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Invitation to MorphoSys’ Year-End Results 2019 Conference Call on March 19, 2020 (news with additional features)

On March 12, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that it will publish its results for the financial year 2019 on March 18, 2020 at 10:00pm CET (9:00pm GMT; 5:00pm EDT) (Press release, MorphoSys, MAR 12, 2020, View Source [SID1234555496]).

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MorphoSys’ Management team will host a conference call and webcast on March 19, 2020 at 2:00pm CET (1:00pm GMT; 9:00am EDT) to present MorphoSys’ results for the financial year 2019 and provide a financial and operational outlook for 2020.

Date of the conference call: Thursday, March 19, 2020
Time: 2:00pm CET (1:00pm GMT, 9:00am EDT)
Dial-in numbers:
Germany: +49 69 201 744 220
United Kingdom: +44 203 009 2470
USA: +1 877 423 0830
Participant PIN: 48530958#

Participants are kindly requested to dial in up to 10 minutes before the call to ensure a secure line and a prompt start.

The presentation slides and webcast link will be available at the Company’s website at View Source

A replay of the conference will also be available at the corporate website following the live event.

Novavax Reports Fourth Quarter and Full Year 2019 Financial Results

On March 12, 2020 Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, reported its financial results and operational highlights for the fourth quarter and twelve months ended December 31, 2019 (Press release, Novavax, MAR 12, 2020, View Source [SID1234555495]).

"We remain on track to announce top-line results from our pivotal Phase 3 clinical trial for NanoFlu by the end of this month. Positive clinical data from this trial would support a subsequent U.S. BLA using the FDA’s accelerated approval pathway," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We continue to make progress towards partnering our ResVax program and recently announced progress in our efforts to develop a vaccine against COVID-19, with the goal of moving one or more optimized COVID- 19 candidates into the clinic by the end of this spring."

Fourth Quarter 2019 and Subsequent Operational Highlights

NanoFlu Program

·Results of the pivotal Phase 3 clinical trial for NanoFlu, Novavax’ recombinant quadrivalent seasonal influenza vaccine candidate, are expected later this month. The trial includes 2,652 healthy older adults across 19 U.S. clinical sites. The primary objective of the randomized, observer-blinded, active-controlled trial is to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains and safety compared against a licensed vaccine, Fluzone Quadrivalent.

·Positive top-line results from this Phase 3 clinical trial would support a subsequent U.S. biologics license application (BLA) and licensure of NanoFlu using the U.S. Food and Drug Administration’s (FDA) accelerated approval pathway. In addition, in January 2020, the FDA granted Fast Track designation for NanoFlu.

COVID-19 Program

·Novavax recently announced that the Coalition for Epidemic Preparedness Innovations (CEPI) awarded an initial funding of $4 million to support its effort to develop a COVID-19 vaccine. CEPI and Novavax are having ongoing discussions on additional funding from CEPI to address Novavax’ costs through Phase 1.

·Novavax began efforts to develop a novel vaccine to protect against COVID-19 in January. Novavax has produced and is currently assessing multiple nanoparticle vaccine candidates in animal models prior to advancing to clinical trials. Initiation of Phase I clinical testing is expected in May or June 2020. Novavax expects to utilize its proprietary Matrix-M adjuvant with its COVID-19 vaccine candidate to enhance immune responses.

ResVax Program

·Novavax is continuing its discussions with both global regulatory authorities and potential partners to explore the opportunity to bring ResVax to market.

Matrix-M Partnership

·Earlier today, Novavax announced a commercial license agreement related to its Matrix-M vaccine adjuvant. Matrix-M is a key component of Serum Institute of India’s malaria vaccine candidate, which it licensed from Jenner Institute at Oxford University. The vaccine candidate is currently in a Phase 2b clinical trial being conducted in Burkina Faso with top-line data expected in the second quarter of 2020.

Corporate

·Through utilization of At-the-market (ATM) offerings during the fourth quarter of 2019, Novavax raised net proceeds of $30 million. For the twelve months of 2019, Novavax raised net proceeds of $97 million. Subsequent to year-end, through March 6, 2020, Novavax raised additional net proceeds of $156 million.

