Full Press Release Details
Aadi Bioscience Reports First Quarter 2022 Financial Results and Provides a Corporate Update
LOS ANGELES, CA, May 12, 2022 Aadi Bioscience, Inc. (NASDAQ: AADI),
a biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced financial results for the first quarter of 2022 and provided a
We are very pleased and encouraged by the strong demand for FYARRO since its February 22nd launch despite the ultra-rare nature of advanced malignant PEComa, commented Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. A number of factors are believed
to have contributed to the sales in Q1 including pent up demand since FYARRO s approval on November 22, 2021, transition of expanded access and clinical trial patients to the commercial drug, significant physician awareness and favorable
reimbursement, he added.
Dr. Desai continued, Our clinical team has been focused on advancing nab-sirolimus and the first patient
was dosed in our PRECISION 1 tumor-agnostic registration-directed trial in March. Based on data recently presented at AACR, TSC1 and TSC2 genetic alterations within tumors represent one of the larger opportunities within targeted
oncology. We have also partnered with large community oncology center networks and next generation sequencing (NGS) providers to identify these patient candidates for our trial, which we believe will augment the pace of enrollment in the PRECISION 1
trial. We anticipate initial clinical data to be available in the first half of next year.
Recent and First Quarter 2022 Corporate Highlights
First Quarter 2022 Financial Highlights
As of March 31, 2022, cash and cash equivalents totaled $129.8 million, compared to $149.0 million as of December 31, 2021. Based on our
current plans, we expect cash and cash equivalents to fund operations into 2024.
For the three months ended March 31, 2022, net product sales were
$2.3 million resulting from the launch of FYARRO in February. This compares to $0.1 million of grant revenue during the three months ended March 31, 2021. No grant revenue was recognized during the three months ended March 31,
Operating expenses for the three months ended March 31, 2022 were $16.1 million compared to $4.2 million for the same period last
Selling, general and administrative expenses for the three months ended March 31, 2022 were $9.1 million, an $8.5 million increase
over the same period last year. 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 related to the commercial launch
of FYARRO in February 2022.
Research and development expenses for the three months ended March 31, 2022 were $6.8 million, a $3.2 million
increase over the same period last year. This increase was primarily the result of increased clinical trial expenses and costs related to the buildout of the organization.
Net loss for the three months ended March 31, 2022 was $13.9 million compared to $5.5 million for the three months ended March 31, 2021.
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
FYARRO can 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
Immunizations 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 PEComa
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.
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
Dose interruptions of FYARRO due to
an adverse reaction occurred in 22 (65%) patients. Adverse reactions which required dosage interruption in >5% of patients included stomatitis in 6 (18%) patients, pneumonitis in 5 (15%) patients, anemia in 3 (9%) patients, and dehydration,
dermatitis acneiform, and thrombocytopenia in 2 (6%) patients each.
Dose reductions of FYARRO due to an adverse reaction occurred in 12 (35%) patients. Adverse reactions which required dose reductions in > 5% of patients
included stomatitis and pneumonitis in 3 (9%) patients each.
Reduce the dosage of FYARRO to 56 mg/m2 when used concomitantly with a moderate or weak cytochrome P-450 3A4 (CYP3A4) inhibitor. Avoid concomitant use with drugs that are strong CYP3A4 and/or P-glycoprotein (P-gp) inhibitors and inducers and with grapefruit and grapefruit
Use in Specific Populations
Based on the mechanism of action and findings in animals, FYARRO can cause fetal harm when administered to a pregnant woman. Advise females of the
potential risk to a fetus and to avoid becoming pregnant while receiving FYARRO.
Sirolimus is present in the milk of lactating rats. There is potential for serious adverse effects from sirolimus in breastfed infants based on mechanism of
action. Because of the potential for serious adverse reactions in breastfed infants from FYARRO, advise women not to breastfeed during treatment with FYARRO and for 2 weeks after the last dose.
Females and Males of Reproductive Potential
cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to starting treatment with FYARRO. Advise females of reproductive potential to use effective contraception and avoid
becoming pregnant during treatment with and for at least twelve weeks after the last dose of FYARRO. Advise males with female partners of reproductive potential to use effective contraception and avoid fathering a child during treatment with FYARRO
and for at least twelve weeks after the last dose of FYARRO. Although there are no data on the impact of FYARRO on fertility, based on available clinical findings with oral formulation of sirolimus and findings in animals, male and female fertility
may be compromised by the treatment with FYARRO.
The safety and effectiveness of FYARRO in pediatric patients have not been established.
Of the 34 patients treated with FYARRO,
44% were 65 years of age and older, and 6% were 75 years of age and older. Clinical studies of FYARRO did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
FYARRO is not recommended for use in
patients with severe hepatic impairment. Reduce FYARRO dosage in patients with mild or moderate hepatic impairment.
Full prescribing information can be
About Malignant PEComa
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