On August 12, 2022 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, obesity and non-alcoholic steatohepatitis (NASH), reported that it has agreed to sell, by way of an underwritten public offering, 12,250,000 shares of its common stock at a price of $2.42 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 14,630,000 shares of common stock at a price of $2.4199 per pre-funded warrant, for expected aggregate gross proceeds of approximately $65.0 million, before deducting underwriting discounts and commissions and other offering expenses (Press release, Terns Pharmaceuticals, AUG 12, 2022, View Source [SID1234618432]). The purchase price per share of each pre-funded warrant represents the per share public offering price for the common stock, minus the $0.0001 per share exercise price of such pre-funded warrant. The offering is expected to close on August 16, 2022, subject to customary closing conditions. All of the securities are being offered by Terns.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The offering was oversubscribed and led by new investors Fairmount and Venrock Healthcare Capital Partners and included participation from existing top-tier healthcare investors.

Cowen and Company, LLC is acting as lead book-running manager for the offering. UBS Securities LLC is also acting as a bookrunner for the offering.

Terns intends to use the net proceeds from the offering, together with existing cash and cash equivalents, as follows: (1) to initiate and complete one or more clinical studies in the United States and/or Europe to assess TERN-701 and advance the product candidate into Phase 2 clinical development in chronic myeloid leukemia; (2) to advance the clinical development of TERN-601 in obesity through the completion of Phase 2-enabling studies and initiate a Phase 2 clinical trial of TERN-601 in obesity; (3) to complete the ongoing Phase 2a DUET trial of TERN-501 as monotherapy and in combination with TERN-101 in NASH patients; and (4) for working capital and general corporate purposes.

The public offering is being made pursuant to a registration statement on Form S-3 previously filed with the Securities and Exchange Commission ("SEC"), which became effective on March 14, 2022. A prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the prospectus supplement and accompanying prospectus relating to this offering, when available, may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 1-833-297-2926 or by e-mail: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification of these securities under the securities laws of any such state or other jurisdiction.

On August 12, 2022 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on discovering and developing innovative gamma-delta T cell therapies that utilize its DeltEx platform, reported financial results and operational highlights for the quarter ended June 30, 2022 (Press release, In8bio, AUG 12, 2022, View Source [SID1234618288]). In addition, the Company provided an overview of recent corporate developments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our team continues to execute and advance our gamma-delta programs on multiple fronts. Our Phase 1 clinical trials for both DeltEx product candidates, INB-200 in GBM and INB-100 in leukemia patients undergoing stem cell transplantation, continue to progress with encouraging durability data. We introduced our iPSC derived gamma-delta T cell platform at the ASGCT (Free ASGCT Whitepaper) annual meeting, and we have been receiving positive feedback on this new program," said William Ho, CEO and co-founder of IN8bio. "During the quarter and into July, we continued to expand our management team; we have attracted talented individuals who have built their careers and established their reputations in well-recognized companies like Genentech, Novartis, Janssen, Bristol Myers Squibb and Covance. We believe they will be instrumental in shaping IN8bio’s future. The IN8bio team continues to be disciplined, and we are working to dedicate our resources to accelerating IN8bio’s growth and momentum."

Business Highlights & Clinical Updates

In May 2022, IN8bio unveiled a new preclinical program focused on developing induced pluripotent stem cell (iPSC) derived gamma-delta T cells and presented its early findings at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting. Uniquely, IN8bio has been able to demonstrate the ability to derive both Vd1+ and Vd2+ iPSC gamma-delta T cell clones. These iPSC-derived gamma-delta T cells demonstrated robust cytotoxicity and can be genetically modified with an internally developed chimeric antigen receptor (CAR-T) construct at a high transduction yield. Scalable iPSC-based cellular manufacturing is designed to create for a uniform and renewable therapeutic product available "off-the-shelf" for patients.
In June 2022, IN8bio provided an update on the INB-200 Phase 1 clinical trial in newly diagnosed glioblastoma multiforme (GBM) patients at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Five of six fully dosed patients exceeded both median and expected progression-free survival (PFS), and two patients exceeded the expected overall survival (OS) benchmarks as of June 3, 2022. All patients demonstrated a manageable toxicity profile with no evidence of cytokine release syndrome (CRS), tumor lysis syndrome (TLS) or immune effector cell-associated neurotoxicity syndrome (ICANS).
In June 2022, IN8bio held a successful pre-investigational new drug application (pre-IND) meeting with the Food and Drug Administration. The meeting provided guidance and confirmed IND filing requirements for the INB-400 program. IN8bio expects to file the IND by year-end.
In July 2022, IN8bio announced a patent covering the composition of matter for IN8bio’s Drug Resistant Immunotherapy (DRI) platform. The patent broadens the Company’s intellectual property coverage of genetically engineered innate immune cells beyond gamma-delta T cells to include NK cells.
In July 2022, IN8bio provided an update from the ongoing Phase 1 clinical trial of INB-100 in leukemia patients undergoing haploidentical stem cell transplantation. All three high-risk AML patients from the first cohort continue to demonstrate durable morphologic complete responses (CR) and remain progression-free and alive for more than one year. Two of the three patients remain in morphologic CR for more than two years. The safety profile continues to be manageable with no dose-limiting toxicities.
Recent Team Growth

