On August 8, 2023 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported financial results for the second quarter ended June 30, 2023, as well as recent business highlights (Press release, C4 Therapeutics, AUG 8, 2023, View Source [SID1234633958]).

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"In the first half of 2023, we achieved important objectives to support the continued advancement of our degrader medicine portfolio. We completed an exclusive licensing agreement with Betta Pharmaceuticals to develop CFT8919, our EGFR-L858R degrader, in Greater China, strengthened our leadership team, and progressed three clinical studies across multiple cancer indications," said Andrew Hirsch, president and chief executive officer of C4 Therapeutics. "In the second half of the year, we expect to share clinical updates from the dose escalation portion of the ongoing Phase 1/2 trials for our two lead programs, CFT7455 in multiple myeloma and CFT8634 in synovial sarcoma and SMARCB1-null cancers."

SECOND QUARTER 2023 AND RECENT ACHIEVEMENTS

CFT7455: CFT7455 is an oral degrader of IKZF1/3 for the treatment of multiple myeloma (MM) and non-Hodgkin’s lymphomas (NHL).

Progressed the Phase 1/2 Clinical Trial: The dose escalation portion of the CFT7455 Phase 1/2 clinical trial continues in MM and NHL. The three arms of the trial are evaluating CFT7455 as a monotherapy for MM, in combination with dexamethasone for MM and as a monotherapy for NHL.
Presented New Preclinical Data at the International Conference on Malignant Lymphoma (ICML): In June 2023, C4T presented preclinical CFT7455 data in NHL demonstrating potent anti-tumor activity in peripheral and CNS models of NHL as a single agent or in combination with clinically approved agents.
CFT8634: CFT8634 is an oral degrader of BRD9 for the treatment of synovial sarcoma and SMARCB1-null solid tumors.

Progressed the Phase 1/2 Clinical Trial: The dose escalation portion of the CFT8634 Phase 1/2 clinical trial continues in synovial sarcoma and SMARCB1-null solid tumors.
Initiated the first enrichment cohort: In August, C4T initiated the first enrichment cohort to further assess pharmacodynamic and safety data. This planned additional cohort further helps support enrollment demand for the ongoing dose escalation portion of the CFT8634 Phase 1/2 clinical trial.
CFT1946: CFT1946 is an oral degrader targeting BRAF V600 mutations for the treatment of solid tumors including non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and melanoma.

Progressed the Phase 1/2 Clinical Trial: The dose escalation portion of the CFT1946 Phase 1/2 clinical trial continues in V600 solid tumors, including NSCLC, CRC and melanoma. Trial sites are now open and enrolling patients in the U.S. and Europe.
Presented Trial in Progress Poster at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting: In June 2023, C4T presented a trial in progress poster titled "A Phase 1/2 Study of CFT1946, A Novel Bifunctional Degradation Activating Compound, or BiDAC Degrader, of Mutant BRAF V600 as Monotherapy and in Combination with Trametinib, in Mutant BRAF V600 Solid Tumors."
CFT8919: CFT8919 is an oral degrader designed to be potent and selective against EGFR L858R for non-small cell lung cancer (NSCLC).

Exclusive Licensing Agreement with Betta Pharmaceuticals in Greater China: In May 2023, C4T entered into an exclusive license and collaboration agreement for the development and commercialization of CFT8919 in Greater China, including Hong Kong SAR, Macau SAR and Taiwan. C4T expects to receive a total of $35.0 million, which includes $10.0 million in upfront cash paid in June 2023 under the collaboration agreement and a $25.0 million one-time equity investment under the stock purchase agreement. Additionally, C4T is eligible for up to $357.0 million in potential milestones and low to mid-double-digit percent royalties on net sales in the licensed territories.
Investigational New Drug (IND) Application Clearance Achieved: In June 2023, the U.S. Food and Drug Administration (FDA) cleared C4T’s IND application for CFT8919. C4T expects to initiate clinical trial activities outside Greater China following the completion of Betta Pharmaceuticals’ Phase 1 dose escalation study in Greater China.
CORPORATE UPDATES

In July 2023, C4T appointed two new senior leaders. Leonard (Len) Reyno, M.D., joined C4T as chief medical officer with nearly 30 years of clinical development experience, spanning first-in-human studies to Phase IV clinical trials. Mary Christian, Pharm.D. joined C4T as senior vice president, regulatory with more than two decades of experience in regulatory and drug development.
UPCOMING KEY MILESTONES

