On August 14, 2023 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, 2023 (Press release, LianBio, AUG 14, 2023, View Source [SID1234634365]).

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"During the first half of 2023, we achieved multiple clinical development milestones and advanced our pipeline closer to patients in need of new treatment options," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "Over the next twelve months, we are looking forward to our first anticipated approval in China, building and developing our cardiovascular sales force, filing an NDA to support approval of TP-03 in China, and initiating a pivotal trial of infigratinib in gastric cancer. We believe we are well positioned for LianBio’s first launches in our territories later this year when we begin to commercialize mavacamten in Singapore and Macau."

Recent Business Highlights and Clinical Development Updates

Mavacamten commercial preparation ongoing in China with NDA under priority review; Asia Pacific regulatory milestones achieved with Singapore and Macau approvals granted and additional NDA under review in Hong Kong

•In the second quarter of 2023, LianBio continued to progress the Company’s collaboration with the Chinese Cardiovascular Association (CCA) to develop HCM centers of excellence (COE), with 17 key hospitals now taking part in the CCA’s HCM COE pilot program.
•In July 2023, LianBio announced data from the Phase 3 EXPLORER-CN trial of mavacamten in Chinese symptomatic oHCM patients were accepted for a late-breaking presentation at the European Society of Cardiology (ESC) Congress 2023.
•In June 2023, mavacamten was approved for the treatment of adults with symptomatic oHCM in Singapore.
•In May 2023, mavacamten was approved for the treatment of adults with symptomatic New York Heart Association Class II-III oHCM in the Macau Special Administrative Region.
•In April 2023, LianBio announced topline results from the Phase 3 EXPLORER-CN trial evaluating mavacamten in Chinese patients with oHCM. EXPLORER-CN met the primary endpoint, demonstrating statistically significant and clinically meaningful improvement in Valsalva left ventricular outflow tract gradient from baseline to week 30 compared to placebo. Mavacamten also demonstrated improvement across all secondary endpoints. Mavacamten demonstrated a safety profile consistent with previous studies.

•In April 2023, the China NMPA accepted with priority review the NDA for mavacamten for the treatment of adults with symptomatic oHCM.
Registrational Phase 3 LIBRA clinical trial of TP-03 for the treatment of Chinese Demodex blepharitis patients completed enrollment; TP-03 approved in the United States
•In July 2023, LianBio partner Tarsus Pharmaceuticals announced the U.S. Food and Drug Administration’s approval of TP-03 for the treatment of adults with Demodex blepharitis.
•In June 2023, LianBio announced completion of enrollment in the Phase 3 LIBRA clinical trial of TP-03 in Chinese Demodex blepharitis patients. LianBio expects the LIBRA trial to support TP-03 registration in China.
Positive topline data announced from Phase 2a trial of infigratinib in Chinese patients with gastric cancer and receipt of Breakthrough Therapy Designation in China
•In June 2023, LianBio announced topline results from the Company’s Phase 2a proof of concept trial evaluating infigratinib in patients with third-line or later gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification. The trial demonstrated a confirmed objective response rate (ORR) of 25.0% (n=20). The observed mediation duration of response was 3.8 months.
•Based on these data, the NMPA granted Breakthrough Therapy Designation to infigratinib for the treatment of gastric cancer.
Phase 1 clinical trial of SHP2 inhibitor BBP-398 in combination with osimertinib in Chinese non-small cell lung cancer (NSCLC) patients with EGFR mutations initiated
•In August 2023, LianBio announced the initiation of a Phase 1 trial of BBP-398 in combination with osimertinib in Chinese NSCLC patients with EGFR mutations.
•In July 2023, LianBio entered into a clinical supply agreement with AstraZeneca in China to procure osimertinib for this clinical trial.
Commercial infrastructure build continues with Chief Commercial Officer appointment
•In April 2023, Pascal Qian was promoted to Chief Commercial Officer to oversee the continued growth of the company’s commercial capabilities. He will continue to also serve as the company’s China General Manager.
Business is well-positioned to achieve anticipated milestones
•Current cash runway is projected to extend into the first half of 2025.
Key Anticipated Milestones
Mavacamten
•LianBio expects to begin enrolling patients in BMS’s ongoing Phase 3 ODYSSEY-HCM trial of mavacamten in non-obstructive HCM (nHCM) in China in mid-2024.
•LianBio anticipates NDA approval in China in mid-2024, and commercial launch in China in the second half of 2024.
•LianBio expects to launch mavacamten in Singapore and Macau in the fourth quarter of 2023.
•LianBio plans to file NDAs to support mavacamten approval in Taiwan and Thailand in the fourth quarter of 2023.
TP-03
•LianBio expects to report topline data from the Phase 3 LIBRA trial of TP-03 in Chinese patients with Demodex blepharitis in the fourth quarter of 2023.
Infigratinib
•Data from the Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification were accepted for a poster presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, to be held October 20-24 in Madrid.
•LianBio expects to initiate a pivotal Phase 2 trial of infigratinib in locally advanced or metastatic gastric cancer patients with FGFR2 gene amplification in the first half of 2024 to support regulatory approval in China.
BBP-398
•LianBio expects to initiate a Phase 1 clinical trial of BBP-398 in combination with a PD-1 inhibitor in advanced solid tumors in the first half of 2024.

