On August 9, 2022 Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotechnology company focused on developing novel drugs for cancer, fibrosis and inflammation, reported that promising interim clinical data from its Phase I study of BBT-176, a fourth-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) (Press release, Bridge Biotherapeutics, AUG 9, 2022, View Source [SID1234617968]). The data, presented at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer (IASLC WCLC 2022), show promising early evidence of efficacy and favorable tolerability in patients with non-small cell lung cancer (NSCLC).

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The oral presentation delivered by Sun Min Lim, M.D., Ph.D., assistant professor at Yonsei University College of Medicine, discussed the correlation between molecular response and radiologic response in patient participants in the study. One patient with advanced NSCLC showing C797S triple mutations, confirmed as one of the partial response (PR) cases, showed up to 53 percent decrease of EGFR mutant allele frequency compared to the baseline. Data from the five patients who had been treated with BBT-176 over 100 days suggested that circulating tumor DNA (ctDNA) analysis enabled with liquid biopsy may be useful not only in identifying those most likely to benefit from fourth-generation EGFR TKI treatments such BBT-176, but also monitoring therapeutic response with treatment of a fourth-generation EGFR TKI.

The study also confirmed the preliminary efficacy of BBT-176 in treating advanced NSCLC patients harboring an EGFR mutation who had previously been treated with at least one EGFR TKI. Adverse events were primarily low grade, with GI toxicities and skin rash being most common, necessitating dose modifications in some patients. The pharmacokinetic profile of BBT-176 was shown to be dose-proportional in the study.

As the study continues, investigators will explore the recommended Phase 2 dose (RP2D) based on the overall safety, efficacy and tolerability information collected. Upon determination of the RP2D, investigators are expected to initiate the Phase 2 study next year.

Session and Presentation Information
Title: BBT-176, a 4th-generation EGFR TKI, for Progressed NSCLC after EGFR TKI Therapy: PK, Safety and Preliminary Efficacy from Phase 1 Study
Session Title: Overcoming Resistance to EGFR Inhibitors
Session Number: MA07.09
Presentation Session: August 8, 2022, 12:52 pm CET
Presenting Author: Sun Min Lim, M.D., Ph.D., Yonsei University College of Medicine
Session Discussant: Pasi A. Jänne, M.D., Ph.D., Dana-Farber Cancer Institute

On August 8, 2022 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported financial results for the second quarter ended June 30, 2022 and provided a business update (Press release, Precision Biosciences, AUG 8, 2022, View Source [SID1234617742]).

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"This past quarter, we have executed on many important aspects of our business. From manufacturing optimization to clinical trial progress to business development and operational advancements, we are making strides towards delivering on the potential of ARCUS genome editing for drug development and adding significant cash to our balance sheet. Most exciting this past quarter, we entered into a collaboration agreement with Novartis to develop a potential one-time treatment option for hemoglobinopathies including sickle cell disease and beta thalassemia using ARCUS for gene insertion. We are very excited about expanding ARCUS into potential indications that require more complex edits, such as gene insertion," said Michael Amoroso, Chief Executive Officer at Precision BioSciences.

"For our CAR T programs, Q2 2022 was also an exciting time for us to share encouraging new interim clinical data for our lead PBCAR0191 program. We believe the latest update validated the signal of high response rates to PBCAR0191 observed among CAR T relapsed patients we reported at the 2021 American Society for Hematology (ASH) (Free ASH Whitepaper) meeting, further supporting our potential path forward in this patient population. We have recently released optimized batches of our PBCAR19B clinical trial material and look forward to commencing dosing in the next cohort of patients this quarter. In addition, we dosed PBCAR269A in combination with nirogacestat at Dose Level (DL) 3. We expect to provide additional updates across our CAR T portfolio by the end of the year," concluded Michael Amoroso.

