On May 10, 2021 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported financial results for the three months ended March 31, 2021 and highlighted recent corporate updates (Press release, Heron Therapeutics, MAY 10, 2021, View Source [SID1234579600]).

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Recent Corporate Updates

Acute Care Franchise

New Drug Application Resubmission for HTX-011 Under Review: The New Drug Application (NDA) resubmission for HTX-011, an investigational agent for the management of postoperative pain, submitted November 12, 2020 to the U.S. Food and Drug Administration (FDA), continues under review. The FDA set a PDUFA goal date of May 12, 2021.
Initiation of Expanded Phase 2 Clinical Study of HTX-034 for the Treatment of Postoperative Pain: In March 2021, Heron initiated the expanded Phase 2 clinical study in patients undergoing bunionectomy with HTX-034, Heron’s next-generation product for the treatment of postoperative pain.
NDA for HTX-019 Planned in Late 2021 for Prevention of PONV in Adults: In the Phase 1 bioequivalence study, HTX-019 32 mg as a 30-second intravenous (IV) injection was bioequivalent to oral aprepitant 40 mg, which is approved for the prevention of postoperative nausea and vomiting (PONV). A 505(b)(2) NDA for HTX-019 for PONV in adults is planned for late 2021.
Oncology Care Franchise

2021 Net Product Sales: For the three months ended March 31, 2021, oncology care franchise net product sales were $20.0 million, compared to $25.4 million for the same period in 2020. The Coronavirus Disease 2019 (COVID-19) pandemic reduced cancer screening procedures and new patient treatment starts in 2020 resulting in fewer clinic anti-emetic administrations during the first quarter of 2021 compared to the prior year and last quarter. Heron is assisting Community Oncology Alliance with its campaign to get patients back into screening. With the greater availability of COVID-19 vaccines and the declining rates of infection, Heron believes that the number of patients receiving cancer treatment will begin to return to normal levels.
CINVANTI Net Product Sales: Net product sales of CINVANTI (aprepitant) injectable emulsion for the three months ended March 31, 2021 were $18.5 million, compared to $25.2 million for the same period in 2020. Based on recently signed agreements with key customers, Heron believes the most significant impact of the generic arbitrage is over and expects to grow CINVANTI market share in 2021 and beyond.
SUSTOL Net Product Sales: Net product sales of SUSTOL (granisetron) extended-release injection for the three months ended March 31, 2021 were $1.5 million, compared to $0.2 million for the same period in 2020. In the first quarter of 2021, Heron reinstated promotion and contracting of SUSTOL to restore growth in 2021 and beyond.
Full-Year 2021 Net Product Sales Guidance: Heron expects full-year 2021 net product sales for the oncology care franchise of $130 million to $145 million.
"We have no outstanding questions on the pending NDA and are currently in labelling discussions with the FDA, as we prepare for the anticipated commercial launch of HTX-011 in the U.S.," said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. "For the oncology care franchise, we expect the market to pick up in the second quarter and we recently signed a large, multi-year contract for CINVANTI that will help increase net product sales throughout 2021."

Financial Results

Net product sales for the three months ended March 31, 2021 were $20.0 million, compared to $25.4 million for the same period in 2020.

Heron’s net loss for the three months ended March 31, 2021 was $52.6 million, or $0.58 per share, compared to $51.6 million, or $0.57 per share for the same period in 2020. Net loss for the three months ended March 31, 2021 included non-cash, stock-based compensation expense of $11.5 million, compared to $12.0 million for the same period in 2020.

As of March 31, 2021, Heron had cash, cash equivalents and short-term investments of $166.5 million, compared to $208.5 million as of December 31, 2020. Net cash used for operating activities for the three months ended March 31, 2021 was $41.9 million, compared to $32.9 million for the same period in 2020. Heron expects that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2022.

About HTX-011 for Postoperative Pain (ZYNRELEF in Europe)

HTX-011, an investigational non-opioid analgesic, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. The FDA granted Breakthrough Therapy designation to HTX-011 and the NDA received Priority Review designation. A complete response letter was received from the FDA regarding the NDA for HTX-011 in June 2020 relating to non-clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls issues were identified. Heron resubmitted an NDA to the FDA for HTX-011 in November 2020 and the FDA set a PDUFA goal date of May 12, 2021. In September 2020, the European Commission granted a marketing authorization for ZYNRELEF (also known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. As of January 1, 2021, ZYNRELEF is approved in 31 European countries including the countries of the European Union and European Economic Area and the United Kingdom.

