On August 12, 2022 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between chronic, low-grade inflammation and age-related diseases, reported financial results and recent business highlights for its second quarter ended June 30, 2022 (Press release, HCW Biologics, AUG 12, 2022, View Source [SID1234618260]).

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"We have achieved several milestones in the first half of 2022, and some important pieces of our strategic plan have fallen into place. First, we are now a clinical-stage company, with the entry of our lead product candidate, HCW9218, into the clinic in a solid tumor cancer trial. Our pancreatic study is not far behind, and we expect to initiate this clinical trial in the third quarter. Next, we have produced promising data in preclinical studies for our lead product candidate, HCW9302, in the treatment of proinflammatory diseases driven by activated inflammasomes. We used this data as a basis for a pivotal scientific paper for HCW9302 that we expect to be published in a high-impact, peer-reviewed journal by the end of the year," stated Hing C. Wong, Ph.D., Founder and CEO of the Company.

Dr. Wong continued, "By working with preeminent National Cancer Institute designated Comprehensive Cancer Centers, it appears that we have mitigated some of the risk for maintaining our expected rate of patient enrollment. At our current pace, we expect to be in a position to provide an early human-experience data readout from the clinical trials for HCW9218 by the end of 2022. While it is very early, we are encouraged by how patients are responding to HCW9218."

Dr. Wong reported, "HCW Biologics has advanced one of our key strategic initiatives – establishing our own domestic manufacturing capability. We have committed to purchase a 36,000 square foot building in Miramar, Florida that will be the new headquarters for our offices, research labs, and manufacturing facility. To buildout our new facilities, our team will leverage their past experience in constructing similar facilities. We expect to complete the project by the end of 2023, and to move into our new facility shortly thereafter. Currently, contract manufacturers are experiencing backlogs of up to two years. With our own manufacturing facility, we believe we will have better control over our supply chain as we advance to later-stage clinical trials requiring additional clinical materials, as well as fulfilling our obligations to our licensee, Wugen."

Business Highlights:

On May 19, 2022, the Masonic Cancer Center, University of Minnesota, announced that they opened a new Phase 1 solid tumor cancer clinical trial and treated their first patient with HCW9218, an injectable, bifunctional immunotherapeutic, developed by HCW Biologics Inc. This Phase 1, first-in-human clinical trial is enrolling patients that have advanced solid tumors with progressive disease after prior chemotherapies.
On August 2, 2022, HCW Biologics was granted U.S. Patent No. 11,401,324 which contains claims for immunotherapeutic compounds comprised of a single-chain chimeric polypeptide with two target-binding domains on a scaffold made of an extracellular domain of human tissue factor. This patent provides protection for the underlying intellectual property on which the Company has based its lead product candidate, HCW9302. The issuance of the Company’s first patent with such broad claims marks an important step in the evolution of its patent portfolio.
On August 10, 2022, HCW Biologics committed to purchase a building located in Miramar, Florida for approximately $10.0 million, as the Company’s new headquarters. The Company received a commitment for a five-year term facility to finance the purchase, expansion, and improvement of the new property. An initial takedown equal to 65% of the purchase price will be funded on the closing date which is expected to be on August 15, 2022. The term facility may be increased to provide additional funding for expansion and improvements of the property; however, future borrowings will be subject to full credit approval and due diligence by the lender.
Second Quarter 2022 Financial Results:

