On August 15, 2022 Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a biopharmaceutical company focused on autoimmune diseases, reported second quarter 2022 results and provided a business update (Press release, Tocagen, AUG 15, 2022, View Source [SID1234618355]).

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"Forte is excited to continue down our new path as we develop novel compounds for the treatment of autoimmune diseases, including potentially graft versus host disease (GvHD), vitiligo and alopecia areata which represent combined markets of over $6 billion." said Paul Wagner, Ph.D., President and Chief Executive Officer of Forte Biosciences. "We expect FB-102, our lead molecule, to be in the clinic late 2023 or early 2024. We believe that our innovative approach to treating autoimmune disease has the potential to drive significant value for Forte shareholders. Beyond FB-102 we will continue to strategically evaluate opportunities to create value for shareholders."

Second Quarter 2022 Business Highlights

In May 2022, Forte appointed Steve Doberstein, Ph.D. to its board of directors, which further strengthened Forte’s board of directors. Dr. Doberstein previously served at the Chief Research and Development Officer at Nektar Therapeutics and has led research efforts at Xencor, FivePrime, Exelixis and Xoma.

In June 2022, Forte announced that Dr. Hubert Chen, M.D., joined the company as Chief Scientific Officer and President. Dr. Chen previously served as Chief Medical Officer at Metacrine, a clinical-stage company focused on the treatment of liver and gastrointestinal diseases. Prior, he was the Chief Scientific and Medical Officer of Pfenex, vice president of clinical development at Aileron Therapeutics, vice president of translational medicine at Regulus Therapeutics, and senior director of clinical research at Amylin Pharmaceuticals.

"Forte is tremendously fortunate that Steve and Hubert have agreed to join Forte. They are both thought leaders in the industry and will add significant experience and perspective to our pre-clinical and clinical development efforts." said Dr. Wagner.

Forte ended the second quarter of 2022 with approximately $38.5 million in cash and cash equivalents. Forte had approximately 14.8 million shares of common stock outstanding as of June 30, 2022. Subsequent to the June quarter-end, Forte issued an additional 5.6 million shares of common stock between July 1 and August 10, 2022 for gross proceeds of approximately $7.0 million under its At-the-Market (ATM) financing facility further strengthening its balance sheet.

Second Quarter 2022 Operating Results

Research and development expenses were $1.0 million and $3.5 million for the three months ended June 30, 2022 and 2021, respectively. Research and development expenses were $1.7 million and $6.8 million for the six months ended June 30, 2022 and 2021, respectively. The decreases in 2022 were primarily due to the wind down of our FB-401 program as the Company began the shift in development activities to autoimmune indications with FB-102.

General and administrative expenses were $2.0 million and $2.2 million for the three months ended June 30, 2022 and 2021, respectively. The decrease in 2022 was primarily due to a decrease in legal and professional expenses partially offset by an increase in stock-based compensation and other expenses. General and administrative expenses were $3.8 million and $3.6 million for the six months ended June 30, 2022 and 2021, respectively. The increase in 2022 was primarily due to an increase in stock-based compensation expense partially offset by a decrease in legal and professional expenses.

Net loss per share were ($0.21) and ($0.43) for the three months ended June 30, 2022 and 2021, and ($0.38) and ($0.79) for the six months ended June 30, 2022 and 2021, respectively.

On August 15, 2022 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company leveraging the power of the mitochondria and the peptides encoded in its genome to develop potential breakthrough therapeutics targeting chronic and age-related diseases, reported its financial results for the second quarter ended June 30, 2022 and highlighted recent corporate progress (Press release, CohBar, AUG 15, 2022, View Source [SID1234618354]).

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"We remain excited about the opportunity for CB5138-3 and its potential to make a significant impact on the treatment of IPF. During the prior quarter, we continued to build out our clinical capabilities to support this second program entering the clinic," stated Dr. Joseph Sarret, Chief Executive Officer. "Looking ahead, we are moving forward with promising interim formulations of CB5138-3 to support our planned IND filing in the second half of 2023. In addition, we continue to expand our research and target identification activities to further explore the potential of our mitochondrial peptide library using our Mito+ platform."

Recent Updates and Second Quarter 2022 Highlights

IND Filing for CB5138-3 on Track: The company continued to advance CB5138-3, its lead program for Idiopathic Pulmonary Fibrosis (IPF), through IND-enabling studies and formulation activities. In the second half of 2023, CohBar expects to submit an Investigational New Drug Application (IND) for CB5138-3 to the US Food and Drug Administration.

