On August 11, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, reported financial results for the second quarter of 2022 and Company updates (Press release, Hookipa Biotech, AUG 11, 2022, View Source [SID1234618090]).

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"We continued to observe validation of our novel arenaviral platform in the second quarter with key Phase 1 data presented at ASCO (Free ASCO Whitepaper) for HB-200 in head and neck cancer and our plans to move forward with the Phase 2 program," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We have expanded our clinical portfolio with the concurrent FDA acceptance of our investigational new drug application for HB-300 in prostate cancer and our Drug Master File. The Drug Master File is significant as it supports the implementation of our platform approach, facilitating reduced cycle time between preclinical studies and clinical entry of our pipeline projects across various cancer types."

HOOKIPA Portfolio Highlights

In July, HOOKIPA announced that the US FDA accepted HOOKIPA’s Investigational New Drug Application for HB-300 for the treatment of metastatic castration-resistant prostate cancer. A Drug Master File was also accepted, facilitating reduced cycle time between completion of preclinical studies and clinical entry of HOOKIPA’s pipeline projects.

In June, HOOKIPA announced positive Phase 1 data and Phase 2 plans for HB-200 for the treatment of advanced head and neck cancers at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Alternating 2-vector therapy showed superior antigen-specific T cell responses, more robust anti-tumor activity and similar tolerability vs. single-vector therapy. The Phase 2 trial will proceed with alternating 2-vector therapy alone and in combination with pembrolizumab, which will help inform the randomized Phase 2 trial planned to start in the first half of 2023.

In June, HOOKIPA presented preclinical data on its novel arenaviral HIV therapeutic vaccines. The data were presented at the Keystone Symposium and highlighted robust and high-quality immune responses following administration of arenaviral therapeutic vaccines in a preclinical setting. Alternating 2-vector therapy induced greater immune response than single-vector therapy, translating to a significant reduction in viral load.

In April, new data were announced at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting showing HOOKIPA’s arenaviral immunotherapies induced potent T cell responses in novel combinations and against tumor self-antigens. Preclinical data also expanded evidence on arenaviral immunotherapy targeting self-antigens, reinforcing the scientific approach for the HB-300 program in prostate cancer.
HOOKIPA Leadership Updates

In May, HOOKIPA announced the promotion of Christine D. Baker to Chief Operating Officer. Baker was previously Chief Business Officer for HOOKIPA.

In June, HOOKIPA announced several executive leadership changes. Igor Matushansky, Chief Medical Officer and Global Head of Research and Development transitioned to Chair of HOOKIPA’s Scientific Advisory Board. Katia Schlienger, Senior Vice President and Head of Immuno-oncology was promoted to Executive Vice President, Clinical Development. Roman Necina, Chief Technology Officer, was appointed to the newly created role of Chief Development Officer.
Upcoming Anticipated Milestones

Phase 2 HB-200 data in combination with pembrolizumab in HPV16+ head and neck cancer:
First-line initial data expected in the second half of 2022
Second-line initial data expected in the second half of 2022

Randomized Phase 2 HB-200 study in combination with pembrolizumab in first-line for HPV16+ HNSCC: First half of 2023 (Fast Track designation)

Hepatitis B therapeutic IND: 2022 (Gilead-led)

Prostate cancer First Patient Enrolled expected in first quarter of 2023
Second Quarter 2022 Financial Results

Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of June 30, 2022 was $118.9 million compared to $66.9 million as of December 31, 2021. The increase was primarily attributable to funds resulting from the amended and restated Gilead collaboration agreement and the follow-on financing in March 2022, partly offset by cash used in operating activities.

Revenue was $2.7 million for the three months ended June 30, 2022, compared to $5.4 million for the three months ended June 30, 2021. The decrease was primarily due to lower cost reimbursements received under the Collaboration Agreement with Gilead. The $4.0 million milestone payment and the $15.0 million initiation fee received in the three months ended March 31, 2022 largely remained recorded as deferred revenue to be recognized in future accounting periods.

Research and Development Expenses: HOOKIPA’s research and development expenses were $16.1 million for the three months ended June 30, 2022, compared to $19.6 million for the three months ended June 30, 2021. The decrease for the three months ended June 30, 2022 compared to the three months ended June 30, 2021 was primarily driven by lower manufacturing expenses for our HB-200 and Gilead partnered programs, a decrease in personnel-related expenses including stock-based compensation, and a decrease in laboratory consumables that was partially offset by an increase in professional and consulting fees and an increase in training and recruitment expenses.

