On February 24, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the fourth quarter ended December 31, 2021 (Press release, Curis, FEB 24, 2022, View Source [SID1234608959]).

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"2021 was a year marked by significant clinical progress across our pipeline of targeted cancer therapies, including our report of positive updated data from our ongoing Phase 1/2 TakeAim Leukemia study of emavusertib (CA-4948) demonstrating a favorable safety profile and encouraging anti-cancer activity, with expansion into multiple combination trials in R/R hematologic malignancies. We have also identified a potential registrational path for CA-4948 as a monotherapy in genetically-defined patient populations, and reported promising initial safety data highlighting the potential of CI-8993 to activate multiple anti-cancer immune mechanisms," said James Dentzer, President and Chief Executive Officer of Curis. "As we look ahead, we expect 2022 to be a year of meaningful clinical updates from across our ongoing clinical trials, as we plan on providing additional updates on expanded clinical data for emavusertib and an update on a potential rapid regulatory path to bring this novel therapy to a genetically-defined patient population in dire need. We will continue our dose-escalation study for CI-8993 to determine the recommended Phase 2 dose and to assess signs of anti-cancer activity. We also look forward to presenting data from both of our combination trials with emavusertib in AML/MDS and in B Cell Cancers this year.

"We are also pleased to have expanded our leadership with three new executives that will bring expertise to strengthen our internal capabilities. We are also delighted with the appointment of John Hohneker, M.D. to the Board of Directors as we continue to grow our team and build our capabilities to deliver a new class of therapies to our patients," added Mr. Dentzer.

Full Year 2021 and Recent Operational Highlights

Precision oncology, emavusertib (IRAK4 Inhibitor; Aurigene collaboration):

Today, Curis announced that it will be implementing the new name "emavusertib" for all future references of CA-4948, including in scientific publications and corporate materials. The Company also announced new branding of its existing clinical trials of emavusertib as TakeAim Leukemia and TakeAim Lymphoma to highlight the targeting mechanisms.
In January 2022, Curis presented an updated expanded data set supporting earlier preliminary efficacy data of emavusertib in R/R AML/MDS whose disease is characterized by spliceosome or FLT3 mutation, suggesting a favorable safety and anti-cancer activity profile compared to standard of care therapies for these patient populations. The safety profile observed showed emavusertib was well-tolerated across multiple dose levels, including at the Recommended Phase 2 Dose of 300 mg BID. Enrollment of the study is currently ongoing, and Curis expects to have discussions with the FDA in the first half of 2022 regarding the potential for a rapid registrational path for emavusertib as a monotherapy in genetically defined patient populations. Curis expects to provide additional data from the R/R AML/MDS study at a medical meeting in 2022.
In October 2021, Curis initiated dosing in the combination stage of the TakeAim Leukemia study of emavusertib plus azacitidine or venetoclax. The combination therapy portion includes two arms: emavusertib plus azacitidine, for patients naïve to HMA, and emavusertib plus venetoclax, for patients naïve to venetoclax.
In October 2021, Curis announced new preclinical data highlighting the potential of emavusertib in additional hematologic malignancies in two presentations at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual Conference on Molecular Targets and Cancer Therapeutics. The preclinical data concluded emavusertib is synergistic with small molecule therapies targeted BCR signaling and suggest it can overcome or reduce secondary resistance to the therapies in marginal zone lymphoma.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):

In January 2022, Curis announced that the ongoing Phase 1 dose escalation study of CI-8993 demonstrated a promising safety profile, with no dose-limiting toxicities observed, and encouraging PK/PD activity, suggesting the possibility that CI-8993 can activate multiple anti-cancer immune mechanisms, including mechanisms that are not addressed by currently approved checkpoint inhibitors. The initial safety data from this trial is based on 13 patients in the first two dose cohorts of 0.15mg/kg and 0.3mg/kg. Curis expects to report expanded safety and tolerability data, along with PK, PD, and anti-cancer data from the trial in the second half of 2022.
Corporate:

