On February 24, 2022 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its fourth quarter and year ended Dec. 31, 2021 (Press release, Myriad Genetics, FEB 24, 2022, View Source [SID1234608977]). The company also reiterated financial guidance for 2022 and provided an update on business performance and strategic growth plans.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"With the focus and dedication of our 2,400 teammates, we improved quarterly and annual results despite continued headwinds from the COVID-19 pandemic. I want to thank our entire team for a great year delivering on our mission of advancing the health and well-being of our patients while executing on our transformation and growth plan," said Paul J. Diaz, president and Chief Executive Officer. "In the fourth quarter we gained traction on our new commercial strategy with new product launches, tech-enabled capabilities, and more customer-centric tools that we believe will provide a strong foundation for continued growth and innovation. However, we also saw an adverse impact from the Omicron variant toward the end of 2021 and into the new year, particularly in our hereditary cancer business."

Financial and Operational Highlights:

Diagnostic test volumes in the fourth quarter of 2021 of 237,000 were flat year-over-year and decreased 5% sequentially from the third quarter of 2021. Excluding divested businesses, diagnostic test volumes for the quarter increased 13% year-over-year and 5% sequentially. Sequential volumes were impacted by constraints in access to healthcare providers and staffing challenges due to the COVID-19 pandemic.
Hereditary cancer volumes for the quarter decreased 9% year-over-year and increased 2% sequentially.
Prenatal test volumes in Women’s Health for the quarter increased 4% year-over-year and 3% sequentially.
Tumor profiling test volumes in Oncology for the quarter were flat year-over-year and increased 1% sequentially.
Pharmacogenomics test volumes in Mental Health for the quarter increased 63% year-over-year and 8% sequentially.
Overall, average selling price (ASP) in the fourth quarter of 2021 increased 10% year-over-year and 1% sequentially after excluding positive revenue adjustments related to better-than-expected cash collections on tests ordered in prior periods. Improvements in ASP across Myriad’s product portfolio are primarily due to the benefits realized from investments made in revenue cycle management.
Total revenue in the fourth quarter of 2021 was $160.8 million, an increase of 4% year-over-year.
Excluding the divested business revenue, RBM, Autoimmune and myPath, quarterly revenue increased 19% year-over-year.
The following table summarizes year-over-year quarterly revenue changes by product category (excluding divested assets):

GAAP gross margin in the fourth quarter of 2021 was 71.5%; adjusted gross margin in the quarter was 71.8%, which increased 170 basis points year-over-year and 10 basis points sequentially.
GAAP total operating expenses in the fourth quarter of 2021 were $158.1 million; adjusted operating expenses in the quarter decreased $6.2 million sequentially to $115.3 million.
GAAP operating loss in the fourth quarter of 2021 was $(43.1) million, improving $5.1 million year-over-year; adjusted operating income was $0.1 million, increasing $11.4 million year-over year.
Diluted GAAP EPS in the fourth quarter of 2021 were $(0.10), increasing $0.40 year-over-year; adjusted EPS were $(0.02), increasing $0.10 year-over-year.
Ended the fourth quarter of 2021 with $398.8 million in cash, cash equivalents and investments and no debt outstanding.
Business Performance and Highlights:

Women’s Health
The Myriad Women’s Health business serves women of all ancestries by assessing their risk of cancer and offers prenatal testing solutions for those who are pregnant or planning a family. Women’s Health delivered revenue of $64.0 million in the fourth quarter of 2021, an increase of 14% year-over-year and an increase of 8% sequentially from the third quarter of 2021.

Hereditary Cancer
The new MyRisk Hereditary Cancer test with RiskScore for all ancestries is part of the company’s mission to increase health equity and make genetic testing more inclusive. Together, MyRisk with RiskScore provides a personalized 5-year and lifetime breast cancer risk assessment for all women, regardless of ancestry – the first of its kind. Myriad Genetics provides a genetically informed breast cancer risk assessment as part of a comprehensive panel – expanding access to genetic testing for more patient populations. More than 91,000 women received a RiskScore assessment in 2021, including over 16,000 women with non-European ancestry.
RiskScore results are informed by a combination of genetic markers, clinical and biological variables, personal and family history, and ancestry-specific data. RiskScore is available at no additional cost to women who take the MyRisk test, and we estimate that more than 56% of women qualify for medical management after the company’s testing compared to 10% with standard hereditary cancer testing.
Prenatal
Myriad Genetics saw another strong quarter from its Prequel noninvasive prenatal screening (NIPS) test including proprietary AMPLIFY technology, which significantly enhances the test’s performance and works to reduce test failure rates so that patients may avoid unnecessary invasive procedures.
The company plans to launch a combined prenatal and carrier screening test, FirstGene, in 2023. Delivering the clinical value of both Prequel and Foresight to expecting parents, FirstGene is designed to simplify the NIPS and carrier screening process by requiring only one maternal sample, enabling more patients to get answers faster.
Oncology
Myriad’s Oncology business provides hereditary cancer testing, including MyRisk, for patients who have cancer. It also provides tumor profiling products such as the EndoPredict breast cancer prognostic test, the Prolaris prostate cancer test, and the MyChoice CDx companion diagnostic test for predicting response to PARP inhibitors. The Oncology business delivered revenue of $67.4 million in the fourth quarter of 2021, an increase of 12% year-over-year and a decrease of 12% sequentially from the third quarter of 2021.

