On August 16, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported financial results for the second quarter ended June 30, 2021 and highlighted recent developments (Press release, Inhibikase Therapeutics, AUG 16, 2021, View Source [SID1234586638]).

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Key Business and Clinical Highlights

Begin evaluation of IkT-148009 in Parkinson’s patients: Following a teleconference on July 22, 2021with the U.S. Food and Drug Administration (FDA), Inhibikase and the FDA agreed that the Company may begin a Phase 1b extension study to evaluate the safety, tolerability and pharmacokinetics of the Company’s lead drug candidate IkT-148009 in Parkinson’s patients. The Phase 1b extension study will also assess cognitive, motor function, gut motility and measures of alpha-synuclein aggregate clearance in multiple compartments, as exploratory endpoints.

Interim chronic toxicology studies of IkT-148009 will be submitted to the U.S. FDA to permit 13 week dosing in patients: Inhibikase expects to submit 13-week interim pivotal toxicology studies of IkT-148009 in rodent and primate to the FDA for regulatory review in the third quarter of 2021. Following the Agency’s review, the Company expects to extend dosing in patients out to 3 months. The Company expects to complete the remaining requirements for chronic dosing in the 4th quarter of 2021 and submit the data to the FDA for review early in the 1st quarter 2022.

Investigational New Drug (IND) application for IkT-001Pro in CML: IkT-001Pro is the Company’s prodrug formulation of Imatinib mesylate, designed as a potentially safer, better tolerated treatment for Imatinib-sensitive cancers such as stable-phase Chronic Myeloid Leukemia (CML). Inhibikase expects to file an IND application in the 3rd quarter of 2021, with initiation of clinical development as soon as practicable, subject to FDA acceptance of the IND.

Successfully completed $45 million follow-on public offering of common stock: In June, 2021 Inhibikase raised $45 million in gross proceeds from its follow-on offering of 15 million shares of its common stock. The company plans to use the net proceeds, together with existing funds, to fund the costs of its Phase 1b extension study for IkT-148009 in Parkinson’s patients, validate target engagement markers in the central and peripheral nervous system, and further support the clinical development of IkT-001Pro through Phase 2 studies.
"In the second quarter of 2021, we completed the financing necessary to validate the first mechanistically defined treatment for sporadic and inherited Parkinson’s disease and related disorders," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "On the clinical front, following a successful Phase 1 program in older healthy adults, we are advancing into Parkinson’s patients with the initiation of our Phase 1b extension study. This study will provide the first opportunity to evaluate mechanistically-defined therapeutics for this devastating disease. This is an important step for the Company, as we believe IkT-148009 has the potential to drive functional recovery in the brain and gastrointestinal tract, clear pathologic alpha-synuclein aggregates, and block neurodegeneration and neuroinflammation in Parkinson’s disease. Looking ahead, we remain on track to file an IND for IkT-001Pro, our prodrug formulation of Imatinib for CML, in the third quarter and submit 13-week pivotal toxicology studies of IkT-148009 to the FDA."

Second Quarter Financial Results

Net Loss: Net loss for the quarter ended June 30, 2021, was $2.6 million or $0.22 per share, compared to a net loss of $0.4 million, or $0.05 per share in the second quarter 2020.

Net loss for the six months ended June 30, 2021, was $5.3 million or $0.47 per share, compared to a net loss of $1.0 million, or $0.12 per share in the six months ended June 30, 2020.

R&D Expenses: Research and development expenses were $2.4 million for the quarter ended June 30, 2021 compared to $0.3 million in the second quarter 2020. The increase was driven by a $1.0 million increase in grant related research expenditures and a $1.1 million increase in non-grant related research. The non-grant related research was incurred primarily in connection with the Company’s PD Phase I clinical trial.