Curis expanded its executive leadership capabilities, adding Felix Geissler, M.D., Ph.D., as Vice President of Medical Affairs, Kimberly Steinmann, M.D., as Vice President of Clinical Development, and Dora Ferrari, as Vice President of Clinical Operations. Drs. Geissler and Steinmann, and Ms. Ferrari are reporting directly to Dr. Reinhard von Roemeling, Senior Vice President, Clinical Development.
Curis expanded its Board of Directors with the appointment of John Hohneker, M.D. to the Board of Directors.
Upcoming 2022 Planned Milestones

In the first half of 2022, discuss potential for rapid registrational path for emavusertib with FDA
In the first half of 2022, report initial data for emavusertib in combination with ibrutinib in NHL
In 2022, report updated data for emavusertib in AML/MDS monotherapy
In the second half of 2022, report initial efficacy data for CI-8993 (VISTA)
In the second half of 2022, report initial data for emavusertib in combination with azacitadine or venetoclax in AML/MDS
Full Year and Fourth Quarter 2021 Financial Results

For the year ended December 31, 2021, Curis reported a net loss of $45.4 million, or $0.50 per share on both a basic and diluted basis, as compared to a net loss of $29.9 million, or $0.61 per share on both a basic and diluted basis in 2020. For the fourth quarter of 2021, Curis reported a net loss of $13.6 million or $0.15 per share on both a basic and diluted basis as compared to a net loss of $7.5 million, or $0.11 per share on both a basic and diluted basis, for the same period in 2020.

Revenues for the year ended December 31, 2021, were $10.6 million as compared to $10.8 million for the same period in 2020. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Revenues for the fourth quarters of 2021 and 2020 were $3.1 million and $3.0 million, respectively.

Operating expenses for the year ended December 31, 2021, were $52.7 million, as compared to $35.7 million for the same period in 2020. Operating expenses for the fourth quarter of 2021 were $15.7 million, as compared to $9.3 million for the same period in 2020, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.5 million for the years ended December 31, 2021 and 2020. Cost of royalty revenues were $0.2 million for the fourth quarter of 2021 and 2020.

Research and Development Expenses. Research and development expenses were $34.9 million for the year ended December 31, 2021, as compared to $23.1 million for the same period in 2020. Research and development expenses were $10.8 million for the fourth quarter of 2021 as compared to $5.6 million for the same period in 2020. The increase was primarily attributable to increased clinical and manufacturing costs for our programs and higher personnel counts as a result of additional headcount.

General and Administrative Expenses. General and administrative expenses were $17.3 million for the year ended December 31, 2021, as compared to $12.1 million for the same period in 2020. General and administrative expenses were $4.8 million for the fourth quarter of 2021, as compared to $3.5 million for the same period in 2020. The increase in general administrative expense was driven primarily by higher costs for stock-based compensation, professional and consulting services, personnel, and insurance as compared to the prior year.

Other Expense, Net. Net other expense was $3.4 million for the year ended December 31, 2021, as compared to $5.0 million for the same period in 2020. For the fourth quarter of 2021 and 2020, net other expense was $1.1 million and $1.2 million, respectively. Net other expense primarily consisted of imputed interest expense related to royalty payments.

As of December 31, 2021, Curis’s cash, cash equivalents and investments totaled $139.8 million, and there were approximately 91.6 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2024.

Conference Call Information

Curis management will host a conference call today, February 24, 2022, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.

To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

On February 24, 2022 MannKind Corporation (Nasdaq: MNKD) reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Mannkind, FEB 24, 2022, View Source [SID1234608975]).

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"We had a solid fourth quarter with Afrezza net revenue hitting a record $11.3 million and we ended the year with over $260 million in cash and investments on our balance sheet," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "Although the extension of the Tyvaso DPI review is frustrating, our manufacturing team remains focused on producing pre-launch supplies of Tyvaso DPI for our collaboration partner, United Therapeutics."

