On February 28, 2022 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported an oral presentation on poziotinib at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies (TAT) Congress 2022 being held virtually March 7-8, 2022 (Press release, Spectrum Pharmaceuticals, FEB 28, 2022, View Source [SID1234609148]). Details of the presentation are as follows:

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Title: Efficacy and safety of poziotinib in treatment-naïve HER2 exon 20 insertion (ex20ins) mutated non-small cell lung cancer (NSCLC): ZENITH20-4
Speaker: Sophie Sun, M.D., FRCPC
Session Type: Mini oral session
Date and Time: March 7, 2022 at 5:50 p.m. CET / 11:50 a.m. ET
Presentation Number: 26MO

The presentation will be published online on the ESMO (Free ESMO Whitepaper) website at 12 p.m. CET / 6 a.m. ET on March 7, 2022. It will also be available on the Spectrum Pharmaceuticals website after the presentation at View Source

On February 28, 2022 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers, reported its financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update (Press release, Revolution Medicines, FEB 28, 2022, View Source [SID1234609147]).

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"Revolution Medicines continues to advance our integrated RAS-focused pipeline consisting of innovative RAS(ON) Inhibitors and RAS Companion Inhibitors. RMC-6236, a RASMULTI(ON) inhibitor, and RMC-6291, a KRASG12C(ON)-selective inhibitor, are both on track to enter the clinic this year. In addition, we recently reported the addition of two new oral, covalent, mutant-selective RAS(ON) inhibitors to our development-stage pipeline. RMC-9805 is a selective inhibitor of KRASG12D(ON), and RMC-8839 is a selective inhibitor of KRASG13C(ON), neither target of which is served today by targeted drugs," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines.

"Our RAS Companion Inhibitor pipeline also continues to mature. We disclosed that a first patient has been dosed in RMC-4630-03, our global Phase 2 study of RMC-4630 in combination with sotorasib in patients with non-small cell lung cancer carrying a KRASG12C mutation. In addition, in the dose escalation phase of our Phase 1/1b clinical trial of RMC-5552, our selective inhibitor of mTORC1, we reported preliminary evidence of clinical activity against advanced tumors with mutations associated with hyperactive mTORC1 signaling. We look forward to advancing each of these promising programs in 2022 toward our goal to serve substantial unmet needs among patients with RAS-addicted cancers."

RAS(ON) Inhibitors – Revolution Medicines continues to build on its innovative RAS(ON) Inhibitor platform, producing an expansive collection of tri-complex inhibitors targeting diverse oncogenic RAS variants through highly differentiated chemical and pharmacologic profiles.

RMC-6236 (RASMULTI) – RMC-6236 is a first-in-class, potent, oral RAS-selective tri-complex, RASMULTI(ON) inhibitor designed to treat cancers driven by a variety of KRAS mutations, including those that can emerge following treatment with KRASG12C(OFF) inhibitors.

The company reported data at the AACR (Free AACR Whitepaper)-NCI-EORTC Conference demonstrating that RMC-6236 induced significant regressions in in vivo tumor xenograft models of non-small cell lung cancer (NSCLC), pancreatic cancer and colorectal cancer (CRC) bearing KRASG12D, KRASG12V, KRASG12R or KRASG12C driver mutations.
During the AACR (Free AACR Whitepaper)-NCI-EORTC Conference, the company presented data from a preclinical combination study evaluating RMC-6236 with a PD-1 inhibitor demonstrating that RMC-6236 alone induces anti-tumor immunity in vivo and also exhibits additive anti-tumor benefit with checkpoint inhibition as indicated by complete and durable responses.
The company also presented an expanded dataset at the Gastrointestinal Cancer Drug Development Summit demonstrating the ability of both RMC-6236 and RMC-6291 to induce tumor regressions in xenograft models of RAS-mutant CRC.
The company remains on track to submit an Investigational New Drug application (IND) for RMC-6236 in the first half of this year as its first of multiple RAS(ON) inhibitor IND submissions currently planned during 2022-2023, and anticipates disclosing evidence of first-in-class single agent activity for RMC-6236 in 2023.