Second Quarter 2023 Financial Results

Research & Development Expenses

Research and development expenses were $9.5 million for the second quarter of 2023 compared to $28.6 million for the second quarter of 2022, and $20.3 million for the six month period ended June 30, 2023 compared to $40.9 million for the six month period ended June 30, 2022. The decrease was primarily attributable to increased milestone payments in 2022 and was partially offset by higher development activities to support clinical trials in 2023.

General & Administrative Expenses

General and administrative expenses were $15.6 million for the second quarter of 2023 compared to $14.6 million for the second quarter of 2022, and $30.7 million for the six month period ended June 30, 2023 compared to $30.6 million for the six month period ended June 30, 2022. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and was partially offset by lower expenses for legal, consulting and accounting services.

Net Loss

Net loss was $21.6 million for the second quarter of 2023 compared to net loss of $42.4 million for the second quarter of 2022, and $45.7 million for the six month period ended June 30, 2023 compared to $70.1 million for the six month period ended June 30, 2022.

Cash Balance

Cash, cash equivalents, marketable securities and restricted cash at June 30, 2023 totaled $267.3 million compared to $302.4 million as of December 31, 2022. LianBio projects its current cash, cash equivalents, marketable securities, and restricted cash will be sufficient to fund its current operating plan into the first half of 2025.

On August 14, 2023 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 difficult-to-treat cancers and rare genetic diseases, reported financial results and recent corporate highlights for the second quarter ended June 30, 2023 (Press release, Mustang Bio, AUG 14, 2023, View Source [SID1234634364]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "In the second quarter of 2023, Mustang continued to advance the development of our lead clinical candidate MB-106, a CD20-targeted, autologous CAR T cell therapy to treat relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL"). Data from the ongoing Phase 1/2 single-institution clinical trial at Fred Hutchinson Cancer Center ("Fred Hutch") presented at two prestigious medical meetings in June continue to demonstrate the promise of MB-106 as a viable outpatient treatment option with a favorable safety and efficacy profile. On a parallel track, our multicenter, open-label, non-randomized Phase 1/2 clinical trial continues to accrue patients and we expect to disclose initial data soon. In particular, MB-106 has the potential to fill a significant unmet need in many difficult-to-treat cancers including Waldenstrom macroglobulinemia ("WM"), as there are currently no CAR T treatments for WM approved by the U.S. Food and Drug Administration ("FDA"). We anticipate the results from our multicenter Phase 1 indolent lymphoma arm of the multicenter clinical trial to support an accelerated Phase 2 registration strategy for WM, with the first pivotal Phase 2 patient with WM to be treated potentially in the first quarter of 2024. We also plan to report more extensive safety and efficacy data from the multicenter trial later this year and to initiate a pivotal phase 2 trial in at least one additional B-cell malignancy later in 2024."

