On August 6, 2020 Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing treatments for immune mediated diseases, reported financial results for the second quarter ended June 30, 2020 (Press release, Principia Biopharma, AUG 6, 2020, View Source [SID1234563097]).

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"We are very pleased with the progress the company made on each program in the first half of the year despite the ongoing COVID-19 pandemic challenges. Our investigators were able to present additional positive data for both ITP and pemphigus and Sanofi announced positive Phase 2 data in multiple sclerosis," said Martin Babler, president and chief executive officer of Principia. "With the initiation of a Phase 3 trial in patients with relapsing multiple sclerosis, we received a $50 million milestone payment from Sanofi which enhances our balance sheet and allows us to continue strong execution on our programs."

Six-month and year-to date program highlights

Rilzabrutinib for the treatment of pemphigus

Announced full data set from the Phase 2 Part B pemphigus BELIEVE PV trial during the virtual late-breaker research session of the American Academy of Dermatology

Results to date demonstrate a positive risk/benefit profile while decreasing daily corticosteroid usage

Enrollment of the PEGASUS Phase 3 trial continues to be on target

Rilzabrutinib for the treatment of ITP

Announced updated positive data from an ongoing Phase 1/2 trial in 47 heavily pre-treated patients during the virtual session of the European Hematology Association (EHA) (Free EHA Whitepaper)

Interim results demonstrate rilzabrutinib reaches primary endpoint in 50 percent of patients treated > 12 weeks with 400 mg twice-daily dose; demonstrated fast onset and durable responses

Granted orphan drug designation by the European Commission (EC)

Anticipate initiating a pivotal Phase 3 trial by the end of 2020, assuming no COVID-19 related impact

Rilzabrutinib for the treatment of IgG4-RD

Announced the expansion of development of rilzabrutinib into IgG4-RD

PRN473 Topical for the treatment of immune mediated diseases of the skin

Announced expansion of its BTK franchise with PRN473 Topical

Initiated two Phase 1 trials in Australia — a single ascending dose/multiple dose trial in healthy volunteers and a challenge study

Anticipate Phase 1 single ascending dose/multiple dose trial results in the second half of 2020

PRN2246/SAR442168 for the treatment of multiple sclerosis

Demonstrated a significant reduction in disease activity in partner Sanofi’s Phase 2 relapsing multiple sclerosis (MS) trial

Met primary and secondary objectives with 85 percent or greater relative reduction achieved in the number of new gadolinium-enhancing T1 and new or enlarging T2 hyperintense lesions

First patient dosed in Sanofi’s Phase 3 trial in relapsing MS, triggering a $50 million milestone payment in the third quarter of 2020

Immunoproteasome Inhibitor

Selected a candidate molecule to move forward into the preclinical development phase

General Corporate Highlights

Hosted a virtual Analyst Event highlighting BTK inhibitors’ significant potential beyond B cells, how rilzabrutinib is differentiated from other BTKs due to its reversible covalent binding as well the company’s maturing pipeline and research focus

The company has hired key employees to meet the expanded development programs and expected organizational growth

Second Quarter 2020 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $316.5 million as of June 30, 2020, compared to $367.8 million as of December 31, 2019. In addition, the company received an additional $50.0 million milestone payment from Sanofi in the third quarter of 2020.

Revenues: Collaboration revenues were $50.0 million for the three months ended June 30, 2020, compared to $30.0 million for the same period in 2019, for the achievement of clinical development milestones in our Sanofi collaboration.

R&D Expenses: Total research and development expenses were $30.9 million for the three months ended June 30, 2020, including stock-based compensation expense of $3.9 million, compared to $18.7 million for the same period in 2019, including stock-based compensation expense of $1.8 million. The increase in total research and development expenses was mainly driven by an increase in rilzabrutinib program costs, due to the progression of our global Phase 3 trial in pemphigus, ongoing Phase 2 trial in ITP and certain

Anticipate initiating a Phase 2 trial in the second half of 2020

manufacturing campaigns to supply drug products for our rilzabrutinib clinical trials, the initiation of our Phase 1 trial for PRN473 Topical in March 2020 and an increase in employee-related expenses.