Recent Developments and Upcoming Milestones:

Ex Vivo Allogeneic CAR T Portfolio:

PBCAR0191: PBCAR0191, azercabtagene zapreleucel (azer-cel), is Precision’s lead investigational anti-CD19 allogeneic CAR T candidate in a Phase 1/2a clinical trial of adult subjects with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL). In June 2022, Precision provided new interim data as of May 31, 2022, including high and durable clinical response rates among subjects who received a median of five prior lines of therapy. Evaluable subjects in the latest cohort of the study had the following results:

100% Overall Response Rate (ORR) and 73% Complete Response (CR) rate

50% durable response rate greater than six months

No Grade 3 or greater cytokine release syndrome (CRS) was observed in either dosing cohort. One Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) was recorded in each cohort that rapidly resolved to Grade 1 within 24 to 48 hours. Two Grade 5 events associated with late occurring encephalopathy suspected to be related to fludarabine-associated neurotoxicity occurred. There was no evidence of graft versus host disease.

In the second half of 2022, Precision plans to continue dosing subjects with optimized PBCAR0191 CAR T cells in this relapsed patient population while further reducing its lymphodepletion dose to standard levels.

PBCAR19B: PBCAR19B is Precision’s second generation, anti-CD19 targeting allogeneic CAR T candidate designed to evade immune rejection by host T cell and natural killer (NK) cells with a single-gene edit to knock-down beta-2 microglobulin and insert an HLA-E transgene. Manufacturing optimization for PBCAR19B was implemented in the first quarter of 2022. New clinical trial material has been released, and the company plans to commence dosing in the next cohort, DL 2 (flat dose of 540 million cells), in the third quarter of 2022.

PBCAR269A: PBCAR269A is Precision’s investigational allogeneic CAR T cell candidate targeting B-cell maturation antigen (BCMA) for R/R multiple myeloma. Precision is evaluating PBCAR269A in a Phase 1/2a study in combination with nirogacestat, a gamma secretase inhibitor (GSI) developed by SpringWorks Therapeutics. Precision has completed DL2 (2.0 × 106 cells/kg) of PBCAR269A plus GSI and is initiating the next cohort at DL3 (flat dose of 480 ×106 cells) to further evaluate efficacy. To date, peak expansion rates observed at DL2 plus the GSI have been equivalent to DL4 (960 × 106 cells flat dose) monotherapy with no dose limiting toxicities observed.

Precision expects to provide the next update on its clinical ex vivo allogeneic CAR T programs toward year-end 2022.

In Vivo Gene Editing Portfolio:

Novartis In Vivo Gene Editing Collaboration: In June 2022, Precision announced it had entered into an exclusive worldwide in vivo gene editing research and development collaboration and license agreement with Novartis. As part of the agreement, Precision will develop a single, custom ARCUS nuclease designed to insert, in vivo, a therapeutic transgene at a "safe harbor" location in the genome as a potential one-time transformative treatment option for diseases including certain hemoglobinopathies such as sickle cell disease and beta thalassemia. Precision will conduct in vitro characterization, with Novartis then assuming responsibility for all subsequent research, development, manufacturing and commercialization activities.

In addition to a $25 million equity investment from Novartis in Precision’s common stock at $2.01 per share received in June 2022, Precision received an upfront cash payment of $50 million on July 12, 2022 and is eligible to receive up to an aggregate amount of approximately $1.4 billion in additional payments for future milestones. Precision is also eligible to receive certain research funding and tiered royalties ranging from the mid-single digits to low-double digits on product sales, should Novartis successfully commercialize a therapy from the collaboration.

Lilly In Vivo Gene Editing Programs: Precision continues its in vivo gene editing collaboration with Lilly and is applying ARCUS nucleases for three initial targets, including Duchenne muscular dystrophy in muscle, a central nervous system directed target and a liver directed target.

