On August 11, 2022 LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, LianBio, AUG 11, 2022, View Source [SID1234618141]).

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"In the second quarter, LianBio achieved meaningful milestones that we believe serve as a testament to our strength in navigating the complex regulatory environments in Greater China and Asia," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "We continue to grow our organization, bringing on key new team members across clinical, medical affairs, quality and commercial functions. Despite clinical site and agency disruptions due to COVID-19 lockdowns in Shanghai and other cities in China, LianBio continued to execute our key clinical development and regulatory priorities, completing enrollment in the Phase 3 EXPLORER-CN trial of mavacamten and submitting marketing applications for both mavacamten and infigratinib in Asia Pacific territories. We believe the enthusiasm for mavacamten’s potential as a treatment for obstructive hypertrophic cardiomyopathy (oHCM) among both the clinical community and the world’s largest oHCM population is high, and we expect to report topline results from EXPLORER-CN in mid-2023. As we work to complete the EXPLORER-CN study over the coming months to support registration in China, we turn our focus to potential launch and preparations for LianBio’s next phase of evolution as a commercial-stage company. We remain on track to initiate three additional registration-enabling clinical programs in China this year, solidifying our position as a key partner in cross-border drug development. I am continually proud of our global team’s efforts to bring innovative medicines to patients in Asia."

Recent Business Highlights and Clinical Development Updates

Mavacamten progress continues in Asia with enrollment completed in China Phase 3 trial and New Drug Application submitted in Singapore

In May 2022, LianBio submitted an NDA to the Singapore Health Sciences Authority for mavacamten for the treatment of adults with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy (oHCM). The submission was based on the U.S. Food and Drug Administration (FDA) approval of mavacamten.
In August 2022, enrollment was completed in the Phase 3 EXPLORER-CN clinical trial of mavacamten in Chinese patients with oHCM.
Infigratinib New Drug Application in 2nd line cholangiocarcinoma submitted in Hong Kong

In July 2022, LianBio submitted an NDA to the Department of Health, the Hong Kong Special Administrative Region, China, for infigratinib for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. The submission was based on the FDA approval of infigratinib.
Development partner ReViral Ltd. acquired by Pfizer Inc.

In June 2022, Pfizer completed its acquisition of LianBio’s development partner ReViral and its respiratory syncytial virus therapeutic candidates, including sisunatovir. LianBio holds development and commercial rights to sisunatovir in mainland China, Hong Kong, Macau and Singapore.
LYR-210 clinical development program refined

LianBio plans to conduct a Phase 3 China standalone trial to support regulatory approval in China, leveraging the results of development partner Lyra’s ongoing Phase 3 trial, which is expected to complete enrollment in mid-2023.
Development partner Tarsus advances TP-03 into clinical trial in second indication

In August 2022, LianBio’s development partner Tarsus initiated a Phase 2a clinical trial of TP-03 in patients with meibomian gland disease (MGD).
Development partner Landos Biopharma reports data from NX-13 program

In August 2022, Landos announced topline results from a Phase 1b clinical trial of NX-13 demonstrating NX-13 was well tolerated. Based on these data, Landos plans to initiate a Phase 2 clinical trial to evaluate the safety, efficacy and optimal dosing of NX-13 in ulcerative colitis patients.
Business is well-positioned to achieve anticipated milestones

Current cash runway is projected to extend into the second half of 2024.
Key Milestones Anticipated in 2022 and 2023

Mavacamten

LianBio expects to report topline data from the Phase 3 EXPLORER-CN trial of mavacamten in Chinese patients with symptomatic oHCM in mid-2023.
TP-03

LianBio expects to initiate a Phase 3 study in Chinese patients with Demodex blepharitis in the second half of 2022. LianBio expects this study will support registration of TP-03 in China.
NBTXR3

LianBio expects to begin dosing patients in Nanobiotix’s global Phase 3 NANORAY-312 clinical trial of NBTXR3 for the treatment of locally advanced head and neck squamous cell carcinoma in elderly patients ineligible for cisplatin in the second half of 2022. LianBio expects this study will support registration of NBTXR3 in China and other LianBio-licensed territories in Asia.
Infigratinib

Enrollment is ongoing in LianBio’s Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR genomic alterations.
LianBio expects to begin dosing Chinese patients in Helsinn’s ongoing global pivotal Phase 3 PROOF-301 clinical trial of infigratinib in first-line cholangiocarcinoma (CCA) patients with FGFR2 gene fusions/translocations in the second half of 2022.
BBP-398