Dr. Litchman continued, "Mustang also announced a strategic transaction and partnership with uBriGene (Boston) Biosciences Inc. ("uBriGene"). Manufacturing support from uBriGene and its acquisition of our state-of-the-art clinical- and commercial-scale cell and gene therapy manufacturing facility allows us to significantly reduce annualized operating and interest expense by at least $28 million to ensure focus on data readouts for key programs and extend our cash runway."

Financial Results:

● As of June 30, 2023, Mustang’s cash and cash equivalents and restricted cash totaled $16.1 million, compared to $58.8 million at March 31, 2023, and $76.7 million as of December 31, 2022, a decrease of $42.7 million for the quarter and a decrease of $60.6 million year-to-date, which reflects the repayment of the Runway Term Loan in April 2023.
● Research and development expenses were $10.8 million for the second quarter of 2023, compared to $15.2 million for the second quarter of 2022. Non-cash, stock-based expenses included in research and development were $(0.1) million for the second quarter of 2023, compared to $0.4 million for the second quarter of 2022.
● General and administrative expenses were $3.1 million for the second quarter of 2023, compared to $3.1 million for the second quarter of 2022. Non-cash, stock-based expenses included in general and administrative expenses were $0.2 million for the second quarter of 2023, compared to $0.2 million for the second quarter of 2022.
● Net loss attributable to common stockholders was $16.2 million, or $2.00 per share, for the second quarter of 2023, compared to a net loss attributable to common stockholders of $19.1 million, or $2.50 per share, for the second quarter of 2022.
Recent Corporate Highlights:

● In July 2023, Mustang announced that the Company amended its previously announced asset purchase agreement with uBriGene, the U.S. subsidiary of uBriGene Group, a leading cell and gene therapy contract development and manufacturing organization, and closed the transaction. Per the terms of the amended asset purchase agreement, at closing, uBriGene acquired all of Mustang’s assets primarily relating to the manufacturing and production of cell and gene therapies at Mustang’s state-of-the-art clinical- and commercial-scale cell and gene therapy manufacturing facility in Worcester, Massachusetts, for upfront consideration of $6 million in cash. Mustang’s lease to the premises on which the facility is located (as well as related contracts and manufacturing personnel) did not transfer at closing because such transfer requires the consent of the landlord, which has requested additional time to consider the proposed transfer. An additional $5 million contingent payment will be payable to Mustang upon (i) Mustang’s raising $10 million in gross proceeds from equity raises following the closing of the transaction and (ii) completion of the assignment of Mustang’s lease to uBriGene, which remains subject to landlord’s approval, within two years of the closing. Until the lease is transferred to uBriGene, Mustang will retain its facility lease and facility personnel, and will continue to occupy the leasehold premises and manufacture its lead product candidate, MB-106, at that site.
● Mustang’s lead clinical candidate is MB-106, a CD20-targeted, autologous CAR T cell therapy to treat a wide range of hematologic malignancies, including WM and follicular lymphoma ("FL"). MB-106 continues to demonstrate a favorable safety and efficacy profile in both the Phase 1/2 Fred Hutch single institution and Mustang multicenter Phase 1/2 clinical trials.
● In June 2023, Phase 1/2 data from the WM cohort in the Fred Hutch clinical trial for MB-106 were presented in a poster session at the European Hematology Association (EHA) (Free EHA Whitepaper) 2023 Hybrid Congress. All six patients in the study were previously treated with Bruton’s tyrosine kinase inhibitors ("BTKi"), and their disease continued to progress while on BTKis. Overall, 83% (5/6) of the patients treated with MB-106 responded to treatment, including 2 complete responses ("CR"), 1 very good partial response ("VGPR"), 1 partial response ("PR") and 1 minor response. In addition, 1 patient experienced stable disease. One of the patients who achieved a CR has remained in remission for 22 months, with an immunoglobulin M ("IgM") level that decreased rapidly to the normal range after treatment with MB-106 and has remained normal since. No patient has started additional anti-WM treatment after being treated with MB-106. From a safety perspective, cytokine release syndrome ("CRS") occurred in five patients: two patients with grade 1 and three patients with grade 2. One patient experienced grade 1 immune effector cell-associated neurotoxicity syndrome ("ICANS"). No grade 3 or 4 CRS or grade 2, 3 or 4 ICANS has been observed.
● Also in June 2023, Fred Hutch presented MB-106 data from the FL cohort of its clinical trial in an oral presentation at the 17th International Conference on Malignant Lymphoma. A total of 20 patients with relapsed FL with confirmed CD20 expression participated in the study and had day 28 assessment.
Median age was 63 years (range: 44 – 81), and median prior lines of treatment was 4 (range: 1 – 12). High-risk features included patients with progression of disease within 24 months of first-line chemoimmunotherapy (POD24) (n=15, 75%), history of histologic transformation (n=4, 20%), and prior treatment with a CD19 target CAR T (n=1, 5%). Overall response rate ("ORR") was 95% (19/20), and CR rate was 80% (16/20). Patients who received higher dose levels (3.3 x 106 and 1.0 x 107 cells/kg) had an ORR of 100% and a CR rate of 91%. Ten patients are in remission over one year, seven of whom are over two years. One patient, previously treated with a CD19-targeted CAR T-cell therapy, achieved a CR and remains in remission after 18 months. From a safety profile perspective, all CRS events were grade 1 (n=5, 25%) or grade 2 (n=1, 5%), with no grade ≥ 3 CRS events. There was no occurrence of ICANS of any grade.
● In parallel, Mustang’s multicenter, open-label, non-randomized Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106, continues to accrue, and Mustang anticipates escalation to the final dose level in the Phase 1 indolent lymphoma arm in the third quarter of this year. The FDA granted Orphan Drug Designation to MB-106 for the treatment of WM, and results from this arm are expected to support an accelerated Phase 2 registration strategy for WM, with the first pivotal Phase 2 patient with WM to be treated potentially in the first quarter of 2024. Mustang plans to report initial safety and efficacy data from the multicenter trial soon, with additional safety and efficacy data from the trial expected in the fourth quarter. Finally, Mustang expects to initiate a pivotal phase 2 trial in at least one additional B-cell malignancy later in 2024.
● Mustang continues to collaborate with the Mayo Clinic to progress its exclusively licensed novel in vivo CAR T technology platform that may be able to transform the administration of CAR T therapies and has the potential to be used as an off-the-shelf therapy. Mustang anticipates the publication of proof-of-concept research in a murine tumor model in 2023.
● In April 2023, Mustang effected a 15-for-1 reverse stock split of its issued and outstanding common stock. Mustang’s common stock began trading on a split-adjusted basis on the Nasdaq Capital Market as of the commencement of trading on April 4, 2023.

On August 14, 2023 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported its financial results for the second quarter ended June 30, 2023 (Press release, Lisata Therapeutics, AUG 14, 2023, View Source [SID1234634363]).

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"The second quarter generated strong momentum for Lisata. We continued to advance multiple ongoing and planned clinical studies centered around our lead investigational product, LSTA1," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. "Of note, we implemented key changes to the Phase 2b ASCEND trial which now includes an additional cohort of subjects for the evaluation of a second dose of LSTA1 in patients with first-line, metastatic pancreatic ductal adenocarcinoma ("mPDAC"). We intend to use the results of ASCEND to explore possible conditional approvals globally and to design an optimized Phase 3 program. We also saw the initiation of the iLSTA study in Australia and the launch of our BOLSTER trial, which is the first fully sponsored study of LSTA1 by Lisata. Finally, we are delighted to announce that we have entered into a technology transfer agreement for our Tumor Penetrating Nanocomplex (TPN) Platform with Impilo Therapeutics, Inc. ("Impilo"), a newly formed company being led by former Lisata Chief Business Officer, David Slack. We are pleased that the TPN technology will be in the hands of a team of people with deep expertise in the field of RNA-based therapeutics development."

Dr. Mazzo continued, "Also, notably, in this quarter we took a number of cash conservation decisions which resulted in the extension of projected capital supporting operations into the first quarter of 2026. Now with more than two years of capital available on our balance sheet based on our current expected capital needs, we believe we are well-placed to focus on the execution of our development plans and achieve our goal of getting to meaningful clinical data readouts as soon as possible."

