On May 6, 2021 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported financial results for the first quarter of 2021 (Press release, Dynavax Technologies, MAY 6, 2021, View Source [SID1234579341]).

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"The first quarter of 2021 continued to build on our successful execution in 2020. With the combined strength of opportunities from HEPLISAV-B and CpG 1018, we believe 2021 will be a transformational year for Dynavax," commented Ryan Spencer, Chief Executive Officer of Dynavax. "HEPLISAV-B continues to take market share in accounts targeted by our field sales team, reaching a new high this quarter, which reinforces our belief that it will become the standard of care in the U.S. for adult hepatitis B vaccination."

Mr. Spencer continued, "Dynavax is making progress on numerous collaborations for its proven vaccine adjuvant CpG 1018 across multiple indications, including COVID-19, pertussis, and universal flu. Our COVID-19 collaborations have advanced significantly in recent months with multiple partners targeting emergency or conditional authorization in the second half of 2021. Importantly, these collaborations are now generating significant revenue for Dynavax, with first quarter CpG 1018 revenue of $74.6 million. Additionally, last week we expanded our agreement with CEPI whereby they fund manufacturing of CpG 1018 for future sales to CEPI grantees, providing the opportunity for additional revenue in 2021 from COVID-19 collaborations. The emerging portfolio of product opportunities with CpG 1018 has the potential to drive significant revenue growth beyond this year."

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

Net product revenue for HEPLISAV-B during the first quarter 2021 was $8.3 million compared to $10.5 million for the first quarter 2020, driven by increased market share offset by a reduction in vaccine utilization due to the COVID-19 pandemic.
Market share in accounts targeted by the field sales team increased to 27%, up from 21% market share in the first quarter of 2020.
Final immunogenicity and interim safety results of the ongoing clinical trial (HBV-24) evaluating HEPLISAV-B in patients undergoing hemodialysis evaluating a new 4-dose regimen of HEPLISAV-B demonstrated a seroprotection rate of 89.3%. Interim safety data showed HEPLISAV-B is well tolerated and no safety concerns were observed. Full safety data are expected by the end of 2021.
Positive results from the post-marketing observational surveillance study (HBV-25) in over 69,000 patients demonstrated the study met the primary endpoint and showed no evidence of an increased risk of acute myocardial infarction associated with vaccination with HEPLISAV-B compared to Engerix-B.
CpG 1018 (ADVANCED VACCINE ADJUVANT)

Net product revenue for CpG 1018 during the first quarter 2021 was $74.6 million.
In February, Dynavax initiated a Phase 1 clinical trial of Tdap-1018, its tetanus, diphtheria, and acellular pertussis (Tdap) booster vaccine product candidate adjuvanted with CpG 1018.
In March, Clover Biopharmaceuticals dosed the first participant in SPECTRA, a global Phase 2/3 clinical trial for its trimeric SARS-CoV 2 spike (S) protein vaccine adjuvanted with CpG 1018.
In April, Valneva reported positive initial results for Part A of the Phase 1/2 clinical trial of its VLA2001 COVID-19 vaccine candidate adjuvanted with CpG 1018 and subsequently initiated a pivotal Phase 3 clinical trial.
In April, Medigen published positive Phase 1 clinical study data demonstrating neutralizing antibody titers 1.8 to 3.9 times that of human convalescent sera for its COVID-19 vaccine candidate adjuvanted with CpG 1018 and has completed enrollment of over 4,000 participants in its on-going Phase 2 clinical trial.
In April, CEPI expanded its agreement with the Company to provide funding to manufacture CpG 1018 for its COVID-19 vaccine grantees, increasing total funding under the loan agreement from $99 million to $176 million.
2021 MILESTONES

Multiple data readouts from our CpG 1018 COVID-19 collaboration partners throughout the year
Data from the ongoing Phase 1 clinical trial of Tdap-1018 in the fourth quarter
Launch HEPLISAV-B in the EU in the fourth quarter
FINANCIAL RESULTS
Total Revenue. Total revenues for the first quarter of 2021 were $83.3 million, including $82.9 million of net product revenue, an increase from total revenue for the first quarter of 2020 of $10.9 million.