CFT7455: Present Phase 1 dose escalation data from the Phase 1/2 clinical trial of Arm B1, evaluating CFT7455 as a monotherapy in MM, in the second half of 2023.
CFT8634: Present Phase 1 dose escalation data from the Phase 1/2 clinical trial for synovial sarcoma and SMARCB1-null solid tumors in the second half of 2023.
SECOND QUARTER 2023 FINANCIAL RESULTS

Revenue: Total revenue for the second quarter of 2023 was $2.7 million, compared to $13.8 million for the second quarter of 2022. The decrease in revenue was due to a reduction of revenue recognized for research activities under the Biogen and Calico collaborations. Total revenue for the second quarter of 2023 reflects revenue recognized under collaboration agreements with Roche and Biogen, and total revenue recognized in the second quarter of 2022 reflects revenue recognized under collaborations agreements with Roche, Biogen, and Calico.

Research and Development (R&D) Expense: R&D expense for the second quarter of 2023 was $29.9 million, compared to $31.3 million for the second quarter of 2022. The reduction in R&D expense was primarily attributable to a decrease in IND-enabling activities as programs transition to the clinic.

General and Administrative (G&A) Expense: G&A expense for the second quarter of 2023 was $10.3 million, compared to $9.9 million for the second quarter of 2022. The higher G&A expense was attributable to a slight increase in professional fees.

Net Loss and Net Loss per Share: Net loss for the second quarter of 2023 was $35.9 million, compared to $27.4 million for the second quarter of 2022. Net loss per share for the second quarter of 2023 was $0.73 compared to $0.56 for the second quarter of 2022.

Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of June 30, 2023, were $286.7 million, compared to $337.1 million as of December 31, 2022. The decrease in cash was primarily driven by expenditures to fund operations, partially offset by the $10.0 million upfront payment received from Betta Pharmaceuticals. C4T expects that its cash, cash equivalents and marketable securities as of June 30, 2023, along with the anticipated equity investment from an affiliate of Betta Pharmaceuticals, will be sufficient to fund planned operating expenses and capital expenditures into the second half of 2025.

On August 8, 2023 bluebird bio, Inc. (NASDAQ: BLUE) ("bluebird bio" or the "Company") reported financial results and business highlights for the second quarter ended June 30, 2023, including recent commercial and operational progress, and regulatory updates (Press release, bluebird bio, AUG 8, 2023, View Source [SID1234633956]).

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"As we approach the anniversaries of the FDA approvals of ZYNTEGLO and SKYSONA, we have continued to advance our commercial strategy and prove the model for the gene therapy field on our path to profitability," said Andrew Obenshain, chief executive officer, bluebird bio. "Additionally, with the ongoing FDA review of lovo-cel and potential approval by the end of this year, bluebird is preparing for our largest opportunity yet to impact the lives of patients and families – a gene therapy for individuals living with sickle cell disease in the US."

RECENT HIGHLIGHTS

ZYNTEGLO (betibeglogene autotemcel) Commercial Launch

bluebird continues to build on the launch of ZYNTEGLO for beta-thalassemia. To date, there have been 11 patient starts for ZYNTEGLO.
To date, the Company has received zero ultimate denials from commercial or government payers for ZYNTEGLO; prior authorization approvals for drug product remain consistent at approximately two weeks.
As previously communicated, patient starts remain the key commercial metric during the first year of the ZYNTEGLO launch.
SKYSONA (elivaldogene autotemcel) Commercial Launch

Cell collection has been completed for 5 patients for SKYSONA to date.
Since approval, bluebird has activated four QTCs to administer SKYSONA for patients with cerebral adrenoleukodystrophy (CALD).
lovo-cel BLA Acceptance and Priority Review

On June 21, 2023, bluebird bio announced that the FDA accepted for priority review its BLA for lovotibeglogene autotemcel (lovo-cel), the Company’s gene therapy for individuals living with sickle cell disease (SCD). bluebird is pursuing FDA approval for lovo-cel for patients ages 12 and older who have a history of vaso-occlusive events (VOEs). The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2023.
lovo-cel ICER Review

In its ongoing review of the cost-effectiveness of gene therapies for sickle cell disease, the Institute for Clinical and Economic Review (ICER) determined that lovo-cel will be cost effective at a price up to $2.26 million when considering the societal perspective. bluebird anticipates setting a price for lovo-cel upon potential FDA approval.
UPCOMING ANTICIPATED MILESTONES