In early 2022, Myriad Genetics will launch Precise Tumor for molecular tumor profiling – part of a suite of Precise Oncology Solutions that combines the company’s MyRisk germline hereditary cancer testing technology and its MyChoice CDx companion diagnostic test with a Myriad tumor profiling test powered by Illumina’s TSO500 technology and run by Intermountain Precision Genomics.
With Precise, patients and their healthcare providers will receive one comprehensive solution from one laboratory with one team of scientists interpreting the results, which the company believes significantly improves the quality and ease of use of the results. The combined product offering will be sold through the Myriad Oncology sales force throughout the United States and is expected to be launched this quarter.
Myriad Genetics recently announced plans to develop new genetic testing products for cancer applications in the liquid biopsy Bx and Measurable Residual Disease (MRD) spaces.
The company also announced plans to expand its market leading FDA approved companion diagnostic test, MyChoice CDx, to other indications including breast, prostate and pancreatic cancers for expanded pharma clinical trials and commercial testing.
Mental Health
Myriad’s Mental Health business consists of the GeneSight psychotropic test that covers 61 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions. GeneSight helps physicians understand how genetic alterations impact patient response to antidepressants and other drugs. In the pharmacogenomics category, GeneSight delivered revenue of $29.4 million in the fourth quarter of 2021, an increase of 63% year-over-year and 22% sequentially from the third quarter of 2021.

GeneSight saw a strong increase in new ordering providers with over 2,900 physicians ordering GeneSight for the first time in the quarter. The total number of ordering physicians increased 7% sequentially. 95% of these providers are ordering through the Company’s new online portal.
GeneSight home-based kits now represent approximately 30% of all orders. This number is expected to increase as telehealth becomes a more common alternative to in-person care and as the company expands its telemedicine partnerships.
The Mental Health business has successfully implemented its ongoing commercial transformation with the rightsizing of its field sales force, growing its inside sales force, and executing a robust digital marketing plan to meet patients and clinicians where they are searching for mental health treatments online. Following its successful use in Mental Health, this model is now being extended to other Myriad business units.
Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2022 financial guidance:

(in millions,
except per
share amounts) Revenue Gross Margins GAAP OPEX Adjusted OPEX GAAP EPS Adjusted EPS
FY 2022 $670 – $700 70% – 72% $556 – $566 $470 – $480 $(0.90) – $(0.70) $0.00 – $0.20
Myriad’s fiscal year 2022 non-GAAP guidance begins with the comparable GAAP financial measure and excludes the impact of stock-based compensation expense ($36.5 million), non-cash amortization associated with acquisitions ($41.0 million) and special items such as costs related to transformation initiatives ($8.5 million). These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The company will provide further details on its business outlook during the conference call today and discuss the fourth-quarter financial results and fiscal year 2022 financial guidance.

Conference Call and Webcast
A conference call will be held today, Thursday, Feb. 24, 2022, at 4:30 p.m. EST to discuss Myriad’s financial results and business developments for the fourth quarter 2021. The dial-in number for domestic callers is 1-800-926-5188. International callers may dial 1-212-231-2901. All callers will be asked to reference reservation number 22015280. An archived replay of the call will be available for seven days by dialing 1-800-633-8284 and entering the reservation number above. The conference call and slide presentation will be available through a live webcast at www.myriad.com.

Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its fourth quarter and year ended Dec. 31, 2021. The company also reiterated financial guidance for 2022 and provided an update on business performance and strategic growth plans.