RMC-6291 (KRASG12C) – RMC-6291 is a first-in-class, potent, oral and selective tri-complex inhibitor of KRASG12C(ON) with a differentiated preclinical profile designed to serve patients with cancers driven by KRASG12C.

The company reported data at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) demonstrating superior outcomes with orally administered RMC-6291 as compared to adagrasib in preclinical models of KRASG12C NSCLC.
Initial clinical development for RMC-6291 will seek to establish best-in-class activity against KRASG12C tumors.
The company remains on track to submit an IND for RMC-6291 in the first half of 2022 and anticipates disclosing preliminary evidence of superior activity in 2023.

RMC-9805 (KRASG12D) – RMC-9805 is an oral, mutant-selective, covalent inhibitor of KRASG12D(ON) which is the primary tumor driver in more than 50,000 new patients primarily with colorectal, pancreatic or lung cancer annually in the United States.

The company selected RMC-9805 as a development candidate and advanced it into IND-enabling development.
The company reported data at the AACR (Free AACR Whitepaper)-NCI-EORTC Conference showing RMC-9805 covalently and selectively modifies KRASG12D.
RMC-9805 displayed its first- and best-in-class potential by inducing tumor regressions achieved following repeat oral dosing in vivo in tumor xenograft models of KRASG12D-driven pancreatic cancer and CRC.
The company remains on track to submit an IND for RMC-9805 in the first half of 2023.

RMC-8839 (KRASG13C) – RMC-8839 is an oral, mutant-selective, covalent inhibitor of KRASG13C(ON) that Revolution Medicines believes is the first compound to directly target KRASG13C, an important therapeutic target primarily for lung cancer and select CRC patients who are not currently served by any targeted RAS drug.

The company selected RMC-8839 as a development candidate and advanced it into IND-enabling development.
The company reported data at the AACR (Free AACR Whitepaper)-NCI-EORTC Conference showing RMC-8839 covalently and selectively modifies KRASG13C.
The company remains on track to submit an IND for RMC-8839 in the second half of 2023.

Continued expansion of other RAS(ON) Inhibitor programs – Revolution Medicines continues to progress its growing portfolio of orally bioavailable, mutant-selective RAS(ON) Inhibitors designed to target RAS variants driving RAS-addicted cancers that are unserved by targeted drugs.

The company reported multiple discovery programs pursuing additional mutant-selective compounds for various cancer mutations at RAS hotspots G12 (e.g. G12V and G12R), G13 (i.e. G13D) and Q61.
The company has a goal of nominating a fifth development candidate in the second half of 2022.
RAS Companion Inhibitors – Revolution Medicines continues to advance and expand multiple clinical studies of its RAS Companion Inhibitors designed to provide maximum clinical benefit in RAS-addicted cancers.

RMC-4630 (SHP2 Inhibitor) – RMC-4630, a potent, oral, selective inhibitor of the SHP2 protein, is being advanced in partnership with, and is primarily funded by, Sanofi our global SHP2 development and commercialization partner.

RMC-4630 and KRASG12C inhibitor Lumakras (sotorasib)
Amgen is currently evaluating RMC-4630 in an active Phase 1b study in combination with Amgen’s KRASG12C(OFF) inhibitor, sotorasib in its CodeBreaK 101c study. Amgen recently announced it plans to share data in the second half of 2022.
As a complement to the CodeBreaK 101c study, the company is sponsoring RMC-4630-03, a global Phase 2 study of RMC-4630 in combination with sotorasib. The first patient in RMC-4630-03 has been dosed and enrollment is ongoing patients with NSCLC carrying a KRASG12C mutation who have failed prior standard therapy and who have not previously been treated with a RAS inhibitor. The company is sponsoring the RMC-4630-03 study under its global partnership with Sanofi and conducting the trial in collaboration with Amgen, which is supplying sotorasib to study sites globally. The company expects to complete enrollment of this study in the second half of 2022 and to provide preliminary evidence of clinical benefit in 2022, with additional evidence of clinical benefit as a RAS Companion Inhibitor expected to be provided in 2023.