Product Revenue, Net. HEPLISAV-B product revenue, net was $8.3 million in the first quarter of 2021 compared to $10.5 million in the same period in 2020. CpG 1018 product revenue, net was $74.6 million in the first quarter of 2021 compared to $0.0 million in the same period in 2020.

Cost of Sales – Product. Cost of sales – product for the first quarter 2021 increased to $24.6 million, compared to $2.4 million for the first quarter of 2020. The increase was primarily due to manufacturing costs for CpG 1018.

Research and Development Expenses (R&D). R&D expenses for the first quarter of 2021 increased to $7.8 million, compared to $4.7 million for the first quarter of 2020. The increase is primarily due to development activities related to process improvements at our Dusseldorf facility and higher headcount, partially offset by a decrease in business travel due to COVID-19 travel restrictions. In addition, non-cash stock-based compensation in the first quarter of 2020 included reversal of expenses related to cancellation of certain equity grants.

Selling, General and Administrative Expenses (SG&A). SG&A expenses for the first quarter of 2021 increased to $22.4 million, compared to $20.9 million for the first quarter of 2020. Compensation and related personnel costs increased due to higher headcount and an accrual of benefits for a former executive in connection with his retirement, offset by the decrease in business travel due to COVID-19 travel restrictions. Non-cash stock-based compensation increased due to higher headcount.

Income from Operations and Net Income. Income from operations for the first quarter of 2021 was $28.5 million compared to a loss of $19.3 million in the first quarter of 2020. Net income for the first quarter of 2021 was $0.9 million compared to a net loss of $12.6 million for the first quarter of 2020. Basic and diluted net income per share was $0.01 for the first quarter of 2021, compared to a basic net loss of $0.15 per share and diluted net loss per share of $0.25 in the first quarter of 2020.

Cash Position. Cash, cash equivalents and marketable securities totaled $232.7 million at March 31, 2021.

CONFERENCE CALL AND WEBCAST INFORMATION
Dynavax will hold a conference call today 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 www.dynavax.com. Alternatively, participants may dial (866) 420-4066 or (409) 217-8237 and refer to conference ID 4533398. A replay of the webcast will be available for 30 days following the live event.

Please see Important Safety Information below.

For more information about HEPLISAV-B, visit View Source

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,I and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.II Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.III Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.IV

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

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

Safety and effectiveness of HEPLISAV-B have not been established in adults on hemodialysis.

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 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%).

Important EU/EEA Product Information
HEPLISAV B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
The use of HEPLISAV B should be in accordance with official recommendations.
It can be expected that hepatitis D will also be prevented by immunisation with HEPLISAV B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

For full EU/EEA. Prescribing Information for HEPLISAV-B, click here.

Important EU/EEA Safety information
Do not receive HEPLISAV B if you have had a sudden life-threatening, allergic reaction after receiving HEPLISAV B in the past, or if you are allergic to any of components of this vaccine, including yeast. Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.
Appropriate medical treatment and supervision should be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
The administration of HEPLISAV B should be postponed in subjects suffering from acute severe febrile illness.
Immunocompromised persons may have a diminished immune response to HEPLISAV B.
Because of the long incubation period of hepatitis B, it is possible for unrecognised HBV infection to be present at the time of immunisation. HEPLISAV B may not prevent HBV infection in such cases.
There are very limited data on the immune response to HEPLISAV B in individuals who did not mount a protective immune response to another hepatitis B vaccine.
As a precautionary measure, it is preferable to avoid the use of HEPLISAV B during pregnancy. Vaccination during pregnancy should only be performed if the risk-benefit ratio at the individual level outweighs possible risks for the fetus.
The most common patient-reported side effects reported within 7 days of vaccination were pain, swelling or redness at the injection site, feeling tired, headache, muscle aches, feeling unwell and fever.

About CpG 1018 Adjuvant
CpG 1018 is the adjuvant used in HEPLISAV-B. Dynavax developed CpG 1018 adjuvant to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. CpG 1018 adjuvant provides a well- developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine.