Fourth Quarter 2021 Results

Total revenues were $12.5 million for the fourth quarter of 2021, reflecting Afrezza net revenue of $11.3 million and collaborations and services revenue of $1.2 million. Afrezza net revenue increased 13% compared to $10.1 million in the fourth quarter of 2020 as a result of higher demand, a more favorable cartridge mix, price, and lower gross-to-net deductions. Collaborations and services revenue decreased $7.2 million compared to the fourth quarter of 2020 due to a decrease in revenue recognized from the initial License Agreement with United Therapeutics ("UT"), which was substantially completed in the third quarter of 2021. Revenue associated with the commercial production of Tyvaso DPI was deferred in the fourth quarter of 2021 and will be recognized over the period when commercial product is sold to UT.

Afrezza gross profit for the fourth quarter of 2021 was $7.0 million compared to $6.4 million in the same period of 2020, an increase of $0.6 million, or 10%, which was driven by an increase in Afrezza sales, partially offset by an increase in cost of goods sold. Cost of goods sold increased by $0.6 million, or 18%, compared to the same period in 2020, primarily due to a $2.0 million increase in inventory write-offs partially offset by $1.8 million in reduced manufacturing-related spending. Afrezza gross margin in the fourth quarter of 2021 was 62% compared to 64% for the same period in 2020.

Cost of revenue – collaborations and services increased by $4.5 million in the fourth quarter compared to 2020 due to increased pre-approval manufacturing activity for Tyvaso DPI.

Research and development ("R&D") expenses for the fourth quarter of 2021 were $3.9 million compared to $1.5 million for the fourth quarter of 2020. This $2.4 million increase was mainly related to pre-clinical development of inhaled clofazimine as well as the Afrezza pediatrics clinical study (INHALE-1).

Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2021 were $22.7 million compared to $17.1 million for the fourth quarter of 2020. This $5.6 million increase was primarily attributable to higher Afrezza promotional expenses and patient support services as well as increased stock-based compensation.

For the fourth quarter of 2021, the gain on foreign currency translation (for insulin purchase commitments denominated in Euros) was $1.6 million compared to a loss of $4.0 million for the fourth quarter of 2020. The fluctuation was due to a change in the U.S. dollar to Euro foreign currency exchange rate.

Interest expense on financing liability was $1.4 million for the fourth quarter of 2021 and represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, CT.

Interest expense on debt for the fourth quarter of 2021 was $2.8 million compared to $2.4 million for the fourth quarter of 2020. This increase of $0.4 million was the result of interest on the $230.0 million 2.5% senior convertible notes issued in the first quarter of 2021, partially offset by a decrease in interest expense on Mann Group promissory notes as a result of (i) the repayment of $35.1 million of outstanding principal under the Mann Group non-convertible note, (ii) the $10.0 million reduction of principal and interest on the Mann Group convertible note from a conversion to our common stock and (iii) a decrease of the interest rate from 7.00% to 2.50% on the remaining promissory note.

The net loss for the fourth quarter of 2021 was $28.1 million, or $0.11 per share, compared to $26.4 million in the fourth quarter of 2020, or $0.11 per share. The $1.7 million increase in the net loss was primarily due to a decrease in revenues from collaboration and services as well as increases in cost of revenue for collaborations and services and in SG&A expenses, partially offset by a gain on purchase commitment as well as the effect of the one-time acquisition of in-process R&D from QrumPharma in the fourth quarter of 2020.

Twelve Months Ended December 31, 2021

Total revenues were $75.4 million for the year ended December 31, 2021 reflecting Afrezza net revenue of $39.2 million and collaborations and services revenue of $36.3 million. Afrezza net revenue increased 21% compared to $32.3 million for the year ended December 31, 2020, primarily driven by higher demand, a more favorable cartridge mix, price, and lower gross-to-net deductions. Collaborations and services revenue increased $3.5 million compared to 2020 due to additional development work associated with our collaboration with UT.