"With the focus and dedication of our 2,400 teammates, we improved quarterly and annual results despite continued headwinds from the COVID-19 pandemic. I want to thank our entire team for a great year delivering on our mission of advancing the health and well-being of our patients while executing on our transformation and growth plan," said Paul J. Diaz, president and Chief Executive Officer. "In the fourth quarter we gained traction on our new commercial strategy with new product launches, tech-enabled capabilities, and more customer-centric tools that we believe will provide a strong foundation for continued growth and innovation. However, we also saw an adverse impact from the Omicron variant toward the end of 2021 and into the new year, particularly in our hereditary cancer business."

Financial and Operational Highlights:

Diagnostic test volumes in the fourth quarter of 2021 of 237,000 were flat year-over-year and decreased 5% sequentially from the third quarter of 2021. Excluding divested businesses, diagnostic test volumes for the quarter increased 13% year-over-year and 5% sequentially. Sequential volumes were impacted by constraints in access to healthcare providers and staffing challenges due to the COVID-19 pandemic.
Hereditary cancer volumes for the quarter decreased 9% year-over-year and increased 2% sequentially.
Prenatal test volumes in Women’s Health for the quarter increased 4% year-over-year and 3% sequentially.
Tumor profiling test volumes in Oncology for the quarter were flat year-over-year and increased 1% sequentially.
Pharmacogenomics test volumes in Mental Health for the quarter increased 63% year-over-year and 8% sequentially.
Overall, average selling price (ASP) in the fourth quarter of 2021 increased 10% year-over-year and 1% sequentially after excluding positive revenue adjustments related to better-than-expected cash collections on tests ordered in prior periods. Improvements in ASP across Myriad’s product portfolio are primarily due to the benefits realized from investments made in revenue cycle management.
Total revenue in the fourth quarter of 2021 was $160.8 million, an increase of 4% year-over-year.
Excluding the divested business revenue, RBM, Autoimmune and myPath, quarterly revenue increased 19% year-over-year.
The following table summarizes year-over-year quarterly revenue changes by product category (excluding divested assets):

GAAP gross margin in the fourth quarter of 2021 was 71.5%; adjusted gross margin in the quarter was 71.8%, which increased 170 basis points year-over-year and 10 basis points sequentially.
GAAP total operating expenses in the fourth quarter of 2021 were $158.1 million; adjusted operating expenses in the quarter decreased $6.2 million sequentially to $115.3 million.
GAAP operating loss in the fourth quarter of 2021 was $(43.1) million, improving $5.1 million year-over-year; adjusted operating income was $0.1 million, increasing $11.4 million year-over year.
Diluted GAAP EPS in the fourth quarter of 2021 were $(0.10), increasing $0.40 year-over-year; adjusted EPS were $(0.02), increasing $0.10 year-over-year.
Ended the fourth quarter of 2021 with $398.8 million in cash, cash equivalents and investments and no debt outstanding.
Business Performance and Highlights:

Women’s Health
The Myriad Women’s Health business serves women of all ancestries by assessing their risk of cancer and offers prenatal testing solutions for those who are pregnant or planning a family. Women’s Health delivered revenue of $64.0 million in the fourth quarter of 2021, an increase of 14% year-over-year and an increase of 8% sequentially from the third quarter of 2021.

Hereditary Cancer
The new MyRisk Hereditary Cancer test with RiskScore for all ancestries is part of the company’s mission to increase health equity and make genetic testing more inclusive. Together, MyRisk with RiskScore provides a personalized 5-year and lifetime breast cancer risk assessment for all women, regardless of ancestry – the first of its kind. Myriad Genetics provides a genetically informed breast cancer risk assessment as part of a comprehensive panel – expanding access to genetic testing for more patient populations. More than 91,000 women received a RiskScore assessment in 2021, including over 16,000 women with non-European ancestry.
RiskScore results are informed by a combination of genetic markers, clinical and biological variables, personal and family history, and ancestry-specific data. RiskScore is available at no additional cost to women who take the MyRisk test, and we estimate that more than 56% of women qualify for medical management after the company’s testing compared to 10% with standard hereditary cancer testing.
Prenatal
Myriad Genetics saw another strong quarter from its Prequel noninvasive prenatal screening (NIPS) test including proprietary AMPLIFY technology, which significantly enhances the test’s performance and works to reduce test failure rates so that patients may avoid unnecessary invasive procedures.
The company plans to launch a combined prenatal and carrier screening test, FirstGene, in 2023. Delivering the clinical value of both Prequel and Foresight to expecting parents, FirstGene is designed to simplify the NIPS and carrier screening process by requiring only one maternal sample, enabling more patients to get answers faster.
Oncology
Myriad’s Oncology business provides hereditary cancer testing, including MyRisk, for patients who have cancer. It also provides tumor profiling products such as the EndoPredict breast cancer prognostic test, the Prolaris prostate cancer test, and the MyChoice CDx companion diagnostic test for predicting response to PARP inhibitors. The Oncology business delivered revenue of $67.4 million in the fourth quarter of 2021, an increase of 12% year-over-year and a decrease of 12% sequentially from the third quarter of 2021.

