On August 4, 2022 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer, reported financial results for the second quarter ended June 30, 2022 (Press release, AVEO, AUG 4, 2022, View Source [SID1234617535]).

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"At the beginning of April 2022, we entered the second year of the FOTIVDA commercial launch with increased momentum and confidence as demonstrated by continued sales growth and, most recently, FOTIVDA’s elevated status by the National Comprehensive Cancer Network (NCCN). We believe this momentum will continue to build in the second half of 2022 and we continue to be confident in our FOTIVDA U.S. net product revenue guidance for fiscal year 2022 of $100.0 million to $110.0 million," stated Michael Bailey, President and Chief Executive Officer of AVEO. "In addition to the strong sales momentum and elevated NCCN status, we were pleased to see the success of the FOTIVDA commercial launch recently recognized as having ‘overperformed’ in an independent market analysis1 of first launches by emerging pharmaceutical and biotech companies. With this growing external recognition of our commercial acumen, we believe that we can further leverage our capabilities by identifying potential additional commercial stage assets to add to our portfolio."

"On the clinical development front, our Phase 3 TiNivo-2 trial, remains on track to complete patient enrollment in the second quarter of 2023. For the balance of the portfolio, we have reduced our planned R&D spend to focus exclusively on development initiatives that we believe will effectively position our pipeline assets to create partnering opportunities. This partnering focused R&D strategy is consistent with our overall strategy of leveraging partners to provide funding for the development of our portfolio and minimizing R&D investment from AVEO while retaining all, or a portion of, the North American oncology commercial rights related to these product candidates," said Mr. Bailey.

Second Quarter 2022 and Recent Highlights

Continued quarter over quarter growth of FOTIVDA U.S. net product revenue and prescriptions in Q2 2022.
Second quarter 2022 U.S. net product revenue increased 24% to $25.0 million compared with U.S. net product revenue of $20.1 million in the first quarter of 2022, and increased 271% compared with $6.7 million of U.S. net product revenue in the second quarter of 2021.
Second quarter 2022 gross-to-net estimate of 17.8%.
In the second quarter of 2022, 1,157 commercial prescriptions were filled, representing an 18% increase compared with 977 filled in the first quarter of 2022 and a 309% increase compared with 283 filled in the second quarter of 2021.
Based on third party data, AVEO continues to be a leader in the number of new third-line R/R RCC patient starts during the second quarter of 2022.
AVEO was recognized by ZS Associates for its commercial launch and received the "Distinguished Excellence" Award at the 28th Annual Communicator Awards sponsored by the Academy of Interactive and Visual Arts for AVEO’s Multi-Media/Public Relations Campaign that supported the commercial launch of FOTIVDA.
Announced Updated National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines Elevating FOTIVDA (tivozanib) to Category 1 Treatment for R/R RCC Patients.
FOTIVDA elevated to Category 1 status as a subsequent therapy for RCC patients who have received two or more prior therapies in the latest Kidney Cancer Treatment Guidelines released on June 17, 2022.
NCCN is a recognized standard for clinical policy in cancer care, which impacts physician treatment decisions, reimbursement and treatment pathways.
In a recent third party market research survey, 80% of respondents indicated that the elevation of FOTIVDA to Category 1 status would positively impact their prescribing decisions.
Presented additional analysis on overall survival (OS) from the TIVO-3 trial and tivozanib activity and safety profile in non-clear cell (ncc) RCC at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting.
Exploratory long-term OS analyses of data from the TIVO-3 trial continues to trend in favor of tivozanib demonstrating an OS hazard ratio of 0.89.
A conditional survival analysis was performed at the 12 month progression free survival landmark, showing a statistically significant 55% relative reduction (HR 0.45; 95% CI 0.22–0.91) in the risk of death with tivozanib over sorafenib in this third- and fourth-line treatment population and a median OS of 48.3 months in patients receiving tivozanib compared with a median OS of 32.8 months in patients receiving sorafenib, a non-selective VEGFR-TKI.
Tivozanib demonstrated activity and a favorable safety profile in a subgroup analysis of patients with nccRCC from the 2010 Phase 2 randomized discontinuation trial evaluating tivozanib in patients with nccRCC.
Enrollment ongoing for Phase 3 TiNivo-2 Trial in R/R RCC following prior immunotherapy; Expect to complete enrollment in the second quarter 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 prior immune checkpoint inhibitor therapy. If successful, the company believes 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. AVEO currently expects enrollment in the TiNivo-2 trial to be completed in the second quarter of 2023.
Completed drug substance manufacturing for Ficlatuzumab and entered into a clinical trial collaboration and supply agreement in North America with Eli Lilly and Company (Lilly) to provide ERBITUX (cetuximab).
AVEO completed drug substance manufacturing for ficlatuzumab in the second quarter of 2022. The drug substance is expected to be used in connection with a potential Phase 3 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.
The Lilly agreement is similar to the clinical trial collaboration and supply agreement the company entered into with Merck KGaA, Darmstadt, Germany earlier this year to provide ERBITUX (cetuximab), an anti-EGFR antibody, clinical drug supply outside of North America for the potential Phase 3 registrational trial.
AVEO expects to continue to discuss potential registrational clinical trial designs with the FDA and to continue to seek a strategic partner to fund development expenses. 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.
Second Quarter 2022 Financial Highlights