Afrezza gross profit was $22.3 million for the year ended December 31, 2021, an increase of $5.1 million, or 30%, compared to a gross profit of $17.2 million in the prior year, which was attributable to an increase in Afrezza sales, partially offset by an increase in cost of goods sold. Cost of goods sold increased by $1.8 million, or 12%, for the year ended December 31, 2021 compared to the prior year, primarily due to a $2.0 million fee for the amendment of the Insulin Supply Agreement, a $1.5 million increase in inventory write-offs, and a $1.0 million increase related to reduced manufacturing activities. The increase in cost of goods sold was partially offset by $2.3 million in reduced manufacturing-related spending, lower per-unit cost from increased manufacturing efficiencies and the termination of a free goods program in December 31, 2020.

R&D expenses for the year ended December 31, 2021 were $12.3 million compared to $6.2 million for the prior year. This $6.1 million increase was primarily attributable to costs incurred to develop our product pipeline and to begin the Afrezza pediatrics clinical study (INHALE-1).

SG&A expenses for the year ended December 31, 2021 were $77.4 million compared to $59.0 million for the prior year. This $18.4 million increase was primarily attributable to higher Afrezza promotional expenses, patient support services, increased headcount and stock-based compensation and our voluntary reduction in compensation in the prior year in response to the COVID-19 pandemic.

For the year ended December 31, 2021, the gain on foreign currency translation (for insulin purchase commitments denominated in Euros) was $6.6 million compared to a loss of $8.0 million for the prior year. The fluctuation was due to a change in the U.S. dollar to Euro foreign currency exchange rate.

Interest expense on financing liability was $1.4 million for the year ended December 31, 2021 and represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, CT.

Interest expense on debt for the year ended December 31, 2021 was $15.2 million compared to $9.5 million for the prior year. This $5.7 million increase was primarily due to interest expense on the $230.0 million 2.5% senior convertible notes as well as a $3.7 million milestone obligation that was achieved during the first quarter of 2021, partially offset by a decrease in interest expense on Mann Group promissory notes as a result of (i) the repayment of $35.1 million of outstanding principal under the Mann Group non-convertible note, (ii) the $10.0 million reduction of principal and interest on the Mann Group convertible note from a conversion to our common stock and (iii) a decrease of the interest rate from 7.00% to 2.50% on the remaining promissory note.

The net loss for the year ended December 31, 2021 was $80.9 million, or $0.32 per share, compared to $57.2 million net loss for the year ended December 31, 2020, or $0.26 per share. The higher net loss was mainly attributable to the $22.1 million non-cash loss on extinguishment of the Mann Group convertible note net of a $4.9 million non-cash gain on extinguishment of the PPP loan, as well as an increase in SG&A expenses and in cost of revenue – collaboration and services, partially offset by an increase in Afrezza net revenues and revenues from collaboration and services, a gain on purchase commitment as well as the effect of the one-time acquisition of in-process R&D from QrumPharma in the prior year. On a non-GAAP basis, excluding the expense incurred for the loss on extinguishment of the Mann Group convertible note offset by the gain on extinguishment of the PPP loan, and the Amphastar amendment fee, the net loss for the year ended December 31, 2021 was $61.7 million, or $0.25 per share.

Cash, cash equivalents, restricted cash, and investments as of December 31, 2021 was $260.7 million compared to $67.2 million as of December 31, 2020. The increase was mainly due to the sale of senior convertible notes in the first quarter of 2021 for $230.0 million and the cash received from the sale-leaseback of our Danbury, CT manufacturing facility of approximately $100 million, offset by operating costs for 2021.

Non-GAAP Measures

To supplement our unaudited condensed consolidated financial statements presented under U.S. generally accepted accounting principles (GAAP), we are presenting certain non-GAAP financial measures. We are providing these non-GAAP financial measures to disclose additional information to facilitate the comparison of past and present operations, and they are among the indicators management uses as a basis for evaluating our financial performance. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends.

These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our unaudited condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of its adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by us in this report have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

The following table reconciles our gross margin financial measure to a non-GAAP presentation as adjusted for the nonrecurring amendment fee related to an amendment to our Insulin Supply Agreement.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind’s website for 14 days.

On February 24, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported financial results for the fourth quarter and full-year periods ended December 31, 2021 and provided an update on recent company developments (Press release, SpringWorks Therapeutics, FEB 24, 2022, View Source [SID1234608990]).