About HTX-034 for Postoperative Pain

HTX-034, an investigational non-opioid analgesic, is a triple-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam and aprepitant, an additional agent that further potentiates the activity of bupivacaine. HTX-034 is formulated in the same proprietary polymer as HTX-011. By combining two different mechanisms that each enhance the activity of the local anesthetic bupivacaine, HTX-034 is designed to provide superior and prolonged analgesia. Local administration of HTX-034 in a validated preclinical postoperative pain model resulted in sustained analgesia for 7 days.

About HTX-019 for PONV

HTX-019 is an IV injectable emulsion formulation designed to directly deliver aprepitant, the active ingredient in EMEND (aprepitant) capsules, which is the only substance P/neurokinin-1 (NK1) receptor antagonist (RA) to be approved in the U.S. for the prevention of PONV in adults. The FDA-approved dose of oral EMEND is 40 mg for PONV, which is given within 3 hours prior to induction of anesthesia for surgery. In a Phase 1 clinical trial, 32 mg of HTX-019 as a 30-second IV injection was demonstrated to be bioequivalent to oral aprepitant 40 mg.

About CINVANTI (Aprepitant) Injectable Emulsion

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI is a 30-minute IV infusion or a 2-minute IV injection.

CINVANTI is under investigation for the treatment of COVID-19 as a daily 2-minute IV injection when added to the current standard of care.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL (Granisetron) Extended-Release Injection

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

On May 10, 2021 Novavax, Inc. (NASDAQ: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, reported its financial results and operational highlights for the first quarter ended March 31, 2021 (Press release, Novavax, MAY 10, 2021, View Source [SID1234579621]).

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"Novavax made great strides over the first quarter to pave the path for our COVID-19 vaccine candidate, NVX-CoV2373, notably achieving statistically significant efficacy across our Phase 3 UK and Phase 2b South Africa trials," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "In parallel, we have secured additional manufacturing and supply agreements, expanding our global supply chain to over 10 countries. In the coming months, we look forward to delivering on critical milestones, including announcing final data from our PREVENT-19 Phase 3 trial, completing our regulatory submissions, evaluating NVX-CoV2373 in younger populations and continuing to develop our booster strategy to address the evolving COVID-19 pandemic. As we continue our dialogue with regulatory authorities for authorization, we remain committed to promptly delivering our vaccine globally, ensuring equitable access and expansive distribution."

First Quarter 2021 and Recent Highlights

COVID-19 Clinical Development

Reported final efficacy analysis from UK Phase 3 trial and complete analysis from South Africa Phase 2b trial, expanding upon previously reported interim results
Demonstrated 100% protection against severe disease
Confirmed 96.4% efficacy against original strain of COVID-19 and 86.3% efficacy against B.1.1.7 variant strain in UK Phase 3 trial
Demonstrated efficacy of 88.9% in adults over the age of 65 and efficacy of 90.9% in adults with high-risk medical comorbidities in UK Phase 3 trial
Demonstrated efficacy of 55.4% among HIV-negative participants in South Africa Phase 2b trial, with the vast majority of cases due to the B.1.351 escape variant
South Africa Phase 2b results published in the New England Journal of Medicine
UK Phase 3 results submitted for publication to peer-reviewed journal and posted to medRxiv.org
Completed successful enrollment of 30,000 participants for PREVENT-19; final analysis to be reported in the second quarter of 2021
Initiated pediatric expansion of PREVENT-19 to evaluate efficacy, safety and immunogenicity of NVX-CoV2373 in adolescents
Enrolling up to 3,000 adolescent participants aged 12-17 across up to 75 sites in the U.S.
Blinded crossover expected to begin six months after initial set of vaccinations
Initiated crossovers and progressed booster studies of NVX-CoV2373
Initiated crossovers in PREVENT-19, UK Phase 3 and South Africa Phase 2b trials to ensure all trial participants have access to active vaccine
Completed 6-month booster doses in the U.S. and Australia Phase 2 study with immunology results expected in the third quarter of 2021
Com-COV2 Phase 2 clinical trial conducted by University of Oxford and UK Vaccines Taskforce
NVX-CoV2373 is one of four COVID-19 vaccines administered during trial to evaluate combined vaccine regimens in 1,050 participants
Top-line data expected in the third quarter of 2021
Advanced development of variant strain vaccines into preclinical studies
Preclinical data from study of B.1.351 variant strain vaccine candidate showed strong antibody response and functional immune response in non-human primates when boosted one year after receiving NVX-CoV2373
Expect to initiate clinical evaluation of one or more candidates
Successful collaboration on partner-initiated trials to advance clinical developmentof NVX-CoV2373
Takeda completed enrollment of 200 participants in Phase 1/2 clinical trial in Japan
Serum Institute of India (Serum Institute) completed enrollment of initial cohort in Phase 2/3 clinical trial in India, with total study including 1,600 participants
COVID-19 Manufacturing and Supply