Cash and cash equivalents: On June 30, 2022, the Company’s cash balance was $42.1 million, consisting of $15.4 million in cash and cash equivalents, $17.0 million in short-term investments, and $9.7 million in long-term investments. Investments are all U.S. Treasury bills or notes. The Company estimates that the current cash balance, along with a commitment for a term facility for the purchase of the Company’s new headquarters, is sufficient to fund operations and capital expenditures through the end of 2023.
Revenues: Revenues were $454,000 for the three-month period ended June 30, 2022, and there were no revenues in the three-month period ended June 30, 2021. Revenues were $3.6 million for the six-month period ended June 30, 2022, and there were no revenues in the six-month period ended June 30, 2021. Revenues were derived exclusively from the sale of clinical development material to our licensee, Wugen.
Research and development (R&D) expenses: R&D expenses were $1.7 million for the three-month period ended June 30, 2021, as compared to $2.0 million for the three-month period ended June 30, 2022, an 18% increase, due primarily to an increase in preclinical expenses. R&D expenses were $4.0 million for the six-month period ended June 30, 2021, as compared to $3.8 million for the six-month period ended June 30, 2022, a 5% decrease, due primarily to a decrease in manufacturing and materials expenses partially offset by an increase in preclinical expenses.
General and administrative (G&A) expenses: G&A expenses were $1.1 million for the three-month period ended June 30, 2021, as compared to $1.7 million for the three-month period ended June 30, 2022, a 55% increase. G&A expenses were $2.2 million for the six-month period ended June 30, 2021, as compared to $3.6 million for the six-month period ended June 30, 2022, a 64% increase. These increases reflect higher salaries, benefits and related expenses as a result of stock-based compensation expense associated with an equity award to the Company’s CEO upon completion of the Company’s IPO, an increase for Board compensation under our non-employee director compensation program, and an increase in insurance costs and other expenses related to operating as a public company.
Net loss: Net loss was $2.8 million for the three-month period ended June 30, 2021, compared to $3.5 million for the three-month period ended June 30, 2022. Net loss was $5.6 million for in each of the six-month periods ended June 30, 2021 and June 30, 2022. Net loss for the six-month period ended June 30, 2021 included the impact of forgiveness of the Company’s PPP loan. Net loss for the six-month period ended June 30, 2022 included the impact of unrealized loss on investments resulting from changes in interest rates.

On August 12, 2022 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended June 30, 2022 (Press release, Soligenix, AUG 12, 2022, View Source [SID1234618259]).

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"We have accomplished a number of important milestones thus far in 2022, with more significant milestones anticipated before year-end," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Under our Specialized Biotherapeutics business segment, the results of our successful Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study evaluating HyBryte (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL) were published in the prestigious JAMA Dermatology. We received agreement from the U.S. Food & Drug Administration (FDA) on an initial pediatric study plan for HyBryte which stipulates our intention to request a full waiver of pediatric studies upon submission of the HyBryte new drug application (NDA) in the fourth quarter of this year. Additionally, we are expanding into new disease indications with synthetic hypericin (SGX302) having received FDA investigational new drug (IND) clearance for a Phase 2a clinical trial in mild-to-moderate psoriasis, also expected to begin in the fourth quarter of this year.

Our Public Health Solutions business segment, supported by funding from the National Institute of Allergy and Infectious Diseases, continues to achieve key objectives that have the potential to play an important role in the Biden-Harris Administration’s initiatives for pandemic preparedness. Recently, we demonstrated 100% protection of non-human primates against both lethal Sudan ebolavirus and Marburg marburgvirus challenge using a bivalent, thermostabilized vaccine formulated in a single vial. This same heat stable subunit vaccine platform technology has been applied to the development of our COVID-19 vaccine, CiVax, which has demonstrated rapid and broadly functional vaccine and booster responses, including against delta and omicron variants. We also entered into a strategic partnership with SERB Pharmaceuticals to supply our novel ricin antigen in support of their early stage ricin therapeutic development program."

Dr. Schaber continued, "With approximately $20.2 million in cash, not including our non-dilutive government funding, we anticipate having the capital required to achieve our near-term milestones, including NDA filing and initiation of the Phase 2a psoriasis study, while we continue to evaluate various strategic options, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments
On July 27, 2022, the Company announced it had received agreement from the FDA on an initial pediatric study plan for HyBryte for the treatment of CTCL. To view this press release, please click here.

On July 25, 2022, the Company announced it had signed a worldwide exclusive license to supply its ricin antigen to SERB Pharmaceuticals, for development of a novel therapeutic treatment against ricin toxin poisoning. To view this press release, please click here.

On July 20, 2022, the Company announced that the results of its successful Phase 3 FLASH study evaluating HyBryte for the treatment of CTCL has been published in the Journal of the American Medical Association (JAMA) Dermatology. To view this press release, please click here.