G&A Expenses: General and administrative expenses were $9.2 million for the three months ended June 30, 2020, including stock-based compensation expense of $3.1 million, compared to $5.2 million for the same period in 2019, including stock-based compensation expense of $1.7 million. The increase in total general and administrative expenses was primarily driven by increased employee-related expenses and costs related to operating as a public company.

Net Income (Loss): For the three months ended June 30, 2020, net income was $10.8 million compared to net income of $7.1 million for the same period in 2019.

On August 6, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the second quarter ended June 30, 2020 (Press release, Puma Biotechnology, AUG 6, 2020, View Source [SID1234563096]). Unless otherwise stated, all comparisons are for the second quarter of 2020 compared to the second quarter of 2019.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net NERLYNX product revenue in the second quarter of 2020 was $48.8 million, compared to $53.8 million in the second quarter of 2019. Net NERLYNX product revenue in the first six months of 2020 was $97.4 million, compared to $99.4 million in the first six months of 2019.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $3.4 million, or $0.09 per basic share and $0.08 per diluted share, for the second quarter of 2020, compared to a net loss of $37.4 million, or $0.97 per basic and diluted share, for the second quarter of 2019. Net loss for the first six months of 2020 was $13.5 million, or $0.34 per basic and diluted share, compared to a net loss of $47.5 million, or $1.23 per basic and diluted share, for the first six months of 2019.

Non-GAAP adjusted net income was $14.0 million, or $0.36 per basic share and $0.35 per diluted share, for the second quarter of 2020, compared to non-GAAP adjusted net loss of $22.0 million, or $0.57 per basic and diluted share, for the second quarter of 2019. Non-GAAP adjusted net income for the first six months of 2020 was $6.0 million, or $0.15 per basic and diluted share, compared to non-GAAP adjusted net loss of $13.9 million, or $0.36 per basic and diluted share, for the first six months of 2019. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income (loss) and a reconciliation of GAAP net income (loss) per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the second quarter of 2020 was $16.2 million, compared to $44.2 million for the second quarter of 2019. Net cash provided by operating activities for the first six months of 2020 was $4.7 million, compared to $28.1 million for the first six months of 2019. At June 30, 2020, Puma had cash, cash equivalents and marketable securities of $107.3 million, compared to $111.6 million at December 31, 2019.

"We are pleased to announce that despite the challenges presented by the COVID-19 situation as well as a significant inventory draw down by specialty pharmacies in the quarter, we were able to achieve NERLYNX revenues that were within the Company’s previously stated second quarter guidance range," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Although we anticipate that COVID-19 may continue to impact our revenues going forward, we remain focused on and committed to providing support to patients battling breast cancer. The addition of Jeff Ludwig to our team as Chief Commercial Officer demonstrates our commitment to increasing the global success of NERLYNX. Maintaining the health and safety of our employees remains a priority for all of us at Puma, and we are pleased with the accomplishments made by our team as they adjusted to working remotely and responding to any COVID-related challenges."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) reporting Phase II data from the hormone receptor positive breast cancer cohort of the SUMMIT trial of neratinib in patients with HER2 mutations in the fourth quarter of 2020; (ii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2020; (iii) reporting data from the Phase II TBCRC-022 trial of the combination of Kadcyla plus neratinib in patients with HER2 positive breast cancer with brain metastases who have previously been treated with Kadcyla in the first half of 2021; (iv) conducting a pre-

NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2 mutated hormone receptor positive breast cancer in the first half of 2021; and (v) receiving regulatory decisions for an extended adjuvant HER2-positive early stage breast cancer indication in additional countries."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue, and royalty revenue. For the second quarter of 2020, total revenue was $70.6 million, of which $48.8 million was net product revenue, $20.7 million was license revenue received from Puma’s sub-licensees, and $1.1 million was royalty revenue from Puma’s sub-licensees. This compares to total revenue for the second quarter of 2019 of $53.9 million, of which $53.8 million was net product revenue and $0.1 million was royalty revenue from Puma’s sub-licensees. For the first six months of 2020, total revenue was $121.8 million, of which $97.4 million was net product revenue, $22.7 million was license revenue received from Puma’s sub-licensees, and $1.7 million was royalty revenue also from Puma’s sub-licensees. This compares to total revenue for the first six months of 2019 of $153.0 million, of which $99.4 million was net product revenue, $53.5 million was license revenue received from Puma’s sub-licensees, and $0.1 million was royalty revenue also from Puma’s sub-licensees.

