On August 12, 2021 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported financial results for the quarter ended June 30, 2021, and provided an update on the company (Press release, Schrodinger, AUG 12, 2021, View Source [SID1234586475]).

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"The second quarter was highly productive for Schrödinger. We continued to make progress on our key strategic priorities, including our investments to advance our internal drug discovery pipeline and drive adoption of our software," stated Ramy Farid, Ph.D., chief executive officer at Schrödinger. "We announced a collaboration on a new program with Zai Lab, which expands our pipeline and provides the option to co-develop and co-commercialize in collaboration with an established commercial leader in oncology. We look forward to sharing additional updates on our progress throughout the year, and remain committed to making strategic investments in our business to drive long-term growth of the company."

Recent Business Highlights

Continued pipeline progress

During the second quarter, Schrödinger continued to advance its MALT1, CDC7 and Wee1 preclinical development programs. The company has initiated IND-enabling studies for its MALT1 program, and CDC7 and Wee1 continue to advance toward IND-enabling studies. Subject to completion of the preclinical data packages, the company expects to submit up to three IND applications in 2022, with the first submission to the FDA expected in the first half of next year. Schrödinger expects to present preclinical data from at least one of its internal programs in the second half of 2021.
The company continued to advance discovery efforts to allow the addition of new programs to the company’s internal pipeline in 2021.
Collaborations highlight continued strategic execution

In August, Schrödinger and Zai Lab Limited announced a global discovery, development and commercialization collaboration focused on a novel DNA damage response program in oncology. The research program will be conducted jointly by the Schrödinger and Zai Lab scientific teams. Following the selection of a development candidate, Zai Lab will assume primary responsibility for global development, manufacturing and commercialization. Schrödinger has the option to equally fund clinical development in the U.S. with Zai Lab, as well as the option to co-commercialize in the U.S. The companies will share research expenses for the program, and Zai Lab will make an upfront payment to Schrödinger to help fund Schrödinger’s share of research costs. If Schrödinger elects to co-fund clinical development of a product candidate under the collaboration, it will be entitled to 50 percent of any profits from the commercialization of such product candidate in the U.S. Schrödinger will also be eligible to receive up to approximately $338 million in preclinical, development, regulatory and sales-based milestone payments. Additionally, Schrödinger is entitled to receive royalties on net sales outside the U.S.
In June, Schrödinger’s partner, Ajax Therapeutics, completed a $40 million financing to support the advancement of Ajax’s lead drug development programs targeting hematologic malignancies. Through the companies’ collaboration, Schrödinger and Ajax scientists are working together to design and optimize molecules targeting cytokine signaling pathways.
Continued commitment to education and publication

In August, Schrödinger hosted its first annual Educator’s Day, which brought together K-12 and university educators from across the globe to discuss the growing role of computational tools in the classroom. The company also announced "Teaching with Schrödinger," a new initiative to develop curricula for academic institutions to teach students about chemical interactions, drug design and materials research using Schrödinger software.
During the second quarter, Schrödinger scientists authored multiple publications in peer-reviewed journals, independently and with customers, supporting application of the company’s platform to advance both drug discovery and materials science. Materials science advancements included research with the Edwards Air Force Base to develop molecular dynamics simulations to aid in the development of next-generation aerospace materials, as well as research with Panasonic Corp. to identify new molecules that can improve the efficiency of printed electronics.
Second Quarter 2021 Financial Results

Revenue was $29.8 million for the second quarter of 2021, a 29 percent increase compared to the second quarter of 2020.
Software revenue was $24.1 million for the second quarter of 2021, a 15 percent increase compared to the second quarter of 2020.
Drug discovery revenue was $5.7 million for the second quarter of 2021, compared to $2.2 million in the second quarter of 2020. Discovery revenue in the second quarter of 2021 included $3.3 million in revenue from our collaboration with Bristol Myers Squibb. Discovery revenue in the second quarter of 2021 also included a payment from a collaborator for the acquisition of intellectual property from Schrödinger related to a drug discovery program following the achievement of a lead optimization milestone.
Gross profit was $12.0 million in the second quarter of 2021, compared to $13.6 million in the second quarter in 2020. Software gross margin was 77 percent in the second quarter of 2021, compared to 82 percent for the same period in the prior year, reflecting planned investment to drive and support large-scale adoption of Schrödinger’s platform.
Operating expenses for the second quarter of 2021 were $42.3 million, compared to $30.7 million in the second quarter of 2020, driven by expenses required to scale the company’s business and advance its internal drug discovery programs.
Other expense, which included gains and losses on equity investments, changes in fair value of equity investments and interest income, was $4.6 million in the second quarter of 2021 compared to income of $13.1 million for the second quarter of 2020 due to adjustments to the fair value of the company’s equity investments.
Net loss, after adjusting for non-controlling interest, was $34.6 million for the second quarter of 2021, compared to a net loss of $3.4 million in the second quarter of 2020, driven by adjustments to the fair value of the company’s equity investments as well as planned investments to advance the company’s growth strategy.
Cash, cash equivalents, restricted cash and marketable securities as of June 30, 2021 were $616.6 million, compared to $649.0 million as of March 31, 2021.
Full-Year 2021 Financial Outlook