Financial Results for the Three and Twelve Months Ended December 31, 2019

Share and per share data have been restated to reflect the reverse stock split that was completed in May 2019.

Novavax reported a net loss of $31.8 million, or $1.13 per share, for the fourth quarter of 2019, compared to a net loss of $49.3 million, or $2.57 per share, for the fourth quarter of 2018. For the twelve months ended December 31, 2019, the net loss was $132.7 million, or $5.51 per share, compared to a net loss of $184.7 million, or $9.99 per share, for the same period in 2018.

Novavax revenue in the fourth quarter of 2019 was $8.8 million, compared to $6.1 million in the same period in 2018. This 44% increase was driven by $7.5 million in revenue for the recovery of additional costs under the closeout of the HHS BARDA contract, partially offset by lower revenue from the completion of enrollment of participants in the Prepare trial in second quarter of 2018.

Research and development expenses decreased 32% to $29.3 million in the fourth quarter of 2019, compared to $43.4 million in the same period in 2018. This decrease was primarily due to decreased development activities of ResVax, lower employee-related costs and other cost savings due to the Catalent transaction, partially offset by NanoFlu’s Phase 3 clinical trial and development activities.

General and administrative expenses decreased to $8.2 million in the fourth quarter of 2019, compared to $9.2 million for the same period in 2018.

Interest income (expense), net for the fourth quarter of 2019 was ($3.1) million, compared to ($2.8) million for the same period of 2018.

As of December 31, 2019, Novavax had $82.2 million in cash, cash equivalents, marketable securities and restricted cash, compared to $103.9 million as of December 31, 2018. Net cash used in operating activities for the twelve months of 2019 was $136.6 million, compared to $184.8 million for same period in 2018.

Conference Call

Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 5695528. A replay of the conference call will be available starting at 7:30 p.m. ET on March 11, 2020 until 7:30 p.m. ET on March 18, 2020. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 5695528.

A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "Investor Info"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website until June 11, 2020.

About NanoFlu and Matrix-M

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes. Top-line data from Novavax’ ongoing Phase 3 clinical trial of NanoFlu is expected late in the first quarter of 2020.

About COVID-19

A new strain of coronavirus first appeared in late 2019 in China before beginning its rapid spread across the globe. The disease, named COVID-19, continues to cause severe pneumonia-like symptoms in many of those infected. Coronaviruses, so named for their "crown-like" appearance, are a large family of viruses that spread from animals to humans and include diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) in addition to COVID-19. While much remains unknown about the new coronavirus, it is known that the virus can spread via human-to-human transmission before any symptoms appear.

Marker Therapeutics Reports Full Year 2019 Operating and Financial Results

On March 12, 2020 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported financial results for the full year ended December 31, 2019 (Press release, TapImmune, MAR 12, 2020, View Source [SID1234555494]).

"With a clear path forward for our Phase 2 trial in AML patients with our novel T cell therapy, and the cash resources needed to advance our studies, 2020 is shaping up to be a busy and productive year for our Company," said Peter L. Hoang, President & CEO of Marker Therapeutics. "Based on promising results observed with our MultiTAA T cell therapy across various forms of cancer in investigator-sponsored trials, we are also evaluating opportunities for additional Marker-sponsored trials."

PROGRAM UPDATES

Multi-Antigen Targeted (MultiTAA) T Cell Therapies

Marker Prepares to Initiate Phase 2 AML Trial

In February 2020, the Company announced an updated study protocol for its Phase 2 clinical trial of MultiTAA T cell therapy in post-allogeneic hematopoietic stem cell transplant patients with acute myeloid leukemia (AML) in both the adjuvant and active disease setting. Under an amended trial design, the U.S. Food and Drug Administration (FDA) has permitted the trial to move forward with the safety lead-in. During the second half of 2020, Marker expects to complete enrollment of the first three patients and to submit the information required by the FDA to lift a partial clinical hold during the second half of 2020. The Company does not currently expect the partial clinical hold to significantly impact site or patient enrollment.

