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Onconova Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update

On August 12, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported financial results for the three months ended June 30, 2021 and provided a business update (Press release, Onconova, AUG 12, 2021, View Source [SID1234586433]).

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Highlights for the second quarter of 2021 and subsequent weeks include:

Enrollment in the first cohort of the Phase 1 solid tumor study of ON 123300 in the United States is complete with no dose limiting toxicities (DLT’s) observed. The second cohort is currently open for enrollment.
The Phase 1 solid tumor study of ON 123300 in China is ongoing with no DLT’s observed to date. The study is currently enrolling the third dose cohort.
The investigator-initiated Phase 1/2 study evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated non-small cell lung cancer (NSCLC) continues to progress. Initial data from the trial provide preliminary evidence of the anti-cancer activity of rigosertib-nivolumab combination therapy in patients who had previously failed all standard of care treatment, including checkpoint inhibition, and show that the maximum tolerated dose of rigosertib in combination with nivolumab was not yet determined in the three cohorts of the trial’s dose-escalation phase.
The first patient was dosed in an investigator-initiated Phase 2 study designed to assess the efficacy and safety of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB)-associated locally advanced/metastatic squamous cell carcinoma (SCC), an ultra-rare and invariably fatal condition.
The Company strengthened its management team with the appointment of Mark Gelder, M.D., as Chief Medical Officer.
Preclinical data published in the peer-reviewed journal Molecular Cancer show that rigosertib synergistically enhanced the efficacy of immune checkpoint blockade in a murine melanoma model via the induction of immune-mediated cancer cell death, supporting the continued clinical evaluation of rigosertib in combination with checkpoint inhibitors.
Management Commentary

"During the second quarter we achieved key clinical and corporate milestones," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "In our lead ON 123300 program, we initiated our U.S. Phase 1 study and recently opened enrollment to the second cohort, and our partner, HanX Biopharmaceuticals, is currently enrolling to the third dose cohort of the complementary Phase 1 study underway in China. Through these trials, which are evaluating different dosing administration regimens, we aim to inform the design of a future Phase 2 basket trial evaluating ON 123300 in multiple high unmet need indications, including CDK 4/6 inhibitor refractory HR+ HER2- metastatic breast cancer. Given ON 123300’s ability in preclinical studies to overcome resistance to the most widely prescribed CDK 4/6 inhibitor, we believe this novel multi-kinase inhibitor has the potential to be a best-in-class therapy for this and other cancers."

Dr. Fruchtman continued, "Beyond our lead program, we also reported very encouraging preliminary results from the investigator-initiated study evaluating rigosertib plus nivolumab in advanced KRAS-mutated NSCLC. These results highlighted the doublet’s favorable safety profile and provided preliminary evidence of efficacy in an extremely challenging patient population. Additional preliminary data from the trial is expected to be presented at a RAS-focused medical meeting in September. Looking forward, we will continue to leverage investigator-initiated programs to further rigosertib’s clinical development, while maintaining our primary focus and resources on ON 123300. Milestones ahead for the remainder of the year include continued progress of our ON 123300 clinical trials, expansion of rigosertib investigator-initiated studies program, and potentially acquiring new assets to augment our pipeline. With a strong financial position and a talented management team that was recently bolstered by the appointment of Dr. Mark Gelder as CMO, we believe we are well positioned to take advantage of the product development opportunities presented."

Second Quarter Financial Results

Cash and cash equivalents as of June 30, 2021 were $43.7 million, compared with $19.0 million as of December 31, 2020. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for more than eighteen months.

Research and development expenses were $1.9 million for the second quarter of 2021, compared with $4.8 million for the second quarter of 2020. The decrease was primarily related to higher clinical trial and consulting expenses in the 2020 period due to the INSPIRE study.

General and administrative expenses were $2.9 million for the second quarter of 2021, compared with $2.6 million for the second quarter of 2020. The increase was primarily due to expenses related to special meetings by proxy in the 2021 period.

Net loss for the second quarter of 2021 was $4.2 million, or $0.27 per share on 15.8 million weighted average shares outstanding, compared with a net loss for the second quarter of 2020 of $7.4 million, or $0.65 per share on 11.3 million weighted average shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the second quarter of 2021, provide a business update and answer questions. Interested parties can participate by dialing (855) 428-5741 (domestic callers) or (210) 229-8823 (international callers) and using conference ID 3876025.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

Vincerx Pharma Reports Second Quarter 2021 Financial Results and Provides a Corporate Update

On August 12, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Vincerx Pharma, AUG 12, 2021, View Source [SID1234586432]).