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"2021 was another year of strong execution for SpringWorks as we advanced our targeted oncology portfolio and continued to build a fully-integrated biopharmaceutical company with capabilities spanning research, early and late-stage development, and commercial," said Saqib Islam, Chief Executive Officer of SpringWorks. "2022 is set up to be a meaningful year for us and the patients we are working to serve as we expect to share data across our pipeline, including topline data from the Phase 3 DeFi study and clinical data across our BCMA and biomarker-defined metastatic solid tumor programs. We believe we have a strong infrastructure that will allow us to continue to build upon the multiple opportunities we have created and drive our growth in 2022 and beyond."

Recent Business Highlights and Upcoming Milestones

Rare Oncology

SpringWorks is conducting the Phase 3 DeFi trial evaluating nirogacestat in adult patients with progressing desmoid tumors. DeFi is an event-driven trial with a primary endpoint of progression-free survival. The Company expects to trigger the topline analysis from the Phase 3 DeFi trial in the first quarter of 2022 and to report these data during the first half of the year.
Recruitment is ongoing in a Phase 2 study sponsored by the Children’s Oncology Group evaluating nirogacestat in pediatric patients with desmoid tumors.
In November 2021, SpringWorks completed enrollment in the Phase 2b ReNeu trial evaluating mirdametinib in adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN).
Patients continue to be dosed in a Phase 1/2 clinical trial evaluating mirdametinib in children and young adults with low-grade glioma.
B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma

SpringWorks continues to advance nirogacestat as a potential cornerstone of BCMA combination therapy across modalities in collaboration with seven industry leaders.

In October 2021, SpringWorks announced an update from its ongoing clinical collaboration with GlaxoSmithKline evaluating nirogacestat in combination with BLENREP (belantamab mafodotin-blmf) in patients with relapsed or refractory multiple myeloma. The first combination dose level, which is evaluating 0.95 mg/kg Q3W BLENREP plus nirogacestat, has been expanded based on encouraging preliminary data observed in the dose exploration Phase 1 portion of the nirogacestat DREAMM-5 sub-study. Initial clinical data are expected to be presented in mid-2022. The 0.95 mg/kg Q3W BLENREP + nirogacestat cohort has advanced into a randomized Phase 2 expansion and is now enrolling patients to further explore the safety and efficacy profile of the combination versus a 2.5 mg/kg Q3W BLENREP monotherapy control arm, which is the same as the FDA approved monotherapy dose and schedule of BLENREP. In parallel, additional dose levels and schedules of BLENREP plus nirogacestat continue to be evaluated in the Phase 1 portion of the study. In addition, two new sub-studies will evaluate the BLENREP plus nirogacestat combination together with standard-of-care multiple myeloma therapies in the DREAMM-5 trial (pomalidomide plus dexamethasone and lenalidomide plus dexamethasone). Data from these two new sub-studies may enable future clinical trials in earlier lines of multiple myeloma.
In December 2021, the Company entered into a clinical trial collaboration agreement with AbbVie, Inc. to evaluate nirogacestat in combination with ABBV-383, AbbVie’s investigational CD3 bispecific antibody directed against BCMA, in patients with relapsed or refractory multiple myeloma.
In December 2021, SpringWorks announced that the first patient has been dosed in a Phase 1b/2 trial evaluating nirogacestat with elranatamab (PF-06863135), Pfizer’s investigational BCMA CD3-targeted bispecific antibody, in patients with relapsed or refractory multiple myeloma.
In addition to the current ongoing studies, SpringWorks expects that a Seagen-sponsored trial of nirogacestat + SEA-BCMA and an AbbVie-sponsored Phase 1b trial of nirogacestat + ABBV-383 will each initiate enrollment in the first half of 2022.
Biomarker-Defined Metastatic Solid Tumors

