On May 16, 2022 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics targeting DNA damage response pathways reported that it has acquired Atrin Pharmaceuticals Inc. ("Atrin") and reported financial results for the three months ended March 31, 2022 (Press release, Aprea, MAY 16, 2022, View Source [SID1234614630]).

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Business Operations Update:

On May 16, 2022 Aprea completed the acquisition of Atrin, a privately held biotechnology company focused on the discovery and development of novel therapeutics targeting proteins in the DNA damage response, or DDR, pathway in oncology through synthetic lethality. The Company believes its cash and cash equivalents as of March 31, 2022 will be sufficient to meet its current projected operating requirements through the second half of 2023.

With the acquisition of the Atrin programs, Aprea intends to shift its primary focus to the ATR inhibitor ATRN-119, which will be studied as both a monotherapy and in combination with standard of care in Phase 1/2a clinical trials in solid tumor malignancies. In parallel with ATRN-119 development, Atrin initiated separate programs for a second-generation ATR inhibitor, ATRN-354, with potentially improved potency and pharmacokinetics, as well as for a potentially highly potent and selective WEE1 inhibitor – ATRN-W1051. These programs are expected to enter IND-enabling studies in 2022 and Aprea anticipates filing Investigational New Drug applications for these programs in 2023. Furthermore, with the acquisition of Atrin, Aprea obtained an active proprietary development platform to drive the identification of new oncology drug targets and biomarkers.

"Aprea has explored a range of strategic alternatives to maximize shareholder value and we believe the acquisition of Atrin represents an opportunity to create substantial value for Aprea shareholders," said Christian Schade, Chairman and Chief Executive Officer of Aprea. "The founders of Atrin are pioneers in the development of novel oncology compounds in the DNA damage pathway. We are excited to work with the Atrin team to begin clinical development of Atrin’s lead ATR program over the coming months, hasten the development of its differentiated WEE1 program, and support a robust platform to build a pipeline of novel inhibitors of the DDR pathway."

"We are excited to join forces with Aprea and expedite the clinical development of our lead programs and drug development platform," said Oren Gilad, Ph.D., the former Chief Executive Officer of Atrin. "Aprea’s knowledge of the p53 pathway in oncology is complimentary to Atrin’s in-house expertise in developing novel targets in the DNA damage response pathway. With supportive resources we look forward to moving our programs into clinical development to better understand the importance of our robust synthetic lethality platform."

Management and Organization

Christian Schade, our current Chairman and Chief Executive Officer will remain with Aprea along with Scott Coiante, our current Senior Vice President and Chief Financial Officer, and Greg Korbel will remain with Aprea, but will transition from his current role as Senior Vice President and Chief Business Officer to Senior Vice President and Chief Operating Officer. Our management team will be expanded with the appointment of Dr. Gilad, the former Chief Executive Officer of Atrin, who will be President of Aprea and Ze’ev Weiss, the former Chief Business Officer of Atrin, who will be the Chief Business Officer of Aprea. After the 2022 annual stockholder meeting of Aprea, Dr. Gilad will assume the role of Chief Executive Officer from Mr. Schade and Mr. Schade will continue as Executive Chairman of the Board of Directors.

In conjunction with the transaction, the Aprea board was expanded to eight members. Immediately following the consummation of the transaction, the Aprea board will consist of, Dr. Gilad, Mike Grissinger, Rif Pamukcu, and Marc Duey, each of whom were members of the Atrin board who will join the Aprea board, and current Aprea Board members Christian Schade, Jack Henneman, Richard Peters and Bernd Seizinger. Christian Schade will remain the Executive Chairman of the Aprea Board for up to six months, and he would remain as Non-Executive Chairman thereafter. Aprea and Atrin have agreed to expand the Aprea board to nine members following Aprea’s 2022 annual stockholder meeting. The Aprea Board plans to fill the remaining vacancy after such meeting.

About the Transactions

The acquisition of Atrin was structured as a stock-for-stock transaction whereby all of Atrin’s outstanding equity interests were exchanged for a combination of shares of Aprea common stock and shares of Series A non-voting convertible preferred stock (the "Series A preferred stock"). Subject to Aprea stockholder approval, each share of Series A preferred stock will, at the option of the holder, convert into 10 shares of common stock, subject to certain beneficial ownership limitations set by each holder. On a pro forma basis and based upon the number of shares of Aprea common stock and preferred stock issued in the acquisition, holders of Aprea equity holders immediately prior to the acquisition will own approximately 41.2% of Aprea on an as-converted basis and former Atrin equity holders will own approximately 58.8% of Aprea on an as-converted basis immediately after these transactions. The acquisition was approved by the Board of Directors of Aprea and the Board of Directors and the requisite equity holders of Atrin. The closing of the transactions was not subject to the approval of Aprea stockholders.

