On September 10, 2021 IN8bio, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T-cell therapies utilizing its DeltEx platform, reported financial results and operational highlights for the second quarter ended June 30, 2021 (Filing, 3 mnth, JUN 30, In8bio, 2021, SEP 10, 2021, View Source [SID1234587529]). In addition, the Company provided an overview of recent corporate developments.

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"In the second quarter and subsequent months, we have demonstrated progress in both of our clinical programs," said William Ho, Chief Executive Officer and co-founder of IN8bio. "We successfully completed treatment of the first cohort in the INB-200 Phase 1 trial using our genetically modified gamma-delta T cell candidate in development for treating solid tumors. We also completed dosing of the first cohort of the Phase 1 trial of INB-100, an allogeneic gamma-delta T cell product candidate in development for leukemia patients. We anticipate reporting updates to both programs in the coming months, and given our strengthened cash position from the IPO, we will continue to progress our trials and other pipeline programs."

Successful Initial Public Offering

On August 3, 2021, IN8bio completed its initial public offering, in which it issued and sold 4,000,000 shares of common stock at a public offering price of $10.00 per share. The net proceeds to the Company were approximately $32.6 million, after deducting underwriting discounts, commissions and estimated offering expenses. On September 7, 2021, subsequent to the IPO, there were 18,754,553 shares of common stock outstanding.

Second Quarter Business Highlights & Company Updates

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During the second quarter, IN8bio presented data demonstrating in vitro activity of INB-300, our DeltEx drug-resistant immunotherapy (DRI) CAR-T cells against glioblastoma multiforme (GBM) at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021. Gamma-delta T cells were engineered with a chlorotoxin CAR-T binding domain and a chemotherapy resistance gene, which enhances binding to tumor cells and survival of concomitant dosing with alkylating chemotherapies, such as temozolomide, or TMZ.
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During the second quarter, IN8bio presented data at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from the first cohort of a Phase 1 clinical trial of INB-200 in patients with newly diagnosed GBM. INB-200 was generally well tolerated with no observed infusion reactions, cytokine release syndrome (CRS), neurotoxicity or dose limiting toxicities (DLTs). Enrollment for the second cohort of this trial was initiated. All three treated patients exceeded their expected median progression-free survival based on their respective age and O-6-Methylguanine-DNA Methyltransferase (MGMT) status. The Company expects to report additional data from this Phase 1 trial by the end of 2021.
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In July 2021, IN8bio appointed Emily Fairbairn and Luba Greenwood as two independent members of the Company’s Board of Directors. Ms. Fairbairn is currently a principal of Transcend Partners and was co-founder and CEO of Ascend Capital. Ms. Greenwood serves as Managing Partner of Binney Street Capital LLC, a venture capital fund established by the Dana Farber Cancer Institute.
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In August 2021, IN8bio completed dosing of the first cohort of INB-100, a Phase 1 clinical trial of donor-derived allogeneic gamma-delta T cells in leukemia patients undergoing hematopoietic stem cell transplant (HSCT). No severe adverse infusion reactions or DLTs were observed. The first two patients continue in complete remission more than one year after treatment. The Company expects to report initial results from the first cohort in this Phase 1 trial in 2022, with topline results for all cohorts in 2023.

Second Quarter 2021 Financial Highlights

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Cash position: As of June 30, 2021, the Company has cash of $12.0 million, compared to $18.0 million as of December 31, 2020. Subsequent to the end of the second quarter, the Company completed its initial public offering that raised net proceeds of $32.6 million after underwriting discounts, commissions and estimated offering expenses of $7.4 million.
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Research and development (R&D) expense: Research and development expense was $2.1 million for the three months ended June 30, 2021, compared to $1.8 million for the comparable prior year period. The increase in R&D expense was due primarily to third-party costs associated with our clinical programs for INB-200 and increased personnel costs, including non-cash stock-based compensation.
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General and administrative expense: General and administrative expense was $1.0 million for the three months ended June 30, 2021, compared to $1.1 million for the comparable prior year period. The decrease was due primarily to decreased legal and professional fees partially offset by increased personnel costs, including non-cash stock-based compensation.
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Net loss: The Company reported a net loss of $3.1 million and a net loss attributable to common stockholders of $3.8 million, or ($1.00) per basic and diluted common share, for the three months ended June 30, 2021, compared to a net loss of $2.9 million and a net loss attributable to common stockholders of $3.2 million, or ($0.92) per basic and diluted common share, for the comparable prior year period.