"During the past quarter, we achieved an important milestone in dosing the first patient in our Phase 1b study of VIP152, our selective PTEFb/CDK9 inhibitor, in MYC-driven indications, building upon the compelling signals of monotherapy activity observed in the dose-escalation study and exploratory cohort in double-hit lymphoma," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "Looking ahead, we intend to continue our strong execution in the clinic with the initiation of our Phase 1 dose escalation study in CLL relapsed/refractory to venetoclax and BTK inhibitors in the second half of this year. Our balance sheet provides us with a solid foundation to continue to execute on our clinical and regulatory goals."

Recent Highlights

Announced first patient dosed in Phase 1b study of VIP152, a potent and selective inhibitor of CDK9, in MYC-driven relapsed or refractory aggressive lymphomas and advanced solid tumors
Ongoing Phase 1b expansion, first-in-human (FIH) study is in patients with advanced cancer and consists of two expansion arms. Arm 1 will enroll up to 30 patients with relapsed/refractory aggressive lymphoma, including DLBCL, transformed follicular lymphoma, and blastoid mantle cell lymphoma. Arm 2 will enroll up to 40 patients with advanced solid tumors, including patients with ovarian cancer, triple negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration. All patients must have confirmed MYC overexpression or translocation.

Presented clinical data in a poster presentation entitled "Safety and efficacy of VIP152, a PTEFb / CDK9 inhibitor, in patients with double-hit lymphoma" at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Published an article entitled "Changing for the Better: Discovery of the Highly Potent and Selective CDK9 Inhibitor VIP152 Suitable for Once Weekly Intravenous Dosing for the Treatment of Cancer," in the Journal of Medicinal Chemistry

Announced inclusion in the Russell 3000 and Microcap Indexes
Second Quarter 2021 Financial Results

Vincerx Pharma ended the second quarter with $85.6 million in cash and cash equivalents, which includes the proceeds from the recent public warrant redemption, compared to $61.8 million at December 31, 2020.

Net loss for the second quarter ended June 30, 2021 was $2.0 million, or $0.12 per share, basic and diluted.

Research and development (R&D) expenses were $10.7 million for the quarter ended June 30, 2021, consisting primarily of $3.0 million in headcount related costs, $3.3 million of outside services in preparation for and support of our clinical trials and $4.4 million in stock-based compensation expense.

General and administrative (G&A) expenses were $6.7 million for the quarter ended June 30, 2021, consisting primarily of $1.2 million in headcount related costs, $3.3 million of outside services in support of our operations as a public company and $2.2 million in stock-based compensation expense.

Spectrum Pharmaceuticals Reports Second Quarter 2021 Financial Results and Corporate Update

On August 12, 2021 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported financial results for the three-month period ended June 30, 2021 and provided a corporate update (Press release, Spectrum Pharmaceuticals, AUG 12, 2021, View Source [SID1234586431]).

"Momentum continues to build with poziotinib and the submission of the NDA later this year is our top corporate priority," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We are also seeking clarification on the recent CRL for ROLONTIS and are planning to have a Type A meeting with the FDA as soon as possible."

Pipeline Updates

Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations

Preparation is continuing for the poziotinib new drug application (NDA) seeking an indication for the use of poziotinib in patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations. Submission of the NDA, based on the positive results of Cohort 2 from the ZENITH20 clinical trial, is planned for later this year.
Clinically meaningful data for poziotinib was presented in June at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting that showed its CNS activity in patients with NSCLC with EGFR or HER2 exon 20 mutations. These data were based on Cohorts 1-3 and included three patients achieving intracranial complete responses.
Enrollment for Cohort 4 of first-line patients with NSCLC HER2 exon 20 mutations is continuing in the ZENITH20 clinical trial. Poziotinib is currently being administered at a dose of 8mg BID in first line treatment.
Patient enrollment is also continuing in Cohort 5 which is now dosing exclusively at 8mg BID.
ROLONTIS (eflapegrastim), a novel long-acting G-CSF

Received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in connection with the biologics license application (BLA) for ROLONTIS. The CRL cited deficiencies related to manufacturing and a reinspection will be necessary. The company is seeking further clarification from the FDA and plans to meet with the agency as soon as possible.
Three-Month Period Ended June 30, 2021 (All numbers are from Continuing Operations and are approximate)

GAAP Results

Spectrum recorded a net loss of $49.9 million, or $0.32 loss per basic and diluted share, in the three-month period ended June 30, 2021, compared to a net loss of $32.2 million, or $0.29 loss per basic and diluted share, in the comparable period in 2020. Total research and development expenses were $29.1 million in the quarter, as compared to $21.7 million in the same period in 2020. Selling, general and administrative expenses were $15.0 million in the quarter, compared to $14.7 million in the same period in 2020.

