On August 1, 2019 Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported it will release second quarter and first half 2019 financial results after the market closes on Thursday, August 8th, 2019 (Press release, Intrexon, AUG 1, 2019, View Source [SID1234537985]). The Company will host a conference call that day at 5:30 PM ET to discuss the results and provide a general business update.

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The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1‑412-317-6061 (International) and providing the number 4443860 to join the Intrexon Corporation Call. Participants may also access the live webcast through Intrexon’s website in the Investors section at View Source

On August 1, 2019 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported financial results for the second quarter ended June 30, 2019 (Press release, Corvus Pharmaceuticals, AUG 1, 2019, View Source [SID1234538009]).

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"Corvus continues to be a leader in the field of drug development targeting the adenosine pathway, with complementary lead programs – ciforadenant and CPI-006 – that have shown promising activity in a range of solid tumors. We also have a third program in the clinic, CPI-818, which is an ITK inhibitor for the treatment of patients with advanced T-cell lymphomas. Together, I believe these three programs position Corvus as a leader in the development of second-generation immuno-oncology agents," said Richard A. Miller, M.D., president and chief executive officer of Corvus. "At ASCO (Free ASCO Whitepaper) this year, initial clinical data on CPI-006 was presented in an oral session and subsequently selected for the Highlight of the Day session. The data demonstrated activity as a monotherapy and in combination with ciforadenant and that CPI-006 represents a potential novel immuno-oncology approach via activation of immune cells and the inhibition of adenosine production. We plan to continue presenting new data on our programs at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting and other meetings over the remainder of the year."

Recent Achievements
Ciforadenant (CPI-444): A2A Receptor Antagonist of Adenosine

Continued enrollment of patients with renal cell cancer (RCC) in an amended Phase 1b/2 clinical trial evaluating ciforadenant in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. The RCC patients in the trial have failed treatments with anti-PD-(L)1 antibodies and tyrosine kinase inhibitors. This trial is also evaluating the use of a novel gene expression biomarker known as the Adenosine Signature, that may have the potential to predict patients most likely to respond to therapy.
Amending our ongoing Phase 1b/2 study to include an arm evaluating ciforadenant in combination with Tecentriq in patients with prostate cancer. This arm will also evaluate the use of the Adenosine Signature.
Continued follow-up in a Phase 1b/2 trial of ciforadenant and Tecentriq being conducted by Genentech as part of their MORPHEUS platform. The study is evaluating this combination in patients who have failed no more than two prior regimens.
CPI-006: Immunomodulatory Anti-CD73 Antibody

Continued enrollment of up to 350 patients with advanced cancer in a Phase 1/1b clinical trial evaluating CPI-006 as a single agent and in combination with either ciforadenant or pembrolizumab. The trial is currently enrolling patients in the dose escalation phase for CPI-006 administered as a monotherapy and in combination with ciforadenant.
Initial clinical data covering 20 patients with advanced, refractory cancer from the Phase 1/1b trial was delivered in an oral presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2019. The initial data showed a trend toward longer disease control with higher doses of CPI-006, and enhanced disease control with CPI-006 in combination with ciforadenant compared with monotherapy. Additional highlights from the presentation:
Clinical and laboratory results demonstrated potential for a new immuno-oncology approach with CPI-006 via activation of immune cells and the inhibition of adenosine production.
Dose-dependent disease control when administered as a monotherapy and in combination with ciforadenant.
CPI-006 was well tolerated at all dose levels, with no dose-limiting toxicities. Grade 1 infusion reactions were detected (N=3 patients) and mitigated with premedication with acetaminophen and antihistamine. Grade 3 or 4 toxicities included a grade 3 anemia (N=1).
CPI-818: A small molecule ITK inhibitor

Continued enrolling patients with T-cell lymphomas, including peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and others, in a Phase 1/1b study with CPI-818, an ITK inhibitor.
Anticipated Events in 2H 2019