In early 2022, Myriad Genetics will launch Precise Tumor for molecular tumor profiling – part of a suite of Precise Oncology Solutions that combines the company’s MyRisk germline hereditary cancer testing technology and its MyChoice CDx companion diagnostic test with a Myriad tumor profiling test powered by Illumina’s TSO500 technology and run by Intermountain Precision Genomics.
With Precise, patients and their healthcare providers will receive one comprehensive solution from one laboratory with one team of scientists interpreting the results, which the company believes significantly improves the quality and ease of use of the results. The combined product offering will be sold through the Myriad Oncology sales force throughout the United States and is expected to be launched this quarter.
Myriad Genetics recently announced plans to develop new genetic testing products for cancer applications in the liquid biopsy Bx and Measurable Residual Disease (MRD) spaces.
The company also announced plans to expand its market leading FDA approved companion diagnostic test, MyChoice CDx, to other indications including breast, prostate and pancreatic cancers for expanded pharma clinical trials and commercial testing.
Mental Health
Myriad’s Mental Health business consists of the GeneSight psychotropic test that covers 61 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions. GeneSight helps physicians understand how genetic alterations impact patient response to antidepressants and other drugs. In the pharmacogenomics category, GeneSight delivered revenue of $29.4 million in the fourth quarter of 2021, an increase of 63% year-over-year and 22% sequentially from the third quarter of 2021.

GeneSight saw a strong increase in new ordering providers with over 2,900 physicians ordering GeneSight for the first time in the quarter. The total number of ordering physicians increased 7% sequentially. 95% of these providers are ordering through the Company’s new online portal.
GeneSight home-based kits now represent approximately 30% of all orders. This number is expected to increase as telehealth becomes a more common alternative to in-person care and as the company expands its telemedicine partnerships.
The Mental Health business has successfully implemented its ongoing commercial transformation with the rightsizing of its field sales force, growing its inside sales force, and executing a robust digital marketing plan to meet patients and clinicians where they are searching for mental health treatments online. Following its successful use in Mental Health, this model is now being extended to other Myriad business units.
Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2022 financial guidance:

(in millions,
except per
share amounts) Revenue Gross Margins GAAP OPEX Adjusted OPEX GAAP EPS Adjusted EPS
FY 2022 $670 – $700 70% – 72% $556 – $566 $470 – $480 $(0.90) – $(0.70) $0.00 – $0.20
Myriad’s fiscal year 2022 non-GAAP guidance begins with the comparable GAAP financial measure and excludes the impact of stock-based compensation expense ($36.5 million), non-cash amortization associated with acquisitions ($41.0 million) and special items such as costs related to transformation initiatives ($8.5 million). These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The company will provide further details on its business outlook during the conference call today and discuss the fourth-quarter financial results and fiscal year 2022 financial guidance.

Conference Call and Webcast
A conference call will be held today, Thursday, Feb. 24, 2022, at 4:30 p.m. EST to discuss Myriad’s financial results and business developments for the fourth quarter 2021. The dial-in number for domestic callers is 1-800-926-5188. International callers may dial 1-212-231-2901. All callers will be asked to reference reservation number 22015280. An archived replay of the call will be available for seven days by dialing 1-800-633-8284 and entering the reservation number above. The conference call and slide presentation will be available through a live webcast at www.myriad.com.

On February 24, 2022 Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported corporate highlights and financial results for the full year 2021 (Press release, Morphic Therapeutic, FEB 24, 2022, View Source [SID1234608976]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