The company ended the quarter with cash, cash equivalents, and marketable securities of $158.8 million.

Non-GAAP Results

Spectrum recorded a non-GAAP net loss of $39.3 million, or $0.25 loss per basic and diluted share, in the three-month period ended June 30, 2021, compared to a non-GAAP net loss of $31.8 million, or $0.28 loss per basic and diluted share, in the comparable period in 2020. Non-GAAP research and development expenses were $27.8 million, as compared to $20.6 million in the same period of 2020. Non-GAAP selling, general and administrative expenses were $11.9 million, as compared to $11.8 million in the same period in 2020.

Conference Call

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website View Source on August 12, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

Brickell Biotech Reports Second Quarter 2021 Financial Results and Provides Corporate Update

On August 12, 2021 Brickell Biotech, Inc. ("Brickell" or the "Company") (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Vical, AUG 12, 2021, View Source [SID1234586430]).

"We have made tremendous progress this year advancing our Phase 3 clinical development program for sofpironium bromide gel, 15% as a potential treatment option for primary axillary hyperhidrosis, or excessive underarm sweating. Since initiating the Phase 3 Cardigan I and II studies in late 2020, we have completed enrollment in both pivotal studies, and the last enrolled hyperhidrosis patient has completed the Cardigan I study," commented Robert Brown, Chief Executive Officer of Brickell. "We remain on track to announce topline data for both studies concurrently in the fourth quarter of 2021, and if these studies are successful, we expect to proceed towards an NDA submission to the U.S. FDA in mid-2022."

Mr. Brown continued, "Our development partner, Kaken Pharmaceutical, continues to ramp up its commercial launch of sofpironium bromide gel, 5% (ECCLOCK) in Japan. We are encouraged by Kaken’s early sales progress, as well as its continued investment in the commercialization of ECCLOCK, disease state awareness and lifecycle management activities. To this point, Kaken has recently initiated a Phase 1 clinical study to explore the pharmacokinetics (PK), safety and efficacy of sofpironium bromide gel in patients with primary palmoplantar hyperhidrosis, or excessive sweating from the palms and soles. We look forward to seeing the results of this study, which will help us determine next development steps, if any, in this new potential indication for sofpironium bromide gel."

Business and Recent Developments

Final patient has completed the Phase 3 Cardigan I study and enrollment completed in the Phase 3 Cardigan II study. Each pivotal clinical study is evaluating sofpironium bromide gel, 15% in approximately 350 subjects with primary axillary hyperhidrosis in the U.S.
Phase 1 clinical study assessing the PK, safety and efficacy of sofpironium bromide gel in patients with primary palmoplantar hyperhidrosis was initiated by Kaken in Japan. 5.3% and 2.8% of the population in Japan are estimated to be affected by primary palmar and plantar hyperhidrosis, respectively1.
Following the recent $8.1 million capital raise, the Company believes it has sufficient cash to fund its operations beyond the potential NDA submission to the U.S. FDA, which is anticipated in mid-2022.
Upcoming Milestones

Final patient expected to complete the Phase 3 Cardigan II study in the third quarter of 2021.
Expect to concurrently report topline results from the U.S. Cardigan I and II studies in the fourth quarter of 2021.
Potential NDA submission to the U.S. FDA anticipated in mid-2022, pending the outcome of the ongoing Phase 3 clinical program.
Kaken to continue ramping up commercialization efforts for ECCLOCK in Japan and evaluating additional hyperhidrosis indications for sofpironium bromide gel.
Financial Results

Second Quarter 2021 Financial Results

The Company reported cash and cash equivalents of $24.4 million as of June 30, 2021, compared to $30.1 million as of December 31, 2020.

Revenue was $0.2 million for the second quarter of 2021 and consisted of royalty revenue recognized from sales of ECCLOCK in Japan by Kaken, which increased from $17 thousand for the first quarter of 2021. Revenue was $0.6 million for the second quarter of 2020, which was driven by collaboration revenue recognized for research and development funding provided by Kaken to Brickell in 2018.

Research and development expenses were $8.8 million for the second quarter of 2021, compared to $2.7 million for the second quarter of 2020. This increase was primarily due to an increase in clinical costs related to the Phase 3 Cardigan studies, which were initiated in the fourth quarter of 2020.