Research and development expenses were $4.8 million for the six months ended June 30, 2021 compared to $0.5 million in the six months ended June 30, 2020. The increase was driven by a $2.1 million increase in grant related research expenditures and a $2.1 million increase in non-grant related research. The non-grant related research was expended primarily in connection with the Company’s Phase I clinical trial in older healthy subjects.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2021 were $1.6 million compared to $0.4 million for the second quarter in 2020. The increase was primarily the result of increased non-cash stock compensation expense of $0.1 million, increased director and officer’s liability insurance of $0.3 million related to the Company’s IPO in December 2020, increased legal fees, board fees, investor relation and consulting fees of $0.3 million relating to operating as a public company registrant since December 2020 and a net increase of $0.5 million for other normal operating expenses

Selling, general and administrative expenses for the six months ended June 30, 2021 were $3.2 million compared to $0.9 million for the six months ended June 30, 2020. The increase was primarily the result of increased non-cash stock compensation expense of $0.5 million, increased director and officer’s liability insurance of $0.7 million related to the Company’s initial public offering in December 2020, increased legal fees, board fees, investor relation and consulting fees of $0.6 million relating to operating as a public company registrant since December 2020 and a net increase of $0.5 million for other normal operating expenses.

Cash Position: Cash and cash equivalents were $46.8 million as of June 30, 2021. This includes approximately $41.1 million of proceeds from Inhibikase’s June, 2021 public offering of common stock, after deducting underwriting discounts and commissions and offering expenses payable by Inhibikase. The Company expects that existing cash and cash equivalents will be sufficient to fund operations into the first-half of 2023.

On August 16, 2021 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that its Board of Directors declared a quarterly cash dividend of $0.62 per share, payable on October 20, 2021 to shareholders of record of Quest Diagnostics common stock on October 5, 2021 (Press release, Quest Diagnostics, AUG 16, 2021, View Source [SID1234586654]).

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On August 16, 2021 Sino Biological, a Beijing company that offers biological research reagents and related contract research services to global markets, reported that it has completed a $772 million IPO on Shenzhen’s ChiNext Exchange (Press release, Sino Biopharmaceutical, AUG 16, 2021, View Source [SID1234586738]). On the first day of trading, the stock closed 68% higher at a market capitalization of $5.2 billion. The company, which was founded in 2007, said the IPO funds would represent a new starting point, allowing Sino Biological to expand its existing capabilities.

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On August 16, 2021 Celularity Inc. ("Celularity") (Nasdaq:CELU), a clinical-stage biotechnology company developing off-the-shelf placental-derived allogeneic therapies, reported financial results for the quarter ended June 30, 2021, and provided a summary of recent corporate highlights (Press release, Celularity, AUG 16, 2021, View Source [SID1234591816]).

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"This has been an exciting time for Celularity, with the achievement of multiple transformational milestones and significant progress in our unique approach to cellular medicine," said Robert J. Hariri, M.D., Ph.D., founder, Chairperson and Chief Executive Officer of Celularity. "Most notably, this quarter marked our transition to a public company through a merger with GX Acquisition Corp., which along with a companion PIPE provided significant funds to support our work. Additionally, we made noteworthy advances in our clinical programs, including the expansion of our Phase 1 trial in patients with acute myeloid leukemia, to include difficult to treat patient populations. Beyond our program development, we forged new strategic and commercial partnerships with companies at the forefront of their respective fields that continue our legacy of pioneering new and innovative approaches to cellular medicine. We look forward to continuing to advance the field of cellular medicine and developing treatments capable of addressing significant unmet needs in cancer, autoimmune and infectious disease."

Corporate Highlights

Celularity closed the merger with GX Acquisition Corp. ("GXGX"). Proceeds from the transaction totaled approximately $138 million, which included funds held in GXGX’s trust account and a concurrent private placement investment in public equity (PIPE) financing led by existing Celularity shareholders.
Celularity expanded its ongoing Phase 1 clinical trial of CYNK-001 in patients with acute myeloid leukemia (AML) (NCT04310592) to include patients with relapsed/refractory AML (r/r AML) in addition to its ongoing trial in patients positive for minimal residual disease (MRD).
The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to Celularity’s CYNK-001, a non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, for the treatment of patients with malignant gliomas.
Celularity entered an exclusive strategic partnership with Imugene Ltd to develop a novel oncolytic virus – allogeneic chimeric antigen receptor (CAR) T-cell immunotherapy combination for the treatment of solid tumors. The collaboration will initially explore the therapeutic potential of a combination of Imugene’s CF33-CD19 oncolytic virus (onCARlytics) and Celularity’s placental-derived CD19 targeting CAR T-cell therapy, CYCART-19.
Celularity established a partnership to leverage Palantir’s next generation software and computational capabilities to analyze Celularity’s cellular data and accelerate research and development activities.
On July 1, 2021, Celularity announced its agreement with Arthrex whereby Arthrex would receive exclusive rights to distribute and commercialize Celularity’s placental-derived biomaterial products for orthopedics and sports medicine in the U.S. Under the terms of the agreement, Celularity will provide Arthrex with exclusive commercial distribution rights for orthopedic surgery and sports medicine and will continue to be responsible for product manufacturing and supply.
Second Quarter 2021 Financial Results

