On May 7, 2020 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS),reported its financial and operating results for the first quarter ended March 31, 2020 and provided a business update (Press release, Radius, MAY 7, 2020, View Source [SID1234557289]).

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"In these challenging and unprecedented times, I am proud of the Radius team’s quick response and key measures to ensure the safety of our employees, while also providing patients and customers with uninterrupted access to TYMLOS and our investigational medicines," said Jesper Hoeiland, former Chief Executive Officer of Radius. "I am very enthusiastic about the prospects for Radius and look forward to working with Kelly to make this transition as seamless and effective as possible," added Jesper.

"I look forward to building on the strong momentum established by Jesper with the TYMLOS franchise and guiding the development of the Company and the achievement of its objectives and advancing it to the next level," said Kelly Martin, President and CEO of Radius Health.

COVID-19 Response

In response to the ongoing COVID-19 pandemic, Radius has implemented a number of initiatives to support the safety of its employees and customers and mitigate impacts on the supply of TYMLOS and its investigational medicines to patients and healthcare providers, and advance its clinical studies. Our current expectations for the timing of enrollment and completion of our ongoing clinical trials, particularly for wearABLe and EMERALD, are based on our assumptions that during the second half of 2020, the effects of the COVID-19 pandemic will begin to subside as "shelter-in-place" policies and other restrictive measures are relaxed. As a result, we believe that enrollment rates will increase to near normal pre-pandemic levels, and for our wearABLe trial, our ex-U.S. trial sites are activated within the timelines we expect. The Company will continue to assess the pandemic and any potential impact it may

have on its operations, financial condition, guidance and plans. The mitigation measures that we have implemented to address potential challenges from the pandemic include the following:

Safety of Employees: A work-from-home mandate for employees was implemented in mid-March with enhanced utilization of technical tools and capabilities to accomplish secure remote access and conduct of virtual business.

Patient Access to TYMLOS: With the implementation of a new streamlined distribution model utilizing several specialty distributors, Radius is able to support seamless patient access to TYMLOS. TYMLOS is administered at home and over 90% of patients currently have the option to receive TYMLOS via home delivery. To date, Radius has observed no disruptions in its supply chain for the production and shipments of TYMLOS or its clinical trial medications. The Company has secured inventories of TYMLOS and its investigational medications until the end of the year and continues to manufacture to ensure continuity of supply.

Continued Patient Care and HCP Support: Radius’ commercial organization is providing virtual interactions to connect with healthcare providers, assisting their offices with continued access to TYMLOS tools and enabling supply of samples via online processes. The Company’s clinical educator team has also switched to virtual practices to continue support to both new patients and patients on treatment.

Supporting Ongoing Clinical Trials: Radius is working with clinical trial sites and clinical research organizations to provide virtual capabilities for site initiations, remote trial monitoring, virtual safety assessments at home, options for local procedures to reduce travel, and home delivery of investigational products. The Company is following regulatory guidance from the FDA and EMA on the conduct of clinical trials during the COVID-19 pandemic, providing support to each site, and prioritizing study visits for key efficacy assessments to maintain data quality and integrity.

TYMLOS (abaloparatide) injection

First quarter 2020 U.S. net sales of TYMLOS were $47.9 million, a 61% increase over the first quarter of 2019.

By the end of the first quarter 2020, TYMLOS’ average U.S. anabolic market share rose to 44% and it achieved a 53% share of new anabolic patient starts. With this growth trajectory, Radius remains confident TYMLOS will become the U.S. anabolic market leader in 2020 (based on TRx1).

In April, there has been a decline in new patient starts due to the decrease in physician office visits resulting from government restrictions in response to the pandemic. Assuming that during the second half of the year the impacts of the pandemic begin to subside as the shelter-in-place measures are relaxed and states re-open, Radius expects new TYMLOS prescriptions to increase and return to near normal pre-pandemic levels.