Investigator-Sponsored Trials with MultiTAA T Cell Therapy Continue to Generate Positive Results

Marker previously reported interim data from an ongoing Phase 1/2 clinical trial of MultiTAA T cell therapy for the treatment of patients with pancreatic adenocarcinoma being conducted by its partners at the Baylor College of Medicine (BCM). In this trial, the modified T cells exhibited activity against both targeted tumor-associated antigens (TAA) and non-targeted TAAs, indicating induction of antigen spreading. To date, there has not been any cytokine release syndrome or neurotoxicity observed in this trial.

T Cell-Based Vaccines

Phase 2 Triple Negative Breast Cancer Trial Progressing

Marker’s T cell-based vaccine program in triple negative breast cancer has delivered the following results as of September 30, 2019:

·Based on a preliminary analysis of 34 patients enrolled in the triple negative breast cancer trial, 31 patients showed meaningful immune response to vaccine treatment;

·Of 80 patients treated at 11 clinical sites, 16 have shown disease progression following treatment with TPIV200.

Phase 2 Platinum-Sensitive Advanced Ovarian Cancer Trial

·As previously announced, Marker has discontinued the development of TPIV200 in patients with platinum-sensitive advanced ovarian cancer based on an unblinded review of interim results from the trial conducted by the Data Safety Monitoring Board (DSMB). While the DSMB did not express safety concerns, Marker elected to discontinue the trial as it did not meet the threshold for probability of clinical benefit based upon the Company’s pre-specified criteria.

FINANCING UPDATE

·On March 2, 2020, Marker announced that the Company entered into a Common Stock Purchase Agreement of up to $30 million with Aspire Capital Fund, LLC, a Chicago-based institutional investor and long-term Marker shareholder.

FULL YEAR 2019 FINANCIAL RESULTS

Cash Position and Guidance: At December 31, 2019, Marker had cash and cash equivalents of $43.9 million. The Company believes that the financial flexibility provided by the Aspire transaction will enable the cash runway to extend beyond the second quarter of 2021.

R&D Expenses: Research and development expenses were $12.8 million for the year ended December 31, 2019 compared to $8.0 million for the year ended December 31, 2018. The increase was primarily attributable to increases in personnel-related expenses relating to the build-up of Marker’s internal infrastructure, an increase in clinical consulting and professional expenses relating to preparation of the AML trial, an increase in process development expenses, offset by a decrease in clinical trial expenses due to the stages of ongoing clinical trials and the decreased number of active patients in such trials.

G&A Expenses: General and administrative expenses were $10.0 million for the year ended December 31, 2019, compared to $24.4 million for the year ended December 31, 2018. The decrease was primarily attributable to a decrease of $12.8 million in stock-based compensation expenses due to executive stock option grants issued in fiscal year 2018, as well as a decrease in merger-related expenses during fiscal year 2019, offset by increased expenses in headcount-related and legal and other professional expenses.

Net Loss: Marker reported a net loss of $21.4 million for the year ended December 31, 2019, compared to a net loss of $148.0 million for the year ended December 31, 2018.

Molecular Templates, Inc. Reports Fourth Quarter 2019 Financial Results

On March 12, 2020 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported financial results for the fourth quarter of 2019 (Press release, Molecular Templates, MAR 12, 2020, View Source [SID1234555493]). As of December 31, 2019, MTEM’s cash and investments totaled $126.6 million, which is expected to fund operations into 2022.

"In 2019, we made important progress by advancing our pipeline programs, establishing a new collaboration outside of oncology with a premier partner, and strengthening our balance sheet with a successful equity financing," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "We now have five ongoing studies across three clinical programs: three Phase 2 studies for MT-3724, a Phase 1 study for MT-5111, and a Phase 1 study with our partner Takeda for TAK-169. We also expect our earlier stage programs to advance in 2020, including an IND filing for MT-6402 (our PD-L1 ETB with antigen seeding), preclinical data presentations on ETBs against new targets, and continued progress in our multi-target collaborations with Takeda and Vertex."

