Core Viewpoint - Instil Bio has experienced a significant stock price increase due to the in-licensing of IMM2510, a bispecific antibody, which is seen as a potential competitor to leading cancer therapies like Keytruda [2][3]. Company Developments - Instil Bio's shares surged approximately 235% from September 6 to September 12, raising its year-to-date gain to 510% [2]. - The company in-licensed IMM2510 in August, which targets PD-L1 and VEGF, shifting its focus from cell-based cancer therapies [3]. - Instil Bio's collaboration with ImmuneOnco Biopharmaceuticals is noteworthy, as a similar bispecific antibody, ivonescimab, has shown promising results in China [3]. Market Potential - Instil Bio's market capitalization has increased significantly, with analysts suggesting it could be undervalued given the potential of IMM2510 [4]. - Baird analyst Jack Allen raised the price target for Instil Bio to $180 per share, indicating a potential gain of 235% from its recent price [4]. Clinical Trials and Data - IMM2510 has not yet completed clinical trials, and initial studies have shown limited efficacy, with only three out of 25 patients experiencing tumor shrinkage [5]. - The comparison between IMM2510 and ivonescimab highlights potential differences in efficacy, but data is still limited [5]. Financial Position - Instil Bio leased a cell therapy manufacturing site to AstraZeneca for over $7.5 million annually, which will help reduce cash burn but not eliminate losses [6]. - The company ended June with $152.6 million in cash after a cash burn of $39.2 million in the first half of 2024, indicating a need for future capital raises [6]. Investment Considerations - Instil Bio represents a high-risk, high-reward investment opportunity, with potential for significant gains if clinical data for IMM2510 is positive [7]. - The stock is deemed suitable only for investors with a high tolerance for risk due to the uncertainties surrounding its clinical trials and financial needs [7].

Core Viewpoint - Instil Bio, Inc. has seen an increase in stock price following the in-licensing of ImmuneOnco's PD-L1/VEGF bispecific antibody IMM2510, which is positioned in a competitive and promising oncology market [1][2][7] Company Developments - Instil Bio in-licensed ex-China development and commercial rights to IMM2510, which allows commercialization outside Greater China, but incurs an upfront payment of $50 million and potential future costs exceeding $2 billion [2][5] - The company also acquired another candidate, IMM27M, an ADCC-enhanced anti-CTLA-4 antibody, which may enhance treatment efficacy when combined with IMM2510 [1][4] Competitive Landscape - The PD-1/VEGF bispecific antibody space is gaining traction, with competitors like Summit Therapeutics demonstrating clinically meaningful benefits in non-small cell lung cancer (NSCLC) [1][3] - IMM2510's unique ability to bind to all VEGF ligands and its superior ADCC killing capability may provide a competitive edge over existing therapies [1][3][4] Clinical Data - Clinical trials have shown that ivonescimab achieved a progression-free survival (PFS) of 11.4 months compared to Keytruda's 5.82 months, indicating the potential effectiveness of PD-L1/VEGF bispecific antibodies [3] - A phase 1 study of IMM2510 demonstrated safety with no dose-limiting toxicities observed across a range of doses [3][4] Financial Position - As of June 30, 2024, Instil Bio reported cash and equivalents of $152.6 million, supported by a successful IPO that raised $339 million [5] - The company has a cash burn rate of approximately $13.6 million per quarter, indicating a sufficient cash runway to fund operations beyond 2026 [5] Future Prospects - Instil Bio's strategy includes exploring combination therapies with IMM2510 and IMM27M, which may enhance treatment efficacy for solid tumors [4][7] - Analysts have raised price targets significantly, reflecting optimism about the company's potential in the oncology market [2][7]

