On MAY 5, 2022 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the quarter ended March 31, 2022 and provided a business update (Press release, INmune Bio, MAY 5, 2022, View Source [SID1234613788]).

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Q1 2022 and Recent Corporate Highlights

DN-TNF Platform Highlights (XPro and INB03):

Dosed the first patient in the Phase II trial using XPro to treat patients with mild Alzheimer’s Disease (AD). The primary endpoint will examine cognition using the Early AD/MCI Alzheimer’s Cognitive Composite (EMACC). Data is anticipated in the second half of 2023.
Delivered multiple oral and poster presentations at AD/PD 2022 (International Conference on Alzheimer’s and Parkinson’s Disease).
Presented breast cancer data at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which suggested the use of INmune Bio’s DN-TNF candidate, INB03, may help reverse resistance to immunotherapy patients with HER2+ cancers.
INKmune Platform Highlights:

Planned expansion of INKmune program to include AML and new site in EU.
2 of 3 patients with MDS/AML remain stable more than 6 months after the last treatment with INKmune.
INKmune shows best-in-class therapeutic persistence measured by activated tumor killing NK cells (NKG2D+ NK cells) in the peripheral blood or bone marrow more than 100 days after INKmune treatment in the two patients with stable disease
Highlighted the potential of INKmune primed NK cells to treat solid tumors by improving the ability of natural killer (NK) cells to survive hostile tumor microenvironments and by increased avidity, a necessary step for cancer cell killing, compared to NK cells primed with cytokines (IL-2, IL15).
Upcoming Milestones:

Initiate Xpro Phase 2 program for Mild Cognitive Impairment (MCI) in patients 1H 2022.
Initiate XPro Phase 2 program for treatment resistant depression (TRD), funded in part by a $2.9 million NIH grant, by 2H 2022.
Continued enrollment and opening of sites for XPro Phase 2 program for mild AD.
Initiate INKmune Phase 1 program in ovarian cancer or solid tumor in 2H 2022.
Additional open-label Phase 1 trial data of INKmune in high-risk MDS/AML.
Report top-line data from Phase 2 trial of Xpro in MCI patients in mid-2023.
Report top-line data from Phase 2 trial of XPro in Mild AD patients in 2H 2023.
Report pre-clinical INKmune data in renal cell carcinoma and nasopharyngeal carcinoma.
"Our scientific platforms continue to showcase our unique approach to repairing dysfunction of the innate immune system," stated RJ Tesi, M.D., CEO of INmune Bio. "In April, we announced the dosing of our first patient treated with XPro1595 ("XPro) in the treatment of neuroinflammation as a cause of mild Alzheimer’s disease (AD) in a Phase II clinical trial AD02, a blinded, randomized, placebo-controlled multicenter study in Australia, in Canada and in the United States that will assess the cognitive and functional impact of XPro in 201 mild AD patients. A second blinded, randomized, placebo-controlled Phase 2 trial in patients with mild cognitive impairment (MCI) is also planned. It appears that targeting amyloid and tau have little therapeutic benefit. Newer treatment strategies such as targeting glial dysfunction with XPro is supported by pre-clinical and epidemiologic studies. We expect top-line results from both clinical trials in 2023."

"The impact of inflammation and in particular TNF is increasingly apparent as evinced by recent genetic (link) studies," stated CJ Barnum, VP of CNS Development at INmune Bio. "These Phase 2 studies are the first step in determining the extent to which neutralizing solTNF will benefit MCI and AD patients. Our expectations are high, and we look forward to sharing the results next year.

"The clinical and scientific framework around INKmune, our NK cell targeting platform continues to grow. We have already observed that two of the three patients treated with INKmune for MDS/AML remain off therapy with their disease controlled for more than 6 months since their last dose of INKmune," said Dr. Mark Lowdell, Chief Scientific Officer of INmune Bio. "We are demonstrating the effectiveness of INKmune in treatment of hematologic malignancies but believe the most promising application will be using INKmune to treat residual disease in solid tumors."

"Separately, we presented additional pre-clinical breast cancer data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, which further demonstrated the use of our DN-TNF oncology drug candidate, INB03, to potentially help reverse resistance to immunotherapy for women with HER2+ breast cancer. With this robust collection of data in multiple indications, we are optimistic for the coming quarters and look forward to sharing our continued results with shareholders and clinicians alike," stated Dr. Tesi.