Development Portfolio Highlights

LSTA1 as a treatment for solid tumor cancers in combination with other anti-cancer agents
LSTA1 is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to penetrate solid tumors more effectively. LSTA1 actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor, while normal tissues are not expected to be affected. In preclinical models, LSTA1 has also shown the ability to modify the tumor microenvironment, thereby making tumors more susceptible to immunotherapies. Lisata and its development collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies and RNA-based therapeutics. To date, LSTA1 has also demonstrated favorable safety, tolerability and activity in completed and ongoing clinical trials designed to test its ability to enhance delivery of standard-of-care chemotherapy for pancreatic cancer. Currently, LSTA1 is the subject of multiple ongoing or planned Phase 1b/2a and 2b clinical studies being conducted globally in a variety of solid tumor types in combination with a variety of anti-cancer regimens. These studies include:

•ASCEND: Phase 2b double-blind, randomized, placebo-controlled clinical trial evaluating LSTA1 in patients with mPDAC. The trial is being conducted at up to 40 sites in Australia and New Zealand led by the Australasian Gastro-Intestinal Trials Group in collaboration with the University of Sydney and with the National Health and Medical Research Council Clinical Trial Centre at the University of Sydney as the Coordinating Centre. Enrollment completion is projected for the second quarter of 2024; however, current enrollment already exceeds 70% of the target, so earlier enrollment completion may be achieved.

•BOLSTER: Phase 2a placebo-controlled basket trial in the U.S., Europe, Canada, and Asia evaluating LSTA1 in combination with standards of care in advanced solid tumors including head and neck, esophageal and cholangiocarcinoma. Enrollment is now open and the Company hopes to soon announce the first patient treated.

•CENDIFOX: Phase 1b/2a open-label trial in the U.S. of LSTA1 in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon and appendiceal cancers. The trial continues to make steady progress with enrollment completion expected by the fourth quarter of 2023 and data readouts in 2024.

•LSTA1 is currently being evaluated in combination with gemcitabine and nab-paclitaxel in a Phase 1b/2a open-label trial in China led by Qilu Pharmaceutical. During the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting, Qilu Pharmaceutical presented an abstract sharing preliminary data from the study which, thus far, has corroborated previously reported findings from the phase 1b/2a trial of LSTA1 plus gemcitabine and nab-paclitaxel conducted in Australia in patients with mPDAC. Final data is expected by the end of the second quarter of 2024.

•iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia evaluating LSTA1 in combination with the checkpoint inhibitor, durvalumab, plus standard-of-care chemotherapy, nab-paclitaxel and gemcitabine, versus standard-of-care alone in patients with locally advanced non-resectable PDAC. Enrollment completion is expected by the end of the second quarter of 2024.

•The Company plans to study LSTA1 in combination with temozolomide in Glioblastoma Multiforme ("GBM"). This study is designed as a Phase 2a double-blind, placebo-controlled, randomized, proof-of-concept study evaluating LSTA1 when added to standard of care temozolomide versus temozolomide and matching LSTA1 placebo in subjects with newly diagnosed GBM. It will be conducted across multiple sites in Estonia and Latvia and is targeted to enroll 30 patients with a randomization of 2:1 LSTA1 + SoC versus Placebo + SoC. Target for first patient treated is in the fourth quarter of 2023. Importantly and as the Company recently announced, LSTA1 has been granted orphan designation by the U.S. FDA for malignant glioma.This action by the FDA not only highlights the unmet medical need but also recognizes the potential of LSTA1 to benefit patients in this indication.

•Lisata is also planning to study LSTA1 in combination with HIPEC interoperative intraperitoneal lavage in peritoneal carcinomatosis, which develops as a result of the contiguous spread of primary cancers such as ovarian, colorectal and appendiceal along the peritoneum. The study is a Phase I single-center, unblinded, randomized controlled trial to determine the safety and tolerability of

LSTA1 administered intraperitoneally in patients with peritoneal metastases from colorectal, appendiceal, or ovarian cancer undergoing Cytoreductive Surgery ("CRS") and HIPEC. Twenty-one total participants will be randomized 2:1 to receive LSTA1 with HIPEC versus HIPEC alone after CRS. We anticipate that this study will also be up and running in the fourth quarter of 2023 and the first patient being treated shortly thereafter.