Operating Costs and Expenses

Total operating costs and expenses were $63.5 million for the second quarter of 2020, compared to $79.7 million for the second quarter of 2019. Operating costs and expenses in the first six months of 2020 were $128.9 million, compared to $168.9 million in the first six months of 2019.

Cost of Sales

Cost of sales was $9.4 million for the second quarter of 2020 and $18.5 million for the first six months of 2020, compared to $9.3 million for the second quarter of 2019 and $17.3 million for the first six months of 2019.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $29.4 million for the second quarter of 2020, compared to $33.5 million for the second quarter of 2019. SG&A expenses for the first six months of 2020 were $60.3 million, compared to $79.0 million for the first six months of 2019. The $18.7 million year-over-year decrease for the first six months resulted primarily from a decrease in stock-based compensation expense of approximately $7.9 million, a decrease in professional fees and expenses of approximately $7.7 million, a decrease in expenses associated with travel and meetings of approximately $2.5 million, and a decrease of approximately $0.4 million in payroll and payroll-related expenses.

Research and Development Expenses

Research and development (R&D) expenses were $24.7 million for the second quarter of 2020, compared to $36.9 million for the second quarter of 2019. R&D expenses for the first six months of 2020 were $50.1 million, compared to $72.6 million for the first six months of 2019. The $22.5 million year-over-year decrease for the first six months resulted primarily from a decrease in clinical trial expense of approximately $13.5 million, a decrease in employee stock-based compensation expense of approximately $6.1 million, and a decrease in consultant and contractors expenses of approximately $2.9 million primarily due to the close out of certain clinical trials.

Total Other Income (Expenses)

Total other expenses were $3.7 million for the second quarter of 2020 and $6.4 million for the first six months of 2020, compared to total other expenses of $11.6 million for the second quarter of 2019 and $31.6 million for the first six months of 2019. The $25.2 million year-over-year decrease for the first six months primarily resulted from a decrease in debt extinguishment loss of approximately $8.1 million, a decrease in legal verdict expense of approximately $16.2 million, and a decrease in interest expense of approximately $2.0 million, partially offset by a decrease in interest income of approximately $1.3 million.

Conference Call

Puma Biotechnology will host a conference call to report its second quarter 2020 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 6, 2020. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On August 6, 2020 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported financial results for the second quarter ended June 30, 2020 and provided corporate updates (Press release, Arcus Biosciences, AUG 6, 2020, View Source [SID1234563095]).

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"The multitude and quality of accomplishments from the Arcus team over the course of these dynamic few months have illustrated Arcus’s extraordinary commitment to its vision to consistently create, develop and deliver life-changing therapies to patients," said Terry Rosen, Ph.D., Chief Executive Officer. "In this short period of time, Arcus and Gilead executed a partnership framework that enables Arcus to expand and accelerate the opportunities inherent in Arcus’s broad pipeline and discovery organization and expedite Arcus’s evolution into a sustainable, fully-integrated biopharmaceutical company. Arcus’s concurrent public offering raised additional funding to support aggressive advancement of four clinical molecules in highly pursued immuno-oncology pathways – TIGIT, the Adenosine Axis, and PD-1, including its near-term goals to expand its development programs and begin potential registrational studies in 2021. In addition, Arcus reported early clinical activity of etrumadenant (AB928) plus mFOLFOX-6 in late-line metastatic colorectal cancer during this year’s AACR (Free AACR Whitepaper) conference, further enhancing the growing confidence in etrumadenant and its unique biological mechanism and providing basis for expanded future studies in the metastatic colorectal cancer setting. We are excited for this momentum to continue building in the second half of 2020 as we advance our mission to serve patients."