Revenues for the three months ended June 30, 2021, experienced a decrease of $0.3 million compared to the prior year. This was due to a decrease in product sales and rentals revenue resulting from the $24.5 million sale of the MIST/UltraMIST assets in August 2020, partially offset by (i) an increase of $0.6 million in license, royalty and other revenues related to the license arrangement with Sanuwave and (ii) an increase of $0.2 million in services revenues primarily due to higher biobanking storage revenues.
Research and development expenses for the three months ended June 30, 2021, increased $7.1 million compared to the prior year. The increase in research and development expenses was primarily due to a non-cash stock compensation charge related to the grant of fully vested senior management awards.
Selling, general and administrative expenses for the three months ended June 30, 2021, increased $21.3 million compared to the prior year, primarily due to a non-cash stock-based compensation charge related to the grant of fully vested non-employee director and senior management awards.
Net loss for the second quarter of 2021 was $64.5 million, or $2.69 per share.

On August 16, 2021 Exelixis, Inc. (Nasdaq: EXEL) and Invenra, Inc. reported that they have expanded their discovery and licensing collaboration to include an additional 20 oncology targets (Press release, Exelixis, AUG 16, 2021, View Source [SID1234586622]). The augmented partnership builds on the two companies’ ongoing collaboration and license agreement to discover and develop mono-specific and multi-specific antibodies for incorporation into novel biologics to treat cancer, which was originally announced in May 2018 and expanded in October 2019.

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"We believe the continued success of our collaboration with the Exelixis team speaks to the quality of our unique and versatile antibody discovery platform, and we are proud to continue to support the Exelixis oncology pipeline"

"We’re very pleased with the successful relationship we’ve had with Invenra to-date and look forward to expanding our existing collaboration to include additional oncology targets," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. "As Exelixis seeks to build a differentiated next-generation pipeline in oncology, we’re leveraging Invenra’s expertise in antibody and bispecific discovery to provide key building blocks for potential future Exelixis biologics, including antibody-drug conjugates. Our expanded collaboration with Invenra accelerates and deepens our work together and furthers Exelixis’ mission to pursue cancer therapies that help patients live longer and recover stronger."

Under the terms of this newly expanded collaboration, Exelixis has agreed to pay Invenra an upfront fee of $15.0 million, as well as additional fees and funding for the option to nominate up to 20 additional targets in oncology. Invenra will be eligible for development, regulatory, and commercial milestones, as well as tiered royalties on net sales of any approved products. Exelixis will own all antibody sequences discovered from the collaboration for all therapeutic uses in oncology and any other disease areas. The expanded collaboration also provides Exelixis with an option to obtain development and commercialization rights to certain of Invenra’s future internal pipeline programs, in exchange for an opt-in fee.

"We believe the continued success of our collaboration with the Exelixis team speaks to the quality of our unique and versatile antibody discovery platform, and we are proud to continue to support the Exelixis oncology pipeline," said Roland Green, Ph.D., Co-Founder and Chief Executive Officer of Invenra. "Additionally, we expect that the financial support provided to us by Exelixis will allow Invenra to further expand our research capabilities and advance our pipeline, including our best-in-class tumor selective Treg depleter, as we aim to harness the human immune response and optimize therapies to address a broader range of cancers."

Under the terms of the original agreement, announced by the parties on May 2, 2018, Exelixis and Invenra are currently collaborating to discover and develop mono-specific and multi-specific antibodies using Invenra’s antibody and B-Body platforms. Invenra is responsible for antibody lead discovery and generation. Exelixis leads investigational new drug (IND)-enabling studies, manufacturing, and clinical development in single-agent and combination therapy regimens, as well as future regulatory and commercialization activities. Invenra is eligible to receive payments based on the achievement of specific pre-clinical, clinical development, and regulatory milestones. Upon successful commercialization of a product, Invenra is eligible to receive milestone payments and royalties. Prior to today’s announcement, the companies expanded their collaboration on October 31, 2019 to generate additional programs.