EXHIBIT 99.1
Press Release Dated November 5, 2015
Geron Corporation Reports Third Quarter 2015 Financial Results
MENLO PARK, Calif., November 5, 2015 --Geron Corporation (Nasdaq: GERN) today reportedfinancial results forthe third quarter endedSeptember 30,2015.
For the third quarter of2015, the company reported net income of$27.2 million,or $0.17 pershare, compared toa net lossof $9.5 million,or $(0.06) pershare, for thecomparable2014 period.Net income for the first ninemonths of 2015 was $8.5million, or $0.05 per share, compared toanet loss of $26.7 million, or $(0.18) per share,for the comparable 2014period. The company endedthe third quarter of 2015with $151.8 million in cash andinvestments.
Revenuesfor the third quarter of 2015 were $35.4million compared to $160,000for the comparable 2014 period.Revenuesfor the first nine months of2015 were $36.2 million compared to $975,000 for the comparable 2014period. Revenues for thethree and nine month periods ending September 30, 2015 included the full recognition ofthe $35.0million upfrontpayment fromJanssen Biotech, Inc. (Janssen)as collaboration revenue upon thecompany’stransfer of the imetelstat license rights and completion of technology transfer-related activities outlined under the imetelstat collaboration agreement with Janssen. The upfrontcash payment was receivedinDecember 2014 and recorded as deferred revenue atthat time.
Total operating expensesfor the thirdquarter of 2015 were $8.3million compared to $10.1 million for thecomparable 2014 period. Research anddevelopmentexpenses for the third quarter of 2015 were $4.1 million compared to $6.0 millionfor the comparable 2014 period. General and administrative expenses for the third quarter of 2015 were $4.3 million compared to $4.1million for the comparable2014 period.
Total operating expensesfor the firstnine months of2015 were $28.1 million compared to $28.3 million forthe comparable 2014 period. Research anddevelopmentexpenses for the first ninemonths of 2015 were $13.8millioncompared to $16.4 million for the comparable 2014period. General and administrative expenses for the first nine months of 2015 were $12.9 million compared to $11.9 million for the comparable2014 period.Year-to-dateoperatingexpenses for2015 also included restructuring charges of $1.3 million inconnectionwith the company’sorganizational resizing announced inMarch 2015.
The decrease in researchand development expensesfor the three and nine month periods ending September 30,2015, compared to the same periods in2014, was primarily the netresult of lower costs for themanufacturing ofimetelstat and reducedpersonnel-related costs resulting from theorganizationalresizing, partially offset byincreasedcosts for the development ofimetelstat forhematologic myeloid malignancies in collaboration with Janssen. The company expects research and development expenses to increaseduring the remainder of theyearas the development of imetelstat continues in collaboration with Janssen. The increase in general andadministrative expenses for the threeand nine month periods ending September30, 2015, compared to thesameperiods in 2014, was primarily the result of higher non-cash stock-based compensationexpenseand increasedlegal costs associated with the company’s patent portfolio.
Interest and other income for the thirdquarter of 2015 amountedto $187,000 compared to $91,000 for the comparable 2014 period. Interest andother incomefor the first nine months of2015 was $481,000 compared to$273,000for the comparable 2014 period. The increase in interest and other income for the three and ninemonth periods ending September 30, 2015, compared to thesame periodsin 2014, primarily reflectshigher yields on the company’sinvestment portfolio. The company has not incurred anyimpairmentcharges on its investmentportfolio.
Recent Company Events
| ● | Two papers were published in the September 3, 2015 issue of The New England Journal of Medicine (NEJM) with results from two clinical studies in which imetelstat was shown to have disease-modifying activity thought to be associated with the selective inhibition of the malignant progenitor cell clones responsible for the underlying disease in two hematologic myeloid malignancies, essential thrombocythemia (ET) and myelofibrosis (MF). The papers are available online at www.NEJM.org.
|
| ● | In September 2015, the first patient was dosed in the IMbark™ study, a Phase 2 clinical trial to evaluate the activity of two dose levels of imetelstat in patients with DIPSS intermediate-2 or high-risk myelofibrosis who have relapsed after or are refractory to a JAK inhibitor. Multiple medical centers across North America, Europe and Asia are planned to participate in this clinical trial. For more information about the IMbark™ study being conducted by Janssen, please visit http://clinicaltrials.gov/ct2/show/NCT02426086.
|
| ● | Three abstracts describing clinical and non-clinical data on imetelstat were accepted for presentation at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition to be held in Orlando, Florida from December 5-8, 2015. The abstracts were published on November 5, 2015 on the ASH website at www.hematology.org. |
Conference Call
At 4:30 p.m. EST on November 5, 2015, Geron’s management will host a conference call to discuss the company’sthird quarter financial results and recent events.
Participants can access the conference call live via telephone by dialing 888-288-0246 (U.S.); 440-996-5682(international). The passcode is 69664109. A live audio-only webcast is also available at http://edge.media-server.com/m/p/8h3xqwwa/lan/en. The audio webcast of the conference call will be available for replayapproximately one hour following the live broadcast through December 5, 2015.