Company Highlights and Upcoming Milestones

Corporate

On November 18, 2019, MTEM and Vertex Pharmaceuticals announced a strategic research collaboration to discover and develop novel targeted conditioning regimens that may enhance the hematopoietic stem cell transplant process, including transplants conducted as part of treatment with ex vivo CRISPR/Cas9 gene editing therapies such as CTX001. Under the collaboration, MTEM will conduct research activities for the use of ETBs for up to two targets selected by Vertex. The initial research will be focused on discovering a novel conditioning regimen using MTEM’s ETB technology platform. In addition, Vertex has an option to select a second target as part of the collaboration. Vertex made an up-front payment of $38 million to MTEM, including an equity investment. MTEM is also eligible to receive future development, regulatory and sales milestones and option payments of up to $522 million (across two targets) and tiered royalty payments on future sales.
On November 21, 2019, MTEM announced the pricing of an underwritten equity offering, the net proceeds of which were approximately $53.4 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by MTEM.
On February 19, 2020, MTEM announced the initiation of dosing in a Phase 1 study investigating TAK-169 in patients with relapsed/refractory multiple myeloma. Co-developed with Takeda Pharmaceutical Company Limited ("Takeda"), TAK-169 is a potential first-in-class CD38-targeting ETB. As a result of achieving this milestone, MTEM received a $10 million payment from Takeda.
MT-3724 (CD20 ETB)

At the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2019, MTEM presented the final results from the MT-3724 Phase 1/1b monotherapy study. The presentation included safety data on doses from 5-100 μg/kg, and efficacy data on 13 serum rituximab negative (RTX-neg) diffuse large B-cell lymphoma (DLBCL) or mixed DLBCL/FL subjects of whom 5 responded (38% objective response rate) across the range of 5 to 50 μg/kg doses. Of the 5 responses, 2 were complete responses (CRs) and 3 were partial responses (PRs). Three patients had stable disease (including 2 patients with 49% and 47% tumor reductions) and 5 patients had progressive disease. Of the 5 serum RTX-neg subjects with DLBCL who received MT-3724 at 50 μg/kg, the maximum tolerated dose (MTD), 3 responded (2 CRs, 1 PR).
MTEM is currently conducting three ongoing Phase 2 studies in relapsed/refractory DLBCL: a monotherapy study that has the potential to be pivotal, a combination study with chemotherapy, and a combination study with lenalidomide.
In January 2020, MTEM reported that the combination study with lenalidomide has demonstrated preliminary evidence of tolerability and efficacy with lenalidomide at standard doses and MT-3724 at 10 μg/kg. MT-3724 dosing at higher doses with lenalidomide is ongoing.
In January 2020, MTEM reported that the combination study with GemOx has demonstrated preliminary evidence of efficacy but Grade 2 innate immune adverse effects were seen with standard doses of gemcitabine and oxaliplatin and 10 μg/kg doses of MT-3724. The study protocol has been amended to include a revised schedule in which MT-3724 dosing is initially sequenced with GemOx dosing.
MTEM expects to report updates on all three MT-3724 studies throughout 2020.
TAK-169 (CD38 ETB)

Takeda and MTEM are currently conducting a Phase 1 study for TAK-169 in relapsed/refractory multiple myeloma.
In December 2019, TAK-169 received Orphan Drug Designation from the FDA.
MT-5111 (HER2 ETB)

In December 2019, MTEM presented preclinical data on MT-5111 at the San Antonio Breast Cancer Symposium (SABCS).
The Phase 1 study of MT-5111 in HER2-positive cancers is ongoing with multiple sites open for enrollment.
MTEM expects to announce interim clinical results from the MT-5111 Phase 1 study in 2Q20 and additional data from the dose escalation portion of the study in 4Q20.
Research

MTEM expects to file an IND application for MT-6402, its ETB targeting PD-L1 (with antigen seeding), in 2H20.
Several other ETB candidates are in preclinical development against targets including CTLA-4, SLAMF-7, and CD45.
In 2020, MTEM expects to present preclinical data on new targets and new ETBs at conferences.
Financial Results

The net loss attributable to common shareholders for the fourth quarter of 2019 was $15.9 million, or $0.41 per basic and diluted share. This compares with a net loss attributable to common shareholders of $6.6 million, or $0.18 per basic and diluted share, for the same period in 2018.