On May 6, 2021 ChromaDex Corp. (NASDAQ:CDXC) reported first quarter 2021 financial results (Press release, ChromaDex, MAY 6, 2021, View Source [SID1234579340]).

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First Quarter 2021 and Recent Highlights

Total net sales of $14.7 million, up 2% from $14.3 million in the year ago quarter.
Tru Niagen net sales of $12.4 million, a 12% increase from the year ago quarter.
Gross margin of 62.9%, a 500 basis point increase from the year ago quarter.
Net loss was ($7.4) million or ($0.12) per share, down $0.02 per share year-over-year.
Adjusted EBITDA excluding total legal expense, a non-GAAP measure, was a loss of ($0.7) million, a $0.4 million decline year-over-year.
Announced retail distribution of Tru Niagen in Walmart stores across the United States beginning in June 2021.
Announced strategic supply agreement with Health & Happiness Group (H&H), a global leader in premium health, human and pet nutrition and personal care brands to sell Niagen in its exclusively formulated Swisse products.
Announced strategic supply agreement with Ro, a healthcare technology company, to sell Niagen in specially-formulated Roman products.
Appointed former Nestlé executive, Fadi Karam as Chief Marketing Officer.
Appointed Dr. David L. Katz, a globally recognized authority on lifestyle medicine, to the ChromaDex Scientific Advisory Board.
"This has been an incredible year for ChromaDex strategically," said ChromaDex CEO, Rob Fried. "We signed three important deals with Walmart, H&H, and Ro. We also strengthened our balance sheet with a $25 million capital raise and announced the results of exciting scientific research on Niagen. We had some short-term supply chain disruptions that impacted first quarter sales, but the long-term prospects look stronger than ever."

Results of operations for the three months ended March 31, 2021

For the three months ended March 31, 2021 ("Q1 2021"), ChromaDex reported net sales of $14.7 million, up 2% compared to $14.3 million in the first quarter of 2020 ("Q1 2020"). The increase in Q1 2021 revenues was driven by growth in sales of Tru Niagen, largely offset by lower Niagen and other ingredient sales.

Gross margin percentage improved by 500 basis points to 62.9% in Q1 2021 compared to 57.9% in Q1 2020. The improvement in gross margin percentage was driven by the positive impact of increased Tru Niagen consumer product sales and product cost savings initiatives.

Operating expenses increased by $2.4 million to $16.6 million in Q1 2021, compared to $14.2 million in Q1 2020. The increase in operating expenses was driven by $1.8 million of higher selling and marketing expenses, and an increase of $0.7 million in general and administrative expense, partially offset by $0.1 million of lower research and development expense. The increase in general and administrative expense was driven by $2.6 million of higher legal expense, partially offset by $1.0 million of lower severance and restructuring expenses and $0.8 million of lower shares-based compensation expense.

The net loss for Q1 2021 was ($7.4) million or ($0.12) per share as reported compared to a net loss of ($5.9) million or ($0.10) per share for Q1 2020 as reported. Adjusted EBITDA excluding total legal expense, a non-GAAP measure, was a loss of ($0.7) million for Q1 2021, compared to a loss of ($0.3) million for Q1 2020, a $0.4 million decline.

ChromaDex defines Adjusted EBITDA excluding total legal expense as net income or (loss) which is adjusted for interest, income tax, depreciation, amortization, non-cash stock compensation costs, severance and restructuring expense, bad debt expense related to Elysium Health and total legal expense.

For Q1 2021, the net cash flow from operating activities was ($5.4) million, versus ($5.2) million in Q1 2020.

2021 Outlook

Looking forward, for the full year, the Company expects continued, steady revenue growth driven by its global ecommerce business, as well as growth with existing and new strategic partners, and that the growth rate will accelerate beginning in the second quarter. The Company expects continued gross margin improvement to slightly better than 60%, roughly flat R&D expense and slightly higher selling and marketing expense as a percentage of net sales year-over-year. The Company expects slightly higher general and administrative expense, excluding severance, restructuring and legal expense. The Company plans to increase investments and resources to drive brand awareness and accelerate its R&D pipeline to capitalize on growth in the NAD+ market globally.