Updated clinical and immunologic data from the Phase 1/1b clinical trial of CPI-006 monotherapy and combination with ciforadenant is expected to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in November 2019.
Presentation on identification and role of biomarkers in adenosine pathway therapies is expected to be presented at SITC (Free SITC Whitepaper).
Preclinical and early clinical data regarding CPI-818 is expected to be presented in late 2019 or early 2020.
Financial Results

At June 30, 2019, Corvus had cash, cash equivalents and marketable securities totaling $96.8 million, as compared to cash, cash equivalents and marketable securities of $114.6 million at December 31, 2018. Corvus expects full-year 2019 net cash used in operating activities to be between $38 and $42 million and estimates ending 2019 with cash, cash equivalents and marketable securities of between $73 and $77 million.

Research and development expenses for the three months ended June 30, 2019 totaled $10.6 million, as compared to $9.7 million for the same period in 2018. The increase of $0.9 million was primarily due to an increase in CPI-006 program costs.

The net loss for the three months ended June 30, 2019 was $13.0 million, compared to a net loss of $11.6 million for the same period in 2018. Total stock compensation expense for the three months ended June 30, 2019 was $1.9 million, as compared to $1.7 million for the same period in 2018.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, August 1, 2019, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2019 financial results. The conference call can be accessed by dialing 1-888-599-8686 (toll-free domestic) or 1-720-543-0302 (international) and using the conference ID 2091306. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days following the call.

On August 1, 2019 Modra Pharmaceuticals B.V. ("Modra") reported the start of patient treatment in its Phase IIb clinical study evaluating the efficacy and tolerability of its lead candidate, ModraDoc006/r, in metastatic Castration-Resistant Prostate Cancer (mCRPC) (Press release, Modra Pharmaceuticals, AUG 1, 2019, View Source [SID1234538041]). ModraDoc006/r is a proprietary oral therapeutic based on the standard intravenous taxane chemotherapy, docetaxel. In evaluation to-date, ModraDoc006/r has shown potential to reduce important toxicities, such as neutropenia and neuropathy, with the possibility of enhancing the efficacy of treatment, in addition to providing the benefits of oral ‘at-home’ administration. The trial will be conducted at approximately 40 clinical centers in the United States and Europe, with initial data readout expected during the first half of 2021. The compound is also being tested in a Phase II clinical study in breast cancer, which began earlier this year.

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"Prostate cancer is one of the most commonly diagnosed malignancies in men in the Western world, with docetaxel typically administered as the first line of chemotherapy treatment in the metastatic setting. Improving outcomes for these patients by reducing key toxicities and enhancing efficacy associated with the use of chemotherapy would meet a significant need. Our objective is therefore to demonstrate clinical benefit over current standard of care while also making a positive impact on patients’ lives," commented Colin Freund, CEO of Modra.

"Based on our existing pre-clinical and clinical data, we believe ModraDoc006/r has the potential to favorably impact treatment outcomes and raise the quality of life for prostate cancer patients," explained Dr. Edwin de Wit, Chief Development Officer of Modra. "This comparative Phase IIb trial will enable us to evaluate the benefits of oral ModraDoc006/r versus standard of care intravenous docetaxel."

The Phase IIb study, randomized 1:1 Modra006/r versus intravenous docetaxel, will evaluate 100 mCRPC patients eligible for first line systemic chemotherapy. The primary endpoint is objective response rate as assessed by response evaluation criteria in solid tumors (RECIST 1.1). The secondary endpoints include efficacy, safety and health-related quality of life assessments.

"Intravenously administered chemotherapy is widely used, but nevertheless always involves a significant time investment for patients in regard to travel to and from the clinic and receiving the treatment itself, as well as the considerable burden of dealing with its side effects. To that end, ModraDoc006/r has the potential to become an exciting new oral option for prostate cancer which retains or improves on the therapeutic characteristics of docetaxel and easily incorporates chemotherapy within the lives of cancer patients," added Ulka Vaishampayan, MD, Principal Investigator of the study and Professor of Oncology at Karmanos Cancer Institute, Detroit.

