On May 10, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported financial results for the first quarter ended March 31, 2021 and provided an update on its recent corporate activities and outlook (Press release, Halozyme, MAY 10, 2021, View Source [SID1234579570]).

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"The first quarter marked a strong start to 2021 highlighted by record quarterly royalty revenue driven by the continued successful launch of subcutaneous DARZALEX worldwide," said Dr. Helen Torley, president and chief executive officer. "Our pipeline of partnered product candidates using ENHANZE technology continues to build momentum with four new clinical study starts in the first quarter. Additionally, we were able to strengthen our balance sheet on highly attractive terms reflective of the strong anticipated cash flow generation and growth prospects for Halozyme."

Recent Partner Highlights:

Janssen achieved several important successes related to the subcutaneous formulation of DARZALEX (daratumumab) using ENHANZE technology during the first quarter and since including:
Janssen Pharmaceutical K.K. announced approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) in March for the subcutaneous formulation of DARZALEX (known as DALACURO in Japan) for the treatment of multiple myeloma. Accordingly, Halozyme recognized $5 million in milestone revenues.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced Health Canada approved DARZALEX SC (daratumumab injection), a subcutaneous (SC) formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd, also known as DCyBorD) in April for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. There were previously no approved therapies for the disease.
Janssen Biotech, Inc. received U.S. Food and Drug Administration accelerated approval in January for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. There were previously no approved therapies for the disease.
In March, Horizon completed dosing for its first trial exploring a subcutaneous (SC) formulation of TEPEZZA (teprotumumab-trbw) using ENHANZE technology. The trial is a small, single-dose Phase 1 pharmacokinetic trial which includes evaluating the use of ENHANZE drug-delivery technology for a SC formulation, which could potentially shorten drug administration time, reducing healthcare practitioner time and offering additional flexibility and convenience for patients.
Bristol Myers Squibb (BMS) has advanced plans to initiate a Phase 3 study of nivolumab with ENHANZE technology for patients with advanced or metastatic clear cell renal cell carcinoma during the second quarter of 2021. Accordingly, Halozyme recognized $25 million in milestone revenues.
During the first quarter, argenx reached two important achievements related to its development of efgartigimod using ENHANZE including:
In February 2021, argenx announced a "go" decision for its late-stage ADHERE trial evaluating subcutaneous (SC) efgartigimod using ENHANZE technology in chronic inflammatory demyelinating polyneuropathy (CIDP). argenx plans to continue enrollment to include approximately 130 patients to support potential registration of SC efgartigimod for the treatment of CIDP.
In January 2021, argenx initiated a Phase 3 study of ARGX-113 using ENHANZE technology in pemphigus vulgaris and pemphigus foliaceus, rare autoimmune diseases that cause painful blisters on the skin and mucous membranes.
Recent Corporate Highlights:

In March 2021, the Company completed the sale of $805.0 million aggregate principal amount of the 2027 Convertible Senior Notes. A portion of the net proceeds were used to repurchase 80% of the 2024 Convertible Senior Notes. In connection with the note repurchase, the Company paid the holders $370.2 million in cash and issued 9.08 million shares.
During the first quarter, the Company repurchased approximately 1.8 million shares of common stock for $76.2 million at an average price per share of $42.89, partially offsetting shares issued to 2024 Convertible Senior Notes holders.
First Quarter and Full Year 2021 Financial Highlights

Revenue for the first quarter was $89.0 million compared to $25.4 million for the first quarter of 2020. The year-over-year increase was primarily driven by $30.0 million in milestone revenues from BMS and Janssen, an increase in royalty revenue attributable to subcutaneous DARZALEX and an increase in product sales. Revenue for the quarter included $36.9 million in royalties, an increase of 119% compared to $16.8 million in the prior year period.
Cost of product sales for the first quarter was $18.2 million, compared to $5.8 million for the first quarter of 2020. The year-over-year increase was primarily driven by higher product sales, principally the sales of bulk rHuPH20 to the Company’s partners.
Research and development expenses for the first quarter were $9.0 million, compared to $10.2 million for the first quarter of 2020. The decrease in expenses was due to the discontinuation of some development related activities for PEGPH20 and closure of the Company’s oncology operations, partially offset by an increase in costs to support additional ENHANZE targets.
Selling, general and administrative expenses for the first quarter were $11.1 million, compared to $12.6 million for the first quarter of 2020. The decrease was primarily due to one-time costs in the prior year related to the discontinuation of the Company’s development activities for PEGPH20 and closure of its oncology operations.
Operating Income: On a GAAP basis in the first quarter of 2021, operating income was $50.7 million, compared to an operating loss of $3.2 million in the first quarter of 2020.
Net Income: On a GAAP basis in the first quarter of 2021, net income was $27.9 million, compared with a net loss of $6.1 million in the first quarter of 2020. Non-GAAP net income was $54.3 million in the first quarter of 2021, compared with Non-GAAP net income of $1.9 million in the first quarter of 2020.1
Earnings per Share: On a GAAP basis in the first quarter of 2021, diluted earnings per share was $0.19, compared with a loss per share of $0.04 in the first quarter of 2020. On a non-GAAP basis diluted earnings per share was $0.37, compared with diluted earnings per share of $0.02 in the first quarter of 2020.1
Cash, cash equivalents and marketable securities were $764.3 million at March 31, 2021, compared to $368.0 million at December 31, 2020.
During the first quarter, the Company repurchased 1.8 million shares of common stock for $76.2 million at an average price of $42.89, bringing the total for share repurchases since the announcement of the Company’s three-year share repurchase program to $426.2 million at an average price of $21.99.
Financial Outlook for 2021