Investor Conference Call

ChromaDex management will host an investor conference call to discuss the first quarter results and provide a general business update on Thurs., May 6, at 4:30 p.m. ET.

Participants should call in at least 10 minutes prior to the call. The dial-in information is as follows:

The earnings press release, and its accompanying financial exhibits, will be available on the Investor Relations section of the Company website, www.chromadex.com.

On May 6, 2021 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported its financial results for the first quarter ended March 31, 2021 and provided additional corporate updates (Press release, Ziopharm, MAY 6, 2021, View Source [SID1234579339]). The Company will host a conference call and webcast today at 4:30 pm ET.

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Recent Corporate Highlights and Updates

Announced that the infusion of the first patient in the CD19-Specific Rapid Personalized Manufacturing (RPM) CAR-T Phase I Clinical Trial being conducted in Taiwan by the Company’s Joint Venture partner, Eden BioCell, occurred in March.

Presented a poster entitled "Hotspot mutations in KRAS and TP53 targeted by TCR-T cells genetically modified with the Sleeping Beauty transposon/transposase system" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual 2021 Annual Meeting.

Completed construction of the GMP facility in Houston with follow on activities for facility qualification and validation to take place over the summer. The Company will then qualify the manufacturing process in the facility and file an IND amendment to enable GMP manufacturing to supplement its CMO partner’s capacity for the TCR-T hotspot trial.

Announced it is winding down its existing Controlled IL-12 clinical program. Data indicated potential clinical benefits in a variety of cancers, including recurrent glioblastoma. The Company will continue to seek a partner for this program while re-deploying resources and will explore synergies between this technology and its cell therapy programs. The Company anticipates a headcount reduction of approximately 15% related to this wind down.

Anticipate the closure of the CD19 RPM CAR-T Allogeneic Phase I Trial at MD Anderson Cancer Center. The trial closure is expected to occur during the second or third quarter of 2021.

Plans to hold its Annual Meeting of Stockholders on May 19, 2021 at 9:00 am EDT. The meeting will be held virtually. Shareholders and interested stakeholders may attend the annual meeting online using the link below. Shareholders may submit questions during the meeting and vote shares electronically during the meeting by visiting www.virtualshareholdermeeting.com/ZIOP2021.
"Our first quarter was highlighted by execution and important strategic decisions that focus our capital on our prioritized development programs," said Heidi Hagen, Chief Executive Officer of Ziopharm. "In the coming months, we are focused on delivering important milestones on our clinical trials, including our first TCR-T trial, where we plan to treat patients beginning in the second half of the year, and continued progress on the Eden BioCell CD19-specific RPM CAR-T Trial in Taiwan."

First Quarter 2021 Financial Results

Research and development expenses were $13.3 million for the first quarter of 2021, compared to $12.7 million for the first quarter of 2020, primarily reflecting increase in cell therapy program costs offset by a decrease in Controlled IL-12 program costs.

General and administrative expenses were $8.2 million for the first quarter of 2021, compared to $6.0 million for the first quarter of 2020. The increase in general and administrative expenses is primarily due to increased employee related expenses and legal costs associated with its expanded patent portfolio.

Net loss for the first quarter of 2021, was $21.6 million, or $(0.10) per share, compared to a net loss of $18.3 million, or $(0.09) per share, for the first quarter of 2020.

Cash and cash equivalents, as of March 31, 2021 were $100.1 million.

Additionally, a prepayment of approximately $5.1 million remains for work to be conducted by the Company at MD Anderson under the Company’s research and development agreements.
Earnings Conference Call and Webcast
Ziopharm will host a conference call and webcast for the investment community today, May 6, 2021, at 4:30 p.m. EDT. The conference call can be accessed by dialing 855-327-6837 (U.S. and Canada) or 631-891-4304 (International). The passcode for the conference call is 10013973. The live webcast may be accessed using the link here, or by visiting the "Investors" section of the Ziopharm website at www.ziopharm.com. The call will be recorded and available for replay on the Company’s website for approximately 90 days after the call.