About metastatic Castration-Resistant Prostate Cancer (mCRPC)

mCRPC is an advanced form of prostate cancer and the fourth most common cause of cancer death overall. mCRPC is resistant to surgical treatment or androgen deprivation therapy, an antihormone therapy used to prevent the growth of prostate cancer cells.

About ModraDoc006/r

ModraDoc006/r is a proprietary boosted taxane chemotherapy based on docetaxel, an intravenously administered therapy that is very broadly used in a variety of tumor types. ModraDoc006 – an oral docetaxel tablet – is given in combination with ritonavir (r), which acts as a booster to increase the systemic bioavailability of ModraDoc006. ModraDoc006/r is designed to combine the convenience and practicality of taking chemotherapy treatment at home with the potential for an improved safety profile and enhanced efficacy, as compared to standard IV docetaxel.

On August 1, 2019 IVERIC bio, Inc. (Nasdaq: ISEE) reported financial and operating results for the second quarter ended June 30, 2019 and provided a business update (Press release, Ophthotech, AUG 1, 2019, View Source [SID1234537986]).

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"We are pleased with the Company’s progress as we achieved several milestones to advance and expand our gene therapy pipeline for orphan inherited retinal diseases, or IRDs," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "We entered into exclusive global license agreements for rights to gene therapy product candidates for the treatment of BEST1-related IRDs and Leber congenital amaurosis type 10, or LCA10. We are encouraged by new research data from our miniCEP290 collaboration that support our plans to move this program forward in LCA10, and we expanded our gene therapy portfolio with the addition of a minigene research program for USH2A related IRDs, including Usher syndrome type 2A and USH2A-associated nonsyndromatic autosomal recessive retinitis pigmentosa. Manufacturing activities for IC-100 and IC-200, our two lead gene therapy product candidates, are currently ongoing using state-of-the-art manufacturing capabilities of Paragon Gene Therapy, part of Catalent Biologics."

Kourous A. Rezaei, MD, Chief Medical Officer of IVERIC bio added, "With the addition of the USH2A program to our portfolio, IVERIC bio is seeking to treat vision loss associated with what are reportedly the most common form of autosomal dominant retinitis pigmentosa (rhodopsin-mediated) and the most common form of autosomal recessive retinitis pigmentosa (USH2A-related). Retinitis pigmentosa is the most common orphan IRD. We look forward to presenting our gene therapy pipeline and discussing our programs in greater detail with highly-recognized gene therapy scientists and key opinion leaders in retinal diseases at our upcoming Gene Therapy R&D Investor Day."

Second Quarter 2019 and Recent Highlights

Orphan IRD Gene Therapy Programs

IC-100: Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)
Natural history studies and IND-enabling activities for IC-100 are ongoing. The Company expects to initiate a Phase 1/2 clinical trial for IC-100 in the second half of 2020.

IC-200: BEST1-Related IRDs
In April 2019, the Company entered into an exclusive global license agreement with the University of Pennsylvania and the University of Florida Research Foundation for rights to develop and commercialize novel adeno-associated virus (AAV) gene therapy product candidates for the treatment of BEST1-related IRDs, including Best vitelliform macular dystrophy, also known as Best disease. The Company expects to initiate a Phase 1/2 clinical trial for IC-200 in the first half of 2021.

miniCEP290: Leber Congenital Amaurosis Type 10 (LCA10)
Encouraging results from the Company’s collaboration with the University of Massachusetts Medical School (UMass Medical School) in its miniCEP290 program led the Company to exercise its option and, in July 2019, the Company entered into an exclusive global license agreement with the University of Massachusetts for rights to develop and commercialize mutation independent novel AAV minigene therapy product candidates for the treatment of LCA10, which is due to mutations in the CEP290 gene and is the most common type of LCA.