About Geron
Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-classtelomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visitwww.geron.com.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding: (i) Geron’s potential receipt of development, regulatory and sales milestones, as well as royalties on potential future sales of imetelstat commercialized under the collaboration agreement with Janssen; (ii) timing of planned and potential clinical trials of imetelstat to be conducted under the collaboration agreement with Janssen, including the Phase 2 study in myelofibrosis and the Phase 2 study in myelodysplastic syndromes, and other potential activities under the collaboration agreement with Janssen; (iii) the safety and efficacy of imetelstat; (iv) Geron’s desire to diversify its product portfolio; (v) financial projections and expectations; (vi) intellectual property protection; and (vii) other statements that are not historical facts, constitute forward-looking statements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties,include, without limitation, risks and uncertainties related to: (i) the uncertain, time-consuming and expensive product development and regulatory process, including whether Geron and Janssen will succeed in overcoming all of the clinical safety and efficacy, technical, scientific, manufacturing and regulatory challenges in the development and commercialization of imetelstat; (ii) the fact that Geron may not receive any milestone, royalty or other payments from Janssen because Janssen may terminate the collaboration agreement for any reason; (iii) the ability of Geron and Janssen to protect and maintain intellectual property rights for imetelstat; (iv) Geron’s dependence on Janssen for the development, regulatory approval, manufacture and commercialization of imetelstat, including the risks that if Janssen were to breach or terminate the collaboration agreement or otherwise fail to successfully develop and commercialize imetelstat and in a timely manner, or at all, Geron would not obtain the anticipated financial and other benefits of the collaboration agreement with Janssen and the clinical development or commercialization of imetelstat could be delayed or terminated; (v) whether imetelstat is safe and efficacious, and whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (vi) whether imetelstat can be applied to any or to multiple hematologic malignancies; (vii) unanticipated expenses or charges resulting from the organizational resizing; (viii) whether Geron will obtain additional products or engage in any strategic transaction; and (ix) the need for future capital. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors,” including Geron’s quarterly report on Form 10-Q for the quarter ended June 30, 2015. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
CONTACT:
Anna Krassowska, Ph.D.
Investor and Media Relations
650-473-7765
investor@geron.com
media@geron.com
Financial table follows.
GERON CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
| | Three Months Ended | | Nine Months Ended |
| | September 30, | | September 30, |
| (In thousands, except share and per share data) | | 2015 | | 2014 | | 2015 | | 2014 |
| Revenues: | | | | | | | | | | | | | | | | |
| Collaboration revenue | | $ | 35,000 | | | $ | — | | | $ | 35,000 | | | $ | — | |
| License fees and royalties | | | 363 | | | | 160 | | | | 1,151 | | | | 975 | |
| Total revenues | | | 35,363 | | | | 160 | | | | 36,151 | | | | 975 | |
| | | | | | | | | | | | | | | | | |
| Operating expenses: | | | | | | | | | | | | | | | | |
| Research and development | | | 4,050 | | | | 5,994 | | | | 13,849 | | | | 16,356 | |
| Restructuring charges | | | (41 | ) | | | — | | | | 1,306 | | | | — | |
| General and administrative | | | 4,334 | | | | 4,073 | | | | 12,911 | | | | 11,920 | |
| Total operating expenses | | | 8,343 | | | | 10,067 | | | | 28,066 | | | | 28,276 | |
| Income (loss) from operations | | | 27,020 | | | | (9,907 | ) | | | 8,085 | | | | (27,301 | ) |
| | | | | | | | | | | | | | | | | |
| Unrealized gain on derivatives | | | — | | | | 289 | | | | 16 | | | | 366 | |
| Interest and other income | | | 187 | | | | 91 | | | | 481 | | | | 273 | |
| Interest and other expense | | | (22 | ) | | | (22 | ) | | | (68 | ) | | | (61 | ) |
| Net income (loss) | | $ | 27,185 | | | $ | (9,549 | ) | | $ | 8,514 | | | $ | (26,723 | ) |
| | | | | | | | | | | | | | | | | |
| Net income (loss) per share: | | | | | | | | | | | | | | | | |
| Basic | | $ | 0.17 | | | $ | (0.06 | ) | | $ | 0.05 | | | $ | (0.18 | ) |
| Diluted | | $ | 0.17 | | | $ | (0.06 | ) | | $ | 0.05 | | | $ | (0.18 | ) |
| | | | | | | | | | | | | | | | | |
| Shares used in computing net income (loss) per share: | | | | | | | | | | | | | | | | |
| Basic | | | 158,151,747 | | | | 156,843,989 | | | | 157,922,075 | | | | 152,338,668 | |
| Diluted | | | 162,669,681 | | | | 156,843,989 | | | | 162,448,893 | | | | 152,338,668 | |
GERON CORPORATION
CONDENSED BALANCE SHEETS
| September 30, | | December 31, |
| (In thousands) | 2015 | | 2014 |
| (Unaudited) | | (Note 1) |
| Current assets: | | | | | |
| Cash, cash equivalents and restricted cash | $ | 17,089 | | $ | 43,062 |
| Current marketable securities | | 102,857 | | | 108,645 |
| Other current assets | | 2,069 | | | 1,699 |
| Total current assets | | 122,015 | | | 153,406 |
| | | | | | |
| Noncurrent marketable securities | | 31,821 | | | 18,932 |
| Property and equipment, net | | 183 | | | 173 |
| $ | 154,019 | | $ | 172,511 |
| | | | | | |
| Current liabilities(Note 2) | $ | 6,125 | | $ | 41,799 |
| Stockholders’ equity | | 147,894 | | | 130,712 |
| $ | 154,019 | | $ | 172,511 |
| Note 1: | Derived from audited financial statements included in the company’s Annual Report on Form 10-K for the year ended December 31, 2014. |
| |
| Note 2: | Current liabilities balance as of December 31, 2014 includes $35 million in deferred revenue resulting from the upfront cash payment received under the collaboration with Janssen in December 2014. The company fullyrecognized the $35 million upfront payment as collaboration revenue upon the company’s transfer of theimetelstat license rights and completion of technology transfer-related activities in the third quarter of 2015. |
###