Secured additional manufacturing capacity for NVX-CoV2373 globally, with continued progress toward achieving full manufacturing capacity
Anticipated capacity revised to 100 million doses per month by the end of the third quarter of 2021, with remainder of capacity expected to come online in the fourth quarter to support 150 million doses per month
Reached agreement in principle with GSK to support ‘fill and finish’ manufacturing of up to 60 million doses of NVX-CoV2373 for use in the UK
Established manufacturing presence in Canada through Memorandum of Understanding with Canadian government to produce NVX-CoV2373 at National Research Council’s Biologics Manufacturing Centre
Advanced purchase agreements globally, ensuring equitable access to low, middle and high income countries
Finalized advance purchase agreement with Government of Canada to supply 52 million doses with an option for up to an additional 24 million doses
Finalized advance purchase agreement with Gavi, the Vaccine Alliance, to provide 1.1 billion doses to the COVAX Facility
Novavax to manufacture and distribute 350 million doses to participants of the COVAX Facility
Serum Institute to manufacture and distribute remaining balance of the 1.1 billion doses to low- and middle-income countries
Furthered existing partnerships to expand global access of NVX-CoV2373
Finalized exclusive license agreement with Takeda for the development, manufacturing and commercialization of NVX-CoV2373
Takeda to manufacture over 250 million doses of NVX-CoV2373 annually
Takeda in discussions with Government of Japan to potentially purchase 150 million doses of NVX-CoV2373
Expanded existing partnership with SK bioscience to include license agreement for the manufacturing and commercialization of NVX-CoV2373
SK bioscience to supply 40 million doses to the Republic of Korea
COVID-19 Regulatory Pathway

Progressed regulatory processes for authorization of NVX-CoV2373 with multiple regulatory agencies globally
Intend to file for authorization with the U.S. Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) in Europe in the third quarter of 2021
Rolling reviews initiated with regulatory authorities, including Health Canada, Australian Therapeutic Goods Administration, New Zealand Medsafe, MHRA and EMA
SK bioscience initiated regulatory submission process in collaboration with Novavax to the Republic of Korea’s Ministry of Food and Drug Safety
Combination Vaccine

NanoFlu/NVX-CoV2373 combination vaccine candidate induced protective responses in preclinical studies
Preclinical data manuscript submitted for publication to a peer-reviewed journal and posted on bioRxiv.org
Expect to initiate clinical evaluation later this year
Malaria R21 Vaccine / Matrix-M Adjuvant Collaboration

Phase 2b clinical trial results for the University of Oxford’s malaria vaccine candidate (R21), including Matrix-M adjuvant, published in Preprints with The Lancet
Trial included 450 participants aged 5-17 months in Burkina Faso
Demonstrated high efficacy of 77% when using 5 micrograms of antigen and 50 micrograms of Matrix-M adjuvant
Novavax to manufacture and supply Matrix-M adjuvant to Serum Institute for use in R21
Serum Institute has rights to use the vaccine, comprised of R21 with Matrix-M adjuvant, in endemic regions, while Novavax will have rights to sell and distribute the vaccine in travelers’ and military vaccine markets
Phase 3 licensure trial underway in 4,800 participants, aged 5-36 months, across four countries in Africa to evaluate the safety and efficacy of R21
Corporate Highlights

Strengthened corporate leadership with executive management promotions and hiring
Gale E. Smith, Ph.D. promoted to Senior Vice President, Discovery and Preclinical Research and Chief Scientist
Madelyn ‘Lyn’ Caltabiano, Ph.D. as Senior Vice President, Global Program Management
Troy Morgan, J.D. as Senior Vice President, Chief Compliance Officer
Henrietta Ukwu, M.D. as Senior Vice President, Chief Regulatory and Quality Officer
Financial Results for the Three Months Ended March 31, 2021

Novavax reported a net loss of $223 million, or $3.05 per share, for the first quarter of 2021, compared to a net loss of $26 million, or $0.58 per share, for the first quarter of 2020.

