On August 12, 2021 MediciNova, Inc., (Nasdaq: MNOV, JASDAQ:4875), a biopharmaceutical company developing small-molecule therapeutics, reported financial results for the second quarter ended June 30, 2021 and provided a business update including results of a safety review from the ongoing Phase 2 trial of MN-166 (ibudilast) in glioblastoma and results from the completed Phase 2 trial of MN-001 (tipelukast) in idiopathic pulmonary fibrosis (IPF) (Press release, MediciNova, AUG 12, 2021, View Source [SID1234586562]).

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"Over the past quarter, we have continued to advance our novel anti-inflammatory candidates across all stages of development. Through our BARDA partnership, we initiated the first animal model study for MN-166 (ibudilast) as a treatment for chlorine gas-induced lung injury and reached agreement on the second animal model study. We received a notice of allowance for a pending patent application which covers MN-166 (ibudilast) for the treatment of ophthalmic disease, showcasing its broad applicability. In addition, our legacy programs remain strong, with positive results from a Phase 2 trial in alcohol use disorder recently published in Nature’s Translational Psychiatry, which serves as further validation for the underlying mechanism of MN-166 (ibudilast) and its potential to drive powerful neurological results. To that end, we continue to enroll patients in our ongoing Phase 3 trial in ALS, and the European Patent Office recently issued a notice of intention to grant for a pending patent application which covers the combination of MN-166 (ibudilast) and riluzole for the treatment of ALS. In collaboration with our ALS investigators Dr. Brooks and Dr. Oskarsson, we recently hosted a webinar for ALS patients and community members highlighting encouraging data reported to-date and the potential of MN-166 (ibudilast) to bridge a long-standing treatment gap without compromising safety," commented Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova. "Turning to our MN-001 (tipelukast) programs, although our Phase 2 trial in IPF did not demonstrate a clear clinical effect on most of the outcome measures, there were fewer worsening IPF events in the MN-001 group and the drug did demonstrate an effect on reducing LOXL2, a biomarker for IPF. We are currently working with collaborators to finalize the protocol for our next planned Phase 2 trial of MN-001 in NASH. Across our programs, we continue to operate a highly cash-efficient business model and believe we are well-positioned for a successful second half."

Clinical Highlights

MN-166 (ibudilast)

New patents cover MN-166 (ibudilast) for treatment of ophthalmic disease (U.S.) and ALS (Europe): In July 2021, the Company announced that it received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the treatment of ophthalmic disease, which, once issued, is expected to expire no earlier than October 2039. The Company also received a Notice of Intention to Grant from the European Patent Office for a pending patent application which covers the combination of MN-166 (ibudilast) and riluzole for the treatment of amyotrophic lateral sclerosis (ALS) which is expected to expire no earlier than November 2035. The Company previously announced results from its Phase 2 ALS trial which showed a higher rate of responders for the MN-166 (ibudilast) plus riluzole group as compared to the riluzole-only group.

Positive results from Phase 2 trial in AUD published in Nature journal: In June 2021, the Company announced that positive results from a Phase 2 trial of MN-166 (ibudilast) in alcohol use disorder (AUD) were published in Nature’s Translational Psychiatry. The study was a randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the effect of 14 days of MN-166 (ibudilast) treatment on mood, heavy drinking, and neural reward signals in 52 individuals with AUD. Key results reported in the publication showed that MN-166 (ibudilast) did not have a significant effect on negative mood but it reduced the odds of heavy drinking across time by 45% (p=0.04) and reduced alcohol craving on non-drinking days (p=0.02).

Initiated preclinical animal study under partnership with BARDA: In June 2021, the Company announced it initiated a sheep study and reached agreement to conduct a mouse study under its partnership with the Biomedical Advanced Research and Development Authority (BARDA) to investigate the efficacy of MN-166 (ibudilast) as a potential medical countermeasure (MCM) against chlorine gas-induced lung damage such as acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). The sheep study will investigate MN-166 (ibudilast) in an ovine model of chlorine-induced acute lung injury, and will evaluate pulmonary function, lung injury and edema formation, cardiopulmonary hemodynamics, and systemic vascular permeability. The murine model will evaluate survival, clinical outcomes, body weights, lung weights, and upper respiratory tract histopathology after exposing mice to chlorine gas and treating them with MN-166 (ibudilast) or control.