During the first quarter of 2020, Radius executed a transition of the Company’s external distribution model from full-line wholesalers to specialty distributors and specialty pharmacies. Under this distribution model, both the specialty distributors and specialty pharmacies take physical delivery of TYMLOS and pharmacies dispense TYMLOS directly to patients. This new streamlined distribution model has further improved the home delivery process for TYMLOS, achieved sustainable cost efficiencies, and is expected to have a positive impact on the gross to net sales ratio for TYMLOS.

Pipeline Highlights

Abaloparatide-SC

The ATOM Phase 3 Study, which is assessing the efficacy and safety of abaloparatide-SC in men with osteoporosis, has completed approximately 90% of its enrollment. Radius expects to complete recruitment this year and report top-line data in the second half of 2021.

The TYMLOS bone histomorphometry study, which evaluated the early effects of abaloparatide-SC on tissue-based indices of bone formation and resorption in postmenopausal women, met its primary endpoint of change from baseline to 3 months in mineralizing surface in the cancellous bone envelope, which is a strong indicator of bone formation. Radius expects to present data from this study in the second half of 2020.

Abaloparatide-Patch

The wearABLe Phase 3 study continues to advance enrollment amid slowdown from the pandemic. The screening failure rate has significantly decreased after the implementation of a revised enrollment plan and addition of targeted bone specialty sites in the U.S. In Europe, regulatory reviews are underway, with first conditional approvals already received for sites to be initiated in the second quarter of this year.

At this time, Radius expects to complete recruitment in the later part of the third quarter of 2020 and report top-line data from the study in the second half of 2021.

Elacestrant

The EMERALD Phase 3 study is continuing to advance its global enrollment. The recruitment activity which slowed down in April because of the pandemic is resuming at sites in countries where COVID-19 restrictions have been eased.

At this time, Radius expects completion of recruitment in the study in the fourth quarter of this year and to report top-line data in the second half of 2021.

Financial Highlights and Guidance

Radius has decreased its full-year TYMLOS U.S. net revenue guidance mid-point by 10%, taking the impacts from the COVID-19 pandemic into consideration, and assuming a return to normalized pre-pandemic demand patterns in the second half of 2020. At this time, the Company expects full-year TYMLOS U.S. net revenue to be between $190 and $220 million and its full-year cash burn to be below $100 million, excluding net cash from the existing non-dilutive credit facility.

Radius had $23 million net cash outflows in the first quarter and closed the quarter with a $138 million cash balance. The Company has drawn $10M from the term loan that it secured in January. Radius expects access to non-dilutive financing for another $30M from the second and third tranche of the term loan and up to $20M from the working capital revolver that it entered into in January.

Anticipated Milestones in 2020

Clinical Pipeline

Complete recruitment in Phase 3 ATOM study

Complete recruitment in Phase 3 wearABLe study

Complete recruitment in Phase 3 EMERALD study

TYMLOS

Grow full-year TYMLOS U.S. net sales to between $190 and $220 million

Capture U.S. anabolic TRx market leadership in 2H 2020

First Quarter 2020 Financial Results

Three Months Ended March 31, 2020

For the three months ended March 31, 2020, Radius reported a net loss of $37.7 million, or $0.81 per share, compared to a net loss of $42.8 million, or $0.94 per share, for the three months ended March 31, 2019.

For the three months ended March 31, 2020, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, depreciation, non-cash interest obligations under debt obligations, and amortization of intangible assets, was $27.4 million, or $0.59 per share, compared to non-GAAP adjusted net loss of $31.8 million, or $0.70 per share, for the three months ended March 31, 2019.

For the three months ended March 31, 2020, we recorded approximately $47.9 million of net product revenue compared to $29.8 million for the three months ended March 31, 2019.

For the three months ended March 31, 2020, research and development expense was $39.0 million compared to $23.3 million for the three months ended March 31, 2019, an increase of $15.8 million, or 68%. This increase was primarily driven by a $11.1 million increase in abaloparatide-patch program costs, a $3.4 million increase in elacestrant program costs, a $0.9 million increase in professional support costs, and a $0.4 million increase in abaloparatide-SC program costs.