As of August 12, 2021, Schrödinger continues to expect total revenue to range from $124 million to $142 million, with software revenue expected to range from $102 million to $110 million and drug discovery revenue expected to range from $22 million to $32 million for the fiscal year ending December 31, 2021. Additional details are as follows:

Schrödinger expects the majority of anticipated second half software revenue growth to occur in the fourth quarter of 2021.
Drug discovery revenue can be highly variable quarter to quarter based on the timing of potential milestones related to collaborative agreements.
Schrödinger continues to aggressively fund R&D to advance its technology and drug discovery pipeline. The company continues to expect operating expense growth to be higher than the 42 percent annual growth rate reported in 2020 and expects software gross margin to be lower than the 81 percent reported in 2020.
Webcast and Conference Call Information

Schrödinger will host a conference call to discuss its second quarter financial results on Thursday, August 12, 2021, at 8:30 a.m. ET. The conference call can be accessed live by dialing (833) 727-9520 (domestic) or +1 (830) 213-7697 (international) and referring to conference ID 5365647 The webcast can also be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source The archived webcast will be available on Schrödinger’s website for approximately 90 days following the event.

On August 12, 2021 Vaccitech plc (NASDAQ: VACC) reported its financial results for the second quarter, ended June 30, 2021, and provided an overview of the Company’s recent corporate developments (Press release, Vaccitech, AUG 12, 2021, View Source [SID1234586514]). Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer.

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"The second quarter of 2021 was our first as a public company following our initial public offering that closed in May," said Bill Enright, CEO of Vaccitech. "Capital raised by that transaction as well as from a Series B private round earlier this year is being applied to our chronic infectious disease and oncology programs. We continue to make significant progress across all of our ongoing programs, including the recent announcement of our clinical collaboration with Arbutus."

Second Quarter and Recent Corporate Developments

Closed an initial public offering of American Depository Shares for total gross proceeds of $110.5 million.
Signed a clinical trial collaboration agreement with Arbutus Biopharma Corporation to evaluate an innovative therapeutic combination for the treatment of subjects with chronic hepatitis B virus (HBV) infection (CHB) who are already receiving standard-of-care nucleoside or nucleotide analog (NA) therapy. The Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus’s RNAi therapeutic, AB-729, followed by the Company’s immunotherapy candidate, VTP-300, in NA-suppressed subjects with CHB.
Upcoming Milestones

In the fourth quarter of 2021, the Company expects to announce topline safety and immunogenicity data from the Phase 1 trial of VTP-300, HBV001, in healthy volunteers and patients with chronic HBV infection.
In the same quarter, the Company expects to initiate dosing in the Phase 1/2a trial of VTP-600 in patients with non-small cell lung cancer in combination with a checkpoint inhibitor and chemotherapy.
In the first quarter of 2022, the Company intends to conduct an interim efficacy review, of HBV002, the Phase 1/2a clinical trial of VTP-300 in patients with chronic HBV infection.
In the second quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, the Phase 1/2a clinical trial of VTP-200 in patients with high-risk and persistent HPV infection.
Second Quarter 2021 Financial Highlights:

Cash position: As of June 30, 2021, cash and cash equivalents were $243.6 million, compared to $43.3 million as of December 31, 2021. The increase was primarily due to completion of the Series B financing in the first quarter of 2021, which raised a further $125.3 million, and to the initial public offering in the second quarter, which raised gross proceeds of $110.5 million. The Company believes its cash and cash equivalents are sufficient to fund operations into the first half of 2024.
Research and development (R&D) expenses: Research and development expenses were $4.5 million for the second quarter of 2021 compared to $3.9 million for the comparable period of the prior year. The increase in R&D expenses was primarily due to increased spending on progressing the development of VTP-300 and VTP-850.
General and administrative expenses: General and administrative expenses were $12.4 million for the second quarter of 2021 compared to $1.0 million for the comparable period of the prior year. The increase was primarily attributable to higher personnel costs, reflecting mainly an increase in the Company’s headcount over the prior period and vesting of certain share awards upon IPO, and higher insurance costs associated with operating as a public company.
Net loss: The Company generated a net loss attributable to shareholders of $15.9 million, or $0.64 per share on both basic and fully diluted bases, for the second quarter of 2021 compared to a net loss of $3.6 million, or $0.45 per share on both basic and fully diluted bases, for the same period of the prior year.

On August 12, 2021 MediciNova, Inc., (Nasdaq: MNOV, JASDAQ:4875), a biopharmaceutical company developing small-molecule therapeutics, reported financial results for the second quarter ended June 30, 2021 and provided a business update including results of a safety review from the ongoing Phase 2 trial of MN-166 (ibudilast) in glioblastoma and results from the completed Phase 2 trial of MN-001 (tipelukast) in idiopathic pulmonary fibrosis (IPF) (Press release, MediciNova, AUG 12, 2021, View Source [SID1234586562]).

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"Over the past quarter, we have continued to advance our novel anti-inflammatory candidates across all stages of development. Through our BARDA partnership, we initiated the first animal model study for MN-166 (ibudilast) as a treatment for chlorine gas-induced lung injury and reached agreement on the second animal model study. We received a notice of allowance for a pending patent application which covers MN-166 (ibudilast) for the treatment of ophthalmic disease, showcasing its broad applicability. In addition, our legacy programs remain strong, with positive results from a Phase 2 trial in alcohol use disorder recently published in Nature’s Translational Psychiatry, which serves as further validation for the underlying mechanism of MN-166 (ibudilast) and its potential to drive powerful neurological results. To that end, we continue to enroll patients in our ongoing Phase 3 trial in ALS, and the European Patent Office recently issued a notice of intention to grant for a pending patent application which covers the combination of MN-166 (ibudilast) and riluzole for the treatment of ALS. In collaboration with our ALS investigators Dr. Brooks and Dr. Oskarsson, we recently hosted a webinar for ALS patients and community members highlighting encouraging data reported to-date and the potential of MN-166 (ibudilast) to bridge a long-standing treatment gap without compromising safety," commented Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova. "Turning to our MN-001 (tipelukast) programs, although our Phase 2 trial in IPF did not demonstrate a clear clinical effect on most of the outcome measures, there were fewer worsening IPF events in the MN-001 group and the drug did demonstrate an effect on reducing LOXL2, a biomarker for IPF. We are currently working with collaborators to finalize the protocol for our next planned Phase 2 trial of MN-001 in NASH. Across our programs, we continue to operate a highly cash-efficient business model and believe we are well-positioned for a successful second half."

Clinical Highlights

MN-166 (ibudilast)

New patents cover MN-166 (ibudilast) for treatment of ophthalmic disease (U.S.) and ALS (Europe): In July 2021, the Company announced that it received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the treatment of ophthalmic disease, which, once issued, is expected to expire no earlier than October 2039. The Company also received a Notice of Intention to Grant from the European Patent Office for a pending patent application which covers the combination of MN-166 (ibudilast) and riluzole for the treatment of amyotrophic lateral sclerosis (ALS) which is expected to expire no earlier than November 2035. The Company previously announced results from its Phase 2 ALS trial which showed a higher rate of responders for the MN-166 (ibudilast) plus riluzole group as compared to the riluzole-only group.

Positive results from Phase 2 trial in AUD published in Nature journal: In June 2021, the Company announced that positive results from a Phase 2 trial of MN-166 (ibudilast) in alcohol use disorder (AUD) were published in Nature’s Translational Psychiatry. The study was a randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the effect of 14 days of MN-166 (ibudilast) treatment on mood, heavy drinking, and neural reward signals in 52 individuals with AUD. Key results reported in the publication showed that MN-166 (ibudilast) did not have a significant effect on negative mood but it reduced the odds of heavy drinking across time by 45% (p=0.04) and reduced alcohol craving on non-drinking days (p=0.02).