Financial Performance - For the three months ended June 30, 2024, the net loss was $14.9 million, a decrease of $3.7 million compared to a net loss of $18.7 million for the same period in 2023[89]. - The net loss for the first half of 2024 was $39.2 million, an improvement of $36.5 million compared to a net loss of $75.7 million in 2023[94]. - Cash used in operating activities was $25.0 million for the six months ended June 30, 2024, compared to $54.2 million in 2023, indicating a reduction in cash outflow[111]. - Cash used in operating activities for the six months ended June 30, 2023 was $54.2 million, consisting of a net loss of $75.7 million and a $9.2 million net change in operating assets and liabilities[113]. Expenses - Research and development expenses decreased to $2.9 million for the three months ended June 30, 2024, down from $8.5 million in 2023, primarily due to reduced headcount and discontinued clinical manufacturing activities[90]. - General and administrative expenses were $10.7 million for the three months ended June 30, 2024, compared to $11.5 million in 2023, reflecting a decrease in headcount-related costs[91]. - Total operating expenses for the three months ended June 30, 2024, were $14.1 million, down from $21.0 million in 2023, indicating a reduction of $6.9 million[89]. - Research and development expenses decreased to $10.2 million in the first half of 2024 from $29.1 million in 2023, a reduction of $19.0 million[95]. - General and administrative expenses were $23.1 million for the six months ended June 30, 2024, down from $24.7 million in 2023, reflecting a decrease of $1.6 million[96]. - Restructuring and impairment charges were approximately $0.5 million for the three months ended June 30, 2024, down from $1.0 million in 2023, with expectations for additional charges in 2024[92]. - Restructuring and impairment charges fell to $4.8 million in 2024 from $25.6 million in 2023, a decrease of $20.8 million[97]. - Interest expense increased to $2.0 million for the three months ended June 30, 2024, compared to $0.6 million in 2023, reflecting higher costs associated with loans[89]. Cash and Investments - Cash, cash equivalents, marketable securities, and long-term investments totaled $152.6 million as of June 30, 2024, consisting of $6.8 million in cash and cash equivalents, $141.8 million in marketable securities, and $4.0 million in long-term investments[75]. - As of June 30, 2024, the company had cash, cash equivalents, marketable securities, and long-term investments totaling $152.6 million[98]. - Cash provided by investing activities for the six months ended June 30, 2024 was $21.2 million, primarily from marketable securities investments of $20.6 million[114]. - The outstanding principal amount under the mortgage construction loan was $82.8 million as of June 30, 2024[101]. Future Outlook - The company expects to continue incurring net losses for the foreseeable future due to ongoing research and development activities[75]. - The company expects additional restructuring and impairment charges in 2024 due to workforce reductions and other actions related to its 2024 Plan[97]. - The company plans to evaluate opportunities for a potential sale of its Tarzana manufacturing site to extend its cash runway[102]. - In August 2024, the company entered into an agreement with ImmuneOnco involving an upfront payment of $10 million and potential future payments totaling up to $2.1 billion[106]. Company Status - The company remains an "emerging growth company" and intends to rely on certain exemptions from public company reporting requirements[118]. - The company may delay adopting new accounting standards until it is no longer an emerging growth company or opts out of the transition period provided in the JOBS Act[119]. - The company will remain an emerging growth company until the earliest of December 31, 2026, or when total annual gross revenue exceeds $1.235 billion[120]. - The company is classified as a "smaller reporting company" and may continue to rely on exemptions from certain disclosure requirements[121]. - The market value of the company's shares held by non-affiliates must be less than $250.0 million to maintain smaller reporting company status[121]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its smaller reporting company status[123].

Instil Bio Reports Second Quarter 2024 Financial Results and Provides Corporate Update – In-licensed SYN-2510/IMM2510, a potentially best-in-class PD-L1xVEGF bispecific antibody, and SYN27M/IMM27M, a next-generation ADCC-enhanced anti-CTLA-4 antibody – Entered into a 15-year lease for our cell therapy manufacturing facility to AstraZeneca Pharmaceuticals LP DALLAS, TX, August 13, 2024 (GLOBE NEWSWIRE) Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing ...

In-licensed SYN-2510/IMM2510, a potentially best-in-class PD-L1xVEGF bispecific antibody, and SYN-27M/IMM27M, a next-generation ADCC-enhanced anti-CTLA-4 antibody Entered into a 15-year lease for our cell therapy manufacturing facility to AstraZeneca Pharmaceuticals LP DALLAS, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, today reported its second quarter 2024 financial results and ...