For the three months ended March 31, 2020, selling, general and administrative expense was $36.4 million compared to $41.2 million for the three months ended March 31, 2019, a decrease of $4.8 million, or 12%. This decrease was primarily the result of a $2.9 million decrease in professional support costs, a $1.4 million decrease in compensation and travel entertainment costs, and a $0.6 million decrease in occupancy and depreciation costs. These decreases were partially offset by a $0.1 million increase in other operating expenses.

As of March 31, 2020, Radius had $138.5 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of March 31, 2020 and funds available to us through our credit facilities, we believe that, prior to the consideration of potential proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans, U.S. commercial and other operational activities for at least twelve months from the date of this press release.

On May 7, 2020 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported financial and operating results for the first quarter ended March 31, 2020 (Press release, BioTime, MAY 7, 2020, View Source [SID1234557288]). Lineage management will host a conference call today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2020 financial and operating results and to provide a business update.

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"Lineage has adapted quickly to an unprecedented business environment. We ensured the safety of our teams while maintaining the continuity of our global operations and advancing our programs with meaningful clinical data and contractual arrangements," stated Brian M. Culley, Lineage CEO. "Looking ahead, we believe we are well positioned to achieve many of our 2020 objectives. Most notably, a clinical update recently presented at the ARVO meeting provided a more comprehensive picture of treatment with OpRegen, where certain patients were able to see better, have less growth to their area of geographic atrophy, and read faster, representing important enhancements to vision and quality of life metrics. We also are excited about exercising our option to regain control of the VAC platform for immuno-oncology and expand it to the development of a vaccine for coronaviruses such as SARS-CoV-2, the virus which causes COVID-19."

2020 Plans and Objectives:

-Present new OpRegen data from the ongoing Phase 1/2a clinical trial as available throughout the year.

-Complete patient enrollment in the U.S. with the Gyroscope Orbit SDS and new thaw-and-inject formulation in the ongoing Phase 1/2a clinical trial of OpRegen for the treatment of dry AMD.

-Meet with the U.S. Food and Drug Administration (FDA) to discuss the further clinical development of OpRegen.

-Evaluate partnership opportunities for the OpRegen program and other development assets.

-Report VAC2 clinical data from the initial patients treated in the ongoing Phase 1 trial in NSCLC (non-small cell lung cancer) run by Cancer Research UK.

-Enhance commercial utility of OPC1 program by introducing commercially enabling improvements to the manufacturing process in our GMP manufacturing facility.

-Continue engagement with the investment and medical communities with virtual participation at medical and healthcare industry conferences, ongoing throughout 2020.

-Strengthen existing partnerships with the National Institutes of Health, the Israel Innovation Authority, the California Institute for Regenerative Medicine and Cancer Research UK.

Seek non-dilutive support for certain programs, as may be available, including for coronavirus vaccine development.

Balance Sheet and Cash Flow Highlights

Cash, cash equivalents, and marketable securities totaled $25.8 million as of March 31, 2020. Marketable securities include our remaining ownership of unrestricted securities in OncoCyte Corporation (OncoCyte), AgeX Therapeutics, Inc. (AgeX) and Hadasit Bio-Holdings Ltd (Hadasit).

We have continued to fund our operations primarily by selling a portion of our marketable securities. On January 2, 2020, we sold 2,383,090 shares of OncoCyte stock for net proceeds of approximately $5.0 million. On April 23, 2020, we sold an additional 1,672,689 shares of OncoCyte stock for net proceeds of approximately $3.7 million. We continue to hold approximately 4.3 million shares of OncoCyte stock that are valued at $11.3 million as of May 5, 2020, based on the closing price of its common stock on that date. All of our marketable securities are now in companies in which we hold less than 10% of the outstanding shares.

In conjunction with the sale of AgeX shares to Juvenescence Limited (Juvenescence) in 2018, we also hold a $21.6 million promissory note bearing 7% annual interest that matures on August 30, 2020. As of March 31, 2020, the outstanding principal and accrued interest on the note was $24.0 million. If, prior to August 30, 2020, Juvenescence completes an initial public offering resulting in gross proceeds of at least $50.0 million, the promissory note automatically converts into the Juvenescence securities.