In connection with acquisition of Atrin, each holder of Aprea common stock as of immediately before the closing of the transaction will be entitled to a non-transferrable contingent value right ("CVR"). Holders of the CVR will be entitled to receive certain payments from proceeds received by Aprea, if any, related to the disposition, if any, of its legacy p53 reactivator assets during the 2-year period following the closing of the transaction.

Wedbush PacGrow is serving as exclusive strategic advisor to Aprea, H.C. Wainwright & Co. is serving as exclusive strategic advisor to Atrin, Sidley Austin LLP is serving as legal counsel to Aprea, and DLA Piper LLP (US) is serving as legal counsel to Atrin.

Immediately after the completion of the acquisition, Aprea is expected to have pro forma cash on hand, before transaction-related expenses, of approximately $48 million (unaudited) and cash runway through the second half of 2023.

Additional details will be available in an updated corporate presentation that can be found in the investor section of the Aprea website at Link.

First Quarter Financial Results

Cash and cash equivalents: As of March 31, 2022, the Company had $47.6 million of cash and cash equivalents compared to $53.1 million of cash and cash equivalents as of December 31, 2021. The Company believes its cash and cash equivalents as of March 31, 2022 will be sufficient to meet its current projected operating requirements through the second half of 2023.
Research and Development (R&D) expenses: R&D expenses were $4.1 million for the quarter ended March 31, 2022, compared to $6.8 million for the comparable period in 2021. The decrease in R&D expenses was primarily due to decreases in clinical trial activity and related costs for (i) our pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for the frontline treatment of TP53 mutant MDS, (ii) our Phase 2 post-transplant MDS/AML clinical trial, (iii) our Phase 1 AML trial, (iv) our Phase 1/2 solid tumor trial and our Phase 1 dose-escalation trial of APR-548.
General and Administrative (G&A) expenses: G&A expenses were $4.0 million for the quarter ended March 31, 2022, compared to $3.4 million for the comparable period in 2021. The increase in G&A expenses was primarily due to increases in legal expense and non-cash stock-based compensation expense.
Net loss: Net loss was $7.9 million, or $0.36 per share for the quarter ended March 31, 2022, compared to a net loss of $9.7 million, or $0.46 per share for the quarter ended March 31, 2021. The Company had 21,974,302 shares of common stock outstanding as of March 31, 2022.
Conference Call and Webcast Details

Aprea will host a webcast on May 16, 2022 at 4:30pm EDT to discuss the acquisition. The webcast can be accessed under the "Events Calendar" in the Investors section of the Aprea website at Link

On May 16, 2022 Proteros biostructures GmbH ("Proteros"), an expert in integrated structure-based drug discovery, reported an expansion of its collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) focused on the discovery and development of novel epigenetic drugs (Press release, AstraZeneca, MAY 16, 2022, View Source [SID1234614614]). The new multi-year agreement builds on an ongoing collaboration with AstraZeneca announced in June 2021, to include the development of small molecule inhibitors targeting a second cancer-associated epigenetic protein.

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Under the terms of this new agreement, Proteros will receive research funding and will be eligible for success-based research, development, and commercial milestone payments of up to USD 75 million plus tiered royalties on annual net sales. The collaboration combines Proteros’ expertise in the identification and characterization of inhibitors with novel binding mechanisms for technically challenging drug targets with AstraZeneca’s leadership in the discovery and development of oncology medicines.

"The expansion of our agreement with AstraZeneca with an additional drug discovery program reflects our successful ongoing collaboration to identify selective inhibitors for notoriously challenging disease targets," said Dr. Torsten Neuefeind, CEO of Proteros. "This agreement strengthens our collaboration with a global biopharmaceutical leader and we look forward to joining forces again to discover novel inhibitors with the potential to effectively treat cancer patients in the future."

The Proteros platform will ensure high selectivity to a specific target variant within and across multiple protein families through biochemical, biophysical and cellular assays supported by rapid turnaround in the structural determination of drug-target interactions by X-ray crystallography and cryo-Electron Microscopy technologies.

On May 16, 2022 AbbVie (NYSE: ABBV) and Cugene Inc., a clinical-stage biotechnology company focused on developing next-generation precision immunology and oncology medicines to treat autoimmune disease and cancer, reported an exclusive worldwide license option agreement for CUG252, a potential best-in-class Treg-selective IL-2 mutein, as well as other novel IL-2 muteins, for the potential treatment of autoimmune and inflammatory diseases (Press release, AbbVie, MAY 16, 2022, View Source [SID1234614611]).