2021 and Recent Corporate Highlights
•Presented positive phase 1 data supporting MORF-057’s target product profile as an oral bioavailable, potent and specific inhibitor of the α4β7 integrin at the European Crohn’s and Colitis Organisation (ECCO) Virtual Congress 2021
◦MORF-057 was well tolerated in all dose cohorts with no safety signals observed
◦Pharmacokinetic and pharmacodynamic data strongly supported MORF-057 progression into phase 2 with an oral twice daily dosing profile
◦Saturation (>99%) of the α4β7 receptor was observed in all subjects at all timepoints at trough concentrations using 100mg BID, our Ph2a dose
◦T-Cell concentration changes provided further evidence for MORF-057’s ability to replicate the known mechanism of the approved therapeutic, vedolizumab
◦Phase 2a trial of MORF-057 in patients with moderate to severe ulcerative colitis expected to begin in the first quarter of 2022 and Phase 2b to begin mid-year 2022
•Presented positive preclinical data from Morphic’s immuno-oncology program at the AACR (Free AACR Whitepaper) Annual Meeting 2021 demonstrating that potent and specific inhibition of αvβ8, in combination with checkpoint inhibitors, potentiated anti-tumor activity in tumors refractory to checkpoint inhibition monotherapy
◦Additional preclinical data presented at the SITC (Free SITC Whitepaper) Annual Meeting in November 2021 provided further rationale to explore αvβ8 inhibition in combination with immunotherapy to drive anti-tumor responses and survival benefits
•Focused research and development collaboration efforts with AbbVie and Janssen on higher-potential integrin targets in multiple therapeutic areas
◦The Janssen collaboration is now primarily focused on discovering activators of a specific integrin target, including antibody activators
◦Development activities by AbbVie for the αVβ6 target have been discontinued while research activities in the AbbVie collaboration continue on separate integrin targets
•Completed $245 million upsized public offering of common stock providing cash runway until the end of 2024
•Appointed Susannah Gray, a veteran leader in healthcare finance and strategy with three decades of experience, and Nisha Nanda, Ph.D., an experienced leader in preclinical and clinical-stage development strategy across multiple therapeutic areas, to the Morphic Board of Directors
•Thanked Nilesh Kumar, Ph.D., for his leadership and support as member of the Morphic Board of Director as he steps down from his role
◦Dr. Kumar has served as a Director of Morphic since 2017 when he was a Partner at Novo Ventures and Novo Ventures invested in Morphic as private company
◦Dr. Kumar has elected to transition off the Morphic Board of Directors after his transition from Novo Ventures to a new investment firm

"Morphic achieved each of its critical goals in 2021, and MORF-057 in particular significantly outpaced our expectations. The results from our Phase 1 studies with MORF-057 validate our proprietary MInT platform and have elevated our confidence as we embark on the global phase 2 clinical program in ulcerative colitis. We also presented exciting results from our immuno-oncology program demonstrating that αvβ8 inhibition, in combination with checkpoint inhibitors, has great potential to drive responses in checkpoint-refractory tumors," said Praveen Tipirneni, M.D., President and Chief Executive Officer of Morphic Therapeutic.

Financial Results for the full year 2021

•Net loss for the year ended December 31, 2021 was $95.5 million or $2.67 per share compared to a net loss of $45.0 million or $1.47 per share for the year ended December 31, 2020
•Revenue was $19.8 million for the year ended December 31, 2021, compared to $44.9 million for the year ended December 31, 2020. The decrease was mainly due to AbbVie’s option exercise on our αvβ6 integrin inhibitor program in the third quarter of 2020 for $20 million
•Research and development expenses were $87.8 million for the year ended December 31, 2021, as compared to $73.6 million for the year ended December 31, 2020. The increase was primarily attributable to higher manufacturing and development costs along with higher pre-clinical and clinical trial costs to support our lead product candidate MORF-057
•General and administrative expenses were $27.8 million for the year ended December 31, 2021, compared to $18.5 million for the year ended December 31, 2020. The increase was due to increased headcount and higher professional and consulting costs associated with ongoing business development activities and Morphic operating as a public company

As of December 31, 2021, Morphic had cash, cash equivalents and marketable securities of $408.1 million, compared to $228.3 million as of December 31, 2020. In the full year and fourth quarter 2021, Morphic raised net proceeds of $25.7 million and $1.1 million from the use of our At-The Market (ATM) facility. To date in 2022, Morphic has not issued any stock through its ATM facility. Morphic believes its cash, cash equivalents and marketable securities as of December 31, 2021, will be sufficient to fund operating expenses and capital expenditure requirements until the end of 2024.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported financial results for the year ended December 31, 2021 (Press release, MacroGenics, FEB 24, 2022, View Source [SID1234608974]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are excited about our 2022 plans for our B7-H3-directed programs for the potential treatment of multiple solid tumors. We believe we are well-positioned to be a leader in this promising field and are prioritizing our efforts around B7-H3. First, I am pleased to share that later this quarter, we plan to meet with the U.S. Food and Drug Administration (FDA) to discuss the design of a potential registration-directed study of MGC018 in patients with metastatic castration-resistant prostate cancer (mCRPC). Second, we expect to initiate a study of MGC018 in combination with lorigerlimab, our bispecific DART molecule targeting PD-1 and CTLA-4, in the coming weeks. And third, during the second half of this year, we intend to provide an update from a study of our second B7-H3 targeted molecule, enoblituzumab, being evaluated in combination with two of our checkpoint molecules in front-line squamous cell carcinoma of the head and neck (SCCHN). Beyond these B7-H3 programs, we are advancing several of our other clinical-stage molecules and have a variety of ongoing preclinical activities intended to expand our pipeline of differentiated investigational product candidates for the potential treatment of cancer," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics.