Based on the latest information from collaboration partners and planned expenditures for the year, the Company continues to expect:

Revenues of $375 million to $395 million, representing year-over-year growth of 40%-48%;
GAAP Operating Income of $215 million to $235 million, representing year-over-year growth of 49% – 63%;
GAAP Net Income of $190 million to $210 million, representing year-over-year growth of 47%-63% and Non-GAAP Net Income of $235 million to $255 million, representing year-over-year growth of 47% – 59%;1
GAAP Diluted Earnings per Share of $1.25 to $1.40, representing year-over-year growth of 37%-54%; and Non-GAAP Diluted Earnings per Share of $1.55 to $1.70, representing year-over-year growth of 38%-52%.1
The Company plans to repurchase up to an additional $49 million in common stock this year for a total of up to $125 million in common stock during 2021 as part of the $550 million three-year share repurchase plan authorized by Halozyme’s board of directors in 2019. The amount and timing of shares to be repurchased in 2021 will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements.

Webcast and Conference Call

Halozyme will webcast its Quarterly Update Conference Call for the first quarter of 2021 today, Monday, May 10, 2021 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To register for this conference call, please use this link: View Source After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call.

On May 10, 2021 Novo Nordisk A/S reported that entered into an agreement to purchase 5,610,000 B shares of DKK 0.20 to a value of DKK 2,586 million from Novo Holdings A/S (Press release, Novo Nordisk, MAY 10, 2021, View Source [SID1234579588]). This transaction is part of Novo Nordisk A/S’ 2021 share repurchase programme of up to a total of DKK 18 billion to be executed during a 12-month period beginning 3 February 2021. The transaction price is DKK 461.04 per share and has been calculated as the three-day volume weighted average market price from 5 May 2021 to 7 May 2021 in the open window following the announcement of Novo Nordisk A/S’ quarterly financial results.

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Prior to the sale of B shares, Novo Holdings A/S’ ownership of Novo Nordisk A/S was 28.5% of the share capital and 76.9% of the votes. Following the transaction, Novo Holdings A/S owns 537,436,000 A shares of DKK 0.20 and 116,129,000 B shares of DKK 0.20, corresponding to 28.3% of the capital and 76.8% of the votes in Novo Nordisk A/S.

The transaction is in line with the announcement on 5 May 2021 that Novo Holdings A/S intends to maintain its ownership of Novo Nordisk A/S’ share capital around 28%.

In addition, transactions related to Novo Nordisk’s incentive programmes have resulted in a net transfer from Novo Nordisk of 9,954 B shares in the period from 5 May 2021 to 7 May 2021.

With the transactions stated above, Novo Nordisk A/S owns a total of 11,257,435 B shares of DKK 0.20, corresponding to 0.5% of the share capital, as treasury shares. The total amount of A and B shares in the company is 2,310,000,000 of DKK 0.20 including treasury shares.

On May 10, 2021 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that management will present at the Bank of America Securities 2021 Virtual Health Care Conference on Thursday, May 13, 2021 at 10:15 a.m. ET (Press release, Vertex Pharmaceuticals, MAY 10, 2021, View Source [SID1234579606]).

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The audio portion of management’s remarks will be available live through Vertex’s website, www.vrtx.com in the "Investors" section under the "News and Events" page. A replay of the conference webcast will be archived on the company’s website.

On May 10, 2021 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that HyBryte (hypericin) was awarded an "Innovation Passport" for the treatment of early stage cutaneous T-cell lymphoma (CTCL) in adults under the United Kingdom’s (UK’s) Innovative Licensing and Access Pathway (ILAP) (Press release, Soligenix, MAY 10, 2021, View Source [SID1234579634]).