"We continue to move forward on our planned three Phase II programs this year and believe we are well positioned to deliver on potential value creating milestones in both our DN-TNF and INKmune platforms," concluded Dr. Tesi.

Financial Results for the Quarter Ended March 31, 2022:

Net loss attributable to common stockholders for the quarter ended March 31, 2022 was approximately $6.9 million, compared to approximately $4.6 million for the quarter ended March 31, 2021.

Revenues totaled approximately $0.2 million for the first quarter 2022 compared to approximately $0.0 million for the first quarter 2021.

Research and development expense totaled approximately $4.3 million for the first quarter 2022 compared to approximately $2.5 million during the first quarter 2021.

General and administrative expense was approximately $2.3 million for the first quarter 2022 compared to approximately $2.1 million during the first quarter 2021.

Other expense was approximately $0.4 million for the first quarter 2022 compared to approximately $0.0 million during the first quarter 2021.

As of March 31, 2022, the Company had cash and cash equivalents of approximately $66.7 million.

During the quarter, RJ Tesi, Mark Lowdell, David Moss and Kelly Ganjei bought 82,900 shares for approximately $700,000 as previously reported in an 8-K filed with the SEC. As of May 5, 2022, the Company had approximately 17.9 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

Date: May 5, 2022
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-877-407-0784
Participant Dial-in (international): 1-201-689-8560
Conference ID: 13728543

A live audio webcast of the call can be accessed using this link: View Source

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through May 12, 2022 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13728543.

About XPro

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

About INKmune

INKmune is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma, ovarian cancer, breast cancer.

On May 5, 2022 Phosplatin Therapeutics Inc., a clinical stage pharmaceutical company focused on oncology therapeutics, reported that the Company has changed its name to Promontory Therapeutics Inc. ("Promontory") (Press release, Promontory Therapeutics, MAY 5, 2022, View Source [SID1234615801]). The new name reflects the Company’s growth and evolution, and its goal to become the leading company within oncology therapeutics advancing small molecule immunotherapies.

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"Our new corporate identity is aspirational, as we continue our growth and research and development efforts because we believe that small molecule immunotherapy has arrived, and that we are leaders within this area of cancer care," said Robert Fallon, Promontory President and Chief Executive Officer. "Through our internal work, coupled with our ongoing collaborations with global leaders in the field, we’ve developed unique insight into the development of highly-differentiated small molecule immunogenic agents, including our lead therapeutic candidate, PT-112."

Promontory is led by a strong management team, board of directors, and Scientific Advisory Board with in-depth industry knowledge. The company’s lead agent, PT-112, is a small molecule therapeutic agent that promotes immunogenic cell death (ICD), a rare form of cancer cell death based upon the release of damage associated molecular patterns (DAMPs), which engage specific pattern recognition receptors on dendritic cells that promote the adaptive anti-cancer immune response. PT-112’s highly potent induction of ICD has been validated in relevant cancer models and the drug is currently being studied in three Phase 2 trials for metastatic castration-resistant prostate cancer, thymoma and thymic carcinoma, and in combination with PD-L1 checkpoint inhibitor avelumab for non-small cell lung cancer.

To learn more about Promontory Therapeutics’ mission, as well as PT-112 visit promontorytx.com.

On May 5, 2022 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported financial results for the first quarter ended March 31, 2022 and provided recent corporate updates (Press release, Bicycle Therapeutics, MAY 5, 2022, View Source [SID1234613610]).

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"We have made significant progress recently across our oncology pipeline," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We reported interim data for the Phase I portion of the Phase I/II trial in BT8009, showing an overall response rate, or ORR, of 50% in the 5mg/m2 weekly cohort in patients with urothelial cancer and an encouraging tolerability profile. We believe BT8009 has the potential to offer clinically meaningful differentiation compared to currently available therapies and we look forward to advancing the program once the dose escalation phase is complete. We also look forward to initiating the BT5528 Phase II expansion cohorts soon."