Updates on Proprietary Programs

B7-H3 Programs: MacroGenics is developing two investigational, clinical product candidates that target B7-H3, an antigen with broad expression across multiple solid tumor types and a member of the B7 family of molecules involved in immune regulation. Recent highlights for these two molecules include:

MGC018 is an antibody-drug conjugate (ADC) that targets B7-H3. MacroGenics presented encouraging preliminary clinical results from an ongoing Phase 1/2 study of MGC018 in patients with solid tumors at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meetings in 2021. The Phase 1/2 study expansion cohorts are fully enrolled for patients with mCRPC (n=40) and smaller cohorts of patients (n=approximately 20 each) with non-small cell lung cancer (NSCLC), melanoma and triple negative breast cancer (TNBC), while the Company continues to recruit patients for the SCCHN cohort. MacroGenics plans to meet with FDA later this quarter to discuss its development strategy in mCRPC. In addition, the Company intends to provide an update on clinical data from the dose expansion cohorts in the second half of 2022 as the data further mature. Finally, beyond monotherapy, the Company expects to initiate a combination study of MGC018 with lorigerlimab across multiple indications in the coming weeks.

Enoblituzumab is an Fc‐engineered, monoclonal antibody (mAb) that targets B7‐H3. MacroGenics continues to recruit patients into its Phase 2 study of enoblituzumab in combination with retifanlimab, the Company’s investigational, anti-PD-1 antibody that was licensed to Incyte, in front-line patients with SCCHN who are PD-L1 positive and with tebotelimab in SCCHN patients who are PD-L1 negative. The Company expects to complete enrollment of the PD-L1 positive patient cohort during the first half of this year and provide an update on this cohort during the second half of the year. I-Mab, MacroGenics’ partner in Greater China, announced in December that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) approved its Investigational New Drug (IND) submission for the initiation of a Phase 2 trial in China for enoblituzumab in combination with pembrolizumab in patients with solid tumors, including NSCLC, urothelial carcinoma and other selected cancers.
DART Molecules for Immune Checkpoint Blockade: MacroGenics is studying multiple investigational, PD-1-directed programs to provide further differentiation from existing PD-1-based treatment options and enable combination opportunities across the Company’s portfolio. Recent highlights include:

Lorigerlimab (formerly MGD019) is a bispecific, tetravalent DART molecule targeting PD-1 and CTLA-4. MacroGenics is conducting a Phase 1/2 dose expansion study in cohorts of patients with microsatellite stable colorectal cancer (MSS CRC), mCRPC, melanoma and checkpoint-naïve NSCLC. The Company anticipates sharing data from this ongoing study in the second half of 2022. As described above, MacroGenics expects to initiate a dose escalation study of MGC018 in combination with lorigerlimab in the coming weeks.

Tebotelimab is a bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. Tebotelimab was evaluated in a Phase 1/2 dose expansion study in several tumor types and is currently being studied in combination with enoblituzumab in SCCHN. The Company expects to provide an update on potential future development plans for tebotelimab in the second half of 2022. MacroGenics’ partner in Greater China, Zai Lab, recently informed the Company that it has decided to discontinue development of tebotelimab for indications it was enrolling in its territory and is evaluating future development plans in other indications.
Bispecific CD123 × CD3 DART molecule: MacroGenics has prioritized the development of MGD024, its investigational, next-generation CD123 × CD3 DART molecule, and will discontinue the development of flotetuzumab. Recent updates of these DART molecules include:

MGD024 is a next-generation, humanized CD123 × CD3 DART molecule designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, and permitting intermittent dosing through a longer half-life. In November, MacroGenics announced submission of an IND application for MGD024 to FDA. At the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December, MacroGenics presented preclinical data from the combination of MGD024 with standard-of-care agents used to treat CD123-positive hematological malignancies. The Company expects to initiate a Phase 1 dose escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia (AML), pending IND clearance by FDA.