Enrollment is ongoing in a Phase 1b/2 trial evaluating mirdametinib with BeiGene’s RAF dimer inhibitor, lifirafenib, in adult patients with RAS/RAF mutant and other MAPK pathway aberrant solid tumors. Initial clinical data from the BeiGene-sponsored trial are expected to be presented at an upcoming SpringWorks-sponsored R&D Day.
Enrollment is ongoing in a Phase 1 trial of BGB-3245 in adult patients with RAF mutant solid tumors. BGB-3245 is a selective RAF dimer inhibitor being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene. Initial clinical data from the MapKure-sponsored trial are expected to be presented at an upcoming SpringWorks-sponsored R&D Day.
Enrollment is ongoing in a Phase 1b/2a platform study sponsored by Memorial Sloan Kettering Cancer Center evaluating mirdametinib both as a monotherapy and as a combination therapy in advanced solid tumors harboring selected MAPK-activating mutations.
Preclinical data from the TEAD inhibitor program are expected to be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2022.
In October 2021, SpringWorks entered into an exclusive worldwide license agreement with Dana-Farber Cancer Institute (Dana-Farber) and a sponsored research agreement with Stanford Medicine for a portfolio of novel small molecule inhibitors of Epidermal Growth Factor Receptor (EGFR) designed for the treatment of EGFR-mutant cancers. In addition, SpringWorks entered into a collaboration agreement with Ab Magnitude Ventures Group, LLC and Ab Magnitude Fund, LP (collectively, "Ab Magnitude") to collaborate on target discovery and initial hit finding to advance next generation oncology therapeutics. SpringWorks and Ab Magnitude will also collaborate on the portfolio of EGFR inhibitors in-licensed by SpringWorks from Dana-Farber, with Ab Magnitude supporting optimization and characterization of the portfolio using its computational structural biology platform.
Fourth Quarter and Full Year 2021 Financial Results

Revenue: SpringWorks did not recognize any revenue for the fourth quarter or year ended December 31, 2021, and the Company does not currently have any sources of recurring revenue. The fourth quarter and full year 2020 included revenue of $35.0 million, attributable to the nonrefundable upfront payment from Jazz Pharmaceuticals in October 2020, related to the asset purchase and exclusive license agreement between SpringWorks and Jazz Pharmaceuticals under which Jazz acquired SpringWorks’ fatty acid amide hydrolase (FAAH) inhibitor program.
Research and Development (R&D) Expenses: R&D expenses were $29.3 million and $101.7 million for the fourth quarter and full-year periods, respectively, compared to $15.3 million and $51.9 million for the comparable periods of 2020. The increases in R&D expenses were attributable to an increase in internal costs driven by the growth in employee costs associated with increases in the number of R&D personnel and an increase in stock-based compensation expense as well as an increase in external costs related to drug manufacturing and trial costs, as well as the $11.0 million nonrefundable upfront payment for the in-licensing of the TEAD inhibitor program.
General and Administrative (G&A) Expenses: G&A expenses were $26.5 million and $71.8 million for the fourth quarter and full-year periods, respectively, compared to $8.5 million and $29.5 million for the comparable periods of 2020. The increases in G&A expenses were primarily attributable to the hiring of additional personnel in our G&A functions as we continued to expand our operations to support the organization, including commercialization preparation efforts that are underway, and an increase in stock-based compensation expense. In addition, G&A expenses included an increase in information technology costs, and consulting and professional services, including legal, regulatory and compliance.
Net Loss Attributable to Common Stockholders: SpringWorks reported a net loss of $56.1 million, or $1.15 per share, for the fourth quarter of 2021 and a net loss of $173.9 million, or $3.59 loss per share, for the year ended December 31, 2021. This compares to net income of $11.3 million, or $0.23 per share, for the fourth quarter of 2020 and a net loss of $45.6 million, or $1.05 per share for the year ended December 31,2020.
Cash Position: Cash, cash equivalents and marketable securities were $432.7 million as of December 31, 2021.
COVID-19 Update

To date, the COVID-19 pandemic has had a relatively modest impact on SpringWorks’ business operations, in particular on SpringWorks’ clinical trial programs, and SpringWorks is undertaking considerable efforts to mitigate the various challenges presented by this crisis. For further details and descriptions of the risks associated with the COVID-19 pandemic, please see the Risk Factors in SpringWorks’ periodic filings with the Securities and Exchange Commission and refer to the Forward-Looking Statements section in this press release.