Initiated preclinical animal study under partnership with BARDA: In June 2021, the Company announced it initiated a sheep study and reached agreement to conduct a mouse study under its partnership with the Biomedical Advanced Research and Development Authority (BARDA) to investigate the efficacy of MN-166 (ibudilast) as a potential medical countermeasure (MCM) against chlorine gas-induced lung damage such as acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). The sheep study will investigate MN-166 (ibudilast) in an ovine model of chlorine-induced acute lung injury, and will evaluate pulmonary function, lung injury and edema formation, cardiopulmonary hemodynamics, and systemic vascular permeability. The murine model will evaluate survival, clinical outcomes, body weights, lung weights, and upper respiratory tract histopathology after exposing mice to chlorine gas and treating them with MN-166 (ibudilast) or control.

Continued enrollment of Phase 3 trial in ALS: The Company continues to enroll patients in the Phase 3 clinical trial, COMBAT-ALS, which is evaluating MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS). The Phase 3 trial is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of MN-166 (ibudilast) in ALS patients after 12 months of treatment followed by a 6-month open-label extension phase. The primary endpoint is change from baseline in ALSFRS-R score at month 12 and survival time. To provide further education on the potential of MN-166 (ibudilast) to treat patients with ALS, the Company hosted an informational webinar in June 2021. The webinar, which included presentations from Dr. Björn Oskarsson, lead clinical investigator of COMBAT-ALS, and Dr. Benjamin Rix Brooks, who led the first clinical study of MN-166 (ibudilast) in patients with ALS, provided an overview of the drug’s mechanism of action, the COMBAT-ALS study design, and findings from the Phase 2 trial in ALS. A replay of the webinar can be viewed here.

Partnering process ongoing for progressive MS program: The Company is engaged in a process with potential partners regarding MN-166 (ibudilast) that could lead to funding for a Phase 3 trial in progressive multiple sclerosis (PMS). Based on encouraging Phase 2b data, especially among secondary progressive MS (SPMS) patients without relapse, and discussions with FDA, the Phase 3 trial plan is to enroll SPMS patients without relapse with 3-month confirmed disability progression as the primary endpoint.

Completed Glioblastoma safety review: The Company has completed a safety review of Part 1 of the Phase 2 trial of MN-166 (ibudilast) in combination with temozolomide, which enrolled 15 subjects with recurrent glioblastoma. This is an open-label clinical trial at Dana-Farber Cancer Institute which includes a dose-escalation portion (Part 1) followed by a fixed-dose treatment period (Part 2). There were no concerning safety signals observed in Part 1 and there were no serious adverse events related to MN-166 (ibudilast). 5 out of 15 subjects completed cycle 6 without disease progression, i.e. 33% of subjects were progression-free at 6 months.

Enrolling subjects in COVID-19 ARDS Phase 2 trial: The Company has completed 75% of planned enrollment in the Phase 2 trial of MN-166 (ibudilast) in COVID-19 at risk for ARDS. This is a randomized, double-blind, placebo-controlled study in hospitalized COVID-19 subjects at risk for developing ARDS and receiving standard of care including anticoagulation. The primary endpoints include the proportion of subjects free from respiratory failure at Day 7, mean change from baseline in clinical status using the NIAID 8-point ordinal scale at Day 7, the percentage of patients with improvement in clinical status at Day 7, and mean change in cytokine levels from baseline to Day 7.
MN-001 (tipelukast)

Phase 2 trial results in IPF: The Phase 2 trial of MN-001 (tipelukast) in idiopathic pulmonary fibrosis (IPF) completed enrollment of 15 subjects including 10 subjects in the MN-001 (tipelukast) group and 5 subjects in the placebo group. This Phase 2 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of MN-001 (tipelukast) in IPF over a 26-week treatment period. Although there were no clinically meaningful trends in favor of MN-001 (tipelukast) for the majority of the clinical outcome measures in this small study, there were no worsening IPF events (acute IPF exacerbation or hospitalization due to respiratory symptoms) in the MN-001 (tipelukast) group compared to one worsening IPF event in the placebo group. MN-001 (tipelukast) demonstrated a substantial reduction in LOXL2, a biomarker for IPF, whereas LOXL2 increased in the placebo group. MN-001 (tipelukast) was safe and well tolerated.