Tumor Penetrating Nanocomplex (TPN) Platform Technology Transfer

The tumor penetrating nanocomplex (TPN) platform targets intracellular delivery of RNA-based drugs to prevent solid tumor growth. The TPN is designed so that it could not only bind a protein overexpressed on the surface of human cancer cells, but also pass through the membrane by way of a cell-penetrating peptide. Once inside the cells, the TPN is expected to release an RNA-based drug directed against the tumor. Lisata has agreed to transfer this technology to Impilo. Under the terms of the technology transfer agreement, Lisata will receive an equity stake in Impilo upon closing. Lisata is not obliged to commit any capital or additional resources to the program’s future development.

Second Quarter 2023 Financial Highlights

Research and development expenses remained constant at approximately $3.2 million for the three months ended June 30, 2023 and three months ended June 30, 2022. Expenses this quarter were primarily due to study start up activities associated with the LSTA1 BOLSTER trial, enrollment activities for the LSTA1 ASCEND study and chemistry, manufacturing and control (CMC) activities for LSTA1 to support all development activities.
General and administrative expenses were approximately $3.7 million for the three months ended June 30, 2023, compared to $3.5 million for the three months ended June 30, 2022, representing an increase of $0.2 million or 6.5%. This was primarily due to severance costs associated with the elimination of the Chief Business Officer position on May 1, 2023, partially offset by non-recurring merger related costs in the prior year.
Overall, net losses were $4.0 million for the three months ended June 30, 2023, compared to $6.6 million for the three months ended June 30, 2022, a decrease of approximately 40% primarily due to $2.2 million in non-dilutive funding received as an approved participant of the Technology Business Tax Certificate Transfer Program sponsored by the New Jersey Economic Development Authority.

Balance Sheet Highlights

As of June 30, 2023, the Company had cash, cash equivalents and marketable securities of approximately $57.6 million. Based on its current expected capital needs, the Company believes that its projected capital will fund its current proposed operations into the first quarter of 2026 encompassing anticipated data milestones from all its ongoing and planned clinical trials.

Conference Call Information

Lisata will hold a live conference call on Tuesday, August 15, 2023, at 8:30 a.m. Eastern time to discuss financial results, provide a business update and answer questions.

Those wishing to participate must register for the conference call by way of the following link: CLICK HERE TO REGISTER. Registered participants will receive an email containing conference call details with dial-in options. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time.
A live webcast of the call will also be accessible under the Investors & News section of Lisata’s website and will be available for replay beginning two hours after the conclusion of the call for 12 months.

On August 14, 2023 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold placed on the company’s CART-ddBCMA investigational new drug for the treatment of patients with relapsed or refractory multiple myeloma (rrMM) and reported financial results for the second quarter ended June 30, 2023 (Press release, Arcellx, AUG 14, 2023, View Source [SID1234634362]).

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"We have worked closely with FDA to expeditiously resolve the clinical hold and we thank them for their collaboration and dialogue throughout this process," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "During the review process, we updated our trial protocol, and were pleased that FDA allowed for expanded bridging therapies, which better aligns our protocol with current clinical practice. As a key step to enhancing protocol adherence related to the prevention and management of the risk of adverse events, we retrained clinical sites. Importantly, during the partial clinical hold, FDA approved dosing of all 17 patients who had been enrolled but not yet dosed prior to the hold, minimizing treatment disruption for patients and clinicians. We and our partners at Kite remain confident in CART-ddBCMA’s potential as a best-in-class therapy for the treatment of patients with rrMM given the totality of data to date across our studies. We have a strong balance sheet funding operations through BLA filing and into 2026. We look forward to presenting data from our Phase 1 study later this year as well as preliminary data from the iMMagine-1 study in the second half of 2024. Additionally, we continue to expect commercial launch of CART-ddBCMA to be in 2026."