LianBio expects to initiate a Phase 1 monotherapy clinical trial of BBP-398 in advanced solid tumors in the fourth quarter of 2022.
LianBio also expects to initiate a Phase 1 clinical trial of BBP-398 in combination with an EGFR-inhibitor in non-small cell lung cancer in the first half of 2023.
Second Quarter 2022 Financial Results

Research & Development Expenses
Research and development expenses were $28.6 million for the second quarter of 2022 compared to $93.0 million for the second quarter of 2021, and $40.9 million for the six month period ended June 30, 2022 compared to $146.4 million for the six month period ended June 30, 2021. The decrease was primarily attributable to increased milestone payments in 2021, and was offset by higher development activities to support clinical trials and personnel-related expenses in 2022.

General & Administrative Expenses
General and administrative expenses were $14.6 million for the second quarter of 2022 compared to $6.5 million for the second quarter of 2021, and $30.6 million for the six month period ended June 30, 2022 compared to $13.6 million for the six month period ended June 30, 2021. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and higher expense for legal, consulting and accounting services.

Net Loss
Net loss was $42.4 million for the second quarter of 2022 compared to net loss of $100.4 million for the second quarter of 2021, and $70.1 million for the six month period ended June 30, 2022 compared to $162.0 million for the six month period ended June 30, 2021.

Cash Balance
Cash, cash equivalents, marketable securities and restricted cash at June 30, 2022 totaled $349.4 million compared to $403.2 million as of December 31, 2021. LianBio projects its current cash, cash equivalents, marketable securities, and restricted cash will be sufficient to fund its current operating plan into the second half of 2024.

On August 11, 2022 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported business updates and financial results for the second quarter ended June 30, 2022 (Press release, Poseida Therapeutics, AUG 11, 2022, View Source [SID1234618140]).

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"We continue to advance our pipeline in both cell and gene therapy, powered by strategic collaborations that validate our unique genetic engineering platform technologies while giving us access to resources and non-dilutive capital," said Mark Gergen, Chief Executive Officer of Poseida. "In cell therapy, we recently announced a broad partnership with Roche focused on developing allogeneic CAR-T cell therapies in hematologic malignancies, including P-BCMA-ALLO1 in multiple myeloma, while preserving a large opportunity for Poseida within the solid tumor space. We look forward to delivering on future milestones with Roche in cell therapy, with our partner Takeda in liver- and HSC-directed in vivo gene therapy, as well as our internal programs in both cell and gene therapy as we continue to execute on future opportunities for growth."

Business Development Update

Cell Therapy Collaboration with Roche

In August, the Company announced it had entered into a strategic collaboration and license agreement with Roche focused on the research and development of allogeneic CAR-T cell therapies directed to hematologic malignancies utilizing Poseida’s proprietary genetic engineering platforms.

Under the agreement, Roche will receive from Poseida either exclusive rights or options to develop and commercialize a number of allogeneic CAR-T programs in Poseida’s portfolio that are directed to hematologic malignancies, including P-BCMA-ALLO1, an allogeneic CAR-T for the treatment of relapsed/refractory multiple myeloma, or R/R MM, and for which a Phase 1 study is underway, and P-CD19CD20-ALLO1, an allogeneic dual CAR-T for the treatment of B cell malignancies. The Company anticipates an IND filing and initiation of a Phase 1 clinical trial for P-CD19CD20-ALLO1 in the first half of 2023.

Poseida will receive $110.0 million upfront from Roche and could receive up to $110.0 million in near-term fees and milestone and other payments. In addition, subject to Roche exercising its options and contingent on achievement of specified development, regulatory, and net sales milestone events, Poseida is eligible to receive payments potentially up to $6.0 billion in aggregate value, as well as tiered net sales royalties into the low double digits, across the multiple programs.

For a subset of both the Poseida portfolio programs licensed or optioned to Roche and the parties’ future collaboration programs, Poseida will conduct the Phase 1 studies and manufacture clinical materials before transitioning the programs to Roche for further development and commercialization. Roche will be solely responsible for the late-stage clinical development and global commercialization of all products that are subject to the collaboration. The effectiveness of the agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, or HSR Act.

Program Updates

The Company currently has three ongoing CAR-T programs in the clinic, including two allogeneic CAR-T programs progressing in Phase 1 clinical trials:

BCMA Program

P-BCMA-ALLO1 is an allogeneic CAR-T program targeting R/R MM. The Company is currently evaluating P-BCMA-ALLO1 in a Phase 1 clinical trial and this program is now partnered with Roche. Poseida expects initial clinical data from its Phase 1 clinical trial in the second half of 2022 subject to coordination with its partner, Roche.