Dr. Lee continued: "Beyond our Bicycle Toxin Conjugates, or BTCs, we continue to be encouraged as we progress our Bicycle TICA programs forward, including BT7480, which is advancing in the dose escalation portion of the Phase I clinical trial. Underscoring our efforts is a strong balance sheet and we anticipate our cash and cash equivalents will provide financial runway through 2024."

First Quarter 2022 and Recent Highlights

Announced Interim BT8009 Phase I Clinical Trial Results at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. In April 2022, Bicycle announced interim Phase I results from the Phase I/II trial of BT8009, a second-generation BTC targeting Nectin-4. As of March 7, 2022, thirty-seven patients have been dosed in the Phase I/II trial of BT8009. A total of twelve response evaluable urothelial cancer (UC) patients have been dosed in monotherapy cohorts of 2.5mg/m2 and 5.0mg/m2 weekly in the ongoing trial. Four response evaluable UC patients were dosed at 2.5mg/m2 weekly, with one patient observed to have tumor reductions constituting a confirmed partial response (PR) and two patients observed to have stable disease (SD). Eight response evaluable UC patients were dosed at 5.0mg/m2 weekly, with four patients observed to have a confirmed complete response (CR) or PR, including one patient with a CR and three patients with a PR, and two patients with SD, reflecting a 50% ORR and 75% disease control rate. The median duration of response has not yet been reached in either the 2.5 mg/m2 or 5.0mg/m2 cohort, with four of the five responders in these cohorts still on therapy after at least 24 weeks, and a tolerability profile that remains consistent with earlier results from this trial.

Exploration of additional doses and frequencies continues, and Bicycle intends to provide further updates this year.
Announced Updated Preclinical Data on SARS-CoV-2 Antivirals at the 2022 Microbiology Society Annual Meeting. Bicycle created a wide range of <10kDa molecules with high binding affinity to the SARS-CoV-2 spike protein and then tested them in partnership with researchers at the Medical Research Council Laboratory of Molecular Biology. They were shown to be highly active in vitro at preventing SARS-CoV-2 infection of human cells. These compounds were further tested in partnership with experts at the University of Liverpool and shown to be highly potent when administered in vivo to rodent models of SARS-CoV-2 infection. These molecules have also been shown to be active in vitro across many of the SARS-CoV-2 variant strains, including Alpha, Beta, Delta and Omicron.
Financial Results

Cash and cash equivalents were $407.4 million as of March 31, 2022, compared to $438.7 million as of December 31, 2021. The decrease in cash is primarily due to cash used in operating activities.
Research and development expenses were $14.3 million for the three months ended March 31, 2022, compared to $9.7 million for the three months ended March 31, 2021. The increase in expense of $4.6 million was primarily due to increased discovery and platform-related expenses, as well as increased personnel-related expenses, including $1.2 million of incremental non-cash share-based compensation expense.
General and administrative expenses were $17.0 million for the three months ended March 31, 2022, compared to $8.1 million for the three months ended March 31, 2021. The increase of $8.9 million for the three months ended March 31, 2022 as compared to the same period in the prior year was primarily due to $5.2 million incremental non-cash share-based compensation expense, personnel-related costs and increased professional and consulting costs.
Net loss was $27.6 million, or $(0.93) basic and diluted net loss per share, for the three months ended March 31, 2022, compared to net loss of $16.2 million, or $(0.73) basic and diluted net loss per share, for three months ended March 31, 2021.

On May 5, 2022 OPKO Health, Inc. (NASDAQ: OPK) reported that operating and financial results for the three months ended March 31, 2022 after the close of the U.S. financial markets on Monday, May 9, 2022 (Press release, Opko Health, MAY 5, 2022, View Source [SID1234613654]). OPKO’s senior management will provide a business update and discuss results as well as financial guidance during a conference call and live audio webcast on May 9th beginning at 4:30 p.m. Eastern time.

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CONFERENCE CALL & WEBCAST INFORMATION

OPKO encourages participants to pre-register for the conference call using this link. Callers who pre-register will be given a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing (866) 777-2509 (U.S.) or (412) 317-5413 (International). A webcast of the call may also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until May 16, 2022 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 6587528. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

On May 5, 2022 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported financial results for the first quarter ended March 31, 2022 (Press release, AVEO, MAY 5, 2022, View Source [SID1234613670]).