Recent Business Progress

Announced clinical hold and clinical hold lifted by FDA for the company’s iMMagine-1 Phase 2 Clinical Program. On June 19, 2023, Arcellx announced that its iMMagine-1 study had been placed on partial clinical hold by FDA following a recent patient death, which involved a patient who was treated with CART-ddBCMA despite becoming ineligible for treatment under the trial protocol prior to CART-ddBCMA infusion. Subsequently, the patient was managed in a manner that conflicted with the trial protocol. On August 14, 2023, Arcellx announced that FDA had lifted the partial clinical hold after aligning with FDA on modifications to the iMMagine-1 trial protocol related to the prevention and management of the risk of adverse events within the trial. As a key effort to enhance protocol adherence, Arcellx retrained clinical sites. Additionally, FDA allowed an expansion of treatment options for therapies that patients in the iMMagine-1 trial are permitted to receive between apheresis and CAR-T infusion (also known as bridging therapies) to better align its protocol with current clinical practice. The company anticipates presenting preliminary data from the iMMagine-1 study in the second half of 2024.

Second Quarter 2023 Financial Highlights

Cash, cash equivalents, and marketable securities:
As of June 30, 2023, Arcellx had cash, cash equivalents, and marketable securities of $506.5 million. Arcellx anticipates that its cash, cash equivalents, and marketable securities will fund its operations into 2026.

Collaboration revenue:
Collaboration revenue was $14.3 million and $0 for the quarters ended June 30, 2023 and 2022, respectively. The revenue results for the three months ended June 30, 2023 is from the recognition of research and development performed under the arrangement described in the recent license and collaboration agreement with Kite Pharma, Inc. (Kite). Revenue is being recognized on a percentage of completion basis over the term of the contract with Kite.

R&D expenses:
Research and development expenses were $28.3 million and $22.1 million for the quarters ended June 30, 2023 and 2022, respectively, an increase of $6.2 million. This increase was primarily driven by higher external costs associated with the advancement of the company’s CART-ddBCMA clinical program and personnel.

G&A expenses:
General and administrative expenses were $15.5 million and $9.2 million for the quarters ended June 30, 2023 and 2022, respectively, an increase of $6.3 million. This increase was driven by primarily by personnel and professional fees.

Net loss:
Net loss was $23.9 million and $30.8 million for the quarters ended June 30, 2023 and 2022, respectively.

On August 14, 2023 CohBar, Inc. (NASDAQ: CWBR) reported its financial results and highlights for the second quarter ended June 30, 2023 (Press release, CohBar, AUG 14, 2023, View Source [SID1234634361]).

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Second Quarter 2023 Summary and Financial Results

● Entered into Definitive Merger Agreement with Morphogenesis: In May 2023, CohBar announced that the company entered into a definitive merger agreement with a privately held biotechnology company, Morphogenesis, Inc. ("Morphogenesis"), for an all-stock transaction to advance a late-stage oncology pipeline. The combined company is expected to operate under the name "TuHURA Biosciences, Inc." and to trade on The Nasdaq Capital Market ("Nasdaq"). The transaction is expected to close in the fourth quarter of 2023.

● Cash, Cash Equivalents and Investments: The company had cash, cash equivalents and investments of $12.3 million as of June 30, 2023, compared to $15.7 million as of December 31, 2022.

● R&D Expenses: Research and development expenses were $0.2 million for the three months ended June 30, 2023, compared to $1.2 million in the prior year quarter. The lower research and development expenses are due to the suspension of our development activities.

● G&A Expenses: General and administrative expenses were $4.3 million for the three months ended June 30, 2023, compared to $1.6 million in the prior year quarter. The increase in general and administrative expenses was primarily due to costs related to the merger with Morphogenesis and compensation charges incurred related to the retention of our key executives.

● Net Loss: For the three months ended June 30, 2023, net loss, which included $0.3 million of non-cash expenses, was $4.3 million, or $1.49 per basic and diluted share. For the three months ended June 30, 2022, net loss, which included $0.5 million of non-cash expenses, was $2.7 million, or $0.94 per basic and diluted share.