PBGENE-PH1: Precision has initiated IND-enabling activities for its PBGENE-PH1 candidate designed to knock out the HAO1 gene as a potential one-time treatment for primary hyperoxaluria type 1 (PH1). In the first quarter of 2022, the Company initiated a non-human primate (NHP) study for PBGENE-PH1 delivered by LNP and is targeting an IND or CTA submission in 2023, subject to evaluation of data from the ongoing preclinical NHP study. Preclinical data for Precision’s PBGENE-PH1 was presented at the 2022 American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting and demonstrated a robust knockdown of the HAO1 protein in non-human primates following a single administration of an ARCUS nuclease via AAV.

PBGENE-HBV: Precision’s gene editing program for chronic Hepatitis B applies ARCUS to knock out persistent covalently closed circular DNA (cccDNA) and inactivate integrated hepatitis B genomes, potentially achieving durable HBV S-antigen (HBsAg) loss and reducing viral persistence. Preclinical data from this program was presented during the Gene Editing in Cancer and Complex Diseases oral session at the ASGCT (Free ASGCT Whitepaper) Annual Meeting and within the same month published online in Molecular Therapy in May 2022. As reported, ARCUS efficiently targeted and degraded hepatitis B virus (HBV) cccDNA by 85% and reduced expression of HBsAg by 77% in HBV-infected primary human hepatocytes (PHH). Importantly, the optimized specificity of the ARCUS nuclease completely prevented detectable chromosomal translocations in the PHH model. PBGENE-HBV candidate is in pre-clinical development and Precision is targeting an IND/CTA submission in 2024 following completion of pre-clinical and IND enabling studies.

PBGENE-PCSK9: In 2021, Precision initiated a collaboration with iECURE, pursuant to which iECURE is expected to advance Precision’s PBGENE-PCSK9 candidate through preclinical activities as well as a Phase 1 study in familial hypercholesterolemia. As of this date, IND enabling activities for PBGENE-PCSK9 have not been completed. We are in discussions with iECURE and will provide an update on the program when more information is available.

Quarter Ended June 30, 2022 Financial Results:

Cash and Cash Equivalents: As of June 30, 2022, Precision had approximately $184.1 million in cash and cash equivalents, including receipts of $25.0 million from Novartis’ equity investment in the Company and proceeds from the June 2022 underwritten offering of the Company’s common stock, described below. The Company expects that existing cash and cash equivalents, including the cash payment of $50.0 million received from Novartis on July 12, 2022, expected operational receipts, and available credit will be sufficient to fund its operating expenses and capital expenditure requirements to the end of 2024.

In June 2022, Precision announced the closing of an underwritten offering of 35,971,224 shares of its common stock at an offering price of $1.39 per share, for total net proceeds of approximately $46.7 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company.

Revenues: Total revenues for the quarter ended June 30, 2022 were $3.8 million, as compared to $68.8 million for the same period in 2021. The decrease of $65.0 million in revenue during the quarter ended June 30, 2022 was primarily the result of the absence of $62.5 million in revenue recognized under the Servier Agreement in April 2021 subsequent to full satisfaction of the performance obligation, a $1.5 million decrease in revenue recognized under the Lilly Agreement, and a $0.9 million decrease in revenue recognized from an agriculture partnering collaboration.

Research and Development Expenses: Research and development expenses were $22.9 million for the quarter ended June 30, 2022, as compared to $37.2 million for the same period in 2021. The decrease of $14.3 million was primarily due to a decrease of $11.3 million related to the Servier Program Purchase Agreement, a decrease of $2.1 million in external development costs associated with our allogeneic CAR T product candidates, a decrease of $1.3 million in employee-related costs due to reduced headcount, and a decrease of $1.7 million in clinical manufacturing organization and research costs related to our preclinical studies. These decreases were partially offset by a $1.5 million increase in sublicensing royalty payable to Duke on the Novartis upfront payment.

General and Administrative Expenses: General and administrative expenses were $10.5 million for the quarter ended June 30, 2022, as compared to $9.9 million for the same period in 2021. The increase of $0.6 million was primarily due to costs required to meet our growing infrastructure needs, including consulting fees and employee-related costs associated with increased share-based compensation expense.