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"We recently celebrated the one-year anniversary of our U.S. commercial launch of FOTIVDA (tivozanib). During the first quarter of 2022, we reported that, based on third party data, FOTIVDA had taken the leadership position in new patient starts for our targeted third-line relapsed or refractory advanced (R/R) renal cell carcinoma (RCC) population. This is a tremendous accomplishment, which we view as a leading indicator of progress towards our goal of becoming the overall market share leader and standard of care in the third-line R/R RCC setting, which we believe would in turn drive our continued growth. Based on what we have seen and heard to date, we continue to feel confident about our $100 million to $110 million full year 2022 FOTIVDA U.S. net product revenue guidance," stated Michael Bailey, President and Chief Executive Officer of AVEO. "In addition, with our Phase 3 TiNivo-2 trial evaluating tivozanib in combination with nivolumab underway, we are seeking to generate data to support regulatory approval of tivozanib (combined with nivolumab) in the larger second line R/R RCC market following prior immune checkpoint inhibitor therapy."

"Our team also continues to advance our pipeline of monoclonal antibodies. Collectively, we believe our commercial and clinical development activities offer exciting opportunities to improve patient care while also building long-term value for our shareholders," said Mr. Bailey.

First Quarter 2022 and Recent Highlights

Continued quarter over quarter growth of FOTIVDA U.S. net product revenue and prescriptions in Q1 2022.
First quarter 2022 U.S. net product revenue increased 20% to $20.1 million compared with U.S. net product revenue of $16.8 million in the fourth quarter of 2021, which reflects inventory shipped to distributors during the quarter and a gross-to-net estimate of 18.5% during the first quarter of 2022.
977 commercial prescriptions filled in the first quarter of 2022, representing a 25% increase from 780 commercial prescriptions filled in the fourth quarter of 2021.
FOTIVDA, based on third party data, has continued to hold its leadership position in the share of new patients starts in third-line R/R RCC for the first quarter. AVEO views new patient share starts as an important leading indicator of progress toward its objective to become the overall market share leader and the standard of care in the third-line R/R RCC setting.
Encouraging long-term follow up data for progression free survival (PFS) and overall survival (OS) from the Phase 3 TIVO-3 Clinical Trial of tivozanib in R/R advanced RCC patients were presented at the 2022 ASCO (Free ASCO Whitepaper) GU Cancers Symposium.
These new long-term PFS data from patients with five years of follow up further support the durable response and improved PFS previously observed in patients treated with FOTIVDA, including:
Landmark long-term PFS rates were consistently higher among patients treated with FOTIVDA as compared with patients treated with sorafenib (12% vs. 2% and 8% vs. 0% at three and four years, respectively), representing a clinically meaningful outcome for patients in the third- and fourth-line treatment setting.
Long-term OS was also analyzed and a non-significant trend favoring FOTIVDA continued to emerge with accumulation of events (HR 0.89).
Topline data for first-line cohort of the DEDUCTIVE trial were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium.
New efficacy and safety data from the first line (cohort A) of the Phase 1b/2 clinical trial of tivozanib in combination with AstraZeneca’s IMFINZI (durvalumab) demonstrated a 28% partial response (PR) rate and disease control rate of 72% (PR plus stable disease) with a median PFS of 7.3 months and a 1-year OS of 76%. The data continues to support the efficacy and safety of tivozanib as an attractive vascular endothelial growth factor receptor inhibitor to use in combination with immune checkpoint inhibitors in first line metastatic hepatocellular carcinoma (HCC) patients.
The DEDUCTIVE trial is currently enrolling cohort B of second line patients after treatment with bevacizumab and atezolizumab. This cohort, which will enroll up to 20 subjects, has the potential to be the first clinical study to demonstrate benefit in the emerging population of HCC patients who have previously received immunotherapy.

Enrollment ongoing for Phase 3 TiNivo-2 Trial in R/R RCC following prior immunotherapy; Expect to complete enrollment in the first half of 2023.