Revenues for the fourth quarter of 2019 were $6.2 million, compared to $4.7 million for the same period in 2018. Revenues for the fourth quarter of 2019 were comprised of revenues from collaborative research and development agreements with Takeda, and grant revenue from CPRIT. Total research and development expenses for the fourth quarter of 2019 were $16.6 million, compared with $7.6 million for the same period in 2018. Total general and administrative expenses for the fourth quarter of 2019 were $6.0 million, compared with $3.9 million for the same period in 2018.

Geron Corporation Reports Fourth Quarter and Full Year 2019 Financial Results and 2020 Milestones

On March 12, 2020 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic myeloid malignancies, reported financial results for the fourth quarter and year ended December 31, 2019 as well as 2020 milestones (Press release, Geron, MAR 12, 2020, View Source [SID1234555492]). The Company ended fiscal year 2019 with $159.2 million in cash and marketable securities.

"2019 was a pivotal year for Geron as we completed the imetelstat program transition, assembled an impressive in-house team with a proven track record in drug development, and advanced imetelstat into late-stage development with the opening of our IMerge Phase 3 clinical trial in lower risk myelodysplastic syndromes," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "In 2020, we plan to complete enrollment in IMerge, announce our decision regarding any potential late-stage development plans for myelofibrosis by mid-year, and commence a proof of concept study in additional hematologic myeloid malignancies. With a strong team in place to execute these plans, we look forward to further advancing the development of imetelstat."

Planned 2020 Milestones

Geron is planning for the following milestones in 2020:

Complete enrollment for the Phase 3 IMerge clinical trial in lower risk myelodysplastic syndromes (MDS) by the end of 2020

Recently reported Phase 2 data continued to indicate meaningful and durable transfusion independence potentially achievable with imetelstat treatment in high transfusion burdened patients (> 4 units per 8 weeks). The Phase 3 IMerge clinical trial was opened for enrollment in August 2019, and the first patient was dosed in October 2019. As of the end of February 2020, 63% of planned clinical sites were opened for enrollment. Topline results are expected by mid-year 2022.

Determine a potential registration strategy for imetelstat in myelofibrosis (MF)

As a follow up to an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2019, Geron plans to submit Phase 3 trial design proposals to the FDA and, in the second quarter, discuss with the FDA a potential regulatory approval path for imetelstat in MF. Geron expects to announce its decision regarding any potential late-stage development plans for MF by mid-year 2020.

Expect to present updated data and new analyses from the Phase 2 IMerge and IMbark clinical trials at future medical conferences

Geron expects to present more mature data from the Phase 2 IMerge clinical trial in lower risk MDS for the continued treatment and follow-up of remaining patients, including durability of transfusion independence.

Geron also expects to present new analyses from the IMbark Phase 2 clinical trial that correlate the median overall survival observed with other clinical endpoints from the trial. In addition, the new analyses are expected to provide further support for the potential improvement in overall survival as an indication of disease-modifying activity of imetelstat treatment in myelofibrosis.

Commence a proof of concept study of imetelstat in additional hematologic myeloid malignancies

Geron plans to expand imetelstat’s clinical development program with a proof of concept study in Intermediate-2 or High-risk, or higher risk, MDS and acute myeloid leukemia (AML) and expects to commence such a study by the end of the fourth quarter 2020.