Net cash used in operating activities for the three months ended March 31, 2020 was approximately $5.0 million, a decrease of $4.3 million as compared to $9.3 million in the same period of 2019. This level of quarterly activity was in line with our budgeted annual net operational spend of $16 million for 2020. As a result of incremental expenses we anticipate incurring during the remainder of the year related to the early exercise of our option with Cancer Research UK, our plans for the development of a prophylactic vaccine against SARS-CoV-2 and other coronaviruses, and delays caused by COVID-19 to our OpRegen clinical trial, we anticipate our net operational spend for 2020 will increase modestly.

First Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from research grants, royalties and licensing fees. Total revenues for the three months ended March 31, 2020 were $0.5 million, a decrease of $0.4 million as compared to $0.9 million for the same period in 2019. The decrease was primarily related to a $0.4 million decrease in grant revenue due to the timing of grant related activities for OpRegen and other ophthalmic applications.

Operating Expenses: Operating expenses are comprised of research and development (R&D) expenses and general and administrative (G&A) expenses. Total operating expenses for the three months ended March 31, 2020 were approximately $7.8 million, a decrease of $5.8 million as compared to $13.6 million for the same period in 2019.

R&D Expenses: R&D expenses for the three months ended March 31, 2020 were $3.3 million, an approximate decrease of $1.7 million as compared to $5.0 million for the same period in 2019. The overall decrease was primarily related to decreases of $1.8 million in OpRegen and other ophthalmic application expenses and $0.4 million in Renevia expenses, offset by an increase of approximately $0.5 million in OPC1 expenses.

G&A Expenses: G&A expenses for the three months ended March 31, 2020 were $4.5 million, a decrease of $4.1 million as compared to approximately $8.6 million for the same period in 2019. The decrease was primarily attributable to a $3.3 million reduction in expenses related to our merger with Asterias Biotherapeutics, Inc. (Asterias), a $0.9 million decrease in salaries, benefits and severance costs primarily related to terminated personnel, a $0.4 million reduction in accounting expenses, a $0.1 million reduction in rent expenses and a $0.1 million reduction in consulting expenses, offset by a $0.5 million increase in legal and patent expenses and a $0.2 million increase related to the cessation of shared services reimbursements.

Loss from Operations: Loss from operations for the three months ended March 31, 2020 was $7.4 million, an approximate decrease of $5.4 million as compared to $12.8 million for the same period in 2019.

Other (Expense) Income, Net: Other income/(expenses), net for the three months ended March 31, 2020 reflected other expense, net of ($1.0) million, compared to other income, net of $47.7 million for the same period in 2019. The variance was primarily related to changes in the value of equity method investments and marketable equity securities for the applicable periods, as well as foreign currency translation adjustments related to Lineage’s international subsidiaries. The value of Lineage’s OncoCyte shares increased by $37.7 million in the three months ended March 31, 2019, which contributed greatly to the overall balance in other income, net for that period.

Net loss attributable to Lineage: The net loss attributable to Lineage for the three months ended March 31, 2020 was $8.4 million, or $0.06 per share (basic and diluted), compared to a net income attributable to Lineage of $39.3 million, or $0.30 per share (basic and diluted), for the same period in 2019.

Conference Call and Webcast

Lineage will host a conference call and webcast today, at 1:30 pm PT/4:30 pm ET to discuss its first quarter 2020 financial results and to provide a business update. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. Interested parties may also access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through May 14, 2020, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 7948501.

On May 7, 2020 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the first quarter ended March 31, 2020 (Press release, Nektar Therapeutics, MAY 7, 2020, View Source [SID1234557287]).

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Cash and investments in marketable securities at March 31, 2020 were approximately $1.5 billion as compared to $1.6 billion at December 31, 2019.

"Amid the challenges of the evolving COVID-19 pandemic, our Nektar team made significant progress to advance our various clinical studies for our immuno-oncology pipeline while also prioritizing the safety of the patients we serve, our employees and the physicians and staff in our clinical trial network," said Howard W. Robin, President and CEO of Nektar. "For our ongoing studies in oncology, we are working with our global study sites to ensure that patients continue to receive uninterrupted access to study treatment and that we preserve the integrity and conduct of our trials. Many of our clinical trial timelines remain intact; however, at this time, we currently expect that enrollment and study starts managed by our partners will likely be delayed from three to six months. From an operational perspective, Nektar’s strong financial position coupled with decisive mitigation actions to address the potential impact to our business, provides a solid foundation for Nektar as we navigate this unprecedented time."