RMC-4630 and KRASG12C inhibitor adagrasib
Sanofi is planning a combination study under its global SHP2 partnership with the company evaluating RMC-4630 (also known as SAR442720) in combination with Mirati’s KRASG12C inhibitor, adagrasib. This study expands the evaluation of the potential benefit of adding RMC-4630 in this class of KRASG12C(OFF) inhibitors.

RMC-4630 and PD-1 inhibitor pembrolizumab (Keytruda)
The TCD16210 study sponsored by Sanofi continues evaluating RMC-4630 in combination with pembrolizumab, a PD-1 inhibitor. Sanofi has recently begun treating patients in an expansion cohort evaluating this combination in first-line treatment for patients with PDL-1 positive lung cancer.
RMC-5552 (mTORC1/4EBP1 Inhibitor) – RMC-5552 is a potent, selective bi-steric inhibitor of mTORC1 that suppresses phosphorylation and inactivation of 4EBP1.

The company recently reported initial findings from the ongoing dose escalation portion of its Phase 1/1b clinical trial of RMC-5552, including preliminary evidence of clinical activity against advanced tumors with mutations associated with hyperactive mTORC1 signaling. The data showed that all four efficacy evaluable patients treated with 6 mg per week experienced disease control, including one patient exhibiting a confirmed partial response with a 63% reduction from baseline and the other three with stable disease. The company anticipates disclosing additional evidence of single agent activity in 2023.
The company aims to evaluate RMC-5552 in combination with RAS(ON) Inhibitors in patients carrying both RAS and mTOR pathway mutations, representing approximately 30,000 new patients per year in the United States.
Fourth Quarter and Full Year 2021 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities were $577.1 million as of December 31, 2021, compared to $440.7 million as of December 31, 2020. The increase was primarily due to proceeds from the company’s public equity offering in February 2021.

Revenue: Total revenue, consisting of revenue from the company’s collaboration agreement with Sanofi, was $9.5 million for the quarter ended December 31, 2021, compared to $8.8 million for the quarter ended December 31, 2020.

Total revenue was $29.4 million for the year ended December 31, 2021, compared to $43.0 million for the year ended December 31, 2020. During the third quarter of 2021, the company recorded a non-cash, non-recurring GAAP accounting adjustment that reduced collaboration revenue by $8.5 million as a result of a change in estimate of the accounting transaction price and percentage of completion of work performed to date under its agreement with Sanofi. The decrease in revenue in 2021 was primarily due to the non-cash revenue adjustment and lower reimbursed manufacturing costs.

R&D Expenses: Research and development expenses were $53.7 million for the quarter ended December 31, 2021, compared to $37.0 million for the quarter ended December 31, 2020. Research and development expenses were $186.9 million for the year ended December 31, 2021, compared to $132.3 million for the year ended December 31, 2020. The increases were primarily due to an increase in research expenses associated with the company’s pre-clinical research portfolio, an increase in personnel-related expenses related to additional headcount, and an increase in stock-based compensation.

G&A Expenses: General and administrative expenses were $8.7 million for the quarter ended December 31, 2021, compared to $5.8 million for the quarter ended December 31, 2020. General and administrative expenses were $30.5 million for the year ended December 31, 2021, compared to $21.4 million for the year ended December 31, 2020. The increases were primarily due to an increase in stock-based compensation, an increase in personnel-related expenses related to additional headcount, and higher legal and accounting fees.

Net Loss: Net loss was $52.7 million for the quarter ended December 31, 2021, compared to net loss of $34.2 million for the quarter ended December 31, 2020. Net loss was $187.1 million for the year ended December 31, 2021, compared to net loss of $108.2 million for the year ended December 31, 2020.

2022 Financial Guidance

Revolution Medicines expects full year 2022 GAAP net loss to be between $260 million and $290 million, which includes estimated non-cash stock-based compensation expense of $35 million to $40 million.