2019 Accomplishments

Clinical – Advanced MDS development and presented data supporting potential late-stage development in MDS and MF

○Presented updated data from the Phase 2 IMerge clinical trial at the European Hematology Association (EHA) (Free EHA Whitepaper) meeting in June 2019 that reported continued meaningful and durable transfusion independence.
○Commenced screening and enrollment for the Phase 3 IMerge clinical trial in August 2019 and dosed the first patient in October 2019.
○Presented Phase 2 IMbark data at EHA (Free EHA Whitepaper) corroborating potential survival benefit of imetelstat in relapsed/refractory MF patients when compared to closely matched patients from real-world data treated with best available therapy.

Regulatory – Initiated FDA interactions to determine potential for late-stage development in MF

○The FDA granted Fast Track designation to imetelstat for the treatment of adult patients with Intermediate-2 or High-risk relapsed/refractory MF in September 2019.
○Conducted an End of Phase 2 meeting with the FDA in the fourth quarter of 2019.

Operational – Completed transition of imetelstat development program and enhanced development capabilities

○Transitioned the imetelstat program back to Geron in the third quarter of 2019, including transfer of imetelstat investigational new drug (IND) sponsorship in May 2019.
○Throughout 2019, recruited hematology-oncology research and development expertise, including many team members with prior experience with imetelstat, as well as both early- and late-stage development experience, to establish a multi-functional development team to support current and future development plans.
○Re-established manufacturing supply chain to manufacture imetelstat.
Fourth Quarter and Full Year 2019 Results

For the fourth quarter of 2019, the Company reported a net loss of $29.1 million, or $0.15 per share, compared to $7.3 million, or $0.04 per share, for the fourth quarter of 2018. Net loss for the full year of 2019 was $68.5 million, or $0.36 per share, compared to $27.0 million, or $0.15 per share, for the full year of 2018.

Revenues for the three and twelve months ended December 31, 2019 were $171,000 and $460,000, respectively, compared to $375,000 and $1.1 million for the same periods in 2018. Revenues for the three and twelve months ended December 31, 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 twelve months ended December 31, 2019 were $30.2 million and $73.0 million, respectively, compared to $10.0 million and $32.1 million for the same periods in 2018. Research and development expenses for the three and twelve months ended December 31, 2019 were $24.9 million and $52.1 million, respectively, compared to $5.1 million and $13.4 million for the same periods in 2018. 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 IMerge Phase 3 clinical trial; purchase of inventories of drug product, drug substance and raw materials from Janssen; and higher personnel-related costs for the expanding development team. General and administrative expenses for the three and twelve months ended December 31, 2019 were $5.3 million and $20.9 million, respectively, compared to $4.9 million and $18.7 million for the same periods in 2018. 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 general and administrative headcount to support the development organization.

Interest and other income for the three and twelve months ended December 31, 2019 was $925,000 and $4.2 million, respectively, compared to $1.1 million and $3.3 million for the same periods in 2018. The overall increase in interest and other income in 2019 when compared to 2018 primarily reflects higher yields on the Company’s marketable securities portfolio.

The Company ended the 2019 fiscal year with $159.2 million in cash and marketable securities. The Company expects these funds to be sufficient to continue the IMerge clinical trial in 2020 and to commence a proof of concept study in 2020.

Projected 2020 Financial Guidance

For fiscal year 2020, the Company expects its operating expense burn to range from $70 to $75 million, which includes costs related to the global Phase 3 IMerge clinical trial in MDS; validation of supply chain vendors for the manufacturing of imetelstat; further interactions with the FDA in connection with the planned submission of Phase 3 trial design proposals in MF and discussion regarding a potential regulatory approval path in MF; and commencement of a proof of concept study of imetelstat.

As of December 31, 2019, the Company had 46 employees. The Company plans to grow to a total of approximately 55 to 60 employees by year-end 2020, of which the majority will be research and development personnel.

Conference Call

Geron will host a conference call to discuss fourth quarter and full year 2019 financial results and 2020 milestones at 4:30 p.m. ET on Thursday, March 12, 2020.

Participants may access the conference call live via telephone by dialing domestically +1 (866) 393-4306 or internationally +1 (734) 385-2616. The conference ID is 5528886. 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. Clinical studies of imetelstat sponsored by Geron include 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 (MF). Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.