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Selective IL-2 muteins have the potential to represent a major advancement in the standard of care for patients with autoimmune and inflammatory diseases. Cugene’s lead candidate, CUG252, is an engineered IL-2 mutein designed to selectively activate and expand immune-suppressive Treg cells while reducing undesired IL-2 activity on other IL-2 receptor expressing cells for the treatment of autoimmune diseases. CUG252 is currently in a Phase 1 study in healthy volunteers.

"AbbVie is committed to developing novel therapies in immunology where unmet needs remain for patients living with complex autoimmune and inflammatory conditions," said Tom Hudson, MD, senior vice president, R&D, chief scientific officer, AbbVie. "Our partnership with Cugene is the latest in our efforts to develop and advance potential next-generation therapies like CUG252."

"We are very pleased to partner with AbbVie, a global leader in the development and commercialization of innovative immunology therapies," said Luke Li, M.D., Chief Executive Officer of Cugene Inc. "AbbVie is an ideal partner for CUG252, with their commitment to R&D, deep therapeutic area expertise, and the global resources needed to maximize CUG252’s therapeutic potential for patients suffering from autoimmune diseases. Today’s agreement highlights Cugene’s unique precision engineering platform that has yielded multiple product candidates, including CUG252. We look forward to collaborating with AbbVie to transform clinical outcomes in autoimmune disease."

Under the terms of the agreement, Cugene will receive an upfront payment of $48.5 million, and will also be eligible to receive development and regulatory milestones and a license option exercise payment if AbbVie exercises the option. In addition, Cugene may also receive commercialization and sales-based milestones and tiered royalties. AbbVie will receive an option to obtain an exclusive license for certain IL-2 muteins, including CUG252. During the option period, Cugene will conduct a Phase 1b study in patients with autoimmune/inflammatory disease. Upon exercise of the option, AbbVie will conduct all future clinical development, manufacturing and commercialization activities for CUG252.

On May 16, 2022 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported financial results for the first quarter ended March 31, 2022, and provided a corporate update on key events since the start of 2022 (Press release, Vaccinex, MAY 16, 2022, View Source [SID1234614593]).

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"I am pleased to report that Vaccinex’s clinical programs for oncology and neurodegenerative disease have made substantial progress this year. In oncology, we were gratified to report promising Phase Ib safety results and to observe two complete responses (CRs) in the first three patients enrolled in the open label, Phase 1b/2 KEYNOTE-B84 trial. The trial is evaluating the use of pepinemab in combination with KEYTRUDA (pembrolizumab) as first-line treatment for patients with advanced recurrent or metastatic head and neck cancer. We are hopeful that, with continued positive results, this combination may represent a novel option for patients with head and neck cancer, including those whose tumors express low levels of the PD-L1 biomarker and who have limited treatment choices," said Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex.

Dr. Zauderer continued, "In neurodegenerative disease, enrollment in the Phase 1/2a SIGNAL-AD trial in mild Alzheimer’s Disease continues to progress, and we plan to soon publish the results of the SIGNAL Huntington’s Disease study that we believe showed promise of slowing or preventing cognitive decline."

Dr. Zauderer continued, "Looking ahead, we expect to complete enrollment in the KEYNOTE-B84 and SIGNAL-AD trials in 2022. Data read outs are planned from the KEYNOTE-B84 during H2:2022 and topline data from the SIGNAL-AD trial are expected in H2:2023. These data will help to guide the regulatory and product development path for pepinemab. We look forward to continue to update the clinical community and investors on our progress."

Pepinemab Clinical Updates and Upcoming Milestones:

Oncology: Head and Neck Cancer

Enrollment is underway in the Phase 1b/2 clinical trial evaluating pepinemab in combination with Merck’s anti-PD-1 immune checkpoint therapy KEYTRUDA (pembrolizumab) in recurrent or metastatic head and neck cancer.

Multiple prior studies1-3 suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed in head and neck cancer, there is strong rationale for development in this indication.

In January 2022, Vaccinex reported two complete responses in the first three patients enrolled. Vaccinex reported further details of these patient responses (Abstract CT-11) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2022) on Monday, April 11, 2022.

The KEYNOTE-B84 study is planned to enroll up to 65 subjects across 18 U.S. trial sites and will assess whether combination immunotherapy with pepinemab and pembrolizumab can improve responses in this population. Key endpoints of the study will include objective response, progression free survival and overall survival.