On June 28, 2022, the Company announced that the FDA had cleared the IND application for its Phase 2a clinical trial titled, "Phase 2 Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis." To view this press release, please click here.

On June 23, 2022, the Company announced it had achieved 100% protection of non-human primates against lethal Marburg marburgvirus challenge using a bivalent, thermostabilized vaccine formulated in a single vial, reconstituted only with sterile water immediately prior to use. To view this press release, please click here.

On June 1, 2022, the Company announced a publication describing key binding characteristics of its Innate Defense Regulator, dusquetide, to the p62 protein. To view this press release, please click here.

On May 23, 2022, the Company announced the United States Patent and Trademark Office had issued a Notice of Allowance for the patent application titled "Compositions and Methods of Manufacturing Trivalent Filovirus Vaccines." To view this press release, please click here.
Financial Results – Year Ended June 30, 2022
Soligenix’s revenues for the quarter ended June 30, 2022 were $0.4 million as compared to $0.2 million for the quarter ended June 30, 2021. Revenues primarily included licensing revenue from the Company’s strategic partnership with SERB Pharmaceuticals and payments on government contracts and grants. The Company has received government funding to support the development of: RiVax, its ricin toxin vaccine candidate; SGX943, for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, its thermostabilization platform technology; and CiVax, its vaccine candidate for the prevention of COVID-19.

Soligenix’s basic net loss was $2.4 million, or ($0.06) per share, for the quarter ended June 30, 2022, as compared to $1.9 million, or ($0.05) per share, for the three months ended June 30, 2021. The increase in net loss was primarily attributed to an increase in legal and consulting services associated with the arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries as well as an increase in research and development expenses associated with preparation of the upcoming HyBryte NDA filing.

Research and development expenses were $2.0 million as compared to $1.9 million for the quarter ended June 30, 2022 and 2021, respectively. The increase in research and development spending for the quarter ended June 30, 2022 was primarily attributable to the increased expenses associated with preparation of the upcoming HyBryte NDA filing.

General and administrative expenses were $1.4 million and $1.1 million for the quarter ended June 30, 2022 and 2021, respectively. This increase in general and administrative expenses is primarily attributable to an increase in legal and consulting services associated with the arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries.

As of June 30, 2022, the Company’s cash position was approximately $20.2 million.

On August 12, 2022 Leap Therapeutics, Inc. (NASDAQ: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the second quarter ended June 30, 2022 (Press release, Leap Therapeutics, AUG 12, 2022, View Source [SID1234618258]).

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Leap Highlights:

Initiation of Part C of the ongoing DisTinGuish study to evaluate DKN-01, Leap’s anti-Dickkopf 1 (DKK1) antibody, in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, and chemotherapy compared to a tislelizumab and chemotherapy control arm, in patients with gastric or gastroesophageal junction cancer (G/GEJ)

Initiation of a new company-sponsored trial of DKN-01 in combination with standard of care bevacizumab and chemotherapy in second-line patients with colorectal cancer (CRC)

Supporting an investigator-initiated trial of DKN-01 plus pembrolizumab in patients with endometrial cancer to be conducted at The University of Texas M.D. Anderson Cancer Center and at the University of Alabama at Birmingham

Presented initial clinical data from an investigator-sponsored Phase 1b/2a dose escalation and dose expansion study of DKN-01 as a monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer (mCRPC) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Cash and cash equivalents totaled $90.9 million at June 30, 2022, expected to provide financial runway to mid-2024
"The Company has made important steps during the second quarter to expand the development of DKN-01 with the initiation of a randomized controlled clinical trial in combination with BeiGene’s tislelizumab and chemotherapy in first-line G/GEJ cancer patients. The results to date from Part A and B of our DisTinGuish study have been compelling, and we look forward to further data readouts in the second half of the year," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We are also excited to initiate a company-sponsored study in second-line colorectal cancer patients and to support an investigator-initiated study with Merck’s anti-PD-1 antibody pembrolizumab in endometrial cancer patients, as part of a broad strategy for the global development of DKN-01."