General and administrative expenses were $2.9 million for the second quarter of 2021, compared to $3.0 million for the second quarter of 2020. The decrease was primarily due to lower costs for professional-related fees associated with capital raising activities that occurred in the second quarter of 2020.

Total other income, net was $0.4 million for the second quarter of 2021, compared to $7 thousand for the second quarter of 2020. The increase was primarily due to a gain on extinguishment of debt of approximately $0.4 million that resulted from the forgiveness of the Paycheck Protection Program Loan in June 2021.

Brickell’s net loss was $11.1 million for the second quarter of 2021 compared to $5.1 million for the second quarter of 2020.

Conference Call and Webcast Information

Brickell’s management will host a conference call today at 4:30 p.m. ET to discuss the financial results and recent corporate developments. The dial-in number for the conference call is 1-877-705-6003 for domestic participants and 1-201-493-6725 for international participants, with Conference ID #13720599. A live webcast of the conference call can be accessed at View Source or through the "Investors" tab on the Brickell Biotech website at View Source A replay will be available on this website shortly after conclusion of the event for 90 days.

About Sofpironium Bromide

Sofpironium bromide is Brickell’s lead investigational product candidate and is a new chemical entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are intended to exert their action locally and are potentially rapidly metabolized into a less active metabolite once absorbed into the blood. Sofpironium bromide gel, 15% is currently being evaluated in a U.S. pivotal Phase 3 clinical program for the treatment of primary axillary hyperhidrosis, and sofpironium bromide gel, 5% is approved in Japan for the same indication under the brand name ECCLOCK. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor D.Sc., d.h.c. (multi), HoF, Graduate Research Professor Emeritus, University of Florida.

About Hyperhidrosis

Hyperhidrosis is a debilitating, life-altering medical condition where a person sweats beyond what is physiologically required for thermoregulation of the body. More than 15 million people, or 4.8% of the population of the United States, and 12.76% of the population in Japan, are believed to suffer from hyperhidrosis1,2. Primary axillary (underarm) hyperhidrosis is the targeted first indication for sofpironium bromide and is the most common site of occurrence of hyperhidrosis, affecting an estimated 65% of patients with hyperhidrosis in the United States. Additional information can be found on the International Hyperhidrosis Society website: View Source

Nkarta Reports Second Quarter 2021 Financial Results and Business Progress

On August 12, 2021 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported financial results for the second quarter ended June 30, 2021 (Press release, Nkarta, AUG 12, 2021, View Source [SID1234586429]).

"Nkarta continues to set the pace for NK cell therapy as we build on the strengths of our next generation platform and advance our two co-lead clinical programs," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "During the period, we initiated collaboration activities with CRISPR Therapeutics, added new platform capabilities for rapid innovation, and expanded our manufacturing footprint – all designed to stay ahead of the technology curve and transform the scientific insights of cell therapy into meaningful medicines for cancer patients. Nkarta remains on track to report initial clinical data from our Phase 1 study of NKX101 by the end of this year."

RECENT ACCOMPLISHMENTS AND FUTURE MILESTONES

NKX101

Nkarta aims to present initial clinical data from its ongoing clinical trial of NKX101 by year end 2021. In the Phase 1 study, patients receive multiple doses of NKX101 during a 28-day treatment cycle and are eligible to receive subsequent cycles of treatment upon evidence of tolerability and disease response.
NKX019

Nkarta expects patient dosing in a Phase 1 clinical trial of NKX019 to initiate in the second half of 2021 and has begun manufacturing of clinical supply of NKX019 at its in-house cGMP clinical manufacturing facility in South San Francisco, California.
Manufacturing

Nkarta entered a lease agreement to establish a combined manufacturing facility and company headquarters. The manufacturing facility will produce materials for potential pivotal trials and commercial launch of multiple engineered NK cell therapy products. The expanded manufacturing footprint, centered in South San Francisco, California, builds upon Nkarta’s existing 2,700 square foot cGMP clinical manufacturing facility.
Pipeline and Platform

In May 2021, Nkarta and CRISPR Therapeutics announced a research and development collaboration to co-develop and co-commercialize two chimeric antigen receptor (CAR) NK cell product candidates, one targeting CD70, and one combining NK and T cells (NK+T), each enhanced with genome engineering. The collaboration also gives Nkarta a license to CRISPR/Cas9 gene editing technology for use in its own engineered NK cell therapy products.