Net Loss: Net loss was $31.0 million, or $(0.46) per share (basic and diluted), for the quarter ended June 30, 2022, as compared to net income of $21.7 million, or $0.38 per share (basic) and $0.36 per share (diluted), for the same period in 2021.

Corporate:

Executive Leadership: In May 2022, Juli Blanche was appointed Chief People Officer and a member of the senior leadership team. Ms. Blanche joined Precision from Bristol-Myers Squibb where she was Senior Vice President and HR Business Partner, Global Commercialization. She brings over 25 years of strategic business partnership and enterprise leadership experience in the pharmaceutical and financial services industries.

Board of Directors: In May 2022, Melinda Brown was appointed as a Director on Precision’s Board of Directors and Chair of the Board’s Audit Committee. Ms. Brown is a financial expert with proven experience leading accounting, finance and enterprise risk management teams in large, public companies, including Tapestry, Inc. and PepsiCo, Inc.

Together, Ms. Blanche and Ms. Brown provide substantial executive leadership that will be paramount for Precision as the company embarks upon the next phase of its life cycle.

On August 8, 2022 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results and provided a business update for the second quarter ended June 30, 2022 (Press release, Syndax, AUG 8, 2022, View Source [SID1234617776]).

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"The coming quarters are poised to be transformational for Syndax with topline data from both the revumenib and axatilimab pivotal programs expected starting in the first half of 2023," said Michael A. Metzger, Chief Executive Officer. "As we continue to advance these programs in areas of significant unmet need, we are focused on executing a broad clinical development plan that fully realizes the potential of both compounds and builds upon the robust datasets presented to date."

"For revumenib, which we believe is positioned to serve as a first-to-market and best-in-class menin inhibitor for patients with mNPM1 and MLLr acute leukemias, we look forward to sharing updated data from the Phase 1 portion of the AUGMENT-101 trial, enrolling patients with relapsed/refractory (R/R) disease, in the fourth quarter of this year. Beyond the R/R setting, we are committed to creating additional value for the revumenib program by expanding into newly diagnosed and maintenance settings in mNPM1 and MLLr acute leukemias, as well as into colorectal cancer (CRC), our first assessment of revumenib in solid tumors. We also expect similarly broad utility with axatilimab, which we believe could have a meaningful impact in multiple fibrotic diseases. Building on the data in chronic graft versus host disease (cGVHD), we are looking forward to initiating a 52-week Phase 2b trial of axatilimab in patients with idiopathic pulmonary fibrosis (IPF) in the fourth quarter of this year."

Recent Pipeline Progress and Anticipated Milestones

Revumenib

The pivotal Phase 2 portion of AUGMENT-101 is ongoing and the Company continues to expect completion of enrollment in one of the three pivotal cohorts by year-end. The trials are enrolling a total of 64 adult and up to 10 pediatric patients across each of three distinct trial populations: patients with NPM1 mutant acute myeloid leukemia (AML), patients with MLLr AML, and patients with MLLr acute lymphocytic leukemia (ALL). Based on discussions with the U.S. Food and Drug Administration, AUGMENT-101 may serve as the basis for regulatory filings in each of the three distinct populations. The Company expects to report topline data from the trials starting in the first half of 2023, with the potential for the first New Drug Application filing later in 2023. The Company also anticipates announcing updated data from the Phase 1 portion of the AUGMENT-101 trial in the fourth quarter of 2022.
Two trials, BEAT-AML and AUGMENT-102, are ongoing and will assess the safety, tolerability, and preliminary anti-leukemic efficacy of revumenib and establish an appropriate Phase 2 dose when used in combination with other approved agents. BEAT-AML is a front-line combination trial of revumenib with venetoclax and azacitidine being conducted as part of the Leukemia & Lymphoma Society’s Beat AML Master Clinical Trial. AUGMENT-102 is a trial assessing revumenib in combination with chemotherapy in patients with R/R mNPM1 or MLLr acute leukemias.
The Company expects the Australasian Leukaemia and Lymphoma Group (ALLG) to initiate the INTERCEPT trial of revumenib as monotherapy in patients with AML who are minimal residual disease-positive (MRD+) following initial treatment, in the fourth quarter of 2022. The trial is a part of the INTERCEPT AML Master Clinical Trial, a collaborative clinical trial investigating novel therapies to target early relapse and clonal evolution as pre-emptive therapy in AML. Revumenib is the first menin inhibitor to be included in the INTERCEPT AML Master Clinical Trial.
The Company previously announced it intends to initiate a proof-of-concept clinical trial of revumenib in patients with unresectable metastatic microsatellite stable CRC in the fourth quarter of 2022.
Axatilimab