Summary of Q1 2020 Financial Results

Revenue in the first quarter of 2020 was $50.6 million as compared to $28.2 million in the first quarter of 2019. The increase was due primarily to the recognition of a $25.0 million milestone payment from Bristol-Myers Squibb related to the initiation of the registrational trial of bempegaldesleukin plus Opdivo in muscle-invasive bladder cancer.

Total operating costs and expenses in the first quarter of 2020 were $184.2 million as compared to $148.9 million in the first quarter of 2019. Total operating costs and expenses increased primarily as a result of impairment of assets and other costs for NKTR-181, partially offset by a decrease in R&D.

During the first quarter of 2020, Nektar reported $45.2 million in impairment charges and additional costs related to the discontinuation of the NKTR-181 program, which was announced in January 2020. This includes $19.7 million for the impairment of advance payments to contract manufacturers for commercial batches of NKTR-181, and $25.5 million of additional costs, primarily for non-cancellable commitments to contract manufacturers and certain severance costs.

R&D expense in the first quarter of 2020 was $109.0 million as compared to $118.5 million for the first quarter of 2019. The decrease was due primarily to pre-commercial manufacturing costs for NKTR-181 incurred during the three months ended March 31, 2019.

G&A expense was $26.2 million in the first quarter of 2020 as compared to $25.0 million in the first quarter of 2019.

Net loss for the first quarter of 2020 was $138.7 million or $0.78 basic and diluted loss per share as compared to a net loss of $119.6 million or $0.69 basic and diluted loss per share in the first quarter of 2019. The loss per share for the first quarter of 2020 includes $0.25 loss per share for the impairment charges and additional costs related to the discontinuation of the NKTR-181 program.

COVID-19 Business Update and Review

Nektar remains committed to advancing its mission of bringing forth novel therapies for the treatment of cancer and autoimmune disorders. The company continues to closely monitor the evolving situation with COVID-19 to prepare for and minimize the potential impact to the business as a result of the COVID-19 pandemic.

Nektar-Sponsored Clinical Trials:

●Nektar has numerous clinical trials underway in cancer treatment facilities across the globe that are continuing to proceed. Over the past several months, Nektar deployed a strategy to allow continued enrollment and new study site initiations at facilities that have demonstrated operational readiness and are equipped to provide superior care and uninterrupted access to study treatment and patient services. For all ongoing clinical trials, Nektar is working closely with clinical trial sites to understand their needs during this time. The company is utilizing remote monitoring when possible to oversee study conduct. Nektar has adopted processes to allow for telemedicine and closer access to patient care where and when appropriate so it can continue all data collection processes and support patient safety. Nektar continues to monitor the evolving situation and the impact of COVID-19 for all of its clinical trials.

●Nektar also continues to monitor and support patients by leveraging alternative methods for maintaining clinical trial integrity, and to properly record patient event data that may be related to the COVID-19 pandemic, incorporating recent direction and flexibility provided by the United States Food and Drug Administration and other regulatory authorities.

●The majority of Nektar-run clinical studies in oncology have not experienced any significant delays. Nektar cautions that the evolving landscape could impact these statements and could still delay late-stage studies or enrollment of new patients into clinical trials in the future. Nektar currently believes that it could experience delays of approximately three months with respect to previously-provided timelines for earlier stage Nektar-run studies, such as the PROPEL study, where the initiation of planned new investigator sites in Europe was delayed due to the COVID-19 pandemic.

Nektar Manufacturing and Supply:

●At this time, Nektar does not anticipate any supply interruptions for manufacturing, including its preparations for scale-up of commercial supply of bempegaldesleukin, which are underway. The company has sufficient clinical trial material on hand to treat all patients in the studies for bempegaldesleukin, NKTR-262, NKTR-255 and NKTR-358, which are either underway or planned to start in 2020. Nektar and its manufacturing partners are continuing to regularly assess the situation.