In April 2022, IN8bio announced the expansion of its clinical and regulatory teams with the appointments of Urvashi Patel, Ph.D., Vice President, Regulatory Affairs, and Stacey Bilinski, Vice President, Clinical Operations. They bring more than a combined 45 years of clinical and regulatory experience to the IN8bio team.
In July 2022, IN8bio appointed Kenneth R. LaMontagne, Ph.D., as Senior Vice President, Business Development to lead the Company’s business development activities. Dr. LaMontagne is an industry leader with more than 20 years of experience, including licensing, collaborations, search and evaluation, M&A and corporate strategy including in the fields of cell therapy and oncology. He gained his experience in both large pharma and small biopharmaceutical companies.
Second Quarter 2022 Financial Results
Research and development (R&D) expenses were $3.5 million for the three months ended June 30, 2022, compared to $2.1 million for the comparable prior year period. The increase in R&D expenses were primarily due to (i) increased third-party clinical trial and IND-related activities, (ii) contract manufacturing costs for the ongoing INB-200 clinical trial and (iii) increased personnel-related costs, including salaries, benefits and stock-based compensation due to increased headcount.

General and administrative expenses were $3.7 million for the three months ended June 30, 2022, compared to $1.0 million for the comparable prior year period. The increase was primarily due to increased headcount, insurance, legal expenses, and expenses associated with operating as a public company.

The Company reported a net loss attributable to common stockholders of $7.2 million, or $0.38 per basic and diluted common share, for the three months ended June 30, 2022, compared to a net loss attributable to common stockholders of $3.8 million, or $1.00 per basic and diluted common share, for the comparable prior year period.

As of June 30, 2022, the Company had cash of $25.7 million, compared to $37.0 million as of December 31, 2021. The decrease in cash was primarily due to cash used by the Company in R&D and continued operations to advance its programs along with ongoing construction of a state-of-the-art ~10,000 sq. ft. R&D facility in Birmingham, AL.

On August 12, 2022 Privo Technologies, Inc. ("Privo") reported that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Privo’s PRV platform delivery of cisplatin for the treatment of carcinoma in situ (CIS) of the anterior 2/3 of the oral cavity (Press release, Privo Technologies, AUG 12, 2022, View Source [SID1234618272]). This represents Privo’s third ODD for a rare disease following their approval in oral cavity cancers and anal cancers. Privo Technologies is a phase 3 clinical stage biopharmaceutical company that has designed and developed a nanoengineered drug delivery platform to safely deliver highly potent and toxic APIs locoregionally, led by founder and CEO Manijeh Goldberg, PhD.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Achieving this important regulatory milestone means we are one step closer to bringing new treatment options to patients diagnosed with oral CIS. The standard of care currently is surgery, resulting in severe disfigurement and poor quality of life. Our novel transmucosal delivery system with embedded cisplatin loaded nanoparticles, PRV111, allows for patients to be treated with topical chemotherapy providing an alternative to surgery that effectively treats cancer while maintaining the form and function of the oral cavity," said Dr. Goldberg.

FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers that includes assistance in the drug development process, tax credits for clinical costs, exemption from FDA PDUFA fees, and seven years of post-approval exclusivity.