DKN-01 Development Update

DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the DKK1 protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways, which play an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells.

Leap and BeiGene Announced Initiation of Part C of the Ongoing DisTinGuish Study to Evaluate DKN-01, in Combination with Tislelizumab and Chemotherapy Compared to a Tislelizumab and Chemotherapy Control Arm, in Patients with G/GEJ. The DisTinGuish study (NCT04363801) is a Phase 2 study of DKN-01 in combination with tislelizumab and standard of care (SOC) chemotherapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. Part C of the DisTinGuish study will enroll approximately 160 first-line, HER2-negative patients who have had no prior therapy for unresectable locally advanced or metastatic G/GEJ adenocarcinoma. Patients will be randomized 1:1 to study DKN-01 in combination with tislelizumab and SOC chemotherapy, compared to tislelizumab and SOC chemotherapy. The primary objective of Part C is progression-free survival (PFS) in patients whose tumors express high levels of DKK1 (DKK1-high). Secondary objectives of Part C include PFS in all patients regardless of DKK1 expression, as well as overall survival (OS) and objective response rate (ORR) as measured by RECIST v1.1 in DKK1-high and all patients.

Leap Announced Initiation of the DeFiance Study of DKN-01 in Combination with SOC Bevacizumab and Chemotherapy in Second-line Patients with CRC. The DeFianCe study (NCT05480306) is a Phase 2 study of DKN-01 in combination with bevacizumab and SOC chemotherapy in patients with advanced CRC who have received one prior systemic therapy. The study is designed with an initial 20 patient cohort and to then expand into a 130 patient randomized controlled trial against bevacizumab and SOC chemotherapy. The primary objective is PFS. Secondary objectives include ORR, duration of response (DOR), and OS.

Leap Announced the Support of an Investigator-initiated Trial of DKN-01 Plus Pembrolizumab in Patients with Endometrial Cancer to be Conducted at The University of Texas M.D. Anderson Cancer Center and at the University of Alabama at Birmingham. The investigator-initiated trial of DKN-01 in combination with pembrolizumab is an open-label, Bayesian design, Phase 2 trial and will initially enroll 15 patients each into DKK1-high and DKK1-low cohorts. If the efficacy criteria is met in either or both of the 15 patient cohort(s), then the cohort(s) will be expanded by an additional 15 patients. The primary objective of the study is ORR. Secondary objectives include clinical benefit rate (CBR), PFS, OS, and DOR.

Leap Presented Initial Clinical Data from the Investigator-Sponsored Study of DKN-01 Plus Docetaxel in Patients with Prostate Cancer at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. In May 2022, the Company presented initial clinical data from the investigator-sponsored Phase 1b/2a dose escalation and dose expansion study testing DKN-01 as monotherapy or in combination with docetaxel in mCRPC. Highlights from the data include:
No DLTs were observed at DKN-01 300mg or 600mg dose levels as monotherapy or in combination with docetaxel, and no treatment-related adverse events occurred in either cohort
No partial responses (PR) were seen in the monotherapy cohort with best overall response of stable disease in 2 out of 5 evaluable patients
In the combination cohort, all 6 patients had a greater than 50% reduction in PSA levels (PSA50), and the 5 patients with measurable disease each had a PR by RECIST (3 confirmed, 2 unconfirmed)
Confirmed partial responses in the combination cohort were observed in both DKK1 high and low expressing tumors, including in 2 out of 3 patients with aggressive variant prostate cancer
Selected Second Quarter 2022 Financial Results

Net Loss was $17.0 million for the second quarter 2022, compared to $9.5 million for the same period in 2021. The increase was primarily due to an increase in manufacturing costs related to clinical trial material, an increase in clinical trial costs due to patient enrollment and the duration of patients on study in the DisTinGuish trial and an increase in the number of research and development employees to support the development of DKN-01.