Expanded Coverage for CB4211 with Two New Patents: The U.S. Patent and Trademark Office issued a patent, U.S. No. 11,332,497, covering methods of use of CB4211 for treating obesity. In addition, a Japanese patent covering CB4211 and related compositions, as well as a CB4211 medicine for treating NASH, was issued.

Strengthened Board with Appointment of Effie Tozzo, Ph.D: CohBar announced the appointment of Dr. Effie Tozzo as an independent director to the company’s board of directors. Dr. Tozzo brings 26 years of research and development expertise at both established pharmaceutical and innovative biotechnology companies, including extensive experience in mitochondria research.

Garnered Shareholder Approval to Effect a Reverse Stock Split: CohBar shareholders approved an amendment to the company’s certificate of incorporation to effect a reverse stock split by a ratio not to exceed 1-for-30. The company may utilize this corporate action to regain compliance with the Nasdaq $1.00 minimum bid price requirement. The company previously received an extension from Nasdaq to November 7, 2022 to achieve compliance with the Nasdaq listing requirements.
Second Quarter 2022 Financial Highlights

Cash, Cash Equivalents and Investments: The company had cash, cash equivalents and investments of $20.1 million as of June 30, 2022, compared to $26.2 million as of December 31, 2021. The cash burn for the quarter ended June 30, 2022 was approximately $3.5 million.

R&D Expenses: Research and development expenses were $1.2 million for the three months ended June 30, 2022, compared to $2.6 million in the prior year quarter. The decrease in research and development expenses was primarily due to lower preclinical and clinical trial costs due to the timing of those expenses.

G&A Expenses: General and administrative expenses were $1.6 million for the three months ended June 30, 2022, compared to $2.6 million in the prior year quarter. The decrease in general and administrative expenses was due to a decrease in compensation and stock-based compensation costs primarily due to the departure of the company’s former CEO in the prior year period.

Net Loss: For the three months ended June 30, 2022, net loss, which included $0.5 million of non-cash expenses, was $2.7 million, or $0.03 per basic and diluted share. For the three months ended June 30, 2021, net loss, which included $1.0 million of non-cash expenses, was $5.2 million, or $0.08 per basic and diluted share.
Details for the Conference Call:

A simultaneous webcast of the call will be accessible via the Investors section of the CohBar website at www.cohbar.com.
For individuals participating in the Investor Call or webcast, please call or login to the conference audio approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on August 15, 2022, through 11:59 p.m. Eastern Time on September 5, 2022. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID No. 13730421. The audio recording will also be available at www.cohbar.com during the same period.

On August 15, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives today, reported financial results and business highlights for the second quarter ended June 30, 2022 (Press release, Aileron Therapeutics, AUG 15, 2022, View Source [SID1234618353]).

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"As we announced earlier this month, we are pleased that we have extended our cash runway, which is now expected to fund our operations through the end of 1Q 2024. We expect that our cash resources will support key planned data readouts from our ongoing breast cancer trial, including initial data in 4Q 2022, an interim readout in 2Q 2023, and topline results in 3Q 2023, in addition to pivotal trial readiness activities, subject to the breast cancer trial data and discussions with the FDA," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron.

Dr. Aivado continued, "Supportive care continues to be a severely underserved medical need. Available pharmacologic therapies, like G-CSF for severe neutropenia and EPO for anemia, have limited efficacy and are associated with severe toxicities of their own. For several other toxicities, like alopecia, there are no approved pharmacologic therapies. Chemotherapy-induced toxicities frequently can lead to dose reductions and delays, significant adverse impact on quality of life, and premature treatment discontinuations. By delivering a chemoprotective agent that can effectively protect multiple tissue types simultaneously, we have the potential to usher in a new era in supportive care where ‘whole patient care’ becomes the accepted and expected standard."

Second Quarter 2022 and Recent Highlights

Preparing to re-initiate enrollment of Phase 1b breast cancer clinical trial. As recently announced, Aileron anticipates reinitiating enrollment in the breast cancer trial under the amended protocol in the coming weeks. The Phase 1b open-label, single-arm, multicenter trial is designed to evaluate the chemoprotective effect of 1.2 mg/kg dose of ALRN-6924 against severe neutropenia, as well as chemotherapy-induced alopecia, and other hematologic and non-hematologic toxicities in breast cancer patients with p53-mutant tumors who are undergoing either neoadjuvant or adjuvant treatment with docetaxel, doxorubicin and cyclophosphamide, also known as TAC. Previous data has shown that up to 75% of patients receiving TAC experience severe neutropenia in cycle 1 despite prophylactic use of G-CSF1, and up to 98% of patients experience alopecia2.