Flotetuzumab is the Company’s first-generation, investigational, bispecific CD123 × CD3 DART molecule. An interim efficacy threshold from the single-arm study evaluating flotetuzumab in patients who were refractory to induction therapy was met with manageable safety. However, the Company has recently decided to prioritize the development of MGD024 and discontinue development of flotetuzumab, in view of the Company’s belief that MGD024 may offer certain advantages over flotetuzumab, including easier dose administration and a more facile means to combine with other agents.
Margetuximab is an Fc-engineered mAb that targets the HER2 oncoprotein, which is expressed by certain breast, gastroesophageal and other solid tumor cells. MARGENZA (margetuximab-cmkb) was launched in March 2021 by MacroGenics and its commercial partner, Eversana Life Science Services, LLC, for the treatment of adult patients with metastatic HER2-positive breast cancer, in combination with chemotherapy, who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. In January 2022, Zai Lab announced that the China NMPA accepted the New Drug Application (NDA) for margetuximab for the treatment of the same HER2-positive breast cancer indication.

Zai Lab recently informed MacroGenics that they have decided to discontinue enrollment of Module B of the MAHOGANY study in gastric cancer based on their review of both the clinical data and the changing treatment landscape. MacroGenics previously announced in November 2021 that the Company had decided to discontinue enrollment of Module A of the MAHOGANY study.

Selected Partnered Program Updates:

IMGC936 is an investigational ADC that targets ADAM9, a cell surface protein over-expressed in several solid tumor types, and is being developed jointly under a 50/50 collaboration with ImmunoGen, Inc. Under the collaboration, ImmunoGen is leading clinical development of IMGC936 in a Phase 1 clinical trial evaluating safety and pharmacokinetics in multiple solid tumors and has indicated they anticipate disclosing initial data in 2022.

Teplizumab is an investigational, anti-CD3 monoclonal antibody acquired from MacroGenics by Provention Bio, Inc. under an asset purchase agreement in 2018 for which MacroGenics is entitled to receive future milestone payments and royalties on net sales. Provention is developing teplizumab for the treatment of type 1 diabetes (T1D). On February 22, 2022, Provention announced that it had resubmitted the Biologics License Application (BLA) for teplizumab for the delay of clinical T1D in at-risk individuals. The BLA resubmission followed Provention’s Type B meeting with FDA earlier in the year.
2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2021, were $243.6 million, compared to $272.5 million as of December 31, 2020.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $77.4 million for the year ended December 31, 2021, compared to total revenue of $104.9 million for the year ended December 31, 2020. Revenue for the year ended December 31, 2021 included $12.3 million net sales of MARGENZA.
R&D Expenses: Research and development expenses were $214.6 million for the year ended December 31, 2021, compared to $193.2 million for the year ended December 31, 2020. The increase was primarily related to development, manufacturing and clinical trial costs related to MGC018, as well as other preclinical molecules and increased clinical expenses related to enoblituzumab and lorigerlimab. These increases were partially offset by decreased development and manufacturing costs related to retifanlimab for Incyte and decreased clinical costs and BLA support for margetuximab.
SG&A Expenses: Selling, general and administrative expenses were $63.0 million for the year ended December 31, 2021, compared to $42.7 million for the year ended December 31, 2020. The increase was primarily related to the MARGENZA launch, as well as labor-related costs and legal expenses.
Net Loss: Net loss was $202.1 million for the year ended December 31, 2021, compared to net loss of $129.7 million for the year ended December 31, 2020.
Shares Outstanding: Shares outstanding as of December 31, 2021 were 61,307,428.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of December 31, 2021, plus anticipated and potential collaboration payments, and product revenues should enable it to fund its operations through 2023. Such guidance does not reflect anticipated expenditures related to the potential late-stage development of MGC018 in mCRPC or further expansion of studies currently ongoing.
Conference Call Information

MacroGenics will host a conference call today at 4:30 p.m. (ET) to discuss financial results for the year ended December 31, 2021 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 1067087.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On February 24, 2022 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported fourth quarter and full year 2021 financial results and provided a corporate update (Press release, Kura Oncology, FEB 24, 2022, View Source [SID1234608973]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We have made meaningful advancements across our programs during the past year, and we begin 2022 with significant momentum, resources and enthusiasm," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "By mid-2022, we expect to have three independent drug development programs with potential to create value in both solid and liquid tumor indications with high unmet need. We anticipate meaningful data catalysts for each of these programs in the next six to 24 months, beginning with top-line data from our KOMET-001 Phase 1b study. And we approach these catalysts from a position of strength, with an experienced team and more than $500 million in cash."