Annual Meeting of Stockholders
Ziopharm will host its annual meeting virtually on May 19, 2021 at 9:00 am. Shareholders and interested stakeholders may attend the meeting, submit questions, and vote their shares electronically during the meeting by visiting www.virtualshareholdermeeting.com/ZIOP2021.

On May 6, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported financial results for the first quarter of 2021 (Press release, Oncternal Therapeutics, MAY 6, 2021, View Source [SID1234579338]). Oncternal management will host a webcast today at 5:00 p.m . ET to discuss its first quarter of 2021 financial results and to provide a business update.

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"We are continuing to advance our ROR1-focused platform in both liquid and solid tumors, while laying the groundwork for developing new ROR1 targeting cell therapies. Based on encouraging data recently reported at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, we are evaluating cirmtuzumab for other clinical development opportunities in solid tumors while continuing our FDA dialogue on a potential registration strategy in mantle cell lymphoma (MCL). In addition, we are supporting TK216, an ETS inhibitor which has generated encouraging results in Ewing sarcoma," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We also look forward to presenting several key clinical data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held virtually from June 4-8, 2021."

Recent Highlights

In April 2021, we presented two scientific posters at the AACR (Free AACR Whitepaper) Annual Meeting, which showcased the promise of cirmtuzumab in treating solid tumors.
In a Phase 1b investigator-initiated clinical trial in heavily pre-treated patients with metastatic HER2-negative breast cancer treated with a combination of cirmtuzumab and paclitaxel, eight of 14 evaluable patients had a partial response (PR), one of which remained durable for 52 weeks, for an objective response rate (ORR) of 57%. Four additional patients (29%) had stable disease (SD). These results were consistent with the previously reported interim results of the study, and compared favorably to historical results for single-agent paclitaxel, particularly for patients such as these who had received a median of six prior therapies for metastatic disease. Cirmtuzumab when given with paclitaxel was well-tolerated and demonstrated no added toxicity over what was expected with paclitaxel alone. The trial is expected to enroll a total of 15 evaluable patients.
In a preclinical study of cirmtuzumab used to treat high-grade serous ovarian cancer (HGSOC) and endometrial cell lines in vitro alone or in combination with chemotherapeutic agents cisplatin and paclitaxel, cirmtuzumab demonstrated single agent activity and enhanced the anti-proliferative effects of chemotherapeutic agents in both ovarian and endometrial cancer cell models. Oncternal is currently evaluating next steps for cirmtuzumab in solid tumors including breast and ovarian cancer.
In April 2021, we appointed Chase Leavitt as General Counsel.
In April 2021, we announced that updated interim clinical trial results from Oncternal’s study of TK216 in patients with Ewing sarcoma will be presented in an oral session, and updated interim clinical trial results from Oncternal and UCSD’s study of cirmtuzumab plus ibrutinib in patients with MCL or chronic lymphocytic leukemia (CLL) will be presented in a poster session at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2021.
Expected Upcoming Milestones

Cirmtuzumab (ROR1 antibody) programs
Clinical data update for patients with MCL and CLL treated with cirmtuzumab plus ibrutinib in the ongoing Phase 1/2 study will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting
Preclinical data in additional ROR1-expressing tumors is expected to be available in the third quarter of 2021
ROR1 CAR-T program
First-in-human dosing is expected in the first half of 2022
TK216 (ETS inhibitor) program
Clinical data update for patients with Ewing sarcoma treated in the ongoing Phase 1/2 study will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting
Preclinical data in additional ETS-driven tumors is expected to be available in the third quarter of 2021
First Quarter 2021 Financial Results

Our grant revenue was $0.7 million for the first quarter ended March 31, 2021. Our grant revenue is derived from a sub-award under a grant from the California Institute for Regenerative Medicine (CIRM) to UC San Diego, which was awarded to advance our Phase 1/2 clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with MCL or CLL.