AVEO continues to enroll patients in the Phase 3 TiNivo-2 clinical trial evaluating tivozanib in combination with nivolumab (OPDIVO), Bristol Myers Squibb’s antibody directed against PD-1, as compared with tivozanib monotherapy in patients with R/R RCC who have progressed following one or two lines of therapy, one of which was an immune checkpoint inhibitor. If successful, we believe data from this trial has the potential to support U.S. Food and Drug Administration (FDA) approval of tivozanib in combination with nivolumab in R/R RCC and expand the market opportunity for FOTIVDA into the larger second line R/R RCC setting. Bristol Myers Squibb is providing nivolumab clinical drug supply pursuant to a clinical trial collaboration and supply agreement. AVEO currently expects enrollment in the TiNivo-2 trial to be completed in the first half of 2023.
Secured clinical trial collaboration and supply agreement with NiKang Therapeutics, Inc. (NiKang) to evaluate tivozanib in combination with NKT2152.
On track to initiate a Phase 2 clinical trial to evaluate the safety and efficacy of tivozanib in combination with NKT2152, NiKang’s hypoxia inducible factor 2α (HIF2α), to treat clear cell RCC in mid-2022.
Started scale up activities for the manufacturing of ficlatuzumab clinical supply in the second quarter of 2022.
AVEO started scale up activities for the manufacturing of ficlatuzumab clinical supply in the second quarter of 2022 to enable the initiation of a potential registrational clinical trial in human papillomavirus (HPV) negative recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the first half of 2023. AVEO expects to continue to discuss the registrational pivotal clinical trial designs with the FDA and to continue to seek a strategic partner. In September 2021, AVEO announced that the FDA granted Fast Track designation for the investigation of the combination of ficlatuzumab and cetuximab for the treatment of patients with R/R HNSCC.
First Quarter 2022 Financial Highlights

At March 31, 2022, AVEO reported $79.0 million in cash, cash equivalents and marketable securities, as compared with $87.3 million at December 31, 2021.
Total revenue for the first quarter of 2022 was approximately $20.9 million compared with $1.9 million for the first quarter of 2021.
FOTIVDA U.S. net product revenue was $20.1 million for the first quarter of 2022 compared with $1.1 million for the first quarter of 2021.
Research and development expense for the first quarter of 2022 was $10.2 million compared with $5.8 million for the first quarter of 2021.
Selling, general and administrative expense for the first quarter of 2022 was $17.3 million compared with $15.1 million for the first quarter of 2021. The increase in selling, general and administrative expense for the first quarter 2022 is primarily due to a full quarter of costs associated with the commercial launch of FOTIVDA.
Net loss for the first quarter of 2022 was $10.2 million, or net loss of $0.30 per basic and diluted share, compared with a net loss of $22.1 million for the first quarter of 2021, or net loss of $0.81 per basic and diluted share.
Financial Guidance

AVEO believes that its $79.0 million in cash, cash equivalents and marketable securities as of March 31, 2022, along with expected net product revenues from the sales of FOTIVDA in the United States, will enable AVEO to maintain its current operations for a period of more than 12 months from the date of filing of its Quarterly Report on Form 10-Q for the quarter ended March 31, 2022.

AVEO currently expects to achieve full year 2022 FOTIVDA U.S. net product revenues between $100.0 million and $110.0 million. AVEO expects that commercial expenses will be approximately $50.0 million in 2022. AVEO expects general and administrative expenses will remain at approximately $20.0 million for the year. Research and development expenses are expected to be in the range of $60.0 million to $70.0 million in 2022 in support of AVEO’s existing pipeline plans. In addition, AVEO expects that gross margins will continue to be in the mid-to-high 80th percentile in 2022.

Conference Call and Webcast

In connection with this announcement, AVEO will host a conference call and audio webcast today, May 5, 2022, at 8:30 A.M. Eastern Time. The call can be accessed by dialing (800) 954-1051 (U.S. and Canada) or (303) 223-0117 (international). The passcode for the conference call is 22018215. To access the live webcast, or the subsequent archived recording, please visit the Calendar of Events sub-section within the Investors section of the AVEO website at www.aveooncology.com.

About FOTIVDA (tivozanib)

FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.1 FOTIVDA was discovered by Kyowa Kirin.

INDICATIONS

FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.

Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.

Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.

Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.

Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.

Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.

Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS
The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.

DRUG INTERACTIONS

Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.
Females and Males of Reproductive Potential: Can impair fertility.
Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

About Advanced Renal Cell Carcinoma

According to the American Cancer Society’s 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.2 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,3 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.