Continued enrollment of Phase 3 trial in ALS: The Company continues to enroll patients in the Phase 3 clinical trial, COMBAT-ALS, which is evaluating MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS). The Phase 3 trial is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of MN-166 (ibudilast) in ALS patients after 12 months of treatment followed by a 6-month open-label extension phase. The primary endpoint is change from baseline in ALSFRS-R score at month 12 and survival time. To provide further education on the potential of MN-166 (ibudilast) to treat patients with ALS, the Company hosted an informational webinar in June 2021. The webinar, which included presentations from Dr. Björn Oskarsson, lead clinical investigator of COMBAT-ALS, and Dr. Benjamin Rix Brooks, who led the first clinical study of MN-166 (ibudilast) in patients with ALS, provided an overview of the drug’s mechanism of action, the COMBAT-ALS study design, and findings from the Phase 2 trial in ALS. A replay of the webinar can be viewed here.

Partnering process ongoing for progressive MS program: The Company is engaged in a process with potential partners regarding MN-166 (ibudilast) that could lead to funding for a Phase 3 trial in progressive multiple sclerosis (PMS). Based on encouraging Phase 2b data, especially among secondary progressive MS (SPMS) patients without relapse, and discussions with FDA, the Phase 3 trial plan is to enroll SPMS patients without relapse with 3-month confirmed disability progression as the primary endpoint.

Completed Glioblastoma safety review: The Company has completed a safety review of Part 1 of the Phase 2 trial of MN-166 (ibudilast) in combination with temozolomide, which enrolled 15 subjects with recurrent glioblastoma. This is an open-label clinical trial at Dana-Farber Cancer Institute which includes a dose-escalation portion (Part 1) followed by a fixed-dose treatment period (Part 2). There were no concerning safety signals observed in Part 1 and there were no serious adverse events related to MN-166 (ibudilast). 5 out of 15 subjects completed cycle 6 without disease progression, i.e. 33% of subjects were progression-free at 6 months.

Enrolling subjects in COVID-19 ARDS Phase 2 trial: The Company has completed 75% of planned enrollment in the Phase 2 trial of MN-166 (ibudilast) in COVID-19 at risk for ARDS. This is a randomized, double-blind, placebo-controlled study in hospitalized COVID-19 subjects at risk for developing ARDS and receiving standard of care including anticoagulation. The primary endpoints include the proportion of subjects free from respiratory failure at Day 7, mean change from baseline in clinical status using the NIAID 8-point ordinal scale at Day 7, the percentage of patients with improvement in clinical status at Day 7, and mean change in cytokine levels from baseline to Day 7.
MN-001 (tipelukast)

Phase 2 trial results in IPF: The Phase 2 trial of MN-001 (tipelukast) in idiopathic pulmonary fibrosis (IPF) completed enrollment of 15 subjects including 10 subjects in the MN-001 (tipelukast) group and 5 subjects in the placebo group. This Phase 2 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of MN-001 (tipelukast) in IPF over a 26-week treatment period. Although there were no clinically meaningful trends in favor of MN-001 (tipelukast) for the majority of the clinical outcome measures in this small study, there were no worsening IPF events (acute IPF exacerbation or hospitalization due to respiratory symptoms) in the MN-001 (tipelukast) group compared to one worsening IPF event in the placebo group. MN-001 (tipelukast) demonstrated a substantial reduction in LOXL2, a biomarker for IPF, whereas LOXL2 increased in the placebo group. MN-001 (tipelukast) was safe and well tolerated.

Preparing for second Phase 2 trial in NASH: Following the early completion of its Phase 2 trial evaluating MN-001 (tipelukast) in nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD) due to positive interim data, the Company is now working to finalize a protocol for a larger Phase 2 trial in NASH. In the first Phase 2 trial, MN-001 (tipelukast) demonstrated a statistically significant reduction in the primary endpoint of mean serum triglycerides (p=.02). The Company will provide further updates upon initiation of the next trial.
Second Quarter 2021 Financial Results

Cash Position: As of June 30, 2021, cash and cash equivalents were $77.8 million, as compared to cash and cash equivalents of $60.4 million as of June 30, 2020. This increase was primarily due to approximately $20 million received in a private placement transaction which closed in January 2021. The Company expects current cash and cash equivalents to fund operations at least through the end of 2022.