Our total operating expenses for the first quarter ended March 31, 2021 were $6.7 million. Research and development expenses for the quarter totaled $3.9 million, and general and administrative expenses for the quarter totaled $2.8 million. Net loss for the first quarter was $5.9 million, or a loss of $0.12 per share, basic and diluted.

As of March 31, 2021, we had $111.2 million in cash and cash equivalents. We believe these funds will be sufficient to fund our operations into 2023. As of March 31, 2021, we had approximately 49.4 million shares of common stock outstanding.

Management Webcast

As previously announced, Oncternal will host a webcast today, May 6, 2021, at 5:00 p.m. ET (2:00 p.m. PT). The live webcast will be available online and may be accessed from the "Investors" page of the company website at View Source A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

On May 6, 2021 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 first quarter 2021 financial results and corporate updates (Press release, Iovance Biotherapeutics, MAY 6, 2021, View Source [SID1234579337]).

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Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance, stated, "During the first quarter of 2021 we continued to work on our potency assays in support of a BLA for lifileucel, which is our top priority at Iovance. We continued developing multiple assays in parallel and submitted additional potency assay data to the FDA. I am also very pleased to highlight the strength of clinical data for TIL being presented at the recent and upcoming medical meetings and journal publications, including the first clinical data for TIL in combination with pembrolizumab in melanoma at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting. We believe durable responses for Iovance TIL in relapsed or refractory metastatic melanoma, paired with data to be presented for TIL in combination with anti-PD1 therapy in earlier treatment settings, solidify the broader potential for Iovance TIL and further demonstrate our leadership in the development, manufacturing, and potential commercialization of TIL cell therapy."

First Quarter 2021 Highlights and Recent Corporate Updates

Clinical:

TIL therapy, lifileucel, in melanoma: Updated data from Cohort 2 in the C-144-01 study of lifileucel in advanced melanoma were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting. As of the December 2020 data cutoff for the presentation, lifileucel showed a 36.4% overall response rate (4.5% complete responses and 31.8% partial responses); median duration of response (DOR) was not reached at 28.1 months of median study follow up as assessed by investigators (n=66). Available care for Cohort 2 patients is chemotherapy, with an overall response rate of four to 10 percent and overall survival of only seven to eight months. Updated Cohort 2 data has been accepted for an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. A manuscript of the Cohort 2 data has also been accepted for a forthcoming publication in a high impact oncology journal.
TIL therapy, lifileucel, in cervical cancer: The C-145-04 study of lifileucel, formerly LN-145, is intended to support a BLA submission for metastatic cervical cancer. Inclusion of both pivotal cohort 1 (post-chemotherapy) and cohort 2 (post-anti-PD-1/PDL-1) in the BLA may strengthen the potential label and reflect the expected upcoming treatment landscape in cervical cancer. Patient dosing is complete in both Cohorts 1 and 2, and enrollment continues in Cohort 3 (lifileucel in combination with pembrolizumab in cervical cancer patients who are naïve to anti-PD-1 therapy).
TIL therapy in non-small cell lung cancer (NSCLC): Iovance has activated 10 U.S. clinical sites and patients have consented in the potential registration-directed study, IOV-LUN-202, to investigate LN-145 in patients with recurrent or metastatic NSCLC, without driver mutations, who previously received a single line of approved systemic therapy (combined checkpoint inhibitor (CPI) plus chemotherapy). The company also continues to investigate LN-145 in several additional NSCLC populations with unmet need across three cohorts in the IOV-COM-202 basket study.
TIL therapy in combination with pembrolizumab in melanoma and head and neck squamous cell carcinoma (HNSCC): Iovance is investigating TIL in combination with pembrolizumab in earlier treatment settings in melanoma and HNSCC. Initial data from Cohort 1A in the IOV-COM-202 study, which is evaluating lifileucel in combination with pembrolizumab in melanoma, will be presented at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting. Patients with HNSCC continue to enroll in the expanded Cohort 2A in the IOV-COM-202 study to receive LN-145 in combination with pembrolizumab.
TIL clinical program updates: To date, over 450 patients have been dosed with Iovance TIL products with more than a 90 percent manufacturing success rate.
Regulatory