General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2022 were $5.0 million, compared to $5.1 million for the three months ended June 30, 2021. The decrease was primarily due to a decrease in personnel-related expenses and a decrease in other expenses that was partially offset by an increase in professional and consulting fees. The decrease in personnel-related expenses resulted from decreased stock compensation expenses and the conversion of a portion of the base salaries of the Company’s executive team for the six months ended June 30, 2022 into common stock with a fair value below the conversion rate, that was partially offset by a growth in headcount along with increased salaries in our general and administrative functions.

Net Loss: HOOKIPA’s net loss was $16.4 million for the three months ended June 30, 2022 compared to a net loss of $17.2 million for the three months ended June 30, 2021. This decrease was primarily due to a decrease in research and development expenses.

On August 11, 2022 Cardinal Health (NYSE: CAH) reported that its Board of Directors has elected Jason Hollar as the company’s next Chief Executive Officer, effective September 1, 2022 (Press release, Cardinal Health, AUG 11, 2022, View Source [SID1234618089]). Hollar will also join the Board of Directors effective August 11, 2022. Hollar will succeed current Chief Executive Officer, Mike Kaufmann.

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Hollar, an experienced financial and operating executive, has served as Cardinal Health’s Chief Financial Officer since May 2020, leading financial activities across the enterprise, including financial strategy, capital deployment, treasury, tax, investor relations, risk management, accounting and reporting. During his tenure, he has helped Cardinal Health prioritize investments in growth businesses, strengthened the balance sheet, and returned capital to shareholders. Prior to joining Cardinal Health, Hollar served as Chief Financial Officer and Executive Vice President for Tenneco. Before that, Hollar served as Chief Financial Officer and Senior Vice President of finance for Sears Holdings Corporation.

In addition, Patricia English will serve as Cardinal Health’s interim Chief Financial Officer, working with Hollar to ensure a smooth transition. English currently serves as Chief Accounting Officer and Senior Vice President of Cardinal Health and previously served as Vice President of accounting in both the pharmaceutical and medical segments. Cardinal Health’s Board will engage an executive search firm to evaluate candidates for the permanent Chief Financial Officer position.

"Mike has been a tremendous leader during his tenure at Cardinal Health, helping the company navigate a period of unprecedented challenges, directing strategic investments for growth and innovation, and cultivating an inclusive and vibrant workforce culture. We are grateful for Mike’s many contributions over his more than 30 years of service and wish him the best in his future endeavors," said Gregory Kenny, Cardinal Health’s Independent Chairman of the Board. "We look forward to leveraging Jason’s broad executive experience and are confident in his ability to lead Cardinal Health on a path to long-term growth."

Kaufmann said, "I am grateful for the privilege of serving alongside such a dedicated, purpose-driven, and talented team over the past three decades. It was truly the honor of a lifetime to serve as CEO of Cardinal Health these last five years. The Board and I are confident that Jason is the right person to lead Cardinal Health in the years to come."

Hollar said, "I sincerely appreciate the confidence the Board has placed in me to help position the company for future growth. This is a transformational period at Cardinal Health and I am humbled to have the opportunity to lead a business that plays such a vital role in the healthcare ecosystem. I look forward to working closely with Cardinal Health’s talented employees, management team, and Board as we continue to build upon our strong foundation and deliver value to our customers, communities and shareholders."

Hollar continued, "I also look forward to continuing to work alongside Trish, who has been a valuable member of the Cardinal Health family for over sixteen years. She brings a strong combination of financial expertise and leadership experience to the role as interim Chief Financial Officer."

About Jason Hollar
Jason Hollar has been Chief Financial Officer of Cardinal Health since May 2020, leading financial activities across the enterprise including financial strategy, capital deployment, treasury, tax, investor relations, accounting and reporting. Hollar has deep executive experience as well as expertise leading in dynamic environments, most recently serving as the Chief Financial Officer of Tenneco Inc., a global automotive products and services company. As Tenneco’s Executive Vice President and Chief Financial Officer, Hollar was responsible for financial planning and analysis, accounting and reporting, tax, treasury and investor relations for the company. Hollar joined Tenneco in June 2017 from Sears Holdings Corporation, where he served as Chief Financial Officer and Senior Vice president finance. Prior to Sears, Hollar worked with both Delphi Automotive and Navistar International in a number of senior finance roles. He served as Delphi’s corporate controller and as Vice President of finance for the company’s powertrain systems division, which also included oversight of the Europe, Middle East and Africa regions. At Navistar, he held finance positions of increasing responsibility in the company’s engine group, South America operations and corporate financial planning and analysis. Hollar received his Master of Business Administration from The University of Chicago and his bachelor’s degree in business from Indiana University.