As we continue to navigate through these unique and unprecedented times for the biotechnology industry and the world as a whole, the Arcus team has demonstrated their ability to be nimble and quickly adapt to shifting environments. We would like to acknowledge our staff for their extraordinary commitment to our mission, as well as the patients, caregivers and investigators that enabled our ongoing and new clinical trials and our shareholders for their ongoing support, particularly with respect to our May financing. We would also like to express our gratitude to Gilead for their collaborative efforts in designing, executing and closing an alliance that enables and cements Arcus’s trajectory toward becoming an independent biopharmaceutical company and to our colleagues at Taiho for their highly-regarded long-term support of Arcus since our early days and continued partnership in Japan. We enter the second half of 2020 in a stronger position than ever.

Recent Key Highlights

•

Established a 10-year collaboration with Gilead that provides Gilead with access to Arcus’s broad and growing immuno-oncology pipeline and Arcus with substantial, non-dilutive funding through opt-in payments and ongoing R&D support.

"All-in" framework with global co-development for optioned programs allows both companies to combine their expertise and resources to bring transformative therapies to patients.

Arcus retains rights to co-commercialize optioned programs in the U.S., with equal profit sharing, and receives double-digit royalties on sales outside of the U.S.

Concurrent with the execution of the Gilead partnership, Arcus successfully completed a public offering of common stock, raising approximately $348 million in gross proceeds. This financing included participation by Gilead, in addition to the capital provided as part of the collaboration agreement. This represents the company’s first public financing since its March 2018 initial public offering, providing new and existing stockholders an additional opportunity to participate in the next phase of growth of the company.

Presented early clinical activity of etrumadenant plus mFOLFOX-6 in late-line metastatic colorectal cancer (mCRC) patients in the ARC-3 study at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting, including the following observations:

A disease control rate (DCR) of 76% across all lines of therapy (requiring a minimum of 2 disease assessments).

A DCR of 64% in third-line or higher mCRC patients, with a median time on treatment of nearly 17 weeks.

Several deep responses were observed across first- to third-line plus patients including patients with tumors shown to have KRAS/BRAF mutations; in further evidence of the deep responses associated with therapy, five patients discontinued study treatment at the investigator’s discretion to undergo surgical resection with curative intent.

An additional clinical study to further evaluate and advance etrumadenant in mCRC is planned and in development.

Initiated enrollment in ARC-6, a Phase 1b/2 platform trial in metastatic castrate resistant prostate cancer, evaluating various combinations of etrumadenant, zimberelimab, and AB680, alone or in combination, with standard of care therapies.

Appointed Bob Goeltz as Chief Financial Officer (CFO). Mr. Goeltz is a proven leader with substantial operational experience in both large and small cap biopharmaceutical company environments. His experience includes CFO roles at UNITY Biotechnology and CytomX Therapeutics, and an 11-year tenure at Amgen where he also served as the CFO of Onyx Pharmaceuticals after its acquisition by Amgen.

Appointed David Lacey, M.D. and Merdad Parsey, M.D., Ph.D. to Arcus’s Board of Directors.

Anticipated Near-Term Corporate Milestones

Presentation of efficacy and safety data from the ongoing ARC-4 study, a Phase 1/1b study of etrumadenant plus carboplatin, pemetrexed and anti-PD-1 therapy in patients with metastatic non-small cell lung cancer at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 in September: Abstract #1309P. The presentation will include an update on the dose-escalation cohort, as well as ongoing evaluation of the Ph1b expansion data assessing mutant EGFR patients who have failed 1-2 prior tyrosine kinase inhibitor (TKI) therapies.

Recommended dose for expansion for AB680 from the Phase 1 dose-escalation portion of ARC-8, a combination trial evaluating AB680 plus zimberelimab with gemcitabine/nab-paclitaxel in first-line metastatic pancreatic cancer.

Preliminary randomized data from two Phase 2 clinical collaborations with Genentech involving combination trials with etrumadenant in metastatic colorectal and pancreatic cancers, expected in the fourth quarter of 2020.

Preliminary randomized data from ARC-7, a Phase 2 trial involving domvanalimab (AB154) with unique intra-portfolio combinations in first-line metastatic high PD-L1 NSCLC, expected in the fourth quarter of 2020.