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ILAP was launched at the start of 2021 to accelerate the development and access to promising medicines, thereby facilitating patient access to new medicines. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with the Medicines and Healthcare Products Regulatory Agency (MHRA) and other stakeholders including the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC). The decision to award the Innovation Passport to the HyBryte program was made by the Innovative Licensing and Access Pathway Steering Group, which is comprised of representatives from MHRA, NICE, and SMC.

The innovation passport designation is the first step in the ILAP process and triggers the MHRA and its partner agencies to create a target development profile to chart out a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include a 150-day accelerated assessment, rolling review and a continuous benefit risk assessment.

"We are very pleased to have been granted the Innovation Passport to go along with the Promising Innovative Medicine (PIM) designation previously received in the UK," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We look forward to engaging MHRA and its partner agencies to make HyBryte available to patients as quickly as possible."

About HyBryte

HyBryte (SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light 16 to 24 hours later which triggers apoptosis of the cell. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

The Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received HyBryte treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte treatment in the first cycle was safe and well tolerated.

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes. HyBryte continued to be safe and well tolerated. Additional analyses also indicated that HyBryte is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.

The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte throughout all 3 cycles of treatment, 49% of them demonstrated a treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte continued to be well tolerated despite extended and increased use of the product to treat multiple lesions. Follow-up visits were completed in Q4 2020, and the clinical study report to support the NDA is in the process of being finalized.

Overall safety of HyBryte is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte’s mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte potentially represents the safest available efficacious treatment for CTCL. With no systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.

The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.

On May 10, 2021 AVEO Oncology (Nasdaq: AVEO), a commercial and clinical development stage biopharmaceutical company, reported financial results for the first quarter ended March 31, 2021 and provided a business update (Press release, AVEO, MAY 10, 2021, View Source [SID1234579544]).

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"The first quarter of 2021 was a transformational time for AVEO marked by the U.S. Food and Drug Administration (FDA) approval and launch of FOTIVDA, our first commercial product, and the advancement of our pipeline, all of which is supported by a strong balance sheet," said Michael Bailey, president and chief executive officer of AVEO. "Our sales team is now fully deployed, and we are encouraged by the early commercial activity supporting the FOTIVDA launch. We look forward to continuing to execute on our goal of establishing FOTIVDA as a standard of care within its renal cell carcinoma (RCC) indication."

"In parallel, we remain focused on the continued advancement of the remainder of our clinical programs. This includes the evaluation of FOTIVDA in the immunotherapy combination setting, with patient enrollment in the pivotal Phase 3 TiNivo-2 study of FOTIVDA in combination with OPDIVO anticipated to commence mid-year and the Phase 2 hepatocellular carcinoma (HCC) DEDUCTIVE trial reporting encouraging Phase 1b results at ASCO (Free ASCO Whitepaper) GI earlier this year. Beyond FOTIVDA, we continue to expect several key inflection points with the balance of our clinical pipeline later this year, including a go/no go decision on progressing to a pivotal study for ficlatuzumab in head and neck squamous cell carcinoma (HNSCC), the advancement of our Phase 1 study of AV-380 and an update on potential clinical development plans for AV-203."

FOTIVDA U.S. Regulatory and Commercial Updates

U.S. Commercial Launch Underway Following FDA Approval of FOTIVDA for the Treatment of Adult Patients with Relapsed or Refractory Advanced RCC Following Two or More Prior Systemic Therapies.
Announced FDA approval of FOTIVDA for the treatment of adults with relapsed or refractory advanced RCC following two or more prior systemic therapies on March 10, 2021.
Net product revenue for the first quarter of 2021 was $1.1 million, which reflects inventory shipped to distributors and a 15.0% gross to net estimate in the last week of March as FOTIVDA became commercially available on March 22, 2021.
All distributors that made orders in the first quarter have placed reorders for the second quarter.
As of April 30, 2021, 49 prescriptions have been filled and 75 samples have been requested and delivered.
In March 2021, AVEO announced that the National Comprehensive Cancer Network updated its Clinical Practice Guidelines to include FOTIVDA as a recommended regimen for subsequent therapy.
Tivozanib Clinical Updates

