Aadi Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
Aadi Bioscience, Inc. (AADI) reported its financial results for Q4 and the full year of 2021, ending with $149.0 million in cash. The company launched FYARRO, the only FDA-approved treatment for malignant PEComa, added to NCCN Guidelines as the preferred therapy. The PRECISION 1 trial for nab-sirolimus targeting TSC1 and TSC2 alterations is now open for enrollment. However, Q4 operating expenses rose to $16.9 million, and the net loss for FY 2021 reached $110.7 million, significantly impacted by a $74.2 million impairment charge.
- FYARRO received U.S. FDA approval as the first treatment for advanced malignant PEComa.
- Cash and cash equivalents totaled $149.0 million, expected to fund operations into 2024.
- PRECISION 1 trial for nab-sirolimus is now open for enrollment.
- Operating expenses increased significantly to $112.3 million for FY 2021.
- Net loss attributable to common stockholders for FY 2021 was $110.7 million, a substantial decline from $4.5 million the previous year.
- A non-cash impairment charge of $74.2 million was recorded, impacting financial results.
-FYARRO™ approved November 22, 2021 and launched February 23, 2022-
-FYARRO added to NCCN® Guidelines as the only preferred therapy to treat malignant PEComa-
-PRECISION 1 tumor agnostic study for TSC1 or TSC2 alterations open for enrollment-
-Ended fourth quarter 2021 with
LOS ANGELES, March 17, 2022 (GLOBE NEWSWIRE) -- 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
- In February 2022, Aadi announced the launch and commercial availability of FYARRO (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant PEComa.
- FYARRO (also known as nab-sirolimus) was added to the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN® Guidelines) as the only preferred treatment regimen for malignant PEComa.
- A seasoned commercial team has been hired to call on key centers of excellence that target the majority of the malignant PEComa U.S. patient population, and a distribution network has been established to support the launch of FYARRO. Payer coverage is tracking positively, and product orders have already been received and sent to patients in need.
- Aadi opened enrollment for its Phase 2 tumor-agnostic registrational trial, PRECISION 1, to evaluate nab-sirolimus in adult and adolescent patients 12 years and older with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes in February 2022. The trial consists of two separate arms for TSC1 or TSC2 alterations. Initial clinical data from PRECISION 1 are expected in the first half of 2023.
2021 Corporate Development and Operational Highlights
FYARRO Approval
- On November 22, 2021, Aadi received U.S. Food and Drug Administration (FDA) approval of its first proprietary product. FYARRO is the first and only FDA-approved treatment for advanced malignant PEComa in adults and was approved in less than four months after the NDA acceptance, and priority review designation was announced on July 26, 2021.
Merger Completion and Public Listing on Nasdaq
- On August 26, 2021, Aadi completed its merger with Aerpio Pharmaceuticals, Inc. (“Aerpio”), a publicly traded biotechnology company (previously traded on the Nasdaq Global Select Market under “ARPO”), and the combined company began trading on the Nasdaq Capital Market as “AADI” post-merger. As part of the merger, each share of private Aadi common stock was converted into the right to receive 0.3172 shares of Aerpio common stock following a 15:1 reverse split of Aerpio’s common stock.
- Concurrent to the closing of the merger, the combined company closed the previously announced
$155 million private investment in a public equity (PIPE) financing of its common stock.
Board and Leadership: Key Appointments
- Aadi’s board and leadership team were strengthened with the following appointments in 2021:
- Emma Reeve was appointed to Aadi’s Board of Directors and as chair of the Audit Committee. Ms. Reeve brings over 25 years of value creation in pharmaceutical, medical device and bio-pharma service companies and a successful track record of transitioning companies from private to public.
- Brendan Delaney was appointed to the role of Chief Operating Officer. Mr. Delaney has had an established career in oncology-focused commercial leadership roles, launching multiple groundbreaking new products and building effective and cohesive commercial teams. As Chief Commercial Officer at Immunomedics, Inc., Brendan led the launch of TRODELVY®, the first TROP-2 directed antibody-drug conjugate for the treatment of triple-negative breast cancer. Immunomedics was acquired by Gilead Sciences, Inc. for
$21 billion . - Scott M. Giacobello, CPA, was appointed to the role of Chief Financial Officer and Treasurer. Most recently, Mr. Giacobello was the Chief Financial Officer of GW Pharmaceuticals plc until its
$7.2 billion acquisition by Jazz Pharmaceuticals. - Loretta M. Itri, M.D., FACP® was appointed to the role of Chief Medical Officer. Dr. Itri’s extensive career spans clinical and regulatory global-leadership roles at both major pharmaceutical and biopharmaceutical companies, Dr. Itri has overseen the development and regulatory approval of multiple therapeutic compounds. Most recently, Dr. Itri was Chief Medical Officer at Immunomedics, Inc, where she oversaw the development program and approval of TRODELVY®.
2021 Fourth Quarter and Full Year Financial Highlights
As of December 31, 2021, cash and cash equivalents totaled
For the year ended December 31, 2021, we recognized
Operating expenses for the fourth quarter were
Research and development expenses for the fourth quarter were
General and administrative expenses for the fourth quarter were
Net loss attributable to common stockholders for the fourth quarter was
About the National 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.