ZYNTEGLO

The Company is on track to scale to 40-50 QTCs by the end of 2023. bluebird’s QTC network is designed to maximize its commercial opportunity in beta-thalassemia and to prioritize proximity to individuals with living with SCD in anticipation of a 2024 commercial launch for lovo-cel, if approved by the FDA.
SKYSONA

The Company continues to anticipate 5-10 patient starts this year as previously guided.
LOVO-CEL

The FDA has set a PDUFA goal date for December 20, 2023, and if approved, the Company anticipates commercial launch in early 2024. bluebird estimates approximately 20,000 individuals living with SCD (or one-fifth of the U.S. SCD population) may be eligible for gene therapy.
SECOND QUARTER 2023 FINANCIAL RESULTS

Cash Position: The Company’s cash, cash equivalents, marketable securities and restricted cash balance was approximately $291 million, as of June 30, 2023. The Company anticipates full-year 2023 cash burn to be in the range of $270-$300 million, as previously guided. Based on current operating plans, bluebird expects its cash, cash equivalents, marketable securities and restricted cash, inclusive of revenue will be sufficient to meet bluebird’s planned operating expenses and capital expenditure requirements into the fourth quarter of 2024. Excluding $45 million of restricted cash, which is currently unavailable for use, bluebird estimates cash runway into the second quarter of 2024. Please see our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 for further information regarding our cash runway guidance and other financial results.
Revenue, net: Total revenue, net was $6.9 million for the three months ended June 30, 2023, compared to $1.5 million for the three months ended June 30, 2022. The increase of $5.4 million was primarily due to SKYSONA and ZYNTEGLO product revenue.
SG&A Expenses: Selling, general and administrative expenses were $40.3 million for the three months ended June 30, 2023, compared to $36.7 million for the three months ended June 30, 2022. SG&A includes lease expense related to 50 Binney Street; however, sublease income is presented in other income (expense), net. Excluding the lease expense for 50 Binney St., SG&A expenses were $30.7 million for the three months ended June 30, 2023, compared to $28.2 million for the three months ended June 30, 2022. This increase is mainly attributable to commercial costs driven by marketing activities for ZYNTEGLO and SKYSONA in the United States and the performance of commercial readiness activities in the United States for lovo-cel, in anticipation of potential approval, as well as costs related to employee compensation, benefits, and other head-count related expenses.
R&D Expenses: Research and development expenses were $42.3 million for the three months ended June 30, 2023, compared to $63.8 million for the three months ended June 30, 2022. The decrease of $21.5 million was primarily due to manufacturing costs related to SKYSONA and ZYNTEGLO now being included in inventory and cost of product revenue, as well as decreased employee compensation, benefit and other headcount-related expenses and a decrease in information technology and facility related costs in 2023.
Net income (loss): Net loss was $72.9 million for the three months ended June 30, 2023, compared to a net loss of $100.1 million for the three months ended June 30, 2022.
CONFERENCE CALL DETAILS

bluebird will hold a conference call to discuss second quarter financial results and commercial launch progress on Tuesday, August 8 at 8:00 am ET.

To access the call via telephone, please register at this link https://register.vevent.com/register/BI4fa1d86317c74333813f6827624e43ae to receive a dial in number and unique PIN to access the live conference call.

The live webcast of the call may be accessed by visiting the "Events & Presentations" page within the Investors & Media section of the bluebird website at View Source A replay of the webcast will be available on the bluebird website for 90 days following the event.

On August 8, 2023, bluebird bio, Inc. (the "Company") reported to have entered into an Open Market Sale AgreementSM (the "Sales Agreement") with Jefferies LLC ("Jefferies") to sell shares of the Company’s common stock, par value $0.01 per share (the "Common Stock"), with aggregate gross sales proceeds of up to $125.0 million , from time to time, through an "at the market" equity offering program under which Jefferies will act as sales agent (Filing, 8-K, bluebird bio, AUG 8, 2023, View Source [SID1234633955]).