Preparing for second Phase 2 trial in NASH: Following the early completion of its Phase 2 trial evaluating MN-001 (tipelukast) in nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD) due to positive interim data, the Company is now working to finalize a protocol for a larger Phase 2 trial in NASH. In the first Phase 2 trial, MN-001 (tipelukast) demonstrated a statistically significant reduction in the primary endpoint of mean serum triglycerides (p=.02). The Company will provide further updates upon initiation of the next trial.
Second Quarter 2021 Financial Results

Cash Position: As of June 30, 2021, cash and cash equivalents were $77.8 million, as compared to cash and cash equivalents of $60.4 million as of June 30, 2020. This increase was primarily due to approximately $20 million received in a private placement transaction which closed in January 2021. The Company expects current cash and cash equivalents to fund operations at least through the end of 2022.

Research, Development and Patents Expenses: R&D and patents expenses were $2.5 million for the three months ended June 30, 2021, compared to $2.2 million for the three months ended June 30, 2020. The increase of $0.3 million was primarily due to higher clinical trial expenses from the ongoing clinical trial of MN-166 (ibudilast) in ALS.

General and Administrative Expenses: G&A expenses were $1.8 million for the three months ended June 30, 2021, compared to $2.3 million for the three months ended June 30, 2020. The decrease of $0.5 million was primarily due to lower stock compensation expense for performance-based stock options resulting from a decrease in our stock price and decreased consultant fees.

Net Loss: Net loss was $4.3 million for the three months ended June 30, 2021, or ($0.09) per basic and diluted share, as compared to a net loss of $4.5 million for the three months ended June 30, 2020, or ($0.10) per basic and diluted share.

On August 12, 2021 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its second quarter 2021 financial results and provided a corporate update (Press release, Instil Bio, AUG 12, 2021, View Source [SID1234586379]).

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"We confirm our commitment to initiating a Phase 2 trial of ITIL-168 in advanced melanoma in the second half of 2021," said Bronson Crouch, Chief Executive Officer of Instil. "With the installation and ongoing qualification of modular clean room pods at our Tarzana, California facility and our progress toward activating additional manufacturing capabilities in Manchester, U.K., we expect increased clinical manufacturing capacity in late 2021 and early 2022 to support our clinical development plans for ITIL-168 and ITIL-306. Our commitment to innovation in manufacturing continues with the development of a shortened 21-day manufacturing process with robust levels of TIL transduction efficiency for ITIL-306, our first genetically engineered CoStAR-TIL. We expect to pursue further enhancements to both ITIL-168 and ITIL-306 manufacturing processes in the future."

Second Quarter 2021 Highlights and Anticipated Milestones:

Clinical Development:

Presented Clinical Data in Advanced Melanoma at AACR (Free AACR Whitepaper): Instil presented clinical data demonstrating a 67% objective response rate and 19% complete response rate from a compassionate use program of TILs for the treatment of metastatic melanoma as a late-breaking e-Poster at the AACR (Free AACR Whitepaper) virtual meeting in April 2021.

Orphan Drug Designation: On April 27, 2021, ITIL-168 received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of melanoma stages IIB to IV.

Phase 2 Clinical Trial Initiation of ITIL-168: Instil expects to start a Phase 2 clinical trial of ITIL-168 for the treatment of advanced melanoma in the second half of 2021. Topline safety and efficacy data would be expected in 2023, followed by submission of a BLA to the FDA and a Marketing Authorization Application to the European Medicines Agency expected in 2023 and 2024, respectively.

Phase 1 Clinical Trial Initiation of ITIL-306: Instil expects to start a Phase 1 clinical trial of ITIL-306 for the treatment of FOLR1-expressing cancer in the first half of 2022.
Manufacturing and Technical Operations:

Facility Readiness for Clinical Trials: Current manufacturing capacity in the U.K. is sufficient to support capacity needs at the start of the expected upcoming Phase 2 clinical trial of ITIL-168. Further expansion of our U.K. manufacturing capacity is expected later this year. Instil has also installed and begun qualification of its modular clean room pods at its Tarzana, California facility. These pods will support U.S. regional manufacturing and are expected to begin producing clinical batches in the first half of 2022.