Enrollment is ongoing in the Company’s global pivotal Phase 2 AGAVE-201 trial of axatilimab in patients with cGVHD. The trial is evaluating the safety and efficacy of three dosing regimens of axatilimab. The primary endpoint will assess objective response rate based on the 2014 NIH consensus criteria for cGVHD, with key secondary endpoints including duration of response and improvement in modified Lee Symptom Scale score. The Company remains on track to report topline data in the first half of 2023, with the potential for a Biologics License Application filing later in 2023.
The Company plans to initiate a Phase 2b trial to assess the efficacy, safety and tolerability of axatilimab in patients with IPF in the fourth quarter of 2022. This 52-week, randomized, double-blind and placebo-controlled trial is expected to enroll approximately 170 patients. The primary endpoint will assess the change from baseline in forced vital capacity, which is the current registrational endpoint in IPF.
The Company is working with its partner, Incyte, to plan additional trials of axatilimab in earlier lines of cGVHD, and expects that Incyte will initiate a Phase 1 trial of axatilimab in combination with Jakafi in patients with steroid-refractory cGVHD in the fourth quarter of 2022.
Corporate Updates

In June 2022, the Company announced the appointment of Keith A. Goldan as Chief Financial Officer. Mr. Goldan brings to Syndax nearly thirty years of leadership and operational experience at several pharmaceutical, biotechnology, and medical technology companies.
Second Quarter 2022 Financial Results

As of June 30, 2022, Syndax had cash, cash equivalents, short-term and long-term investments of $378.9 million and 60.4 million shares outstanding, that included 4.0 million pre-funded warrants.

Second quarter 2022 research and development expenses increased to $29.7 million from $16.9 million for the prior year period. The increase was primarily due to increased clinical and manufacturing activities for revumenib and axatilimab.

General and administrative expenses for the second quarter 2022 increased to $8.0 million from $5.8 million for the prior year period. The increase is primarily due to increased employee related expenses and professional fees.

For the three months ended June 30, 2022, Syndax reported a net loss attributable to common stockholders of $37.6 million, or $0.62 per share, compared to a net loss attributable to common stockholders of $22.9 million, or $0.44 per share, for the prior year period.

Financial Update and Guidance

For the third quarter of 2022, the Company expects research and development expenses to be $25 to $30 million, and total operating expenses to be $35 to $40 million. For the full year of 2022, the Company continues to expect research and development expenses to be $130 to $140 million and total operating expenses to be $160 to $170 million.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, August 8, 2022.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website. Alternatively, the conference call may be accessed through the following:

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website at www.syndax.com approximately 24 hours after the conference call and will be available for 90 days following the call.

On August 8, 2022 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported operating results for the second quarter ended June 30, 2022 and provided pipeline updates (Press release, AnaptysBio, AUG 8, 2022, View Source [SID1234617792]).

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"We are excited with our progress as we continue to execute on our ongoing clinical studies and anticipate top-line data from the imsidolimab HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa later this quarter and are pleased to announce top-line data from the rosnilimab AZURE Phase 2 trial in moderate-to-severe alopecia areata is now accelerated into Q1 2023," said Daniel Faga, interim president and chief executive officer of AnaptysBio. "With over $570 million in cash at the end of Q2, and reiterating 2022 net cash burn of $90 to $100 million, Anaptys is well capitalized to execute as we move forward in our strategic portfolio review."