Initiation of a Phase 1 clinical trial for at least one of our existing discovery/preclinical development programs in late 2020/early 2021.

Through most of the second quarter, Arcus’s employees had been working remotely due to shelter-in-place orders, but in late June, Arcus began to transition its laboratory-based personnel back into its facilities. Arcus instituted a regular testing/monitoring program for COVID-19 in order to minimize the risks to Arcus’s employees as they return to work. Arcus continues to actively monitor the COVID-19 pandemic and its effects on our clinical trial operations, research and development programs, key vendors and employees. While we do not anticipate modifications to the timelines above, this will depend on future developments which are currently unknown, including aFinancial Results for the Second Quarter 2020 and Six Months Ended June 30, 2020

Cash, cash equivalents and investments in marketable securities were $462.5 million as of June 30, 2020, compared to $188.3 million at December 31, 2019. After June 30, 2020, Arcus received a $175 million upfront payment and $200 million equity investment upon closing of our partnership with Gilead on July 13, 2020, the amounts of which will be included in our results for the period ended September 30, 2020. The increase at June 30, 2020 as compared to December 31, 2019 was due to the completion of a public equity offering in May 2020 resulting in net proceeds of $326.2 million, partially offset by cash utilized for operations during the first half of 2020.

Revenues: Collaboration and license revenue were $1.8 million for each of the three months ended June 30, 2020 and 2019. Collaboration and license revenue was $3.5 million for each of the six months ended June 30, 2020 and 2019. The revenue in each of these periods was recognized from non-refundable upfront payments previously received and deferred for recognition pursuant to our option and license agreement with Taiho Pharmaceutical.

R&D Expenses: Research and development expenses were $35.7 million for the three months ended June 30, 2020, compared to $25.0 million for the same period in 2019. The increase in expense was due to increases in manufacturing costs required to supply our clinical studies, increases in clinical costs for our ongoing clinical studies, as well as increases in employee compensation costs primarily driven by increases in our headcount. Research and development expenses were $58.8 million for the six months ended June 30, 2020, compared to $40.6 million for the same period in 2019.

G&A Expenses: General and administrative expenses were $11.4 million for the three months ended June 30, 2020, compared to $5.9 million for the same period in 2019. The increase in expense was due to increases in legal and accounting expenses resulting from our collaboration agreement with Gilead and our ongoing public company compliance obligations. Employee compensation costs also increased primarily due to an increase in headcount and related costs. General and administrative expenses were $18.4 million for the six months ended June 30, 2020, compared to $10.9 million for the same period in 2019.

Net Loss: Net loss was $45.1 million for the three months ended June 30, 2020, compared to $28.1 million for the same period in the prior year. The increase in net loss as compared to the prior period was primarily attributable to an increase in operating expenses as noted above. Net loss for the six months ended June 30, 2020 was $72.8 million, compared to $45.8 million for the same period in 2019.

ny new information that may emerge concerning the duration and/or severity of the outbreak and any resurgences, any new actions by government authorities to contain the spread of the virus, and when and to what extent normal economic and operating conditions can resume.

On August 6, 2020 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported financial results for the second quarter ended June 30, 2020 (Press release, Geron, AUG 6, 2020, View Source [SID1234563094]). The Company will host a conference call today at 4:30 p.m. ET to discuss second quarter financial results and current events.

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"In the second quarter, we achieved a number of key milestones that have changed the trajectory of the Company," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "After a successful meeting with the FDA, we announced plans to move forward with a Phase 3 clinical trial in refractory MF with overall survival as the primary endpoint. This decision was based on overall survival data from the IMbark Phase 2 trial that suggest imetelstat treatment could potentially double the remaining life expectancy for patients who have become refractory to JAK inhibitors."

Dr. Scarlett added, "We reported clinically meaningful transfusion independence with longer durability from more mature data in the IMerge Phase 2 trial in lower risk MDS, which included 29% of patients being transfusion-free for more than one year. We also raised additional capital in the second quarter that we expect will sufficiently fund our development plans for the ongoing Phase 3 IMerge trial in lower risk MDS and the upcoming Phase 3 trial in refractory MF into the second half of 2022. These achievements, along with our experienced development team, position Geron to become a leader in the treatment of hematologic myeloid malignancies over the next several years."