At June 30, 2022, AVEO reported $77.2 million in cash, cash equivalents and marketable securities, as compared with $87.3 million at December 31, 2021.
Total revenue for the second quarter of 2022 was approximately $25.3 million compared with $7.6 million for the second quarter of 2021.
FOTIVDA U.S. net product revenue was $25.0 million for the second quarter of 2022 compared with $6.7 million for the second quarter of 2021.
Research and development expense for the second quarter of 2022 was $12.3 million compared with $6.9 million for the second quarter of 2021.
Selling, general and administrative expense for the second quarter of 2022 was $17.1 million compared with $14.9 million for the second quarter of 2021.
Net loss for the second quarter of 2022 was $8.3 million, or net loss of $0.24 per basic and diluted share, compared with a net loss of $13.6 million for the second quarter of 2021, or net loss of $0.40 per basic and diluted share.
Financial Guidance

AVEO believes that its $77.2 million in cash, cash equivalents and marketable securities as of June 30, 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 June 30, 2022.

AVEO has reaffirmed its full year 2022 FOTIVDA U.S. net product revenue guidance of $100.0 million to $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 now expected to be approximately $50.0 million in 2022, a reduction from the prior range of $60.0 million to $70.0 million as the company will focus its spending on clinical development programs to expand the commercial opportunity of tivozanib for the treatment of RCC and to position the company’s other product candidates for further development by partners and minimize R&D investment from AVEO while retaining all, or a portion of, the North American oncology commercial rights related to these product candidates. One of these initiatives includes the company’s decision, along with its partner at AstraZeneca, to close further enrollment in the second-line cohort of the DEDUCTIVE trial, a Phase 1b/2 clinical trial studying the combination of IMFINZI (durvalumab) and tivozanib in patients with advanced, unresectable hepatocellular carcinoma as part of its efforts to streamline R&D spend. 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, August 4, 2022, at 4:30 P.M. Eastern Time. The call can be accessed by dialing (877) 423-9813 (U.S. and Canada) or (201) 689-8573 (international). The passcode for the conference call is 13730553. 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.2 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.3 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,4 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.

On August 4, 2022 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and financial results for the second quarter ending June 30, 2022 (Press release, PTC Therapeutics, AUG 4, 2022, View Source [SID1234617534]).

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"We made significant progress in the second quarter toward achieving our ambitious goals for 2022. We continued to generate strong revenue growth, to expand our product portfolio, and to advance our pipeline," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "PTC has a broad and deep pipeline across a range of diseases, and we eagerly anticipate important results for several registration-directed studies during the next six to twelve months and this will continue our transformational growth."

Key Corporate Updates:

The Duchenne muscular dystrophy (DMD) franchise continued to show strong growth, with second quarter total net product revenue of $134 million, or 32% year-over-year growth.
Translarna total net product revenue increased 46% year-over-year to $77 million, with growth coming from new patients in existing geographies and continued geographic expansion.
Emflaza total net product revenue grew 16% year-over-year to $57 million, driven by new patient starts, broader access, continued high compliance and appropriate weight-based dosing.
The FDA approved a label extension for Evrysdi (risdiplam) to include infants under 2 months old with SMA. Evrysdi is a product of the SMA collaboration among PTC, the SMA Foundation and Roche.
In July 2022, Upstaza (eladocagene exuparvovec), our gene therapy for AADC deficiency, received marketing authorization by the European Commission.
First group purchase order for Tegsedi in Brazil was fulfilled.
Key Clinical/Regulatory Updates:

PTC recently announced positive topline results of the placebo-controlled portion of Study 041 for Translarna. The Study 041 results add to the totality of evidence demonstrating the clinical benefit of Translarna.
PTC will update topline results of FITE-19 study of emvododstat for COVID-19 on second quarter call.
PTC continues to make progress in additional ongoing clinical studies:
The APHENITY Phase 3 trial of PTC923 for PKU, with results anticipated by the end of 2022.
The PIVOT-HD Phase 2 trial of PTC518 for Huntington’s disease, with data from the first 12 weeks of the placebo-controlled trial anticipated by the end of 2022.
The MIT-E Phase 2/3 vatiquinone trial for mitochondrial disease associated seizures, with results anticipated in the first quarter of 2023.
The MOVE-FA Phase 3 vatiquinone trial for Friedreich ataxia, with results anticipated in the second quarter of 2023.
Second Quarter 2022 Financial Highlights:

Total revenues were $165.5 million for the second quarter of 2022, compared to $116.7 million for the second quarter of 2021.
Total revenue includes net product revenue across the commercial portfolio of $143.7 million for the second quarter of 2022, compared to $103.1 million for the second quarter of 2021. Total revenue also includes royalty revenue of $21.8 million in the second quarter of 2022, compared to $13.6 million for the second quarter of 2021.
Translarna net product revenues were $77.0 million for the second quarter of 2022, compared to $52.6 million for the second quarter of 2021. These results reflect an increase in net product sales coming from new patients in existing geographies and continued geographic expansion.
Emflaza net product revenues were $56.8 million for the second quarter of 2022, compared to $49.1 million for the second quarter of 2021. These results reflect new patient starts, broader access, continued high compliance, and appropriate weight-based dosing.
Roche reported year to date 2022 Evrysdi sales of approximately CHF 500 million, resulting in royalty revenue of $21.8 million to PTC in the second quarter of 2022, as compared to $13.6 million for the second quarter of 2021.
Based on U.S. GAAP (Generally Accepted Accounting Principles), GAAP R&D expenses were $157.3 million for the second quarter of 2022, compared to $125.5 million for the second quarter of 2021. The increase reflects increased investment in research programs and advancement of the clinical pipeline.
Non-GAAP R&D expenses were $143.5 million for the second quarter of 2022, excluding $13.8 million in non-cash, stock-based compensation expense, compared to $112.0 million for the second quarter of 2021, excluding $13.4 million in non-cash, stock-based compensation expense.
GAAP SG&A expenses were $79.9 million for the second quarter of 2022, compared to $68.9 million for the second quarter of 2021. The increase reflects our continued investment to support commercial activities including our expanding commercial portfolio.
Non-GAAP SG&A expenses were $66.0 million for the second quarter of 2022, excluding $13.9 million in non-cash, stock-based compensation expense, compared to $56.6 million for the second quarter of 2021, excluding $12.3 million in non-cash, stock-based compensation expense.
Change in the fair value of deferred and contingent consideration was a $15.2 million gain for the second quarter of 2022, compared to a $0.7 million loss for the second quarter of 2021. The change in fair value of deferred and contingent consideration is related to the fair valuation of potential future consideration to be paid to former equity holders of Agilis Biotherapeutics, Inc. (Agilis) in connection with PTC’s acquisition of Agilis, which closed in August 2018.
Net loss was $152.1 million for the second quarter of 2022, compared to net loss of $118.4 million for the second quarter of 2021.
Cash, cash equivalents, and marketable securities was $505.5 million on June 30, 2022, compared to $773.4 million at December 31, 2021.
Shares issued and outstanding as of June 30, 2022 were 71,505,889.
PTC Reaffirms Full Year 2022 Financial Guidance:

PTC anticipates total revenues for the full year 2022 to be between $700 and $750 million.
PTC anticipates net product revenues for the DMD franchise for the full year 2022 to be between $475 and $495 million.
PTC anticipates GAAP R&D and SG&A expense for the full year 2022 to be between $915 and $965 million.
PTC anticipates Non-GAAP R&D and SG&A expense for the full year 2022 to be between $800 and $850 million, excluding estimated non-cash, stock-based compensation expense of $115 million.
Non-GAAP Financial Measures:

In this press release, the financial results of PTC are provided in accordance with GAAP and using certain non-GAAP financial measures. In particular, the non-GAAP financial measures exclude non-cash, stock-based compensation expense. These non-GAAP financial measures are provided as a complement to financial measures reported in GAAP because management uses these non-GAAP financial measures when assessing and identifying operational trends. In management’s opinion, these non-GAAP financial measures are useful to investors and other users of PTC’s financial statements by providing greater transparency into the historical and projected operating performance of PTC and the company’s future outlook. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. Quantitative reconciliations of the non-GAAP financial measures to their respective closest equivalent GAAP financial measures are included in the table below.