On February 24, 2022 Element Biosciences, Inc., developer of a new and disruptive DNA sequencing platform, reported a partnership with Dovetail Genomics demonstrating the value and performance of Dovetail’s proximity ligation-based next-generation sequencing (NGS) library prep solutions on Element’s AVITI System (Press release, Element Biosciences, FEB 24, 2022, View Source [SID1234609009]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The ability to unlock access to genomic structure enables cutting-edge science in the fields of epigenetics, developmental biology, cancer research, conservation and evolutionary biology. Advances in chromatin conformation capture technologies sit at the forefront of this effort. Dovetail Genomics’ best-in-class products and services capture 3D genome architecture alongside primary sequence information using NGS approaches.

"We are pleased to form a partnership with Dovetail Genomics to deliver seamless compatibility between the AVITI System and Dovetail’s library preparation kits. Their proximity ligation technology couples well with Element’s improvements in sequencing accuracy, lower optical duplication rate and consistency of data, across a range of applications," said Shawn Levy, Senior Vice President of Applications and Scientific Affairs at Element Biosciences.

"We are thrilled to partner with Element Biosciences to add Dovetail Genomics’ cutting-edge proximity ligation technology to this new and exciting NGS platform," said Dovetail CEO Todd Dickinson. "The long-range, unbiased nature of the Dovetail data opens up many new applications not typically accessible with a short-read platform, offering a richer view of the genome from every sequencing run."

To learn more about the AVITI System, including detailed specifications, application data, and performance testimonials, register now for Element’s virtual event on March 14th, 9 a.m. PT / 5 p.m. CET, at View Source

On February 24, 2022 Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), reported that the company’s year-end report for January – December 2021 is now available on the company’s website, www.isofolmedical.com (View Source) (Press release, Isofol Medical, FEB 24, 2022, View Source [SID1234608930]).

Schedule your 30 min Free 1stOncology Demo!
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Fourth quarter, October –December 2021
Net revenue amounted to TSEK 4,704 (18,680) and other revenue to TSEK 0 (18)
The result for the period amounted to TSEK -61,170 (-54,659)
Earnings per share amounted to SEK -0.38 (-0.66)
Cash and cash equivalents on December 31 amounted to TSEK 379,448 (116,393)
January – December 2021
Net revenue amounted to TSEK 22,407 (37,119) and other revenue to TSEK 0 (18)
The result for the period amounted to TSEK -200,251 (-188,992)
Earnings per share amounted to SEK -1.59 (-3.07)
The Board of Directors proposes that no dividend will be paid for the 2021 financial year
Significant events during the fourth quarter 2021
On October 21, Isofol’s shares were listed on Nasdaq Stockholm.
Isofol was granted Fast Track Designation by the US Food and Drug Administration (FDA) for arfolitixorin for the treatment of advanced colorectal cancer (CRC).
Isofol announced that the FDA denied a request from the company to adjust the censoring rules for the ongoing AGENT study’s secondary endpoint after more patients than expected proceeded to other treatments before they reached tumor progression (PFS). However, the study’s primary endpoint, objective response rate (ORR), was not affected and an agreement for a new cut-off point for top-line results is expected in spring 2022.
Significant events after the event of the period
Jenny Sundqvist assumed her role as Chief Commercial Officer on January 1, 2022.
VD´s comment:
"In the fourth quarter of 2021, efforts to establish the best possible conditions ahead of a future commercial launch continued. The Fast Track Designation that we received will be valuable for us in this regard as we complete the final stages of the AGENT study, as it enables among other things more frequent dialogue with the FDA. Finally, we are proud to have written a new chapter in Isofol’s history and raised more awareness of the company through the listing in the MidCap segment of Nasdaq Stockholm’s main market in October." says CEO Ulf Jungnelius.

The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CET, on February 24, 2022.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global pivotal Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.