Partner-Sponsored Clinical Trials:

●For Nektar’s pharmaceutical partners, management practices around ongoing and planned clinical trial activities have varied during the COVID-19 situation. Based upon Nektar’s current assessment of activities of its pharmaceutical partners, at this time, Nektar currently expects adjustments of timelines for projected study endpoints, study enrollment rate and study starts of between three to six months. However, this is subject to change as the situation is evolving and will depend upon how long COVID-19 precautionary measures remain in place.

First Quarter 2020 and Recent Business Highlights:

●In February 2020, Nektar announced the publication of preclinical bempegaldesleukin data in two manuscripts in Nature Communications showing how bempegaldesleukin works synergistically with multiple immune-based therapies to enhance T-cell-mediated tumor control.

●In January 2020, Nektar and Bristol-Myers Squibb announced a new joint development plan that expands the ongoing registrational program for bempegaldesleukin plus Opdivo (nivolumab) from three ongoing registrational trials in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic renal cell carcinoma (RCC) to include two additional registrational trials in adjuvant melanoma and muscle-invasive bladder cancer. In addition, a Phase 1/2 study will be initiated to evaluate bempegaldesleukin plus nivolumab in combination with axitinib in first-line RCC in order to support a future registrational trial. Bristol-Myers Squibb will also independently conduct and fund a Phase 1/2 study in first-line non-small-cell lung cancer with bempegaldesleukin and nivolumab.

Conference Call to Discuss First Quarter 2020 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, Thursday, May 7, 2020.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through June 1, 2020.

To access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 8288857 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

On May 7, 2020 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results and a corporate update for the first quarter ended March 31, 2020 (Press release, Mirati, MAY 7, 2020, View Source [SID1234557286]).

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"Despite the challenges many are facing related to the COVID-19 pandemic, we have continued to advance all of our clinical and preclinical programs. MRTX849, our selective KRAS G12C inhibitor program, is progressing according to plan including enrollment in the registration-enabling arm of the KRYSTAL Phase 1/2 clinical trial in patients with non-small cell lung cancer (NSCLC) receiving 2nd or 3rd line therapy. We have initiated combination trials of MRTX849 with pembrolizumab, cetuximab and TNO155," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer at Mirati Therapeutics. "Today, we are also pleased to report updated overall survival (OS) data for our sitravatinib program. Our on-going Phase 2 trial of sitravatinib in combination with nivolumab (MRTX-500), continues to demonstrate durable efficacy. Preliminary median OS of 18.1 months was observed for the subset of patients who received the combination as their 2nd or 3rd line of therapy, which is the same profile of patients currently enrolling in SAPPHIRE, our global, randomized Phase 3 clinical trial. We look forward to presenting additional data from the MRTX-500 trial at a future medical conference."

RECENT CORPORATE UPDATES:

MRTX849 (KRAS G12C Inhibitor)

Enrollment is ongoing in the KRYSTAL clinical trial including the following arms: single-agent MRTX849 Phase 2 registrational arm as 2nd or 3rd line therapy in NSCLC as well as the combinations of MRTX849 with a PD-1 (pembrolizumab) in NSCLC and with an EGFR inhibitor (cetuximab) in colorectal cancer (CRC).

Began enrolling patients in the combination trial of MRTX849 with Novartis’ SHP2 inhibitor, TNO155, in 2nd or 3rd line NSCLC and CRC.

On March 17th, the Journal of Internal Medicine published a paper online "Targeting KRAS G12C mutant cancer with a mutation‐specific inhibitor" lead author on the manuscript was James G. Christensen, Ph.D., Executive Vice President and Chief Scientific Officer at Mirati Therapeutics.

On April 6th, the Journal of Medicinal Chemistry published a paper online, "Identification of the Clinical Development Candidate MRTX849, a Covalent KRAS G12C Inhibitor for the Treatment of Cancer" senior author on the manuscript was Matthew Marx, Ph.D., Vice President of Drug Discovery at Mirati Therapeutics.