MUC1C Program

P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate targeting solid tumors derived from epithelial cells, including breast and ovarian cancers. Poseida is currently evaluating P-MUC1C-ALLO1 in a Phase 1 clinical trial, with an initial clinical data update on the program expected in the second half of 2022.

PSMA Program

P-PSMA-101 is a solid tumor autologous CAR-T product candidate targeting prostate-specific membrane antigen, or PSMA, being developed to treat patients with metastatic castrate-resistant prostate cancer, or mCRPC, and the Company has recently added salivary gland carcinoma to its clinical protocol. Poseida is currently evaluating P-PSMA-101 in a Phase 1 clinical trial and presented encouraging preliminary results from its Phase 1 clinical trial of P-PSMA-101 in its first solid tumor indication on February 2022 at ASCO (Free ASCO Whitepaper)-GU. The Company may provide a further clinical update at a scientific meeting or forum, likely in 2023. Poseida also has a second-generation program, P-PSMA-ALLO1, which is an allogeneic program, targeting PSMA utilizing a VH binder, in preclinical development.

Liver-Directed Gene Therapy Programs

Poseida is advancing multiple gene therapy programs in liver-directed diseases, including its wholly-owned P-OTC-101 program for the in vivo treatment of the urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene. The Company has made the decision to develop the P-OTC-101 program utilizing a hybrid delivery system and is working on an updated timeline for the program.

Poseida is also advancing its P-FVIII-101 program partnered with Takeda, which is in development for the in vivo treatment of Hemophilia A. P-FVIII-101 utilizes piggyBac gene modification delivered

via lipid nanoparticle that has demonstrated stable and sustained Factor VIII expression in animal models.

Other Business and Board Leadership Updates

Underwritten Public Offering

On August 8, 2022, the Company completed the sale of an aggregate of 23,000,000 shares of its common stock in an underwritten public offering, at a price of $3.50 per share, including 3,000,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares. The net proceeds to Poseida from the offering were approximately $75.3 million after deducting underwriting discounts and commissions and estimated offering expenses.

George M. Church, Ph.D., to Chair Poseida’s Gene Therapy Scientific Advisory Board

In July 2022, the Company announced that renowned geneticist George M. Church, Ph.D., will serve as chair of the Company’s newly formed Gene Therapy Scientific Advisory Board. In this role, Dr. Church will provide advice and counsel on the research and development efforts that drive the Company’s innovative gene therapies.

Charles M. Baum, M.D., Ph.D., Appointed to Board of Directors

In May 2022, Charles M. Baum, M.D., Ph.D., was appointed to the Company’s Board of Directors. Dr. Baum is currently President, Head of Research and Development, and a member of the Board of Directors at Mirati Therapeutics Inc., a company he founded and where he served as CEO from 2012 to 2021.

Financial Results for the Second Quarter 2022

Revenues

Revenues were $2.7 million for the second quarter ended June 30, 2022, and $4.1 million for the six months ended June 30, 2022, consisting of revenue earned from the collaboration and license agreement with Takeda that the Company entered into in the fourth quarter of 2021, compared to no revenue for the same periods in 2021.

Research and Development Expenses

Research and development expenses were $35.0 million for the three months ended June 30, 2022, compared to $36.0 million for the same period in 2021. The decrease was primarily due to the wind-down of the Company’s P-BCMA-101 autologous program as the Company transitions to the allogeneic program, offset by an increase in active clinical programs and personnel costs to support those efforts.

For the six months ended June 30, 2022, research and development expenses were $83.9 million, compared to $65.1 million for the same period in 2021. The increase was primarily due to the contract termination to reduce the Company’s autologous manufacturing footprint, costs related to its clinical stage programs from an increase in the number of ongoing clinical trials, and personnel expenses to support these efforts, offset by the wind-down of the Company’s P-BCMA-101 autologous program.

General and Administrative Expenses

General and administrative expenses for the three months ended June 30, 2022 and 2021, were $9.2 million and $8.9 million, respectively. For the six months ended June 30, 2022 and 2021, general and administrative expenses were $18.8 million and $17.2 million, respectively. The increases were primarily related to an increase in personnel expenses due to an increase in headcount, which included an increase in stock-based compensation expense.