On September 10, 2021 Advaxis, Inc., a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported its financial results for the third quarter ended July 31, 2021 and provides a business update (Press release, Advaxis, SEP 10, 2021, View Source [SID1234587528]).

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Third Quarter Ended July 31, 2021 Financial Results and Recent Key Accomplishments:

●Entered into a definitive merger agreement with Biosight Ltd. The proposed merger will create a public company, operating as Biosight Therapeutics, to advance a pipeline of clinical-stage oncology programs including Biosight’s lead product, aspacytarabine (BST-236). The combined company is expected to have approximately $50 million in cash, cash equivalents and marketable securities at closing. Following the closing, which is expected to occur in the 4th calendar quarter of 2021, Advaxis will be renamed Biosight Therapeutics and is expected to trade on the Nasdaq Capital Market under the ticker symbol "BSTX".

●The combined company anticipates the following milestones across the combined pipeline over the next 12-18 months:

○Topline results in 65 patients from the ongoing Phase 2 trial of aspacytarabine, which has completed enrolment, as first-line therapy in acute myeloid leukemia (AML) patients who are unfit for standard chemotherapy

■Recent data presented at 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting showed that aspacytarabine alone achieved complete remission (CR) rates of 39% across all evaluable patients (n=46) with 63% of cases analyzed to date with negative minimal residual disease (MRD(-) and median duration of response not yet reached at 12 months. Altogether these results are encouraging considering the high-risk factors in this population at baseline;

○Initial results from the Phase 2 trial of aspacytarabine in collaboration with the European cooperative group, Groupe Francophone des Myélodysplasies (GFM) in patients with relapsed/refractory AML and higher-risk Myelodysplastic Syndrome (MDS);

○Initiation in the U.S. of a second, Phase 2 trial of aspacytarabine in patients with relapsed/refractory AML and higher-risk MDS;

○Results from the ongoing Phase 1/2 trial with ADXS-503 in combination with pembrolizumab in non-small cell lung cancer; and

○Initial results from the Phase 1 trial of ADXS-504 in biochemically recurrent prostate cancer

●Initiated Phase 1 clinical trial of ADXS-504 being conducted at Columbia University Irving Medical Center for the treatment of biochemically recurrent prostate cancer, expanding the off-the-shelf ADXS-HOT program to a second indication

●Presented updated clinical data from Part B of the ongoing Phase 1/2 trial of ADXS-503 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in non-small cell lung cancer (NSCLC) at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting; data presented from the Part B arm of this study, demonstrate a disease control rate of 44%, with durable clinical benefit observed including a partial response (PR) and stable disease (SD) sustained for over a year, and another observed SD lasting over 6 months. An additional SD was maintained for approximately 4 months. Translational and biomarker results demonstrate on-mechanism immune activation tied to clinical benefit

●Presented data from Part B of the ongoing Phase 1/2 study of ADXS-503 in combination with KEYTRUDA (pembrolizumab) at the Non-Small Cell Lung Cancer Drug Development Summit

●Announced Nasdaq extension, to November 22, 2021, to regain compliance with the $1.00 minimum bid price rule and complete merger transaction with Biosight, Ltd.

●Cash balance at July 31, 2021 of $45.3 million

Management Commentary

"We are thrilled by the transformative potential of our proposed merger with Biosight and believe the opportunity to build a diversified clinical pipeline with both early and late-stage oncology assets will benefit both patients and our stockholders," said Kenneth A. Berlin, President, Chief Executive Officer and Interim Chief Financial Officer of Advaxis. "We expect that the coming months will provide data readouts from our expanded off-the-shelf neoantigen program in both NSCLC and prostate cancer which will build upon our strong foundation of data show consistent clinical benefit, the potential to enhance and/or restore responsiveness to checkpoint inhibitors and on-mechanism innate and adaptive immune system stimulation. These results, in combination with key data readouts from Biosight’s ongoing studies evaluating aspacytarabine in AML and MDS, will elucidate the promise of the combined clinical pipeline across both solid tumors and hematological malignancies and disorders. We look forward to continued progress in the clinic and expect to provide updated guidance regarding the proposed merger before year end."

Third Quarter Ended July 31, 2021 Financial Results

Research and development expenses for the third quarter of fiscal year 2021 were $1.70 million, compared with $3.46 million for the third quarter of fiscal year 2020. The decrease of $1.76 million was primarily attributable to the substantial reduction in costs associated with the winding down of clinical studies that have been discontinued.

