 in the prior year, a decrease of approximately 12.9%[6] - Selling, general, and administrative expenses for the nine months ended September 30, 2024, were $102,361,000, compared to $47,734,000 for the same period in 2023, reflecting an increase of about 114.5%[6] - Stock-based compensation for employees and directors increased to $24,392 from $14,110, representing an increase of approximately 72.5%[12] Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2024, was $174,673, compared to $126,805 for the same period in 2023, indicating a significant increase of approximately 37.7%[12] - Cash, cash equivalents, and restricted cash at the end of the period were $62,198, up from $31,245 at the end of the previous period, reflecting an increase of approximately 99.5%[12] - The company reported a net cash used in investing activities of $2,493 for the nine months ended September 30, 2024, compared to $227,891 in the previous period, reflecting a significant decrease of approximately 98.9%[12] Stock and Equity - As of March 31, 2024, Geron Corporation had 591,163,808 common shares outstanding, reflecting an increase from 508,731,846 shares as of March 31, 2023[10] - The total additional paid-in capital as of June 30, 2024, was $2,027,173,000, up from $1,799,841,000 as of June 30, 2023[10] - The company issued 41,999,998 shares of common stock in connection with the exercise of warrants, raising $141,000,000[9] Inventory and Product Revenue - Inventory decreased by $20,283 during the nine months ended September 30, 2024, with no prior period data available for comparison[12] - The company began capitalizing inventory related to RYTELO in the quarter ended June 30, 2024, following its approval on June 6, 2024[20] - As of September 30, 2024, net product revenue from U.S. sales of RYTELO was $28,209,000, with gross product revenue of $32,657,000, resulting in total gross-to-net adjustments of $4,448,000[57] Debt and Financing - The outstanding principal amount under the Hercules Loan Agreement was $80.0 million as of September 30, 2024, with a net carrying value of $83.8 million, which includes accrued end of term charges[77] - The interest rate on the Hercules Loan Agreement was set at 12.5% as of September 30, 2024, with an interest-only period extended through December 31, 2024[76] - Future minimum payments under the Hercules Loan Agreement total $92.50 million, with $2.55 million due in the remainder of 2024 and $89.95 million in 2025[79] Legal and Compliance - The company has not established any reserve for potential liabilities related to future lawsuits, which could materially impact its financial statements[80] - Geron Corporation is currently not involved in any material pending legal proceedings, which may help in focusing resources on business activities[80] Marketable Securities - The company has not recorded any allowances for credit losses on available-for-sale securities for the three and nine months ended September 30, 2024, indicating no unrealized losses attributable to credit factors[64] - The fair value of marketable securities as of September 30, 2024, was $316,742,000, with gross unrealized losses of $1,010,000[60] Agreements and Commitments - As of September 30, 2024, Geron has noncancelable commercial purchase commitments totaling approximately $62.4 million related to contract manufacturing agreements for RYTELO[84] - Geron entered into a revenue participation right purchase agreement with Royalty Pharma, receiving an upfront payment of $125.0 million in exchange for tiered revenue interest payments on RYTELO sales[97]

Live Chat on The Biotech Forum has been dominated by discussion of lucrative buy-write or covered call opportunities on selected biotech stocks over the past several months. To see what I and the other season biotech investors are targeting as trading ideas real-time, just join our community at The Biotech Forum by clicking HERE .It has been a year and a half since my last look at an oncology name called Geron Corporation (NASDAQ: GERN ) . To understate things, it has been a busy and potentially transformat ...

Financial Data and Key Metrics Changes - Geron Corporation reported $28.2 million in net product revenue from RYTELO for Q3 2024, significantly higher than the $164,000 reported in Q3 2023, indicating a strong commercial launch performance [35] - Total net revenue for Q3 2024 was $28.3 million, compared to $214,000 for the same period in 2023, reflecting the successful introduction of RYTELO [35] - Total operating expenses for Q3 2024 were $56.5 million, up from $47.8 million in Q3 2023, primarily due to increased commercial launch expenses [36] Business Line Data and Key Metrics Changes - RYTELO's initial quarter of product revenue demonstrates the company's effective execution as a commercial entity, with demand coming from 388 ordering centers, representing about 45% of targeted accounts [21] - The company achieved a strong IP position with FDA's orphan drug exclusivity for lower-risk MDS until June 2031, providing exclusivity in the U.S. through August 2037 [9] Market Data and Key Metrics Changes - In the U.S., payers covering approximately 70% of covered lives have implemented medical coverage policies for RYTELO consistent with its FDA label [23] - The company anticipates the CHMP review of RYTELO's marketing authorization application in Europe could be completed by late 2024 or early 2025, with potential EU approval in the first half of 2025 [11] Company Strategy and Development Direction - The primary focus is on maximizing RYTELO's market opportunity in the U.S. and preparing for its potential launch in select EU markets starting in 2026 [10][30] - The company aims to optimize patient access and revenues for imetelstat in prioritized EU countries, leveraging experienced third parties for market access and distribution [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term commercial value of RYTELO, emphasizing the high unmet need in lower-risk MDS and the product's compelling value proposition [8] - The company is optimistic about the trajectory of RYTELO's sales and expects continued demand and growth momentum into 2025 [28] Other Important Information - Geron completed a synthetic royalty transaction and a debt financing transaction, generating $250 million in gross proceeds, which will provide critical flexibility for growth and investment [13][14] - The company expects total operating expenses for fiscal year 2024 to be in the range of approximately $260 million to $270 million [39] Q&A Session Summary Question: Growth cadence expectations for RYTELO - Management expects steady consistent growth across all patient segments, particularly in second-line treatments, but is not providing specific guidance at this time [67] Question: Clarification on royalty percentage rates - The royalty agreement is competitive, with a cap at 1.65x the initial payment, and management is confident in reaching this cap based on internal revenue projections [70][72] Question: Utilization split between academic and community prescribers - The current split is approximately 65% community prescribers and 35% academic, with expectations for continued growth in both segments [91] Question: Initial real-world experience with RYTELO - Early feedback indicates that real-world performance aligns with clinical trial data, and physicians are comfortable managing cytopenias associated with RYTELO [86][88] Question: Plans for expanding sales in the U.S. - The additional capital will support U.S. commercialization efforts and preparation for a potential EU launch, while maintaining a cash buffer of over 12 months [100]

Geron (GERN) came out with a quarterly loss of $0.04 per share versus the Zacks Consensus Estimate of a loss of $0.09. This compares to loss of $0.08 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 55.56%. A quarter ago, it was expected that this drugmaker would post a loss of $0.11 per share when it actually produced a loss of $0.10, delivering a surprise of 9.09%.Over the last four quarters, the company has surpassed consens ...

RYTELO™ (imetelstat) is FDA approved for the treatment of low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemiaTransaction increases Royalty Pharma’s synthetic royalty funding to $925 million in 2024, highlighting the significant opportunity for this attractive funding modality NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it will acquire a synthetic royalty on U.S. sales of Geron Corporation’s (Nasdaq: GERN) RYTELO for $ ...

Exhibit 99.1 geror Geron Corporation Reports Third Quarter 2024 Financial Results and Recent Business Highlights Achieved $28.2 million in RYTELO™ (imetelstat) net product revenue in first full quarter of sales Received $250 million in gross proceeds from synthetic royalty and debt financings with Royalty Pharma and Pharmakon Advisors, with access to an additional $125 million in debt FOSTER CITY, Calif., November 7, 2024 -- Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aimi ...