Net Loss

Net loss was $43.0 million and $101.1 million for the three and six months ended June 30, 2022, respectively, compared to net loss of $45.7 million and $84.0 million for the three and six months ended June 30, 2021, respectively.

Cash Position

As of June 30, 2022, the Company’s cash, cash equivalents and short-term investments balance was $142.6 million, excluding approximately $75.3 million of the net proceeds from the underwritten public offering that Poseida received in August 2022 and $110.0 million of the upfront payment from Roche that the Company, subject to HSR Act clearance, expects to receive in 2022. Poseida expects that its cash, cash equivalents and short-term investments together with expected upfront and near-term fees and milestones other payments from Roche and proceeds from its recent public offering will be sufficient to fund operations into at least mid-2024.

On August 11, 2022 Athenex, Inc. ("Athenex") (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported the pricing of its underwritten public offering of 35,333,334 shares of its common stock and accompanying warrants to purchase up to 35,333,334 shares of common stock at a combined public offering price of $0.75 per share and accompanying warrant and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to 4,666,666 shares of its common stock and accompanying warrants to purchase up to 4,666,666 shares of common stock at a combined public offering price of $0.749 per share and accompanying warrant (Press release, Athenex, AUG 11, 2022, View Source [SID1234618139]). The pre-funded warrants have an exercise price of $0.001 per share, are exercisable immediately, and will expire five years following the date of issuance. The warrants have an exercise price of $1.00 per share, are exercisable immediately, and will expire five years following the date of issuance. The gross proceeds to Athenex from the offering, before underwriting discounts and commissions and offering expenses, are expected to be approximately $30 million. The offering is expected to close on August 15, 2022, subject to customary closing conditions.

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Athenex intends to use the net proceeds from the proposed offering to fund ongoing clinical development for its product candidates and for working capital and other general corporate purposes.

SVB Securities is acting as sole book-running manager for the offering.

The offering is being made only by means of a previously filed effective registration statement (including a base prospectus) and a preliminary prospectus supplement. Copies of the final prospectus supplement and accompanying prospectus, when available, may also be obtained from: SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [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 by 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 under the securities laws of any such state or jurisdiction.

On August 11, 2022 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported financial results and recent corporate highlights for the second quarter ended June 30, 2022 (Press release, Mustang Bio, AUG 11, 2022, View Source [SID1234618138]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are very pleased with the significant clinical and regulatory milestones achieved in the first half of 2022 for our portfolio of cell and gene therapies. Interim Phase 1/2 data on MB-106, our CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHLs") and chronic lymphocytic leukemia ("CLL"), were presented at several prestigious medical meetings. MB-106 continues to demonstrate high efficacy and a favorable safety profile across all patients with a wide range of hematologic malignancies including follicular lymphoma ("FL"), CLL, diffuse large B-cell lymphoma ("DLBCL") and Waldenstrom macroglobulinemia ("WM"), with no cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome greater than grade 2. Additionally, the U.S. Food and Drug Administration ("FDA") granted Orphan Drug Designation to MB-106 for WM, a rare type of B-NHL. We are excited by the continued progress of MB-106 and anticipate dosing the first patient shortly in a multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL under Mustang’s Investigational New Drug application ("IND"). Furthermore, we expect to enroll 3 to 6 patients in this trial by the end of 2022 and to disclose data from both the single-center Fred Hutch trial and the multicenter Mustang trial in the fourth quarter of this year. We also continued to advance our recurrent glioblastoma ("rGBM") clinical program. Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2022 support the safety of administering our two clinical candidates, MB-108 (Nationwide Children’s herpes simplex virus type 1 oncolytic virus) and MB‐101 (City of Hope’s IL13Rα2‐targeted CAR T cell therapy), sequentially to optimize treatment in a regimen designated as MB-109, for which we plan to file an IND in 2023."