Additional Data from the TIVO-3 Study to be Presented at 2021 ASCO (Free ASCO Whitepaper) Annual Meeting in June 2021. Additional data from the TIVO-3 study will be featured during two poster presentations at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)(ASCO) Annual Meeting in June 2021. The presentations, titled "TIVO-3: Durability of response and updated overall survival of tivozanib versus sorafenib in metastatic renal cell carcinoma (mRCC)" and "Temporal characteristics of treatment-emergent adverse events and dose modifications with tivozanib and sorafenib in the phase 3 TIVO-3 study of relapsed or refractory mRCC", will be featured on Friday, June 4.
Announced a Collaboration with Bristol Myers Squibb to Evaluate FOTIVDA in Combination with OPDIVO in a Planned Pivotal Phase 3 TiNivo-2 Trial in IO Relapsed or Refractory RCC. In March 2021, AVEO announced that it entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE: BMS) to evaluate FOTIVDA in combination with OPDIVO, Bristol Myers Squibb’s anti-PD-1 therapy, in the planned pivotal Phase 3 TiNivo-2 trial in patients with advanced relapsed or refractory RCC following prior immunotherapy exposure. Bristol Myers Squibb will provide OPDIVO clinical drug supply for the study. AVEO will serve as the study sponsor and will be responsible for costs associated with the trial execution. AVEO recently received feedback from the FDA on the trial design and expects to commence enrollment in the trial in mid-2021.
Presented New Analyses from the Phase 3 TIVO-3 Study at ASCO (Free ASCO Whitepaper) 2021 GU Cancers Symposium. In February 2021, AVEO presented key subgroup and quality of life analyses from the Phase 3 TIVO-3 study at the ASCO (Free ASCO Whitepaper) 2021 Genitourinary (GU) Cancers Symposium. The results further demonstrate the potential tolerability benefits of tivozanib. A copy of each presentation is available in the Scientific Publications & Presentations section of AVEO’s website.
Results from Phase 1b Portion of DEDUCTIVE Study in HCC Presented at 2021 ASCO (Free ASCO Whitepaper) GI Cancer Symposium. In January 2021, results from the Phase 1b portion of the Phase 1b/2 DEDUCTIVE clinical trial of tivozanib in combination with IMFINZI (durvalumab), AstraZeneca’s (LSE/STO/Nasdaq: AZN) human monoclonal antibody directed against programmed death-ligand 1, in patients with HCC were presented at the 2021 ASCO (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium. There were no dose-limiting toxicities with the combination recorded in the DEDUCTIVE trial. In addition, the combination demonstrated a 29% partial response (PR) rate and a 71% disease control rate (PR + stable disease), which is comparable to findings with bevacizumab and TECENTRIQ (atezolizumab), an emerging standard of care in the same setting. Completion of enrollment in the ongoing Phase 2 portion of the study, which is expected to enroll up to an additional 30 subjects, is anticipated later this year.
Ficlatuzumab Clinical Update

Enrollment Complete in Phase 2 Open Label Randomized Study of Ficlatuzumab in HNSCC; Results Expected to Be Presented at ASCO (Free ASCO Whitepaper) in June 2021; Phase 3 Go/No Go Decision Anticipated for Mid-2021. In January 2021, AVEO announced completion of enrollment in its randomized confirmatory Phase 2 study of ficlatuzumab as a single agent or in combination with cetuximab (ERBITUX), an EGFR-targeted antibody, in metastatic HNSCC patients who have failed prior immunotherapy, chemotherapy and cetuximab. Ficlatuzumab is AVEO’s potent humanized immunoglobulin G1 (IgG1) monoclonal antibody that targets hepatocyte growth factor (HGF). The study was designed to confirm findings from a Phase 1/2 study of ficlatuzumab and cetuximab where the combination was well-tolerated and resulted in a disease control rate of 67%, as well as prolonged progression-free survival and overall survival compared to historical controls.

Results from the Phase 2 study are expected to be presented in a poster discussion at ASCO (Free ASCO Whitepaper) in June 2021. Following the ASCO (Free ASCO Whitepaper) data presentation, AVEO plans to announce a go/no go Phase 3 decision for ficlatuzumab in HNSCC.