Recent Highlights

Patient enrollment continues in KOMET-001 Phase 1b study of ziftomenib (KO-539) – In January 2022, Kura received authorization from the U.S. Food and Drug Administration (FDA) to proceed with its KOMET-001 trial of ziftomenib (formerly KO-539) in patients with relapsed or refractory acute myeloid leukemia (AML), following agreement with the FDA on an enhanced mitigation strategy for differentiation syndrome. Differentiation syndrome is known to be an on-target effect associated with a number of therapeutic agents, including menin inhibitors, which may induce differentiation of leukemic blasts. Patients already enrolled in the Phase 1b expansion cohorts were eligible to remain on study during the partial clinical hold and enrollment of new patients has resumed.

Multiple milestones and data readouts from KOMET-001 expected in 2022 – Kura expects to complete enrollment of 24 patients in the Phase 1b study of ziftomenib by the second quarter of 2022, after which it will assess the patients in each expansion cohort for safety and tolerability, pharmacokinetics and exposure, as well as efficacy. The Company expects to identify the recommended Phase 2 dose for ziftomenib and report top-line data from the Phase 1b study by the third quarter of 2022, with updated data from KOMET-001 reserved for a medical meeting in the fourth quarter of 2022. Meanwhile, Kura continues to add sites in the U.S. and Europe in anticipation of the subsequent Phase 2 registration-enabling portion of KOMET-001.

First patients dosed in Phase 1/2 trial of tipifarnib plus alpelisib in HNSCC – Last year, Kura announced a clinical collaboration with Novartis to evaluate the combination of tipifarnib and the PI3Kα inhibitor alpelisib in patients with head and neck squamous cell carcinoma (HNSCC). The Company believes this combination has the potential to increase the total addressable population for tipifarnib to as much as 50% of patients with HNSCC. In December 2021, the first patient was dosed in a Phase 1/2 clinical trial (KURRENT) of tipifarnib in combination with alpelisib. The initial cohort includes patients who have PIK3CA-dependent HNSCC. The Company expects to initiate an HRAS overexpression cohort in KURRENT by the third quarter of 2022.

Preclinical data supporting next-generation FTI program at AACR (Free AACR Whitepaper) – Kura’s next-generation farnesyl transferase inhibitor (FTI) program is designed to target novel farnesylated targets and address large solid tumor indications of high unmet need through combination regimens, with a focus on delaying the onset of drug resistance. An abstract from one of the Company’s academic collaborators, with preclinical data supporting the first opportunity in non-small cell lung cancer (NSCLC), has been accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2022. Kura plans to perform initial clinical evaluation with tipifarnib in NSCLC while continuing its IND-enabling studies of KO-2806, the lead development candidate in the Company’s next-generation FTI program.
Financial Results

Research and development expenses for the fourth quarter of 2021 were $21.0 million, compared to $17.5 million for the fourth quarter of 2020. Research and development expenses for the full year 2021 were $84.7 million, compared to $60.4 million for the prior year.

General and administrative expenses for the fourth quarter of 2021 were $12.1 million, compared to $8.8 million for the fourth quarter of 2020. General and administrative expenses for the full year 2021 were $46.5 million, compared to $31.5 million for the prior year.

Net loss for the fourth quarter of 2021 was $32.7 million, compared to a net loss of $26.2 million for the fourth quarter of 2020. Net loss for the full year 2021 was $130.5 million, compared to a net loss of $89.6 million for the prior year. Net loss for the fourth quarter and full year 2021 included non-cash share-based compensation expense of $6.4 million and $23.6 million, respectively, $3.7 million and $12.8 million for the same periods in 2020.

Cash, cash equivalents and short-term investments totaled $518.0 million as of December 31, 2021, compared with $633.3 million as of December 31, 2020. Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2024.
2022 Milestones

Complete enrollment of 24 patients in the KOMET-001 Phase 1b expansion cohorts by the second quarter.

Identify the recommended Phase 2 dose of ziftomenib (KO-539) and report top-line data from the Phase 1b expansion cohorts by the third quarter.

Present updated data from KOMET-001 at a medical meeting in the fourth quarter.

Initiate the HRAS overexpression cohort in the KURRENT trial of tipifarnib plus alpelisib by the third quarter.

Report preclinical data supporting the use of a FTI to delay the onset of drug resistance in NSCLC in the second quarter.

Submit an IND application for KO-2806 by the end of the year.
Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, February 24, 2022, to discuss the financial results for the fourth quarter and full year 2021 and to provide a corporate update. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and entering the conference code: 8645626. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.