Presented new non-clinical data demonstrating ALRN-6924 protected human hair follicles and their stem cells from paclitaxel-induced toxicity and irreversible stem cell damage. The new ex vivo data – developed in collaboration with Professor Ralf Paus, M.D., DSc, FRSB and his colleagues at the Dr. Phillip Frost Department of Dermatology & Cutaneous Surgery at the University of Miami Miller School of Medicine – were highlighted in a late-breaking oral presentation at the Society of Clinical Dermatology Annual Meeting. The data demonstrated proof of principle that ALRN-6924 can temporarily arrest the cell cycle in human scalp hair follicles and their stem cells as well as protect hair follicles from paclitaxel-induced toxicity and irreversible stem cell damage.

Reported new pharmacodynamic (PD) effect and mechanism of action data from the recently completed Phase 1 pharmacology study of ALRN-6924 in healthy human volunteers. Previous PD data demonstrated that serum levels of MIC-1 were correlated with bone marrow p21, which is a marker for cell cycle arrest. The most recent PD data demonstrated that higher doses of ALRN-6924 prolonged the elevation of serum MIC-1 in a dose-dependent fashion. Based on these findings, Aileron believes that prolonged elevation of serum levels of MIC-1 at higher ALRN-6924 dose levels should indicate prolonged cell cycle arrest in bone marrow and other tissues, and thereby prolonged chemoprotection. Aileron has submitted these and other results from the healthy volunteer study for presentation at a scientific congress in 2H 2022.

Strengthened intellectual property (IP) portfolio with additional composition of matter patent for ALRN-6924 in China. The China National Intellectual Property Administration granted Aileron patent No. ZL 2020114599292, providing exclusivity over the composition of matter of ALRN-6924. Aileron’s strong IP portfolio comprises over 160 U.S. and foreign patents, including ALRN-6924 compositions of matter, drug product formulations, methods of manufacture, and methods of use. Aileron maintains exclusive worldwide rights to its proprietary peptide drug technology and ALRN-6924.

Appointed Susan L. Drexler, MBA, CPA, as Interim CFO. Ms. Drexler is an accomplished executive with over 25 years of experience with development- and commercial-stage life science companies in financial management, M&A and licensing deals, financial planning & analysis, and business analytics. Ms. Drexler was most recently CFO with Harmony Biosciences Holdings, Inc., where she oversaw finance, accounting, and IT operations.
Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents, and investments on June 30, 2022, were $32.4 million, compared to $45.9 million on December 31, 2021. Based on its current operating plan, the company expects its existing cash, cash equivalents, and investments will fund operations through the end of first quarter of 2024.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2022, were $5.4 million, compared to $3.9 million for the quarter ended June 30, 2021. R&D expenses increased by $1.6 million which was primarily due to $1.0 million of spending for our Phase 1b clinical trial in breast cancer, $0.2 million of increased spending for our Phase 1b clinical trial in non-small cell lung cancer, and $0.3 million of increased manufacturing costs for ALRN-6924 to support our clinical trials and research studies.

General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2022, were $2.6 million compared to $2.2 million for the quarter ended June 30, 2021. G&A expenses increased by $0.5 million, which was primarily due to an increase in professional services fees during the second quarter of 2022 as compared to the same period in 2021.

Net Loss: Net loss for the quarter ended June 30, 2022, was $8.0 million, compared to $5.7 million for the corresponding quarter in 2021. The basic and diluted net loss per share for the second quarter of 2022 was $0.09 compared to $0.06 for the second quarter of 2021.

On August 15, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported that financial results for the quarter ended June 30, 2022 (Press release, Panbela Therapeutics, AUG 15, 2022, View Source [SID1234618352]). Management is hosting an earnings conference call today at 4:30 p.m. ET.

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The second quarter was marked by meaningful progress.