miniUSH2A: USH2A-Related IRDs Including Usher Syndrome Type 2A and USH2A-Associated Nonsyndromatic Autosomal Recessive Retinitis Pigmentosa
In July 2019, the Company entered into a sponsored research agreement with UMass Medical School and an exclusive option agreement with the University of Massachusetts for rights to develop and commercialize novel AAV gene therapy product candidates utilizing a mutation independent minigene therapy approach for the treatment of USH2A-related IRDs. This group of orphan IRDs include Usher syndrome Type 2A and USH2A-associated nonsyndromatic autosomal recessive retinitis pigmentosa.

Gene Therapy Manufacturing
In June 2019, the Company announced that it had entered into a strategic manufacturing relationship with Paragon Gene Therapy, part of Catalent Biologics. This agreement is for production and manufacturing of AAV vectors for pre-clinical activities and planned Phase 1/2 clinical trials for IC-100 and IC-200.

Gene Therapy R&D Investor Day Scheduled
The Company will host its first "Gene Therapy R&D Investor Day" in New York, NY on Friday, September 13, 2019. The agenda includes updates from IVERIC bio’s management on its gene therapy portfolio in orphan IRDs, and scientific discussions from gene therapy scientists and key opinion leaders in orphan inherited retinal diseases including;

Guangping Gao, PhD, University of Massachusetts Medical School

William A. Beltran, DVM, PhD, University of Pennsylvania

Charles A. Gersbach, Duke University

Hemant Khanna, PhD, University of Massachusetts Medical School

Gustavo D. Aguirre, VMD, PhD, University of Pennsylvania School of Veterinary Medicine

Andreas K. Lauer, MD, Oregon Health & Science University

Bart P. Leroy, MD, PhD, Ghent University and Children’s Hospital of Philadelphia

Alfred S. Lewin, PhD, University of Florida

Therapeutic Programs
The Company expects initial top-line data for its ongoing Phase 2b clinical trial of Zimura (avacincaptad pegol), a C5 complement inhibitor, for the treatment of geographic atrophy secondary to dry age-related macular degeneration to be available in the fourth quarter of 2019. The Company expects initial top-line data for its Phase 2b clinical trial of Zimura for the treatment of autosomal recessive Stargardt disease to be available in the second half of 2020.

Second Quarter 2019 Financial Results

Operational Update
As of June 30, 2019, the Company had $106.9 million in cash and cash equivalents. After taking into account the Company’s recent in-licensing transaction for its miniCEP290 program and sponsored research agreement for its miniUSH2A program, the Company reaffirms its estimate that year-end 2019 cash and cash equivalents will range between $80 million and $85 million. This estimate is based on its current 2019 business plan, including the continuation of its current research and development programs. This estimate does not reflect any additional expenditures, including associated development

costs, in the event the Company in-licenses or acquires any new product candidates or commences any new sponsored research programs.

R&D Expenses: Research and development expenses were $10.0 million for the quarter ended June 30, 2019, compared to $8.5 million for the same period in 2018. For the six months ended June 30, 2019, research and development expenses were $17.7 million compared to $16.2 million for the same period in 2018. Research and development expenses increased primarily due to increases in costs associated with the Company’s gene therapy programs and HtrA1 inhibitor program, offset by decreases in costs associated with the Company’s Zimura programs, personnel expenses and professional and consulting fees.

G&A Expenses: General and administrative expenses were $5.2 million for the quarter ended June 30, 2019, compared to $6.3 million for the same period in 2018. For the six months ended June 30, 2019, general and administrative expenses were $10.7 million compared to $12.0 million for the same period in 2018. General and administrative expenses decreased primarily due to decreases in costs to support the Company’s operations and infrastructure.

Net Income: The Company reported a net loss for the quarter ended June 30, 2019 of $14.4 million, or ($0.35) per diluted share, compared to a net loss of $13.2 million, or ($0.37) per diluted share, for the same period in 2018. For the six months ended June 30, 2019, the Company reported a net loss of $26.9 million or ($0.65) per diluted share, compared to a net loss of $26.3 million or ($0.73) for the same period in 2018.

