Full Press Release Details
Aadi Reports Fourth Quarter and Full Year 2021 Financial Results
and Provides Business Update
-FYARRO approved November 22, 2021 and launched February 23, 2022-
-FYARRO added to NCCN Guidelines as the only preferred therapy to treat
-PRECISION 1 tumor agnostic study for TSC1 or TSC2 alterations open for enrollment-
-Ended fourth quarter 2021 with $149.0 million in cash and cash equivalents-
LOS ANGELES, March 17, 2022 Aadi Bioscience, Inc. ( Aadi ) (Nasdaq: AADI), a biopharmaceutical company focused on developing and
commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a business update.
We are well-positioned in 2022 with a strong team, a solid balance sheet, and a highly promising recently approved drug, stated Neil Desai, Ph.D.,
Founder, President and Chief Executive Officer of Aadi. With our recent launch of FYARRO and a new tumor-agnostic registrational trial for nab-sirolimus underway, Aadi is on track with our previously outlined goals and our vision of
offering a new cancer treatment to underserved patient populations.
FYARRO: Recent Highlights
Development and Operational Highlights
Merger Completion and Public Listing on Nasdaq
Board and Leadership: Key Appointments
2021 Fourth Quarter and Full Year Financial Highlights
As of December 31, 2021, cash and cash equivalents totaled $149.0 million, compared to $4.5 million as of December 31, 2020. Based on our
current plans, we expect cash and cash equivalents to fund operations into 2024.
For the year ended December 31, 2021, we recognized
$1.0 million of license revenue related to a milestone payment pursuant to our license agreement with EOC Pharma. This compares to the $14.0 million received during the year ended December 31, 2020, related to the non-refundable upfront payment for the rights and license granted to EOC Pharma under the license agreement for the further development and commercialization of FYARRO in the People s Republic of China, Hong
Kong Special Administration Region, Macao Special Administrative Region and Taiwan.
Operating expenses for the fourth quarter were $16.9 million
compared to $5.7 million in the prior year quarter. For the year ended December 31, 2021, operating expenses totaled $112.3 million, an increase of $95.2 million compared to $17.1 million for the same period in 2020. The
increase in operating expenses for the full year ended December 31, 2021 is due primarily to a non-cash impairment charge related to an acquired contract intangible asset of $74.2 million incurred in
conjunction with the merger which was previously reported in the third quarter, and increases in research and development and general and administrative expenses.
Research and development expenses for the fourth quarter were $7.2 million compared to $5.3 million in the prior year quarter. For the year ended
December 31, 2021, research and development expenses increased approximately $4.7 million, to $19.7
million compared to $15.0 million for the same period in 2020. This increase was primarily the result of increased expenses associated with our clinical and commercial drug manufacturing
compared to the same periods in 2020.
General and administrative expenses for the fourth quarter were $9.7 million, a $9.3 million increase
over the prior year quarter. For the year ended December 31, 2021, general and administrative expenses increased by approximately $16.4 million, to $18.5 million from $2.1 million for the same period in 2020. This increase was
primarily the result of increased personnel expenses related to the buildout of our commercial operations and infrastructure, as well as increased marketing expenses to prepare for the commercial launch of FYARRO in 2022. We also incurred
approximately $2.0 million of compensation expense related to former Aerpio executives as a result of the merger.
Net loss attributable to common
stockholders for the fourth quarter was $16.0 million compared to net income attributable to common stockholders of $7.8 million in the prior year quarter. Net loss attributable to common stockholders for the year ended December 31,
2021 was $110.7 million compared with $4.5 million in the prior year, primarily driven by the non-cash impairment charge of $74.2 million previously reported in the third quarter, and an
increase in drug manufacturing and marketing expenses to prepare for the commercial launch in 2022 which were discussed above.
Comprehensive Cancer Network (NCCN)
The NCCN is a not-for-profit alliance of 27 leading U.S. cancer centers devoted to patient care, research and education, is dedicated to improving the quality, effectiveness and efficiency of cancer care. The intent of the
NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care including physicians, nurses, pharmacists, payers, patients and their families with the ultimate goal of improving patient care and
outcomes. For more information about the National Comprehensive Cancer Network go to: https://www.nccn.org/home/about
About Malignant PEComa
Advanced malignant PEComa, defined by the World Health Organization as mesenchymal tumors composed of distinctive cells that show a focal
association with blood-vessel walls and usually express both melanocytic and smooth muscle markers, are a rare subset of soft-tissue sarcomas, with an undefined cell of origin. While there is no formal epidemiology for malignant PEComa, it is
estimated that there are about 100-300 new patients per year in the United States. Malignant PEComas may arise in almost any body site (typically the uterus, retroperitoneum, lung, kidney, liver,
genitourinary, and gastrointestinal tract with a female predominance) and can have an aggressive clinical course including distant metastases and ultimately death. The estimated prognosis based on retrospective reports is 12-16 months. Cytotoxic chemotherapies typically used for sarcoma show minimal benefit. Malignant PEComas have been shown to frequently harbor mutations in the TSC1 and/or TSC2 genes that result in the activation of
mTOR pathway making it a rational therapeutic target for this disease.
About the PRECISION 1 Trial
The PRECISION 1 Trial is a multi-center, open-label, tumor-agnostic pivotal study, of nab-sirolimus designed as a basket trial that will evaluate
approximately 120 adult and adolescent patients with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. The trial will have two independent arms of 60 patients each to separately evaluate patients with
either TSC1 or TSC2 inactivating alterations. Aadi has received Fast Track designation to evaluate nab-sirolimus in this indication from the FDA. The trial opened for enrollment in February 2022.
FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid
cell tumor (PEComa).
Important Safety Information
FYARRO is contraindicated in patients
with a history of severe hypersensitivity to sirolimus, other rapamycin derivatives, or albumin.
Warnings and Precautions
Stomatitis, including mouth ulcers and oral
mucositis, occurred in 79% of patients treated with FYARRO, including 18% Grade 3. Stomatitis was most often first reported within 8 weeks of treatment. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently
cause myelosuppression including anemia, thrombocytopenia and neutropenia. Anemia occurred in 68% of patients; 6% were Grade 3. Thrombocytopenia and neutropenia occurred in 35% of patients each. Obtain blood counts at baseline and every 2 months for
the first year of treatment and every 3 months thereafter, or more frequently if clinically indicated. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.
FYARRO can cause infections. Infections such
as urinary tract infections (UTI), upper respiratory tract infections and sinusitis occurred in 59% of patients. Grade 3 infections occurred in 12% of patients, including a single case each of a UTI, pneumonia, skin, and abdominal infections.
Monitor patients for infections, including opportunistic infections. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.
FYARRO can cause hypokalemia. Hypokalemia occurred in 44% of patients including 12% Grade 3 events. Monitor potassium levels prior to starting FYARRO and
implement potassium supplementation as medically indicated. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.
FYARRO can cause hyperglycemia.
Hyperglycemia occurred in 12% of patients treated with FYARRO, all of which were Grade 3 events. Monitor fasting serum glucose prior to starting FYARRO. During treatment, monitor serum glucose every 3 months in
non-diabetic patients, or as clinically indicated. Monitor serum glucose more frequently in diabetic patients. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently
Interstitial Lung Disease / Non-Infectious Pneumonitis
FYARRO can cause interstitial lung disease (ILD) / non-infectious pneumonitis. ILD /
non-infectious pneumonitis occurred in 18% of patients treated with FYARRO, of which all were Grades 1 and 2. Based on the severity of the adverse reaction, withhold, reduce the dose, or permanently
serious and sometimes fatal hemorrhage. Hemorrhage occurred in 24% of patients treated with FYARRO, including Grade 3 and Grade 5 events in 2.9% of patients each. Monitor patients for signs and symptoms of hemorrhage. Based on the severity of
adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.
Hypersensitivity Reactions
FYARRO can cause hypersensitivity reactions. Hypersensitivity reactions, including anaphylaxis, angioedema, exfoliative dermatitis, and hypersensitivity
vasculitis have been observed with administration of the oral formulation of sirolimus. Hypersensitivity reactions including anaphylaxis have been observed with human albumin administration. Monitor patients closely for signs and symptoms of
infusion reactions during and following each FYARRO infusion in a setting where cardiopulmonary resuscitation medication and equipment are available. Monitor patients for at least 2 hours after the first infusion and as clinically needed for each
subsequent infusion. Reduce the rate, interrupt infusion, or permanently discontinue FYARRO based on severity and institute appropriate medical management as needed.
Embryo-Fetal Toxicity
Based on animal studies and the mechanism of action, FYARRO can cause fetal harm when administered to a pregnant woman. In animal studies, mTOR inhibitors
caused embryo-fetal toxicity when administered during the period of organogenesis at maternal exposures that were equal to or less than human exposures at the recommended lowest starting dose. Advise pregnant women of the potential risk to a fetus.
Advise females of reproductive potential to avoid becoming pregnant and to use effective contraception while using FYARRO and for 12 weeks after the last dose.
Azoospermia or oligospermia may be
observed in patients treated with FYARRO. FYARRO is an anti-proliferative drug and affects rapidly dividing cells such as germ cells.
and Risks Associated with Live Vaccines
No studies in conjunction with immunization have been conducted with FYARRO. Immunization during FYARRO
treatment may be ineffective. Update immunizations according to immunization guidelines prior to initiating FYARRO, if possible. Immunization with live vaccines is not recommended during treatment and avoid close contact with those who have received
live vaccines while on FYARRO. The interval between live vaccinations and initiation of FYARRO should be in accordance with current vaccination guidelines for patients on immunosuppressive therapies.
Risk of Transmission of Infectious Agents with Human Albumin
FYARRO contains human albumin, a derivative of human blood. Human albumin carries only a remote risk of transmission of viral diseases because of effective
donor screening and product manufacturing processes. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been associated with
Adverse Reactions in
The most common adverse reactions ( 30%) were stomatitis in 27 (79%) patients; fatigue and rash in 23 (68%) patients each; infection in
20 (59%) patients; nausea and edema in 17 (50%) patients each; diarrhea, musculoskeletal pain and decreased weight in 16 (47%) patients each; decreased appetite in 15 (44%) patients; cough in 12 (35%) patients; and vomiting and dysgeusia in 11
(32%) patients each.
Laboratory Abnormalities in PEComa
The most common Grade 3 to 4 laboratory abnormalities ( 6%) were decreased lymphocytes in 7 (21%) patients; increased glucose and decreased potassium in
4 (12%) patients each; decreased phosphate in 3 (9%) patients; and decreased hemoglobin and increased lipase in 2 (6%) patients each.
Dosage interruptions