Q2 and Recent Highlights:

First Patient Enrolled in its Aspire Trial.
Received approval from the Australian Human Research Ethics Committee (HREC) to expand the company’s global clinical trial to Australia.
Closed on the acquisition of Cancer Prevention Pharmaceuticals, Inc. (CPP).
Hosted a virtual R&D Day on the company’s investigational drug, ivospemin (SBP-101), as a polyamine metabolism modulator in ovarian cancer.
Poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April 2022. The work reflects the company’s ongoing collaboration with Johns Hopkins University School of Medicine.
"Through the second quarter we significantly increased our addressable market at Panbela. First, during the quarter we closed on our definitive agreement to acquire CPP. The combined entity targets an estimated $5 billion aggregated market opportunity. Additionally, we presented ovarian cancer data at AACR (Free AACR Whitepaper), supporting SBP-101’s potential use beyond our first indication, pancreatic cancer," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "Via our acquisition of CPP and organic operational advancements, Panbela now has a diversified pipeline, with an ability to hit multiple targets. The development programs now consists of the randomized, double-blind, placebo controlled trial in first line metastatic pancreatic cancer patients, and a Phase III clinical trial funded by the National Cancer Institute (the "NCI") for the study of colon cancer risk reduction and colon adenoma therapy ("CAT"). Additional programs are evaluating a single agent tablet eflornithine (CPP-1X) or high dose powder eflornithine sachet (CPP-1X-S) for several indications including prevention of gastric cancer and treatment of high risk refractory neuroblastoma. As we now have programs ranging from pre-clinical to registration studies, including a lead asset with a fully funded registration trial scheduled to begin in early 2023, we expect a steady flow of achievements."

During the second half of 2022, we expect to announce final data from our Phase I untreated metastatic pancreatic cancer study, and the opening of a neoadjuvant pancreatic cancer investigator-initiated trial with ivospemin (SBP-101). With the closing of the CPP transaction, we also anticipate achieving additional milestones during the remainder of 2022 that will reflect the increased flow of planned development activity and data. These milestones include initiation of a Phase I/II program in non-small cell lung cancer and a Phase II study in Type I onset Diabetes.

Second quarter ended June 30, 2022 Financial Results

General and administrative expenses were $1.3 million in the second quarter of 2022, compared to $1.2 million in the second quarter of 2021. The change is due primarily to legal fees, associated with the acquisition of CPP.

Research and development expenses were $20.0 million in the second quarter of 2022, inclusive of a one-time, non-cash expense of $17.7 million. This expense was the write-off of in process research and development (or IPR&D). The company has accounted for the acquisition of CPP as an asset purchase. IPR&D represents the asset purchased and asset acquisition accounting requires writing off this asset immediately after the acquisition. The remaining R&D expense in the quarter of approximately $2.3 million compares to $1.0 million in the second quarter of 2021. This is related to an increase in spending on our clinical studies.

Net loss in the second quarter of 2022 was $21.1 million, or $1.51 per diluted share, compared to a net loss of $2.2 million, or $0.22 per diluted share, in the second quarter of 2021.

Total cash was $2.5 million as of June 30, 2022. Total current assets were $3.5 million and current liabilities were $6.2 million as of the same date. Also at June 30, 2022, total noncurrent assets, consisting of cash deposits held by our contract research organization, were $3.1 million. New notes payable on the balance sheet, the result of the acquisition of CPP, totaled approximately $6.9 million. Current portion of the notes payable plus accrued interest totaled approximately $1.7 million.

Conference Call Information

About our Pipeline

The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of news flow with programs ranging from pre-clinical to registration studies.

SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months which is final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment is well tolerated and has potential activity.

On August 15, 2022 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 business highlights and financial results for the second quarter ended June 30, 2022 (Press release, Arcellx, AUG 15, 2022, View Source [SID1234618351]).

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"We are excited about the rapid progress we’ve made since becoming a public company in February of this year," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "In the second quarter, we achieved meaningful milestones with the presentation of new clinical data for our lead product candidate, CART-ddBCMA, during an oral presentation at ASCO (Free ASCO Whitepaper); strengthened our balance sheet with a successful follow-on offering, raising gross proceeds of $128.8 million; dosed our first patient in ACLX-001, our Phase 1 study utilizing our Arc-SparX technology; and expanded our management team and Board of Directors with exceptional professionals adding to the diversity of our team. In the second half of this year, we look forward to presenting an encore presentation of our CART-ddBCMA Phase 1 study at ESMO (Free ESMO Whitepaper), initiating our Phase 2 pivotal CART-ddBCMA (iMMagine) trial in patients with relapsed or refractory multiple myeloma (r/r MM), presenting longer-term patient data from our Phase 1 CART-ddBCMA expansion trial in r/r MM, and initiating our Phase 1 ARC-SparX clinical trial of ACLX-002 in patients with acute myeloid leukemia and high-risk myelodysplastic syndrome. We’re committed to establishing Arcellx as a leading cell therapy organization by continuing to scale our business, advancing our novel platform to help as many patients as possible, and attracting and retaining exceptional talent."