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Under the Sales Agreement, the Company will set the parameters for the sale of shares, including any price, time or size limits or other customary parameters or conditions. Subject to the terms and conditions of the Sales Agreement, sales of Common Stock, if any, will be made by any method permitted that is deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. The Company will pay Jefferies a commission equal to up to 3.0% of the gross proceeds of any Common Stock sold through Jefferies under the Sales Agreement, and also has provided Jefferies with customary representations, warranties, covenants and indemnification rights. The Sales Agreement may be terminated by the Company upon written notice to Jefferies or by Jefferies upon written notice to the Company, each upon ten trading days’ notice to the other party.

Any sales of shares under the Sales Agreement will be made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-271772) filed with the Securities and Exchange Commission (the "Commission") on May 9, 2023, which was declared effective by the Commission on May 19, 2023. The Company filed a prospectus supplement with the Commission on August 8, 2023 in connection with the offer and sale of the shares pursuant to the Sales Agreement.

The foregoing is only a brief description of the material terms of the Sales Agreement and is qualified in its entirety by reference to the full agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Latham & Watkins LLP, counsel to the Company, has issued an opinion to the Company, dated August 8, 2023, regarding the validity of the shares of Common Stock to be issued and sold pursuant to the Sales Agreement. A copy of the opinion is filed as Exhibit 5.1 to this Current Report on Form 8-K.

In addition, as previously disclosed, on June 22, 2022, the Company entered into an Equity Distribution Agreement (the "Equity Distribution Agreement") with Goldman Sachs & Co. LLC ("Goldman") to sell shares of Common Stock with aggregate gross sales proceeds of up to $75.0 million, from time to time, through an "at the market" equity offering program under which Goldman acted as sales agent.

On August 7, 2023, the Company delivered written notice to Goldman, effective as of such date, to terminate the Equity Distribution Agreement, pursuant to Section 8(a) thereof. The Company is not subject to any termination penalties related to the termination of the Equity Distribution Agreement. As of August 8, 2023, the Company has sold approximately 10.7 million shares of Common Stock under the Equity Distribution Agreement, resulting in gross proceeds to the Company of approximately $56.2 million.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of any offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On August 8, 2023 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported second quarter 2023 financial results and provided an update on its clinical and pipeline progress (Press release, Beam Therapeutics, AUG 8, 2023, View Source [SID1234633954]).

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"The first half of 2023 has been marked by focused execution across the business, with the singular goal of making an impact on the lives of people suffering from serious diseases," said John Evans, chief executive officer of Beam. "We are very pleased with the continued enrollment progress in the BEACON trial, having now consented enough patients projected to both fill the sentinel cohort and initiate the expansion cohort. In addition, the BEAM-201 trial is now open for enrollment at multiple clinical sites, with the first patient having been consented and dosing expected this quarter. We have also continued to accelerate development of BEAM-302, a potential best-in-class product candidate for patients with alpha-1 anti-trypsin deficiency, and are now prioritizing a BEAM-302 regulatory filing in the first quarter of 2024 as our first in vivo program, with a regulatory filing for BEAM-301 expected to follow shortly thereafter. Our critical manufacturing capability in North Carolina is anticipated to be cGMP ready for both cell manufacturing and LNP manufacturing this year. Finally, Beam is well capitalized to pursue the next wave of growth in its innovative research platform, from non-genotoxic conditioning with ESCAPE in hematology, to next-generation allogeneic cell therapies in cancer and immunology, to a growing number of wholly owned and partnered base editing programs targeting the liver. We believe we are well positioned to establish an industry-leading platform in precision genetic medicine."

Second Quarter 2023 Business Updates and Key 2023-2024 Anticipated Milestones

Hematology Portfolio

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Beam continues to advance its BEACON Phase 1/2 clinical trial, an open-label, single-arm, multicenter study evaluating the safety and efficacy of BEAM-101 in adult patients with severe sickle cell disease (SCD).
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Beam has continued to consent additional patients in the BEACON trial, all of whom are now moving in parallel through the screening, transfusion and mobilization activities required to enable treatment with BEAM-101.
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Beam now anticipates that currently consented patients are sufficient to both fill the sentinel cohort (n=3) and to initiate the expansion cohort. Beam will continue adding additional patients to the BEACON trial through the end of year and beyond, with a total target of 45 treated patients.
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Treatment with BEAM-101, in which the edited cell product is delivered in an autologous bone marrow transplant, will occur on a sequential basis for the first three patients treated in the trial, and then will be given in parallel for all subsequent patients.
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The company continues to anticipate reporting initial data on multiple patients from the BEACON trial in 2024.
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Beam continues to advance and invest in its Engineered Stem Cell Antibody Paired Evasion (ESCAPE) conditioning platform.