Sitravatinib

Announcing updated preliminary data from MRTX-500, the Phase 2 clinical trial evaluating sitravatinib and nivolumab (OPDIVO) in NSCLC patients who have documented disease progression on or after treatment with a checkpoint inhibitor (anti-PD-1/PD-L1 inhibitor). Patients in the prior clinical benefit (PCB) cohort experienced PCB on a checkpoint inhibitor as part of their last treatment regimen prior to enrollment. PCB is defined as either complete response (CR), partial response (PR) or stable disease (SD) for ≥12 weeks. The PCB cohort had been fully enrolled with 87 patients.

As of the data cut-off of January 30, 2020:

Preliminary median OS of 15.6 months for the PCB cohort (n=87).

Preliminary median OS of 18.1 months for the subset of PCB patients who received the combination as either 2nd or 3rd line of therapy after progressing on treatment with a checkpoint inhibitor (n=73), which is a patient cohort consistent with the inclusion criteria for the ongoing SAPPHIRE Phase 3 clinical trial.

The combination has been well-tolerated and most adverse events (AEs) were Grade 1 or 2 and were similar to data presented previously.

Operational Updates
Ended the first quarter 2020 with $695.4 million in cash, cash equivalents, and short-term investments.

Financial Results for the First Quarter 2020

License and collaboration revenues earned for manufacturing and supply services under the Collaboration and License Agreement between the Company and BeiGene, Ltd. ("BeiGene"), dated January 7, 2018, were $0.3 million for the first quarter of 2020 and $1.2 million for the same period in 2019.

Research and development expenses for the first quarter of 2020 were $71.7 million, compared to $34.2 million for the same period in 2019. The increase in research and development expenses is due to an increase in expense associated with the development of MRTX849 and sitravatinib, as well as an increase in salaries and related expense, including an increase in share-based compensation expense. The Company recognized research and development-related share-based compensation expenses of $11.8 million during the first quarter of 2020, compared to $5.2 million for the same period in 2019.

General and administrative expenses for the first quarter of 2020 were $18.0 million, compared to $9.8 million for the same period in 2019. The increase is due primarily to an increase in share-based compensation expense and, to a lesser extent, an increase in employee-related expense, professional services expense and facilities and insurance expense. The Company recognized general and administrative-related share-based compensation expenses of $9.7 million during the first quarter of 2020, compared to $6.0 million for the same period in 2019.

Net loss for the first quarter of 2020 was $86.7 million, or $2.02 per share basic and diluted, compared to net loss of $40.9 million, or $1.17 per share basic and diluted for the same period in 2019.

Cash, cash equivalents, and short-term investments were $695.4 million at March 31, 2020, compared to $415.1 million at December 31, 2019. In January 2020, we completed a public offering of common stock that provided net cash proceeds of $324.0 million.

About MRTX849

MRTX849 is an investigational, orally available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of non-small cell lung cancer (NSCLC) adenocarcinoma patients, 4% of colorectal cancer patients, and subsets of other types of cancer. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MRTX849 is being evaluated in a Phase 1/2 trial treating patients with molecularly identified, KRAS G12C-positive advanced solid tumors and in the first quarter of 2020, enrollment began in the registration enabling cohort in monotherapy NSCLC, colorectal cancer and pancreatic cancer.

About Sitravatinib

Sitravatinib is an investigational spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. Sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients whose cancers have progressed despite treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including the ongoing potentially registration-enabling Phase 3 trial of sitravatinib in combinations with a checkpoint inhibitor in non-small cell lung cancer (NSCLC). In addition, sitravatinib in combinations with checkpoint inhibitors are being evaluated in selected checkpoint inhibitor naïve patients.

On May 7, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2020 (Press release, Puma Biotechnology, MAY 7, 2020, View Source [SID1234557285]). Unless otherwise stated, all comparisons are for the first quarter of 2020 compared to the first quarter of 2019.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net product revenue in the first quarter of 2020 was $48.6 million, compared to net product revenue of $45.6 million in the first quarter of 2019.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $16.9 million, or $0.43 per share, for the first quarter of 2020, compared to a net loss of $10.1 million, or $0.26 per share, for the first quarter of 2019.