Today’s Conference Call and Webcast Reminder:

To access the call by phone, please click here to register and you will be provided with dial-in details. To avoid delays, we recommend participants dial in to the conference call 15 minutes prior to the start of the call. The webcast conference call can be accessed on the Investor section of the PTC website at View Source A replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for 30 days following the call.

On August 4, 2022 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) and AK006 for the treatment of allergic and inflammatory diseases, reported financial results for the second quarter ended June 30, 2022 (Press release, Allakos, AUG 4, 2022, View Source [SID1234617533]).

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Recent Allakos Events

Submitted End-of-Phase 2 briefing package to FDA to discuss Phase 2 KRYPTOS data and development pathway of lirentelimab in patients with eosinophilic esophagitis (EoE). Meeting with FDA scheduled for third quarter of 2022.
Upcoming Allakos Milestones

Report topline data from Phase 3 EoDyssey study of lirentelimab (AK002) in patients with eosinophilic duodenitis (EoD) in third quarter of 2022.
Hold End-of-Phase 2 meeting with FDA during third quarter of 2022 to discuss Phase 2 KRYPTOS data and development path.
Initiate Phase 2b randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria in third quarter of 2022.
Complete IND-enabling studies of AK006 by end of fourth quarter of 2022 and initiate first-in-human study in first half of 2023.
Report topline data from Phase 2 study of subcutaneous lirentelimab in patients with atopic dermatitis in second half of 2023.
Report topline data from Phase 2 study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria in second half of 2023.
Second Quarter 2022 Financial Results

Research and development expenses were $34.4 million in the second quarter of 2022 compared to $41.0 million in second quarter of 2021. Second quarter 2022 research and development expenses decreased by $6.6 million compared to the same period of 2021 primarily due to a decrease in contract research and development and clinical costs primarily relating to lirentelimab, partially offset by an increase in equipment and overhead related costs related to the Company’s corporate facility.

General and administrative expenses were $14.7 million in the second quarter of 2022 compared to $16.2 million in second quarter of 2021. Second quarter 2022 general and administrative expenses decreased by $1.5 million compared to the same period in 2021 due to decreases in equipment and overhead related costs, personnel-related costs and in other general and administrative expenses.

Allakos reported a net loss of $49.1 million in the second quarter of 2022 compared to $57.2 million in the second quarter of 2021. The second quarter of 2022 included non-cash expenses for stock-based compensation of $11.8 million, compared to $11.4 million in the same period in 2021, and depreciation of $1.9 million, compared to $0.4 million in the same period in 2021. Net loss per basic and diluted share was $0.90 for the second quarter of 2022 compared to $1.07 in the second quarter of 2021.

Allakos ended the second quarter of 2022 with $212.4 million in cash, cash equivalents and investments.

On August 4, 2022 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, reported financial results and provided a business update for the quarter ending June 30, 2022 (Press release, Dynavax Technologies, AUG 4, 2022, View Source [SID1234617532]).

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"During the second quarter, we continued to successfully execute on our key priorities and are on track for another profitable year with record revenues for both HEPLISAV-B and CpG 1018 adjuvant," commented Ryan Spencer, Chief Executive Officer of Dynavax. "We are well capitalized to continue to invest in programs that drive revenue growth and deliver progress across our clinical pipeline with a focus on high value vaccine programs where our proven adjuvant may provide meaningful advantages."

SECOND-QUARTER CORPORATE HIGHLIGHTS

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S. and EU that enables series completion with only two doses in one month.