Immunology/Oncology Portfolio

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Beam continues to advance BEAM-201, a multiplex-edited allogeneic CAR-T product candidate, for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LL). Multiple sites for the Phase 1/2 clinical trial of BEAM-201 are now open for enrollment.
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The first patient has consented and is expected to be dosed in the third quarter of 2023.
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Beam also continues to invest in and advance its next-generation allogeneic strategies designed to improve cell persistence and expand the utility and accessibility of cell therapies in cancer and other diseases. The company plans to share updates on these efforts by year-end 2023.
Genetic Disease (in vivo) Portfolio

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Beam continues to advance its two in vivo base editing product candidates, BEAM-301 for the treatment of glycogen storage disease 1a (GSD1a) and BEAM-302 for the treatment of alpha-1 antitrypsin deficiency (AATD), leveraging lipid nanoparticles (LNPs) for delivery to the liver.
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To promote speed to the clinic of a top priority program, the company has leveraged the learnings and capability build from BEAM-301 to accelerate development of BEAM-302, which is now expected to be its first in vivo liver regulatory filing, followed by BEAM-301.
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The company expects to:
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Submit a regulatory application for authorization to initiate clinical trials for BEAM-302 in the first quarter of 2024; and
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Submit a regulatory application for authorization to initiate clinical trials for BEAM-301 in the first half of 2024.
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Beam continues to advance multiple additional in vivo editing programs targeting the liver, including both its wholly owned and collaboration programs, through lead optimization, and advance its LNP delivery technologies for delivery of base editing medicines to the liver and other tissues.
Manufacturing Updates

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Beam continues to expect initiation of current good manufacturing practice compliant operations at its North Carolina manufacturing facility in late 2023.
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Beam is now planning to enable cGMP manufacturing of both autologous cell products in support of its sickle cell programs as well as LNP products in support of its liver programs BEAM-302 and BEAM-301 in its North Carolina facility.
Recent Nature Genetics Preclinical Publication Suggests Base Editing Enables More Uniform HbF Upregulation than Nuclease Editing

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In July, Beam co-founder David Liu, Ph.D., and St. Jude Children’s Research Hospital collaborators Jonathan Yen, Ph.D., and Mitchell Weiss, M.D., Ph.D., published preclinical research comparing five gene editing strategies in CD34+ hematopoietic stem and progenitor cells using either Cas9 nuclease or adenine base editors to induce fetal hemoglobin (HbF) red blood cells. Notably, the data suggest that base editing can provide a strategy for potent, uniform induction of HbF, yielding a consistent, predictable, and precise editing outcome. Conversely, nuclease editing of either the fetal hemoglobin gene or the BCL11A enhancer created a complex, uncontrolled distribution of alleles with a wide range of outcomes for induction of fetal hemoglobin, including numerous cells with minimal or no induction detected. These data illustrate the potential advantages of base editing’s mechanism of action, including the creation of predictable and consistent gene modifications with well-characterized, uniform biological effects across edited cells, as compared to the uncontrolled mixture of allele outcomes that result from nuclease-based knockout through double-stranded breaks.

Second Quarter 2023 Financial Results

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Cash Position: Cash, cash equivalents and marketable securities were $1.1 billion as of June 30, 2023, as compared to $1.1 billion as of December 31, 2022.
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Research & Development (R&D) Expenses: R&D expenses were $97.6 million for the second quarter of 2023, compared to $74.6 million for the second quarter of 2022.
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General & Administrative (G&A) Expenses: G&A expenses were $24.7 million for the second quarter of 2023, compared to $24.1 million for the second quarter of 2022.
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Net Loss: Net loss was $82.8 million for the second quarter of 2023, or $1.08 per share, compared to $72.0 million for the second quarter of 2022, or $1.02 per share.
Cash Runway

Beam expects that its cash, cash equivalents and marketable securities as of June 30, 2023, will enable the company to fund its anticipated operating expenses and capital expenditure requirements at least into 2025. This expectation includes funding directed toward reaching each of the key anticipated milestones for BEAM-101, BEAM-201, BEAM-301 and BEAM-302 described above, as well as continued investments in platform advancements and manufacturing capabilities.

On August 8, 2023 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the second quarter 2023, recent business highlights and key upcoming catalysts (Press release, Atara Biotherapeutics, AUG 8, 2023, View Source [SID1234633953]).