About FYARRO™
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
Contraindication
FYARRO is contraindicated in patients with a history of severe hypersensitivity to sirolimus, other rapamycin derivatives, or albumin.
Warnings and Precautions
Stomatitis
Stomatitis, including mouth ulcers and oral mucositis, occurred in
Myelosuppression
FYARRO can cause myelosuppression including anemia, thrombocytopenia and neutropenia. Anemia occurred in
Infections
FYARRO can cause infections. Infections such as urinary tract infections (UTI), upper respiratory tract infections and sinusitis occurred in
Hypokalemia
FYARRO can cause hypokalemia. Hypokalemia occurred in
Hyperglycemia
FYARRO can cause hyperglycemia. Hyperglycemia occurred in
Interstitial Lung Disease / Non-Infectious Pneumonitis
FYARRO can cause interstitial lung disease (ILD) / non-infectious pneumonitis. ILD / non-infectious pneumonitis occurred in
Hemorrhage
FYARRO can cause serious and sometimes fatal hemorrhage. Hemorrhage occurred in
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.
Male Infertility
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.
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 albumin.
Adverse Reactions
Adverse Reactions in PEComa
The most common adverse reactions (≥
Laboratory Abnormalities in PEComa
The most common Grade 3 to 4 laboratory abnormalities (≥
Dosage interruptions
Dose interruptions of FYARRO due to an adverse reaction occurred in 22 (
Dose reduction
Dose reductions of FYARRO due to an adverse reaction occurred in 12 (
Drug Interactions
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 juice.
Use in Specific Populations
Pregnancy
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.
Lactation
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
FYARRO can 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.
Pediatric
The safety and effectiveness of FYARRO in pediatric patients have not been established.
Geriatric Use
Of the 34 patients treated with FYARRO,
Hepatic Impairment
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 found here.
About Aadi Bioscience
Aadi is a biopharmaceutical company focused on precision therapies for genetically-defined cancers. Aadi’s primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations where other mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site. In November 2021, Aadi received FDA approval for FYARRO™ for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), and in February 2022 Aadi announced the commercial launch of FYARRO in this indication. FYARRO is an mTOR inhibitor bound to human albumin that has demonstrated significantly higher tumor accumulation, greater mTOR target suppression, and increased tumor growth inhibition over other mTOR inhibitors in preclinical models.
Based on data from the AMPECT trial with FYARRO and following discussions with the FDA about other emerging data with FYARRO, Aadi has initiated PRECISION 1, a tumor-agnostic registrational trial in mTOR inhibitor-naïve solid tumors harboring TSC1 or TSC2 inactivating alterations. Aadi also has ongoing studies to evaluate dosing of FYARRO in combination regimens. More information on Aadi’s development pipeline is available on the Aadi website at www.aadibio.com.
Forward-Looking Statements
Aadi cautions you that certain statements included in this press release that are not a description of historical facts are forward-looking statements. These statements are based on Aadi’s current beliefs and expectations. Forward-looking statements include statements regarding: our plans and potential for success relating to commercializing FYARRO; the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of FYARRO; our plans related to further development and manufacturing of FYARRO; the timing of additional clinical trials, including the registrational trial in patients harboring TSC1 and TSC2 inactivating alterations; the timing or likelihood of regulatory filings and approvals of FYARRO, including in potential additional indications and potential filings in additional jurisdictions; anticipated reception of FYARRO in the physician community; and the sufficiency of our existing capital resources and the expected timeframe to fund our future operating expenses and capital expenditure requirements. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to Aadi’s ability to successfully commercialize FYARRO; uncertainties associated with the clinical development and regulatory approval of FYARRO in additional indications, including potential delays in the commencement, enrollment and completion of clinical trials for additional indications; the risk that unforeseen adverse reactions or side effects may occur in the course of commercializing, developing and testing FYARRO; risks associated with the failure to realize any value from FYARRO in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks related to Aadi’s estimates regarding future expenses, capital requirements and need for additional financing; and risks related to the impact of the COVID-19 pandemic on Aadi’s operations, the biotechnology industry and the economy generally.
Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" in Aadi’s Form 10-K filed on March 17, 2022, and elsewhere in Aadi’s reports and other documents that Aadi has filed, or will file, with the SEC from time to time and available at www.sec.gov.
All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
FYARRO™ is a trademark of Aadi Bioscience, Inc.