HEPLISAV-B vaccine achieved net product revenue of $32.7 million for the second quarter of 2022, up 139% compared to $13.7 million for the second quarter of 2021.
Market share in the accounts targeted by the Dynavax field sales team increased to approximately 39%, with total market share increasing to approximately 32% in the second quarter of 2022, up from approximately 30% and 19% respectively, in the second quarter of 2021.
CpG 1018 Adjuvant Supply for COVID-19 Vaccines

Dynavax has established a global portfolio of CpG 1018 adjuvant commercial supply agreements (CSA) currently focused on the development of COVID-19 vaccines across a variety of vaccine platforms.

CpG 1018 adjuvant revenue for the second quarter of 2022 was $222.6 million, up 471% compared to $39.0 million for the second quarter of 2021.
The Company now expects 2022 full-year CpG 1018 adjuvant COVID-19 supply revenue to be between $550 million and $600 million, based on committed orders, with an anticipated full-year gross margin of approximately 60%.
Clinical Pipeline

Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018 adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and real-world commercial use.

Tetanus, diphtheria and pertussis (Tdap) vaccine program: Previously reported interim adult data from an on-going Phase 1 clinical trial evaluating the Company’s adjuvanted Tdap vaccine candidate demonstrated it was well tolerated without safety concerns with immunogenicity data supporting continued advancement. The Company anticipates adolescent data from the same trial in the fourth quarter of 2022.
Shingles vaccine program: The Company recently completed enrollment in the ongoing Phase 1 study evaluating the safety, tolerability, and immunogenicity in adults compared to Shingrix, the leading marketed shingles vaccine in the U.S. Topline data is anticipated in the fourth quarter of 2022.
Plague vaccine candidate: The Company anticipates that in August the first participant will be dosed in a Phase 2 clinical trial evaluating the immunogenicity, safety and tolerability of a plague vaccine candidate utilizing CpG 1018 adjuvant. The clinical trial is being conducted in collaboration with, and funded by, the U.S. Department of Defense.
SECOND-QUARTER FINANCIAL HIGHLIGHTS

Total Revenues and Product Revenue, Net.
Total revenues for the second quarter of 2022 were $256.5 million, compared to $52.8 million for the second quarter of 2021.

U.S. HEPLISAV-B vaccine product revenue, net was $32.7 million for the second quarter of 2022, compared to $13.7 million for the second quarter of 2021. Additionally, approximately $0.9 million was reported in HEPLISAV-B net product sales associated with sales to the Company’s commercialization partner in Germany, Bavarian Nordic.
CpG 1018 adjuvant product revenue, net was $222.6 million in the second quarter of 2022 compared to $39.0 million in the second quarter of 2021.
Selected financial highlights from CpG 1018 adjuvant product supply partnerships for COVID-19 vaccines and vaccine candidates:
The Company recorded approximately $68.0 million in CpG 1018 adjuvant product revenue under its CSA with Valneva. Dynavax does not have any further supply obligations under the CSA.
The Company recorded approximately $51.0 million in CpG 1018 adjuvant product revenue under its CSA with Biological E.
The Company recorded approximately $91.3 million in CpG 1018 adjuvant product revenue under its CSA with Clover.
The Company recorded approximately $12.3 million in CpG 1018 adjuvant product revenue under its CSA with Bio Farma. In May 2022, Dynavax and Bio Farma entered into a CSA for the supply of CpG 1018 adjuvant to be used in Bio Farma’s subunit COVID-19 vaccine candidate, currently in a Phase 3 immunogenicity and safety study.
Cost of Sales – Product. Cost of sales – product for the second quarter of 2022 increased to $83.4 million, compared to $14.8 million for the second quarter of 2021. The increase was primarily due to manufacturing costs for increased volumes of CpG 1018 adjuvant sold to COVID-19 supply partners and increased HEPLISAV-B vaccine sales volume.

Research and Development Expenses (R&D). R&D expenses for the second quarter of 2022 increased to $9.7 million, compared to $7.2 million for the second quarter of 2021. The increase was primarily driven by increased headcount-related compensation and personnel costs, including non-cash stock-based compensation, as well as investments in product candidates utilizing CpG 1018 adjuvant and additional discovery efforts.

Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the second quarter of 2022 increased to $36.2 million, compared to $21.6 million for the second quarter of 2021. The increase was primarily driven by compensation and related personnel costs, including non-cash stock-based compensation, primarily associated with increased headcount as the Company expanded its field sales team to support HEPLISAV-B vaccine commercialization in mid-2021.

Interest Expense. Interest expense was $1.7 million in the second quarter of 2022, a decrease of $1.4 million from $3.1 million in the second quarter of 2021, reflecting a decreased interest rate associated with the Company’s convertible senior notes due 2026.