General and administrative expenses for the three months ended July 31, 2021 were at $2.68 million, compared to $2.38 million in the same three-month period in fiscal 2020. The increase of $0.3 million primarily relates to increases in legal and consulting fees, and were partially offset by decreases in rent and utilities, personnel costs, and charges related to the abandonment of non-strategic intellectual property.

As of July 31, 2021, the Company had approximately $45.3 million in cash and cash equivalents.

On September 10, 2021 UroGen Pharma Ltd., a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference (Press release, UroGen Pharma, SEP 10, 2021, View Source [SID1234587526]). The presentation will be available on-demand via the conference portal and through the Investors section of UroGen’s website, www.urogen.com, beginning at 7:00 a.m. Eastern Time on Monday, September 13, 2021. A replay of the webcast will be available on the website for approximately 30 days.

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On September 10, 2021 Portage Biotech Inc., a clinical-stage immuno-oncology company focused on the development of therapies and treatments targeting cancer treatment resistance, reported that as part of its commitment to investor outreach, management will be participating in the following investor conferences in September 2021 (Press release, Portage Biotech, SEP 10, 2021, View Source [SID1234587524]).

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On September 10, 2021, PerkinElmer, Inc., a Massachusetts corporation, reported$500,000,000 aggregate principal amount of 0.550% Senior Notes due 2023 (the "2023 Notes"), $800,000,000 aggregate principal amount of 0.850% Senior Notes due 2024 (the "2024 Notes"), $500,000,000 aggregate principal amount of 1.900% Senior Notes due 2028 (the "2028 Notes") and $500,000,000 aggregate principal amount of 2.250% Senior Notes due 2031 (the "2031 Notes" and, together with the 2023 Notes, the 2024 Notes and the 2028 Notes, the "Notes") in a public offering pursuant to a registration statement on Form S-3 (File No. 333-230425) and a base prospectus and a prospectus supplement related to the offering of the Notes (the "Offering"), each as previously filed with the Securities and Exchange Commission (the "SEC") (Press release, PerkinElmer, SEP 10, 2021, View Source [SID1234587522]). The Notes were issued under an indenture, dated as of October 25, 2011 (the "Base Indenture") by and between the Company and U.S. Bank National Association (the "Trustee"), as supplemented by a Seventh Supplemental Indenture, dated as of September 10, 2021 (the "Supplemental Indenture" and, together with the Base Indenture, the "Indenture") by and between the Company and the Trustee. The sale of the Notes was made pursuant to the terms of an Underwriting Agreement (the "Underwriting Agreement"), dated as of September 8, 2021, by and among the Company and Goldman Sachs & Co. LLC, BofA
Securities, Inc., J.P. Morgan Securities LLC and Wells Fargo Securities, LLC, as representatives of the several underwriters named in the Underwriting Agreement.
The 2023 Notes will mature on September 15, 2023 and will bear interest at the rate of 0.550% per annum. The 2024 Notes will mature on September 15, 2024 and will bear interest at the rate of 0.850% per annum. The 2028 Notes will mature on September 15, 2028 and will bear interest at the rate of 1.900% per annum. The 2031 Notes will mature on September 15, 2031 and will bear interest at the rate of 2.250% per annum. Interest on the
Notes will be paid semi-annually in arrears on March 15 and September 15 of each year, commencing on March 15, 2022, to holders of record on the preceding March 1 and September 1, respectively.
The Company may not redeem the 2023 Notes or the 2024 Notes prior to September 15, 2022. Prior to July 15, 2028 (two months prior to the maturity date of the 2028 Notes, the "2028 Par Call Date"), in the case of the 2028 Notes or June 15, 2031 (three months prior to the maturity date of the 2031 Notes, the "2031 Par Call Date"), in the case of the 2031 Notes, the Company may redeem the 2028 Notes or the 2031 Notes, as applicable, in whole at any time or in part from time to time, at its option, at a redemption price equal to the greater of (1) 100% of the principal amount of the Notes to be redeemed and (2) the sum of the present values of the remaining scheduled payments of principal and interest thereon (not including any portion of such payments of interest accrued but unpaid as of the date of redemption) assuming that such Notes matured on the applicable Par Call Date, discounted at the date of redemption on a semi-annual basis (assuming a 360-day year of twelve 30-day months), at the Treasury Rate (as defined in the Indenture) plus 15 basis points in the case of the 2028 Notes or 15 basis points in the case of the 2031 Notes, plus, in each case, accrued and unpaid interest thereon to, but excluding, the date of redemption.

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