On August 16, 2021 Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported financial results for the second quarter ended June 30, 2021 and provided a financial and business update (Press release, Protalix, AUG 16, 2021, View Source [SID1234586642]).

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"We continue to work closely with the FDA to address the issues raised in the Complete Response Letter received in April for PRX-102 for the proposed treatment of adult patients with Fabry disease," said Dror Bashan, Protalix’s President and Chief Executive Officer. "We look forward to the meeting with the FDA, which has been scheduled for September 9, 2021. In addition, we strengthened our balance sheet by entering into definitive agreements with a majority of our institutional note holders relating to exchanges by such note holders of a total of $54.65 million principal amount of our outstanding 7.50% Senior Secured Convertible Notes due 2021 for an aggregate of $28.75 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2024, $25.90 million in cash and accrued and unpaid interest through the closing date. We plan to close the exchanges as soon as practicable. This transaction will allow us the use of our cash resources to continue to realize the PRX-102 potential and advance our early-stage pipeline. We are grateful for the continued support from our team members and external partners and look forward to a productive finish to 2021."

2021 Second Quarter and Recent Business Update

Regulatory Updates

On April 28, 2021, the Company, together with its development and commercialization partner, Chiesi Farmaceutici S.p.A., or Chiesi, announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa, or PRX-102, for the proposed treatment of adult patients with Fabry disease. The CRL did not report any concerns relating to the potential safety or efficacy of PRX-102 in the submitted data package.
On August 2, 2021, the Company announced that a Type A meeting request was submitted to the FDA to discuss the CRL dated April 27, 2021 regarding the BLA for PRX-102 for the proposed treatment of adult patients with Fabry disease. The FDA has scheduled the Type A meeting for September 9, 2021.
Clinical Advancements

On June 2, 2021, the Company, together with Chiesi, announced initial top-line results from an interim analysis of the phase III BALANCE clinical trial, a study designed to evaluate the safety and efficacy of 1 mg/kg of PRX-102 dosed every two weeks compared to agalsidase beta (Fabrazyme).
Based on the interim analysis of the 12-month data generated from the BALANCE study, and in combination with previously reported positive data from the phase III BRIGHT and BRIDGE clinical trials of PRX-102, Protalix and Chiesi intend to submit a Marketing Authorization Application (MAA) to the European Medicines Agency for the review of PRX-102 for the proposed treatment of Fabry disease, subject to a positive meeting with the EMA rapporteur.
Corporate & Financial Developments

On August 12, 2021, the Company entered into definitive agreements relating to exchanges of an aggregate of $54.65 million principal amount of the Company’s outstanding 7.50% Senior Secured Convertible Notes due 2021 for an aggregate of $28.75 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2024 (the "Exchange Notes"), $25.90 million in cash and accrued and unpaid interest through the closing date. The exchanges are expected to close as soon as practicable, subject to satisfaction of certain closing conditions. At closing, we will have reduced our debt by $28.75 million and effectively extended the maturity for substantially all of the remaining debt from 2021 until 2024. The support and willingness of our note holders to extend the maturity underscores their confidence in our core technology and expanding pipeline.
On May 13, 2021, the Company and Chiesi entered into a binding term sheet pursuant to which they amended the two exclusive license and supply agreements for PRX-102 in order to provide the Company with near-term capital. Chiesi agreed to make a $10.0 million payment to the Company before the end of the second quarter in exchange for a $25.0 million reduction in a longer-term regulatory milestone payment in the Ex-U.S. Exclusive License and Supply Agreement. All other regulatory and commercial milestone payments remain unchanged. The Company and Chiesi also agreed to negotiate certain manufacturing related matters. The $10.0 million payment was received in June 2021.
On July 2, 2021, the Company entered into an ATM Sales Agreement with H.C. Wainwright & Co., LLC (the agent) whereby the Company may sell, from time-to-time, shares of its common stock through the agent up to an aggregate offering price of $20.0 million. Upon execution of the sales agreement, the Company terminated the ATM Equity Offering Sales Agreement it had previously entered into with BofA Securities, Inc.
Second Quarter 2021 Financial Highlights