Current Events – Clinical Development and Regulatory

Ongoing IMerge Phase 3 Clinical Trial in Myelodysplastic Syndromes (MDS)

As of the end of July 2020, approximately 93% of the 90 clinical sites originally planned for the trial were open for screening and enrollment, compared to 68% in May.

The momentum of patient enrollment has begun to improve as the effects of the COVID-19 pandemic begin to wane in a majority of the countries where IMerge clinical sites are located. The Company continues to expect patient enrollment to be completed by the end of the first quarter of 2021, subject to potential future delays or interruptions associated with COVID-19. To help ensure achievement of this goal, the trial is being expanded from 90 to approximately 130 clinical sites. Geron expects a majority of these 40 new sites to be open for enrollment by the end of the year. Under current enrollment assumptions, the Company continues to expect top-line results in the second half of 2022.

Start-Up Activities for Planned Phase 3 Clinical Trial in Myelofibrosis (MF)

Geron expects to engage over 150 sites across North America, South America, Europe and Asia to participate in the planned global Phase 3 clinical trial in refractory MF. Trial start-up activities underway include identifying potential clinical sites for participation, as well as finalizing the clinical trial protocol. Geron plans to open the trial for screening and enrollment in the first quarter of 2021. Under current planning assumptions, Geron expects to complete patient enrollment in the second half of 2022, to conduct an interim analysis in the first half of 2023 and to conduct a final analysis in the first half of 2024.

European Commission Grants Orphan Drug Designation to Imetelstat for MDS

At the end of July, the European Commission granted orphan drug designation to imetelstat as a potential treatment for MDS based on a positive opinion from the European Medicines Agency Committee for Orphan Medicinal Products. Imetelstat has already been granted orphan drug designation by the United States Food and Drug Administration as a potential treatment for MDS.

Geron Corporation | Confidential and Proprietary

Recent Data Presentations in June

KOL Event Highlighted Compelling Phase 2 Data from the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress

Key opinion leaders within hematologic myeloid malignancies reprised four presentations containing new clinical data and analyses related to imetelstat from the Virtual Edition of the EHA (Free EHA Whitepaper) Annual Congress.

The recent EHA (Free EHA Whitepaper) presentation of more mature data from 38 patients in the IMerge Phase 2 clinical trial in lower risk MDS reported notable continued durability, including a median duration of 8-week transfusion independence of 20 months, which is the longest duration reported to date in this trial. Also reported for the first time, 29% of the 38 patients were transfusion free for more than one year.

In addition, new analyses from the IMbark Phase 2 clinical trial in relapsed/refractory MF correlated the median overall survival observed in the trial with other clinical endpoints, such as improvement in fibrosis. These analyses provide further support for the planned Phase 3 clinical trial in refractory MF.

Overall, the EHA (Free EHA Whitepaper) data and analyses continue to support the potential disease-modifying activity with imetelstat treatment as evidenced by the clinically meaningful durable transfusion independence in the Phase 2 IMerge trial and the improvement in overall survival in the Phase 2 IMbark trial.

Strengthened Balance Sheet to Achieve Development Plans

As of June 30, 2020, Geron had approximately $265 million in cash, cash equivalents, and current and non-current marketable securities. The Company’s cash position reflects net proceeds of approximately $140 million from a public offering of securities in the second quarter. Based on current planning assumptions, the Company expects such funds to be sufficient for its operations into the second half of 2022 when top-line results for the IMerge Phase 3 clinical trial in lower risk MDS and completion of patient enrollment for the planned Phase 3 clinical trial in refractory MF are expected.

Second Quarter and Year-to-Date 2020 Results

For the second quarter of 2020, the Company reported a net loss of $15.8 million, or $0.06 per share, compared to $14.2 million, or $0.08 per share, for the comparable 2019 period. Net loss for the first six months of 2020 was $32.2 million, or $0.14 per share, compared to $24.3 million, or $0.13 per share, for the comparable 2019 period.