Potency assays for lifileucel: Iovance recently submitted additional potency assay data to the FDA, while continuing to evaluate additional assays as backup options in support of the BLA. Submission of the BLA is anticipated during 2021. Expeditious resolution of the potency assay for lifileucel in melanoma is also a key step towards BLA submission plans in cervical cancer.
Manufacturing:

Iovance Cell Therapy Center (iCTC): Activities at the iCTC have commenced to support start of clinical manufacturing in late 2021. The expected commercial manufacturing remains on track to start in 2022.
Generation 3 (Gen 3) manufacturing: A shorter 16-day third generation manufacturing process is being explored in a cohort of metastatic melanoma patients in the IOV-COM-202, where patient dosing has initiated using Gen 3. In addition, a cohort of NSCLC patients in the IOV-LUN-202 study will receive product manufactured by this Gen 3 process.
Corporate:

Cash position of $610.2 million on March 31, 2021 is expected to be sufficient into 2023 to deliver on pipeline programs.
A strong organization of more than 250 employees, of which 76 percent have more than a year of cell therapy experience, is in place to advance research, development, manufacturing, and commercial launch preparations.
On May 6, 2021, Iovance entered into an amended license agreement with the National Institutes of Health (NIH), which adds additional exclusive, worldwide patent rights in certain indications to cytokine-tethered TIL technology and expands the non-exclusive, worldwide field of use to all cancers.
Iovance continues to expand its intellectual property portfolio and currently owns more than 25 granted or allowed U.S. and international patents for compositions and methods of treatment in a broad range of cancers relating to the Gen 2 manufacturing process. Iovance’s Gen 2 patent rights are expected to provide exclusivity through 2038. Iovance’s portfolio also includes patent applications and granted patents directed towards Gen 3 manufacturing, selected TIL products, stable and transient genetic TIL modifications, tumor digest and fragment compositions and methods (including cryopreservation), and combinations of checkpoint inhibitors and TIL products.
First Quarter 2021 Financial Results

Iovance held $610.2 million in cash, cash equivalents, investments and restricted cash at March 31, 2021 compared to $635.0 million at December 31, 2020. The company anticipates that the year-end balance of cash, cash equivalents, investments and restricted cash will be sufficient into 2023.

Jean-Marc Bellemin, Chief Financial Officer, stated, "The continued strength of our balance sheet puts Iovance in an excellent position to fulfill our operating plan and advance our pipeline. We are judicious in our investments to maximize value and deliver on our commitments for patients and our shareholders."

Net loss for the first quarter ended March 31, 2021, was $75.4 million, or $0.51 per share, compared to a net loss of $69.6 million, or $0.55 per share, for the first quarter ended March 31, 2020.

Research and development expenses were $55.9 million for the first quarter ended March 31, 2021, a decrease of $1.0 million compared to $57.0 million for the first quarter ended March 31, 2020.

The decrease in research and development expenses in the first quarter 2020 over the prior year period was primarily attributable to a decrease in manufacturing and clinical costs following the completion of enrollment in the pivotal cohorts for melanoma and cervical cancer.

General and administrative expenses were $19.6 million for the first quarter ended March 31, 2021, an increase of $5.8 million compared to $13.9 million for the first quarter ended March 31, 2020.

The increases in general and administrative expenses in the first quarter 2021 compared to the prior year period was primarily attributable to growth of the internal general and administrative team and higher stock-based compensation expenses.

Webcast and Conference Call

Iovance will host a conference call today at 4:30 p.m. ET to discuss the first quarter 2021 financial results and corporate updates. The conference call dial-in numbers are 1-800-773-2954 (domestic) or 1-847-413-3731 (international) and the access code is 50155289. The live webcast can be accessed in the Investors section of the company’s website at View Source The archived webcast will be available for a year in the Investors section at www.iovance.com.