ITIL-306 Manufacturing Process: Instil’s focus on continued improvements in manufacturing is highlighted by the development of a 21-day manufacturing process for ITIL-306. This process is capable of achieving high TIL transduction efficiencies that are well in excess of published literature.
Second Quarter 2021 Financial and Operating Results:

As of June 30, 2021, cash and cash equivalents totaled $566.7 million, compared to $241.7 million as of December 31, 2020. The Company expects that its cash and cash equivalents as of June 30, 2021 will enable it to fund its operating plan into 2023.

Research and development expenses were $21.2 million and $35.6 million for the three and six months ended June 30, 2021, compared to $2.2 million and $4.2 million for the three and six months ended June 30, 2020.

General and administrative expenses were $14.2 million and $23.2 million for the three and six months ended June 30, 2021, compared to $2.4 million and $4.3 million for the three and six months ended June 30, 2020.

On August 12, 2021 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its second quarter 2021 financial results and provided a corporate update (Press release, Instil Bio, AUG 12, 2021, View Source [SID1234586425]).

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"We confirm our commitment to initiating a Phase 2 trial of ITIL-168 in advanced melanoma in the second half of 2021," said Bronson Crouch, Chief Executive Officer of Instil. "With the installation and ongoing qualification of modular clean room pods at our Tarzana, California facility and our progress toward activating additional manufacturing capabilities in Manchester, U.K., we expect increased clinical manufacturing capacity in late 2021 and early 2022 to support our clinical development plans for ITIL-168 and ITIL-306. Our commitment to innovation in manufacturing continues with the development of a shortened 21-day manufacturing process with robust levels of TIL transduction efficiency for ITIL-306, our first genetically engineered CoStAR-TIL. We expect to pursue further enhancements to both ITIL-168 and ITIL-306 manufacturing processes in the future."

Second Quarter 2021 Highlights and Anticipated Milestones:

Clinical Development:

Presented Clinical Data in Advanced Melanoma at AACR (Free AACR Whitepaper): Instil presented clinical data demonstrating a 67% objective response rate and 19% complete response rate from a compassionate use program of TILs for the treatment of metastatic melanoma as a late-breaking e-Poster at the AACR (Free AACR Whitepaper) virtual meeting in April 2021.

Orphan Drug Designation: On April 27, 2021, ITIL-168 received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of melanoma stages IIB to IV.

Phase 2 Clinical Trial Initiation of ITIL-168: Instil expects to start a Phase 2 clinical trial of ITIL-168 for the treatment of advanced melanoma in the second half of 2021. Topline safety and efficacy data would be expected in 2023, followed by submission of a BLA to the FDA and a Marketing Authorization Application to the European Medicines Agency expected in 2023 and 2024, respectively.

Phase 1 Clinical Trial Initiation of ITIL-306: Instil expects to start a Phase 1 clinical trial of ITIL-306 for the treatment of FOLR1-expressing cancer in the first half of 2022.
Manufacturing and Technical Operations:

Facility Readiness for Clinical Trials: Current manufacturing capacity in the U.K. is sufficient to support capacity needs at the start of the expected upcoming Phase 2 clinical trial of ITIL-168. Further expansion of our U.K. manufacturing capacity is expected later this year. Instil has also installed and begun qualification of its modular clean room pods at its Tarzana, California facility. These pods will support U.S. regional manufacturing and are expected to begin producing clinical batches in the first half of 2022.

ITIL-306 Manufacturing Process: Instil’s focus on continued improvements in manufacturing is highlighted by the development of a 21-day manufacturing process for ITIL-306. This process is capable of achieving high TIL transduction efficiencies that are well in excess of published literature.
Second Quarter 2021 Financial and Operating Results:

As of June 30, 2021, cash and cash equivalents totaled $566.7 million, compared to $241.7 million as of December 31, 2020. The Company expects that its cash and cash equivalents as of June 30, 2021 will enable it to fund its operating plan into 2023.

Research and development expenses were $21.2 million and $35.6 million for the three and six months ended June 30, 2021, compared to $2.2 million and $4.2 million for the three and six months ended June 30, 2020.

General and administrative expenses were $14.2 million and $23.2 million for the three and six months ended June 30, 2021, compared to $2.4 million and $4.3 million for the three and six months ended June 30, 2020.