In September 2020, AVEO regained full global rights to ficlatuzumab and has initiated clinical manufacture of ficlatuzumab to supply a potential Phase 3 clinical trial in HNSCC, as well as additional potential Phase 2 studies in pancreatic cancer and acute myeloid leukemia.
AV-380 Clinical Update

Phase 1 Clinical Study Initiated Following FDA Acceptance of IND Filing. Recently, AVEO initiated enrollment for a Phase 1 study of AV-380, a potent humanized IgG1 monoclonal antibody that targets growth differentiation factor 15 (GDF15), for the potential treatment of cancer cachexia.
AV-203 Clinical Update

To Regain Ex-North American Rights to AV-203. In March 2021, AVEO announced it will regain rights to AV-203 outside of North America, its clinical-stage potent humanized IgG1 monoclonal antibody that targets ErbB3 (also known as HER3), following the voluntary termination of its collaboration and license agreement by CANbridge Life Sciences. AVEO will regain rights to AV-203 in all territories globally, and CANbridge has initiated the process to transfer all preclinical data and materials to AVEO. The Company expects to provide an update on the AV-203 clinical development plan in the second half of 2021.
Corporate Updates

Strong Balance Sheet to Support U.S. Launch of FOTIVDA. In the first quarter of 2021, AVEO added approximately $78.1 million to its balance sheet, consisting of a $20.0 million drawdown under its previously announced $45.0 million loan and security agreement with Hercules Capital. Inc. (NYSE: HTGC, Hercules), $3.1 million from warrant exercises as of March 31, 2021, $3.4 million in stock sales under its at-the-market sales agreement with SVB Leerink LLC and $51.6 million in net proceeds from a public offering of its common stock.
Strengthened Board of Directors with Two New Appointments. AVEO has recently announced the appointments of Kevin Cullen, M.D., and Corinne D. Epperly, M.D., MPH, to its Board of Directors.

Dr. Cullen, a widely recognized clinical oncologist with a specialty in head and neck cancer, is the Marlene and Stewart Greenebaum Distinguished Professor in Oncology and director of the Program in Oncology at the University of Maryland School of Medicine. He also serves as director of the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center.

Dr. Epperly brings over 15 years of experience in oncology as a physician and scientist, blending medicine and business with a proven track record in oncology drug development and launches, commercial and medical strategy, marketing, M&A and operations gained at Iovance Biotherapeutics, VBL Therapeutics, Bristol Myers Squibb, Goldman Sachs and the National Cancer Institute of the NIH.
Appointment of Mike Ferraresso to Chief Commercial Officer. In March 2021, AVEO announced the appointment of Mike Ferraresso to chief commercial officer. He is responsible for managing AVEO’s commercial strategy and operations, including the commercialization of FOTIVDA. Mr. Ferraresso, who joined AVEO in December 2017, most recently served as AVEO’s senior vice president, business analytics and commercial operations. He has over 20 years of commercial pharmaceutical and biotechnology experience, including 15 years developing and commercializing oncology products.
First Quarter 2021 Financial Highlights

AVEO ended Q1 2021 with $121.4 million in cash, cash equivalents and marketable securities as compared with $61.8 million at December 31, 2020.
Total revenue for Q1 2021 was approximately $1.9 million compared with $0.8 million for Q1 2020.
Research and development expense for Q1 2021 was $5.8 million compared with $7.8 million for Q1 2020.
Selling, general and administrative expense for Q1 2021 was $15.1 million compared with $3.7 million for Q1 2020.
Net loss for Q1 2021 was $22.1 million, or net loss of $0.81 per basic and diluted share, compared with a net loss of $8.4 million for Q1 2020, or net loss of $0.52 per basic and diluted share.
Net loss for Q1 2021 reflects an approximate $2.4 million non-cash loss attributable to the increase in the fair value of the 2016 private placement warrant liability that principally resulted from increases in the stock volatility rate that occurred within the first quarter, as well as a shorter remaining term as the warrants approach expiration. Net loss in Q1 2020 reflects an approximate $2.6 million non-cash gain attributable to the decrease in the fair value of the 2016 private placement warrant liability that principally resulted from the decrease in the stock price that occurred within the fiscal year.
Financial Guidance

AVEO believes that its $121.4 million in cash and cash equivalents as of March 31, 2021, along with net product revenues from the commercial launch of FOTIVDA in the United States, would enable AVEO to maintain its current operations for a period of at least 12 months following the filing of its Quarterly Report on Form 10-Q.

AVEO expects commercial spend will be approximately $40 million for the year. Gross margins are expected to be in the mid-to-high 80th percentile and research and development expense is expected to be approximately $40 million for existing pipeline plans during 2021. In addition, quarterly general and administrative expense should approximate the level seen during the first quarter of this year.

Conference Call and Webcast

In connection with this announcement, AVEO will host a conference call and audio webcast today, May 10, 2021, at 4:30 PM Eastern Time. The call can be accessed by dialing (844) 882-7841 (U.S. and Canada) or (574) 990-9828 (international). The passcode for the conference call is 3996993. To access the live webcast, or the subsequent archived recording, please visit 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.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see FOTIVDA Full Prescribing Information which is available at www.FOTIVDA.com.

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.