The Company recorded revenues from selling goods of $3.2 million during the three months ended June 30, 2021, a decrease of $0.4 million, or 11%, compared to revenues of $3.6 million for the same period of 2020.
Revenues from license and R&D services for the three months ended June 30, 2021 were $3.2 million, a decrease of $4.1 million, or 56%, compared to $7.3 million for the same period of 2020. Revenues from license and R&D services are comprised primarily of revenues the Company recognized in connection with its license and supply agreements with Chiesi. The decrease resulted primarily from an updated costs estimation throughout the trials until completion in the amount of $4.1 million and from revenues recognized in connection with the progress of the Company’s clinical trials that have been completed during 2020.
Cost of goods sold for the three months ended June 30, 2021 was $4.7 million, an increase of $2.9 million, or 161%, compared to $1.8 million for the same period in 2020. The increase in cost of goods sold was primarily the result of certain one-time manufacturing costs incurred while preparing for the then anticipated FDA approval of the PRX-102 BLA.
Research and development expenses for the three months ended June 30, 2021 were $7.7 million, a decrease of $1.5 million, or 16%, compared to $9.2 million for the same period of 2020. The decrease was primarily the result of the completion of two out of the three phase III clinical trials of PRX-102 and reduced costs related to the BALANCE study. The Company expects research and development expenses to continue to be its primary expense as it enters into more advanced stages of preclinical and clinical trials for certain of its product candidates.
Selling, general and administrative expenses for the three months ended June 30, 2021 were $3.2 million, an increase of $1.0 million, or 45%, compared to $2.2 million for the same period in 2020. The increase resulted primarily from an increase in corporate costs related to insurance and funding.
Financial expenses, net were $2.1 million for the three months ended June 30, 2021 and $1.9 million for the three months ended June 30, 2020. The increase resulted primarily from an increase in the amortization of debt issuance costs and debt discount.
Cash, cash equivalents and short-term bank deposits were approximately $76.9 million at June 30, 2021.
Net loss for the three months ended June 30, 2021 was approximately $11.2 million, or $0.25 per share, basic and diluted, compared to a net loss of $4.2 million, or $0.13 per share, basic and diluted, for the same period in 2020.
Conference Call and Webcast Information

The Company will host a conference call today, August 16, 2021 at 8:30 am Eastern Daylight Time, to review the clinical, corporate, and financial highlights, which will also be available by webcast. To participate in the conference call, please dial the following numbers prior to the start of the call:

Conference Call Details:

The conference call will be webcast live from the Company’s website and will be available via the following links:

Webcast Details:

Company Link: View Source

Webcast Link: View Source

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

The conference call will be available for replay for two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

On August 16, 2021 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage company leveraging its innovative asset-centric business model to discover, develop and ultimately deliver impactful medicines to patients, reported financial results for the quarter ended June 30, 2021, and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, Centessa Pharmaceuticals, AUG 16, 2021, View Source [SID1234586641]).

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"Centessa has made significant progress since launch and completion of our $250 million Series A financing in January," said Saurabh Saha, M.D., Ph.D., Chief Executive Officer of Centessa. "The successful execution of our upsized initial public offering in the second quarter has substantially enhanced our resources and will support the advancement of our broad portfolio of assets across our 10 subsidiary companies. This added capital, together with the appointment of exceptional industry leaders in key functional areas across the organization, positions us for continued success. We look forward to sharing our progress, including a planned Phase 2a data update from ApcinteX in the coming weeks."

Business Updates

$379.5 Million Initial Public Offering (IPO) Successfully Completed: In the second quarter, Centessa closed its initial public offering of 16,500,000 American Depositary Shares (ADSs). In addition, the underwriters fully exercised their option to purchase an additional 2,475,000 ADSs at the IPO price of $20.00 per ADS, less underwriting discounts and commissions. The gross proceeds to Centessa from its IPO, before deducting underwriting discounts, commissions and other estimated offering expenses, totaled an aggregate of $379.5 million.

Leadership Team Strengthened by Appointment of Key Industry Executives: In May, Centessa announced the leadership appointments of Antoine Yver, M.D., M.Sc., Chief Medical Officer; Tia Bush, Chief Quality Officer; David Chao, Ph.D., Chief Administrative Officer; and Thomas Templeman, Ph.D., Chief Technology Officer. In addition, Marella Thorell was promoted to Chief Accounting Officer, and Carol Stuckley joined the Board of Directors, serving as Chairperson of the Audit Committee. Each of these leaders provides significant expertise in their respective functions and will help drive execution across the Company’s portfolio of programs.
Program Updates and Upcoming Milestones in the Second Half of 2021