Conference Call

Revolution Medicines will host a conference call and webcast this afternoon, February 28, 2022, at 4:30 PM Eastern (1:30 PM Pacific).

To listen to the conference call, please dial (833) 423-0425 or (918) 922-3069, provide conference ID: 9672794 and request the Revolution Medicines conference call. To listen to the live webcast, or access the archived webcast, please visit:  View Source Following the live webcast, a replay will be available on the Company’s website for at least 14 days.

On February 28, 2022 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update (Press release, Protagonist, FEB 28, 2022, View Source [SID1234609146]).

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"This past quarter and the year leading up to it has been a transformational period for Protagonist," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. "Today, we are closer than ever to fulfilling the potential of three diverse strategies reflected in our robust pipeline: (1) moving rusfertide into a Phase 3 registrational study for a rare disease indication like polycythemia vera, (2) completing enrollment for PN-943 Phase 2 proof-of-concept study in a common and prevalent disease like ulcerative colitis, and (3) enabling our partner, Janssen, to progress PN-235 into a Phase 2b study in plaque psoriasis and potentially other indications in inflammatory bowel diseases in the later part of the year. Each of these three assets and their potential to treat diverse diseases represent a multi-billion-dollar opportunity for Protagonist."

Dr. Patel continued: "In the last quarter and year, we have demonstrated exceptional strength of execution in progressing our assets further in clinical development. For rusfertide in PV, we announced updated Phase 2 data at EHA (Free EHA Whitepaper) and ASH (Free ASH Whitepaper), and recently unveiled the design of our Phase 3 VERIFY study, which is set to initiate this quarter. With great anticipation, we look forward to the topline data readout from the Phase 2 IDEAL study of PN-943 in ulcerative colitis in the second quarter of this year. We’re very pleased that the 240-patient Phase 2b study of PN-235 in plaque psoriasis has initiated, with the first patient dosed recently. Looking ahead, we plan to continue to demonstrate our strength of execution across all current and emerging assets in our pipeline, thereby maximizing the opportunities ahead of us for substantial value creation this year."

Fourth Quarter 2021 Recent Developments and Upcoming Milestones

Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders

Most recent data from the ongoing Phase 2 REVIVE study of rusfertide in PV were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) December 2021 Annual Meeting. Findings from the open label portion of this study continued to demonstrate rusfertide’s ability to markedly reduce the need for therapeutic phlebotomies (TP) in a majority of PV patients, along with additional observed effects including rapid, sustained, and durable hematocrit (HCT) control.
Also at ASH (Free ASH Whitepaper) 2021, the Company presented results from the PACIFIC Phase 2 study of rusfertide for PV patients with high HCT levels. Data demonstrated that post-induction, weekly rusfertide treatment rapidly controlled HCT levels without the need for TP.
Protagonist is preparing to initiate the VERIFY study, a pivotal Phase 3 clinical trial of rusfertide for 250 patients living with PV, in Q1 2022. The design of the upcoming clinical trial was also presented at ASH (Free ASH Whitepaper) in December 2021.
Data from an open-label Phase 2 clinical trial of rusfertide in HH were presented at The Liver Meeting in November 2021, hosted by the American Association for the Study of Liver Diseases. This data demonstrated rusfertide’s ability to reduce phlebotomy rates and other biomarkers associated with the disease in the study population. The Company plans to identify potential target sub-populations and next steps in 1H 2022 to advance the program.
PN-943: Oral, gut-restricted, alpha-4-beta-7 Integrin Antagonist for Ulcerative Colitis (UC)

PN-943 is currently being evaluated in moderate-to-severe UC in the Company’s Phase 2 IDEAL study. The clinical trial has completed its target enrollment of 150 patients, and the Company plans to share topline results from the study, including data from the 12-week induction period, in Q2 2022.
PN-235: Oral IL-23 Receptor Antagonist