Conference Call/Web Cast Information
IVERIC bio will host a conference call/webcast to discuss the Company’s financial and operating results and provide a business update. The call is scheduled for August 1, 2019 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 800-458-4121 (USA) or 323-794-2597 (International), passcode 3528260. A live, listen-only audio webcast of the conference call can be accessed on the Investors section of the IVERIC bio website at www.ivericbio.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 3528260.

On August 1, 2019 Geron Corporation (Nasdaq: GERN) reported financial results for the second quarter ended June 30, 2019, and recent events (Press release, Geron, AUG 1, 2019, View Source [SID1234538010]). The Company ended the second quarter with $162.3 million in cash and marketable securities.

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During the second quarter, data from the Phase 2 portion of IMerge was reported at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress that further support Geron’s late-stage development plans for the imetelstat program. Geron continues to plan to open the Phase 3 portion of IMerge in lower risk myelodysplastic syndromes (MDS) for screening and enrollment in August 2019.

"This past quarter, data presented at EHA (Free EHA Whitepaper) for the Phase 2 portion of IMerge reported higher efficacy responses from prior reported data for both 8-week and 24-week RBC-TI rates, highlighting the meaningful and durable transfusion independence potentially achievable with imetelstat treatment in heavily transfusion dependent lower risk MDS patients. Accordingly, we’re very much looking forward to the Phase 3 portion of IMerge opening for screening and enrollment later this month," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "In addition, a second EHA (Free EHA Whitepaper) presentation reported results of statistical analyses in which the months of median overall survival were more than double for imetelstat-treated relapsed/refractory MF patients in IMbark, compared to real-world data from closely matched patients treated with best available therapy. This provides additional support for our ongoing strategic evaluation of potential late-stage development approaches and regulatory scenarios in relapsed/refractory MF as we prepare for an End of Phase 2 meeting with the FDA, which we’re planning to conduct by the end of the first quarter of 2020."

Phase 3 Portion of IMerge Phase 2/3 Clinical Trial – Initial Site Initiations Complete and Trial to Open for Patient Screening and Enrollment in August 2019

In May, Geron completed the transfer of the imetelstat investigational new drug (IND) sponsorship from Janssen Biotech, Inc. (Janssen), and assumed complete development responsibility for imetelstat. Site initiations for the Phase 3 portion of IMerge were completed for several clinical sites in July 2019. Geron is planning for the trial to open for patient screening and enrollment later this month.

IMerge is a two-part Phase 2/3 clinical trial of imetelstat in transfusion dependent patients with lower risk MDS who are relapsed/refractory to erythroid stimulating agents (ESAs). The primary efficacy endpoint is the rate of red blood cell transfusion independence (RBC-TI) lasting at least eight weeks, or 8-week RBC-TI rate, which is defined as the proportion of patients achieving RBC-TI during any consecutive eight weeks since entry into the trial. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, durability of transfusion independence and the amount and relative change in RBC transfusions.

The Phase 3 portion of IMerge is designed as a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that imetelstat improves the rate of RBC-TI compared to placebo.

Approximately 170 patients are planned to be enrolled and randomized in a 2:1 ratio to receive either imetelstat or placebo. Many key aspects from the Phase 2 portion of IMerge remain the same for the Phase 3 portion. A target patient population of non-del(5q) lower risk MDS patients who were naïve to treatment with hypomethylating agents (HMAs) and lenalidomide was identified from the Phase 2 portion and will be enrolled in the Phase 3. In addition, the primary and secondary endpoints, the dose and schedule of imetelstat administration and many of the clinical sites remain the same as in the Phase 2. The Company is planning for the trial to be conducted at multiple medical centers globally, including North America, Europe, Middle East and Asia.