Non-GAAP adjusted net loss was $8.0 million, or $0.20 per share, for the first quarter of 2020, compared to non-GAAP adjusted net income of $8.1 million, or $0.21 per basic share and $0.20 per diluted share, for the first quarter of 2019. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense. For a reconciliation of GAAP net loss to non-GAAP adjusted net income (loss) and GAAP net 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 used in operating activities for the first quarter of 2020 was $11.5 million, compared to $16.1 million used in the first quarter of 2019. At March 31, 2020, Puma had cash, cash equivalents and marketable securities of $100.6 million, compared to cash, cash equivalents and marketable securities of $111.6 million at December 31, 2019.

"We remain focused on providing a significant impact to cancer patients in need. The earlier-than-expected approval of the sNDA of NERLYNX in combination with capecitabine to treat adult patients with HER2-positive metastatic breast cancer who have received two or more prior anti HER2-based regimens in the metastatic setting is an important step toward this goal," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Our global partners also are working hard to bring the drug to market in their respective territories, thereby increasing global access to NERLYNX. Earlier today, we announced that our licensing partner CANbridge Pharmaceuticals received marketing approval of NERLYNX in mainland China. In addition, we are closely monitoring the changing COVID-19 situation. We are pleased to announce that we maintain a significant stock of NERLYNX and do not anticipate any disruption of supply to existing or new patients."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) conducting a pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2 mutated hormone receptor positive breast cancer and HER2 mutated cervical cancer in the first quarter of 2021; (ii) reporting Phase II data from the HER-positive breast and cervical cancer cohort from the SUMMIT trial of neratinib in patients with HER2 mutations in the fourth quarter of 2020; (iii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2020; and (iv) receiving regulatory decisions for an extended adjuvant HER2-positive early stage breast cancer indication in additional countries."

Revenue

Total revenue consists of net product revenue from sales of NERLYNX, Puma’s first commercial product, license revenue and royalty revenue. For the first quarter of 2020, total revenue was $51.2 million, of which $48.6 million was net product revenue, $2.0 million was license revenue from a Puma sub-licensee and $0.6 million was royalty revenue. This compares to total revenue of $99.1 million in the first quarter of 2019, of which $45.6 million was net product revenue and $53.5 million was license revenue from Puma’s sub-licensees.

Operating Costs and Expenses

Total operating costs and expenses were $65.5 million for the first quarter of 2020, compared to $89.2 million for the first quarter of 2019.

Cost of Sales

Cost of sales was $9.1 million for the first quarter of 2020, compared to $8.0 million for the first quarter of 2019.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $30.9 million for the first quarter of 2020, compared to selling, general and administrative expenses of $45.5 million for the first quarter of 2019. The $14.6 million decrease resulted primarily from decreases in professional fees and expenses of approximately $8.7 million, stock-based compensation expense of approximately $5.2 million, payroll and payroll-related expenses of approximately $0.6 million, and travel and meetings of approximately $0.3 million. These decreases were partially offset by an increase in training expenses and compliance fees of approximately $0.2 million.

Research and Development Expenses

Research and development expenses were $25.5 million for the first quarter of 2020, compared to $35.7 million for the first quarter of 2019. The $10.2 million decrease resulted primarily from decreases in clinical trial expense of approximately $4.9 million, stock-based compensation expense of approximately $4.0 million, and consultant and contractors expenses of approximately $1.4 million.

Total Other Income (Expenses)

Total other expenses were $2.6 million for the first quarter of 2020, compared to total other expenses of $20.0 million for the first quarter of 2019. The $17.4 million decrease resulted primarily from decreases in legal verdict expense of approximately $16.3 million and interest expense of approximately $1.5 million. These decreases were partially offset by a decrease in interest income of approximately $0.5 million.

Conference Call

Puma Biotechnology will host a conference call to report its first 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, May 7, 2020. The call may be accessed by dialing 1-866-548-4713 (domestic) or 1-323-794-2093 (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.