About Patricia English
Patricia English has served as Chief Accounting Officer and Senior Vice President of Cardinal Health since September 2020. She previously served as Vice President, pharmaceutical segment accounting at Cardinal Health from January 2019 to August 2020. She also served as Vice President, medical segment accounting from March 2015 to December 2018 and as director, pharmaceutical distribution accounting from June 2011 to March 2015. English holds a bachelor’s degree in accounting from The Ohio State University.

Webcast
Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss fourth quarter and full year results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required. Presentation slides and a webcast replay will be available until August 10, 2023.

On August 11, 2022 Targovax ASA (OSE: TRVX) reported that it will announce its second quarter and first half 2022 results on Thursday 18 August 2022 (Press release, Targovax, AUG 11, 2022, View Source [SID1234618084]). Targovax’s management will present the results at a live streamed webcast at 10:00 am CET to investors, analysts and the press.

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The results report and the presentation will be available at www.targovax.com in the Investors section from 07:00 am CET, on 18 August 2022.

Presentation

There will be a virtual presentation of the results with a live webcast 18 August at 10.00 am CET. You can join the webcast here. It will be possible to ask questions during the presentation.

On August 11, 2022 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported financial results for the quarter ended June 30, 2022 and provided recent business highlights (Press release, Shattuck Labs, AUG 11, 2022, View Source [SID1234618082]).

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"We have made significant progress throughout the second quarter, including dosing patients in our Phase 1 clinical trial of SL-172154 in AML and HR-MDS and advancing SL-172154 in our clinical trial in platinum-resistant ovarian cancer," said Taylor Schreiber, M.D., Ph.D., and Chief Executive Officer of Shattuck. "As we look ahead to the second half of this year, we look forward to beginning to enroll patients at immunologically active dose levels of SL-172154 in combination with liposomal doxorubicin for patients with advanced platinum-resistant ovarian cancer and with azacitidine for patients with AML and HR-MDS. We also continue to make excellent progress advancing our preclinical pipeline from our ARC and GADLEN platforms, and we expect to nominate the next clinical product candidate by the end of this year."

Second Quarter 2022 Recent Business Highlights and Other Recent Developments

ARC Clinical-Stage Pipeline and Preclinical Pipeline

SL-172154 (SIRPα-Fc-CD40L)

Continued Enrollment of SL-172154 Phase 1 Monotherapy Dose-Escalation Clinical Trial in Platinum-Resistant Ovarian Cancer: This open-label, multi-center, dose-escalation clinical trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered intravenously in patients with advanced platinum-resistant ovarian cancer. To date, Shattuck has dose escalated to the anticipated top dose level of 10.0 mg/kg. Most patients at both the 3.0 mg/kg and 10.0 mg/kg dose levels have experienced grade 2 infusion related reactions, which did not lead to any treatment discontinuations. In one of five patients treated at the 10.0 mg/kg dose level, we observed a dose limiting toxicity of alanine transaminase increase. Preliminary data suggest that extending the duration of infusion may reduce the incidence of infusion related reactions. We are currently enrolling additional patients at 3.0 mg/kg with an extended infusion time. To date, we have observed no evidence of destructive anemia in any patient treated. We have observed full receptor occupancy and receptor saturation of CD40 and CD47 at the 3.0 mg/kg dose level and data indicate that both serum cytokine elevations and margination of CD40+ B cells and monocytes have achieved a maximal plateau at doses of 3.0 mg/kg and 10.0 mg/kg. Dose-escalation data from the trial are expected in the first half of 2023.
Combination Trial of SL-172154 with Liposomal Doxorubicin Expected to Begin in the Third Quarter of 2022: This trial will evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamics effects of SL-172154 in combination with liposomal doxorubicin in patients with advanced platinum-resistant ovarian cancer and is anticipated to begin enrollment in the third quarter of 2022. Our starting dose of SL-172154 in this trial is 3.0 mg/kg. Initial combination data from the trial are expected in the first half of 2023.
Enrollment Continues in SL-172154 Phase 1A/B Clinical Trial in AML and HR-MDS: The trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 as both monotherapy and in combination. Our starting dose of SL-172154 in the monotherapy portion of this clinical trial is 1.0 mg/kg. In AML, SL-172154 will be evaluated in combination with both azacitidine and venetoclax. In both HR-MDS and TP53 mutant AML, SL-172154 will be combined with azacitidine. We plan to dose escalate as both monotherapy and in combination in a parallel staggered manner. Initial dose-escalation and combination data from the trial are expected in the first half of 2023.
Provided Clinical Data for Intratumorally Administered SL-172154 in Phase 1 Clinical Trial in Squamous Cell Carcinoma of the Head and Neck (HNSCC) or Skin (CSCC): As of the data cut-off date of April 8, 2022, five patients with cancer, four with CSCC and one with HNSCC, were treated with intratumoral administration of SL-172154 across two dose levels, 0.003 and 0.01 mg. All patients had prior anticancer surgery, four out of five patients had prior radiotherapy, and all patients had prior systemic therapy, with a median of two prior lines. SL-172154 was well tolerated at the two dose levels studied with no dose-limiting toxicities reported, and no significant safety signals were noted. An unconfirmed partial response was observed in a patient with CSCC who experienced a 75 percent reduction in the target lesion, and stable disease was observed in an additional CSCC patient. Increases in CD80, a marker of CD40 activation, have been observed in on-treatment tumor biopsies. Based on the totality of the safety and biomarker data collected to date in the ongoing Phase 1 clinical trial in ovarian cancer patients, Shattuck has decided to focus on developing SL-172154 as an intravenously administered product candidate.
SL-279252 (PD1-Fc-OX40L)