Topline Phase 2a data from ApcinteX’s 24-week repeat dose study evaluating SerpinPC in hemophilia A (HA) and hemophilia B (HB) patients
SerpinPC, a first-in-class coagulation rebalancing agent, is a specific inhibitor of activated protein C (APC) being evaluated as a monthly subcutaneous therapeutic for HA and HB patients that has the potential to significantly reduce bleeding rates.
The Phase 2a has completed dosing and the Company anticipates sharing topline results in the third quarter of 2021.
All subjects who have completed the 24-week repeat dose portion of the study have elected to roll-over into a long-term open-label extension study.
Start-up activities have begun for the ACTION Study, Palladio Biosciences’ global Phase 3 registrational study of lixivaptan in autosomal dominant polycystic kidney disease (ADPKD)
Lixivaptan, a vasopressin V2 receptor antagonist, is being investigated as a potential best-in-class therapy in patients with ADPKD.
The Company anticipates dosing the first patient in the registrational ACTION Study in the first quarter of 2022.
The Company expects to report ongoing safety data from the initial subjects in the open-label ALERT Study of patients who previously discontinued JYNARQUE (tolvaptan) due to liver toxicity in the fourth quarter of 2021.
Phase 1 data from Z Factor’s study evaluating ZF874 for the treatment of alpha-1-antitrypsin deficiency (AATD)
ZF874, a small molecule folding corrector of the Z variant of alpha-1-antitrypsin, is designed to increase serum levels of alpha-1-antitrypsin and reduce liver polymer burden to treat or prevent associated lung and liver disease manifestations associated with AATD.
The Company anticipates providing an update from an ongoing 28-day repeat dose Phase 1 study in subjects with PiXZ genotype by the end of 2021.

Phase 2 trial initiation with Pega-One’s imgatuzumab in advanced cutaneous squamous cell carcinoma (CSCC)
Imgatuzumab, a non-fucosylated epidermal growth factor receptor (EGFR) targeting monoclonal antibody (mAb), is being investigated as a next-generation EGFR agent with enhanced Antibody-Dependent Cellular Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP) properties to potentially address CSCC.
The Company expects to initiate an open label, single arm, Phase 2 trial of imgatuzumab in advanced CSCC by the end of 2021.
Second Quarter 2021 Financial Results

Cash Position: Cash and cash equivalents were $613.8 million as of June 30, 2021, compared to $7.2 million for the Centessa Predecessor Group (comprised of Z Factor Limited, LockBody Therapeutics Ltd, and Morphogen-IX Limited, three of the Centessa Subsidiaries acquired in January 2021) as of December 31, 2020. The increase in cash resulted from $344.1 million in net proceeds from the Company’s initial public offering completed in June 2021, and the full exercise of the underwriters’ option to purchase additional shares, $241.6 million in net proceeds from the Company’s Series A financing completed in January 2021, and cash contributed upon the acquisition of the additional Centessa Subsidiaries, net of cash used during the period. Based on the current, non-risk-adjusted operating plan, the Company expects the cash and cash equivalents as of June 30, 2021, to fund its operations until the end of 2023.

Research & Development (R&D) Expenses: R&D expenses for the Company for the three months ended June 30, 2021, were $18.1 million, compared to $1.9 million for the Centessa Predecessor Group during the three months ended June 30, 2020. The $16.2 million increase is primarily attributable to the growth in the portfolio of product candidates under development following the acquisition of the Centessa Subsidiaries in January 2021, as well as increased spending in the Centessa Predecessor Group.

General & Administrative (G&A) Expenses: G&A expenses for the Company for the three months ended June 30, 2021. were $11.8 million, compared to $0.3 million for the Centessa Predecessor Group during the three months ended June 30, 2020. The $11.5 million increase is primarily attributable to public company costs, the operating costs of Centessa Pharmaceuticals plc and Centessa Pharmaceutical Inc. including professional fees, personnel costs and share-based compensation expense, and the increase in operating costs resulting from the acquired Centessa Subsidiaries.

Change in Fair Value of Contingent Value Rights (CVR): The Company recognized a charge of $11.3 million for the three months ended June 30, 2021, compared to $0.0 million for the three months ended June 30, 2020. The CVR, issued at the time of the acquisition, represents future payments (that will be satisfied through the issuance of Centessa shares) that are contingent upon the dosing of the first patient in a registrational Phase 3 study of Palladio Biosciences’ lixivaptan. The fair value is based on the cumulative probability of achieving this milestone, which increased during the period resulting in the charge.

Net Loss: Net Loss attributable to common stockholders for the quarter ended June 30, 2021, was $41.5 million, or $0.65 per share, compared to a net loss of $2.2 million for the Centessa Predecessor Group for the quarter ended June 30, 2020.

On August 16, 2021 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the second quarter ended June 30, 2021, and provided a corporate update (Press release, VBL Therapeutics, AUG 16, 2021, View Source [SID1234586640]).

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"With $57.2 million in cash that is projected to fund our operations until year-end 2023, we are excited to advance our OVAL study, with PFS as its additional primary endpoint, towards clinical readout in the second half of 2022," said Dror Harats, M.D., Chief Executive Officer of VBL. "Following the FDA request for additional technical production data on VB-111, we prepared and submitted the requested information in early August and are currently awaiting agency guidance. With several important milestones anticipated through the rest of 2021, we look forward to keeping investors apprised of our progress."

