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Geron(GERN) - 2024 Q1 - Quarterly Report
2024-05-02 20:05
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 ...
Geron(GERN) - 2024 Q1 - Earnings Call Transcript
2024-05-02 16:32
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) Reports Q1 Loss, Tops Revenue Estimates
Zacks Investment Research· 2024-05-02 13:21
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 ...
Geron(GERN) - 2024 Q1 - Quarterly Results
2024-05-02 11:09
Exhibit 99.1 Geron Corporation Reports First Quarter 2024 Financial Results and Business Highlights June 16, 2024 PDUFA date for imetelstat NDA for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS FOSTER CITY, Calif., May 2, 2024 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported financial results and business highl ...
The Top 3 Penny Stocks to Buy in April 2024
InvestorPlace· 2024-05-02 10:46
Investing in certain penny stocks to buy during a volatile economy can present unique opportunities for investors. Typically priced below $5 per share (at a discount), these stocks often exhibit heightened volatility, translating into significant short-term gains for those adept at timing the market. Furthermore, penny stocks may offer diversification benefits, as they tend to be less correlated with broader market movements, enabling investors to capitalize on niche market trends and emerging sectors unaff ...
Geron Stock Doubles After Imetelstat Receives FDA Panel Approval
MarketBeat· 2024-03-20 10:10
Key PointsGeron is a biotechnology company specializing in cell therapies to treat various blood cancers.The FDA Advisory Committee voted 12 to 2 in favor of approving Imetelstat, Geron's lead product for treating transfusion-dependent anemia among myelodysplastic syndrome (MDS) patients.The FDA has an action date of June 16, 2023, to make a final decision.5 stocks we like better than GeronGeron Inc. NASDAQ: GERN is a clinical-stage biotech in the medical sector focused on developing cell therapies to treat ...
Geron Corporation Announces Pricing of $150 Million Underwritten Offering of Common Stock and Pre-Funded Warrants
Businesswire· 2024-03-19 13:07
FOSTER CITY, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced the pricing of an underwritten offering consisting of 41,999,998 shares of its common stock at a price of $3.00 per share and pre-funded warrants to purchase 8,002,668 shares of its common stock. The pre-funded warrants are being sold at a price of $2.999 per pre-funded warrant. All of the securities in the offering are to be sold by Geron. The offering included participat ...
Choosing the Right Penny Stocks, 3 Hot Tips
PennyStocks· 2024-03-18 09:21
3 Hot Tips for Choosing the Right Penny Stocks to BuyNavigating the realm of penny stocks can unlock pathways to significant financial growth, presenting a landscape ripe with opportunities for those astute enough to capitalize on them. Central to achieving success in this area is the diligent identification of sectors poised for exponential growth. By aligning investments with industries on the cusp of breakthroughs or benefiting from economic shifts, investors can position themselves to capture the upward ...
Can Geron Corporation maintain momentum following FDA's backing?
Invezz· 2024-03-17 12:31
Friday saw an unprecedented surge in the stock of Geron Corporation (NASDAQ:GERN), with shares ending the day up a staggering 92%. This surge, marking a historic milestone for the company, was ignited by a momentous announcement earlier in the day.An FDA advisory committee’s resounding endorsement of Geron’s lead asset, Imetelstat, sent shockwaves through the market, propelling the stock to new heights. Imetelstat, positioned as a potential breakthrough in the treatment landscape, received a commendation fo ...
Why Is Geron (GERN) Stock Up 94% Today?
InvestorPlace· 2024-03-15 14:47
Geron (NASDAQ:GERN) stock is rocketing higher on Friday following news that advisors to the Food and Drug Administration (FDA) are backing its blood disorder drug, imetelstat.According to a press release from late-stage clinical biopharmaceutical company, the Oncologic Drugs Advisory Committee (ODAC) voted 12 to two in favor of imetelstat. The ODAC specifically noted that the benefits of the drug outweigh the risks.The ODAC reached its conclusion on imetelstat after reviewing data from a Phase 3 clinical tr ...