Net Income. GAAP net income was $128.8 million, or $1.02 per share (basic) and $0.87 per share (diluted) in the second quarter of 2022, compared to GAAP net income of $4.5 million, or $0.04 per share (basic) and $0.02 per share (diluted) in the second quarter of 2021.

Cash and Marketable Securities. Cash and marketable securities were $518.2 million as of June 30, 2022.

2022 Financial Guidance
Dynavax anticipates 2022 revenues, operating expenses, and other costs to be in the ranges shown below, updated from the Company’s previous financial guidance provided on May 5, 2022:

Full-year CpG 1018 adjuvant net product revenues of between $550 million and $600 million, with an associated gross margin anticipated to be approximately 60%
Research and development expenses to be between approximately $50-$60 million
Selling, general and administrative expenses to be between approximately $130-$140 million
Interest expense of approximately $7 million
Conference Call and Webcast Information
Dynavax will host a conference call and live audio webcast on Thursday, August 4, 2022, at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source A replay of the webcast will be available for 30 days following the live event.

To dial into the call, participants will need to register for the call using the caller registration link. It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call.

Important U.S. Product Information
HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.

For full U.S. Prescribing Information for HEPLISAV-B, click here.

Important U.S. Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%), and headache (8% to 17%).

On August 4, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), reported second quarter and first half 2022 financial results and corporate updates (Press release, Iovance Biotherapeutics, AUG 4, 2022, View Source [SID1234617531]).

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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "Iovance continues to solidify our global leadership across all three aspects of our mission to innovate, develop and deliver TIL therapy for patients with cancer. During the second quarter we executed toward our top priority, to submit the BLA for lifileucel in metastatic melanoma, while preparing for commercialization and advancing our robust immuno-oncology pipeline. Following our recent pre-BLA meeting in late July, we are finalizing our BLA to begin submission this month. With many opportunities to create significant value for cancer patients and our shareholders, Iovance is a true pioneer in the industry, driven by our experienced executive leadership team and talented organization with deep cell therapy experience."

Second Quarter 2022 Highlights and Recent Corporate Updates

Regulatory

Iovance TIL therapy (lifileucel) in metastatic melanoma (post-anti-PD-1): Iovance held a successful pre-BLA meeting with the U.S. Food and Drug Administration (FDA) in late July 2022. The FDA provided favorable feedback on the clinical efficacy data from Cohorts 2 and 4 of the C-144-01 clinical trial, including duration of follow up, and the potency assay matrix. The FDA agreed the clinical and safety dataset was sufficient for BLA review. Iovance will commence a rolling BLA submission for lifileucel in metastatic melanoma this month and complete the submission during the fourth quarter.
Clinical

Iovance TIL therapy (lifileucel) in metastatic melanoma:
Positive clinical data in advanced (post-anti-PD-1) metastatic melanoma: Iovance reported positive clinical data from the C-144-01 clinical trial and plans to present additional results at a medical meeting in the second half of 2022.
Frontline (anti-PD-1 naïve) metastatic melanoma: Iovance remains on track to open a Phase 3 trial of lifileucel in combination with pembrolizumab in frontline metastatic melanoma in late 2022. The trial is intended to expand the opportunity for lifileucel as an earlier treatment and serve as a confirmatory study for C-144-01 clinical trial Cohort 4.
Poster at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting: A translational science poster highlighting the potential for lifileucel to benefit patients with melanoma regardless of immune checkpoint inhibitor (ICI) exposure and independent of tumor biomarkers of mutational burden, single-gene mutations, or inflammation.
Iovance TIL therapy (LN-145) in second-line mNSCLC: Enrollment is ongoing at more than 30 active clinical sites in the U.S., Canada and Europe for the IOV-LUN-202 trial of LN-145 in patients with mNSCLC. Iovance is engaged in discussions with the FDA about the potential for IOV-LUN-202 to serve as a registrational trial for LN-145 in mNSCLC and intends to execute an updated regulatory strategy based on this dialogue and feedback.

First in human trial of genetically modified Iovance TIL therapy IOV-4001: site activation and patient recruitment are underway in the IOV-GM1-201 clinical trial of Iovance’s first genetically modified TIL therapy, IOV-4001, for the treatment of previously treated advanced melanoma or mNSCLC. IOV-4001 leverages the gene editing TALEN technology licensed from Cellectis to inactivate PD-1 expression.