On August 12, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics with the potential to modify the course of Parkinson’s disease ("PD") and related disorders, reported financial results for the second quarter ended June 30, 2022 and highlighted recent developments (Press release, Inhibikase Therapeutics, AUG 12, 2022, View Source [SID1234618271]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the second quarter, we continued to make progress across our entire portfolio. We recently opened enrollment in our Phase 2a ‘201’ trial for IkT-148009 for the treatment of Parkinson’s disease. We have now opened nearly a quarter of all sites for the study and we are actively screening patients. In addition, we have submitted our Investigational New Drug (IND) application for IkT-001Pro for patients with chronic myelogenous leukemia to the U.S. Food and Drug Administration (FDA), and expect to initiate our ‘501’ bioequivalence study of IkT-001Pro following FDA review and concurrence," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "Looking ahead, we also expect to share Parkinson’s assessment data from our Phase 1/1b ‘101’ clinical trial of IkT-148009 at the Movement Disorders Society Congress in September and are continuing to advance our regulatory activities in the U.S. and the EU27 as we plan a Phase 2 trial in Multiple System Atrophy. Taken together, we believe that these activities lay the groundwork for continued momentum across our business as we seek to deliver on our mission of bringing novel, disease-modifying treatments to patients suffering from devastating diseases."

Recent Developments and Upcoming Milestones:

Phase 2a ‘201’ Trial of IkT-148009 Open for Enrollment: In May 2022, Inhibikase opened enrollment for its Phase 2a study (‘201 trial’) evaluating IkT-148009 for the treatment of Parkinson’s disease. The Company has opened 11 of 40 planned sites and is actively screening patients. The 201 trial is a 1:1:1:1 randomized, double-blind, twelve-week dosing trial, designed to measure the safety, tolerability and steady-state pharmacokinetics (PK) of three doses of IkT-148009 in up to 120 untreated Parkinson’s patients. The trial will further measure the potential for IkT-148009 to impact the disease globally in the body using a hierarchy of Parkinson’s-related disease assessments in the brain and gut as secondary or exploratory endpoints.

The advancement of IkT-148009 into Phase 2a followed a review of the study protocol, as well as the safety, tolerability and PK data from the 101 clinical trial by the FDA. In the 101 trial, the clinical pharmacology of IkT-148009 in patients paralleled the clinical pharmacology of IkT-148009 in older heathy volunteers. IkT-148009 also demonstrated a favorable safety and tolerability profile up to a dose of 325 mg, with no clinically-significant adverse events observed. Inhibikase plans to present additional data from the 101 trial at the Movement Disorders Society Congress in Madrid, Spain, in September 2022.

Filed IND Application for IkT-001Pro for Stable-Phase Chronic Myelogenous Leukemia (CML): On June 29, 2022, Inhibikase filed its IND application with the FDA for IkT-001Pro, the Company’s prodrug of imatinib mesylate to treat Stable-phase Chronic Myelogenous Leukemia (SP-CML). A clerical error delayed the review of the IND, however the Division of Hematological Malignancies I confirmed that FDA review of the IND should be completed no later than August 26, 2022. Following clearance by the FDA, the Company expects to initiate bioequivalence studies in accordance with the 505(b)(2) regulatory pathway. IkT-001Pro will be evaluated in a two-part dose finding/dose equivalence study in up to 62 healthy volunteers. The study is designed to evaluate the steady-state pharmacokinetics of IkT-001Pro and determine the dose of IkT-001Pro equivalent to 400 mg imatinib mesylate, the standard-of-care dose for SP-CML. Inhibikase expects to initiate this two-part bioequivalence study in the normal course following review of the proposed clinical study by the FDA. Inhibikase will confer with the FDA once bioequivalence is established to begin the New Drug Application, or NDA, process on the proposed approval path for IkT-001Pro under the 505(b)(2) statute. The Company plans to simultaneously pursue a superiority study comparing the selected dose of IkT-001Pro to standard-of-care 400 mg imatinib mesylate in SP-CML patients using a novel two-period, wait-list-crossover-switching study.

Evaluating ongoing studies of IkT-148009 in Animal Models of Multiple System Atrophy (MSA): Inhibikase continues to advance regulatory activities IkT-148009 in both the U.S. and EU27 for the treatment of MSA. The Company is preparing regulatory filings in the US and EU27 to enable the planned Phase 2 MSA trial if IkT-148009 is validated to be active in MSA in animal model studies. Execution of this trial will require the Company to raise additional working capital. Two animal model studies are ongoing and a preliminary assessment in one of the two studies demonstrated an apparent functional benefit following treatment.

Receipt of new patent # 11,407,747 entitled Compositions and methods for inhibiting kinases: This patent was issued August 9, 2022 for the application of the Company’s c-Abl kinase inhibitor portfolio to the treatment of cancer or bacterial or viral infections. This patent is the fifth U.S. patent issued for our portfolio of compounds that inhibit Abelson Tyrosine Kinases for a therapeutic purpose.
Second Quarter 2022 Financial Results

Net Loss: Net loss for the second quarter ended June 30, 2022, was $4.6 million, or $0.18 per share, compared to a net loss of $ 2.6 million, or $0.22 per share for the second quarter in 2021.