Research, Development and Patents Expenses: R&D and patents expenses were $2.5 million for the three months ended June 30, 2021, compared to $2.2 million for the three months ended June 30, 2020. The increase of $0.3 million was primarily due to higher clinical trial expenses from the ongoing clinical trial of MN-166 (ibudilast) in ALS.

General and Administrative Expenses: G&A expenses were $1.8 million for the three months ended June 30, 2021, compared to $2.3 million for the three months ended June 30, 2020. The decrease of $0.5 million was primarily due to lower stock compensation expense for performance-based stock options resulting from a decrease in our stock price and decreased consultant fees.

Net Loss: Net loss was $4.3 million for the three months ended June 30, 2021, or ($0.09) per basic and diluted share, as compared to a net loss of $4.5 million for the three months ended June 30, 2020, or ($0.10) per basic and diluted share.

On August 12, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that the company has executed an exclusive license agreement with Mayo Clinic for a novel technology that may be able to transform the administration of chimeric antigen receptor engineered T cell ("CAR T") therapies and potentially be used as an off-the-shelf therapy.

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The technology, developed by Larry R. Pease, Ph.D., principal investigator and former director of the Center for Immunology and Immune Therapies at Mayo Clinic, is a new platform to administer CAR T therapy using a two-step approach. First, a peptide is administered to the patient to drive the proliferation of the patient’s resident T cells. This is followed by the administration of a viral CAR construct directly into the lymph nodes of the patient. In turn, the viral construct infects the activated T cells and effectively forms CAR T cells in vivo in the patient. Successful implementation may lead to an off-the-shelf product with no need to isolate and expand patient T cells ex vivo.

"We are excited by the possibilities that this novel technology has to offer given our ongoing development of CAR T cell therapies in hematologic and solid tumor cancers," said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang. "The potential use of this technology to facilitate how these treatments are delivered to patients can lead to earlier treatment post diagnosis, and using an off-the-shelf therapy may reduce the cost of care, all of which would help bring more innovative treatments to a broader base of patients in need."

Preclinical proof-of-concept has been established and the ongoing development of this technology will take place at Mayo Clinic.

"The immune cells are activated in vivo using the natural methods employed by the body to deal with infection rather than the artificial activation used to manufacture traditional CAR T cells ex vivo," said Dr. Pease. "This could potentially reduce the substantial toxicities that are characteristic of traditional CAR T therapy."

Mustang plans to file an Investigational New Drug ("IND") application for a multicenter Phase 1 clinical trial once a lead construct has been identified.

Mayo Clinic and Dr. Pease have financial interest in the technology referenced in this announcement. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

On August 12, 2021 KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, reported its financial results for the second quarter ended June 30, 2021 (Press release, KemPharm, AUG 12, 2021, View Source [SID1234586560]).

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"The second quarter of 2021 and recent weeks continued what has been a period of unprecedented growth and opportunity for KemPharm, highlighted by the U.S. commercial launch of AZSTARYS," said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. "AZSTARYS, previously KP415, was conceived based on the vision that our LAT technology was well-suited to developing a prodrug of d-methylphenidate (d-MPH) that could address key patient and prescriber demands that were underserved by ADHD products on the market at the time. Today that vision is a reality, and as the commercial rollout of AZSTARYS by Corium continues, ADHD patients and their caregivers will have the opportunity to benefit from the unique attributes inherent only to AZSTARYS. It is a truly exciting time for KemPharm and, we believe, for the millions of patients seeking a better treatment option for their ADHD symptoms."

Dr. Mickle continued, "In addition to the commercial launch of AZSTARYS, the second quarter was highlighted by the classification of serdexmethylphenidate (SDX) as a Schedule IV controlled substance by the Drug Enforcement Administration (DEA). SDX comprises 70% of the active pharmaceutical ingredient (API) in AZSTARYS, which is classified as a Schedule II controlled substance. Importantly, the classification of SDX as a Schedule IV controlled substance and the unique properties of SDX, we believe, provide us the opportunity to develop an SDX-based product candidate or candidates that could potentially address disease indications for which no therapy currently exists. We have recently initiated a clinical trial with SDX, and in the coming months we expect to report clinical data together with an SDX development plan. Based on the results of the clinical trial, this plan may involve one or more potential product candidates that have the potential to generate substantial near-term and longer-range value for the Company."