Novavax revenue in the first quarter of 2021 was $447 million, compared to $3 million in the same period in 2020. This significant increase was due to increased development activities relating to NVX-CoV2373 for services performed under the U.S. government and Coalition for Epidemic Preparedness Innovations agreements.

Research and development expenses increased to $593 million in the first quarter of 2021, compared to $17 million in the same period in 2020. The significant increase was primarily due to the development of NVX-CoV2373.

General and administrative expenses increased to $63 million in the first quarter of 2021, compared to $9 million for the same period in 2020. The increase was primarily due to increased employee-related costs, stock-based compensation expenses, and supporting our NVX-CoV2373 program.

As of March 31, 2021, Novavax had $2 billion in cash, cash equivalents, marketable securities and restricted cash, compared to $806 million as of December 31, 2020. Net cash provided by operating activities for the first three months of 2021 was $663 million, compared to net cash used in operating activities of $23 million for same period in 2020. The increase in cash provided was primarily due to $772 million in payments under advance purchase agreements recorded as deferred revenue and the timing of payments to third parties.

Through utilization of At-the-market (ATM) offerings during the first quarter of 2021, Novavax raised net proceeds of $565 million.

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 (866) 652-5200 (Domestic) or (412) 317-6060 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 7:30 p.m. ET on May 10, 2021 until 11:59 p.m. ET on May 17, 2021. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 10155684.

A webcast of the conference call can also be accessed on the Novavax website at View Source A replay of the webcast will be available on the Novavax website until August 10, 2021.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated 100% protection against severe disease, efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1 variant and 89.7% overall; and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 100% protection against severe disease and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

About NanoFlu

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.

About Matrix-M

Novavax’ patented saponin-based Matrix-M adjuvant 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, boosting immune response.

On May 10, 2021 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the first quarter 2021 and provided an update on the Company’s recent developments (Press release, FibroGen, MAY 10, 2021, View Source [SID1234579554]).

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"We are pleased at the continued adoption and growth of roxadustat in China," said Enrique Conterno, Chief Executive Officer, FibroGen. "We are looking forward to the roxadustat FDA advisory committee meeting and the approval decision in Europe over the next few months, as well as advancing our late-stage pamrevlumab and roxadustat clinical programs, focused on areas of high unmet need."

Recent Key Events and Other Developments

Regulatory:
The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) will hold an advisory committee (AdCom) meeting to review the new drug application (NDA) for roxadustat in the U.S. The tentative date for the meeting is July 15, 2021.
The Marketing Authorization Application (MAA) for roxadustat for the treatment of anemia in adult patients with chronic kidney disease (CKD) is under regulatory review by the European Medicines Agency (EMA) with an expected decision by mid-2021.
Pamrevlumab was granted Fast Track and Rare Pediatric Disease designations from the FDA for the treatment of Duchenne muscular dystrophy (DMD).
Clinical:
Completed enrollment in the ASPEN and DENALI Phase 3b roxadustat clinical trials with dialysis organizations in dialysis patients with anemia of CKD.
Initiated the LELANTOS-2 Phase 3 clinical trial of pamrevlumab in ambulatory patients with DMD.
China:

Reported roxadustat net product revenue in China of $15.4 million, on a US GAAP basis, including revenue generated from our sales to the distribution entity and FibroGen China’s direct sales.
Total roxadustat net sales in China of $43.5 million by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca, compared to $29.2 million last quarter.
Hospital listings at the end of the first quarter represented approximately 74% of the CKD anemia market opportunity in China.
Presentations / Publications:
Roxadustat data was presented at the following scientific meetings in 2021:
FibroGen and its partners presented four posters at the recent National Kidney Foundation Virtual Spring Clinical Meetings.
FibroGen and its partners presented eight posters at International Society of Nephrology (ISN) World Congress of Nephrology 2021.
Roxadustat Phase 3 manuscripts on the treatment of anemia of CKD were published in peer-reviewed medical journals:
Pooled Analysis of Roxadustat for Anemia in Patients with Kidney Failure Incident to Dialysis (clarifying and updating Pooled ROCKIES/ SIERRAS/HIMALAYAS with journal) – Kidney International Reports
Roxadustat for the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients Not on Dialysis: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ALPS) – Nephrology Dialysis Transplantation
Roxadustat for Chronic Kidney Disease-related Anemia in Non-dialysis Patients (ANDES) – Kidney International Reports
Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study (OLYMPUS) – Journal of the American Society of Nephrology
Roxadustat for anemia in patients with end-stage renal disease incident to dialysis (HIMALAYAS) – Nephrology Dialysis Transplantation
A Randomized Trial of Roxadustat in Anemia of Kidney Failure: SIERRAS Study – Kidney International Reports
Upcoming Data Catalysts

Data from the Phase 2 WHITNEY study of roxadustat in chemotherapy-induced anemia (CIA) expected 2H 2021.
Data from the Phase 3 MATTERHORN study of roxadustat in anemia of MDS expected 1H 2022.
Resection data from the Phase 3 LAPIS study of pamrevlumab in locally advanced pancreatic cancer (LAPC) expected 2H 2022.
Data from the Phase 3 LELANTOS study of pamrevlumab in DMD expected 2H 2022.
Corporate

Appointed Tricia Stewart as Chief People Officer.
Financial

Total revenue for the first quarter of 2021 was $38.4 million, as compared to $24.4 million for the first quarter of 2020. The current quarter revenue consists of $15.4 million net product revenue for roxadustat sales in China, $14.6 million in development revenue, and $8.5 million drug product revenue for roxadustat bulk drug or active pharmaceutical ingredient.
Net loss for the first quarter of 2021 was $71.8 million, or $0.78 net loss per basic and diluted share, compared to a net loss of $78.3 million, or $0.89 net loss per basic and diluted share one year ago.
As of March 31, 2021, FibroGen had $682.6 million in cash, restricted time deposits, cash equivalents, investments, and receivables.
Based on our latest forecast, we estimate our 2021 ending cash to be in the range of $660 to $670 million.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Monday, May 10, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the Company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen first quarter 2021 financial results conference call, and use confirmation number 2036817. A replay of the webcast will be available shortly after the call for a period of four weeks. To access the replay, please dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international), and use passcode 2036817.

About Roxadustat
Roxadustat, an oral medicine, is the first in a new class of medicines, HIF-PH inhibitors, that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin; improved iron absorption and mobilization; and downregulation of hepcidin. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

Roxadustat is approved in China, Japan, and Chile for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). In the U.S., the New Drug Application is under review by the U.S. Food and Drug Administration. In Europe, the Marketing Authorization Application for roxadustat for the treatment of anemia of CKD in patients both on dialysis and not on dialysis was filed by our partner Astellas and accepted by the European Medicines Agency for review on May 2020. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, and are currently in review.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.

About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), an important biological mediator in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

On May 10, 2021 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing its Nano-Pulse Stimulation (NPS) technology, reported financial results for the first quarter of 2021 (Press release, Pulse Biosciences, MAY 10, 2021, View Source [SID1234579582]).