Imsidolimab (Anti-IL-36 receptor) Program

Imsidolimab, our investigational wholly owned anti-IL-36R therapeutic antibody, is in Phase 3 trials in generalized pustular psoriasis (GPP), and we anticipate top-line data from the GEMINI-1 Phase 3 clinical trial in Q4 2023.
We anticipate top-line data from the HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa in Q3 2022.
Rosnilimab (Anti-PD-1 agonist) Program

Rosnilimab, our investigational wholly owned anti-PD-1 agonist therapeutic antibody, is in the AZURE Phase 2 clinical trial in moderate-to-severe alopecia areata, and we anticipate top-line data in Q1 2023.
ANB032 (Anti-BTLA agonist) Program

ANB032, our investigational wholly owned anti-BTLA agonist antibody, recently demonstrated favorable safety and tolerability with no observed dose limiting toxicities and no serious adverse events (SAEs) reported, will be advancing with an IND filing for a Phase 2 clinical trial anticipated in Q4 2022.
Second Quarter Financial Results

Cash, cash equivalents and investments totaled $572.1 million as of June 30, 2022, compared to $615.2 million as of December 31, 2021, for a decrease of $43.1 million. The decrease relates primarily to cash used for operating activities offset by cash received from stock option exercises. Reiterate anticipated 2022 net cash burn of $90 to $100 million.
Collaboration revenue was $1.2 million and $2.2 million for the three and six months ended June 30, 2022, compared to $30.0 million and $41.3 million for the three months and six months ended June 30, 2021. The decrease relates primarily to two development milestones achieved for JEMPERLI for the three months ended June 30, 2021, and three development milestones achieved for JEMPERLI for the six months ended June 30, 2021, and no milestones achieved in 2022.
Research and development expenses were $20.8 million and $43.4 million for the three and six months ended June 30, 2022, compared to $25.3 million and $49.5 million for the three and six months ended June 30, 2021. The decrease was due primarily to reduced imsidolimab manufacturing costs and clinical costs for the Company’s programs. The R&D non-cash stock-based compensation expense was $1.8 million and $3.4 million for the three and six months ended June 30, 2022, as compared to $1.4 million and $2.6 million in the same period in 2021.
General and administrative expenses were $8.2 million and $18.4 million for the three and six months ended June 30, 2022, compared to $5.2 million and $10.7 million for the three and six months ended June 30, 2021. The increase was due primarily to $3.8 million of costs incurred from personnel changes in the first quarter of 2022 and non-cash stock compensation expense. The G&A non-cash stock-based compensation expense was $4.9 million and $11.0 million for the three and six months ended June 30, 2022, which includes $3.2 million of the $3.8 million one-time costs described earlier as compared to $2.3 million and $4.4 million in the same period in 2021.
Net loss was $32.6 million and $68.8 million for the three and six months ended June 30, 2022, or a net loss per share of $1.15 and $2.46, compared to a net loss of $0.4 million and $18.6 million for the three and six months ended June 30, 2021, or a net loss per share of $0.02 and $0.68.

On August 8, 2022 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for allergy, opioid overdose, respiratory and inflammatory disease, reported that it will host an investor conference call on Wednesday, August 10, 2022 at 1:30 p.m. Pacific Time to discuss its financial and operating results for the second quarter 2022 as well as provide a corporate update (Press release, Adamis Pharmaceuticals, AUG 8, 2022, View Source [SID1234617807]). The company’s press release concerning its second quarter 2022 financial results is expected to be available after 1 p.m. Pacific Time on August 10, 2022, and on its website.

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David J. Marguglio, President and CEO of Adamis, will host the call along with other members of the management team. The call is open to the public and will provide an update on recent developments, events that have taken place during the year, and certain goals for future periods. Forward-looking statements concerning expectations regarding future company performance may be made during the conference call.

A live audio webcast of the conference call will also be available via this link, with a replay available shortly after the live event.