Q2 2021 Financial Results:

For Q2 2021, KemPharm reported revenue of $12.0 million, which was comprised of a $10.0 million milestone payment earned upon the DEA scheduling of SDX, and service fee revenue of $2.0 million, as compared to Q2 2020 revenue of $6.9 million, which was derived primarily from a $5.0 million milestone payment earned upon U.S. Food and Drug Administration (FDA) acceptance of the AZSTARYS New Drug Application (NDA) and service fee revenue. The service fee revenue is being earned under consulting arrangements which contractually continue through March 2022.

KemPharm’s net income for Q2 2021 was $6.2 million, or $0.18 per basic share. Recognition of a non-cash deemed dividend of $16.9 million related to the warrant exercise inducement transaction in June 2021 led to a ($10.7) million net loss attributable to common stockholders and diluted shares, or ($0.40) per basic share attributable to common stockholders and diluted share for Q2 2021, compared to net income of $0.9 million, or $0.21 per basic and diluted share for the same period in 2020. Net income for Q2 2021 was driven primarily by operating income of $5.8 million and a non-cash gain on extinguishment of debt of $0.8 million related to the forgiveness of the PPP loan, partially offset by non-cash fair value adjustment loss of $0.4 million related to derivative and warrant liability. The net operating income of $5.8 million for Q2 2021 was a change of $3.2 million compared to net operating income of $2.6 million in the same period in 2020, which was primarily due to an increase in revenue of $5.1 million and a net increase in operating expenses of $1.8 million period over period. The net increase in operating expenses was primarily due to increases in research and development expense of $0.9 million, general and administrative expenses of $0.6 million and royalty and direct contract acquisition costs of $0.4 million.

As of June 30, 2021, total cash and cash equivalents was $132.3 million, which was an increase of $56.4 million compared to March 31, 2021.

As of June 30, 2021, total shares of common stock outstanding was 34,977,923 shares, and fully diluted common shares outstanding was 46,546,998 shares, which included 4,584,889 shares issuable upon exercise of warrants. In addition, no preferred stock is outstanding as of June 30, 2021.

Conference Call Information:

KemPharm will host a conference call and live audio webcast on Thursday, August 12, 2021, at 4:30 p.m. ET, to discuss its corporate and financial results for Q2 2021.

Telephone Access: To access the conference call telephonically, interested participants and investors are required to register via the following online form: View Source

Once registered, all individuals will be provided with participant dial-in numbers, a passcode and a registrant ID, which can then be used to access the conference call.

Participants may register at any time. It is recommended that the registration process be completed at least 15 minutes prior to the start of the call.
Webcast Access: The live audio webcast with slide presentation will be accessible via the Investor Relations section of KemPharm’s website, View Source An archive of the webcast and presentation will be available for 90 days beginning at approximately 5:30 p.m. ET, on August 12, 2021.
About AZSTARYS:

AZSTARYS is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. AZSTARYS consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH.

The complete approved prescribing information for AZSTARYS may be downloaded in PDF format here:
View Source

On August 12, 2021 Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the second quarter ending June 30, 2021 and provided a business update (Press release, Savara, AUG 12, 2021, View Source [SID1234586559]).

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"Over the last 9 months we streamlined our portfolio, reduced and restructured the organization, and significantly strengthened the balance sheet so that we could focus solely on advancing the pivotal Phase 3 IMPALA 2 clinical trial," said Matt Pauls, Chair and Chief Executive Officer, Savara. "With the first patient dosed just over one month ago, numerous sites now activated, and patients dosed the trial is progressing as planned and our timelines remain on track. Importantly, we continue to leverage key learnings from the first IMPALA trial so that we can execute IMPALA 2 with the highest efficiency and quality."

Second Quarter Financial Results (Unaudited)
Savara’s net loss attributable to common stockholders for the three months ended June 30, 2021, was $10.9 million, or $(0.07) per share, compared with a net loss attributable to common stockholders of $9.4 million, or $(0.16) per share, for the three months ended June 30, 2020.

Research and development expenses increased by $1.2 million, or 19.3%, to $7.3 million for the three months ended June 30, 2021, from $6.1 million for the three months ended June 30, 2020. The increase was largely attributable to a $3.6 million increase in costs associated with advancement of the molgramostim in aPAP development program and was partially offset by a decrease in Chemistry Manufacturing and Controls (CMC) and clinical operations activities associated with the wind down of the vancomycin hydrochloride inhalation powder development program.