Research and development expenses were $14.0 million for the three months ended June 30, 2022, compared to $7.2 million for the three months ended June 30, 2021. The increase in research and development expenses was due to an increase of $5.2 million in manufacturing costs related to clinical trial material and manufacturing campaigns, an increase of $1.2 million in clinical trial costs due to patient enrollment and duration of patients on study, an increase of $0.4 million in payroll and other related expenses due to an increase in headcount of our research and development full time employees, and an increase of $0.2 million in stock based compensation expense due to new stock options and restricted stock units granted to research and development full time employees, offset by a decrease of $0.2 million in consulting fees.

General and administrative expenses were $2.9 million for the three months ended June 30, 2022, compared to $2.8 million for the three months ended June 30, 2021. The increase in general and administrative expenses was due to an increase of $0.1 million in stock based compensation expense due to new stock options and restricted stock units granted to general and administrative full time employees.

Cash and cash equivalents totaled $90.9 million at June 30, 2022. Additionally, short-term research and development incentive receivable totaled $1.1 million.

On August 12, 2022 Applied Therapeutics, Inc. (NASDAQ: APLT) (the "Company"), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported financial results for the second quarter ended June 30, 2022 (Press release, Applied Therapeutics, AUG 12, 2022, View Source [SID1234618257]).

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"In the second quarter we continued our progress across our three registrational Phase 3 trials in Galactosemia, SORD Deficiency and Diabetic Cardiomyopathy," said Shoshana Shendelman, PhD, Founder, CEO and Chair of the Board of Applied Therapeutics. "As we look towards the second half of this year, we are excited about the milestones ahead. We expect to complete our 12 month analysis in the pediatric Galactosemia study in September, and plan to announce full enrollment in both SORD Deficiency and DbCM soon. We expect these catalysts to bring us closer to our goal of delivering meaningful new treatments to patients in need."

Recent Highlights

Completed underwritten public offering of equity. In June 2022, the Company closed a public offering of its common stock and warrants with gross proceeds of $30 million, before deducting the underwriting discounts and commissions and offering expenses payable by the Company.

Granted Orphan Medicinal Product Designation by the EMA for AT-007 for Galactosemia. In June 2022, the European Medicines Agency (EMA) designated orphan medicinal product for AT-007 (gavorestat) for the treatment of Galactosemia. Applied Therapeutics plans to meet with the EMA to discuss a potential Marketing Authorization Application (MAA) submission in Europe for conditional approval based on available biomarker data or for full approval based on expected clinical outcomes data.
Financial Results

Cash and cash equivalents and short-term investments totaled $67.7 million as of June 30, 2022, compared with $80.8 million at December 31, 2021.

Research and development expenses for the three months ended June 30, 2022 were $15.4 million, compared to $14.8 million for the three months ended June 30, 2021. The $0.6 million increase was due to an increase in clinical and pre-clinical expense of $2.2 million, primarily related to the progression of the SORD pivotal trial, progression of the AT-007 ACTION-Galactosemia long-term extension adult study, and progression of the AT-007 ACTION-Galactosemia Kids pediatric registrational study; an increase in personnel expenses of $0.3 million due to the increase in headcount in support of our clinical program pipeline; an increase in stock-based compensation of $0.3 million due to new stock option and restricted stock grants; offset by a decrease in drug manufacturing and formulation costs of $2.2 million and a decrease in regulatory and other expenses of $19,000.

General and administrative expenses were $6.1 million for the three months ended June 30, 2022, compared to $11.1 million for the three months ended June 30, 2021. The decrease of $4.9 million was due to a decrease in legal and professional fees of $0.5 million due to lower external legal fees; a decrease in commercial expenses of $2.5 million related to a decrease in spend for commercial operations; a decrease in personnel expenses of $0.4 million related to a decrease in headcount; a decrease in stock-based compensation of $0.7 million relating to options being forfeited during the current period as well as decrease in headcount; a decrease in insurance expenses of $0.1 million related to decreased insurance costs; and a decrease in other expenses of $0.7 million relating to decreased costs of other office expenses.

Net loss for the second quarter of 2022 was $25.9 million, or $0.96 per basic and diluted common share, compared to a net loss of $25.8 million, or $0.99 per basic and diluted common share, for the second quarter 2021. The net loss for the second quarter of 2022 included $4.4 million in a non-cash expense due to a mark-to-market adjustment on warrant liabilities issued as part of the June 2022 public offering.