Next Data and Trial Completion: Data read-outs are expected in H2:2022. Enrollment is expected to be completed and topline data presented in H1:2023.

ASCO Abstract Publication: An abstract of the Phase 1b segment of the study of pepinemab, an inhibitor of semaphorin 4D, in combination with pembrolizumab as first-line treatment of recurrent or metastatic head and neck cancer (KEYNOTE-B84) will be published with the ASCO (Free ASCO Whitepaper) proceedings on May 26, 2022.

Vaccinex has exclusive global commercial and development rights to pepinemab and is sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp. Additional information about the study is available: here.

Other Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in "Window of Opportunity" biomarker studies of head and neck cancer and melanoma.

Neurodegenerative Disease:

Alzheimer’s Disease. Enrollment continues in the Phase 1/2a SIGNAL-AD trial of pepinemab in early Alzheimer’s disease which is being funded in part by the Alzheimer’s Drug Discovery Foundation and by a grant from the Alzheimer’s Association under its 2020 Part the Cloud Program. Additional information about this study is available here.

The randomized, double-blind, placebo-controlled, multi-center safety and biomarker study of pepinemab in early AD is planned to enroll 40 subjects across 15 U.S. trial sites.

Next Data and Trial Completion: Enrollment is expected to be completed by year-end 2022 and topline data are expected in H2:2023.

Huntington’s disease. The Phase 2 double-blind, placebo-controlled SIGNAL trial of pepinemab in patients with early manifest Huntington’s disease (HD) has been completed and we believe the program is Phase-3 ready.

While the Phase 2 study did not meet the prespecified primary endpoints, pre-specified exploratory and post-hoc analyses supports the potential cognitive benefit of treatment with pepinemab in HD patients, particularly those with mild cognitive deficits:

Highly significant improvement (p=0.007) in the (Huntington’s Disease Cognitive Assessment Battery (HD-CAB) Composite score
Significant benefit in reducing apathy severity (p=0.017, 1-sided)
Reduced atrophy (p=0.017) in caudate region of striatum
A striking increase in brain metabolic activity as measured by FDG-PET in most brain regions
Next Steps: The company intends to publish the results of the SIGNAL study in mid-2022. In addition, Vaccinex is in ongoing discussions with potential partners on plans to advance pepinemab into a Phase 3 HD trial.

ActivMAb Updates:

As previously announced, we have entered into several collaborations with pharmaceutical and biotechnology companies employing the unique capabilities of our ActivMAb antibody discovery platform to address difficult to drug G-protein Coupled Receptors (GPCRs) and ion channels known to be strongly associated with diseases.

In April, 2022, Vaccinex announced presentation of an abstract at the 18th Annual PEGS Boston Conference & Expo, May 2-3, 2022, related to ActivMAb’s successful expression and selection of antibodies against multi-pass receptors and its potential application as a tool for drug discovery and development projects.

Corporate Update:

In January 2022, the Company sold 8,747,744 shares of the Company’s common stock at a purchase price of $1.11 per share raising aggregate gross proceeds of approximately $9.7 million. In addition, during the first quarter, the company received $3.5 million of net proceeds from the Open Market Sale Agreement by selling 3,115,197 shares of the Company’s common stock at a weighted average price of $1.16 per share.

Financial Results for the Three Months Ended March 31, 2022:
Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on March 31, 2022 were $16.8 million, as compared to $8.6 million as of December 31, 2021.

Research and Development Expenses. Research and development expenses for the quarter ended March 31, 2022 were $3.0 million as compared to $5.5 million for the comparable period in 2021.

Research and Development expenses are lower in 2022 compared to 2021 primarily attributed to reduced clinical trial costs as a result of the completion of the CLASSICAL-Lung and SIGNAL studies, partially offset by setup expenses for the KEYNOTE B84 and SIGNAL-AD studies as well as a large production run of pepinemab completed in Q1:21.

General and Administrative Expenses. General and administrative expenses for the quarter ended March 31, 2022 were $1.6 million as compared to $1.6 million for the comparable period in 2021.

Essentially flat level of general and administrative expenses reflects careful cost control measures in light of inflationary pressures.

Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the quarter ended March 31, 2022 was $4.6 million and $0.12, respectively, compared to $6.6 million and $0.26 for the comparable period in 2021.