"Mustang is pleased to be a leader in the development of gene therapy treatments for severe combined immunodeficiency ("SCID") patients. Interim Phase 1/2 data on treatment with the same lentiviral vector used in MB-107, our ex vivo lentiviral gene therapy for X-linked SCID ("XSCID") in newly diagnosed infants under the age of two, presented at the American Society of Gene & Cell Therapy ("ASGCT") 25th Annual Meeting showed all 23 treated patients were alive at 2.6-year median follow-up without evidence of malignant transformation, and the treatment established a stable, functioning immune system in patients. We also announced that the first patient successfully received LV-RAG1 ex vivo lentiviral gene therapy to treat recombinase-activating gene-1 ("RAG1") SCID ("RAG1-SCID"), in an ongoing Phase 1/2 multicenter clinical trial taking place in Europe. Mustang has exclusively licensed LV-RAG1 for the development of MB-110, a first-in-class ex vivo lentiviral gene therapy for RAG1-SCID. XSCID and RAG1-SCID make up almost 60% of all SCID cases combined. We look forward to the continued advancement of our SCID clinical program, including our anticipated initiation in 2023 under Mustang’s IND of multicenter pivotal Phase 2 trials for both MB-107 in newborn XSCID patients and MB-207 in previously transplanted XSCID patients."

Recent Corporate Highlights:

In April 2022, Mustang announced that interim Phase 1/2 clinical trial data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell NHL and CLL, were presented at the 2022 Tandem Meetings I Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research. Data demonstrated high efficacy and a favorable safety profile in all patients (n=25). Five dose levels were used during the study, and CRs were observed at all dose levels. Durable responses were observed in a wide range of hematologic malignancies including FL, CLL, DLBCL, and WM. An overall response rate ("ORR") of 96% and a complete response rate ("CR") of 72% were observed in all patients across all dose levels. Within the next 60 days, Mustang expects to dose the first patient in a multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL, and further expects to enroll 3 to 6 patients in this trial by the end of 2022.
Also in April 2022, MB-106 data focused on CLL were presented at the 4th International Workshop on CAR-T and Immunotherapies.
Additionally, in April 2022, Mustang announced interim data from two ongoing investigator-sponsored Phase 1 clinical trials evaluating two clinical candidates, MB‐101 (IL13Rα2‐targeted CAR T cell therapy licensed from City of Hope) and MB-108 (herpes simplex virus type 1 oncolytic virus licensed from Nationwide Children’s Hospital) for the treatment of recurrent glioblastoma ("rGBM"). The data were from a late-breaking poster presented at the AACR (Free AACR Whitepaper) Annual Meeting 2022. Preclinical data also presented support the safety of administering these two therapies sequentially to optimize treatment in a regimen designated as MB-109. Mustang expects to file an IND in 2023 to initiate an MB-109 Phase 1 clinical trial.
In May 2022, interim Phase 1/2 data on treatment with the same lentiviral vector used in MB-107, Mustang’s lentiviral gene therapy for XSCID, also known as bubble boy disease, in newly diagnosed infants under the age of two, were presented in an oral presentation during the Clinical Trials Spotlight Symposium at the ASGCT (Free ASGCT Whitepaper) 25th Annual Meeting. The presentation included updated data from a multicenter Phase 1/2 clinical trial for XSCID in newly diagnosed infants under the age of two at St. Jude Children’s Research Hospital, UCSF Benioff Children’s Hospital in San Francisco and Seattle Children’s Hospital. All 23 treated patients were alive at 2.6-year median follow-up without evidence of malignant transformation.
In June 2022, MB-106 CD20-targeted autologous CAR T cell therapy data were presented in an oral session at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress. Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutchinson Cancer Center and University of Washington presented updated interim data from the ongoing Phase 1/2 clinical trial for B-NHL and CLL. Data presented included a 94% ORR and 78% CR in 18 patients with FL. Overall, for the 26 patients treated on the trial, there was a 96% ORR and 73% CR, including complete responses in both DLBCL patients, both WM patients, and both patients previously treated with CD19-targeted CAR-T therapy (1 DLBCL patient and 1 FL patient).
Also in June 2022, the FDA granted Orphan Drug Designation to MB-106 CD20-targeted autologous CAR T cell therapy for the treatment of WM, a rare type of B-NHL.
In July 2022, Mustang announced that the first patient successfully received LV-RAG1 ex vivo lentiviral gene therapy to treat RAG1-SCID, in an ongoing Phase 1/2 multicenter clinical trial taking place in Europe. LV-RAG1 is exclusively licensed by Mustang for the development of MB-110, a first-in-class ex vivo lentiviral gene therapy for the treatment of RAG1-SCID.
In 2023, Mustang expects to enroll the first patient in a pivotal multicenter Phase 2 clinical trial under Mustang’s IND to evaluate MB-107, a lentiviral gene therapy for the treatment of infants under the age of two with XSCID.
Mustang filed an IND application in December 2021 for its pivotal multicenter Phase 2 clinical trial of MB-207, a lentiviral gene therapy for the treatment of patients with XSCID who have been previously treated with hematopoietic stem cell transplantation ("HSCT") and for whom re-treatment is indicated. The trial is currently on hold pending CMC clearance from the FDA and, based on feedback from the Agency, Mustang expects to enroll the first patient in a pivotal multicenter Phase 2 clinical trial in 2023.
Financial Results:

As of June 30, 2022, Mustang’s cash and cash equivalents and restricted cash totaled $108.4 million, compared to $123.2 million at March 31, 2022 and $110.6 million as of December 31, 2021, a decrease of $14.8 million for the quarter and a decrease of $2.2 million year-to-date.
Research and development expenses were $15.2 million for the second quarter of 2022, compared to $11.9 million for the second quarter of 2021. Non-cash, stock-based expenses included in research and development were $0.4 million for the second quarter of 2022, compared to $0.3 million for the second quarter of 2021.
General and administrative expenses were $3.1 million for the second quarter of 2022, compared to $2.5 million for the second quarter of 2021. Non-cash, stock-based expenses included in general and administrative expenses were $0.2 million for the second quarter of 2022, compared to $0.2 million for the second quarter of 2021.
Net loss attributable to common stockholders was $19.1 million, or $0.19 per share, for the second quarter of 2022, compared to a net loss attributable to common stockholders of $14.4 million, or $0.16 per share, for the second quarter of 2021.

On August 11, 2022 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company advancing precision medicine through its innovative transcriptome-wide profiling technology, reported recent business highlights and financial results for the quarter ended June 30, 2022 (Press release, HTG Molecular Diagnostics, AUG 11, 2022, View Source [SID1234618137]).

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Throughout the quarter ended June 30, 2022, the Company’s technology and strategic development efforts were highlighted in a number of customer and KOL presentations and publications including, but not limited to, the following:

A webinar titled "Integration of the HTG Transcriptome Panel into Preclinical and Clinical Programs to Drive Precision Medicine Research" featuring Pete Ansell, Ph.D., Scientific Director and Research Fellow, Precision Medicine Oncology at AbbVie, addressed how Dr. Ansell and his team at AbbVie have overcome many challenges they have previously faced using FFPE clinical samples by integrating the HTG Transcriptome Panel (HTP) into their biomarker strategies.

In a keynote presentation at the 7th Annual Markets and Markets Biomarker and Companion Diagnostics Conference in San Diego, CA, titled "Implementing Biomarker Strategy in Clinical Trials," Chetan Deshpande, Director, Biomarker Clinical Assay Lead, Global Product Development at Pfizer discussed the challenges that are generally faced in clinical trials and how Pfizer has leveraged HTG’s proprietary gene expression profiling HTG EdgeSeq technology in multiple clinical trials to overcome these challenges.

The first peer-reviewed journal article featuring our HTP was published by one of the participants in our Early Adopter Program in Frontiers in Medicine less than one year after the commercial release of the product.

The Company published a second white paper, further establishing the utility of its transcriptome-informed approach to drug design and discovery utilizing its proprietary HTG EdgeSeq technology.

A webinar addressing "Drug Candidate Attrition – How to Improve Clinical Development Success and Patent Outcomes," including a presentation from key opinion leader, Dr. Robert Spitale, PhD, University of California – Irvine, further outlined the potential uses of RNA-based platform technologies in drug discovery.
In July 2022, the Company entered into an amendment to its June 24, 2020 Loan and Security Agreement ("LSA") with its lender, Silicon Valley Bank. Under the terms of the amendment, Silicon Valley Bank agreed to waive the existing financial covenant through the remaining term of the LSA in exchange for a partial prepayment of outstanding principal. The remaining principal will continue to amortize through December 2023, the original maturity date of the term loan.

Second Quarter 2022 Financial Highlights:

Revenue for the quarter ended June 30, 2022 was $1.5 million, compared with $2.1 million for the same period in 2021, and was comprised entirely of product and product-related services revenue. Sales of the HTP to new and existing customers as consumables and sample processing services represented over 42% of revenue for the quarter ended June 30, 2022.

Net loss from operations for the quarter ended June 30, 2022 was $5.7 million, compared with $4.1 million for the same period in 2021. Net loss per share was $(0.54) for the quarter ended June 30, 2022 compared with $(0.39) for the second quarter of 2021.

Cash, cash equivalents and short-term available-for-sale securities totaled $14.1 million as of June 30, 2022, with current liabilities of approximately $10.2 million and non-current liabilities of $6.5 million.

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time.