On August 12, 2022 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 2022 financial results and provided a corporate update (Press release, Instil Bio, AUG 12, 2022, View Source [SID1234618256]).

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Second Quarter 2022 Highlights and Anticipated Milestones:

Enrollment ongoing in DELTA-1, a Phase 2 trial of ITIL-168 in advanced melanoma with registrational intent: Instil is targeting completion of enrollment in 1H 2023 for the registrational cohort and expects top-line safety and efficacy data in early 2024, which could potentially support a biologics license application (BLA) submission and a European Medicines Agency marketing authorization application (MAA) filing.
Cash runway expected to extend from 2024 into 2025 with anticipated sale-leaseback of Tarzana, CA manufacturing site: Instil expects its current cash reserves along with expected proceeds from a potential sale-leaseback of its Tarzana, CA, manufacturing site to fund Company operations into 2025.
Enrolling Phase 1 study of ITIL-306, Instil’s first CoStAR-TIL: Instil has initiated a Phase 1 study of ITIL-306, its first CoStAR-TIL product candidate. CoStAR is a genetic modification designed to enhance the activity of TILs within the tumor microenvironment. The Phase 1 study of ITIL-306 features a TIL treatment regimen free of IL-2 and will enroll patients with non-small cell lung cancer (NSCLC), ovarian cancer (OC), and renal cell carcinoma (RCC).
Initiated DELTA-2, a Phase 1 study of ITIL-168 in combination with pembrolizumab: Instil has initiated DELTA-2, a Phase 1 study of ITIL-168 in combination with pembrolizumab, which will enroll patients with NSCLC, cervical cancer, and squamous cell carcinoma of the head and neck.
Tarzana, CA manufacturing facility operational: Instil was cleared by the US Food and Drug Administration (FDA) for manufacturing of both ITIL-168 and ITIL-306 at its Tarzana, CA manufacturing facility, which will support DELTA-1, DELTA-2, and ITIL-306 clinical trials.
Presented Preclinical Data on CoStAR T cells at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting: Instil presented findings from preclinical studies evaluating anti-FOLR1 CoStAR T cells in vitro as well as a murine solid tumor model in vivo demonstrating enhanced T cell function and tumor control by CoStAR-modified T cells.

Title: Antitumor activity of T cells expressing a novel anti-folate receptor alpha (FOLR1) costimulatory antigen receptor (CoStAR) in a human xenograft murine solid tumor model and implications for in-human studies.
Presented Product Characterization Data from Unmodified TILs in Cutaneous Melanoma at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper): Instil presented advanced correlative analyses from a cohort of melanoma patients enrolled in a compassionate use program that were treated with TIL products made by Instil at the 25th Annual ASGCT (Free ASGCT Whitepaper) meeting.

Title: Characterization of the Transcriptomic and TCR Clonal Heterogeneity of TIL Therapy Infusion Products by Single-Cell Sequencing and Correlative Analyses With Clinical Efficacy in Patients with Advanced Cutaneous Melanoma.
Second Quarter 2022 Financial and Operating Results:

As of June 30, 2022, we had $354.6 million in total cash and cash equivalents and marketable securities, comprised of $42.5 million in cash and cash equivalents and $312.1 million in marketable securities compared to $454.1 million in total cash and cash equivalents and marketable securities, comprised of $37.6 million in cash and cash equivalents and $416.5 million in marketable securities as of December 31, 2021. The Company expects that its cash, cash equivalents and marketable securities as of June 30, 2022 will enable it to fund its operating plan into 2025 upon completion of the anticipated sale-leaseback of its Tarzana, CA manufacturing site.

Research and development expenses were $41.5 million and $80.7 million for the three and six months ended June 30, 2022, respectively, compared to $21.2 million and $35.6 million for the three and six months ended June 30, 2021, respectively.

General and administrative expenses were $17.2 million and $32.3 million for the three and six months ended June 30, 2022, respectively, compared to $14.2 million and $23.2 million for the three and six months ended June 30, 2021, respectively.