Second Quarter and Year-to-Date 2019 Results

For the second quarter of 2019, the Company reported a net loss of $14.2 million, or $0.08 per share, compared to $6.9 million, or $0.04 per share, for the comparable 2018 period. Net loss for the first six months of 2019 was $24.3 million, or $0.13 per share, compared to $14.1 million, or $0.08 per share, for the comparable 2018 period.

Revenues for the three and six months ended June 30, 2019 were $101,000 and $158,000, respectively, compared to $208,000 and $526,000 for the comparable 2018 periods. Revenues for the three and six months ended June 30, 2019 and 2018 included royalty and license fee revenues under various non-imetelstat license agreements. The decline in revenues reflects a reduction in the number of active research license agreements in 2019 related to the Company’s human telomerase reverse transcriptase, or hTERT, technology as a result of patent expirations on the underlying technology.

Total operating expenses for the three and six months ended June 30, 2019 were $15.3 million and $26.7 million, respectively, compared to $7.5 million and $15.2 million for the comparable 2018 periods. Research and development expenses for the three and six months ended June 30, 2019 were $10.1 million and $16.0 million, respectively, compared to $3.2 million and $5.6 million for the comparable 2018 periods. The increase in research and development expenses, compared to the same periods in 2018, primarily reflects costs for the transition of the imetelstat program, including resuming sponsorship of the ongoing imetelstat clinical trials; expenses for start-up activities for the Phase 3 portion of IMerge; and higher personnel-related costs for the expanding development team. General and administrative expenses for the three and six months ended June 30, 2019 were $5.2 million and $10.6 million, respectively, compared to $4.2 million and $9.6 million for the comparable 2018 periods. The increase in general and administrative expenses, compared to the same periods in 2018, primarily reflects higher corporate and patent legal costs and increased personnel-related expenses for additional headcount to support the development organization.

Interest and other income for the three and six months ended June 30, 2019 was $1.1 million and $2.3 million, respectively, compared to $717,000 and $1.1 million for the comparable 2018 periods. The increase in interest and other income, compared to the same periods in 2018, primarily reflects higher yields on the Company’s increased marketable securities portfolio.

The Company ended the second quarter of 2019 with $162.3 million in cash and marketable securities. Since May 2019, the Company has raised cumulative net cash proceeds of approximately $2.6 million from the sales of an aggregate of 1,893,091 shares of common stock under an At Market Issuance Sales Agreement, after deducting sales commissions and other offering expenses payable by Geron. The Company expects these net cash proceeds to provide additional financial flexibility as it advances the imetelstat development program. The funds will support future development costs, including conducting the Phase 3 portion of IMerge.

2019 Financial Guidance Reaffirmed

For fiscal year 2019, the Company expects total operating expenses to range from $80 to $85 million, of which approximately $20 to $25 million represents one-time costs that include imetelstat program transition activities from Janssen to Geron and purchase of drug product, drug substance and raw materials from Janssen to supply the Phase 3 portion of IMerge and prepare for new drug manufacturing. The Company continues to expect transition of the imetelstat program from Janssen to be completed by the end of the third quarter of 2019.

As of July 31, 2019, the Company had 38 employees, and plans to grow to a total of approximately 45 to 50 employees by year-end 2019, of whom half will be research and development personnel.

Conference Call

Geron will host a conference call to discuss second quarter and year-to-date financial results and recent events at 4:30 p.m. ET on Thursday, August 1, 2019.

Participants may access the conference call live via telephone by dialing domestically +1 (877) 303-9139 or internationally +1 (760) 536-5195. The conference ID is 2379646. A live, listen-only webcast will also be available on the Company’s website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company’s website for 30 days.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat consist of IMerge, a Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS) and IMbark, a Phase 2 trial in Intermediate-2 or High-risk myelofibrosis. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for the treatment of patients with transfusion dependent anemia due to non-del(5q) lower risk MDS who are refractory or resistant to an erythroid stimulating agent.