Iovance TIL therapy (lifileucel) in advanced cervical cancer: Following FDA discussions and feedback on a registration strategy to address the shift in frontline standard of care, Iovance plans to reopen Cohort 2 of the ongoing C-145-04 trial to enroll additional patients who have received prior anti-PD-1 therapy. The expanded Cohort 2 is intended to support a BLA in cervical cancer following progression on chemotherapy and pembrolizumab.
Research Programs for Next-Generation TIL Therapies and Related Technologies

Several targets for genetic modification using the gene-editing TALEN technology, including double genetic knock-out programs, are advancing in preclinical development.

Additional research and preclinical studies include approaches to increase TIL potency using CD39/69 double negative TILs and gene knock-in targets as well as development of a novel interleukin-2 (IL-2) analog (IOV-3001).
Manufacturing

The Iovance Cell Therapy Center (iCTC) is currently operating flex suites for clinical manufacturing and core suites for BLA readiness activities.

Iovance is building capacity to treat thousands of cancer patients annually, with capacity at iCTC for 2,000+ patients and flexibility to expand existing shell space to supply 5,000+ patients per year.
Corporate

Iovance entered into an amendment to its license agreement with the National Institutes of Health (NIH) to include additional exclusive, worldwide patent rights to TIL products expressing IL-12, expanded rights to TIL selection technologies, and additional non-exclusive, worldwide patent rights to certain technologies related to enhancing TIL potency.

Cash position of $430.9 million at June 30, 2022 is expected to be sufficient into 2024.

Iovance currently owns more than 50 granted or allowed U.S. and international patents for TIL compositions and methods of treatment and manufacturing in a broad range of cancers, with Gen 2 patent rights expected to provide exclusivity into 2038. More information on Iovance’s patent portfolio can be found on the Intellectual Property page on www.iovance.com.
Second Quarter and First Half 2022 Financial Results

Iovance had $430.9 million in cash, cash equivalents, investments and restricted cash at June 30, 2022, compared to $602.1 million at December 31, 2021. The cash position is expected to be sufficient to fund current and planned operations into 2024.

Jean-Marc Bellemin, Chief Financial Officer of Iovance, said, "As a late-stage oncology company approaching potential commercialization, we continue to maintain a strong balance sheet through prudent investments in commercial launch preparations, internal manufacturing and pipeline expansion. Our cash position is expected to take us through several milestones to create value for patients and shareholders."

Net loss for the second quarter ended June 30, 2022, was $99.3 million, or $0.63 per share, compared to a net loss of $81.4 million, or $0.53 per share, for the second quarter ended June 30, 2021. Net loss for the six months ended June 30, 2022, was $191.0 million, or $1.21 per share, compared to a net loss of $156.8 million, or $1.04 per share, for the same period ended June 30, 2021.

Research and development expenses were $73.4 million for the second quarter ended June 30, 2022, an increase of $11.3 million compared to $62.1 million for the same period ended June 30, 2021. Research and development expenses were $141.7 million for the six months ended June 30, 2022, an increase of $23.6 million compared to $118.1 million for the same period ended June 30, 2021.

The increases in research and development expenses in the second quarter and first half of 2022 over the prior year periods were primarily attributable to growth of the internal research and development team, including stock-based compensation expense, as well as facility-related and internal research program costs, which were partially offset by lower clinical and manufacturing costs driven by completion of enrollment of pivotal clinical trials.

General and administrative expenses were $26.3 million for the second quarter ended June 30, 2022, an increase of $7.0 million compared to $19.3 million for the same period ended June 30, 2021. General and administrative expenses were $49.7 million for the six months ended June 30, 2022, an increase of $10.8 million compared to $38.9 million for the same period ended June 30, 2021.

The increase in general and administrative expenses in the second quarter and first half of 2022 compared to the prior year periods were primarily attributable to growth of the internal general and administrative and commercial teams, including stock-based compensation expense, facility-related costs associated with the build out of the new corporate headquarters, as well as costs associated with pre-commercial activities.

For additional information, please see the Company’s Selected Condensed Consolidated Balance Sheet and Statement of Operations below.

Webcast and Conference Call

To participate in the conference call, please register at https://register.vevent.com/register/BI25a798dba7074946a0aa3082d603bf41. The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.iovance.com. The archived webcast will also be available for one year