General and administrative expenses were consistent with a slight increase of approximately 1.2%, to $3.2 million for the three months ended June 30, 2021, from $3.1 million for the three months ended June 30, 2020.

As of June 30, 2021, Savara had cash, cash equivalents, and short-term investments of approximately $181 million and debt of approximately $25 million.

On August 12, 2021 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results and provided a corporate update for the second quarter ended June 30, 2021 (Press release, Tempest Therapeutics, AUG 12, 2021, View Source [SID1234586558]).

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"The second quarter of 2021 was an exciting period as Tempest became a public company and the team drove progress in all three of our novel programs," said Steve Brady, chief executive officer of Tempest. "We look forward to the planned opening of the TPST-1120 randomized study in first line hepatocellular carcinoma in collaboration with Roche and the first combination study of TPST-1495, and remain focused on delivering potentially value-creating milestones over the next year and beyond."

Recent Highlights

Public Company Transition: successfully closed merger and concurrent PIPE financing, allowing Tempest to become a public company listed on the Nasdaq Capital Market, and extending runway into 2023 through multiple potential catalysts.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): continued enrollment in monotherapy dose optimization towards recommended Phase 2 dose ("RP2D").
TPST-1120 (clinical PPARα antagonist): (i) completed monotherapy dose escalation and selected 600mg BID as RP2D; (ii) observed stable disease ("SD") in 50% of the monotherapy-treated patients, including prolonged SD in patients with refractory cholangiocarcinoma; and (iii) observed a deep, confirmed partial response in a patient with checkpoint inhibitor-refractory fourth line renal cell carcinoma in the combination study with nivolumab (->60% by RECIST 1.1, durable through 4 scans and ongoing).
TREX-1 Inhibitor (preclinical, tumor-selective STING pathway activator): (i) progressed lead series to picomolar IC50 potency in biochemical assays; and (ii) demonstrated significant proof of concept in a mouse tumor model with systemic delivery of a lead series molecule.
Board of Directors: Christine Pellizzari, J.D., Geoff Nichol, M.B., Ch.B., M.B.A., and Ronit Simantov, M.D., joined the Board of Directors, bringing deeper financial, legal, and clinical development expertise to Tempest.
Planned Near-Term Milestones

TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; (ii) commencement of a combination study with an anti-PD-1 checkpoint inhibitor expected prior to the end of 2021; and (iii) commencement of monotherapy expansion in targeted indications and biomarker-selected patient populations expected in the first half of 2022.
TPST-1120 (clinical PPARα antagonist): (i) identification of RP2D of TPST-1120 in combination with nivolumab expected prior to the end of 2021; and (ii) commencement of first line randomized Phase 1b/2 study in hepatocellular carcinoma patients, under a collaboration with F. Hoffman La Roche, expected within the third quarter.
TREX-1 Inhibitor (preclinical tumor-selective STING pathway activator): planned selection of development candidate in the first half of 2022.
Financial Results

Second Quarter

Tempest ended the second quarter of 2021 with $68.5 million in cash and cash equivalents and short-term restricted cash, compared to $18.8 million in December 31, 2020. The increase was primarily due to the merger and concurrent PIPE, which closed in June 2021.
Net loss and net loss per share for the second quarter of 2021 were $7.1 million and $7.63, respectively, compared to $5.2 million and $11.42, respectively, for the second quarter of 2020. The increase was primarily due to an increase in compensation expense and professional fees associated with the merger.
Research and development expenses for the second quarter of 2021 were $4.2 million, compared to $4.1 million for the same period in 2020. The $0.1 million increase was primarily attributable to increased compensation expenses.
For the three months ended June 30, 2021, general and administrative expenses were $2.6 million compared to $1.1 million for the same period in 2020. The increase was primarily due to growth in compensation expense and professional fees associated with the merger.
Year-to-Date

Net cash used in operations for the six months ended June 30, 2021 was $6.2 million.
Net loss and net loss per share for the six months ended June 30, 2021 were $12.4 million and $17.30, respectively, compared to $9.5 million and $21.28, respectively, for the same period in 2020.
Research and development expenses for the six months ended June 30, 2021 were $7.8 million compared to $7.1 million for the same period in 2020. The $0.7 million increase was primarily due to increased compensation expenses and consulting services.
For the six months ended June 30, 2021, general and administrative expenses were $4.1 million compared to $2.4 million for the same period in 2020.