For more information about FYARRO, visit: https://fyarro.com/
Contacts
Investors:
Irina Koffler
LifeSci Advisors LLC
| AADI BIOSCIENCE, INC. | ||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||
| (In thousands) | ||||||||||
| December 31, | December 31, | |||||||||
| 2021 | 2020 | |||||||||
| Assets | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 148,989 | $ | 4,455 | ||||||
| Accounts receivable | - | 14,149 | ||||||||
| Prepaid expenses and other current assets | 2,283 | 81 | ||||||||
| Total current assets | 151,272 | 18,685 | ||||||||
| Property and equipment, net | 57 | 21 | ||||||||
| Operating lease right-of-use assets | 557 | 119 | ||||||||
| Intangible asset, net | 3,811 | - | ||||||||
| Other assets | 2,213 | - | ||||||||
| Total assets | $ | 157,910 | $ | 18,825 | ||||||
| Liabilities and shareholders' equity (deficit) | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable | $ | 6,439 | $ | 2,392 | ||||||
| Accrued liabilities | 8,445 | 4,099 | ||||||||
| Payable to related party | 258 | 14,314 | ||||||||
| Convertible related party promissory notes payable at fair value | - | 9,029 | ||||||||
| Operating lease liabilities, current portion | 131 | 125 | ||||||||
| Other current liabilities | - | 99 | ||||||||
| Total current liabilities | 15,273 | 30,058 | ||||||||
| Convertible promissory notes payable at fair value | - | 1,102 | ||||||||
| Payable to related party | 5,757 | - | ||||||||
| Operating lease liabilities, net of current portion | 474 | - | ||||||||
| Other liabilities | - | 97 | ||||||||
| Total liabilities | 21,504 | 31,257 | ||||||||
| Stockholders' equity (deficit): | ||||||||||
| Series A preferred stock | - | 1 | ||||||||
| Common stock | 2 | 1 | ||||||||
| Additional paid-in capital | 279,089 | 20,161 | ||||||||
| Accumulated deficit | (142,685 | ) | (32,595 | ) | ||||||
| Total stockholders' equity (deficit) | 136,406 | (12,432 | ) | |||||||
| Total liabilities and stockholders' equity (deficit) | $ | 157,910 | $ | 18,825 | ||||||
| AADI BIOSCIENCE, INC. | |||||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||||
| (In thousands, except shares and earnings per share amounts) | |||||||||||||||||||
| Three months ended | Year Ended | ||||||||||||||||||
| December 31, | December 31, | ||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||
| Revenue | unaudited | ||||||||||||||||||
| License revenue | $ | 1,000 | $ | 14,000 | $ | 1,000 | $ | 14,000 | |||||||||||
| Grant revenue | - | 149 | 120 | 580 | |||||||||||||||
| Total Revenue | 1,000 | 14,149 | 1,120 | 14,580 | |||||||||||||||
| Operating expenses | |||||||||||||||||||
| Research and development | 7,227 | 5,324 | 19,670 | 15,008 | |||||||||||||||
| General and administrative | 9,718 | 421 | 18,511 | 2,121 | |||||||||||||||
| Impairment of intangible asset | - | - | 74,156 | - | |||||||||||||||
| Total operating expenses | 16,945 | 5,745 | 112,337 | 17,129 | |||||||||||||||
| (Loss) income from operations | (15,945 | ) | 8,404 | (111,217 | ) | (2,549 | ) | ||||||||||||
| Other income (expense) | |||||||||||||||||||
| Change in fair value of convertible promissory note | - | (153 | ) | 1,585 | (153 | ) | |||||||||||||
| Gain upon extinguishment of debt | - | - | 196 | - | |||||||||||||||
| Interest income | 12 | - | 13 | 41 | |||||||||||||||
| Interest expense | (57 | ) | (230 | ) | (665 | ) | (815 | ) | |||||||||||
| Total other (expense) income, net | (45 | ) | (383 | ) | 1,129 | (927 | ) | ||||||||||||
| (Loss) income before income taxes | (15,990 | ) | 8,021 | (110,088 | ) | (3,476 | ) | ||||||||||||
| Income tax expense | - | (1 | ) | (2 | ) | (2 | ) | ||||||||||||
| Net and comprehensive (loss) income | (15,990 | ) | 8,020 | (110,090 | ) | (3,478 | ) | ||||||||||||
| Cumulative dividends on convertible preferred stock | - | (247 | ) | (647 | ) | (987 | ) | ||||||||||||
| Net and comprehensive (loss) income attributable to common stockholders | $ | (15,990 | ) | $ | 7,773 | $ | (110,737 | ) | $ | (4,465 | ) | ||||||||
| Net and comprehensive (loss) income per share attributable to common stockholders, basic and diluted | |||||||||||||||||||
| $ | (0.77 | ) | $ | 3.06 | * | $ | (12.41 | ) | $ | (1.76 | ) | ||||||||
| Weighted average number of common shares outstanding used in computing net and comprehensive (loss) income per share attributable to common stockholders, basic and diluted | 20,890,305 | 2,542,358 | 8,923,369 | 2,542,358 | |||||||||||||||
| * Fourth quarter 2020 represents basic earnings per share; fully diluted not presented. | |||||||||||||||||||
FAQ
What were Aadi Bioscience's financial results for Q4 2021?
How much cash does Aadi Bioscience have as of December 31, 2021?
What is the significance of FYARRO for Aadi Bioscience?
When is the initial clinical data from the PRECISION 1 trial expected?
What led to the significant net loss for Aadi Bioscience in 2021?