A Phase 2b study of PN-235 (JNJ-77242113) in participants with moderate-to-severe plaque psoriasis (FRONTIER 1) initiated in early 2022, sponsored by Janssen Biotech (Janssen). PN-235 is a second-generation oral peptide IL-23 receptor antagonist being developed under the worldwide license and collaboration agreement with Janssen. PN-235 is also expected to advance into Phase 2 clinical studies in inflammatory bowel diseases in 2H 2022. The Company will earn a $25 million milestone in connection with the dosing of a third patient in FRONTIER 1. Protagonist is also eligible for a $10 million milestone in connection with the start of the second indication-based Phase 2 study.
Fourth Quarter 2021 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2021 were $326.9 million. The Company expects current cash, cash equivalents and marketable securities to be sufficient to fund its planned operating and capital expenditures through 2024. Our cash forecast will be updated following the PN-943 Phase 2 study UC data readout in the second quarter of 2022.
License and Collaboration Revenue: License and collaboration revenue was $8.6 million for the fourth quarter of 2021 compared to $5.7 million for the same period of 2020. The increase was primarily due to an increase in services provided to Janssen under the collaboration agreement during 2021 related to PN-232 and PN-235 as the company nears completion of the services to be performed. License and collaboration revenue for the full year 2021 was $27.4 million compared to $28.6 million for 2020. The full year 2021 collaboration revenue included a cumulative catch-up amount of $8.0 million following the July 2021 amendment of its collaboration agreement for the development of IL23-R assets with Janssen. Revenue for the prior year 2020 included an update to the forecast for remaining services to be completed under the collaboration, which accelerated our overall percentage completion under the accounting performance obligation and accelerated revenue recognition.
Research and Development ("R&D") Expenses: R&D expenses for the fourth quarter and full year 2021 were $38.4 million and $126.0 million respectively, as compared to $19.5 million and $74.5 million, respectively, for the same periods of 2020. The increases in 2021 were primarily due to the additional costs associated with advancing rusfertide and PN-943 through Phase 2 studies and our preparations for future Phase 3 clinical study initiations, as well as expenses related to our Phase 1 studies for our second-generation IL23-R antagonist assets under the Janssen collaboration. R&D expenses also increased due to higher research spending and employee related costs, including stock-based compensation expenses following recent hiring in support of our advancing research and development programs.
General and Administrative ("G&A") Expenses: G&A expenses for the fourth quarter and full year 2021 were $7.3 million and $27.2 million, respectively, as compared to $5.0 million and $18.6 million for the same periods of 2020. The increases were primarily related to professional fees, insurance costs and employee compensation related expenses, including stock-based compensation expenses, supporting the growth in our operations.
Stock-based Compensation ("SBC") Expenses: SBC expenses for the fourth quarter and full year ended December 31, 2021 were $5.0 million and $16.4 million, respectively, as compared to $2.0 million and $7.9 million, respectively, for the same periods of 2020. The increases in 2021 (included in R&D and G&A expenses above) were primarily attributable to awards granted to new employees hired to support the Company’s continued growth and an increase in the Company’s stock price at the grant dates during 2021.
Net Loss: The fourth quarter 2021 net loss was $36.9 million, or a net loss of $0.77 per share, and for the year ended December 31, 2021, net loss was $125.6 million, or a net loss of $2.71 per share, compared to the fourth quarter of 2020 net loss of $18.9 million, or a net loss of $0.48 per share, and for the year ended December 31, 2020, net loss of $66.2 million, or a net loss of $1.92 per share.

On February 28, 2022 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, reported fourth quarter and full year 2021 financial results (Press release, Pliant Therapeutics, FEB 28, 2022, View Source [SID1234609145]).

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"In 2021 strong execution drove significant advancement of our pipeline. The achievement of strategic milestones and positive data further de-risked our ongoing and potential future clinical programs," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. "We are building on this momentum in 2022 with significant data readouts anticipated in our lead programs of idiopathic pulmonary fibrosis and primary sclerosing cholangitis, as well as planned investigational new drug applications in our oncology and muscular dystrophy programs."