Recent Business Highlights
Completed upsized public offering of common stock and underwriters’ full exercise of option to purchase additional shares. On June 21, 2022, Arcellx announced the closing of its upsized public offering of 8,050,000 shares of common stock, which included the full exercise by the underwriters of their option to purchase an additional 1,050,000 shares of common stock, at a price to the public of $16.00 per share. The aggregate gross proceeds raised in the offering were $128.8 million, before deducting underwriting discounts and commissions and offering expenses, payable by Arcellx. All shares in the offering were offered by Arcellx.

Appointed Maryam Abdul-Kareem as General Counsel. On June 21, 2022, Arcellx appointed Maryam Abdul-Kareem as General Counsel. Ms. Abdul-Kareem brings extensive legal and business expertise in the biopharmaceutical industry, including serving in senior positions at Kinnate Biopharma and AstraZeneca. At Arcellx, she will oversee a broad spectrum of legal, contracts, and compliance matters.

Presented continued robust long-term responses from lead product candidate, CART-ddBCMA, being evaluated in a Phase 1 expansion trial in patients with relapsed or refractory multiple myeloma at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. On June 3, 2022, Arcellx presented new clinical data from its ongoing Phase 1 expansion study of its novel, autologous, CART-ddBCMA therapy for the treatment of patients with r/r MM during an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The data demonstrated 100% ORR; deep and durable responses were observed in patients with poor prognostic factors. Overall, 22 of 31 (71%) evaluable patients reached CR/sCR. Of the 16 patients who have had their 12-month follow-up visit, including 8 patients (50%) who had EMD, 13 (81%) have reached CR/sCR and 9 patients (56%) remaining in ongoing response with a median follow up of 17.7 months. No cases of Grade ≥3 CRS and no delayed neurotoxicity or parkinsonian-like events were observed at the recommended Phase 2 dose of 100 million CAR+ cells (n=25).

Preclinical results from CART-ddBCMA published in Molecular Cancer Therapeutics. In June 2022, Arcellx’s preclinical results for its CART-ddBCMA candidate were published in Molecular Cancer Therapeutics in an article entitled, "Preclinical efficacy of BCMA-directed CAR T cells incorporating a novel D Domain antigen recognition domain." This report demonstrated that ddBCMA CAR T cells cocultured with BCMA-positive cell lines showed highly potent, dose-dependent in vitro measures of cytotoxicity, cytokine production, T-cell degranulation, and T-cell proliferation as well as in vivo tumor suppression in three disseminated BCMA-expressing tumor models. The full online publication can be accessed here.

Appointed Michelle Gilson as Chief Financial Officer. On May 23, 2022, Arcellx announced the appointment of Michelle Gilson as Chief Financial Officer. Ms. Gilson joins Arcellx from Canaccord Genuity, where most recently she served as Managing Director and Senior Equity Research Analyst covering biotechnology companies. Ms. Gilson will oversee the company’s finance function and will play a key role in overall corporate strategy.

Expanded Board of Directors with the appointment of Olivia Ware. On May 16, 2022, Arcellx expanded its Board of Directors with the appointment of Olivia Ware. Ms. Ware, a successful executive, brings a wealth of knowledge with more than 20 years of experience in biotech and pharmaceutical drug development, commercialization, and healthcare management.

Second Quarter 2022 Financial Highlights
Cash, cash equivalents, and marketable securities:
As of June 30, 2022, Arcellx had cash, cash equivalents, and marketable securities of $307.0 million, which is anticipated to fund its operations for at least the next twelve months.

R&D expenses:
Research and development expenses were $23.4 million and $12.6 million for the quarters ended June 30, 2022 and 2021, respectively, an increase of $10.8 million. This increase was driven by higher external costs associated with the advancement of our CART-ddBCMA clinical program, preclinical development of our other pipeline candidates, and increased headcount.

G&A expenses:
General and administrative expenses were $9.2 million and $3.3 million for the quarters ended June 30, 2022 and 2021, respectively, an increase of $5.9 million. This increase was driven by increased headcount, and costs to operate as a public company during the three months ended June 30, 2022 as compared to the same period in 2021, including professional fees related to consulting and accounting, audit and legal services.