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"We are pleased to announce IND clearance for ATA3219, our first allogeneic CAR-T cell product candidate expected to enter the clinic in the coming months as a potential best-in-class treatment for patients with certain B-cell malignancies," said Pascal Touchon, President and Chief Executive Officer of Atara. "Building on this momentum, our discussions with FDA and potential commercial partners for tab-cel in the U.S. are progressing well and we are excited to soon conduct the primary analysis of the EMBOLD Phase 2 study in progressive MS, with clinical and biomarker data from more than 90 patients."

Tabelecleucel (tab-cel or EBVALLO) for Post-Transplant Lymphoproliferative Disease (PTLD)

Continued productive discussions between Atara and FDA have addressed outstanding chemistry, manufacturing, and controls (CMC) questions. A meeting is scheduled to resolve the remaining topic of comparability between clinical and intended commercial process versions which should provide clarity on timing for a potential BLA submission
Following significant levels of engagement, discussions with potential U.S. commercialization partners are advancing
Patients in Europe are now receiving treatment with EBVALLO in the commercial setting, as Pierre Fabre is progressively launching on a country-by-country basis
Atara is investigating label expansion opportunities with its ongoing Phase 2 multi-cohort study with initial data expected in Q4 2023
ATA188 for Progressive Multiple Sclerosis (MS)

Atara plans to communicate data from the primary analysis of the double-blind placebo-controlled Phase 2 EMBOLD study in progressive MS in early November
This communication will include data from more than 90 patients, covering the primary endpoint of confirmed disability improvement (CDI) based on expanded disability status scale (EDSS) at 12 months, other clinical endpoints, and additional biomarkers
In addition, the Company anticipates sharing longer-term results for patients that have completed study visits beyond the 12-month primary endpoint
Atara will present new biomarker analyses from its ongoing Phase 1 trial of ATA188 at the International Society of Neuroimmunology (ISNI) congress taking place August 20-24. The data show ATA188-treated patients who achieved CDI by EDSS exhibited reduced accumulation of plasma Glial Fibrillary Acidic Protein (GFAP), a potential biomarker of disease progression in MS. Additionally, a novel application of TCRβ-sequencing allowed for detection of ATA188-derived EBV-specific TCRβ clonotypes in patients
ATA3219: Allogeneic CD19 CAR T for Various Indications

A Phase 1 study in relapsed/refractory B-cell non-Hodgkin’s lymphoma (NHL) is expected to start in the coming months following Atara’s receipt of a Safe to Proceed letter from FDA in response to an Investigational New Drug Application (IND) submitted for ATA3219. ATA3219 is an allogeneic CD19-1XX CAR+ EBV T cell immunotherapy that incorporates multiple clinically validated technologies designed for T-cell memory, robust expansion and persistence, and potent anti-tumor efficacy
A large unmet medical need remains for CD19-directed CAR T products that can be reliably manufactured at scale, are available in advance of patient need, and are enabling more complete and durable responses with favorable safety
Second Quarter 2023 Financial Results

Cash, cash equivalents and short-term investments as of June 30, 2023, totaled $153.6 million, as compared to $205.4 million as of March 31, 2023
Net cash used in operating activities was $52.8 million for the second quarter 2023, as compared to $64.0 million in the same period in 2022
Atara believes that its cash and investments as of June 30, 2023, will be sufficient to fund the Company’s planned operations into second quarter 2024
Atara reported a net loss of $71.1 million, or $0.68 per share for the second quarter 2023, as compared to net income of $18.5 million, or $0.18 per share for the same period in 2022. Second quarter 2022 net income included $50.9 million of deferred revenue recognized due to the termination of the Bayer Collaboration Agreements and a gain on the sale of the ATOM facility of $50.2 million.
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $13.8 million for the second quarter 2023, as compared to $15.6 million for the same period in 2022
Research and development expenses were $56.1 million for the second quarter 2023, as compared to $64.9 million for the same period in 2022
Research and development expenses include $7.2 million of non-cash stock-based compensation expenses for the second quarter 2023 as compared to $7.9 million for the same period in 2022
General and administrative expenses were $13.3 million for the second quarter 2023, as compared to $18.8 million for the same period in 2022
General and administrative expenses include $5.4 million of non-cash stock-based compensation expenses for the second quarter 2023, as compared to $6.2 million for the same period in 2022