Core Viewpoint - Instil Bio has entered into a definitive agreement to in-license ex-China development and commercialization rights for ImmuneOnco's bispecific antibody IMM2510 and next-generation anti-CTLA-4 antibody IMM27M, indicating a strategic expansion in their oncology pipeline [1][4]. Group 1: Product Details - IMM2510 is a bispecific antibody that combines an anti-PD-L1 antibody with a VEGF receptor "trap," designed to enhance tumor penetration and improve tumor killing through enhanced antibody-dependent cellular cytotoxicity (ADCC) [2]. - IMM2510 has shown promising results in a dose-escalation clinical trial for advanced solid tumors, including responses in patients with squamous non-small cell lung cancer who had previously failed PD-1 inhibitors [2]. - IMM27M is a next-generation anti-CTLA-4 antibody with enhanced ADCC activity, aimed at improving efficacy and reducing toxicity compared to first-generation anti-CTLA-4 antibodies, and has also demonstrated anti-tumor activity in advanced solid tumors [3]. Group 2: Agreement Terms - Under the agreement, Instil's subsidiary will gain global rights for the development and commercialization of IMM2510 and IMM27M outside Greater China, while ImmuneOnco retains rights in Greater China, including Taiwan, Macau, and Hong Kong [4]. - ImmuneOnco will receive an upfront payment and potential near-term payments of up to $50 million, along with additional development, regulatory, and commercial milestones exceeding $2 billion, plus royalties on global ex-China sales [4]. Group 3: Company Background - Instil Bio is a clinical-stage biopharmaceutical company focused on developing novel therapies, with IMM2510 as its lead asset targeting multiple solid tumor cancers [5]. - ImmuneOnco is a clinical-stage biotech company dedicated to discovering and developing biologics for cancer treatment, currently advancing multiple assets, including one in phase III [6].

Core Insights - Instil Bio has entered into a definitive agreement to in-license ex-China development and commercialization rights for ImmuneOnco's bispecific antibody IMM2510 and next-generation anti-CTLA-4 antibody IMM27M [1][4] Group 1: Product Details - IMM2510 is a bispecific antibody that combines an anti-PD-L1 antibody with a VEGF receptor "trap," allowing it to bind multiple VEGF receptor ligands and potentially improve tumor penetration and efficacy [2] - IMM27M is designed to enhance ADCC activity and promote regulatory T cell depletion, aiming to improve efficacy and reduce toxicity compared to first-generation anti-CTLA-4 antibodies [3] Group 2: Clinical Development - IMM2510 has completed a dose-escalation clinical trial for advanced solid tumors, showing responses in patients with squamous non-small cell lung cancer who previously failed PD-1 inhibitors [2] - IMM27M has also completed a dose-escalation clinical trial and has entered combination studies with IMM2510 in China as of July 2024 [3] Group 3: Financial Terms - Under the agreement, Instil will pay an upfront fee and potential near-term payments totaling up to $50 million, along with additional milestone payments exceeding $2 billion and royalties on global ex-China sales [4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the transition period from ________ to ________ 3963 Maple Avenue, Suite 350 Dallas, Texas Commission file number 001-40215 Instil Bio, Inc. FORM 10-Q (Exact name of registrant as specified in its charter) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ...

Financial Performance - As of March 31, 2024, Instil Bio had cash, cash equivalents, marketable securities, and long-term investments totaling $161.5 million, down from $175.0 million as of December 31, 2023[3] - Research and development expenses decreased to $7.3 million for Q1 2024, compared to $20.7 million for Q1 2023, representing a reduction of approximately 64.8%[4] - General and administrative expenses were $12.4 million for Q1 2024, down from $13.2 million in Q1 2023, a decrease of about 6.0%[4] - The net loss per share for Q1 2024 was $3.74, significantly improved from $8.77 in Q1 2023, reflecting a reduction of approximately 57.5%[5] - Non-GAAP net loss per share for Q1 2024 was $2.39, compared to $4.29 in Q1 2023, indicating a decrease of about 44.3%[5] - Total operating expenses for Q1 2024 were $23.96 million, down from $58.45 million in Q1 2023, a reduction of approximately 59.0%[15] - Total assets decreased to $306.3 million as of March 31, 2024, from $325.6 million as of December 31, 2023[13] Future Outlook - Instil Bio expects its cash resources to fund its current operating plan beyond 2026, indicating strong financial stability[3] - The company is preparing for a potential investigator-initiated trial in non-small cell lung cancer with its FRα-CoStAR TIL therapy[6] - Instil is exploring opportunities to in-license or acquire novel therapeutic candidates to address significant unmet medical needs[6]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission file number 001-40215 Instil Bio, Inc. (Exact name of registrant as specified in its charter) Delaware 83-2072195 (State or other jurisdiction ...