Full financial tables are included below. For further details on Vaccinex’s financials, refer to its Form 10-Q filed May 16, 2022, with the Securities and Exchange Commission

REFERENCES:

Shafique MR, Fisher TL, Evans EE, Leonard JEE, Pastore DRE, Mallow CL, Smith E, Mishra V, Schroder A, Chin KA, Beck JT, Baumgart MA, Govindan R, Gabrial NY, Spira AI, Seetharamu N, Lou Y, Mansfield AS, Sanborn RE, Goldman JW, Zauderer M. A Phase Ib/2 Study of Pepinemab in Combination with Avelumab in Advanced Non–Small Cell Lung Cancer. Clin Cancer Res 2021, doi: 10.1158/1078-0432.CCR-20-4792
Clavijo PE, Friedman J, Robbins Y, Moore EC, Smith ES, Zauderer M, Evans EE, Allen CT. Semaphorin4D inhibition improves response to immune checkpoint blockade via attenuation of MDSC recruitment and function. Cancer Immunol Res. 2019 Feb;7(2):282-291
Evans EE, Jonason AS Jr, Bussler H, Torno S, Veeraraghavan J, Reilly C, Doherty MA, Seils J, Winter LA, Mallow C, Kirk R, Howell A, Giralico S, Scrivens M, Klimatcheva K, Fisher TL, Bowers WJ, Paris M, Smith ES, Zauderer M. Antibody blockade of semaphorin 4D promotes immune infiltration into tumor and enhances response to other immunomodulatory therapies. Cancer Immunol Res. 2015 Jun;3(6): 689-701. View Source
About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody that inhibits SEMA4D, which regulates the actin cytoskeleton of cells that plays an important role in tumor immunity and cell interactions in the brain. Preclinical and clinical data show that pepinemab promotes infiltration/activation of dendritic cells and CD8+ T-cells and reverses immunosuppression within the tumor microenvironment. Pepinemab is being evaluated in several studies in oncology and neurodegenerative disease.

About ActivMAb
Vaccinex has developed a proprietary mammalian cell-based antibody discovery platform with unique multi-pass membrane target capabilities. The ActivMAb technology now has four main applications: complex membrane antigen presentation, antibody or antigen discovery, and protein optimization. Vaccinex has entered into an antibody license with Surface Oncology (Cambridge, MA) and into Material Transfer Agreements for drug discovery or process development with major pharmas utilizing this technology. Vaccinex seeks partnering opportunities for co-development or licensing of existing antibodies in our pipeline, discovery of new antibodies and/or applications for this powerful technology.

On May 16, 2022 Instil Bio, Inc. ("Instil" or the "Company") (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 first quarter 2022 financial results and provided a corporate update (Press release, Instil Bio, MAY 16, 2022, View Source [SID1234614592]).

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First 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 by 2022 for the registrational cohort and expects top-line safety and efficacy data in 2023, which could potentially support a biologics license application (BLA) submission and a European Medicines Agency marketing authorization application (MAA) filing.

On track with DELTA-2, a Phase 1 trial of ITIL-168 with pembrolizumab in additional cancers with unmet need: Study is expected to initiate in non-small cell lung cancer (NSCLC), cervical cancer and squamous cell carcinoma of head and neck (HNSCC) in the second quarter of 2022. The study will evaluate ITIL-168 with pembrolizumab in patients who have failed standard therapies.

Readiness to Initiate Phase 1 Study of ITIL-306, the first product candidate from the CoStAR platform, in the second quarter: Instil is on track to initiate a Phase 1 study of ITIL-306, its first genetically engineered TIL using the CoStAR platform in the second quarter of 2022.

Presenting Preclinical Data on the CoStAR Platform at ASCO (Free ASCO Whitepaper) 2022: Instil plans to present in vivo and supporting in vitro data at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. Abstract details are below:

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.
Presenting Product Characterization Data From Unmodified TILs in Cutaneous Melanoma: Instil plans to present advanced correlative analyses on TIL products administered to patients in a compassionate use program at the 25th Annual ASGCT (Free ASGCT Whitepaper) meeting. Abstract details are below:

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. ASGCT (Free ASGCT Whitepaper) link.
Cash Runway Into 2024 through key clinical data expected in 2023: Instil expects its current cash reserves to fund Company operations into 2024.
First Quarter 2022 Financial and Operating Results:

As of March 31, 2022, we had $61.5 million in cash and cash equivalents and $318.0 million in marketable securities, compared to $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 March 31, 2022, will enable it to fund its operating plan into 2024.

Research and development expenses were $39.2 million for the three months ended March 31, 2022, compared to $14.4 million for the three months ended March 31, 2021.

General and administrative expenses were $15.1 million for the three months ended March 31, 2022, compared to $9.0 million for the three months ended March 31, 2021.