Continued Enrollment of SL-279252 Phase 1 Dose-Escalation Clinical Trial in Advanced Solid Tumors: Enrollment of patients with primarily PD-L1 selected tumors continues in the Phase 1 open-label, multi-center, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity and pharmacodynamic effects of SL-279252 in patients with advanced solid tumors and lymphoma. Top-line data from the Phase 1 trial are anticipated in the second half of 2022.
Preclinical

Presented Preclinical Development of Gamma Delta T Cell Engager, or GADLEN, platform at the 3rd Gamma Delta T Therapies Summit in July 2022: Data were presented demonstrating preclinical proof of concept for Shattuck’s butyrophilin heterodimer-based gamma delta T cell engager platform. Data from CD19, CD20, and B7-H3-targeted GADLEN constructs demonstrated the newly described role of co-stimulation during Vg9d2 T cell activation and tumor cell killing. In vivo proof-of-concept data was also presented establishing the ability of the CD20-GADLEN to activate human Vg9d2 T cells to target and serially deplete CD20-expressing human B-cells in a dose-dependent, and highly specific, manner.
Presented Preclinical Development of SL-9258 at the PEGS Conference in May of 2022 and Published the Associated Preclinical Manuscript in the Journal of Immunology in July 2022: SL-9258 (TIGIT-Fc-LIGHT), a dual TIGIT inhibitor and HVEM/LTβR agonist, was shown to induce potent anti-tumor immunity in preclinical mouse models of checkpoint primary and acquired resistance, both alone and when combined with anti-PD1 or anti-PDL1, through the simultaneous blockade of the TIGIT checkpoint pathway and broad immune activation of T, NK, and myeloid cells through the TNF-costimulatory ligand known as LIGHT.
Clinical Pipeline Product Candidate to be Selected in 2022: As Shattuck looks to advance its preclinical pipeline, a new clinical product candidate from our ARC or GADLEN platform is anticipated to be announced in the second half of 2022.
Upcoming Events

Citi’s 17th Annual BioPharma Conference: Management will participate in investor one-on-one meetings and a fireside chat at Citi’s 17th Annual BioPharma Conference from September 7-8, 2022.
H.C. Wainwright 24th Annual Global Investment Conference: Management will participate in investor one-on-one meetings and give a corporate presentation during the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022.
Live and archived audio webcasts of both the fireside chat and presentation will be available by visiting the Events & Presentations section of the Company’s website.
Second Quarter 2022 Financial Results

Cash Position: As of June 30, 2022, cash and cash equivalents and short-term investments were $214.2 million, as compared to $268.8 million as of December 31, 2021.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2022 were $23.0 million, as compared to $14.9 million for the quarter ended June 30, 2021. This increase was primarily driven by increases in process development costs and manufacturing of trial materials to support clinical development of SL-172154, lab supplies, and personnel-related costs.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2022 were $4.8 million, as compared to $5.4 million for the quarter ended June 30, 2021. This decrease was primarily driven by decreases in personnel-related and other operating costs.
Net Loss: Net loss was $27.4 million for the quarter ended June 30, 2022, or $0.65 per basic and diluted share, as compared to a net loss of $23.6 million for the quarter ended June 30, 2021, or $0.56 per basic and diluted share.
2022 Financial Guidance
Shattuck believes its cash and cash equivalents and short-term investments will be sufficient to fund its operations into the second half of 2024, beyond results from its Phase 1 clinical trials of SL-172154 and SL-279252. This cash runway guidance is based on the Company’s current operational plans and excludes any addition funding that may be received, proceeds from business development transactions, or additional costs associated with clinical development activities that may be undertaken.