Second Quarter and Recent Corporate Highlights

VB-111

●In June, VBL presented an update on the progress of the OVAL Phase 3 registration-enabling study of VB-111 in ovarian cancer at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The presentation announced an amendment to the primary endpoint in the OVAL study to include a second, separate primary endpoint of PFS in addition to the original primary endpoint of overall survival (OS).
●As part of VBL’s discussion with the Chemistry, Manufacturing, and Controls (CMC) group of the FDA on VB-111 production, it was agreed that VBL would provide additional documentation on new batches to be used in the OVAL study. VBL prepared and submitted the requested documentation to the FDA in early August and is currently awaiting agency guidance.
●As a precautionary step to preserve supply of FDA-approved batches, in June, VBL voluntarily paused enrollment of new U.S. patients in the OVAL study. Existing patients enrolled in the United States continue on protocol and enrollment continues in Europe, Israel, and in recently opened sites in Japan.
Corporate

In April, VBL closed a public offering raising net proceeds of $26.4 million. The Company’s cash position is expected to fund operations until year-end 2023, through the readout from the OVAL study and potential BLA submission for VB-111 in ovarian cancer.
●In July, VBL announced the appointments of Alison Finger and Michael Rice to its Board of Directors.
●In July, the planned succession for Chairmanship of VBL’s Board of Directors was completed. Marc Kozin, who joined the Board as Vice Chairman in October 2020 was appointed Chairman. Former Chairman, Dr. Bennett Shapiro, stepped down as Chairman but will remain a Director.
Financial Results for the Second Quarter 2021

●As of June 30, 2021, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $57.2 million. In April 2021, VBL raised net proceeds of $26.4 million in a public offering of shares and pre-funded warrants (including partial exercise of the underwriters’ overallotment option). VBL expects that its cash, cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements until year-end 2023.
●Revenues for the second quarter 2021 were $188 thousand, as compared to $158 thousand in the comparable period in 2020.
●R&D expenses, net, were $6.6 million for the second quarter compared to $4.7 million in the comparable period in 2020. This increase is due to the clinical development activity of VB-111 for ovarian cancer, in addition to the advancement of VB-601 toward Investigational New Drug Application (IND) submission.
G&A expenses were $1.5 million for the second quarter compared to $1.3 million in the comparable period in 2020.
●VBL reported a net loss for the quarter ended June 30, 2021, of $8.0 million, or ($0.12) per basic share, compared to a net loss of $5.8 million, or ($0.14) per basic share, in the comparable period in 2020.

The live webcast will be available online and may be accessed from the "Events and Presentation" page of VBL’s website. A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

On August 16, 2021 Incyte (NASDAQ:INCY) and InnoCare (HKEX: 09969) reported that Incyte and a subsidiary of InnoCare have entered into a collaboration and license agreement for the development and commercialization of tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in Greater China (Press release, Incyte, AUG 16, 2021, View Source [SID1234586639]).

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Under the terms of the agreement, InnoCare will pay Incyte US$35 million up front, and Incyte is eligible to receive up to an additional US$82.5 million in potential development, regulatory and commercial milestones, as well as tiered royalties.

InnoCare will receive the rights to develop and exclusively commercialize tafasitamab in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan.

"The collaboration with InnoCare allows us to accelerate the expansion of our partnered portfolio in China," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We believe InnoCare will be an excellent partner to accelerate the development of tafasitamab, and if approved, help bring this innovative therapy to patients and healthcare providers in Greater China."　

"We are honored and excited to partner with Incyte, and are committed to making tafasitamab, an FDA-approved treatment, available to eligible patients in Greater China, upon approval. The strategic collaboration with Incyte will not only enhance our strength in the field of hematology and oncology, but also offer us good opportunity to explore the potential clinical benefit of our BTK inhibitor orelabrutinib in combination with tafasitamab," said Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare. "In addition, we believe that tafasitamab, an innovative CD19 antibody, is critical to solidifying our long-term strategy to strengthen our large molecule capabilities and to enhance combinational therapies with our existing pipelines."

The transaction is effective immediately upon the execution of the collaboration and license agreement.

About Tafasitamab

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

In June 2021, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT). The CHMP opinion is currently being reviewed by the European Commission, which has the authority to grant marketing authorization for medicinal products in the European Union (EU).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

Monjuvi is a registered trademark of MorphoSys AG.

XmAb is a registered trademark of Xencor, Inc.

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.