Nkarta continues to integrate important scientific insights, processes and breakthroughs into its next generation platform. Platform capabilities include:

Multiplexed CRISPR/Cas9 genome engineering
"Armored" cells with membrane-bound IL-15 for persistence
Enhanced expansion, persistence and activity against tumor microenvironment inhibition via CISH deletion
Cytokine activation using IL-12, -15 and -18 to enhance anti-tumor activity persistence and memory-like properties
No requirement for cytokine support
Multi-dose and multi-cycle clinical trial designs
SECOND QUARTER 2021 FINANCIAL HIGHLIGHTS

Cash and Cash Equivalents: As of June 30, 2021, Nkarta had cash, cash equivalents, restricted cash and short-term investments of $280.3 million.

R&D Expenses: Research and development expenses were $16.0 million for the second quarter of 2021. Non-cash stock-based compensation expense included in R&D expense was $1.7 million for the second quarter of 2021.

G&A Expenses: General and administrative expenses were $5.7 million for the second quarter of 2021. Non-cash stock-based compensation expense included in G&A expense was $1.9 million for the second quarter of 2021.

Net Loss. Net loss was $21.5 million, or $0.66 per basic and diluted share, for the second quarter of 2021.
FINANCIAL GUIDANCE

Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into at least the second half of 2023.
About NKX101
NKX101 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with membrane-bound IL15 and a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. By engineering NKX101 with the proprietary NKG2D-based CAR, the ability of NK cells to recognize and kill tumor cells in pre-clinical models is increased significantly compared to non-engineered NK cells. The addition of membrane-bound IL15, a proprietary version of a cytokine for activating NK cell growth, has been shown in pre-clinical models to enhance the proliferation, persistence and sustained activity of NK cells. A multi-center Phase 1 clinical trial of NKX101 in patients with relapsed/refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndromes (MDS) is currently enrolling. Additional information about the clinical trial is available on ClinicalTrials.gov, identifier NCT04623944.

About NKX019
NKX019 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with a CD19-directed chimeric antigen receptor (CAR) and a proprietary, membrane-bound form of interleukin 15 (IL-15). CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. Via its CAR, NKX019 targets and binds to CD19 and eliminates CD19-expressing cells via a robust immune response in preclinical studies. Preclinical models also demonstrate enhanced proliferation, persistence and activity of NK cells with the membrane-bound IL-15, an important cytokine for NK cell survival. Initiation of a Phase 1 clinical trial of NKX019 in patients with relapsed/refractory B cell malignancies in multiple centers in the United States and Australia is planned for the second half of 2021.

About Nkarta’s Platform and Natural Starting Materials
Nkarta’s engineering platform utilizes healthy adult donors as the source for NK cells. By enlisting this natural source of NK cells, Nkarta starts with bona fide NK cells endowed with inherent tumor-recognizing ability and potent cytotoxic function. Healthy donor-derived NK cells are also available in abundance, providing a large quantity of cells with which to begin the efficient two-week manufacturing process. Finally, healthy donor-derived adult cells consist of a diverse repertoire of NK cells, providing Nkarta with the potential to capitalize on the inherent diversity of the innate immune system in selecting donors or NK cell populations with optimal characteristics.

About Nkarta’s NK Cell Technologies
Nkarta has pioneered a novel discovery and development platform for the engineering and efficient production of allogeneic, off-the-shelf natural killer (NK) cell therapy candidates. The approach harnesses the innate ability of NK cells to recognize and kill tumor cells. To enhance the inherent biological activity of NK cells, Nkarta genetically engineers the cells with a targeting receptor designed to recognize and bind to specific proteins on the surface of cancerous cells. This receptor is fused to co-stimulatory and signaling domains to amplify cell signaling and NK cell cytotoxicity. Upon binding the target, NK cells become activated and release cytokines that enhance the immune response and cytotoxic granules that lead to killing of the target cell. All of Nkarta’s NK current cell therapy candidates are also engineered with a membrane-bound IL15, a proprietary version of a cytokine known for activating NK cell growth, to enhance the persistence and activity of the NK cells.

Nkarta’s manufacturing process generates an abundant supply of NK cells that, at commercial scale, is expected to be significantly lower in cost than other current allogeneic and autologous cell therapies. Key to this efficiency is the rapid expansion of donor-derived NK cells using a proprietary NKSTIM cell line, leading to the production of hundreds of individual doses from a single manufacturing run. The platform also features the ability to freeze and store CAR NK cells for an extended period of time and is designed to enable immediate, off-the-shelf administration to patients at the point of care.