Net loss for the six months ended June 30, 2022, was $9.3 million or $0.37 per share, compared to a net loss of $5.3 million, or $0.47 per share in the six months ended June 30, 2021.

R&D Expenses: Research and development expenses were $3.0 million for the second quarter ended June 30, 2022, compared to $2.4 million in the second quarter of 2021. The increase of $0.6 million was driven by a $2.1 million increase in non-grant related research offset by a decrease of $1.4 million in grant related research expenditures and a decrease of $0.1 million in non-cash stock compensation expense. The non-grant related research was expended primarily in connection with the Company’s PD clinical trials.

Research and development expenses were $6.0 million for the six months ended June 30, 2022 compared to $4.8 million in the comparable period in 2021. The $1.2 million increase was driven by a $4.3 million increase in non-grant related research offset by a decrease of $2.7 million in grant related research expenditures and a decrease of $0.4 million in non-cash stock compensation expense. The non-grant related research was expended primarily in connection with the Company’s PD clinical trials.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2022 were $1.7 million compared to $1.6 million for the second quarter in 2021. The increase was primarily from increased headcount resulting in increased compensation expense of $0.1 million, increased legal fees, board fees, investor relation and consulting fees of $0.3 million and a net increase of $0.1 million for other normal operating expenses offset by decreased non-cash stock based compensation expense of $0.4 million.

Selling, general and administrative expenses for the six months ended June 30, 2022 were $3.3 million compared to $3.2 million for comparable period in 2021. The increase was primarily from increased headcount resulting in increased compensation expense of $0.3 million, increased legal fees, board fees, investor relation and consulting fees of $0.6 million and a net decrease of $0.1 million for other normal operating expenses offset by decreased non-cash stock based compensation expense of $0.7 million.

Cash Position: Cash and cash equivalents were $32.2 million as of June 30, 2022. The Company expects that existing cash and cash equivalents will be sufficient to fund its normal operations and capital expenditure requirements through December 31, 2023.

Conference Call Information
The conference call is scheduled to begin at 8:00am ET on Monday, August 15, 2022. Participants should dial 844-825-9789 (United States) or 412-317-5180 (International) with the conference code 10169366. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

On August 12, 2022 Thermo Fisher Scientific reported The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients whose tumors have a HER2 (ERBB2) activating mutations (SNVs & Exon 20 Insertion) in non-small cell lung cancer (NSCLC) who may be candidates for ENHERTU (fam-trastuzumab deruxtecan-nxki) (Press release, Thermo Fisher Scientific, AUG 12, 2022, View Source [SID1234618270]). ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"To ensure patients and clinicians can readily access testing to inform care decisions, we are committed to making NGS accessible and easy to use so patients everywhere will be able to benefit from precision therapies, when indicated."

The FDA approved ENHERTU on August 11 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 (ERBB2) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. The approval follows a Priority Review, granted by the U.S. FDA in April 2022.

Lung cancer is the leading cause of cancer death among both men and women in the United States.i For patients with metastatic NSCLC, prognosis is particularly poor, as only 8% of patients will live beyond five years after diagnosis.ii HER2-mutant NSCLC occurs in approximately 2-4% of patients with non-squamous NCSLC,iii and Enhertu is the first HER2-directed therapy for patients with NSCLC approved in the U.S.

"With care decisions increasingly made based on a tumor’s molecular profile, the FDA’s latest approval of ENHERTU in HER2 mutant metastatic non-small cell lung cancer and the additional approval of the Oncomine Dx Target Test as a companion diagnostic marks a significant step forward for precision oncology," said Garret Hampton, president, clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "To ensure patients and clinicians can readily access testing to inform care decisions, we are committed to making NGS accessible and easy to use so patients everywhere will be able to benefit from precision therapies, when indicated."

The Oncomine Dx Target Test is currently the only distributed NGS CDx that has received regulatory approval and is available in 17 countries for 15 targeted therapies, covering more than 550 million lives globally. It is designed to simultaneously evaluate 23 genes associated with NSCLC. The test received its first approval by the FDA as a CDx in 2017. In the US alone, it is approved for seven targeted therapies for NSCLC and one for cholangiocarcinoma.