About SL-172154
SL-172154 (SIRPα-Fc-CD40L) is an investigational ARC fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor to bolster an anti-tumor immune response in patients with advanced cancer. Multiple Phase 1 clinical trials are ongoing for patients with advanced platinum-resistant ovarian cancer (NCT04406623, NCT05483933) and patients with AML and HR-MDS (NCT05275439).

About SL-279252
SL-279252 (PD1-Fc-OX40L) is an investigational ARC fusion protein designed to simultaneously inhibit the PD-1/PD-L1 interaction and activate the OX40 receptor in patients with advanced cancers. A Phase 1 trial in patients with solid tumors and lymphoma is ongoing (NCT03894618).

On August 10, 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, reported that financial results for the second quarter of 2022 (Press release, Aadi Bioscience, AUG 10, 2022, View Source [SID1234618873]).

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"We continue to progress in key areas after our first full quarter following FYARRO’s launch. We are excited to see FYARRO reaching more patients through continued account adoption and steady growth in overall sales," said Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. "We are also encouraged by the progress on our tumor agnostic PRECISION 1 trial targeting TSC1 and TSC2 inactivating alterations which continues to ramp up, with activation of additional clinical trial sites and patient enrollment. We anticipate providing preliminary data on a meaningful number of patients in this trial during the first half of 2023. In addition, we continue to evaluate strategies for new clinical indications of nab-sirolimus either as single agent or in combination with other targeted therapies with the potential for new programs as early as 2023."

Corporate Updates for the Second Quarter 2022

FYARRO net product sales for the three months ended June 30, 2022 were $3.4 million, the first full quarter of sales following the product launch late in the first quarter.
A product-specific permanent J-code (J9331) for FYARRO from Centers for Medicare and Medicaid Services (CMS) became effective on July 1, 2022. This code is expected to further facilitate reimbursement for FYARRO.
The Company announced its addition to both the U.S. small cap Russell 2000 Index and broad-market Russell 3000 Index at the conclusion of the 2022 Russell indexes annual reconstitution, which captures the 4,000 largest U.S. stocks, ranking them by total market capitalization.
Partnerships with prominent next generation sequencing (NGS) providers and leaders in genomic testing and profiling was announced during the quarter, which included Foundation Medicine, Tempus and others. The Company is leveraging these partnerships to expedite patient identification and recruitment for the ongoing PRECISION 1 trial of nab-sirolimus in patients harboring tumors with inactivating alterations in TSC1 or TSC2 genes, and is making significant progress toward opening the trial in at least 20 major cancer centers and upward of 120 treatment sites in the U.S. by the end of 2022.
A poster presentation entitled, "nab-Sirolimus for patients with advanced malignant PEComa with or without prior mTOR inhibitors: Biomarker results from AMPECT and an expanded access program" was presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The data included exploratory biomarker results reported from the final analysis of mTOR inhibitor-naïve advanced malignant PEComa patients treated with nab-sirolimus in the Advanced Malignant PEComa Trial (AMPECT) trial as well as an analysis of prior mTOR inhibitor exposed advanced malignant PEComa patients treated with nab-sirolimus in the Expanded Access Program (EAP) through June 2021. Findings from both the AMPECT study and the EAP showed greater clinical benefit in patients with TSC1 or TSC2 inactivating alterations who received nab-sirolimus compared to all evaluable patients, regardless of prior mTOR inhibitor exposure.
The Company sponsored a poster at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) which indicated the incidence of advanced cancer patients carrying TSC1 or TSC2 inactivating gene alterations numbered approximately 12,000 annually in the US, thus potentially rendering these patients eligible for nab-sirolimus therapy.
Second Quarter 2022 Financial Results

Cash and cash equivalents on June 30, 2022 were $118.7 million, compared to $149.0 million as of December 31, 2021. Based on current plans, the Company expects cash and cash equivalents to fund operations into 2024.
Total revenue for the quarter ended June 30, 2022 was $3.4 million resulting from sales of FYARRO.
In the second quarter of 2022, the Company recorded a non-cash impairment charge of $3.7 million to write-off the value of an intangible asset related to the Gossamer license agreement with the Company’s predecessor, Aerpio.
Net loss for the three months ended June 30, 2022 was $18.3 million compared to $1.5 million for the three months ended June 30, 2021.
Conference Call Information

The Aadi management team is hosting a conference call and webcast today at 8:30 am ET (5:30 am PT) to provide a corporate update and discuss results for the second quarter of 2022.

Participants may access a live webcast of the call on the "Investors & News" page of the Aadi Biosciences website at aadibio.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

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).

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 first patient in the PRECISION 1 trial was dosed in March 2022.