Fourth Quarter and Recent Highlights

Results from expanded PLN-74809 Phase 1b proof-of-mechanism trial demonstrated clear evidence of on-target biological activity in the lungs of healthy participants. Earlier today, the Company announced that positive data from an expanded PLN-74809 Phase 1b proof-of-mechanism trial demonstrated clear evidence of on-target biological activity in the lungs of 36 healthy participants. Results demonstrated that PLN-74809 inhibited TGF-β activation by up to 92% and 76% at 6- and 24-hours, respectively, following seven days of once-daily dosing. At all dose levels, PLN-74809 demonstrated durable pSmad suppression relative to placebo at 6 hours and 24 hours. PLN-74809 was well tolerated with mostly mild adverse events, and no severe adverse events.
Enrollment was completed in the PLN-74809 Phase 2a INTEGRIS-IPF trial in idiopathic pulmonary fibrosis. INTEGRIS-IPF is a 12-week randomized, dose-ranging, double-blind, placebo-controlled trial evaluating the safety, tolerability and pharmacokinetics of PLN-74809 at doses of 40, 80 or 160 mg in approximately 84 IPF patients. Exploratory endpoints include quantitative lung fibrosis (QLF) imaging, pulmonary function tests as well as select biomarkers. Topline data is anticipated mid-2022.
The U.S. Food and Drug Administration (FDA) authorized the evaluation of long-term treatment with PLN-74809 in patients with IPF. The FDA has authorized evaluation of long-term dosing of PLN-74809 up to 320 mg daily in patients with IPF. This authorization will facilitate longer-term pivotal trials in IPF. PLN-74809 has been administered to over 450 study participants, including healthy volunteers and patients, with no drug-related serious adverse events or severe adverse advents reported to date.
Independent Data Safety Monitoring Board (DSMB) recommended INTEGRIS-IPF Phase 2a Trial continue without modifications. Following the full enrollment of the INTEGRIS-IPF Phase 2a trial, on February 17, 2022, the DSMB recommended the INTEGRIS-IPF trial continue without modification. This review included all patients enrolled in all dose cohorts of the trial. To date, no safety concerns have been identified by the DSMB.
Commenced enrollment of a Phase 2a trial of PLN-74809 at a dose of 320 mg in patients with IPF. The Company began enrollment in a randomized, double-blind, placebo-controlled trial evaluating PLN-74809 at doses of 320 mg administered daily over at least six months, and up to 48 weeks, in approximately 28 patients with IPF. The primary endpoint is the evaluation of PLN-74809 safety and tolerability and the secondary endpoint is the assessment of pharmacokinetics. Exploratory endpoints will measure QLF imaging and pulmonary function tests as well as select biomarkers over 6 months of treatment.
PLN-74809 Phase 2a trial in primary sclerosing cholangitis (PSC) enrollment on track to be completed mid-2022. INTEGRIS-PSC is a 12-week randomized, dose-ranging, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of PLN-74809 at doses of 40, 80 or 160 mg in approximately 84 PSC patients. Exploratory endpoints include fibrosis biomarkers such as Pro-C3 and ELF, changes in ALP and liver imaging. Topline data is expected in late 2022 or early 2023.
Oncology and muscular dystrophy programs progressing through Investigational New Drug (IND) enabling studies. Both programs on track with IND application submissions planned by the end of 2022.
COVID-19 Preparedness

The Company continues to develop and maintain policies and procedures to enable us to operate safely and productively during the COVID-19 pandemic. The Company has experienced delays in clinical trial operations which have impacted and may further impact the expected timing of data readouts. The Company is working closely with clinical sites to continue site initiation and operation activities in compliance with study protocols while observing government and institutional guidelines. The Company intends to provide more specific guidance regarding clinical trial progress and the timing of data readouts as the long-term impacts of the pandemic become better understood.