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Recent Highlights

Commenced the CellFX System Controlled Launch program and onboarded the first 15 participating U.S. and European aesthetic specialty practices in the first quarter, representing significant progress toward the program goal of onboarding 75 Key Opinion Leader (KOL) sites by the end of the third quarter
Submitted anticipated final response to Health Canada regarding the CellFX System Medical Device License, expect completion of the review by the end of the second quarter
Received FDA IDE approval for a feasibility study to assess the treatment of basal cell carcinoma using the CellFX System, enrollment of 30 patients is planned to begin in the second quarter and to be completed by the end of the third quarter
Continued patient enrollment and treatments in an FDA IDE approved pivotal comparison study to assess the treatment of cutaneous non-genital warts using the CellFX System; 51 of 150 patients have been enrolled to date with completion expected as early as the end of the second quarter or early in the third quarter
U.S. consumer research presented at the American Academy of Dermatology (AAD) virtual annual meeting rated aesthetic patients’ willingness to pay premium out-of-pocket fees and prioritize clearance of skin lesions with the CellFX procedure profile ahead of other popular aesthetic procedures
Strengthened balance sheet through $41 million term loan with a maturity of June 2022 and announced an at-the-market (ATM) equity offering program which could raise up to $60 million in aggregate gross proceeds
"In the first quarter of 2021, we achieved two significant milestones in our business with regulatory clearances for our CellFX System in the U.S. and in Europe. With these regulatory clearances in hand, we immediately executed the rollout of our Controlled Launch program of the CellFX System integrated with CellFX CloudConnect services in both these important markets. We have already made meaningful progress onboarding the first group of KOL participants and over the next several months look forward to gaining insights and developing best practices on driving long term adoption and utilization as we move towards full commercial launch later this year," said Darrin Uecker, President and CEO of Pulse Biosciences. "As we continue to execute on our commercial strategy, we plan to build upon these clearances, selectively adding new markets and pursuing additional applications of our CellFX System outside of aesthetic dermatology."

First Quarter 2021 Results
Cash, cash equivalents and investments totaled $59.9 million as of March 31, 2021, compared to $20.5 million as of December 31, 2020. Cash used in the first quarter of 2021 totaled $10.7 million excluding net proceeds received under the Company’s term loan, ATM program and the exercise of warrants. This compares with $9.5 million used in the same period in the prior year and $9.2 million used in the fourth quarter of 2020, excluding net proceeds received from the exercise of warrants.

GAAP operating expenses for the three months ended March 31, 2021 were $18.5 million, compared to $12.0 million for the prior year period. Non-GAAP operating expenses for the first quarter were $11.3 million, compared to $9.1 million for the same period in the prior year. The year-over-year increase in operating expenses was primarily driven by the expansion of commercial and operational infrastructure, including increased headcount, to support commercialization activities.

GAAP net loss for the three months ended March 31, 2021 was ($18.6) million compared to ($11.9) million for the three months ended March 31, 2020. Non-GAAP net loss for the three months ended March 31, 2021 was ($11.4) million compared to ($9.0) million for the three months ended March 31, 2020.

Reconciliations of GAAP to non-GAAP operating expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Impact of COVID-19
The COVID-19 pandemic had minimal impact on the Company’s operations in the first quarter of 2021. Product development, execution of clinical trials, regulatory timelines and Controlled Launch have not been materially affected at this time but due to the uncertain scope and duration of the pandemic, future impact to the Company’s operations and financial results cannot be reasonably estimated.

Webcast and Conference Call Information
Pulse Biosciences’ management will host a conference call today, May 10, 2021 beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-705-6003 for domestic callers or 1-201-493-6725 for international callers. A live and recorded webcast of the event will be available at View Source

On May 10, 2021 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported the development program expansion of vidutolimod (CMP-001) into non-melanoma skin cancers in combination with Libtayo (cemiplimab) under a clinical supply agreement with Regeneron Pharmaceuticals, Inc. ("Regeneron") (Press release, Checkmate Pharmaceuticals, MAY 10, 2021, View Source [SID1234579601]). Vidutolimod is an advanced generation Toll-like receptor 9 (TLR9) agonist, delivered as a biologic virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key component. Cemiplimab is a PD-1 blocking antibody being jointly developed by Regeneron and Sanofi.

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Checkmate and Regeneron will collaborate on a multi-indication, Phase 2, proof-of-concept clinical trial of vidutolimod in combination with cemiplimab in the following patient cohorts: (a) PD-1 treatment-naïve subjects with cutaneous squamous cell carcinoma (CSCC), (b) subjects with cutaneous squamous cell carcinoma (CSCC) that is refractory to PD-1 blockade, and (c) subjects with Merkel cell carcinoma (MCC) that is refractory to PD-1 blockade. Checkmate will be the sponsor of the clinical trial, and Regeneron will supply cemiplimab.

"We’re pleased to collaborate with Regeneron as we expand evaluation of vidutolimod as a potent stimulator of innate immune activity to patients with life-threatening non-melanoma skin cancers such as CSCC and MCC," said Barry Labinger, President and Chief Executive Officer of Checkmate. "We look forward to advancing vidutolimod in combination with Libtayo to further unlock the capabilities and impact of immuno-oncology therapeutics."