Revenues for the three and six months ended June 30, 2020 were $43,000 and $95,000, respectively, compared to $101,000 and $158,000 for the comparable 2019 periods. Revenues in 2020 and 2019 primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets. In connection with the divestiture of Geron’s human embryonic stem cell assets, including intellectual property and proprietary technology, to Lineage Cell Therapeutics, Inc. (formerly BioTime, Inc., which acquired Asterias Biotherapeutics, Inc.) in 2013, Geron is entitled to receive royalties on future product sales.

Total operating expenses for the three and six months ended June 30, 2020 were $16.8 million and $33.7 million, respectively, compared to $15.3 million and $26.7 million for the comparable 2019 periods.

Research and development expenses for the three and six months ended June 30, 2020 were $10.8 million and $21.6 million, respectively, compared to $10.1 million and $16.0 million for the comparable 2019 periods. The increase in research and development expenses for the three and six months ended June 30, 2020, compared to the same periods in 2019, primarily reflects higher clinical development costs associated with the IMerge Phase 3 clinical trial, increased costs in connection with validating the imetelstat manufacturing process at contract manufacturers and higher personnel-related costs for additions to the development team in 2019.

Geron Corporation | Confidential and Proprietary

General and administrative expenses for the three and six months ended June 30, 2020 were $6.0 million and $12.1 million, respectively, compared to $5.2 million and $10.6 million for the comparable 2019 periods. The increase in general and administrative expenses for the three and six months ended June 30, 2020, compared to same periods in 2019, primarily reflects increased personnel-related expenses for additional general and administrative headcount to support growing operational activities.

Interest and other income for the three and six months ended June 30, 2020 was $475,000 and $1.2 million, respectively, compared to $1.1 million and $2.3 million for the comparable 2019 periods. The decrease in interest and other income for the three and six months ended June 30, 2020, compared to same periods in 2019, primarily reflects lower yields on the Company’s reduced marketable securities portfolio.

2020 Financial Guidance Reaffirmed

The Company expects its 2020 operating expense burn to range from $70 to $75 million. This guidance reflects cash conservation measures implemented in April due to the COVID-19 pandemic, such as suspending travel and postponing a planned imetelstat proof of concept study. It also reflects new costs for start-up activities associated with the planned Phase 3 clinical trial in refractory MF and additional costs for the expansion of clinical sites for the IMerge Phase 3 clinical trial.

Conference Call

Geron will host a conference call at 4:30 p.m. ET on Thursday, August 6, 2020 to discuss second quarter financial results and recent events.

A live, listen-only webcast will 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.

Participants may access the conference call live via telephone by dialing domestically +1 (888) 869-1189 or internationally +1 (706) 643-5902. The conference ID is 8496138. To minimize potential registration and access delays, Geron has implemented Direct Event, which allows participants to pre-register online using the following link, View Source Upon registration, a Direct Event Passcode and unique Registrant ID will be sent via email and will be needed in order to enter the conference call. Participants are advised to pre-register at least 10 minutes prior to joining the call.

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 apoptosis of malignant stem and progenitor cells, which allows potential recovery of normal hematopoiesis. Geron’s imetelstat development program includes two registration-enabling studies, IMerge, an ongoing Phase 2/3 clinical trial in lower risk myelodysplastic syndromes (MDS), and a planned Phase 3 clinical trial in refractory myelofibrosis (MF) expected to be open for patient screening and enrollment in the first quarter of 2021. 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.

On August 6, 2020 Navidea Biopharmaceuticals, Inc. (NYSE American:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Thursday, August 13, 2020 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the second quarter ended June 30, 2020 (Press release, Navidea Biopharmaceuticals, AUG 6, 2020, View Source [SID1234563093]).

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Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Director of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

Event: Q2 2020 Earnings and Business Update Conference Call

Date: Thursday, August 13, 2020

Time: 5:00 p.m. (EDT)

U.S. & Canada Dial-in: 877-407-0312

International Dial-in: +1 201-389-0899

Conference ID: 13708190

Webcast Link: View Source

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.