Fourth Quarter 2021 Financial Results

Research and development expenses were $18.8 million, as compared to $17.9 million for the prior-year quarter. The increase was due primarily to employee related expenses and higher costs related to the advancement of several programs and ongoing Phase 1/2 clinical trials.
General and administrative expenses were $7.8 million, as compared to $5.6 million for the prior-year quarter. The increase was due to higher personnel-related and professional services expenses.
Net loss of $24.5 million, as compared to $19.0 million for the prior-year quarter. The increase is due an overall increase in operating expense coupled with a decrease in revenues generated from our license and collaboration agreement.
As of December 31, 2021, the Company had cash, cash equivalents and short-term investments of $200.6 million. The Company believes it has sufficient funds to meet its operating and capital requirements into the second half of 2023.

On February 28, 2022 PharmaMar Group (MSE: PHM) reported recurring revenue growth of 27% to €165 million (Press release, PharmaMar, FEB 28, 2022, View Source [SID1234609144]). These revenues are the sum of net sales plus royalties received for sales.

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The increase in recurring revenues in 2021 is due to the good performance of the oncology business. To year-end, oncology sales revenues totaled €119 million, an 18% increase compared with the sales recorded the previous year. Royalty revenues grew by 162% to €41 million1. This strong growth is mainly due to royalty revenues received from our partner in the United States, Jazz Pharmaceuticals, for sales of Zepzelca (lurbinectedin).

In the case of non-recurring revenues from licensing agreements, these mainly relate, in both 2020 and 2021, to the licensing agreement entered into with Jazz Pharmaceuticals, and total €65 million in 2021 and €140.3 million in 2020. License revenues in 2021 include the accrual of US$25 million (€22 million) from Jazz Pharmaceuticals for achieving certain commercial targets.

The difference in these revenue between years is due to the accounting recognition of the receivables collected in 2020 for the signing of the agreement with Jazz and for the approval of lurbinectedin in the US.

Eliminating the effect of the collections from the lurbinectedin license to Jazz Pharmaceuticals in both 2021 and 2020, PharmaMar Group’s operating profit in 2021 would have increased by 57% with respect to 2020.

In the molecular diagnostics segment, GENOMICA, reported net revenues of €5 million at the end of 2021, compared with €13 million in 2020. This difference was mainly due to lower revenues from Covid-19 tests, PCR, lateral flow and antibody tests, as a result of increased competition, which has led to a significant decrease in the prices of these tests.

In 2021, the Group generated operating cash of €26 million. It should be noted that this cash generation followed an investment of €72 million in R&D, an increase of 34% compared to the resources devoted to this, the previous year.

One of the PharmaMar Group’s most important clinical trials is LAGOON, which will evaluate lurbinectedin for treating patients with relapsed Small-Cell Lung Cancer which commenced in 2021.

If successful, LAGOON will serve as the confirmatory trial for lurbinectedin to secure full approval in the U.S. LAGOON will also be used as a registrational trial with the European Medicines Agency (EMA) to obtain marketing authorization in Europe.

PharmaMar Group increased its net cash position in 2021 to €167 million, from €163 million the previous year thus ending to December 31st, 2021 with cash and cash equivalents (cash and cash equivalents plus current and non-current financial investments) of €212 million and total debt of €45.5 million.

As a result, the PharmaMar Group reported net income of €93 million at the end of 2021.

The Board of Directors of Pharma Mar, S.A. will propose to the Shareholders’ Meeting that a dividend in cash of €0.65 gross per Pharma Mar, S.A. share be paid to shareholders against 2021 earnings, 8% higher than the dividend paid in the previous year.

Conference call on results for analysts and investors

PharmaMar will hold a conference call for analysts and investors on Tuesday, March 1st, 2022, at 13:00 (CET). The numbers to connect to the conference call are: +34 91 901 16 44 (from Spain), +1 646 664 1960 (from the US or Canada) or +44 20 3936 2999 (other countries). Participants’ access code: 146916. To view the webcast, please click on the following link: View Source

The teleconference and the recording of the webcast can be accessed on PharmaMar’s website by visiting the Events Calendar section of the Company’s website at www.pharmamar.com.